Amy Karon

Human papillomavirus vaccine coverage is up slightly, but 40% of girls and 58% of boys aged 13-17 years have not begun the series, according to survey data from the Centers for Disease Control and Prevention.

“Despite overall progress in vaccination coverage among adolescents, HPV vaccination coverage continues to lag behind Tdap and meningococcal conjugate vaccine coverage at state and national levels,” said Dr. Sarah Reagan-Steiner and her associates at the CDC, who analyzed data from the 2014 National Immunization Survey–Teen. “Differences in coverage estimates by vaccine indicate missed opportunities for administering HPV vaccine at visits when Tdap or meningococcal conjugate vaccines are given. Routinely recommending HPV vaccine at ages 11-12 years, during the same visit and with the same emphasis used for other vaccines, is critical.”

The 2014 NIS-Teen assessed vaccination coverage for 20,827 U.S. adolescents aged 13-17 years, the investigators said. The survey involved random-digit dialing the landlines and cell phones of parents to collect demographic data, and mailing follow-up surveys to their children’s clinicians to gather vaccination data (MMWR. 2015 Jul 31;64[29]:784-92.)

From 2013 to 2014, vaccination coverage rose for all routinely recommended vaccines for adolescents, the researchers reported. Coverage for at least one Tdap dose ranged from almost 95% in Connecticut to 71% in Idaho and Mississippi, and coverage for at least one dose of meningococcal conjugate vaccine ranged from 95% in Pennsylvania to 46% in Mississippi. First-dose HPV coverage among adolescent girls rose by 3.3% overall, but ranged from only 38% in Kansas to 76% in Rhode Island.

Rates of HPV vaccination were much larger in several jurisdictions, including two cities (Chicago and Washington) and two states (Georgia and Utah) that received funding to increase HPV vaccination coverage, the researchers said. Strategies that helped increase HPV vaccine coverage included adding HPV vaccination to cancer control plans, partnering with cancer prevention stakeholders, and holding clinician-to-clinician information sessions to stress the need to make strong vaccine recommendations when patients reach 11-12 years of age.

Study limitations included household response rates (60% for landline surveys and 31% for cell phone surveys, and 52%-57% of surveys gathering adequate data from clinicians), Dr. Reagan-Steiner and her associates noted. They reported no conflicts of interest.

Human papillomavirus vaccine coverage is up slightly, but 40% of girls and 58% of boys aged 13-17 years have not begun the series, according to survey data from the Centers for Disease Control and Prevention.

“Despite overall progress in vaccination coverage among adolescents, HPV vaccination coverage continues to lag behind Tdap and meningococcal conjugate vaccine coverage at state and national levels,” said Dr. Sarah Reagan-Steiner and her associates at the CDC, who analyzed data from the 2014 National Immunization Survey–Teen. “Differences in coverage estimates by vaccine indicate missed opportunities for administering HPV vaccine at visits when Tdap or meningococcal conjugate vaccines are given. Routinely recommending HPV vaccine at ages 11-12 years, during the same visit and with the same emphasis used for other vaccines, is critical.”

The 2014 NIS-Teen assessed vaccination coverage for 20,827 U.S. adolescents aged 13-17 years, the investigators said. The survey involved random-digit dialing the landlines and cell phones of parents to collect demographic data, and mailing follow-up surveys to their children’s clinicians to gather vaccination data (MMWR. 2015 Jul 31;64[29]:784-92.)

From 2013 to 2014, vaccination coverage rose for all routinely recommended vaccines for adolescents, the researchers reported. Coverage for at least one Tdap dose ranged from almost 95% in Connecticut to 71% in Idaho and Mississippi, and coverage for at least one dose of meningococcal conjugate vaccine ranged from 95% in Pennsylvania to 46% in Mississippi. First-dose HPV coverage among adolescent girls rose by 3.3% overall, but ranged from only 38% in Kansas to 76% in Rhode Island.

Rates of HPV vaccination were much larger in several jurisdictions, including two cities (Chicago and Washington) and two states (Georgia and Utah) that received funding to increase HPV vaccination coverage, the researchers said. Strategies that helped increase HPV vaccine coverage included adding HPV vaccination to cancer control plans, partnering with cancer prevention stakeholders, and holding clinician-to-clinician information sessions to stress the need to make strong vaccine recommendations when patients reach 11-12 years of age.

Study limitations included household response rates (60% for landline surveys and 31% for cell phone surveys, and 52%-57% of surveys gathering adequate data from clinicians), Dr. Reagan-Steiner and her associates noted. They reported no conflicts of interest.

Human papillomavirus vaccine coverage is up slightly, but 40% of girls and 58% of boys aged 13-17 years have not begun the series, according to survey data from the Centers for Disease Control and Prevention.

“Despite overall progress in vaccination coverage among adolescents, HPV vaccination coverage continues to lag behind Tdap and meningococcal conjugate vaccine coverage at state and national levels,” said Dr. Sarah Reagan-Steiner and her associates at the CDC, who analyzed data from the 2014 National Immunization Survey–Teen. “Differences in coverage estimates by vaccine indicate missed opportunities for administering HPV vaccine at visits when Tdap or meningococcal conjugate vaccines are given. Routinely recommending HPV vaccine at ages 11-12 years, during the same visit and with the same emphasis used for other vaccines, is critical.”

The 2014 NIS-Teen assessed vaccination coverage for 20,827 U.S. adolescents aged 13-17 years, the investigators said. The survey involved random-digit dialing the landlines and cell phones of parents to collect demographic data, and mailing follow-up surveys to their children’s clinicians to gather vaccination data (MMWR. 2015 Jul 31;64[29]:784-92.)

From 2013 to 2014, vaccination coverage rose for all routinely recommended vaccines for adolescents, the researchers reported. Coverage for at least one Tdap dose ranged from almost 95% in Connecticut to 71% in Idaho and Mississippi, and coverage for at least one dose of meningococcal conjugate vaccine ranged from 95% in Pennsylvania to 46% in Mississippi. First-dose HPV coverage among adolescent girls rose by 3.3% overall, but ranged from only 38% in Kansas to 76% in Rhode Island.

Rates of HPV vaccination were much larger in several jurisdictions, including two cities (Chicago and Washington) and two states (Georgia and Utah) that received funding to increase HPV vaccination coverage, the researchers said. Strategies that helped increase HPV vaccine coverage included adding HPV vaccination to cancer control plans, partnering with cancer prevention stakeholders, and holding clinician-to-clinician information sessions to stress the need to make strong vaccine recommendations when patients reach 11-12 years of age.

Study limitations included household response rates (60% for landline surveys and 31% for cell phone surveys, and 52%-57% of surveys gathering adequate data from clinicians), Dr. Reagan-Steiner and her associates noted. They reported no conflicts of interest.

More than half of patients with mild to moderate ulcerative colitis who had not responded to optimized mesalamine treatment achieved clinical remission with the addition of 3 grams of curcumin daily, according to a multicenter randomized controlled trial.

In contrast, at week 4, none of the placebo-plus-mesalamine control group had remitted (odds ratio, 42; 95% confidence interval, 2.3-760; P = .01), reported Dr. Alon Lang of Tel-Aviv University, Israel and his associates. The study appears in the August issue of Clinical Gastroenterology and Hepatology.

Mesalamine and curcumin might have “different but potentially synergistic mechanisms of action, hence producing a better outcome” than monotherapy, wrote Dr. Lang and his coinvestigators.

Mesalamine agents are the backbone of treatment for mild to moderate ulcerative colitis, and patients who do not respond to optimized oral and topical therapy are usually stepped up to corticosteroids or immunomodulators, which can have significant side effects, Dr. Lang and his associates noted.

