Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine
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Zhong Xi Yi Jie He Xue Bao · Mar 2012
Review[Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].
Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. ⋯ The inclusion and exclusion criteria and outcome measures did not match the purposes and contents of post-marketing research in the included studies. They also failed to reflect the basic principles of traditional Chinese medicine in the process of diagnosis and treatment. The demographic characteristics of the patients, the indications for medicine and the syndrome differentiation process were not reported sufficiently and transparently. In order to improve the post-marketing research and promote the rational use of Chinese patent drugs, it is recommended that phase IV clinical trials should establish clear research purpose as well as hypothesis first, and choose scientific and evidence-based study design and outcome measures. In addition, guidelines for implementation of post-marketing research should be developed.
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Zhong Xi Yi Jie He Xue Bao · Mar 2012
Randomized Controlled Trial[Effects of Chinese herbal medicine Bushen Huoxue Granule on quality of life of patients with Parkinson disease: a randomized, double-blinded and placebo-controlled trial].
The main clinical symptoms of Parkinson disease (PD) are resting tremor, muscle rigidity and bradykinesia. There is currently no effective treatment for PD, and dyskinesia symptoms affect the quality of life of patients with PD. The Chinese medicine therapy used for reinforcing kidney and activating blood circulation in treatment of PD was reported to achieve good clinical effects. ⋯ Bushen Huoxue Granule can markedly improve the quality of life of patients with PD.