Efficacy and safety of Saccharomyces boulardii in... : European Journal of Gastroenterology & Hepatology (original) (raw)

Original Articles: Peptic Ulcer, Helicobacter Pylori

Efficacy and safety of Saccharomyces boulardii in prevention of antibiotic-associated diarrhoea due to Helicobacter pylori eradication

Duman, Deniz Güneya; Bor, Serhatb; Özütemiz, Ömerb; Şahin, Tülinc; Oğuz, Dilekc; Iştan, Fahridı; Vural, Tümerd; Sandkci, Maciteı; Işksal, Fatiheı; Şimşek, İlkayf; Soytürk, Müjdef; Arslan, Serapg; Sivri, Bülentg; Soykan, İrfanh; Temizkan, Ayşegülh; Beşşk, Fatihiıı; Kaymakoğlu, Sabahattini; Kalayc, Cemaı

aDepartment of Gastroenterology, Marmara University, School of Medicine, Istanbul

bDepartment of Gastroenterology, Ege University, School of Medicine, Izmir

cDepartment of Gastroenterology, Yüksek Ihtisas Hospital, Ankara

dDepartment of Gastroenterology, Akdeniz University, School of Medicine, Antalya

eDepartment of Gastroenterology, Cukurova University, School of Medicine, Adana

fDepartment of Gastroenterology, Dokuz Eylul University, School of Medicine, Izmir

gDepartment of Gastroenterology, Hacettepe University, School of Medicine, Ankara

hDepartment of Gastroenterology, Ankara University, School of Medicine, Ibn'i Sina Hospital, Ankara

iDepartment of Gastroenterology, Istanbul University, Istanbul School of Medicine, Istanbul, Turkey

Correspondence and requests for reprints to Cem Kalaycı, Bağdat Cad, Veysel Bey Apt No. 82/4, 81030 Kızıltoprak, Istanbul, Turkey.

Tel: +90 532 2537630; fax: +90 216 3460101;

e-mail: [email protected]

Received 7 April 2005 Accepted 25 August 2005

Abstract

Background and aim

Antibiotic-associated diarrhoea may develop during or following Helicobacter pylori eradication. We aimed to evaluate the efficacy and safety of Saccharomyces boulardii in preventing antibiotic-associated diarrhoea in patients receiving antibiotics for H. pylori eradication.

Methods

In a multicentre prospective clinical trial, patients with peptic ulcer disease or non-ulcer dyspepsia were enrolled to receive clarithromycin, amoxicillin and omeprazole for H. pylori eradication for 14 days. These patients were then randomized to receive either S. boulardii 500 mg twice daily (treatment group) or no treatment (control group). The primary outcome measure was the development of diarrhoea during (treatment period) or within 4 weeks after treatment (follow-up period).

Results

Of the 389 patients that were enrolled, 376 completed the study. Within the treatment period, diarrhoea developed in 5.9% of patients in the treatment group and in 11.5% of patients in the control group (_P_=0.049); and in the follow-up period, diarrhoea developed in 1.0% of patients in the treatment group and in 3.8% of patients in the control group (_P_=0.09). Overall diarrhoea rates throughout the whole study period were 6.9% in the treatment group and 15.6% in the control group (_P_=0.007). No significant difference was observed between the treatment and control groups in terms of adverse events.

Conclusion

S. boulardii is an effective and safe treatment for prevention of antibiotic-associated diarrhoea when given concomitantly to patients receiving H. pylori eradication.