©SyedMirazurRahman/Thinkstock

Based on in vitro data supporting the anti-inflammatory and antioxidative properties of curcumin (a phytochemical derived from turmeric), the researchers randomized 50 mesalamine nonresponders who had scored at least 5 but less than 12 on the Simple Clinical Colitis Activity Index to either optimized mesalamine and placebo or optimized mesalamine and 3 grams of curcumin per day. The study excluded patients who had received corticosteroids in the past 12 weeks, were currently receiving anti–tumor necrosis factor agents or cyclosporine, had laboratory abnormalities or significant comorbidities, or had a positive stool culture for Clostridium difficile or enteric pathogens (Clin. Gastroenterol. Hepatol. 2015 [doi:10.1016/j.cgh.2015.02.019])

At week 4, 14 patients (53.8%) in the curcumin-mesalamine group scored 2 or less on the SCCAI, and 17 patients (65.3%) experienced a clinical response, defined as a SCCAI score of 3 or less, the researchers reported. But none of the control group remitted and only three (12.5%) responded clinically (OR, 13.2; 95% CI, 3.1 to 56.6; P < .001), they added. “Admittedly, such nil rate of remission in the placebo arm is much lower than that observed in trials of mesalamine therapy for this indication,” they said. “However, in contrast with prior trials, all patients in the present study were already receiving and failing to respond to optimized oral and topical mesalamine treatment ... it is likely that the zero remission rate and the low (12%) rate of clinical improvement in the placebo arm are a result of this design.”

Use of the SCCAI also could have explained the low remission rate in placebo-treated patients, the researchers said. “Indeed, the SCCAI was recently suggested to be more reflective of actual disease activity compared with other clinical scores, and the strict definition of clinical remission requiring an SCCAI was recently shown to correlate with patients’ genuine sense of remission,” they noted.

In the study, 38% of the intervention group achieved endoscopic remission (a partial Mayo score of 1 or less), compared with none of 16 patients evaluated in the placebo group (OR, 20.7; 95% CI, 1.1 to 393; P = .043). Adverse events were rare and similar between the two groups, the researchers noted.

The trial design lacked a dose-finding component, the sample size was “modest,” and the researchers did not perform a power calculation because no previous studies had looked at the efficacy of curcumin in ulcerative colitis, they wrote.

Sheba Medical Center and the Leona M. and Harry B. Helmsley Charitable Trust helped fund the research. Dr. Lang reported no relevant conflicts of interest, and five coauthors reported relationships with numerous pharmaceutical companies.

More than half of patients with mild to moderate ulcerative colitis who had not responded to optimized mesalamine treatment achieved clinical remission with the addition of 3 grams of curcumin daily, according to a multicenter randomized controlled trial.

In contrast, at week 4, none of the placebo-plus-mesalamine control group had remitted (odds ratio, 42; 95% confidence interval, 2.3-760; P = .01), reported Dr. Alon Lang of Tel-Aviv University, Israel and his associates. The study appears in the August issue of Clinical Gastroenterology and Hepatology.

Mesalamine and curcumin might have “different but potentially synergistic mechanisms of action, hence producing a better outcome” than monotherapy, wrote Dr. Lang and his coinvestigators.

Mesalamine agents are the backbone of treatment for mild to moderate ulcerative colitis, and patients who do not respond to optimized oral and topical therapy are usually stepped up to corticosteroids or immunomodulators, which can have significant side effects, Dr. Lang and his associates noted.

©SyedMirazurRahman/Thinkstock

Based on in vitro data supporting the anti-inflammatory and antioxidative properties of curcumin (a phytochemical derived from turmeric), the researchers randomized 50 mesalamine nonresponders who had scored at least 5 but less than 12 on the Simple Clinical Colitis Activity Index to either optimized mesalamine and placebo or optimized mesalamine and 3 grams of curcumin per day. The study excluded patients who had received corticosteroids in the past 12 weeks, were currently receiving anti–tumor necrosis factor agents or cyclosporine, had laboratory abnormalities or significant comorbidities, or had a positive stool culture for Clostridium difficile or enteric pathogens (Clin. Gastroenterol. Hepatol. 2015 [doi:10.1016/j.cgh.2015.02.019])

At week 4, 14 patients (53.8%) in the curcumin-mesalamine group scored 2 or less on the SCCAI, and 17 patients (65.3%) experienced a clinical response, defined as a SCCAI score of 3 or less, the researchers reported. But none of the control group remitted and only three (12.5%) responded clinically (OR, 13.2; 95% CI, 3.1 to 56.6; P < .001), they added. “Admittedly, such nil rate of remission in the placebo arm is much lower than that observed in trials of mesalamine therapy for this indication,” they said. “However, in contrast with prior trials, all patients in the present study were already receiving and failing to respond to optimized oral and topical mesalamine treatment ... it is likely that the zero remission rate and the low (12%) rate of clinical improvement in the placebo arm are a result of this design.”

Use of the SCCAI also could have explained the low remission rate in placebo-treated patients, the researchers said. “Indeed, the SCCAI was recently suggested to be more reflective of actual disease activity compared with other clinical scores, and the strict definition of clinical remission requiring an SCCAI was recently shown to correlate with patients’ genuine sense of remission,” they noted.

In the study, 38% of the intervention group achieved endoscopic remission (a partial Mayo score of 1 or less), compared with none of 16 patients evaluated in the placebo group (OR, 20.7; 95% CI, 1.1 to 393; P = .043). Adverse events were rare and similar between the two groups, the researchers noted.

The trial design lacked a dose-finding component, the sample size was “modest,” and the researchers did not perform a power calculation because no previous studies had looked at the efficacy of curcumin in ulcerative colitis, they wrote.

Sheba Medical Center and the Leona M. and Harry B. Helmsley Charitable Trust helped fund the research. Dr. Lang reported no relevant conflicts of interest, and five coauthors reported relationships with numerous pharmaceutical companies.

More than half of patients with mild to moderate ulcerative colitis who had not responded to optimized mesalamine treatment achieved clinical remission with the addition of 3 grams of curcumin daily, according to a multicenter randomized controlled trial.

In contrast, at week 4, none of the placebo-plus-mesalamine control group had remitted (odds ratio, 42; 95% confidence interval, 2.3-760; P = .01), reported Dr. Alon Lang of Tel-Aviv University, Israel and his associates. The study appears in the August issue of Clinical Gastroenterology and Hepatology.

Mesalamine and curcumin might have “different but potentially synergistic mechanisms of action, hence producing a better outcome” than monotherapy, wrote Dr. Lang and his coinvestigators.

Mesalamine agents are the backbone of treatment for mild to moderate ulcerative colitis, and patients who do not respond to optimized oral and topical therapy are usually stepped up to corticosteroids or immunomodulators, which can have significant side effects, Dr. Lang and his associates noted.

©SyedMirazurRahman/Thinkstock

Based on in vitro data supporting the anti-inflammatory and antioxidative properties of curcumin (a phytochemical derived from turmeric), the researchers randomized 50 mesalamine nonresponders who had scored at least 5 but less than 12 on the Simple Clinical Colitis Activity Index to either optimized mesalamine and placebo or optimized mesalamine and 3 grams of curcumin per day. The study excluded patients who had received corticosteroids in the past 12 weeks, were currently receiving anti–tumor necrosis factor agents or cyclosporine, had laboratory abnormalities or significant comorbidities, or had a positive stool culture for Clostridium difficile or enteric pathogens (Clin. Gastroenterol. Hepatol. 2015 [doi:10.1016/j.cgh.2015.02.019])

At week 4, 14 patients (53.8%) in the curcumin-mesalamine group scored 2 or less on the SCCAI, and 17 patients (65.3%) experienced a clinical response, defined as a SCCAI score of 3 or less, the researchers reported. But none of the control group remitted and only three (12.5%) responded clinically (OR, 13.2; 95% CI, 3.1 to 56.6; P < .001), they added. “Admittedly, such nil rate of remission in the placebo arm is much lower than that observed in trials of mesalamine therapy for this indication,” they said. “However, in contrast with prior trials, all patients in the present study were already receiving and failing to respond to optimized oral and topical mesalamine treatment ... it is likely that the zero remission rate and the low (12%) rate of clinical improvement in the placebo arm are a result of this design.”

Use of the SCCAI also could have explained the low remission rate in placebo-treated patients, the researchers said. “Indeed, the SCCAI was recently suggested to be more reflective of actual disease activity compared with other clinical scores, and the strict definition of clinical remission requiring an SCCAI was recently shown to correlate with patients’ genuine sense of remission,” they noted.

