Adding community health workers (CHW) to a primary care setting was linked with improved type 2 diabetes management in a safety-net population, new research indicates.

The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.

The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.

Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.

Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”

Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.

The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.

A1c drops with more progress in the intervention

The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.

Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.

Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.

Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
 

Advantages of community workers

In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.

The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.

“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.

Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.

He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.

“They understand the culture, not just the language,” he said. “They have the trust of the community.”

It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.

The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.

“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.

Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
 

Other study strengths

The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.

The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.

“It becomes an alliance between the community health worker and the patient,” he continued.

Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”

The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.

The study authors and Dr. Correa reported no relevant financial relationships.

Adding community health workers (CHW) to a primary care setting was linked with improved type 2 diabetes management in a safety-net population, new research indicates.

The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.

The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.

Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.

Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”

Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.

The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.

A1c drops with more progress in the intervention

The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.

Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.

Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.

Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
 

Advantages of community workers

In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.

The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.

“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.

Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.

He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.

“They understand the culture, not just the language,” he said. “They have the trust of the community.”

It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.

The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.

“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.

Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
 

Other study strengths

The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.

The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.

“It becomes an alliance between the community health worker and the patient,” he continued.

Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”

The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.

The study authors and Dr. Correa reported no relevant financial relationships.

Adding community health workers (CHW) to a primary care setting was linked with improved type 2 diabetes management in a safety-net population, new research indicates.

The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.

The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.

Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.

Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”

Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.

The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.

A1c drops with more progress in the intervention

The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.

Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.

Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.

Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
 

Advantages of community workers

In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.

The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.

“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.

Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.

He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.

“They understand the culture, not just the language,” he said. “They have the trust of the community.”

It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.

The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.

“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.

Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
 

Other study strengths

The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.

The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.

“It becomes an alliance between the community health worker and the patient,” he continued.

Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”

The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.

The study authors and Dr. Correa reported no relevant financial relationships.

In 2019, diabetes mellitus (DM) was the seventh leading cause of death in the United States, and currently, about 11% of the American population has a DM diagnosis.¹ Most have a diagnosis of type 2 diabetes (T2DM), which has a strong genetic predisposition, and the risk of developing T2DM increases with age, obesity, and lack of physical activity.^1,2 Nearly one-quarter of veterans have a diagnosis of DM, and DM is the leading cause of comorbidities, such as blindness, end-stage renal disease, and amputation for patients receiving care from the Veterans Health Administration (VHA).² The elevated incidence of DM in the veteran population is attributed to a variety of factors, including exposure to herbicides, such as Agent Orange, advanced age, increased risk of obesity, and limited access to high-quality food.³

After diagnosis, both the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) emphasize the appropriate use of lifestyle management and pharmacologic therapy for DM care. The use of pharmacologic agents (oral medications, insulin, or noninsulin injectables) is often determined by efficacy, cost, potential adverse effects (AEs), and patient factors and comorbidities.^4,5

The initial recommendation for pharmacologic treatment for T2DM differs slightly between expert guidelines. The ADA and AACE/ACE recommend any of the following as initial monotherapy, listed in order to represent a hierarchy of usage: metformin, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase-4 (DPP-4) inhibitors, with the first 3 agents carrying the strongest recommendations.^4,5 For patients with established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure, it is recommended to start a long-acting GLP-1 RA or SGLT-2 inhibitor. For patients with T2DM and hemoglobin A_1c (HbA_1c) between 7.5% and 9.0% at diagnosis, the AACE/ACE recommend initiation of dual therapy using metformin alongside another first-line agent and recommend the addition of another antidiabetic agent if glycemic goals are not met after regular follow-up. AACE/ACE recommend the consideration of insulin therapy in symptomatic patients with HbA_1c > 9.0%.⁵ In contrast, the ADA recommends metformin as first-line therapy for all patients with T2DM and recommends dual therapy using metformin and another preferred agent (selection based on comorbidities) when HbA_1c is 1.5% to 2% above target. The ADA recommends the consideration of insulin with HbA_1c > 10% or with evidence of ongoing catabolism or symptoms of hyperglycemia.⁴ There are several reasons why insulin may be initiated prior to GLP-1 RAs, including profound hyperglycemia at time of diagnosis or implementation of insulin agents prior to commercial availability of GLP-1 RA.

GLP-1 RAs are analogs of the hormone incretin, which increases glucose-dependent insulin secretion, decreases postprandial glucagon secretion, increases satiety, and slows gastric emptying.^6,7 When used in combination with noninsulin agents, GLP-1 RAs have demonstrated HbA_1c reductions of 0.5% to 1.5%.⁸ The use of GLP-1 RAs with basal insulin also has been studied extensively.^6,8-10 When the combination of GLP-1 RAs and basal insulin was compared with basal/bolus insulin regimens, the use of the GLP-1 RAs resulted in lower HbA_1c levels and lower incidence of hypoglycemia.^6,9 Data have demonstrated the complementary mechanisms of using basal insulin and GLP 1 RAs in decreasing HbA_1c levels, insulin requirements, and weight compared with using basal insulin monotherapy and basal/bolus combinations.^6,9-13 Moreover, 3 GLP-1 RA medications currently on the market (liraglutide, dulaglutide, and semaglutide) have displayed cardiovascular and renal benefits, further supporting the use of these medications.^2,5

Despite these benefits, GLP-1 RAs may have bothersome AEs and are associated with a high cost.⁶ In addition, some studies have found that as the length of therapy increases, the positive effects of these agents may diminish.^9,11 In one study, which looked at the impact of the addition of exenatide to patients taking basal or basal/bolus insulin regimens, mean changes in weight were −2.4 kg at 0 to 6 months, −4.3 kg at 6 to 12 months, −6.2 kg at 12 to 18 months, and −5.5 kg at 18 to 27 months. After 18 months, an increase in weight was observed, but the increase remained lower than baseline.¹¹ Another study, conducted over 12 months, found no significant decrease in weight or total daily dose (TDD) of insulin when exenatide or liraglutide were added to various insulin regimens (basal or basal/bolus).¹³ To date, minimal published data exist regarding the addition of newer GLP-1 RAs and the long-term use of these agents beyond 12 months in patients taking basal/bolus insulin regimens. The primary goal of this study was to evaluate the effect of adding GLP-1 RAs to basal/bolus insulin regimens over a 24-month period.

Methods

This study was a retrospective, electronic health record review of all patients on basal and bolus insulin regimens who received additional therapy with a GLP-1 RA at Veteran Health Indiana in Indianapolis from September 1, 2015, to June 30, 2019. Patients meeting inclusion criteria served as their own control. The primary outcome was change in HbA_1c at 3, 6, 12, 18, and 24 months after initiation of the GLP-1 RA. Secondary outcomes included change in weight and TDD of insulin at 3, 6, 12, 18, and 24 months after the initiation of the GLP-1 RAs and incidence of patient-reported or laboratory-confirmed hypoglycemia and other AEs.

Patients were included if they were aged ≥ 18 years with a diagnosis of T2DM, had concomitant prescriptions for both a basal insulin (glargine, detemir, or NPH) and a bolus insulin (aspart, lispro, or regular) before receiving add-on therapy with a GLP-1 RA (exenatide, liraglutide, albiglutide, lixisenatide, dulaglutide, or semaglutide) from September 1, 2015, to June 30, 2019, and had baseline and subsequent Hb A_1c measurements available in the electronic health record. Patients were excluded if they had a diagnosis of T1DM, were followed by an outside clinician for DM care, or if the GLP-1 RA was discontinued before subsequent HbA_1c measurement. The study protocol was approved by the Research and Development Office of Veteran Health Indiana, and the project was deemed exempt from review by the Indiana University Institutional Review Board due to the retrospective nature of the study.

Data analysis was performed using Excel. Change from baseline for each interval was computed, and 1 sample t tests (2-tailed) compared change from baseline to no change. Due to the disparity in the number of patients with data available at each of the time intervals, a mean plot was presented for each group of patients within each interval, allowing mean changes in individual groups to be observed over time.

Results

One hundred twenty-three subjects met inclusion criteria; 16 patients were excluded due to GLP-1 RA discontinuation before follow-up measurement of HbA_1c; 14 were excluded due to patients being managed by a clinician outside of the facility; 1 patient was excluded for lack of documentation regarding baseline and subsequent insulin doses. Ninety-two patient charts were reviewed. Participants had a mean age of 64 years, 95% were male, and 89% were White. Mean baseline Hb A_1c was 9.2%, mean body mass index was 38.9, and the mean TDD of insulin was 184 units. Mean duration of DM was 10 years, and mean use of basal/bolus insulin regimen was 6.1 years. Most participants (91%) used an insulin regimen containing insulin glargine and insulin aspart; the remaining participants used insulin detemir and insulin aspart. Semaglutide and liraglutide were the most commonly used GLP-1 RAs (44% and 39%, respectively) (Table 1).

Since some patients switched between GLP-1 RAs throughout the study and there was variation in timing of laboratory and clinic follow-up, a different number of patient charts were available for review at each period (Table 2). Glycemic control was significantly improved at all time points when compared with baseline, but over time the benefit declined. The mean change in HbA_1c was −1.1% (95% CI, −1.3 to −0.8; P < .001) at 3 months; −1.0% (95% CI, −1.3 to −0.7; P < .001) at 6 months; −0.9% (95% CI, −1.3 to −0.6; P < .001) at 12 months; −0.9% (95% CI −1.4 to −0.3; P = .002) at 18 months; and −0.7% (95% CI, −1.4 to 0.1; P = .07) at 24 months (Figure 1). Mean weight decreased from baseline −2.7 kg (95% CI, −3.7 to −1.6; P < .001); −4.4 kg (95% CI −5.7 to −3.2; P < .001) at 6 months; −3.9 kg (95% CI −6.0 to −1.9; P < .001) at 12 months; −4.7 kg (95% CI −6.7 to −2.6; P < .001) at 18 months; and −2.8 kg (95% CI, −5.9 to 0.3; P = .07) at 24 months (Figure 2). Mean TDD decreased at 3 months −12 units (95% CI, −19 to −5; P < .001); −18 units (95% CI, −27 to −9; P < .001) at 6 months; −14 units (95% CI, −24 to −5; P = .004) at 12 months; −9 units (95% CI, −21 to 3; P = .15) at 18 months; and −18 units (95% CI, −43 to 5 units; P = .12) at 24 months (Figure 3). The most common AEs were hypoglycemia (30%), diarrhea (11%), nausea (4%), and abdominal pain (3%).

Discussion

Adding a GLP-1 RA to basal/bolus insulin regimens was associated with a statistically significant decrease in HbA_1c at each time point through 18 months. The greatest improvement in glycemic control from baseline was seen at 3 months, with improvements in HbA_1c diminishing at each subsequent period. The study also demonstrated a significant decrease in weight at each time point through 18 months. The greatest decrease in weight was observed at both 6 and 12 months. Statistically significant decreases in TDD were observed at 3, 6, and 12 months. Insulin changes after 12 months were not found to be statistically significant.

Few studies have previously evaluated the use of GLP-1 RAs in patients with T2DM who are already taking basal/bolus insulin regimens. Gyorffy and colleagues reported significant improvements in glycemic control at 3 and 6 months in a sample of 54 patients taking basal/bolus insulin when liraglutide or exenatide was added, although statistical significance was not found at the final 12-month time point.¹³ That study also found a significant decrease in weight at 6 months; however there was not a significant reduction in weight at both 3 and 12 months of GLP-1 RA therapy. There was not a significant decrease in TDD at any of the collected time points. Nonetheless, Gyorffy and colleagues concluded that reduction in TDD leveled off after 12 months, which is consistent with this study’s findings. The small size of the study may have limited the ability to detect statistical significance; however, this study was conducted in a population that was racially diverse and included a higher proportion of women, though average age was similar.¹³

Yoon and colleagues reported weight loss through 18 months, then saw weight increase, though weights did remain lover than baseline. The study also showed no significant change in TDD of insulin after 12 months of concomitant exenatide and insulin therapy.¹¹ Although these results mirror the outcomes observed in this study, Yoon and colleagues did not differentiate results between basal and basal/bolus insulin groups.¹¹ Seino and colleagues observed no significant change in weight after 36 weeks of GLP-1 RA therapy in Japanese patients when used with basal and basal/bolus insulin regimens. Despite the consideration that the population in the study was not overweight (mean body mass index was 25.6), the results of these studies support the idea that effects of GLP-1 RAs on weight and TDD may diminish over time.¹⁴

Within the VHA, GLP-1 RAs are nonformulary medications. Patients must meet certain criteria in order to be approved for these agents, which may include diagnosis of CVD, renal disease, or failure to reach glycemic control with the use of oral agents or insulin. Therefore, participants of this study represent a particular subset of VHA patients, many of whom may have been selected for consideration due to long-standing or uncontrolled T2DM and failure of previous therapies. The baseline demographics support this idea, given poor glycemic control at baseline and high insulin requirements. Once approved for GLP-1 RA therapy, semaglutide is currently the preferred agent within the VHA, with other agents being available for select considerations. It should be noted that albiglutide, which was the primary agent selected for some of the patients included in this study, was removed from the market in 2017 for economic considerations.¹⁵ In the case for these patients, a conversion to a formulary-preferred GLP-1 RA was made.

Most of the patients included in this study (70%) were maintained on metformin from baseline throughout the study period. Fifty-seven percent of patients were taking TDD of insulin > 150 units. Considering the significant cost of concentrated insulins, the addition of GLP-1 RAs to standard insulin may prove to be beneficial from a cost standpoint. Additional research in this area may be warranted to establish more data regarding this potential benefit of GLP-1 RAs as add-on therapy.

Limitations and Strengths

Limitations of this study include a small patient population and a gradual reduction in available data as time periods progressed, making even smaller sample sizes for subsequent time periods. A majority of participants were older males of White race. This could have limited the determination of statistical significance and applicability of the results to other patient populations. Another potential limitation was the retrospective nature of the study design, which may have limited reporting of hypoglycemia and other AEs based on the documentation of the clinician.

Strengths included the length of study duration and the diversity of GLP-1 RAs used by participants, as the impact of many of these agents has not yet been assessed in the literature. In addition, the retrospective nature of the study allows for a more realistic representation of patient adherence, education, and motivation, which are likely different from those of patients included in prospective clinical trials.

