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Abstract
Background: More than 66 traditional Chinese herbal formulas are used for the rehabilitation of brain injuries. Objectives: To report on the quality of randomized clinical trials reporting widely used traditional Chinese medicines (TCM) for vascular dementia (VaD). Methods: English and Chinese databases were searched from inception to February 2009. We identiļ¬ed TCMs that were listed in the Chinese National Essential Drug list (2004) and those commonly used in clinical practice for VaD. Trials on Ginkgo biloba and Huperzine A were excluded because they have been extensively reviewed. The reporting quality was judged according to criteria required for assessment of clinical homogeneity and the risk of bias in Cochrane reviews. Results: Forty-six trials were reviewed, of which 36 trials were described as randomized, four controlled clinical trials and six before-and-after studies. Forty-two trials applied standard Western medicine diagnostic criteria for VaD, although many trials also used integrative TCM criteria. Four studies applied only integrative TCM diagnostic criteria. Interventions were described by their brand name, dosage, route of administration and duration of therapy. Formulation details were not generally provided. All except one study applied standard Western medicine outcome measures although some trials used integrative TCM measures. Five trials assessed both cognitive and global function. Fourteen trials assessed both cognitive function and ADL. None reported the actual method of randomization or the method of allocation concealment. Baseline data of non-outcome measures was reported in 10 studies as a table but more commonly as a few lines of text. Baseline balance was commented on in most studies. Blinding and reasons for dropouts was poorly reported. Conclusions: The quality of reporting of clinical trials of TCM interventions for VaD is generally poor; this is probably related to a lack of awareness of international standards as well as severe editorial restrictions.