Does ultramolecular homoeopathy have any clinical effects? A randomised, double-blind placebo-controlled trial using the homoeopathic pathogenic trial of Belladonna C30 as a model

Objective

To determine if ultramolecular homoeopathic dilutions (commonly prescribed in the clinical situation) have any clinical effects, assessed using the proving of the homoeopathic remedy Belladonna at an ultramolecular dose (C30).

Materials and methods

This was a double-blind, randomised, placebo-controlled study. Healthy students (aged 18–30 years) took part in the 4-week study [randomisation; 1week placebo run-in; 2-week treatment intervention (Belladonna C30 or placebo) and 1-week follow-up]. Daily symptoms were recorded on a structured questionnaire, and were analysed blind, to determine if the subject had proved or not (based on predefined definition of proving). The main outcome measure was the proportion of provers identified in each treatment group.

Results

A total of 253 subjects were entered and randomised into the study (40.7% refused to take part), and 206 subjects completed the study. Twenty-eight subjects were withdrawn due to an adverse event.

No significant differences in proving rates were observed between treatment groups (Belladonna provers n = 14; placebo provers n = 15) based on intention-to-treat analysis. Primary outcome was not affected by seasonality or the individual’s attitude to complementary medicine. A small group of subjects (n = 15, 7%) was identified as proving in the placebo run-in period (‘presentiment provers’). A logistic regression confirmed that being a presentiment prover did predict being an active phase prover (odds ratio 4.87, P = 0.009, confidence interval 1.59, 14.94).

Conclusion

Ultramolecular homoeopathy had no observable clinical effects within the context of this study design.