In the study, 38% of the intervention group achieved endoscopic remission (a partial Mayo score of 1 or less), compared with none of 16 patients evaluated in the placebo group (OR, 20.7; 95% CI, 1.1 to 393; P = .043). Adverse events were rare and similar between the two groups, the researchers noted.

The trial design lacked a dose-finding component, the sample size was “modest,” and the researchers did not perform a power calculation because no previous studies had looked at the efficacy of curcumin in ulcerative colitis, they wrote.

Sheba Medical Center and the Leona M. and Harry B. Helmsley Charitable Trust helped fund the research. Dr. Lang reported no relevant conflicts of interest, and five coauthors reported relationships with numerous pharmaceutical companies.

Neither childhood immunizations nor H1N1 influenza vaccination increased the risk of inflammatory bowel disease, according to a meta-analysis of 11 studies in the August issue of Clinical Gastroenterology and Hepatology published online (2015 [doi:10.1016/j.cgh.2015.04.179]).

“Overall, our results did not find any significant increased risk of developing IBD after childhood immunization with BCG [bacille Calmette-Guérin], diphtheria, tetanus, poliomyelitis, smallpox, pertussis, measles, mumps, and rubella-containing vaccines,” said Dr. Guillaume Pineton de Chambrun of Lille (France) University Hospital and his associates. “The results of this meta-analysis are globally reassuring regarding the risk of developing IBD after childhood vaccination. Vaccines that are developed to protect against an infectious disease or its consequences are, for the majority, not a risk for the subsequent development of intestinal inflammatory disease.”

Steve Mann_ThinkStock

Besides the childhood vaccines, H1N1 vaccination was not linked to IBD in a single large study of adults (risk ratio, 1.13; 95% confidence interval, 0.97-1.32), the investigators said.

Controversies about immunizations and IBD date to at least 1995, when a report by Thompson et al. linked live measles vaccine to the disease (Lancet 1995;345:1071-4), said the investigators. “However, many publications after this report investigating vaccination with measles-containing vaccines did not show any association between immunization and IBD,” they emphasized. “Epidemiologic studies also investigated other vaccines such as BCG, diphtheria, tetanus, poliomyelitis, smallpox, pertussis, rubella, and mumps, reporting conflicting results.”

To further clarify the issue, they compared rates of IBD, Crohn’s disease, and ulcerative colitis among vaccinated and unvaccinated patients from eight case-control and three cohort studies published between 1970 and June 2014. When looking at IBD overall, 95% CIs for RRs all crossed 1.0, indicating no significant associations, they said. A subgroup analysis did link poliomyelitis vaccination with increased risk of developing Crohn’s disease (RR, 2.28; 95% CI, 1.12-4.63) or ulcerative colitis (RR, 3.48; 95% CI, 1.2-9.71), but the studies were dissimilar enough that the results need to be interpreted cautiously, they added.

To find the studies, the researchers searched MEDLINE, EMBASE, and the Cochrane central trials registry for randomized controlled trials, controlled clinical trials, cohort studies, and case-control studies published in any language and that included the terms ulcerative colitis, Crohn’s disease, inflammatory bowel disease, colitis, or ileitis. This approach yielded six population-based and two hospital-based case-control studies, and three population-based cohort studies. The studies of childhood immunizations included 2,399 patients with IBD and 33,747 controls, and the H1N1 study included 14,842 patients with IBD and almost 2 million controls, said the investigators.

The studies were “extremely heterogeneous” in terms of design, sample size, geographic location, and methods used to help patients recall their vaccination history, the investigators noted. “Vaccination protocols varied between countries and evolved through the years, with different types of vaccines and schedules leading to difficulties in risk evaluation,” they said. “Moreover, some vaccines used were live attenuated vaccines such as measles, oral poliomyelitis, or whole-cell pertussis vaccines, and may have a different effect on immune system activation and dysregulation, compared with other inactivated acellular vaccines.”

The Digitscience Foundation supported the research. The researchers declared having no conflicts of interest.

Neither childhood immunizations nor H1N1 influenza vaccination increased the risk of inflammatory bowel disease, according to a meta-analysis of 11 studies in the August issue of Clinical Gastroenterology and Hepatology published online (2015 [doi:10.1016/j.cgh.2015.04.179]).

“Overall, our results did not find any significant increased risk of developing IBD after childhood immunization with BCG [bacille Calmette-Guérin], diphtheria, tetanus, poliomyelitis, smallpox, pertussis, measles, mumps, and rubella-containing vaccines,” said Dr. Guillaume Pineton de Chambrun of Lille (France) University Hospital and his associates. “The results of this meta-analysis are globally reassuring regarding the risk of developing IBD after childhood vaccination. Vaccines that are developed to protect against an infectious disease or its consequences are, for the majority, not a risk for the subsequent development of intestinal inflammatory disease.”

Steve Mann_ThinkStock

Besides the childhood vaccines, H1N1 vaccination was not linked to IBD in a single large study of adults (risk ratio, 1.13; 95% confidence interval, 0.97-1.32), the investigators said.

Controversies about immunizations and IBD date to at least 1995, when a report by Thompson et al. linked live measles vaccine to the disease (Lancet 1995;345:1071-4), said the investigators. “However, many publications after this report investigating vaccination with measles-containing vaccines did not show any association between immunization and IBD,” they emphasized. “Epidemiologic studies also investigated other vaccines such as BCG, diphtheria, tetanus, poliomyelitis, smallpox, pertussis, rubella, and mumps, reporting conflicting results.”

To further clarify the issue, they compared rates of IBD, Crohn’s disease, and ulcerative colitis among vaccinated and unvaccinated patients from eight case-control and three cohort studies published between 1970 and June 2014. When looking at IBD overall, 95% CIs for RRs all crossed 1.0, indicating no significant associations, they said. A subgroup analysis did link poliomyelitis vaccination with increased risk of developing Crohn’s disease (RR, 2.28; 95% CI, 1.12-4.63) or ulcerative colitis (RR, 3.48; 95% CI, 1.2-9.71), but the studies were dissimilar enough that the results need to be interpreted cautiously, they added.

To find the studies, the researchers searched MEDLINE, EMBASE, and the Cochrane central trials registry for randomized controlled trials, controlled clinical trials, cohort studies, and case-control studies published in any language and that included the terms ulcerative colitis, Crohn’s disease, inflammatory bowel disease, colitis, or ileitis. This approach yielded six population-based and two hospital-based case-control studies, and three population-based cohort studies. The studies of childhood immunizations included 2,399 patients with IBD and 33,747 controls, and the H1N1 study included 14,842 patients with IBD and almost 2 million controls, said the investigators.

The studies were “extremely heterogeneous” in terms of design, sample size, geographic location, and methods used to help patients recall their vaccination history, the investigators noted. “Vaccination protocols varied between countries and evolved through the years, with different types of vaccines and schedules leading to difficulties in risk evaluation,” they said. “Moreover, some vaccines used were live attenuated vaccines such as measles, oral poliomyelitis, or whole-cell pertussis vaccines, and may have a different effect on immune system activation and dysregulation, compared with other inactivated acellular vaccines.”

The Digitscience Foundation supported the research. The researchers declared having no conflicts of interest.

Neither childhood immunizations nor H1N1 influenza vaccination increased the risk of inflammatory bowel disease, according to a meta-analysis of 11 studies in the August issue of Clinical Gastroenterology and Hepatology published online (2015 [doi:10.1016/j.cgh.2015.04.179]).

“Overall, our results did not find any significant increased risk of developing IBD after childhood immunization with BCG [bacille Calmette-Guérin], diphtheria, tetanus, poliomyelitis, smallpox, pertussis, measles, mumps, and rubella-containing vaccines,” said Dr. Guillaume Pineton de Chambrun of Lille (France) University Hospital and his associates. “The results of this meta-analysis are globally reassuring regarding the risk of developing IBD after childhood vaccination. Vaccines that are developed to protect against an infectious disease or its consequences are, for the majority, not a risk for the subsequent development of intestinal inflammatory disease.”