There are no clear guidelines dictating the optimal duration of concomitant GLP-1 RA and insulin therapy; however, our study suggests that there may be continued benefits past short-term use. Also our study suggests that patients with T2DM treated with basal/bolus insulin regimens may glean additional benefit from adding GLP-1 RAs; however, further randomized, controlled studies are warranted, particularly in poorly controlled patients requiring even more aggressive treatment regimens, such as concentrated insulins.

Conclusions

In our study, adding GLP-1 RA to basal/bolus insulin was associated with a significant decrease in HbA_1c from baseline through 18 months. An overall decrease in weight and TDD of insulin was observed through 24 months, but the change in weight was not significant past 18 months, and the change in insulin requirement was not significant past 12 months. Hypoglycemia was observed in almost one-third of patients, and gastrointestinal symptoms were the most common AE observed as a result adding GLP-1 RAs. More studies are needed to better evaluate the durability and cost benefit of GLP-1 RAs, especially in patients with high insulin requirements.

Acknowledgments

This material is the result of work supported with resources and facilities at Veteran Health Indiana in Indianapolis. Study data were collected and managed using REDCap electronic data capture tools hosted at Veteran Health Indiana. The authors also acknowledge George Eckert for his assistance with data analysis.

In 2019, diabetes mellitus (DM) was the seventh leading cause of death in the United States, and currently, about 11% of the American population has a DM diagnosis.¹ Most have a diagnosis of type 2 diabetes (T2DM), which has a strong genetic predisposition, and the risk of developing T2DM increases with age, obesity, and lack of physical activity.^1,2 Nearly one-quarter of veterans have a diagnosis of DM, and DM is the leading cause of comorbidities, such as blindness, end-stage renal disease, and amputation for patients receiving care from the Veterans Health Administration (VHA).² The elevated incidence of DM in the veteran population is attributed to a variety of factors, including exposure to herbicides, such as Agent Orange, advanced age, increased risk of obesity, and limited access to high-quality food.³

After diagnosis, both the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) emphasize the appropriate use of lifestyle management and pharmacologic therapy for DM care. The use of pharmacologic agents (oral medications, insulin, or noninsulin injectables) is often determined by efficacy, cost, potential adverse effects (AEs), and patient factors and comorbidities.^4,5

The initial recommendation for pharmacologic treatment for T2DM differs slightly between expert guidelines. The ADA and AACE/ACE recommend any of the following as initial monotherapy, listed in order to represent a hierarchy of usage: metformin, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase-4 (DPP-4) inhibitors, with the first 3 agents carrying the strongest recommendations.^4,5 For patients with established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure, it is recommended to start a long-acting GLP-1 RA or SGLT-2 inhibitor. For patients with T2DM and hemoglobin A_1c (HbA_1c) between 7.5% and 9.0% at diagnosis, the AACE/ACE recommend initiation of dual therapy using metformin alongside another first-line agent and recommend the addition of another antidiabetic agent if glycemic goals are not met after regular follow-up. AACE/ACE recommend the consideration of insulin therapy in symptomatic patients with HbA_1c > 9.0%.⁵ In contrast, the ADA recommends metformin as first-line therapy for all patients with T2DM and recommends dual therapy using metformin and another preferred agent (selection based on comorbidities) when HbA_1c is 1.5% to 2% above target. The ADA recommends the consideration of insulin with HbA_1c > 10% or with evidence of ongoing catabolism or symptoms of hyperglycemia.⁴ There are several reasons why insulin may be initiated prior to GLP-1 RAs, including profound hyperglycemia at time of diagnosis or implementation of insulin agents prior to commercial availability of GLP-1 RA.

GLP-1 RAs are analogs of the hormone incretin, which increases glucose-dependent insulin secretion, decreases postprandial glucagon secretion, increases satiety, and slows gastric emptying.^6,7 When used in combination with noninsulin agents, GLP-1 RAs have demonstrated HbA_1c reductions of 0.5% to 1.5%.⁸ The use of GLP-1 RAs with basal insulin also has been studied extensively.^6,8-10 When the combination of GLP-1 RAs and basal insulin was compared with basal/bolus insulin regimens, the use of the GLP-1 RAs resulted in lower HbA_1c levels and lower incidence of hypoglycemia.^6,9 Data have demonstrated the complementary mechanisms of using basal insulin and GLP 1 RAs in decreasing HbA_1c levels, insulin requirements, and weight compared with using basal insulin monotherapy and basal/bolus combinations.^6,9-13 Moreover, 3 GLP-1 RA medications currently on the market (liraglutide, dulaglutide, and semaglutide) have displayed cardiovascular and renal benefits, further supporting the use of these medications.^2,5

Despite these benefits, GLP-1 RAs may have bothersome AEs and are associated with a high cost.⁶ In addition, some studies have found that as the length of therapy increases, the positive effects of these agents may diminish.^9,11 In one study, which looked at the impact of the addition of exenatide to patients taking basal or basal/bolus insulin regimens, mean changes in weight were −2.4 kg at 0 to 6 months, −4.3 kg at 6 to 12 months, −6.2 kg at 12 to 18 months, and −5.5 kg at 18 to 27 months. After 18 months, an increase in weight was observed, but the increase remained lower than baseline.¹¹ Another study, conducted over 12 months, found no significant decrease in weight or total daily dose (TDD) of insulin when exenatide or liraglutide were added to various insulin regimens (basal or basal/bolus).¹³ To date, minimal published data exist regarding the addition of newer GLP-1 RAs and the long-term use of these agents beyond 12 months in patients taking basal/bolus insulin regimens. The primary goal of this study was to evaluate the effect of adding GLP-1 RAs to basal/bolus insulin regimens over a 24-month period.

Methods

This study was a retrospective, electronic health record review of all patients on basal and bolus insulin regimens who received additional therapy with a GLP-1 RA at Veteran Health Indiana in Indianapolis from September 1, 2015, to June 30, 2019. Patients meeting inclusion criteria served as their own control. The primary outcome was change in HbA_1c at 3, 6, 12, 18, and 24 months after initiation of the GLP-1 RA. Secondary outcomes included change in weight and TDD of insulin at 3, 6, 12, 18, and 24 months after the initiation of the GLP-1 RAs and incidence of patient-reported or laboratory-confirmed hypoglycemia and other AEs.

Patients were included if they were aged ≥ 18 years with a diagnosis of T2DM, had concomitant prescriptions for both a basal insulin (glargine, detemir, or NPH) and a bolus insulin (aspart, lispro, or regular) before receiving add-on therapy with a GLP-1 RA (exenatide, liraglutide, albiglutide, lixisenatide, dulaglutide, or semaglutide) from September 1, 2015, to June 30, 2019, and had baseline and subsequent Hb A_1c measurements available in the electronic health record. Patients were excluded if they had a diagnosis of T1DM, were followed by an outside clinician for DM care, or if the GLP-1 RA was discontinued before subsequent HbA_1c measurement. The study protocol was approved by the Research and Development Office of Veteran Health Indiana, and the project was deemed exempt from review by the Indiana University Institutional Review Board due to the retrospective nature of the study.

Data analysis was performed using Excel. Change from baseline for each interval was computed, and 1 sample t tests (2-tailed) compared change from baseline to no change. Due to the disparity in the number of patients with data available at each of the time intervals, a mean plot was presented for each group of patients within each interval, allowing mean changes in individual groups to be observed over time.

Results

One hundred twenty-three subjects met inclusion criteria; 16 patients were excluded due to GLP-1 RA discontinuation before follow-up measurement of HbA_1c; 14 were excluded due to patients being managed by a clinician outside of the facility; 1 patient was excluded for lack of documentation regarding baseline and subsequent insulin doses. Ninety-two patient charts were reviewed. Participants had a mean age of 64 years, 95% were male, and 89% were White. Mean baseline Hb A_1c was 9.2%, mean body mass index was 38.9, and the mean TDD of insulin was 184 units. Mean duration of DM was 10 years, and mean use of basal/bolus insulin regimen was 6.1 years. Most participants (91%) used an insulin regimen containing insulin glargine and insulin aspart; the remaining participants used insulin detemir and insulin aspart. Semaglutide and liraglutide were the most commonly used GLP-1 RAs (44% and 39%, respectively) (Table 1).

Since some patients switched between GLP-1 RAs throughout the study and there was variation in timing of laboratory and clinic follow-up, a different number of patient charts were available for review at each period (Table 2). Glycemic control was significantly improved at all time points when compared with baseline, but over time the benefit declined. The mean change in HbA_1c was −1.1% (95% CI, −1.3 to −0.8; P < .001) at 3 months; −1.0% (95% CI, −1.3 to −0.7; P < .001) at 6 months; −0.9% (95% CI, −1.3 to −0.6; P < .001) at 12 months; −0.9% (95% CI −1.4 to −0.3; P = .002) at 18 months; and −0.7% (95% CI, −1.4 to 0.1; P = .07) at 24 months (Figure 1). Mean weight decreased from baseline −2.7 kg (95% CI, −3.7 to −1.6; P < .001); −4.4 kg (95% CI −5.7 to −3.2; P < .001) at 6 months; −3.9 kg (95% CI −6.0 to −1.9; P < .001) at 12 months; −4.7 kg (95% CI −6.7 to −2.6; P < .001) at 18 months; and −2.8 kg (95% CI, −5.9 to 0.3; P = .07) at 24 months (Figure 2). Mean TDD decreased at 3 months −12 units (95% CI, −19 to −5; P < .001); −18 units (95% CI, −27 to −9; P < .001) at 6 months; −14 units (95% CI, −24 to −5; P = .004) at 12 months; −9 units (95% CI, −21 to 3; P = .15) at 18 months; and −18 units (95% CI, −43 to 5 units; P = .12) at 24 months (Figure 3). The most common AEs were hypoglycemia (30%), diarrhea (11%), nausea (4%), and abdominal pain (3%).

Discussion

Adding a GLP-1 RA to basal/bolus insulin regimens was associated with a statistically significant decrease in HbA_1c at each time point through 18 months. The greatest improvement in glycemic control from baseline was seen at 3 months, with improvements in HbA_1c diminishing at each subsequent period. The study also demonstrated a significant decrease in weight at each time point through 18 months. The greatest decrease in weight was observed at both 6 and 12 months. Statistically significant decreases in TDD were observed at 3, 6, and 12 months. Insulin changes after 12 months were not found to be statistically significant.

Few studies have previously evaluated the use of GLP-1 RAs in patients with T2DM who are already taking basal/bolus insulin regimens. Gyorffy and colleagues reported significant improvements in glycemic control at 3 and 6 months in a sample of 54 patients taking basal/bolus insulin when liraglutide or exenatide was added, although statistical significance was not found at the final 12-month time point.¹³ That study also found a significant decrease in weight at 6 months; however there was not a significant reduction in weight at both 3 and 12 months of GLP-1 RA therapy. There was not a significant decrease in TDD at any of the collected time points. Nonetheless, Gyorffy and colleagues concluded that reduction in TDD leveled off after 12 months, which is consistent with this study’s findings. The small size of the study may have limited the ability to detect statistical significance; however, this study was conducted in a population that was racially diverse and included a higher proportion of women, though average age was similar.¹³

Yoon and colleagues reported weight loss through 18 months, then saw weight increase, though weights did remain lover than baseline. The study also showed no significant change in TDD of insulin after 12 months of concomitant exenatide and insulin therapy.¹¹ Although these results mirror the outcomes observed in this study, Yoon and colleagues did not differentiate results between basal and basal/bolus insulin groups.¹¹ Seino and colleagues observed no significant change in weight after 36 weeks of GLP-1 RA therapy in Japanese patients when used with basal and basal/bolus insulin regimens. Despite the consideration that the population in the study was not overweight (mean body mass index was 25.6), the results of these studies support the idea that effects of GLP-1 RAs on weight and TDD may diminish over time.¹⁴

Within the VHA, GLP-1 RAs are nonformulary medications. Patients must meet certain criteria in order to be approved for these agents, which may include diagnosis of CVD, renal disease, or failure to reach glycemic control with the use of oral agents or insulin. Therefore, participants of this study represent a particular subset of VHA patients, many of whom may have been selected for consideration due to long-standing or uncontrolled T2DM and failure of previous therapies. The baseline demographics support this idea, given poor glycemic control at baseline and high insulin requirements. Once approved for GLP-1 RA therapy, semaglutide is currently the preferred agent within the VHA, with other agents being available for select considerations. It should be noted that albiglutide, which was the primary agent selected for some of the patients included in this study, was removed from the market in 2017 for economic considerations.¹⁵ In the case for these patients, a conversion to a formulary-preferred GLP-1 RA was made.

Most of the patients included in this study (70%) were maintained on metformin from baseline throughout the study period. Fifty-seven percent of patients were taking TDD of insulin > 150 units. Considering the significant cost of concentrated insulins, the addition of GLP-1 RAs to standard insulin may prove to be beneficial from a cost standpoint. Additional research in this area may be warranted to establish more data regarding this potential benefit of GLP-1 RAs as add-on therapy.

Limitations and Strengths

Limitations of this study include a small patient population and a gradual reduction in available data as time periods progressed, making even smaller sample sizes for subsequent time periods. A majority of participants were older males of White race. This could have limited the determination of statistical significance and applicability of the results to other patient populations. Another potential limitation was the retrospective nature of the study design, which may have limited reporting of hypoglycemia and other AEs based on the documentation of the clinician.

Strengths included the length of study duration and the diversity of GLP-1 RAs used by participants, as the impact of many of these agents has not yet been assessed in the literature. In addition, the retrospective nature of the study allows for a more realistic representation of patient adherence, education, and motivation, which are likely different from those of patients included in prospective clinical trials.

There are no clear guidelines dictating the optimal duration of concomitant GLP-1 RA and insulin therapy; however, our study suggests that there may be continued benefits past short-term use. Also our study suggests that patients with T2DM treated with basal/bolus insulin regimens may glean additional benefit from adding GLP-1 RAs; however, further randomized, controlled studies are warranted, particularly in poorly controlled patients requiring even more aggressive treatment regimens, such as concentrated insulins.

Conclusions

In our study, adding GLP-1 RA to basal/bolus insulin was associated with a significant decrease in HbA_1c from baseline through 18 months. An overall decrease in weight and TDD of insulin was observed through 24 months, but the change in weight was not significant past 18 months, and the change in insulin requirement was not significant past 12 months. Hypoglycemia was observed in almost one-third of patients, and gastrointestinal symptoms were the most common AE observed as a result adding GLP-1 RAs. More studies are needed to better evaluate the durability and cost benefit of GLP-1 RAs, especially in patients with high insulin requirements.

