J M Schmidt1, B Ostermayr. 1. Krankenhaus für Naturheilweisen, Munich, Germany. josef.m.schmidt@lrz.uni-muenchen.de
Abstract
OBJECTIVE: To test whether an ultramolecular dilution of homeopathic Thyroidinum has an effect over placebo on weight reduction of fasting patients in so-called 'fasting crisis'. DESIGN: Randomised, placebo-controlled, double-blind, parallel group, monocentre study. SETTING/LOCATION: Hospital for internal and complementary medicine in Munich, Germany. SUBJECTS:Two hundred and eight fasting patients encountering a stagnation or increase ofweight after a weight reduction of at least 100 g/day in the preceding 3 days. INTERVENTION: One oral dose of Thyroidinum 30cH (preparation of thyroid gland) or placebo. OUTCOME MEASURES: Main outcome measure was reduction of body weight 2 days after treatment. Secondary outcome measures were weight reduction on days 1 and 3, 15 complaints on days 1-3, and 34 laboratory findings on days 1-2 after treatment. RESULTS:Weight reduction on the second day after medication in the Thyroidinum group was less than in the placebo group (mean difference 92 g, 95% confidence interval 7-176 g, P=0.034). Adjustment for baseline differences in body weight and rate of weight reduction before medication, however, weakened the result to a non-significant level (P=0.094). There were no differences between groups in the secondary outcome measures. CONCLUSIONS: Patients receiving Thyroidinum had less weight reduction on day 2 after treatment than those receiving placebo. Yet, since no significant differences were found in other outcomes and since adjustment for baseline differences rendered the difference for the main outcome measure non-significant, this result must be interpreted with caution. Post hoc evaluation of the data, however, suggests that by predefining the primary outcome measure in a different way, an augmented reduction of weight on day 1 after treatment with Thyroidinum may be demonstrated. Both results would be compatible with homeopathic doctrine (primary and secondary effect) as well as with findings from animal research.
RCT Entities:
OBJECTIVE: To test whether an ultramolecular dilution of homeopathic Thyroidinum has an effect over placebo on weight reduction of fasting patients in so-called 'fasting crisis'. DESIGN: Randomised, placebo-controlled, double-blind, parallel group, monocentre study. SETTING/LOCATION: Hospital for internal and complementary medicine in Munich, Germany. SUBJECTS: Two hundred and eight fasting patients encountering a stagnation or increase of weight after a weight reduction of at least 100 g/day in the preceding 3 days. INTERVENTION: One oral dose of Thyroidinum 30cH (preparation of thyroid gland) or placebo. OUTCOME MEASURES: Main outcome measure was reduction of body weight 2 days after treatment. Secondary outcome measures were weight reduction on days 1 and 3, 15 complaints on days 1-3, and 34 laboratory findings on days 1-2 after treatment. RESULTS: Weight reduction on the second day after medication in the Thyroidinum group was less than in the placebo group (mean difference 92 g, 95% confidence interval 7-176 g, P=0.034). Adjustment for baseline differences in body weight and rate of weight reduction before medication, however, weakened the result to a non-significant level (P=0.094). There were no differences between groups in the secondary outcome measures. CONCLUSIONS:Patients receiving Thyroidinum had less weight reduction on day 2 after treatment than those receiving placebo. Yet, since no significant differences were found in other outcomes and since adjustment for baseline differences rendered the difference for the main outcome measure non-significant, this result must be interpreted with caution. Post hoc evaluation of the data, however, suggests that by predefining the primary outcome measure in a different way, an augmented reduction of weight on day 1 after treatment with Thyroidinum may be demonstrated. Both results would be compatible with homeopathic doctrine (primary and secondary effect) as well as with findings from animal research.
Authors: Robert T Mathie; Helmut Roniger; Michel Van Wassenhoven; Joyce Frye; Jennifer Jacobs; Menachem Oberbaum; Marie-France Bordet; Chaturbhuja Nayak; Gilles Chaufferin; John A Ives; Flávio Dantas; Peter Fisher Journal: BMC Med Res Methodol Date: 2012-04-17 Impact factor: 4.615