Steve Mann_ThinkStock

Besides the childhood vaccines, H1N1 vaccination was not linked to IBD in a single large study of adults (risk ratio, 1.13; 95% confidence interval, 0.97-1.32), the investigators said.

Controversies about immunizations and IBD date to at least 1995, when a report by Thompson et al. linked live measles vaccine to the disease (Lancet 1995;345:1071-4), said the investigators. “However, many publications after this report investigating vaccination with measles-containing vaccines did not show any association between immunization and IBD,” they emphasized. “Epidemiologic studies also investigated other vaccines such as BCG, diphtheria, tetanus, poliomyelitis, smallpox, pertussis, rubella, and mumps, reporting conflicting results.”

To further clarify the issue, they compared rates of IBD, Crohn’s disease, and ulcerative colitis among vaccinated and unvaccinated patients from eight case-control and three cohort studies published between 1970 and June 2014. When looking at IBD overall, 95% CIs for RRs all crossed 1.0, indicating no significant associations, they said. A subgroup analysis did link poliomyelitis vaccination with increased risk of developing Crohn’s disease (RR, 2.28; 95% CI, 1.12-4.63) or ulcerative colitis (RR, 3.48; 95% CI, 1.2-9.71), but the studies were dissimilar enough that the results need to be interpreted cautiously, they added.

To find the studies, the researchers searched MEDLINE, EMBASE, and the Cochrane central trials registry for randomized controlled trials, controlled clinical trials, cohort studies, and case-control studies published in any language and that included the terms ulcerative colitis, Crohn’s disease, inflammatory bowel disease, colitis, or ileitis. This approach yielded six population-based and two hospital-based case-control studies, and three population-based cohort studies. The studies of childhood immunizations included 2,399 patients with IBD and 33,747 controls, and the H1N1 study included 14,842 patients with IBD and almost 2 million controls, said the investigators.

The studies were “extremely heterogeneous” in terms of design, sample size, geographic location, and methods used to help patients recall their vaccination history, the investigators noted. “Vaccination protocols varied between countries and evolved through the years, with different types of vaccines and schedules leading to difficulties in risk evaluation,” they said. “Moreover, some vaccines used were live attenuated vaccines such as measles, oral poliomyelitis, or whole-cell pertussis vaccines, and may have a different effect on immune system activation and dysregulation, compared with other inactivated acellular vaccines.”

The Digitscience Foundation supported the research. The researchers declared having no conflicts of interest.

Neither childhood immunizations nor H1N1 influenza vaccination increased the risk of inflammatory bowel disease, according to a meta-analysis of 11 studies in the August issue of Clinical Gastroenterology and Hepatology published online (2015 [doi:10.1016/j.cgh.2015.04.179]).

“Overall, our results did not find any significant increased risk of developing IBD after childhood immunization with BCG [bacille Calmette-Guérin], diphtheria, tetanus, poliomyelitis, smallpox, pertussis, measles, mumps, and rubella-containing vaccines,” said Dr. Guillaume Pineton de Chambrun of Lille (France) University Hospital and his associates. “The results of this meta-analysis are globally reassuring regarding the risk of developing IBD after childhood vaccination. Vaccines that are developed to protect against an infectious disease or its consequences are, for the majority, not a risk for the subsequent development of intestinal inflammatory disease.”

Steve Mann_ThinkStock

Besides the childhood vaccines, H1N1 vaccination was not linked to IBD in a single large study of adults (risk ratio, 1.13; 95% confidence interval, 0.97-1.32), the investigators said.

Controversies about immunizations and IBD date to at least 1995, when a report by Thompson et al. linked live measles vaccine to the disease (Lancet 1995;345:1071-4), said the investigators. “However, many publications after this report investigating vaccination with measles-containing vaccines did not show any association between immunization and IBD,” they emphasized. “Epidemiologic studies also investigated other vaccines such as BCG, diphtheria, tetanus, poliomyelitis, smallpox, pertussis, rubella, and mumps, reporting conflicting results.”

To further clarify the issue, they compared rates of IBD, Crohn’s disease, and ulcerative colitis among vaccinated and unvaccinated patients from eight case-control and three cohort studies published between 1970 and June 2014. When looking at IBD overall, 95% CIs for RRs all crossed 1.0, indicating no significant associations, they said. A subgroup analysis did link poliomyelitis vaccination with increased risk of developing Crohn’s disease (RR, 2.28; 95% CI, 1.12-4.63) or ulcerative colitis (RR, 3.48; 95% CI, 1.2-9.71), but the studies were dissimilar enough that the results need to be interpreted cautiously, they added.

To find the studies, the researchers searched MEDLINE, EMBASE, and the Cochrane central trials registry for randomized controlled trials, controlled clinical trials, cohort studies, and case-control studies published in any language and that included the terms ulcerative colitis, Crohn’s disease, inflammatory bowel disease, colitis, or ileitis. This approach yielded six population-based and two hospital-based case-control studies, and three population-based cohort studies. The studies of childhood immunizations included 2,399 patients with IBD and 33,747 controls, and the H1N1 study included 14,842 patients with IBD and almost 2 million controls, said the investigators.

The studies were “extremely heterogeneous” in terms of design, sample size, geographic location, and methods used to help patients recall their vaccination history, the investigators noted. “Vaccination protocols varied between countries and evolved through the years, with different types of vaccines and schedules leading to difficulties in risk evaluation,” they said. “Moreover, some vaccines used were live attenuated vaccines such as measles, oral poliomyelitis, or whole-cell pertussis vaccines, and may have a different effect on immune system activation and dysregulation, compared with other inactivated acellular vaccines.”

The Digitscience Foundation supported the research. The researchers declared having no conflicts of interest.

Neither childhood immunizations nor H1N1 influenza vaccination increased the risk of inflammatory bowel disease, according to a meta-analysis of 11 studies in the August issue of Clinical Gastroenterology and Hepatology published online (2015 [doi:10.1016/j.cgh.2015.04.179]).

“Overall, our results did not find any significant increased risk of developing IBD after childhood immunization with BCG [bacille Calmette-Guérin], diphtheria, tetanus, poliomyelitis, smallpox, pertussis, measles, mumps, and rubella-containing vaccines,” said Dr. Guillaume Pineton de Chambrun of Lille (France) University Hospital and his associates. “The results of this meta-analysis are globally reassuring regarding the risk of developing IBD after childhood vaccination. Vaccines that are developed to protect against an infectious disease or its consequences are, for the majority, not a risk for the subsequent development of intestinal inflammatory disease.”

Steve Mann_ThinkStock

Besides the childhood vaccines, H1N1 vaccination was not linked to IBD in a single large study of adults (risk ratio, 1.13; 95% confidence interval, 0.97-1.32), the investigators said.

Controversies about immunizations and IBD date to at least 1995, when a report by Thompson et al. linked live measles vaccine to the disease (Lancet 1995;345:1071-4), said the investigators. “However, many publications after this report investigating vaccination with measles-containing vaccines did not show any association between immunization and IBD,” they emphasized. “Epidemiologic studies also investigated other vaccines such as BCG, diphtheria, tetanus, poliomyelitis, smallpox, pertussis, rubella, and mumps, reporting conflicting results.”

To further clarify the issue, they compared rates of IBD, Crohn’s disease, and ulcerative colitis among vaccinated and unvaccinated patients from eight case-control and three cohort studies published between 1970 and June 2014. When looking at IBD overall, 95% CIs for RRs all crossed 1.0, indicating no significant associations, they said. A subgroup analysis did link poliomyelitis vaccination with increased risk of developing Crohn’s disease (RR, 2.28; 95% CI, 1.12-4.63) or ulcerative colitis (RR, 3.48; 95% CI, 1.2-9.71), but the studies were dissimilar enough that the results need to be interpreted cautiously, they added.

