Michael Teut1, Jörn Dahler, Christoph Schnegg. 1. Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, Berlin, Germany. michael.teut@charite.de
Abstract
INTRODUCTION: Homoeopathic provings are a fundamental concept in homoeopathy. The aim of this study was to record the symptoms produced by a homoeopathic drug compared to placebo. METHODS: Randomised, double-blind, placebo-controlled trial with a 1-week baseline, 4-week proving, and 2-week post-observational period. SUBJECTS:15 healthy physicians and medical students volunteered as provers; 11 were randomised to verum and 4 to placebo. Proving substance: Galphimia glauca C12 compared to placebo; maximum intake of 5 days. OUTCOME MEASURES: Proving symptoms according to ICCH definition and the number of proving symptoms. The proving symptoms were analysed qualitatively using the Boenninghausen method. RESULTS: A total of 682 symptoms were observed in both groups. Galphimia glauca provers experienced states of exhaustion, weakness, lack of concentration, feelings of confusion, dryness of mouth, lacrimation, and burning sensation in the eyes. Two provers experienced an amelioration of their allergic rhinitis. Proving symptoms were completely reversible. The statistical analysis showed more ICCH proving symptoms for placebo (mean 72.3 +/- SD 37.3) than for Galphimia (35 +/- 24.2), but the group difference was not significant (95% confidence interval, -78 to 1, p = 0.097). DISCUSSION: Although statistical analysis showed no significant group differences, we observed specific symptoms under Galphimia glauca that correspond to those seen in clinical studies of phytotherapeutic preparations, including relaxing, sedative, anxiolytic, and anti-allergic effects. CONCLUSION: Our results confirm the toxicological and clinical effects of Galphimia glauca compared to placebo, but the ICCH criteria for proving symptoms were not suitable to distinguish between specific and unspecific symptoms. Copyright (c) 2008 S. Karger AG, Basel.
RCT Entities:
INTRODUCTION: Homoeopathic provings are a fundamental concept in homoeopathy. The aim of this study was to record the symptoms produced by a homoeopathic drug compared to placebo. METHODS: Randomised, double-blind, placebo-controlled trial with a 1-week baseline, 4-week proving, and 2-week post-observational period. SUBJECTS: 15 healthy physicians and medical students volunteered as provers; 11 were randomised to verum and 4 to placebo. Proving substance: Galphimia glauca C12 compared to placebo; maximum intake of 5 days. OUTCOME MEASURES: Proving symptoms according to ICCH definition and the number of proving symptoms. The proving symptoms were analysed qualitatively using the Boenninghausen method. RESULTS: A total of 682 symptoms were observed in both groups. Galphimia glauca provers experienced states of exhaustion, weakness, lack of concentration, feelings of confusion, dryness of mouth, lacrimation, and burning sensation in the eyes. Two provers experienced an amelioration of their allergic rhinitis. Proving symptoms were completely reversible. The statistical analysis showed more ICCH proving symptoms for placebo (mean 72.3 +/- SD 37.3) than for Galphimia (35 +/- 24.2), but the group difference was not significant (95% confidence interval, -78 to 1, p = 0.097). DISCUSSION: Although statistical analysis showed no significant group differences, we observed specific symptoms under Galphimia glauca that correspond to those seen in clinical studies of phytotherapeutic preparations, including relaxing, sedative, anxiolytic, and anti-allergic effects. CONCLUSION: Our results confirm the toxicological and clinical effects of Galphimia glauca compared to placebo, but the ICCH criteria for proving symptoms were not suitable to distinguish between specific and unspecific symptoms. Copyright (c) 2008 S. Karger AG, Basel.