Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 1997; 2: 193
Two controlled multicentre post-marketing surveillance studies in bronchitis were compared with respect to patient inclusion and treatment effects.
Both studies were carried out according to the same study protocol and case report form for two different proprietary plant-based medicines (Sinupret and Bronchipret). Both studies were designed to include one half of all patients receiving other mucoactive medications by advising physicians to include patients according to a matched-pair strategy. All medications were then grouped by their active ingredient and a descriptive statistic was carried out for all groups and all clinical parameters before and after 10 days of therapy. Since both studies were identical in concept, design, clinical parameters, control medication and written information for investigators as well as first stage statistical analysis, the reproducibility of such a study can be analysed.
A descriptive comparison of the initial clinical findings of included patients shows differences of –11% up to +53% with a median of 9.1% between both studies. For treatment effects the situation is different, differences between both studies are small and with individual exceptions below 10% with a median of 1.5%.
Reliability of open clinical studies conducted under identical conditions seems to be high with respect to efficacy measures.
