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

Abstract

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.

• Authors: J A Lane, L J Murray, I M Harvey, J L Donovan, P Nair, R F Harvey
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 33 Issue 8 Pg. 922-9 (Apr 2011) ISSN: 1365-2036 [Electronic] England
• PMID: 21366634 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2011 Blackwell Publishing Ltd.

Chemical References

• Organometallic Compounds
• Placebos
• Ranitidine
• Clarithromycin
• bismuth tripotassium dicitrate

Topics

• Adult
• Body Mass Index
• Body Weight
• Clarithromycin (administration & dosage)
• Drug Therapy, Combination
• Dyspepsia (drug therapy)
• Female
• Helicobacter Infections (drug therapy)
• Helicobacter pylori (drug effects)
• Humans
• Male
• Middle Aged
• Organometallic Compounds (administration & dosage)
• Placebos
• Ranitidine (administration & dosage)
• Treatment Outcome