Acknowledgments

This material is the result of work supported with resources and facilities at Veteran Health Indiana in Indianapolis. Study data were collected and managed using REDCap electronic data capture tools hosted at Veteran Health Indiana. The authors also acknowledge George Eckert for his assistance with data analysis.

In 2019, diabetes mellitus (DM) was the seventh leading cause of death in the United States, and currently, about 11% of the American population has a DM diagnosis.¹ Most have a diagnosis of type 2 diabetes (T2DM), which has a strong genetic predisposition, and the risk of developing T2DM increases with age, obesity, and lack of physical activity.^1,2 Nearly one-quarter of veterans have a diagnosis of DM, and DM is the leading cause of comorbidities, such as blindness, end-stage renal disease, and amputation for patients receiving care from the Veterans Health Administration (VHA).² The elevated incidence of DM in the veteran population is attributed to a variety of factors, including exposure to herbicides, such as Agent Orange, advanced age, increased risk of obesity, and limited access to high-quality food.³

After diagnosis, both the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) emphasize the appropriate use of lifestyle management and pharmacologic therapy for DM care. The use of pharmacologic agents (oral medications, insulin, or noninsulin injectables) is often determined by efficacy, cost, potential adverse effects (AEs), and patient factors and comorbidities.^4,5

The initial recommendation for pharmacologic treatment for T2DM differs slightly between expert guidelines. The ADA and AACE/ACE recommend any of the following as initial monotherapy, listed in order to represent a hierarchy of usage: metformin, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase-4 (DPP-4) inhibitors, with the first 3 agents carrying the strongest recommendations.^4,5 For patients with established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure, it is recommended to start a long-acting GLP-1 RA or SGLT-2 inhibitor. For patients with T2DM and hemoglobin A_1c (HbA_1c) between 7.5% and 9.0% at diagnosis, the AACE/ACE recommend initiation of dual therapy using metformin alongside another first-line agent and recommend the addition of another antidiabetic agent if glycemic goals are not met after regular follow-up. AACE/ACE recommend the consideration of insulin therapy in symptomatic patients with HbA_1c > 9.0%.⁵ In contrast, the ADA recommends metformin as first-line therapy for all patients with T2DM and recommends dual therapy using metformin and another preferred agent (selection based on comorbidities) when HbA_1c is 1.5% to 2% above target. The ADA recommends the consideration of insulin with HbA_1c > 10% or with evidence of ongoing catabolism or symptoms of hyperglycemia.⁴ There are several reasons why insulin may be initiated prior to GLP-1 RAs, including profound hyperglycemia at time of diagnosis or implementation of insulin agents prior to commercial availability of GLP-1 RA.

GLP-1 RAs are analogs of the hormone incretin, which increases glucose-dependent insulin secretion, decreases postprandial glucagon secretion, increases satiety, and slows gastric emptying.^6,7 When used in combination with noninsulin agents, GLP-1 RAs have demonstrated HbA_1c reductions of 0.5% to 1.5%.⁸ The use of GLP-1 RAs with basal insulin also has been studied extensively.^6,8-10 When the combination of GLP-1 RAs and basal insulin was compared with basal/bolus insulin regimens, the use of the GLP-1 RAs resulted in lower HbA_1c levels and lower incidence of hypoglycemia.^6,9 Data have demonstrated the complementary mechanisms of using basal insulin and GLP 1 RAs in decreasing HbA_1c levels, insulin requirements, and weight compared with using basal insulin monotherapy and basal/bolus combinations.^6,9-13 Moreover, 3 GLP-1 RA medications currently on the market (liraglutide, dulaglutide, and semaglutide) have displayed cardiovascular and renal benefits, further supporting the use of these medications.^2,5

Despite these benefits, GLP-1 RAs may have bothersome AEs and are associated with a high cost.⁶ In addition, some studies have found that as the length of therapy increases, the positive effects of these agents may diminish.^9,11 In one study, which looked at the impact of the addition of exenatide to patients taking basal or basal/bolus insulin regimens, mean changes in weight were −2.4 kg at 0 to 6 months, −4.3 kg at 6 to 12 months, −6.2 kg at 12 to 18 months, and −5.5 kg at 18 to 27 months. After 18 months, an increase in weight was observed, but the increase remained lower than baseline.¹¹ Another study, conducted over 12 months, found no significant decrease in weight or total daily dose (TDD) of insulin when exenatide or liraglutide were added to various insulin regimens (basal or basal/bolus).¹³ To date, minimal published data exist regarding the addition of newer GLP-1 RAs and the long-term use of these agents beyond 12 months in patients taking basal/bolus insulin regimens. The primary goal of this study was to evaluate the effect of adding GLP-1 RAs to basal/bolus insulin regimens over a 24-month period.

Methods

This study was a retrospective, electronic health record review of all patients on basal and bolus insulin regimens who received additional therapy with a GLP-1 RA at Veteran Health Indiana in Indianapolis from September 1, 2015, to June 30, 2019. Patients meeting inclusion criteria served as their own control. The primary outcome was change in HbA_1c at 3, 6, 12, 18, and 24 months after initiation of the GLP-1 RA. Secondary outcomes included change in weight and TDD of insulin at 3, 6, 12, 18, and 24 months after the initiation of the GLP-1 RAs and incidence of patient-reported or laboratory-confirmed hypoglycemia and other AEs.

Patients were included if they were aged ≥ 18 years with a diagnosis of T2DM, had concomitant prescriptions for both a basal insulin (glargine, detemir, or NPH) and a bolus insulin (aspart, lispro, or regular) before receiving add-on therapy with a GLP-1 RA (exenatide, liraglutide, albiglutide, lixisenatide, dulaglutide, or semaglutide) from September 1, 2015, to June 30, 2019, and had baseline and subsequent Hb A_1c measurements available in the electronic health record. Patients were excluded if they had a diagnosis of T1DM, were followed by an outside clinician for DM care, or if the GLP-1 RA was discontinued before subsequent HbA_1c measurement. The study protocol was approved by the Research and Development Office of Veteran Health Indiana, and the project was deemed exempt from review by the Indiana University Institutional Review Board due to the retrospective nature of the study.

Data analysis was performed using Excel. Change from baseline for each interval was computed, and 1 sample t tests (2-tailed) compared change from baseline to no change. Due to the disparity in the number of patients with data available at each of the time intervals, a mean plot was presented for each group of patients within each interval, allowing mean changes in individual groups to be observed over time.

Results

One hundred twenty-three subjects met inclusion criteria; 16 patients were excluded due to GLP-1 RA discontinuation before follow-up measurement of HbA_1c; 14 were excluded due to patients being managed by a clinician outside of the facility; 1 patient was excluded for lack of documentation regarding baseline and subsequent insulin doses. Ninety-two patient charts were reviewed. Participants had a mean age of 64 years, 95% were male, and 89% were White. Mean baseline Hb A_1c was 9.2%, mean body mass index was 38.9, and the mean TDD of insulin was 184 units. Mean duration of DM was 10 years, and mean use of basal/bolus insulin regimen was 6.1 years. Most participants (91%) used an insulin regimen containing insulin glargine and insulin aspart; the remaining participants used insulin detemir and insulin aspart. Semaglutide and liraglutide were the most commonly used GLP-1 RAs (44% and 39%, respectively) (Table 1).

Since some patients switched between GLP-1 RAs throughout the study and there was variation in timing of laboratory and clinic follow-up, a different number of patient charts were available for review at each period (Table 2). Glycemic control was significantly improved at all time points when compared with baseline, but over time the benefit declined. The mean change in HbA_1c was −1.1% (95% CI, −1.3 to −0.8; P < .001) at 3 months; −1.0% (95% CI, −1.3 to −0.7; P < .001) at 6 months; −0.9% (95% CI, −1.3 to −0.6; P < .001) at 12 months; −0.9% (95% CI −1.4 to −0.3; P = .002) at 18 months; and −0.7% (95% CI, −1.4 to 0.1; P = .07) at 24 months (Figure 1). Mean weight decreased from baseline −2.7 kg (95% CI, −3.7 to −1.6; P < .001); −4.4 kg (95% CI −5.7 to −3.2; P < .001) at 6 months; −3.9 kg (95% CI −6.0 to −1.9; P < .001) at 12 months; −4.7 kg (95% CI −6.7 to −2.6; P < .001) at 18 months; and −2.8 kg (95% CI, −5.9 to 0.3; P = .07) at 24 months (Figure 2). Mean TDD decreased at 3 months −12 units (95% CI, −19 to −5; P < .001); −18 units (95% CI, −27 to −9; P < .001) at 6 months; −14 units (95% CI, −24 to −5; P = .004) at 12 months; −9 units (95% CI, −21 to 3; P = .15) at 18 months; and −18 units (95% CI, −43 to 5 units; P = .12) at 24 months (Figure 3). The most common AEs were hypoglycemia (30%), diarrhea (11%), nausea (4%), and abdominal pain (3%).

Discussion

Adding a GLP-1 RA to basal/bolus insulin regimens was associated with a statistically significant decrease in HbA_1c at each time point through 18 months. The greatest improvement in glycemic control from baseline was seen at 3 months, with improvements in HbA_1c diminishing at each subsequent period. The study also demonstrated a significant decrease in weight at each time point through 18 months. The greatest decrease in weight was observed at both 6 and 12 months. Statistically significant decreases in TDD were observed at 3, 6, and 12 months. Insulin changes after 12 months were not found to be statistically significant.

Few studies have previously evaluated the use of GLP-1 RAs in patients with T2DM who are already taking basal/bolus insulin regimens. Gyorffy and colleagues reported significant improvements in glycemic control at 3 and 6 months in a sample of 54 patients taking basal/bolus insulin when liraglutide or exenatide was added, although statistical significance was not found at the final 12-month time point.¹³ That study also found a significant decrease in weight at 6 months; however there was not a significant reduction in weight at both 3 and 12 months of GLP-1 RA therapy. There was not a significant decrease in TDD at any of the collected time points. Nonetheless, Gyorffy and colleagues concluded that reduction in TDD leveled off after 12 months, which is consistent with this study’s findings. The small size of the study may have limited the ability to detect statistical significance; however, this study was conducted in a population that was racially diverse and included a higher proportion of women, though average age was similar.¹³

Yoon and colleagues reported weight loss through 18 months, then saw weight increase, though weights did remain lover than baseline. The study also showed no significant change in TDD of insulin after 12 months of concomitant exenatide and insulin therapy.¹¹ Although these results mirror the outcomes observed in this study, Yoon and colleagues did not differentiate results between basal and basal/bolus insulin groups.¹¹ Seino and colleagues observed no significant change in weight after 36 weeks of GLP-1 RA therapy in Japanese patients when used with basal and basal/bolus insulin regimens. Despite the consideration that the population in the study was not overweight (mean body mass index was 25.6), the results of these studies support the idea that effects of GLP-1 RAs on weight and TDD may diminish over time.¹⁴

Within the VHA, GLP-1 RAs are nonformulary medications. Patients must meet certain criteria in order to be approved for these agents, which may include diagnosis of CVD, renal disease, or failure to reach glycemic control with the use of oral agents or insulin. Therefore, participants of this study represent a particular subset of VHA patients, many of whom may have been selected for consideration due to long-standing or uncontrolled T2DM and failure of previous therapies. The baseline demographics support this idea, given poor glycemic control at baseline and high insulin requirements. Once approved for GLP-1 RA therapy, semaglutide is currently the preferred agent within the VHA, with other agents being available for select considerations. It should be noted that albiglutide, which was the primary agent selected for some of the patients included in this study, was removed from the market in 2017 for economic considerations.¹⁵ In the case for these patients, a conversion to a formulary-preferred GLP-1 RA was made.

Most of the patients included in this study (70%) were maintained on metformin from baseline throughout the study period. Fifty-seven percent of patients were taking TDD of insulin > 150 units. Considering the significant cost of concentrated insulins, the addition of GLP-1 RAs to standard insulin may prove to be beneficial from a cost standpoint. Additional research in this area may be warranted to establish more data regarding this potential benefit of GLP-1 RAs as add-on therapy.

Limitations and Strengths

Limitations of this study include a small patient population and a gradual reduction in available data as time periods progressed, making even smaller sample sizes for subsequent time periods. A majority of participants were older males of White race. This could have limited the determination of statistical significance and applicability of the results to other patient populations. Another potential limitation was the retrospective nature of the study design, which may have limited reporting of hypoglycemia and other AEs based on the documentation of the clinician.

Strengths included the length of study duration and the diversity of GLP-1 RAs used by participants, as the impact of many of these agents has not yet been assessed in the literature. In addition, the retrospective nature of the study allows for a more realistic representation of patient adherence, education, and motivation, which are likely different from those of patients included in prospective clinical trials.

There are no clear guidelines dictating the optimal duration of concomitant GLP-1 RA and insulin therapy; however, our study suggests that there may be continued benefits past short-term use. Also our study suggests that patients with T2DM treated with basal/bolus insulin regimens may glean additional benefit from adding GLP-1 RAs; however, further randomized, controlled studies are warranted, particularly in poorly controlled patients requiring even more aggressive treatment regimens, such as concentrated insulins.

Conclusions

In our study, adding GLP-1 RA to basal/bolus insulin was associated with a significant decrease in HbA_1c from baseline through 18 months. An overall decrease in weight and TDD of insulin was observed through 24 months, but the change in weight was not significant past 18 months, and the change in insulin requirement was not significant past 12 months. Hypoglycemia was observed in almost one-third of patients, and gastrointestinal symptoms were the most common AE observed as a result adding GLP-1 RAs. More studies are needed to better evaluate the durability and cost benefit of GLP-1 RAs, especially in patients with high insulin requirements.

Acknowledgments

This material is the result of work supported with resources and facilities at Veteran Health Indiana in Indianapolis. Study data were collected and managed using REDCap electronic data capture tools hosted at Veteran Health Indiana. The authors also acknowledge George Eckert for his assistance with data analysis.

From our first days as medical students, we are told that politics and religion are topics to be avoided with patients, but I disagree. Knowing more about our patients allows us to deliver better care. I propose that we consider adding politics and religion to our list of risk factors.

