[Legal status and organization of homeopathic drug testing in Germany]. / Arzneirechtlicher Status und Organisation homöopathischer Arzneimittelprüfungen in Deutschland.

For more than 200 years, homeopathic doctors have been carrying out homeopathic drug provings (HDPs),which embodies the traditional self drug testing, an integral part of the homeopathic medical profession. However,according to national authorities, testing homeopathic drugs is a phase I clinical trial for which the German Federal Drug Law applies. Adapting a 200-year-old primary qualitative study design to modern drug law and Good Clinical Practice Guidelines generates several difficulties, in particular, blinding, informed consent and the classification of adverse events. In addition, in Germany naturopaths (German: 'Heilpraktiker') are excluded from leading HDP trials. The costs are climbing, and the organizational over heads for a HDP are enormous. Implications for the future are discussed.

A homoeopathic proving of Galphimia glauca.

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.