Symptom picture of the homeopathic remedy aspergillus ruber in healthy volunteers: A randomised, double-blind, placebo-controlled study

Aim:

To detect symptoms of healthy volunteers after administration of aspergillus ruber D12.

Methods:

This Homeopathic Drug Proving (HDP) followed the Harmonised ECH-LMHI Guidelines for Provings (2014), in agreement with Dutch and international (ICH; EMA) regulations. Ethical approval was obtained. Duration of observation was 6 weeks. Each volunteer was assigned to a supervisor for frequent assessment of symptoms. Descriptive, general and thematic analysis was performed. A general symptom was defined as a symptom or symptom attribute occurring in 3 or more body locations, reported by 3 or more volunteers.

Results:

All 14 volunteers were female. 3 volunteers received placebo. 6 volunteers were not active as homeopaths. Each volunteer received a maximum of 6 (1 – 6) doses over 1 or 2 days. Most verum symptoms (n = 340) were in 9 sections: Mind, dream, head, face, throat, stomach, abdomen, back, extremities. There were 22, new general symptoms. 8 of 135 placebo symptoms were useful for elimination of 20 verum symptoms, 4 of these 8 placebo symptoms matched in 3 or more volunteers receiving verum. Straightforward elimination of verum symptoms by placebo was disputable. No serious adverse events occurred. Thematic analysis was complex, revealing a symptom development from firmness, resolution, doubt, stepping aside to calmness. During analysis questions arose regarding validation procedures. Independent analysis by multiple researchers with a final consensus meeting, dream amplification, and blinding until after completion of analysis were considered as possibly valuable methods in future HDPs.

Conclusions:

The Harmonised ECH-LMHI guidelines are feasible. A symptom picture was found. Questions regarding analytical procedures arose.