Politics and religion: New risk factors

The importance of politics and religion in the health of patients was clearly demonstrated during the COVID-19 pandemic. Lives were needlessly lost because of stands taken based on religious beliefs or a political ideology. Families, friends, and the community at large were impacted.

Over my years of practice, I have found that while these are difficult topics to address, they should not be avoided. Studies have shown that open acknowledgement of religious beliefs can affect both clinical outcomes and well-being. Religion and spirituality are as much a part of our patient’s lives as the physical parameters that we measure. To neglect these significant aspects is to miss the very essence of the individual.

I made it a practice to ask patients about their religious beliefs, the extent to which religion shaped their life, and whether they were part of a church community. Knowing this allowed me to separate deep personal belief from stances based on personal freedom, misinformation, conspiracies, and politics.

I found that information about political leanings flowed naturally in discussions with patients as we trusted and respected each other over time. If I approached politics objectively and nonjudgmentally, it generally led to meaningful conversation. This helped me to understand the patient as an individual and informed my diagnosis and treatment plan.
 

Politics as stress

For example, on more than one occasion, a patient with atrial fibrillation presented with persistent elevated blood pressure and pulse rate despite adherence to the medical regimen that I had prescribed. After a few minutes of discussion, it was clear that excessive attention to political commentary on TV and social media raised their anxiety and anger level, putting them at greater risk for adverse outcomes. I advised that they refocus their leisure activities rather than change or increase medication.

It is disappointing to see how one of the great scientific advances of our lifetime, vaccination science, has been tarnished because of political or religious ideology and to see the extent to which these beliefs influenced COVID-19 vaccination compliance. As health care providers, we must promote information based on the scientific method. If patients challenge us and point out that recommendations based on science seem to change over time, we must explain that science evolves on the basis of new information objectively gathered. We need to find out what information the patient has gotten from the Internet, TV, or conspiracy theories and counter this with scientific facts. If we do not discuss religion and politics with our patients along with other risk factors, we may compromise our ability to give them the best advice and treatment.

Our patients have a right to their own spiritual and political ideology. If it differs dramatically from our own, this should not influence our commitment to care for them. But we have an obligation to challenge unfounded beliefs about medicine and counter with scientific facts. There are times when individual freedoms must be secondary to public health. Ultimately, it is up to the patient to choose, but they should not be given a “free pass” on the basis of religion or politics. If I know something is true and I would do it myself or recommend it for my family, I have an obligation to provide this recommendation to my patients.

Religious preference is included in medical records. It is not appropriate to add political preference, but the patient benefits if a long-term caregiver knows this information.

During the pandemic, for the first time in my 40+ years of practice, some patients questioned my recommendations and placed equal or greater weight on religion, politics, or conspiracy theories. This continues to be a very real struggle.

Knowing and understanding our patients as individuals is critical to providing optimum care and that means tackling these formally taboo topics. If having a potentially uncomfortable conversation with patients allows us to save one life, it is worth it.
 

Dr. Francis is a cardiologist at Inova Heart and Vascular Institute, McLean, Va. He disclosed no relevant conflict of interest. A version of this article first appeared on Medscape.com.

From our first days as medical students, we are told that politics and religion are topics to be avoided with patients, but I disagree. Knowing more about our patients allows us to deliver better care. I propose that we consider adding politics and religion to our list of risk factors.

Politics and religion: New risk factors

The importance of politics and religion in the health of patients was clearly demonstrated during the COVID-19 pandemic. Lives were needlessly lost because of stands taken based on religious beliefs or a political ideology. Families, friends, and the community at large were impacted.

Over my years of practice, I have found that while these are difficult topics to address, they should not be avoided. Studies have shown that open acknowledgement of religious beliefs can affect both clinical outcomes and well-being. Religion and spirituality are as much a part of our patient’s lives as the physical parameters that we measure. To neglect these significant aspects is to miss the very essence of the individual.

I made it a practice to ask patients about their religious beliefs, the extent to which religion shaped their life, and whether they were part of a church community. Knowing this allowed me to separate deep personal belief from stances based on personal freedom, misinformation, conspiracies, and politics.

I found that information about political leanings flowed naturally in discussions with patients as we trusted and respected each other over time. If I approached politics objectively and nonjudgmentally, it generally led to meaningful conversation. This helped me to understand the patient as an individual and informed my diagnosis and treatment plan.
 

Politics as stress

For example, on more than one occasion, a patient with atrial fibrillation presented with persistent elevated blood pressure and pulse rate despite adherence to the medical regimen that I had prescribed. After a few minutes of discussion, it was clear that excessive attention to political commentary on TV and social media raised their anxiety and anger level, putting them at greater risk for adverse outcomes. I advised that they refocus their leisure activities rather than change or increase medication.

It is disappointing to see how one of the great scientific advances of our lifetime, vaccination science, has been tarnished because of political or religious ideology and to see the extent to which these beliefs influenced COVID-19 vaccination compliance. As health care providers, we must promote information based on the scientific method. If patients challenge us and point out that recommendations based on science seem to change over time, we must explain that science evolves on the basis of new information objectively gathered. We need to find out what information the patient has gotten from the Internet, TV, or conspiracy theories and counter this with scientific facts. If we do not discuss religion and politics with our patients along with other risk factors, we may compromise our ability to give them the best advice and treatment.

Our patients have a right to their own spiritual and political ideology. If it differs dramatically from our own, this should not influence our commitment to care for them. But we have an obligation to challenge unfounded beliefs about medicine and counter with scientific facts. There are times when individual freedoms must be secondary to public health. Ultimately, it is up to the patient to choose, but they should not be given a “free pass” on the basis of religion or politics. If I know something is true and I would do it myself or recommend it for my family, I have an obligation to provide this recommendation to my patients.

Religious preference is included in medical records. It is not appropriate to add political preference, but the patient benefits if a long-term caregiver knows this information.

During the pandemic, for the first time in my 40+ years of practice, some patients questioned my recommendations and placed equal or greater weight on religion, politics, or conspiracy theories. This continues to be a very real struggle.

Knowing and understanding our patients as individuals is critical to providing optimum care and that means tackling these formally taboo topics. If having a potentially uncomfortable conversation with patients allows us to save one life, it is worth it.
 

Dr. Francis is a cardiologist at Inova Heart and Vascular Institute, McLean, Va. He disclosed no relevant conflict of interest. A version of this article first appeared on Medscape.com.

From our first days as medical students, we are told that politics and religion are topics to be avoided with patients, but I disagree. Knowing more about our patients allows us to deliver better care. I propose that we consider adding politics and religion to our list of risk factors.

Politics and religion: New risk factors

The importance of politics and religion in the health of patients was clearly demonstrated during the COVID-19 pandemic. Lives were needlessly lost because of stands taken based on religious beliefs or a political ideology. Families, friends, and the community at large were impacted.

Over my years of practice, I have found that while these are difficult topics to address, they should not be avoided. Studies have shown that open acknowledgement of religious beliefs can affect both clinical outcomes and well-being. Religion and spirituality are as much a part of our patient’s lives as the physical parameters that we measure. To neglect these significant aspects is to miss the very essence of the individual.

I made it a practice to ask patients about their religious beliefs, the extent to which religion shaped their life, and whether they were part of a church community. Knowing this allowed me to separate deep personal belief from stances based on personal freedom, misinformation, conspiracies, and politics.

I found that information about political leanings flowed naturally in discussions with patients as we trusted and respected each other over time. If I approached politics objectively and nonjudgmentally, it generally led to meaningful conversation. This helped me to understand the patient as an individual and informed my diagnosis and treatment plan.
 

Politics as stress

For example, on more than one occasion, a patient with atrial fibrillation presented with persistent elevated blood pressure and pulse rate despite adherence to the medical regimen that I had prescribed. After a few minutes of discussion, it was clear that excessive attention to political commentary on TV and social media raised their anxiety and anger level, putting them at greater risk for adverse outcomes. I advised that they refocus their leisure activities rather than change or increase medication.

It is disappointing to see how one of the great scientific advances of our lifetime, vaccination science, has been tarnished because of political or religious ideology and to see the extent to which these beliefs influenced COVID-19 vaccination compliance. As health care providers, we must promote information based on the scientific method. If patients challenge us and point out that recommendations based on science seem to change over time, we must explain that science evolves on the basis of new information objectively gathered. We need to find out what information the patient has gotten from the Internet, TV, or conspiracy theories and counter this with scientific facts. If we do not discuss religion and politics with our patients along with other risk factors, we may compromise our ability to give them the best advice and treatment.

Our patients have a right to their own spiritual and political ideology. If it differs dramatically from our own, this should not influence our commitment to care for them. But we have an obligation to challenge unfounded beliefs about medicine and counter with scientific facts. There are times when individual freedoms must be secondary to public health. Ultimately, it is up to the patient to choose, but they should not be given a “free pass” on the basis of religion or politics. If I know something is true and I would do it myself or recommend it for my family, I have an obligation to provide this recommendation to my patients.

Religious preference is included in medical records. It is not appropriate to add political preference, but the patient benefits if a long-term caregiver knows this information.

During the pandemic, for the first time in my 40+ years of practice, some patients questioned my recommendations and placed equal or greater weight on religion, politics, or conspiracy theories. This continues to be a very real struggle.

Knowing and understanding our patients as individuals is critical to providing optimum care and that means tackling these formally taboo topics. If having a potentially uncomfortable conversation with patients allows us to save one life, it is worth it.
 

Dr. Francis is a cardiologist at Inova Heart and Vascular Institute, McLean, Va. He disclosed no relevant conflict of interest. A version of this article first appeared on Medscape.com.

Americans are not rushing to receive the updated COVID-19 booster vaccine.

The newest booster became available to the public around Labor Day weekend, and about 4.4 million people have gotten it as of Sept. 21, according to Centers for Disease Control and Prevention data. That figure represents about 1.5% of the people eligible to receive the booster, NBC News reported.

The White House has said the total is probably closer to 5 million people. The CDC totals don’t yet include Texas and Idaho, which use an aggregate vaccination record reporting method for the Pfizer vaccine.

Scott Roberts, MD, a Yale Medicine infectious disease specialist in New Haven, Conn., told NBC News the low numbers are “demoralizing.”

“I would expect a much higher proportion of Americans to have gotten the booster by this point,” he said. “The fact that this booster came out days before Biden said the pandemic is over is a huge mixed message. Now it’s going to be that much harder to convince those at risk who are on the fence to get a booster.”

White House COVID-19 coordinator Ashish Jha, MD, says he thinks demand will pick up in the coming weeks.

“We’ve been thinking and talking about this as an annual vaccine like the flu vaccine. Flu vaccine season picks up in late September and early October. We’re just getting our education campaign going. So we expect to see, despite the fact that this was a strong start, we actually expect this to ramp up stronger,” Dr. Jha said.

The new booster is the third one authorized by the federal government and was redesigned to protect against the currently circulating subvariants BA.4 and BA.5 of the Omicron strain. People who have received a primary vaccine series or a booster at least 2 months before can receive it.

The new Pfizer booster is available for people 12 and up and the Moderna version for people 18 and up. The vaccines can be mixed and matched.

A version of this article first appeared on WebMD.com.

Americans are not rushing to receive the updated COVID-19 booster vaccine.

The newest booster became available to the public around Labor Day weekend, and about 4.4 million people have gotten it as of Sept. 21, according to Centers for Disease Control and Prevention data. That figure represents about 1.5% of the people eligible to receive the booster, NBC News reported.

The White House has said the total is probably closer to 5 million people. The CDC totals don’t yet include Texas and Idaho, which use an aggregate vaccination record reporting method for the Pfizer vaccine.

Scott Roberts, MD, a Yale Medicine infectious disease specialist in New Haven, Conn., told NBC News the low numbers are “demoralizing.”

“I would expect a much higher proportion of Americans to have gotten the booster by this point,” he said. “The fact that this booster came out days before Biden said the pandemic is over is a huge mixed message. Now it’s going to be that much harder to convince those at risk who are on the fence to get a booster.”

White House COVID-19 coordinator Ashish Jha, MD, says he thinks demand will pick up in the coming weeks.

“We’ve been thinking and talking about this as an annual vaccine like the flu vaccine. Flu vaccine season picks up in late September and early October. We’re just getting our education campaign going. So we expect to see, despite the fact that this was a strong start, we actually expect this to ramp up stronger,” Dr. Jha said.

The new booster is the third one authorized by the federal government and was redesigned to protect against the currently circulating subvariants BA.4 and BA.5 of the Omicron strain. People who have received a primary vaccine series or a booster at least 2 months before can receive it.

The new Pfizer booster is available for people 12 and up and the Moderna version for people 18 and up. The vaccines can be mixed and matched.

A version of this article first appeared on WebMD.com.

Americans are not rushing to receive the updated COVID-19 booster vaccine.

The newest booster became available to the public around Labor Day weekend, and about 4.4 million people have gotten it as of Sept. 21, according to Centers for Disease Control and Prevention data. That figure represents about 1.5% of the people eligible to receive the booster, NBC News reported.

The White House has said the total is probably closer to 5 million people. The CDC totals don’t yet include Texas and Idaho, which use an aggregate vaccination record reporting method for the Pfizer vaccine.

Scott Roberts, MD, a Yale Medicine infectious disease specialist in New Haven, Conn., told NBC News the low numbers are “demoralizing.”

“I would expect a much higher proportion of Americans to have gotten the booster by this point,” he said. “The fact that this booster came out days before Biden said the pandemic is over is a huge mixed message. Now it’s going to be that much harder to convince those at risk who are on the fence to get a booster.”

White House COVID-19 coordinator Ashish Jha, MD, says he thinks demand will pick up in the coming weeks.

“We’ve been thinking and talking about this as an annual vaccine like the flu vaccine. Flu vaccine season picks up in late September and early October. We’re just getting our education campaign going. So we expect to see, despite the fact that this was a strong start, we actually expect this to ramp up stronger,” Dr. Jha said.

The new booster is the third one authorized by the federal government and was redesigned to protect against the currently circulating subvariants BA.4 and BA.5 of the Omicron strain. People who have received a primary vaccine series or a booster at least 2 months before can receive it.

The new Pfizer booster is available for people 12 and up and the Moderna version for people 18 and up. The vaccines can be mixed and matched.

A version of this article first appeared on WebMD.com.

Shift workers who confine their eating to the daytime may experience fewer mood symptoms compared to those who eat both day and night, new research suggests.