To find the studies, the researchers searched MEDLINE, EMBASE, and the Cochrane central trials registry for randomized controlled trials, controlled clinical trials, cohort studies, and case-control studies published in any language and that included the terms ulcerative colitis, Crohn’s disease, inflammatory bowel disease, colitis, or ileitis. This approach yielded six population-based and two hospital-based case-control studies, and three population-based cohort studies. The studies of childhood immunizations included 2,399 patients with IBD and 33,747 controls, and the H1N1 study included 14,842 patients with IBD and almost 2 million controls, said the investigators.

The studies were “extremely heterogeneous” in terms of design, sample size, geographic location, and methods used to help patients recall their vaccination history, the investigators noted. “Vaccination protocols varied between countries and evolved through the years, with different types of vaccines and schedules leading to difficulties in risk evaluation,” they said. “Moreover, some vaccines used were live attenuated vaccines such as measles, oral poliomyelitis, or whole-cell pertussis vaccines, and may have a different effect on immune system activation and dysregulation, compared with other inactivated acellular vaccines.”

The Digitscience Foundation supported the research. The researchers declared having no conflicts of interest.

Neither childhood immunizations nor H1N1 influenza vaccination increased the risk of inflammatory bowel disease, according to a meta-analysis of 11 studies in the August issue of Clinical Gastroenterology and Hepatology published online (2015 [doi:10.1016/j.cgh.2015.04.179]).

“Overall, our results did not find any significant increased risk of developing IBD after childhood immunization with BCG [bacille Calmette-Guérin], diphtheria, tetanus, poliomyelitis, smallpox, pertussis, measles, mumps, and rubella-containing vaccines,” said Dr. Guillaume Pineton de Chambrun of Lille (France) University Hospital and his associates. “The results of this meta-analysis are globally reassuring regarding the risk of developing IBD after childhood vaccination. Vaccines that are developed to protect against an infectious disease or its consequences are, for the majority, not a risk for the subsequent development of intestinal inflammatory disease.”

Steve Mann_ThinkStock

Besides the childhood vaccines, H1N1 vaccination was not linked to IBD in a single large study of adults (risk ratio, 1.13; 95% confidence interval, 0.97-1.32), the investigators said.

Controversies about immunizations and IBD date to at least 1995, when a report by Thompson et al. linked live measles vaccine to the disease (Lancet 1995;345:1071-4), said the investigators. “However, many publications after this report investigating vaccination with measles-containing vaccines did not show any association between immunization and IBD,” they emphasized. “Epidemiologic studies also investigated other vaccines such as BCG, diphtheria, tetanus, poliomyelitis, smallpox, pertussis, rubella, and mumps, reporting conflicting results.”

To further clarify the issue, they compared rates of IBD, Crohn’s disease, and ulcerative colitis among vaccinated and unvaccinated patients from eight case-control and three cohort studies published between 1970 and June 2014. When looking at IBD overall, 95% CIs for RRs all crossed 1.0, indicating no significant associations, they said. A subgroup analysis did link poliomyelitis vaccination with increased risk of developing Crohn’s disease (RR, 2.28; 95% CI, 1.12-4.63) or ulcerative colitis (RR, 3.48; 95% CI, 1.2-9.71), but the studies were dissimilar enough that the results need to be interpreted cautiously, they added.

To find the studies, the researchers searched MEDLINE, EMBASE, and the Cochrane central trials registry for randomized controlled trials, controlled clinical trials, cohort studies, and case-control studies published in any language and that included the terms ulcerative colitis, Crohn’s disease, inflammatory bowel disease, colitis, or ileitis. This approach yielded six population-based and two hospital-based case-control studies, and three population-based cohort studies. The studies of childhood immunizations included 2,399 patients with IBD and 33,747 controls, and the H1N1 study included 14,842 patients with IBD and almost 2 million controls, said the investigators.

The studies were “extremely heterogeneous” in terms of design, sample size, geographic location, and methods used to help patients recall their vaccination history, the investigators noted. “Vaccination protocols varied between countries and evolved through the years, with different types of vaccines and schedules leading to difficulties in risk evaluation,” they said. “Moreover, some vaccines used were live attenuated vaccines such as measles, oral poliomyelitis, or whole-cell pertussis vaccines, and may have a different effect on immune system activation and dysregulation, compared with other inactivated acellular vaccines.”

The Digitscience Foundation supported the research. The researchers declared having no conflicts of interest.

More than half of patients with mild to moderate ulcerative colitis who had not responded to optimized mesalamine treatment achieved clinical remission with the addition of 3 grams of curcumin daily, according to a multicenter randomized controlled trial.

In contrast, at week 4, none of the placebo-plus-mesalamine control group had remitted (odds ratio, 42; 95% confidence interval, 2.3-760; P = .01), reported Dr. Alon Lang of Tel-Aviv University, Israel and his associates. The study appears in the August issue of Clinical Gastroenterology and Hepatology.

Mesalamine and curcumin might have “different but potentially synergistic mechanisms of action, hence producing a better outcome” than monotherapy, wrote Dr. Lang and his coinvestigators.

Mesalamine agents are the backbone of treatment for mild to moderate ulcerative colitis, and patients who do not respond to optimized oral and topical therapy are usually stepped up to corticosteroids or immunomodulators, which can have significant side effects, Dr. Lang and his associates noted.

©SyedMirazurRahman/Thinkstock

Based on in vitro data supporting the anti-inflammatory and antioxidative properties of curcumin (a phytochemical derived from turmeric), the researchers randomized 50 mesalamine nonresponders who had scored at least 5 but less than 12 on the Simple Clinical Colitis Activity Index to either optimized mesalamine and placebo or optimized mesalamine and 3 grams of curcumin per day. The study excluded patients who had received corticosteroids in the past 12 weeks, were currently receiving anti–tumor necrosis factor agents or cyclosporine, had laboratory abnormalities or significant comorbidities, or had a positive stool culture for Clostridium difficile or enteric pathogens (Clin. Gastroenterol. Hepatol. 2015 [doi:10.1016/j.cgh.2015.02.019])

At week 4, 14 patients (53.8%) in the curcumin-mesalamine group scored 2 or less on the SCCAI, and 17 patients (65.3%) experienced a clinical response, defined as a SCCAI score of 3 or less, the researchers reported. But none of the control group remitted and only three (12.5%) responded clinically (OR, 13.2; 95% CI, 3.1 to 56.6; P < .001), they added. “Admittedly, such nil rate of remission in the placebo arm is much lower than that observed in trials of mesalamine therapy for this indication,” they said. “However, in contrast with prior trials, all patients in the present study were already receiving and failing to respond to optimized oral and topical mesalamine treatment ... it is likely that the zero remission rate and the low (12%) rate of clinical improvement in the placebo arm are a result of this design.”

Use of the SCCAI also could have explained the low remission rate in placebo-treated patients, the researchers said. “Indeed, the SCCAI was recently suggested to be more reflective of actual disease activity compared with other clinical scores, and the strict definition of clinical remission requiring an SCCAI was recently shown to correlate with patients’ genuine sense of remission,” they noted.

In the study, 38% of the intervention group achieved endoscopic remission (a partial Mayo score of 1 or less), compared with none of 16 patients evaluated in the placebo group (OR, 20.7; 95% CI, 1.1 to 393; P = .043). Adverse events were rare and similar between the two groups, the researchers noted.

The trial design lacked a dose-finding component, the sample size was “modest,” and the researchers did not perform a power calculation because no previous studies had looked at the efficacy of curcumin in ulcerative colitis, they wrote.

Sheba Medical Center and the Leona M. and Harry B. Helmsley Charitable Trust helped fund the research. Dr. Lang reported no relevant conflicts of interest, and five coauthors reported relationships with numerous pharmaceutical companies.

More than half of patients with mild to moderate ulcerative colitis who had not responded to optimized mesalamine treatment achieved clinical remission with the addition of 3 grams of curcumin daily, according to a multicenter randomized controlled trial.

In contrast, at week 4, none of the placebo-plus-mesalamine control group had remitted (odds ratio, 42; 95% confidence interval, 2.3-760; P = .01), reported Dr. Alon Lang of Tel-Aviv University, Israel and his associates. The study appears in the August issue of Clinical Gastroenterology and Hepatology.

Mesalamine and curcumin might have “different but potentially synergistic mechanisms of action, hence producing a better outcome” than monotherapy, wrote Dr. Lang and his coinvestigators.

