Efficacy of artichoke leaf extract in the treatment of patients with functional dyspepsia: a six-week placebo-controlled, double-blind, multicentre trial
Article first published online: 20 NOV 2003
Alimentary Pharmacology & Therapeutics
Volume 18, Issue 11-12, pages 1099–1105, December 2003
How to Cite
Holtmann, G., Adam, B., Haag, S., Collet, W., Grünewald, E. and Windeck, T. (2003), Efficacy of artichoke leaf extract in the treatment of patients with functional dyspepsia: a six-week placebo-controlled, double-blind, multicentre trial. Alimentary Pharmacology & Therapeutics, 18: 1099–1105. doi: 10.1046/j.1365-2036.2003.01767.x
- Issue published online: 20 NOV 2003
- Article first published online: 20 NOV 2003
- Accepted for publication 7 August 2003
Background : This study aimed to assess the efficacy of artichoke leaf extract (ALE) in the treatment of patients with functional dyspepsia (FD).
Methods : In a double-blind, randomized controlled trial (RCT), 247 patients with functional dyspepsia were recruited and treated with either a commercial ALE preparation (2 × 320 mg plant extract t.d.s.) or a placebo. The primary efficacy variable was the sum score of the patient's weekly rating of the overall change in dyspeptic symptoms (four-point scale). Secondary variables were the scores of each dyspeptic symptom and the quality of life (QOL) as assessed by the Nepean Dyspepsia Index (NDI).
Results : Two hundred and forty-seven patients were enrolled, and data from 244 patients (129 active treatment, 115 placebo) were suitable for inclusion in the statistical analysis (intention-to-treat). The overall symptom improvement over the 6 weeks of treatment was significantly greater with ALE than with the placebo (8.3 ± 4.6, vs. 6.7 ± 4.8, P < 0.01). Similarly, patients treated with ALE showed significantly greater improvement in the global quality-of-life scores (NDI) compared with the placebo-treated patients (− 41.1 ± 47.6 vs. − 24.8 ± 35.6, P < 0.01).
Conclusion : The ALE preparation tested was significantly better than the placebo in alleviating symptoms and improving the disease-specific quality of life in patients with functional dyspepsia.