Investigators at Brigham and Women’s Hospital, Boston, created a simulated nightwork schedule for 19 individuals in a laboratory setting. Participants then engaged in two different meal timing models – daytime-only meals (DMI), and meals taken during both daytime and nighttime (DNMC).

Depression- and anxiety-like mood levels increased by 26% and 16%, respectively, among the daytime and nighttime eaters, but there was no such increase in daytime-only eaters.

“Our findings provide evidence for the timing of food intake as a novel strategy to potentially minimize mood vulnerability in individuals experiencing circadian misalignment, such as people engaged in shift work, experiencing jet lag, or suffering from circadian rhythm disorders,” co–corresponding author Frank A.J.L. Scheer, PhD, director of the medical chronobiology program, Brigham and Women’s Hospital, Boston, said in a news release.

The study was published online in the Proceedings of the National Academy of Sciences.
 

Misaligned circadian clock

“Shift workers often experience a misalignment between their central circadian clock in the brain and daily behaviors, such as sleep/wake and fasting/eating cycles,” senior author Sarah Chellappa, MD, PhD, currently the Alexander Von Humboldt Experienced Fellow in the department of nuclear medicine, University of Cologne (Germany). Dr. Chellappa was a postdoctoral fellow at Brigham and Women’s Hospital when the study was conducted.

“They also have a 25%-40% higher risk of depression and anxiety,” she continued. “Since meal timing is important for physical health and diet is important for mood, we sought to find out whether meal timing can benefit mental health as well.”

Given that impaired glycemic control is a “risk factor for mood disruption,” the researchers tested the prediction that daytime eating “would prevent mood vulnerability, despite simulated night work.”

To investigate the question, they conducted a parallel-design, randomized clinical trial that included a 14-day circadian laboratory protocol with 19 healthy adults (12 men, 7 women; mean age, 26.5 ± 4.1 years) who underwent a forced desynchrony (FD) in dim light for 4 “days,” each of which consisted of 28 hours. Each 28-hour “day” resulted in an additional 4-hour misalignment between the central circadian clock and external behavioral/environmental cycles.

By the fourth day, the participants were misaligned by 12 hours, compared to baseline (that is, the first day). They were then randomly assigned to two groups.

The DNMC group – the control group – had a “typical 28-hour FD protocol,” with behavioral and environmental cycles (sleep/wake, rest/activity, supine/upright posture, dark during scheduled sleep/dim light during wakefulness) scheduled on a 28-hour cycle. Thus, they took their meals during both “daytime” and “nighttime,” which is the typical way that night workers eat.

The DMI group underwent a modified 28-hour FD protocol, with all cycles scheduled on a 28-hour basis, except for the fasting/eating cycle, which was scheduled on a 24-hour basis, resulting in meals consumed only during the “daytime.”

Depression- and anxiety-like mood (which “correspond to an amalgam of mood states typically observed in depression and anxiety) were assessed every hour during the 4 FD days, using computerized visual analogue scales.
 

Nutritional psychiatry

Participants in the DNMC group experienced an increase from baseline in depression- and anxiety-like mood levels of 26.2% (95% confidence interval, 21-31.5; P = .001; P value using false discovery rate, .01; effect-size r, 0.78) and 16.1% (95% CI, 8.5-23.6; P = .005; PFDR, .001; effect-size r, 0.47), respectively.

By contrast, a similar increase did not take place in the DMI group for either depression- or anxiety-like mood levels (95% CI, –5.7% to 7.4%, P not significant and 95% CI, –3.1% to 9.9%, P not significant, respectively).

The researchers tested “whether increase mood vulnerability during simulated night work was associated with the degree of internal circadian misalignment” — defined as “change in the phase difference between the acrophase of circadian glucose rhythms and the bathyphase of circadian body temperature rhythms.”

They found that a larger degree of internal circadian misalignment was “robustly associated” with more depression-like (r, 0.77; P = .001) and anxiety-like (r, 0.67; P = .002) mood levels during simulated night work.

The findings imply that meal timing had “moderate to large effects in depression-like and anxiety-like mood levels during night work, and that such effects were associated with the degree of internal circadian misalignment,” the authors wrote.

The laboratory protocol of both groups was identical except for the timing of meals. The authors noted that the “relevance of diet on sleep, circadian rhythms, and mental health is receiving growing awareness with the emergence of a new field, nutritional psychiatry.”

People who experience depression “often report poor-quality diets with high carbohydrate intake,” and there is evidence that adherence to the Mediterranean diet is associated “with lower odds of depression, anxiety, and psychological distress.”

They cautioned that although these emerging studies suggest an association between dietary factors and mental health, “experimental studies in individuals with depression and/or anxiety/anxiety-related disorders are required to determine causality and direction of effects.”

They described meal timing as “an emerging aspect of nutrition, with increasing research interest because of its influence on physical health.” However, they noted, “the causal role of the timing of food intake on mental health remains to be tested.”
 

Novel findings

Commenting for this article, Kathleen Merikangas, PhD, distinguished investigator and chief, genetic epidemiology research branch, intramural research program, National Institute of Mental Health, Bethesda, Md., described the research as important with novel findings.

The research “employs the elegant, carefully controlled laboratory procedures that have unraveled the influence of light and other environmental cues on sleep and circadian rhythms over the past 2 decades,” said Dr. Merikangas, who was not involved with the study.

“One of the most significant contributions of this work is its demonstration of the importance of investigating circadian rhythms of multiple systems rather than solely focusing on sleep, eating, or emotional states that have often been studied in isolation,” she pointed out.

“Growing evidence from basic research highlights the interdependence of multiple human systems that should be built into interventions that tend to focus on one or two domains.”

She recommended that this work be replicated “in more diverse samples ... in both controlled and naturalistic settings...to test both the generalizability and mechanism of these intriguing findings.”

The study was funded by the National Institutes of Health. Individual investigators were funded by the Alexander Von Humboldt Foundation and the American Diabetes Association. Dr. Chellappa disclosed no relevant financial relationships. Dr. Merikangas disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Shift workers who confine their eating to the daytime may experience fewer mood symptoms compared to those who eat both day and night, new research suggests.

Investigators at Brigham and Women’s Hospital, Boston, created a simulated nightwork schedule for 19 individuals in a laboratory setting. Participants then engaged in two different meal timing models – daytime-only meals (DMI), and meals taken during both daytime and nighttime (DNMC).

Depression- and anxiety-like mood levels increased by 26% and 16%, respectively, among the daytime and nighttime eaters, but there was no such increase in daytime-only eaters.

“Our findings provide evidence for the timing of food intake as a novel strategy to potentially minimize mood vulnerability in individuals experiencing circadian misalignment, such as people engaged in shift work, experiencing jet lag, or suffering from circadian rhythm disorders,” co–corresponding author Frank A.J.L. Scheer, PhD, director of the medical chronobiology program, Brigham and Women’s Hospital, Boston, said in a news release.

The study was published online in the Proceedings of the National Academy of Sciences.
 

Misaligned circadian clock

“Shift workers often experience a misalignment between their central circadian clock in the brain and daily behaviors, such as sleep/wake and fasting/eating cycles,” senior author Sarah Chellappa, MD, PhD, currently the Alexander Von Humboldt Experienced Fellow in the department of nuclear medicine, University of Cologne (Germany). Dr. Chellappa was a postdoctoral fellow at Brigham and Women’s Hospital when the study was conducted.

“They also have a 25%-40% higher risk of depression and anxiety,” she continued. “Since meal timing is important for physical health and diet is important for mood, we sought to find out whether meal timing can benefit mental health as well.”

Given that impaired glycemic control is a “risk factor for mood disruption,” the researchers tested the prediction that daytime eating “would prevent mood vulnerability, despite simulated night work.”

To investigate the question, they conducted a parallel-design, randomized clinical trial that included a 14-day circadian laboratory protocol with 19 healthy adults (12 men, 7 women; mean age, 26.5 ± 4.1 years) who underwent a forced desynchrony (FD) in dim light for 4 “days,” each of which consisted of 28 hours. Each 28-hour “day” resulted in an additional 4-hour misalignment between the central circadian clock and external behavioral/environmental cycles.

By the fourth day, the participants were misaligned by 12 hours, compared to baseline (that is, the first day). They were then randomly assigned to two groups.

The DNMC group – the control group – had a “typical 28-hour FD protocol,” with behavioral and environmental cycles (sleep/wake, rest/activity, supine/upright posture, dark during scheduled sleep/dim light during wakefulness) scheduled on a 28-hour cycle. Thus, they took their meals during both “daytime” and “nighttime,” which is the typical way that night workers eat.

The DMI group underwent a modified 28-hour FD protocol, with all cycles scheduled on a 28-hour basis, except for the fasting/eating cycle, which was scheduled on a 24-hour basis, resulting in meals consumed only during the “daytime.”

Depression- and anxiety-like mood (which “correspond to an amalgam of mood states typically observed in depression and anxiety) were assessed every hour during the 4 FD days, using computerized visual analogue scales.
 

Nutritional psychiatry

Participants in the DNMC group experienced an increase from baseline in depression- and anxiety-like mood levels of 26.2% (95% confidence interval, 21-31.5; P = .001; P value using false discovery rate, .01; effect-size r, 0.78) and 16.1% (95% CI, 8.5-23.6; P = .005; PFDR, .001; effect-size r, 0.47), respectively.

By contrast, a similar increase did not take place in the DMI group for either depression- or anxiety-like mood levels (95% CI, –5.7% to 7.4%, P not significant and 95% CI, –3.1% to 9.9%, P not significant, respectively).

The researchers tested “whether increase mood vulnerability during simulated night work was associated with the degree of internal circadian misalignment” — defined as “change in the phase difference between the acrophase of circadian glucose rhythms and the bathyphase of circadian body temperature rhythms.”

They found that a larger degree of internal circadian misalignment was “robustly associated” with more depression-like (r, 0.77; P = .001) and anxiety-like (r, 0.67; P = .002) mood levels during simulated night work.

The findings imply that meal timing had “moderate to large effects in depression-like and anxiety-like mood levels during night work, and that such effects were associated with the degree of internal circadian misalignment,” the authors wrote.

The laboratory protocol of both groups was identical except for the timing of meals. The authors noted that the “relevance of diet on sleep, circadian rhythms, and mental health is receiving growing awareness with the emergence of a new field, nutritional psychiatry.”

People who experience depression “often report poor-quality diets with high carbohydrate intake,” and there is evidence that adherence to the Mediterranean diet is associated “with lower odds of depression, anxiety, and psychological distress.”

They cautioned that although these emerging studies suggest an association between dietary factors and mental health, “experimental studies in individuals with depression and/or anxiety/anxiety-related disorders are required to determine causality and direction of effects.”

They described meal timing as “an emerging aspect of nutrition, with increasing research interest because of its influence on physical health.” However, they noted, “the causal role of the timing of food intake on mental health remains to be tested.”
 

Novel findings

Commenting for this article, Kathleen Merikangas, PhD, distinguished investigator and chief, genetic epidemiology research branch, intramural research program, National Institute of Mental Health, Bethesda, Md., described the research as important with novel findings.

The research “employs the elegant, carefully controlled laboratory procedures that have unraveled the influence of light and other environmental cues on sleep and circadian rhythms over the past 2 decades,” said Dr. Merikangas, who was not involved with the study.

“One of the most significant contributions of this work is its demonstration of the importance of investigating circadian rhythms of multiple systems rather than solely focusing on sleep, eating, or emotional states that have often been studied in isolation,” she pointed out.

“Growing evidence from basic research highlights the interdependence of multiple human systems that should be built into interventions that tend to focus on one or two domains.”

She recommended that this work be replicated “in more diverse samples ... in both controlled and naturalistic settings...to test both the generalizability and mechanism of these intriguing findings.”

The study was funded by the National Institutes of Health. Individual investigators were funded by the Alexander Von Humboldt Foundation and the American Diabetes Association. Dr. Chellappa disclosed no relevant financial relationships. Dr. Merikangas disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Shift workers who confine their eating to the daytime may experience fewer mood symptoms compared to those who eat both day and night, new research suggests.

Investigators at Brigham and Women’s Hospital, Boston, created a simulated nightwork schedule for 19 individuals in a laboratory setting. Participants then engaged in two different meal timing models – daytime-only meals (DMI), and meals taken during both daytime and nighttime (DNMC).

Depression- and anxiety-like mood levels increased by 26% and 16%, respectively, among the daytime and nighttime eaters, but there was no such increase in daytime-only eaters.

“Our findings provide evidence for the timing of food intake as a novel strategy to potentially minimize mood vulnerability in individuals experiencing circadian misalignment, such as people engaged in shift work, experiencing jet lag, or suffering from circadian rhythm disorders,” co–corresponding author Frank A.J.L. Scheer, PhD, director of the medical chronobiology program, Brigham and Women’s Hospital, Boston, said in a news release.

The study was published online in the Proceedings of the National Academy of Sciences.
 

Misaligned circadian clock

“Shift workers often experience a misalignment between their central circadian clock in the brain and daily behaviors, such as sleep/wake and fasting/eating cycles,” senior author Sarah Chellappa, MD, PhD, currently the Alexander Von Humboldt Experienced Fellow in the department of nuclear medicine, University of Cologne (Germany). Dr. Chellappa was a postdoctoral fellow at Brigham and Women’s Hospital when the study was conducted.

“They also have a 25%-40% higher risk of depression and anxiety,” she continued. “Since meal timing is important for physical health and diet is important for mood, we sought to find out whether meal timing can benefit mental health as well.”

Given that impaired glycemic control is a “risk factor for mood disruption,” the researchers tested the prediction that daytime eating “would prevent mood vulnerability, despite simulated night work.”

To investigate the question, they conducted a parallel-design, randomized clinical trial that included a 14-day circadian laboratory protocol with 19 healthy adults (12 men, 7 women; mean age, 26.5 ± 4.1 years) who underwent a forced desynchrony (FD) in dim light for 4 “days,” each of which consisted of 28 hours. Each 28-hour “day” resulted in an additional 4-hour misalignment between the central circadian clock and external behavioral/environmental cycles.

By the fourth day, the participants were misaligned by 12 hours, compared to baseline (that is, the first day). They were then randomly assigned to two groups.

