Background: While rifaximin was able to improve symptoms in patients with irritable bowel syndrome (IBS) in phase III trials, these results are yet to be repeated in phase IV studies.
Aim: To evaluate the treatment response to rifaximin in IBS patients in a phase IV trial.
Methods: IBS patients underwent lactulose hydrogen breath testing (LHBT). LHBT-positive patients were treated with rifaximin for 14 days. Prior to treatment as well as at week 4 and 14 following the start of rifaximin treatment, patients completed a questionnaire assessing symptom severity on a Likert scale from 0 to 10.
Results: One hundred and six of 150 IBS patients (71%) were LHBT-positive and treated with rifaximin. As assessed at week 4 following commencement of the therapy, rifaximin provided significant improvement of the following IBS-associated symptoms: bloating (5.5 ± 2.6 before the start of the treatment vs. 3.6 ± 2.7 at week 4, P<0.001), flatulence (5.0 ± 2.7 vs. 4.0 ± 2.7, P=0.015), diarrhoea (2.9 ± 2.4 vs. 2.0 ± 2.4, P=0.005) and abdominal pain (4.8 ± 2.7 vs. 3.3 ± 2.5, P<0.001). Overall well-being also significantly improved (3.9 ± 2.4 vs. 2.7 ± 2.3, P < 0.001). Similar improvements in IBS symptoms were obtained at week 14. Eighty-six per cent of patients undergoing repetitive LHBT (55/64) tested negative at week 4.
Conclusions: We found a high percentage of LHBT-positive IBS patients. IBS-associated symptoms (bloating, flatulence, diarrhoea, pain) were improved for a period of 3 months following 2 weeks of treatment with rifaximin. We conclude that rifaximin treatment alleviates symptoms in LHBT-positive IBS patients.
© 2012 Blackwell Publishing Ltd.