Phytotherapy in irritable bowel syndrome: a randomised double blind, placebo-controlled clinical trial

Brinkhaus B¹, Hentschel C², Lindner M¹, Schindler G¹, Bauer J³, Kohnen R⁴, Lehmacher W⁵, Schönekäs H³, Hahn EG¹

¹Dept. of Traditional and Complementary Medicine, Dept. of Medicine I, University of Erlangen-Nuremberg, Germany

²Center for Complementary Health Studies, University of Exeter, UK

³Dept. of Medicine VI Gastroenterology, Clinic of Nuremberg, Germany

⁴Department of Psychology II, University of Erlangen-Nuremberg Germany

⁵Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Germany

Objective

With its prevalence of 10%, Irritable Bowel Syndrome (IBS) is the most common functional gastrointestinal disorder. To date, no effective treatment is available, and Complementary Medicine (CM) is increasingly being tried. We investigated the therapeutic effects of two phytotherapeutic agents (monotherapy): Fumaria officinalis (FO) 250 mg extr./tablet, and Curcuma xanthorrhiza (CX), 200 mg extr./tablet standardised to 4.0 mg curcumin. Treatment: 3 tabl./day.

Materials and methods

106 IBS patients were randomized to placebo treatment or phytotherapy (FO: n = 24; CX: n = 24; placebo: n = 58). The severity of the symptoms typical of IBS (pain, bloating) was recorded by means of a score. Quality of life was determined using standardised analog scales. Treatment was applied for 18 weeks, target parameters documented every 6 weeks.

Results

Irrespective of the duration of treatment (6, 12 or 18 weeks), no significant difference was found in the assessment of symptom severity or quality of life between treatment with the phytotherapeutic agents and treatment with placebo. The placebo response rate was 65%.

Conclusion

The test substances (FO and CX) had no significant therapeutic effect on IBS. The high response rate to placebo was no different from that reported in other studies. Also with the aim of avoiding side-effects, CM treatments should be evaluated scientifically before being employed.

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