The DNMC group – the control group – had a “typical 28-hour FD protocol,” with behavioral and environmental cycles (sleep/wake, rest/activity, supine/upright posture, dark during scheduled sleep/dim light during wakefulness) scheduled on a 28-hour cycle. Thus, they took their meals during both “daytime” and “nighttime,” which is the typical way that night workers eat.

The DMI group underwent a modified 28-hour FD protocol, with all cycles scheduled on a 28-hour basis, except for the fasting/eating cycle, which was scheduled on a 24-hour basis, resulting in meals consumed only during the “daytime.”

Depression- and anxiety-like mood (which “correspond to an amalgam of mood states typically observed in depression and anxiety) were assessed every hour during the 4 FD days, using computerized visual analogue scales.
 

Nutritional psychiatry

Participants in the DNMC group experienced an increase from baseline in depression- and anxiety-like mood levels of 26.2% (95% confidence interval, 21-31.5; P = .001; P value using false discovery rate, .01; effect-size r, 0.78) and 16.1% (95% CI, 8.5-23.6; P = .005; PFDR, .001; effect-size r, 0.47), respectively.

By contrast, a similar increase did not take place in the DMI group for either depression- or anxiety-like mood levels (95% CI, –5.7% to 7.4%, P not significant and 95% CI, –3.1% to 9.9%, P not significant, respectively).

The researchers tested “whether increase mood vulnerability during simulated night work was associated with the degree of internal circadian misalignment” — defined as “change in the phase difference between the acrophase of circadian glucose rhythms and the bathyphase of circadian body temperature rhythms.”

They found that a larger degree of internal circadian misalignment was “robustly associated” with more depression-like (r, 0.77; P = .001) and anxiety-like (r, 0.67; P = .002) mood levels during simulated night work.

The findings imply that meal timing had “moderate to large effects in depression-like and anxiety-like mood levels during night work, and that such effects were associated with the degree of internal circadian misalignment,” the authors wrote.

The laboratory protocol of both groups was identical except for the timing of meals. The authors noted that the “relevance of diet on sleep, circadian rhythms, and mental health is receiving growing awareness with the emergence of a new field, nutritional psychiatry.”

People who experience depression “often report poor-quality diets with high carbohydrate intake,” and there is evidence that adherence to the Mediterranean diet is associated “with lower odds of depression, anxiety, and psychological distress.”

They cautioned that although these emerging studies suggest an association between dietary factors and mental health, “experimental studies in individuals with depression and/or anxiety/anxiety-related disorders are required to determine causality and direction of effects.”

They described meal timing as “an emerging aspect of nutrition, with increasing research interest because of its influence on physical health.” However, they noted, “the causal role of the timing of food intake on mental health remains to be tested.”
 

Novel findings

Commenting for this article, Kathleen Merikangas, PhD, distinguished investigator and chief, genetic epidemiology research branch, intramural research program, National Institute of Mental Health, Bethesda, Md., described the research as important with novel findings.

The research “employs the elegant, carefully controlled laboratory procedures that have unraveled the influence of light and other environmental cues on sleep and circadian rhythms over the past 2 decades,” said Dr. Merikangas, who was not involved with the study.

“One of the most significant contributions of this work is its demonstration of the importance of investigating circadian rhythms of multiple systems rather than solely focusing on sleep, eating, or emotional states that have often been studied in isolation,” she pointed out.

“Growing evidence from basic research highlights the interdependence of multiple human systems that should be built into interventions that tend to focus on one or two domains.”

She recommended that this work be replicated “in more diverse samples ... in both controlled and naturalistic settings...to test both the generalizability and mechanism of these intriguing findings.”

The study was funded by the National Institutes of Health. Individual investigators were funded by the Alexander Von Humboldt Foundation and the American Diabetes Association. Dr. Chellappa disclosed no relevant financial relationships. Dr. Merikangas disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

For some parents, resuming sexual intimacy after having a baby is a top priority. For others, not so much – and late-night feedings and diaper changes may not be the only hang-ups.

Dyspareunia – pain during sex – occurs in a substantial number of women after childbirth, and recent research sheds light on how psychological and biomedical factors relate to this condition.

Mode of delivery, for instance, may have less of an effect on sexual well-being than some people suspect.

Despite a perception that cesarean delivery might affect sexual function less than vaginal delivery does, how mothers delivered did not affect how often they had sex postpartum or the amount of enjoyment they got from it, according to research published in BJOG.

Eleven years after delivery, however, cesarean delivery was associated with a 74% increased likelihood of pain in the vagina during sex, compared with vaginal delivery, the researchers found (odds ratio, 1.74; 95% confidence interval, 1.46-2.08).

The results suggest that cesarean delivery “may not help protect against sexual dysfunction, as previously thought,” Flo Martin, a PhD student in epidemiology at the University of Bristol, United Kingdom, and lead author of the study, said in a news release.

For their study, Ms. Martin and her colleagues analyzed data from more than 10,300 participants in the Avon Longitudinal Study of Parents and Children, which recruited women in the United Kingdom who were pregnant in 1991 and 1992.

The researchers had data about pain during sex at 11 years. They had data about sexual enjoyment and frequency at 33  months, 5 years, 12 years, and 18 years after delivery.

If women experienced pain during sex years after cesarean delivery, uterine scarring might have been a cause, Ms. Martin and colleagues suggested. Alternatively, women with dyspareunia before delivery may be more likely to have cesarean surgery, which also could explain the association.

Other studies have likewise found that different modes of delivery generally lead to similar outcomes of sexual well-being after birth.

“Several of my own longitudinal studies have shown limited associations between mode of delivery and various aspects of sexual well-being, including sexual satisfaction, sexual function, and sexual desire,” said Natalie O. Rosen, PhD, director of the Couples and Sexual Health Laboratory at Dalhousie University, Halifax, N.S.

Nevertheless, other published studies have yielded conflicting results, so the question warrants further study, she said.
 

Pain catastrophizing

One study by Dr. Rosen’s group, published in Obstetrics & Gynecology, tracked sexual pain in 582 people from mid-pregnancy to 2 years postpartum.

About 21% of participants experienced moderate pain during sex, as determined by an average pain score greater than 4 on scale of 0-10 points. The rest were classified as having “minimal dyspareunia.”

Pain tended to peak at 3 months postpartum and then steadily decrease in both the moderate and minimal pain groups.

Mode of delivery did not affect the odds that a participant would have moderate dyspareunia. Neither did breastfeeding or prior chronic pain.

“But we did find one key thing to look out for: Those who reported a lot of negative thoughts and feelings about pain, something called pain catastrophizing, were more likely to experience moderate persistent pain during sex,” the researchers said in a video about their findings.

Pain catastrophizing 3 months after delivery was associated with significantly increased odds of following a moderate pain trajectory (odds ratio, 1.09; 95% confidence interval, 1.04-1.15).
 

Let’s talk about #postbabyhankypanky

Caring for a newborn while maintaining a romantic relationship can be challenging, and “there is a lack of evidence-based research aimed at helping couples prevent and navigate changes to their sexual well-being postpartum,” Dr. Rosen said.

During the 2-year study, a growing number of participants reported having sex less often over time. The percentage of women who had engaged in sexual activity in the past 4 weeks was 99% at baseline (20-24 weeks of gestation), 83.5% at 32 weeks of gestation, 73.9% at 3 months postpartum, and 69.6% at 2 years postpartum.

“One crucial way that couples sustain their connection is through their sexuality,” Dr. Rosen said. “Unfortunately, most new parents experience significant disruptions to their sexual function,” such as lower sexual desire or more pain during intercourse.

Dr. Rosen’s group has created a series of videos related to this topic dubbed #postbabyhankypanky to facilitate communication about sex postpartum. She encourages women with dyspareunia to talk with a health care provider because treatments such as cognitive-behavioral therapy, pelvic floor physical therapy, and topical medications can help manage pain.
 

‘Reassuring’ data

Veronica Gillispie-Bell, MD, MAS, director of quality for women’s services at the Ochsner Health System, New Orleans, said that she sees patients with postpartum sexual pain frequently.

Patients typically are instructed to have pelvic rest from delivery until 6 weeks after.

At the 6-week appointment, she tells patients to make sure that they are using lots of lubrication, because vaginal dryness related to hormonal changes during pregnancy and breastfeeding can make sex more painful, regardless of mode of delivery.

For many patients, she also recommends pelvic floor physical therapy.

As the medical director for the Louisiana Perinatal Quality Collaborative – a network of care providers, public health officials, and advocates that aims to improve outcomes for birthing persons, families, and newborns – Dr. Gillispie-Bell also is focused on reducing the rate of cesarean deliveries in the state. The BJOG study showing an increased risk for dyspareunia after a cesarean surgery serves as a reminder that there may be “long-term effects of having a C-section that may not be as obvious,” she said.

“C-sections are life-saving procedures, but they are not without risk,” Dr. Gillispie-Bell said.

Leila Frodsham, MBChB, a spokesperson for the Royal College of Obstetricians and Gynaecologists, told Medscape UK that it was “reassuring” to see “no difference in sexual enjoyment or sexual frequency at any time point postpartum between women who gave birth via cesarean section and those who delivered vaginally.”

“Women should be supported to make informed decisions about how they plan to give birth, and it is vital that health care professionals respect their preferences,” Dr. Frodsham added.

Clinicians should also remain aware that sexual pain is also common during periods of subfertility, perimenopause, and initiation of sexual activity.

Combinations of biological, psychological, and social factors can influence pain during sex, and there is an interpersonal element to keep in mind as well, Dr. Rosen noted.

“Pain during sex is typically elicited in the context of a partnered relationship,” Dr. Rosen said. “This means that this is an inherently interpersonal issue – let’s not forget about the partner who is both impacted by and can impact the pain through their own responses.”

A version of this article first appeared on Medscape.com.

For some parents, resuming sexual intimacy after having a baby is a top priority. For others, not so much – and late-night feedings and diaper changes may not be the only hang-ups.

Dyspareunia – pain during sex – occurs in a substantial number of women after childbirth, and recent research sheds light on how psychological and biomedical factors relate to this condition.

Mode of delivery, for instance, may have less of an effect on sexual well-being than some people suspect.

Despite a perception that cesarean delivery might affect sexual function less than vaginal delivery does, how mothers delivered did not affect how often they had sex postpartum or the amount of enjoyment they got from it, according to research published in BJOG.

Eleven years after delivery, however, cesarean delivery was associated with a 74% increased likelihood of pain in the vagina during sex, compared with vaginal delivery, the researchers found (odds ratio, 1.74; 95% confidence interval, 1.46-2.08).

The results suggest that cesarean delivery “may not help protect against sexual dysfunction, as previously thought,” Flo Martin, a PhD student in epidemiology at the University of Bristol, United Kingdom, and lead author of the study, said in a news release.

For their study, Ms. Martin and her colleagues analyzed data from more than 10,300 participants in the Avon Longitudinal Study of Parents and Children, which recruited women in the United Kingdom who were pregnant in 1991 and 1992.

The researchers had data about pain during sex at 11 years. They had data about sexual enjoyment and frequency at 33  months, 5 years, 12 years, and 18 years after delivery.

If women experienced pain during sex years after cesarean delivery, uterine scarring might have been a cause, Ms. Martin and colleagues suggested. Alternatively, women with dyspareunia before delivery may be more likely to have cesarean surgery, which also could explain the association.

Other studies have likewise found that different modes of delivery generally lead to similar outcomes of sexual well-being after birth.

“Several of my own longitudinal studies have shown limited associations between mode of delivery and various aspects of sexual well-being, including sexual satisfaction, sexual function, and sexual desire,” said Natalie O. Rosen, PhD, director of the Couples and Sexual Health Laboratory at Dalhousie University, Halifax, N.S.

Nevertheless, other published studies have yielded conflicting results, so the question warrants further study, she said.
 

Pain catastrophizing

One study by Dr. Rosen’s group, published in Obstetrics & Gynecology, tracked sexual pain in 582 people from mid-pregnancy to 2 years postpartum.

About 21% of participants experienced moderate pain during sex, as determined by an average pain score greater than 4 on scale of 0-10 points. The rest were classified as having “minimal dyspareunia.”

Pain tended to peak at 3 months postpartum and then steadily decrease in both the moderate and minimal pain groups.

Mode of delivery did not affect the odds that a participant would have moderate dyspareunia. Neither did breastfeeding or prior chronic pain.

“But we did find one key thing to look out for: Those who reported a lot of negative thoughts and feelings about pain, something called pain catastrophizing, were more likely to experience moderate persistent pain during sex,” the researchers said in a video about their findings.

Pain catastrophizing 3 months after delivery was associated with significantly increased odds of following a moderate pain trajectory (odds ratio, 1.09; 95% confidence interval, 1.04-1.15).
 

Let’s talk about #postbabyhankypanky

Caring for a newborn while maintaining a romantic relationship can be challenging, and “there is a lack of evidence-based research aimed at helping couples prevent and navigate changes to their sexual well-being postpartum,” Dr. Rosen said.

During the 2-year study, a growing number of participants reported having sex less often over time. The percentage of women who had engaged in sexual activity in the past 4 weeks was 99% at baseline (20-24 weeks of gestation), 83.5% at 32 weeks of gestation, 73.9% at 3 months postpartum, and 69.6% at 2 years postpartum.

“One crucial way that couples sustain their connection is through their sexuality,” Dr. Rosen said. “Unfortunately, most new parents experience significant disruptions to their sexual function,” such as lower sexual desire or more pain during intercourse.

Dr. Rosen’s group has created a series of videos related to this topic dubbed #postbabyhankypanky to facilitate communication about sex postpartum. She encourages women with dyspareunia to talk with a health care provider because treatments such as cognitive-behavioral therapy, pelvic floor physical therapy, and topical medications can help manage pain.
 

‘Reassuring’ data

Veronica Gillispie-Bell, MD, MAS, director of quality for women’s services at the Ochsner Health System, New Orleans, said that she sees patients with postpartum sexual pain frequently.

Patients typically are instructed to have pelvic rest from delivery until 6 weeks after.

At the 6-week appointment, she tells patients to make sure that they are using lots of lubrication, because vaginal dryness related to hormonal changes during pregnancy and breastfeeding can make sex more painful, regardless of mode of delivery.

For many patients, she also recommends pelvic floor physical therapy.

