Safety and compliance of a complex homeopathic drug (Contramutan N Saft) in the treatment of acute respiratory tract infections: A large observational (non-interventional) study in children and adults focussing on homeopathy specific adverse reactions versus adverse drug reactions

Regul Toxicol Pharmacol. 2015 Jul;72(2):179-84. doi: 10.1016/j.yrtph.2015.04.002. Epub 2015 Apr 14.


Background: This non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug (Contramutan N Saft).

Patients and methods: 1050 outpatients suffering from common cold were treated with the medication for 8days. The study was conducted in 64 outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts.

Results: The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% in average for all groups and the global assessment of the treatment effects attributed to "good" and "very good" in 84.9% of all patients.

Conclusions: The homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.

Keywords: Acute respiratory tract infection; Adverse events; Dosage; Echinacea angustifolia; Eupatorium perfoliatum; Homeopathic aggravation; Mother tincture; Non-interventional study; Proving symptoms; Safety.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Child
  • Child, Preschool
  • Homeopathy
  • Humans
  • Infant
  • Middle Aged
  • Plant Extracts / adverse effects*
  • Plant Extracts / therapeutic use
  • Respiratory Tract Infections / drug therapy*
  • Treatment Outcome
  • Young Adult


  • Plant Extracts