Randomised clinical trial: Helicobacter pylori eradication is associated with a significantly increased body mass index in a placebo-controlled trial

Background Body mass index (BMI) increased following Helicobacter pylori eradication in several Japanese cohorts which requires further investigation. Aim To determine the impact of H. pylori eradication on BMI in a European population. Methods 10,537 unselected people aged 20-59 years were screened for H. pylori. 1558 of the 1634 infected participants were randomised to intervention (eradication therapy: ranitidine bismuth citrate 400 mg and clarithromycin 500 mg twice daily) or placebo for two weeks with follow-up at six months (92%) for weight and dyspepsia symptoms (epigastric pain). Results The mean weight of participants in the intervention group increased from 77.7 kg at baseline to 78.4 kg at six months (unadjusted increase 0.7 kg) and from 76.8 kg to 77.2 kg (0.5 kg) in the placebo group. The adjusted difference between randomised groups was statistically significant at 0.6 kg (95% confidence interval (CI) 0.31, 0.88)). Significantly more participants gained ≥ 3 kg in the intervention group (138/720, 19.2%) compared to the placebo group (92/706, 13.0%) (odds ratio (OR) 1.57 (95% CI 1.17, 2.12)). The mean BMI increased from 27.5 kg/m2 to 27.8 kg/m2 at six months in the intervention group compared with 27.0 kg/m2 to 27.2 kg/m2 in the placebo group (adjusted difference between groups was statistically significant at 0.2 kg/m2 (95% CI 0.11, 0.31)). Dyspepsia was less frequently reported by intervention group participants (168/736, 22.8%, placebo group 209/711, 29.4%), OR 0.71 (95% CI 0.55, 0.93). Conclusions BMI increased significantly following randomisation to H. pylori eradication therapy, possibly due to dyspepsia resolution.