As the medical director for the Louisiana Perinatal Quality Collaborative – a network of care providers, public health officials, and advocates that aims to improve outcomes for birthing persons, families, and newborns – Dr. Gillispie-Bell also is focused on reducing the rate of cesarean deliveries in the state. The BJOG study showing an increased risk for dyspareunia after a cesarean surgery serves as a reminder that there may be “long-term effects of having a C-section that may not be as obvious,” she said.

“C-sections are life-saving procedures, but they are not without risk,” Dr. Gillispie-Bell said.

Leila Frodsham, MBChB, a spokesperson for the Royal College of Obstetricians and Gynaecologists, told Medscape UK that it was “reassuring” to see “no difference in sexual enjoyment or sexual frequency at any time point postpartum between women who gave birth via cesarean section and those who delivered vaginally.”

“Women should be supported to make informed decisions about how they plan to give birth, and it is vital that health care professionals respect their preferences,” Dr. Frodsham added.

Clinicians should also remain aware that sexual pain is also common during periods of subfertility, perimenopause, and initiation of sexual activity.

Combinations of biological, psychological, and social factors can influence pain during sex, and there is an interpersonal element to keep in mind as well, Dr. Rosen noted.

“Pain during sex is typically elicited in the context of a partnered relationship,” Dr. Rosen said. “This means that this is an inherently interpersonal issue – let’s not forget about the partner who is both impacted by and can impact the pain through their own responses.”

A version of this article first appeared on Medscape.com.

For some parents, resuming sexual intimacy after having a baby is a top priority. For others, not so much – and late-night feedings and diaper changes may not be the only hang-ups.

Dyspareunia – pain during sex – occurs in a substantial number of women after childbirth, and recent research sheds light on how psychological and biomedical factors relate to this condition.

Mode of delivery, for instance, may have less of an effect on sexual well-being than some people suspect.

Despite a perception that cesarean delivery might affect sexual function less than vaginal delivery does, how mothers delivered did not affect how often they had sex postpartum or the amount of enjoyment they got from it, according to research published in BJOG.

Eleven years after delivery, however, cesarean delivery was associated with a 74% increased likelihood of pain in the vagina during sex, compared with vaginal delivery, the researchers found (odds ratio, 1.74; 95% confidence interval, 1.46-2.08).

The results suggest that cesarean delivery “may not help protect against sexual dysfunction, as previously thought,” Flo Martin, a PhD student in epidemiology at the University of Bristol, United Kingdom, and lead author of the study, said in a news release.

For their study, Ms. Martin and her colleagues analyzed data from more than 10,300 participants in the Avon Longitudinal Study of Parents and Children, which recruited women in the United Kingdom who were pregnant in 1991 and 1992.

The researchers had data about pain during sex at 11 years. They had data about sexual enjoyment and frequency at 33  months, 5 years, 12 years, and 18 years after delivery.

If women experienced pain during sex years after cesarean delivery, uterine scarring might have been a cause, Ms. Martin and colleagues suggested. Alternatively, women with dyspareunia before delivery may be more likely to have cesarean surgery, which also could explain the association.

Other studies have likewise found that different modes of delivery generally lead to similar outcomes of sexual well-being after birth.

“Several of my own longitudinal studies have shown limited associations between mode of delivery and various aspects of sexual well-being, including sexual satisfaction, sexual function, and sexual desire,” said Natalie O. Rosen, PhD, director of the Couples and Sexual Health Laboratory at Dalhousie University, Halifax, N.S.

Nevertheless, other published studies have yielded conflicting results, so the question warrants further study, she said.
 

Pain catastrophizing

One study by Dr. Rosen’s group, published in Obstetrics & Gynecology, tracked sexual pain in 582 people from mid-pregnancy to 2 years postpartum.

About 21% of participants experienced moderate pain during sex, as determined by an average pain score greater than 4 on scale of 0-10 points. The rest were classified as having “minimal dyspareunia.”

Pain tended to peak at 3 months postpartum and then steadily decrease in both the moderate and minimal pain groups.

Mode of delivery did not affect the odds that a participant would have moderate dyspareunia. Neither did breastfeeding or prior chronic pain.

“But we did find one key thing to look out for: Those who reported a lot of negative thoughts and feelings about pain, something called pain catastrophizing, were more likely to experience moderate persistent pain during sex,” the researchers said in a video about their findings.

Pain catastrophizing 3 months after delivery was associated with significantly increased odds of following a moderate pain trajectory (odds ratio, 1.09; 95% confidence interval, 1.04-1.15).
 

Let’s talk about #postbabyhankypanky

Caring for a newborn while maintaining a romantic relationship can be challenging, and “there is a lack of evidence-based research aimed at helping couples prevent and navigate changes to their sexual well-being postpartum,” Dr. Rosen said.

During the 2-year study, a growing number of participants reported having sex less often over time. The percentage of women who had engaged in sexual activity in the past 4 weeks was 99% at baseline (20-24 weeks of gestation), 83.5% at 32 weeks of gestation, 73.9% at 3 months postpartum, and 69.6% at 2 years postpartum.

“One crucial way that couples sustain their connection is through their sexuality,” Dr. Rosen said. “Unfortunately, most new parents experience significant disruptions to their sexual function,” such as lower sexual desire or more pain during intercourse.

Dr. Rosen’s group has created a series of videos related to this topic dubbed #postbabyhankypanky to facilitate communication about sex postpartum. She encourages women with dyspareunia to talk with a health care provider because treatments such as cognitive-behavioral therapy, pelvic floor physical therapy, and topical medications can help manage pain.
 

‘Reassuring’ data

Veronica Gillispie-Bell, MD, MAS, director of quality for women’s services at the Ochsner Health System, New Orleans, said that she sees patients with postpartum sexual pain frequently.

Patients typically are instructed to have pelvic rest from delivery until 6 weeks after.

At the 6-week appointment, she tells patients to make sure that they are using lots of lubrication, because vaginal dryness related to hormonal changes during pregnancy and breastfeeding can make sex more painful, regardless of mode of delivery.

For many patients, she also recommends pelvic floor physical therapy.

As the medical director for the Louisiana Perinatal Quality Collaborative – a network of care providers, public health officials, and advocates that aims to improve outcomes for birthing persons, families, and newborns – Dr. Gillispie-Bell also is focused on reducing the rate of cesarean deliveries in the state. The BJOG study showing an increased risk for dyspareunia after a cesarean surgery serves as a reminder that there may be “long-term effects of having a C-section that may not be as obvious,” she said.

“C-sections are life-saving procedures, but they are not without risk,” Dr. Gillispie-Bell said.

Leila Frodsham, MBChB, a spokesperson for the Royal College of Obstetricians and Gynaecologists, told Medscape UK that it was “reassuring” to see “no difference in sexual enjoyment or sexual frequency at any time point postpartum between women who gave birth via cesarean section and those who delivered vaginally.”

“Women should be supported to make informed decisions about how they plan to give birth, and it is vital that health care professionals respect their preferences,” Dr. Frodsham added.

Clinicians should also remain aware that sexual pain is also common during periods of subfertility, perimenopause, and initiation of sexual activity.

Combinations of biological, psychological, and social factors can influence pain during sex, and there is an interpersonal element to keep in mind as well, Dr. Rosen noted.

“Pain during sex is typically elicited in the context of a partnered relationship,” Dr. Rosen said. “This means that this is an inherently interpersonal issue – let’s not forget about the partner who is both impacted by and can impact the pain through their own responses.”

A version of this article first appeared on Medscape.com.

The American Academy of Sleep Medicine has issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.

“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” Muhammad Adeel Rishi, MD, MBBS, vice chair of the AASM public safety committee, said in a news release.
 

Spike in poisoning calls

Research previously published in JAMA suggests that the use of melatonin has increased over the past 2 decades among people of all ages.

With this increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.

Federal data show that the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021.

More than 4,000 of the reported ingestions led to a hospital stay, and 287 children required intensive care.

The AASM notes that next to multivitamins, melatonin is the second most popular “natural” product parents give to their children.

Melatonin is widely available over the counter. It’s marketed as a sleep aid, but there is little evidence that taking it as a supplement is effective in treating insomnia in healthy children, the AASM cautions.

Because it is regulated by the U.S. Food and Drug Administration as a dietary supplement, melatonin receives less oversight. Research shows that the melatonin content in supplements can vary widely, the AASM points out.

In one study, amounts of melatonin ranged from less than one-half to more than four times the amounts stated on the labels. The greatest variability in melatonin content was in chewable tablets, which are most likely to be used for children.

“The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose,” said Dr. Rishi, a pulmonology, sleep medicine, and critical care specialist at Indiana University Health Physicians, Indianapolis.

“Parents should talk directly with their child’s health care professional before giving their children melatonin products,” he added.
 

Keep out of reach

The AASM advises that melatonin be managed as any other medication and that it be kept out of reach of children.

Before giving melatonin or any supplement to their children, parents should discuss this decision with a pediatric health care professional.

If use of melatonin is warranted, health care professionals can recommend the appropriate dose and timing in addressing the sleep problem, and they can ensure that the melatonin product that is being used has a USP verified mark.

“Instead of turning to melatonin, parents should encourage children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches,” Dr. Rishi said.

A version of this article first appeared on Medscape.com.

The American Academy of Sleep Medicine has issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.

“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” Muhammad Adeel Rishi, MD, MBBS, vice chair of the AASM public safety committee, said in a news release.
 

Spike in poisoning calls

Research previously published in JAMA suggests that the use of melatonin has increased over the past 2 decades among people of all ages.

With this increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.

Federal data show that the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021.

More than 4,000 of the reported ingestions led to a hospital stay, and 287 children required intensive care.

The AASM notes that next to multivitamins, melatonin is the second most popular “natural” product parents give to their children.

Melatonin is widely available over the counter. It’s marketed as a sleep aid, but there is little evidence that taking it as a supplement is effective in treating insomnia in healthy children, the AASM cautions.

Because it is regulated by the U.S. Food and Drug Administration as a dietary supplement, melatonin receives less oversight. Research shows that the melatonin content in supplements can vary widely, the AASM points out.

In one study, amounts of melatonin ranged from less than one-half to more than four times the amounts stated on the labels. The greatest variability in melatonin content was in chewable tablets, which are most likely to be used for children.

“The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose,” said Dr. Rishi, a pulmonology, sleep medicine, and critical care specialist at Indiana University Health Physicians, Indianapolis.

“Parents should talk directly with their child’s health care professional before giving their children melatonin products,” he added.
 

Keep out of reach

The AASM advises that melatonin be managed as any other medication and that it be kept out of reach of children.

Before giving melatonin or any supplement to their children, parents should discuss this decision with a pediatric health care professional.

If use of melatonin is warranted, health care professionals can recommend the appropriate dose and timing in addressing the sleep problem, and they can ensure that the melatonin product that is being used has a USP verified mark.

“Instead of turning to melatonin, parents should encourage children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches,” Dr. Rishi said.

A version of this article first appeared on Medscape.com.

The American Academy of Sleep Medicine has issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.

“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” Muhammad Adeel Rishi, MD, MBBS, vice chair of the AASM public safety committee, said in a news release.
 

Spike in poisoning calls

Research previously published in JAMA suggests that the use of melatonin has increased over the past 2 decades among people of all ages.

With this increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.

Federal data show that the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021.

More than 4,000 of the reported ingestions led to a hospital stay, and 287 children required intensive care.

The AASM notes that next to multivitamins, melatonin is the second most popular “natural” product parents give to their children.

Melatonin is widely available over the counter. It’s marketed as a sleep aid, but there is little evidence that taking it as a supplement is effective in treating insomnia in healthy children, the AASM cautions.

Because it is regulated by the U.S. Food and Drug Administration as a dietary supplement, melatonin receives less oversight. Research shows that the melatonin content in supplements can vary widely, the AASM points out.

In one study, amounts of melatonin ranged from less than one-half to more than four times the amounts stated on the labels. The greatest variability in melatonin content was in chewable tablets, which are most likely to be used for children.

“The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose,” said Dr. Rishi, a pulmonology, sleep medicine, and critical care specialist at Indiana University Health Physicians, Indianapolis.

“Parents should talk directly with their child’s health care professional before giving their children melatonin products,” he added.
 

Keep out of reach

The AASM advises that melatonin be managed as any other medication and that it be kept out of reach of children.

Before giving melatonin or any supplement to their children, parents should discuss this decision with a pediatric health care professional.

If use of melatonin is warranted, health care professionals can recommend the appropriate dose and timing in addressing the sleep problem, and they can ensure that the melatonin product that is being used has a USP verified mark.

“Instead of turning to melatonin, parents should encourage children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches,” Dr. Rishi said.

A version of this article first appeared on Medscape.com.

Sport climbing can help improve posture in patients with Parkinson’s disease, including older patients, new research suggests.

In a randomized controlled study, those who participated in scaling a wall using ropes and fixed anchors were less stooped at 12 weeks than was a control group that participated in some form of unsupervised physical activity.

The results underscore that it is never too late to learn a new sport or type of movement – and that this type of intervention may have big health payoffs, said study investigator Heidemarie Zach, MD, associate professor of neurology, Medical University of Vienna, Austria.

“There’s no hurdle too high over which you can’t climb, or burden you can’t conquer,”  said Dr. Zach. “As long as you can walk independently and walk up a stair, you can go climbing.”

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Common feature of Parkinson’s disease

The analysis is part of a larger project that included a 2021 study showing a reduced Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score by almost 13 points in patients who participated in sport climbing. The activity was also significantly associated with improved bradykinesia, rigidity, and tremor.

The current analysis focused on stooped posture, which in addition to motor symptoms is a common feature of Parkinson’s disease. This postural deformity can result in significant discomfort, pain, and decreased quality of life.

Pharmaceutical treatments are mostly ineffective for postural deformities, the researchers noted. Physical therapy may help improve symptoms, but only a few randomized studies have examined improved posture in patients with Parkinson’s disease using physiotherapy in general and alternative sports in particular.

Sport climbing is “really unique” in Parkinson’s disease, said Dr. Zach, who has yet to come across other research on this intervention. A climber herself, she recommended it to one of her patients: A 79-year old man with Parkinson’s disease who was a walker and hiker, and who ended up loving the sport. She called him her “pilot patient.”

The single-center study included 48 adult participants up to age 78 years (mean age, 65) with mild to moderate Parkinson’s disease. Most were at Hoehn & Yahr stage 2, with some at stage 3. All had no previous climbing experience. Exclusion criteria included having a condition other than Parkinson’s disease.

