title: 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.
abstract: BACKGROUND
  This non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug (Contramutan N Saft).
  
  
  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.
authors.affiliation: Immanuel Krankenhaus Berlin, Königstraße 63, 14109 Berlin, Germany. Electronic address: a.michalsen@immanuel.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Michalsen
authors.affiliation: Immanuel Krankenhaus Berlin, Königstraße 63, 14109 Berlin, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Uehleke
authors.affiliation: Immanuel Krankenhaus Berlin, Königstraße 63, 14109 Berlin, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Stange
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D006705:Homeopathy; D006801:Humans; D007223:Infant; D008875:Middle Aged; D010936:Plant Extracts / Q000009:adverse effects* / Q000627:therapeutic use; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010936:Plant Extracts
keywords: Acute respiratory tract infection; Adverse events; Dosage; Echinacea angustifolia; Eupatorium perfoliatum; Homeopathic aggravation; Mother tincture; Non-interventional study; Proving symptoms; Safety