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Efficacy of artichoke leaf extract in the treatment of patients with functional dyspepsia: a six‐week placebo‐controlled, double‐blind, multicentre trial
Abstract
Summary: 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.
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“Artichoke leaf extracts (ALE) have been used since long time, in traditional medicine, to treat dyspepsia, and in 2003 Holtmann et al. [13] confirmed this effect in patients with FD.”
In the citing paper
“Holtmann et al. [13] showed that ALE were significantly better than placebo in reducing symptoms and improving the disease-specific quality of life in patients with functional dyspepsia.”
From The Effect of Ginger ( Zingiber officinalis ) and Artichoke ( Cynara cardunculus ) Extract Supplementation on Functional Dyspepsia: A Randomised, Double-Blind, and Placebo-Controlled Clinical Trial (2015) · cites this paper as Holtmann et al. [13]
In the citing paper
“Artichoke leaf extracts (ALE) have been used since long time, in traditional medicine, to treat dyspepsia, and in 2003 Holtmann et al. [13] confirmed this effect in patients with FD.”
In the citing paper
“Anyhow the present study shows that the association of ginger extracts and ALE increases the efficacy on functional dyspepsia treatment with a 16.9% advantage as compared to the data found by Holtmann et al. [13] with ALE alone.”
From The Effect of Ginger ( Zingiber officinalis ) and Artichoke ( Cynara cardunculus ) Extract Supplementation on Functional Dyspepsia: A Randomised, Double-Blind, and Placebo-Controlled Clinical Trial (2015) · cites this paper as Holtmann et al. [13]
In the citing paper
“Considering alpha = 0.05 and a study power of 90% and assuming, on the basis of the results of a previous study of Holtmann et al. [13], a mean sum-score for the primary outcome of 2 in the placebo group and an expected advantage for the intervention group of 0.9 with an estimated standard deviation of 1.5, it was calculated that 120 patients (60 in the experimental group and 60 in the placebo”
From The Effect of Ginger ( Zingiber officinalis ) and Artichoke ( Cynara cardunculus ) Extract Supplementation on Functional Dyspepsia: A Randomised, Double-Blind, and Placebo-Controlled Clinical Trial (2015) · cites this paper as Holtmann et al. [13]
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Cites
Assessment of Functional Gastrointestinal Disease: The Bowel Disease Questionnaire
TALLEY, N. J., PHILLIPS, S. F., WILTGEN, C. M., ZINSMEISTER, A. R., & MELTON, L. J. (1990) · Mayo Clinic Proceedings · doi:10.1016/s0025-6196(12)62169-7 · Cited by 330
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Cited by
Review article: current treatment options and management of functional dyspepsia
Lacy, B. E., Talley, N. J., Locke, G. R., Bouras, E. P., DiBaise, J. K., El‐Serag, H. B., Abraham, B. P., Howden, C. W., Moayyedi, P., & Prather, C. (2012) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2012.05128.x · Cited by 192
Giacosa, A., Guido, D., Grassi, M., Riva, A., Morazzoni, P., Bombardelli, E., Perna, S., Faliva, M. A., & Rondanelli, M. (2015) · Evidence-Based Complementary and Alternative Medicine · doi:10.1155/2015/915087 · Cited by 72
Metadata
- Authors
- Holtmann, G., Adam, B., Haag, S., Collet, W., Grünewald, E., & Windeck, T.
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2003-11-20
- Volume
- 18
- Issue
- 11-12
- Pages
- 1099-1105
- ISSN
- 0269-2813
- 1365-2036
- Cited by
- 119
- References
- 1
- Language
- en
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