Mesalamine agents are the backbone of treatment for mild to moderate ulcerative colitis, and patients who do not respond to optimized oral and topical therapy are usually stepped up to corticosteroids or immunomodulators, which can have significant side effects, Dr. Lang and his associates noted.

©SyedMirazurRahman/Thinkstock

Based on in vitro data supporting the anti-inflammatory and antioxidative properties of curcumin (a phytochemical derived from turmeric), the researchers randomized 50 mesalamine nonresponders who had scored at least 5 but less than 12 on the Simple Clinical Colitis Activity Index to either optimized mesalamine and placebo or optimized mesalamine and 3 grams of curcumin per day. The study excluded patients who had received corticosteroids in the past 12 weeks, were currently receiving anti–tumor necrosis factor agents or cyclosporine, had laboratory abnormalities or significant comorbidities, or had a positive stool culture for Clostridium difficile or enteric pathogens (Clin. Gastroenterol. Hepatol. 2015 [doi:10.1016/j.cgh.2015.02.019])

At week 4, 14 patients (53.8%) in the curcumin-mesalamine group scored 2 or less on the SCCAI, and 17 patients (65.3%) experienced a clinical response, defined as a SCCAI score of 3 or less, the researchers reported. But none of the control group remitted and only three (12.5%) responded clinically (OR, 13.2; 95% CI, 3.1 to 56.6; P < .001), they added. “Admittedly, such nil rate of remission in the placebo arm is much lower than that observed in trials of mesalamine therapy for this indication,” they said. “However, in contrast with prior trials, all patients in the present study were already receiving and failing to respond to optimized oral and topical mesalamine treatment ... it is likely that the zero remission rate and the low (12%) rate of clinical improvement in the placebo arm are a result of this design.”

Use of the SCCAI also could have explained the low remission rate in placebo-treated patients, the researchers said. “Indeed, the SCCAI was recently suggested to be more reflective of actual disease activity compared with other clinical scores, and the strict definition of clinical remission requiring an SCCAI was recently shown to correlate with patients’ genuine sense of remission,” they noted.

In the study, 38% of the intervention group achieved endoscopic remission (a partial Mayo score of 1 or less), compared with none of 16 patients evaluated in the placebo group (OR, 20.7; 95% CI, 1.1 to 393; P = .043). Adverse events were rare and similar between the two groups, the researchers noted.

The trial design lacked a dose-finding component, the sample size was “modest,” and the researchers did not perform a power calculation because no previous studies had looked at the efficacy of curcumin in ulcerative colitis, they wrote.

Sheba Medical Center and the Leona M. and Harry B. Helmsley Charitable Trust helped fund the research. Dr. Lang reported no relevant conflicts of interest, and five coauthors reported relationships with numerous pharmaceutical companies.

More than half of patients with mild to moderate ulcerative colitis who had not responded to optimized mesalamine treatment achieved clinical remission with the addition of 3 grams of curcumin daily, according to a multicenter randomized controlled trial.

In contrast, at week 4, none of the placebo-plus-mesalamine control group had remitted (odds ratio, 42; 95% confidence interval, 2.3-760; P = .01), reported Dr. Alon Lang of Tel-Aviv University, Israel and his associates. The study appears in the August issue of Clinical Gastroenterology and Hepatology.

Mesalamine and curcumin might have “different but potentially synergistic mechanisms of action, hence producing a better outcome” than monotherapy, wrote Dr. Lang and his coinvestigators.

Mesalamine agents are the backbone of treatment for mild to moderate ulcerative colitis, and patients who do not respond to optimized oral and topical therapy are usually stepped up to corticosteroids or immunomodulators, which can have significant side effects, Dr. Lang and his associates noted.

©SyedMirazurRahman/Thinkstock

Based on in vitro data supporting the anti-inflammatory and antioxidative properties of curcumin (a phytochemical derived from turmeric), the researchers randomized 50 mesalamine nonresponders who had scored at least 5 but less than 12 on the Simple Clinical Colitis Activity Index to either optimized mesalamine and placebo or optimized mesalamine and 3 grams of curcumin per day. The study excluded patients who had received corticosteroids in the past 12 weeks, were currently receiving anti–tumor necrosis factor agents or cyclosporine, had laboratory abnormalities or significant comorbidities, or had a positive stool culture for Clostridium difficile or enteric pathogens (Clin. Gastroenterol. Hepatol. 2015 [doi:10.1016/j.cgh.2015.02.019])

At week 4, 14 patients (53.8%) in the curcumin-mesalamine group scored 2 or less on the SCCAI, and 17 patients (65.3%) experienced a clinical response, defined as a SCCAI score of 3 or less, the researchers reported. But none of the control group remitted and only three (12.5%) responded clinically (OR, 13.2; 95% CI, 3.1 to 56.6; P < .001), they added. “Admittedly, such nil rate of remission in the placebo arm is much lower than that observed in trials of mesalamine therapy for this indication,” they said. “However, in contrast with prior trials, all patients in the present study were already receiving and failing to respond to optimized oral and topical mesalamine treatment ... it is likely that the zero remission rate and the low (12%) rate of clinical improvement in the placebo arm are a result of this design.”

Use of the SCCAI also could have explained the low remission rate in placebo-treated patients, the researchers said. “Indeed, the SCCAI was recently suggested to be more reflective of actual disease activity compared with other clinical scores, and the strict definition of clinical remission requiring an SCCAI was recently shown to correlate with patients’ genuine sense of remission,” they noted.

In the study, 38% of the intervention group achieved endoscopic remission (a partial Mayo score of 1 or less), compared with none of 16 patients evaluated in the placebo group (OR, 20.7; 95% CI, 1.1 to 393; P = .043). Adverse events were rare and similar between the two groups, the researchers noted.

The trial design lacked a dose-finding component, the sample size was “modest,” and the researchers did not perform a power calculation because no previous studies had looked at the efficacy of curcumin in ulcerative colitis, they wrote.

Sheba Medical Center and the Leona M. and Harry B. Helmsley Charitable Trust helped fund the research. Dr. Lang reported no relevant conflicts of interest, and five coauthors reported relationships with numerous pharmaceutical companies.

Losing weight through lifestyle changes can significantly improve several measures of nonalcoholic fatty liver disease, particularly if patients lose at least 10% of their body weight, and bariatric surgery is a valid alternative if diet and exercise fail, according to two studies reported in the August issue of Gastroenterology (2015 Apr. 9 [doi:10.1053/j.gastro.2015.04.005]).

Global rates of nonalcoholic fatty liver disease (NAFLD) are up because of the “parallel epidemics” of obesity and type 2 diabetes mellitus, said Dr. Eduardo Vilar-Gomez of the National Institute of Hepatology in Havana, Cuba, who authored the study of lifestyle changes. There are no approved therapies for the more aggressive form of NAFLD, steatohepatitis, he and his associates said. In past studies, patients who lost about 7%-10% of their body weight substantially improved their NAFLD activity score and had reductions in steatosis, lobular inflammation, and ballooning, but the results did not extend to fibrosis, and prospective studies of the effect of lifestyle changes on histology are lacking, the researchers added .

To fill the gap, they followed 293 adults with histologically confirmed nonalcoholic steatohepatitis who completed a 52-week lifestyle intervention program that included keeping a food diary, restricting saturated fats to less than 10% of total intake, and walking at least 200 minutes a week. Patients had not received hypolipidemic treatment in the preceding 3 months and were not allowed to take insulin sensitizers or vitamin E, both of which are potentially beneficial for nonalcoholic steatohepatitis, the investigators said.

At the end of the yearlong program, steatohepatitis had resolved in 25% of patients, 47% had lower NAFLD activity scores, and 19% had regression of fibrosis, the researchers reported. Although only 30% of participants lost at least 5% of their body weight, weight loss correlated positively with resolution of steatohepatitis and with 2-point reductions in histologic activity scores (P <.001). Among patients who lost at least 10% of their body weight, 90% had resolution of steatohepatitis, 45% had regression of fibrosis, and all had improved histologic activity scores, even if they had negative risk factors such as female sex, a baseline body mass index of at least 35 kg/m², and a baseline fasting glucose level of at least 5.5 mmol/L, the investigators added. “Our findings support the current recommendation for weight loss using lifestyle modification as the first step in the management of patients with nonalcoholic steatohepatitis,” they wrote.

