Objective To assess the quality of randomised controlled trials on traditional Chinese medicine (TCM) for coronary heart disease (CHD) angina published from 1977 to 2002. Method We did electronic search in Medline, Embase and hand searched 83 journals of traditional Chinese medicine (the earliest published in 1977 and the latest in June 2002). We assessed the quality of obstained studies. Results Four hundred and forty articles met the criteria,of which 33 (7.5%) described randomization. None of them mentioned allocation concealment; 94.77% (417 studies) mentioned diagnosis criteria; only one mentioned the calculation basement of sample size; 84.09% (370 studies) mentioned comparability of baseline. Fifty three studies (12.05%) noted double-blind; 28 studies used single blind. Twenty-five studies used double-blind. Drop-outs were described in 7 cases without intention-to-treat (ITT); 159 studies applied statistical methods properly, while 4 did not. Ten studies never mentioned statistical methods; 73.18% (322 studies) used forms to express their results. Conclusions Till now, the quantity and quality of RCTs of traditional Chinese medicine for coronary heart disease angina were inadequate. Some well designed scientific methods were not adequately applied.
Background Tongxinluo capsule is a new drug for cardio- cerebral vascular diseases on the national essential drug list of China, and the second-class award of National Science and Technology Development of China, 2001. Objective This review aims to assess the effect (harms and benefits) of Tongxinluo capsule for unstable angina. Search strategy electronic searchs The Cochrane Heart Review Group specialised trials register,The Cochrane Controlled Trials Register, published in the latest issue of the Cochrane Library, MEDLINE, EMBASE, CBM, Chinese Cochrane Centre Controlled Trials Register, Current Controlled Trials (www. controlled-trials. com), The National Research Register Handsearchs We will search 83 journals of Chinese traditional medicine. Inclusion riteria We will include randomised controlled trials of Tonxinluo capsule versus placebo or other current phamarcotherapy or other Chinese medicinal herbs in the participants with unstable angina pectoris. Studies will report mortality (sudden death from acute myocardial infarction), severity of angina pectoris, frequency of acute attack angina, ECG improvement, rate of dosage reducing or taking frequency of nitroglycerine and symptom improvement, etc. Data analysis Data will be included in a meta-analysis if they are available, of sufficient quality and sufficiently similar.