The researchers randomly assigned participants to a sport climbing course or to a control group.

The sport climbing group had a 90-minute climbing session each week for 12 weeks in an indoor gym. Under the supervision of an instructor, they were harnessed and connected to ropes with mats placed on the ground for safety.

The climbing wall was about 15 meters (50 feet) high. Participants typically started at 2 or 3 meters (6.5 to 9.5 feet) and worked their way up, Dr. Zach noted.

Those in the control group were asked to participate for 12 weeks in unsupervised physical activity, as recommended by the World Health Organization and the European Physiotherapy Guidelines for Parkinson’s Disease. This included at least 2.5 hours of moderate-intensity activity or 75 minutes of vigorous activity each week.
 

Whole-body workout

The primary outcome was improvement in posture, measured using a “simple” but highly reliable tool, said Dr. Zach. While the patients stood with their backs straight against a wall, researchers measured the distance in centimeters between the C7 sagittal vertical axis (C7SVA) and the wall.

The mean C7SVA at baseline did not significantly differ between the two groups, at 8.2 cm for the climbing group versus  7.7 cm for the control group. However, results showed only sport climbing was associated with significantly lessened forward flexion of the cervical spine.

The climbing group showed a decrease of the C7SVA by 1.7 cm (95% confidence interval [CI], 0.8-2.6 cm). “So climbers were more erect and less stooped after 12 weeks,” Dr. Zach said.

She noted that the mean difference in the control group was 0.5 cm (95% confidence interval [CI], –0.2 to 1.3 cm), which “is almost nothing.”

There did not seem to be any predictor, such as age, sex, or body mass index, for what patient subgroups benefit the most from the intervention, Dr. Zach noted.

In explaining why climbing helps posture, she said it is akin to “a whole-body workout.” The activity increases upper-body strength by using back and shoulder girdle muscles, as well as joint flexibility, Dr. Zach noted. Movements involved in climbing, such as repeated reaching for a distant hold, stretch the muscles of the hip flexors and hip.

As these movements reduce rigidity, the climbing action may also promote an upright posture. And as wall climbing involves planning and executing movements, it trains spatial body awareness, an important component of maintaining and correcting posture, she said.

Dr. Zach noted a motivational group dynamic likely also contributed to the success of the intervention. “They were cheering each other at the bottom” of the climbing wall, she said.

The results show that posture can be added to the improvements in Parkinson’s disease already documented from climbing, including improved motor symptoms, rigidity, and tremor, she said. The next step on the research agenda is to show whether the intervention has a positive impact on gait, Dr. Zach added.
 

‘Quite adventurous’

Commenting on the research, Rebecca Gilbert, MD, PhD, chief scientific officer at the American Parkinson Disease Association, said she welcomes “any new idea” to help patients with Parkinson’s disease – and that sport climbing sounds “quite adventurous.”

“The general concept that you’re asking the body to move in a novel way is a good thing for everyone and especially for people with Parkinson’s disease,” said Dr. Gilbert, who was not involved with the research.

She noted that in Parkinson’s disease, an ideal exercise intervention includes a combination of four modalities: stretching, balance, aerobics, and strengthening. Rope climbing involves many of these, in addition to a cognitive element, Dr. Gilbert said. It’s also important that patients with Parkinson’s disease participate in an activity they enjoy, she added.

However, she stressed that safety has to be “weighed,” especially for patients with stage 3 Parkinson’s disease, who often have balance problems. “It may be difficult to climb a rope if you have balance problems,” Dr. Gilbert said. “The intervention needs to be tailored to the existing disability, and perhaps this activity is more a reasonable thing for patients at milder stages.”

Dr. Zach and Dr. Gilbert have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sport climbing can help improve posture in patients with Parkinson’s disease, including older patients, new research suggests.

In a randomized controlled study, those who participated in scaling a wall using ropes and fixed anchors were less stooped at 12 weeks than was a control group that participated in some form of unsupervised physical activity.

The results underscore that it is never too late to learn a new sport or type of movement – and that this type of intervention may have big health payoffs, said study investigator Heidemarie Zach, MD, associate professor of neurology, Medical University of Vienna, Austria.

“There’s no hurdle too high over which you can’t climb, or burden you can’t conquer,”  said Dr. Zach. “As long as you can walk independently and walk up a stair, you can go climbing.”

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Common feature of Parkinson’s disease

The analysis is part of a larger project that included a 2021 study showing a reduced Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score by almost 13 points in patients who participated in sport climbing. The activity was also significantly associated with improved bradykinesia, rigidity, and tremor.

The current analysis focused on stooped posture, which in addition to motor symptoms is a common feature of Parkinson’s disease. This postural deformity can result in significant discomfort, pain, and decreased quality of life.

Pharmaceutical treatments are mostly ineffective for postural deformities, the researchers noted. Physical therapy may help improve symptoms, but only a few randomized studies have examined improved posture in patients with Parkinson’s disease using physiotherapy in general and alternative sports in particular.

Sport climbing is “really unique” in Parkinson’s disease, said Dr. Zach, who has yet to come across other research on this intervention. A climber herself, she recommended it to one of her patients: A 79-year old man with Parkinson’s disease who was a walker and hiker, and who ended up loving the sport. She called him her “pilot patient.”

The single-center study included 48 adult participants up to age 78 years (mean age, 65) with mild to moderate Parkinson’s disease. Most were at Hoehn & Yahr stage 2, with some at stage 3. All had no previous climbing experience. Exclusion criteria included having a condition other than Parkinson’s disease.

The researchers randomly assigned participants to a sport climbing course or to a control group.

The sport climbing group had a 90-minute climbing session each week for 12 weeks in an indoor gym. Under the supervision of an instructor, they were harnessed and connected to ropes with mats placed on the ground for safety.

The climbing wall was about 15 meters (50 feet) high. Participants typically started at 2 or 3 meters (6.5 to 9.5 feet) and worked their way up, Dr. Zach noted.

Those in the control group were asked to participate for 12 weeks in unsupervised physical activity, as recommended by the World Health Organization and the European Physiotherapy Guidelines for Parkinson’s Disease. This included at least 2.5 hours of moderate-intensity activity or 75 minutes of vigorous activity each week.
 

Whole-body workout

The primary outcome was improvement in posture, measured using a “simple” but highly reliable tool, said Dr. Zach. While the patients stood with their backs straight against a wall, researchers measured the distance in centimeters between the C7 sagittal vertical axis (C7SVA) and the wall.

The mean C7SVA at baseline did not significantly differ between the two groups, at 8.2 cm for the climbing group versus  7.7 cm for the control group. However, results showed only sport climbing was associated with significantly lessened forward flexion of the cervical spine.

The climbing group showed a decrease of the C7SVA by 1.7 cm (95% confidence interval [CI], 0.8-2.6 cm). “So climbers were more erect and less stooped after 12 weeks,” Dr. Zach said.

She noted that the mean difference in the control group was 0.5 cm (95% confidence interval [CI], –0.2 to 1.3 cm), which “is almost nothing.”

There did not seem to be any predictor, such as age, sex, or body mass index, for what patient subgroups benefit the most from the intervention, Dr. Zach noted.

In explaining why climbing helps posture, she said it is akin to “a whole-body workout.” The activity increases upper-body strength by using back and shoulder girdle muscles, as well as joint flexibility, Dr. Zach noted. Movements involved in climbing, such as repeated reaching for a distant hold, stretch the muscles of the hip flexors and hip.

As these movements reduce rigidity, the climbing action may also promote an upright posture. And as wall climbing involves planning and executing movements, it trains spatial body awareness, an important component of maintaining and correcting posture, she said.

Dr. Zach noted a motivational group dynamic likely also contributed to the success of the intervention. “They were cheering each other at the bottom” of the climbing wall, she said.

The results show that posture can be added to the improvements in Parkinson’s disease already documented from climbing, including improved motor symptoms, rigidity, and tremor, she said. The next step on the research agenda is to show whether the intervention has a positive impact on gait, Dr. Zach added.
 

‘Quite adventurous’

Commenting on the research, Rebecca Gilbert, MD, PhD, chief scientific officer at the American Parkinson Disease Association, said she welcomes “any new idea” to help patients with Parkinson’s disease – and that sport climbing sounds “quite adventurous.”

“The general concept that you’re asking the body to move in a novel way is a good thing for everyone and especially for people with Parkinson’s disease,” said Dr. Gilbert, who was not involved with the research.

She noted that in Parkinson’s disease, an ideal exercise intervention includes a combination of four modalities: stretching, balance, aerobics, and strengthening. Rope climbing involves many of these, in addition to a cognitive element, Dr. Gilbert said. It’s also important that patients with Parkinson’s disease participate in an activity they enjoy, she added.

However, she stressed that safety has to be “weighed,” especially for patients with stage 3 Parkinson’s disease, who often have balance problems. “It may be difficult to climb a rope if you have balance problems,” Dr. Gilbert said. “The intervention needs to be tailored to the existing disability, and perhaps this activity is more a reasonable thing for patients at milder stages.”

Dr. Zach and Dr. Gilbert have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sport climbing can help improve posture in patients with Parkinson’s disease, including older patients, new research suggests.

In a randomized controlled study, those who participated in scaling a wall using ropes and fixed anchors were less stooped at 12 weeks than was a control group that participated in some form of unsupervised physical activity.

The results underscore that it is never too late to learn a new sport or type of movement – and that this type of intervention may have big health payoffs, said study investigator Heidemarie Zach, MD, associate professor of neurology, Medical University of Vienna, Austria.

“There’s no hurdle too high over which you can’t climb, or burden you can’t conquer,”  said Dr. Zach. “As long as you can walk independently and walk up a stair, you can go climbing.”

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Common feature of Parkinson’s disease

The analysis is part of a larger project that included a 2021 study showing a reduced Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score by almost 13 points in patients who participated in sport climbing. The activity was also significantly associated with improved bradykinesia, rigidity, and tremor.

The current analysis focused on stooped posture, which in addition to motor symptoms is a common feature of Parkinson’s disease. This postural deformity can result in significant discomfort, pain, and decreased quality of life.

Pharmaceutical treatments are mostly ineffective for postural deformities, the researchers noted. Physical therapy may help improve symptoms, but only a few randomized studies have examined improved posture in patients with Parkinson’s disease using physiotherapy in general and alternative sports in particular.

Sport climbing is “really unique” in Parkinson’s disease, said Dr. Zach, who has yet to come across other research on this intervention. A climber herself, she recommended it to one of her patients: A 79-year old man with Parkinson’s disease who was a walker and hiker, and who ended up loving the sport. She called him her “pilot patient.”

The single-center study included 48 adult participants up to age 78 years (mean age, 65) with mild to moderate Parkinson’s disease. Most were at Hoehn & Yahr stage 2, with some at stage 3. All had no previous climbing experience. Exclusion criteria included having a condition other than Parkinson’s disease.

The researchers randomly assigned participants to a sport climbing course or to a control group.

The sport climbing group had a 90-minute climbing session each week for 12 weeks in an indoor gym. Under the supervision of an instructor, they were harnessed and connected to ropes with mats placed on the ground for safety.

The climbing wall was about 15 meters (50 feet) high. Participants typically started at 2 or 3 meters (6.5 to 9.5 feet) and worked their way up, Dr. Zach noted.

Those in the control group were asked to participate for 12 weeks in unsupervised physical activity, as recommended by the World Health Organization and the European Physiotherapy Guidelines for Parkinson’s Disease. This included at least 2.5 hours of moderate-intensity activity or 75 minutes of vigorous activity each week.
 

Whole-body workout

The primary outcome was improvement in posture, measured using a “simple” but highly reliable tool, said Dr. Zach. While the patients stood with their backs straight against a wall, researchers measured the distance in centimeters between the C7 sagittal vertical axis (C7SVA) and the wall.

The mean C7SVA at baseline did not significantly differ between the two groups, at 8.2 cm for the climbing group versus  7.7 cm for the control group. However, results showed only sport climbing was associated with significantly lessened forward flexion of the cervical spine.

The climbing group showed a decrease of the C7SVA by 1.7 cm (95% confidence interval [CI], 0.8-2.6 cm). “So climbers were more erect and less stooped after 12 weeks,” Dr. Zach said.

She noted that the mean difference in the control group was 0.5 cm (95% confidence interval [CI], –0.2 to 1.3 cm), which “is almost nothing.”

There did not seem to be any predictor, such as age, sex, or body mass index, for what patient subgroups benefit the most from the intervention, Dr. Zach noted.

In explaining why climbing helps posture, she said it is akin to “a whole-body workout.” The activity increases upper-body strength by using back and shoulder girdle muscles, as well as joint flexibility, Dr. Zach noted. Movements involved in climbing, such as repeated reaching for a distant hold, stretch the muscles of the hip flexors and hip.

As these movements reduce rigidity, the climbing action may also promote an upright posture. And as wall climbing involves planning and executing movements, it trains spatial body awareness, an important component of maintaining and correcting posture, she said.

Dr. Zach noted a motivational group dynamic likely also contributed to the success of the intervention. “They were cheering each other at the bottom” of the climbing wall, she said.

The results show that posture can be added to the improvements in Parkinson’s disease already documented from climbing, including improved motor symptoms, rigidity, and tremor, she said. The next step on the research agenda is to show whether the intervention has a positive impact on gait, Dr. Zach added.
 

‘Quite adventurous’

Commenting on the research, Rebecca Gilbert, MD, PhD, chief scientific officer at the American Parkinson Disease Association, said she welcomes “any new idea” to help patients with Parkinson’s disease – and that sport climbing sounds “quite adventurous.”

“The general concept that you’re asking the body to move in a novel way is a good thing for everyone and especially for people with Parkinson’s disease,” said Dr. Gilbert, who was not involved with the research.

She noted that in Parkinson’s disease, an ideal exercise intervention includes a combination of four modalities: stretching, balance, aerobics, and strengthening. Rope climbing involves many of these, in addition to a cognitive element, Dr. Gilbert said. It’s also important that patients with Parkinson’s disease participate in an activity they enjoy, she added.

However, she stressed that safety has to be “weighed,” especially for patients with stage 3 Parkinson’s disease, who often have balance problems. “It may be difficult to climb a rope if you have balance problems,” Dr. Gilbert said. “The intervention needs to be tailored to the existing disability, and perhaps this activity is more a reasonable thing for patients at milder stages.”

Dr. Zach and Dr. Gilbert have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.