But what if lifestyle changes fail? The impact of bariatric surgery on nonalcoholic steatohepatitis has not been well studied, said Dr. Guillaume Lassailly at CHRU Lille (France). He and his associates therefore followed 109 morbidly obese patients (BMI ≥40 kg/m²) with biopsy-confirmed nonalcoholic steatohepatitis who underwent bariatric surgery at a single tertiary hospital (Gastroenterology 2015 Apr. 25 [doi:10.1053/j.gastro.2015.04.014]) .

One year after surgery, 85% of patients had achieved disease resolution (95% confidence interval, 75.8%-92.2%), the investigators reported. Stratifying patients by baseline Brunt scores showed that those with milder presurgical disease were more likely to have complete resolution than were patients whose disease was severe (94% vs. 70%; P <.05), the researchers added. Histologic analyses supported the findings, revealing steatosis in 60% of presurgical tissue samples, compared with 10% of samples taken a year after surgery. In addition, average NAFLD disease scores dropped from 5 to 1 (P <.001), hepatocyte ballooning decreased in 84% of samples, lobular inflammation decreased in 67%, and Metavir fibrosis scores dropped in one-third of specimens.

Notably, BMI scores for patients with persistent postsurgical disease dropped by an average of only 9.1, compared with 12.3 for patients whose disease resolved (P = .005), said the researchers. Gastric bypass surgery achieved greater weight loss and improvements in disease status, compared with laparoscopic banding, they added. “The encouraging results of the present study suggest that bariatric surgery should be tested in multicenter, randomized controlled trials in morbidly or severely obese patients with nonalcoholic steatohepatitis who did not respond to lifestyle therapy,” they wrote.

The Cuban National Institute of Gastroenterology and Ministry of Health partially funded the study by Dr. Vilar-Gomez and his associates. The French Ministry of Health and the Conseil Regional Nord-Pas de Calais supported the work by Dr. Lassailly and his colleagues. All investigators declared having no relevant financial conflicts of interest.

Losing weight through lifestyle changes can significantly improve several measures of nonalcoholic fatty liver disease, particularly if patients lose at least 10% of their body weight, and bariatric surgery is a valid alternative if diet and exercise fail, according to two studies reported in the August issue of Gastroenterology (2015 Apr. 9 [doi:10.1053/j.gastro.2015.04.005]).

Global rates of nonalcoholic fatty liver disease (NAFLD) are up because of the “parallel epidemics” of obesity and type 2 diabetes mellitus, said Dr. Eduardo Vilar-Gomez of the National Institute of Hepatology in Havana, Cuba, who authored the study of lifestyle changes. There are no approved therapies for the more aggressive form of NAFLD, steatohepatitis, he and his associates said. In past studies, patients who lost about 7%-10% of their body weight substantially improved their NAFLD activity score and had reductions in steatosis, lobular inflammation, and ballooning, but the results did not extend to fibrosis, and prospective studies of the effect of lifestyle changes on histology are lacking, the researchers added .

To fill the gap, they followed 293 adults with histologically confirmed nonalcoholic steatohepatitis who completed a 52-week lifestyle intervention program that included keeping a food diary, restricting saturated fats to less than 10% of total intake, and walking at least 200 minutes a week. Patients had not received hypolipidemic treatment in the preceding 3 months and were not allowed to take insulin sensitizers or vitamin E, both of which are potentially beneficial for nonalcoholic steatohepatitis, the investigators said.

At the end of the yearlong program, steatohepatitis had resolved in 25% of patients, 47% had lower NAFLD activity scores, and 19% had regression of fibrosis, the researchers reported. Although only 30% of participants lost at least 5% of their body weight, weight loss correlated positively with resolution of steatohepatitis and with 2-point reductions in histologic activity scores (P <.001). Among patients who lost at least 10% of their body weight, 90% had resolution of steatohepatitis, 45% had regression of fibrosis, and all had improved histologic activity scores, even if they had negative risk factors such as female sex, a baseline body mass index of at least 35 kg/m², and a baseline fasting glucose level of at least 5.5 mmol/L, the investigators added. “Our findings support the current recommendation for weight loss using lifestyle modification as the first step in the management of patients with nonalcoholic steatohepatitis,” they wrote.

But what if lifestyle changes fail? The impact of bariatric surgery on nonalcoholic steatohepatitis has not been well studied, said Dr. Guillaume Lassailly at CHRU Lille (France). He and his associates therefore followed 109 morbidly obese patients (BMI ≥40 kg/m²) with biopsy-confirmed nonalcoholic steatohepatitis who underwent bariatric surgery at a single tertiary hospital (Gastroenterology 2015 Apr. 25 [doi:10.1053/j.gastro.2015.04.014]) .

One year after surgery, 85% of patients had achieved disease resolution (95% confidence interval, 75.8%-92.2%), the investigators reported. Stratifying patients by baseline Brunt scores showed that those with milder presurgical disease were more likely to have complete resolution than were patients whose disease was severe (94% vs. 70%; P <.05), the researchers added. Histologic analyses supported the findings, revealing steatosis in 60% of presurgical tissue samples, compared with 10% of samples taken a year after surgery. In addition, average NAFLD disease scores dropped from 5 to 1 (P <.001), hepatocyte ballooning decreased in 84% of samples, lobular inflammation decreased in 67%, and Metavir fibrosis scores dropped in one-third of specimens.

Notably, BMI scores for patients with persistent postsurgical disease dropped by an average of only 9.1, compared with 12.3 for patients whose disease resolved (P = .005), said the researchers. Gastric bypass surgery achieved greater weight loss and improvements in disease status, compared with laparoscopic banding, they added. “The encouraging results of the present study suggest that bariatric surgery should be tested in multicenter, randomized controlled trials in morbidly or severely obese patients with nonalcoholic steatohepatitis who did not respond to lifestyle therapy,” they wrote.

The Cuban National Institute of Gastroenterology and Ministry of Health partially funded the study by Dr. Vilar-Gomez and his associates. The French Ministry of Health and the Conseil Regional Nord-Pas de Calais supported the work by Dr. Lassailly and his colleagues. All investigators declared having no relevant financial conflicts of interest.

Losing weight through lifestyle changes can significantly improve several measures of nonalcoholic fatty liver disease, particularly if patients lose at least 10% of their body weight, and bariatric surgery is a valid alternative if diet and exercise fail, according to two studies reported in the August issue of Gastroenterology (2015 Apr. 9 [doi:10.1053/j.gastro.2015.04.005]).

Global rates of nonalcoholic fatty liver disease (NAFLD) are up because of the “parallel epidemics” of obesity and type 2 diabetes mellitus, said Dr. Eduardo Vilar-Gomez of the National Institute of Hepatology in Havana, Cuba, who authored the study of lifestyle changes. There are no approved therapies for the more aggressive form of NAFLD, steatohepatitis, he and his associates said. In past studies, patients who lost about 7%-10% of their body weight substantially improved their NAFLD activity score and had reductions in steatosis, lobular inflammation, and ballooning, but the results did not extend to fibrosis, and prospective studies of the effect of lifestyle changes on histology are lacking, the researchers added .

To fill the gap, they followed 293 adults with histologically confirmed nonalcoholic steatohepatitis who completed a 52-week lifestyle intervention program that included keeping a food diary, restricting saturated fats to less than 10% of total intake, and walking at least 200 minutes a week. Patients had not received hypolipidemic treatment in the preceding 3 months and were not allowed to take insulin sensitizers or vitamin E, both of which are potentially beneficial for nonalcoholic steatohepatitis, the investigators said.

