Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes

Abstract

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.

Unexplored Potential of Traditional Chinese Medicine in Diabetes Mellitus

“…50 In another trial involving 33 patients, KLL when given in combination with Glibenclamide as a treatment to T2DM patients, it was reported that it can produces more effective and less toxic effects than monotherapy with glibenclamide. 51 Another trial involving KLL administration for 1 month was reported to significantly improved blood-glucose-levels in 30 patients of T2DM. 52 Adding to this, it was reported that 8 weeks of treatment with KLL can significantly improve blood glucose levels in T2DM patients (n = 21) with sulfanylurea failure, which is suggestive that the KLL might improve insulin resistance.…”