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

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: A total of 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 2 weeks with follow-up at 6 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 6 months (unadjusted increase of 0.7 kg) and from 76.8 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%) compared with the placebo group (92/706, 13%) [odds ratio (OR) 1.57 (95% CI: 1.17, 2.12)]. The mean BMI increased from 27.5 to 27.8 kg/m(2) at 6 months in the intervention group compared with the increase from 27.0 to 27.2 kg/m(2) in the placebo group [adjusted difference between groups was statistically significant at 0.2 kg/m(2) (95% CI: 0.11, 0.31)]. Dyspepsia was less frequently reported by intervention group participants (168/736, 23%, placebo group 209/711, 29%), OR 0.71 (95% CI: 0.55, 0.93).
CONCLUSION: Body mass index increased significantly following randomisation to H. pylori eradication therapy, possibly due to resolution of dyspepsia.

RCT Entities:   Population Interventions Outcomes