At the end of the yearlong program, steatohepatitis had resolved in 25% of patients, 47% had lower NAFLD activity scores, and 19% had regression of fibrosis, the researchers reported. Although only 30% of participants lost at least 5% of their body weight, weight loss correlated positively with resolution of steatohepatitis and with 2-point reductions in histologic activity scores (P <.001). Among patients who lost at least 10% of their body weight, 90% had resolution of steatohepatitis, 45% had regression of fibrosis, and all had improved histologic activity scores, even if they had negative risk factors such as female sex, a baseline body mass index of at least 35 kg/m², and a baseline fasting glucose level of at least 5.5 mmol/L, the investigators added. “Our findings support the current recommendation for weight loss using lifestyle modification as the first step in the management of patients with nonalcoholic steatohepatitis,” they wrote.

But what if lifestyle changes fail? The impact of bariatric surgery on nonalcoholic steatohepatitis has not been well studied, said Dr. Guillaume Lassailly at CHRU Lille (France). He and his associates therefore followed 109 morbidly obese patients (BMI ≥40 kg/m²) with biopsy-confirmed nonalcoholic steatohepatitis who underwent bariatric surgery at a single tertiary hospital (Gastroenterology 2015 Apr. 25 [doi:10.1053/j.gastro.2015.04.014]) .

One year after surgery, 85% of patients had achieved disease resolution (95% confidence interval, 75.8%-92.2%), the investigators reported. Stratifying patients by baseline Brunt scores showed that those with milder presurgical disease were more likely to have complete resolution than were patients whose disease was severe (94% vs. 70%; P <.05), the researchers added. Histologic analyses supported the findings, revealing steatosis in 60% of presurgical tissue samples, compared with 10% of samples taken a year after surgery. In addition, average NAFLD disease scores dropped from 5 to 1 (P <.001), hepatocyte ballooning decreased in 84% of samples, lobular inflammation decreased in 67%, and Metavir fibrosis scores dropped in one-third of specimens.

Notably, BMI scores for patients with persistent postsurgical disease dropped by an average of only 9.1, compared with 12.3 for patients whose disease resolved (P = .005), said the researchers. Gastric bypass surgery achieved greater weight loss and improvements in disease status, compared with laparoscopic banding, they added. “The encouraging results of the present study suggest that bariatric surgery should be tested in multicenter, randomized controlled trials in morbidly or severely obese patients with nonalcoholic steatohepatitis who did not respond to lifestyle therapy,” they wrote.

The Cuban National Institute of Gastroenterology and Ministry of Health partially funded the study by Dr. Vilar-Gomez and his associates. The French Ministry of Health and the Conseil Regional Nord-Pas de Calais supported the work by Dr. Lassailly and his colleagues. All investigators declared having no relevant financial conflicts of interest.

Patients with type 1 diabetes whose HbA_1c levels exceeded 9.1% before coronary artery bypass grafting were significantly more likely to die or suffer major coronary adverse events over the next 5 years than were those with better glycemic control, researchers reported.

And patients with the worst glycemic control had more than double the risk of death or major coronary adverse events (MACE) as those who were adequately controlled before surgery, Dr. Thomas Nyström at the Karolinska Institutet in Stockholm, Sweden and his associates reported July 27 in the Journal of the American College of Cardiology.

Diabetes affects about one in four patients who undergo revascularization for multivessel coronary artery disease. To understand the links between preoperative hemoglobin A_1c (HbA_1c) levels and adverse postoperative outcomes, the researchers conducted a nationwide, population-based study of 764 type 1 diabetes mellitus patients who underwent coronary artery bypass grafting in Sweden between 1997 and 2012 (J. Am. Coll. Cardiol. 2015; 66: 535-43 [doi: 10.1016/j.jacc.2015.05.054]).

After a median of 4.7 years of follow-up, 44% of patients had died or had experienced MACE, for an incidence rate of 82 events per 1,000 person years, according to the investigators. Risk of death or MACE in the 5 years after surgery was significantly higher when preoperative HbA_1c levels were 10% ore more compared with 7% or less, they said (hazard ratio, 2.25; 95% confidence interval, 1.29 to 3.94).

Risk of death or MACE also was significantly elevated for patients with levels of 9.1% to 10.0%.

“Interventions to achieve better control of blood glucose concentrations and other cardiovascular risk factors in patients with [type I diabetes mellitus] should be evaluated in prospective trials,” the investigators wrote.

The study was supported by the Swedish Society of Medicine, Karolinska Institutet Foundations and Funds, the Mats Kleberg Foundation, and the Swedish Heart and Lung Foundation. The researchers reported having no relevant financial disclosures.

Patients with type 1 diabetes whose HbA_1c levels exceeded 9.1% before coronary artery bypass grafting were significantly more likely to die or suffer major coronary adverse events over the next 5 years than were those with better glycemic control, researchers reported.

And patients with the worst glycemic control had more than double the risk of death or major coronary adverse events (MACE) as those who were adequately controlled before surgery, Dr. Thomas Nyström at the Karolinska Institutet in Stockholm, Sweden and his associates reported July 27 in the Journal of the American College of Cardiology.

Diabetes affects about one in four patients who undergo revascularization for multivessel coronary artery disease. To understand the links between preoperative hemoglobin A_1c (HbA_1c) levels and adverse postoperative outcomes, the researchers conducted a nationwide, population-based study of 764 type 1 diabetes mellitus patients who underwent coronary artery bypass grafting in Sweden between 1997 and 2012 (J. Am. Coll. Cardiol. 2015; 66: 535-43 [doi: 10.1016/j.jacc.2015.05.054]).

After a median of 4.7 years of follow-up, 44% of patients had died or had experienced MACE, for an incidence rate of 82 events per 1,000 person years, according to the investigators. Risk of death or MACE in the 5 years after surgery was significantly higher when preoperative HbA_1c levels were 10% ore more compared with 7% or less, they said (hazard ratio, 2.25; 95% confidence interval, 1.29 to 3.94).

Risk of death or MACE also was significantly elevated for patients with levels of 9.1% to 10.0%.

“Interventions to achieve better control of blood glucose concentrations and other cardiovascular risk factors in patients with [type I diabetes mellitus] should be evaluated in prospective trials,” the investigators wrote.

The study was supported by the Swedish Society of Medicine, Karolinska Institutet Foundations and Funds, the Mats Kleberg Foundation, and the Swedish Heart and Lung Foundation. The researchers reported having no relevant financial disclosures.

Patients with type 1 diabetes whose HbA_1c levels exceeded 9.1% before coronary artery bypass grafting were significantly more likely to die or suffer major coronary adverse events over the next 5 years than were those with better glycemic control, researchers reported.

And patients with the worst glycemic control had more than double the risk of death or major coronary adverse events (MACE) as those who were adequately controlled before surgery, Dr. Thomas Nyström at the Karolinska Institutet in Stockholm, Sweden and his associates reported July 27 in the Journal of the American College of Cardiology.

Diabetes affects about one in four patients who undergo revascularization for multivessel coronary artery disease. To understand the links between preoperative hemoglobin A_1c (HbA_1c) levels and adverse postoperative outcomes, the researchers conducted a nationwide, population-based study of 764 type 1 diabetes mellitus patients who underwent coronary artery bypass grafting in Sweden between 1997 and 2012 (J. Am. Coll. Cardiol. 2015; 66: 535-43 [doi: 10.1016/j.jacc.2015.05.054]).

After a median of 4.7 years of follow-up, 44% of patients had died or had experienced MACE, for an incidence rate of 82 events per 1,000 person years, according to the investigators. Risk of death or MACE in the 5 years after surgery was significantly higher when preoperative HbA_1c levels were 10% ore more compared with 7% or less, they said (hazard ratio, 2.25; 95% confidence interval, 1.29 to 3.94).

Risk of death or MACE also was significantly elevated for patients with levels of 9.1% to 10.0%.

“Interventions to achieve better control of blood glucose concentrations and other cardiovascular risk factors in patients with [type I diabetes mellitus] should be evaluated in prospective trials,” the investigators wrote.

The study was supported by the Swedish Society of Medicine, Karolinska Institutet Foundations and Funds, the Mats Kleberg Foundation, and the Swedish Heart and Lung Foundation. The researchers reported having no relevant financial disclosures.