Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2002; 7: 98
Randomised controlled trials offer the opportunity to assess drug safety in a controlled and objective setting. Such data are important for the estimation of the benefit–risk ratio of medical interventions. However, safety reporting is often poor.
To assess and analyse safety reporting in controlled trials on homoeopathy and develop a scoring system for the quality of safety reporting.
An extensive literature search has been conducted since 2000 to detect all controlled trials published. For each article, the following information was collected by two independent reviewers and entered into an electronic database: general information, quality score/s, design, treatment, outcome, safety reporting, tolerability reporting and further information. As a qualitative parameter, a safety assessment score (SAS-CT) for controlled trials was designed for analysis and scoring of adverse events. The SAS-CT consists of six major domains: (1) adverse events definitely not related to study medication (AEs-NR); (2) serious adverse events definitely not related to study medication (SAEs-NR); (3) dropouts due to AEs/SAEs-NR; (4) adverse drug reactions (ADRs); (5) serious adverse drug reactions (SADRs); (6) dropouts due to ADRs/SADRs. Each domain was assessed independently using prospectively defined decision rules. The maximum total score was 100 points. For assessment of initial aggravations, a separate scoring system (SAS-IA) with a maximum total score of 60 points was developed.
To date, 197 controlled trials on homoeopathy have been analysed. Interim results focusing on the relationship between year/size of publication, peer review, funding, quality score/s, outcome, and safety reporting including score are presented.
