Forschende Komplementärmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine
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Forsch Komplementarmed Klass Naturheilkd · Aug 2004
Randomized Controlled Trial Multicenter Study Clinical TrialRetrolective, comparative, epidemiological cohort study with parallel groups design for evaluation of efficacy and safety of drugs with "well-established use".
The randomized controlled clinical trial (RCT) is accepted as the "golden standard" for the evaluation of efficacy and safety of new drugs. In contrast, to demonstrate efficacy and safety of drugs with "well-established use" that have been on the European Community market for long time, observational comparative epidemiological studies can be used according to the European drug regulation directive. However, because comparative epidemiological cohort studies can share some risk of bias with other nonrandomized observational study designs, there is a need for an approach that could effectively reduce the bias risk in this type of studies. ⋯ Complementary therapy of patients with primary, non-metastatic breast carcinoma with the mistletoe extract Iscador was safe and in comparison to the control group within the same study cohort showed considerably fewer ADRs attributed to concurrent conventional therapy, reduced disease symptoms, and suggested a significant improvement of survival. Despite some methodical limitations that require careful study planning and conduction as well as critical interpretation, the applied study design seems suitable to evaluate the efficacy and safety of drugs with "well-established use", particularly in oncology.
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Forsch Komplementarmed Klass Naturheilkd · Aug 2003
Randomized Controlled Trial Multicenter Study Clinical TrialAcupuncture Randomized Trials (ART) in patients with chronic low back pain and osteoarthritis of the knee - design and protocols.
We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively. ⋯ The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.