Quality Assessment of Clinical Studies on Compound Salvia Pellet (CSP) for Angina Pectoris

Objective To investigate the current situation of randomized controlled trials (RCTs) on compound salvia pellet (CSP) for angina pectoris and assess whether there is adequate evidence for clinical practice. Methods We collected all the published clinical studies on CSP for angina pectoris from 1994 to December 2005, and assessed each included report using the Jadad scale ,the revised CONSORT statement and other self-edited items. Results We finally identified 115 RCTs. Among which , 1 scored 3 points, 6 scored 2 points, 106 scored 1 points and 2 socred 0 points. No RCT performed allocation concealment according to the CONSORT criteria, only 4 RCTs (3.5%) described the generation of the randomization sequence, among which 2 were quasi-randomized. No RCT provided randomization implementation ,1 RCT (0.9%) carried out placebo control, 1 RCT (0.9%) reported endpoint, 9 RCTs (7.8%) adopted single blinding ,4 RCTs (3.5%) reported double blinding ,11 RCTs (9.6%) calculated statistical values, 2 RCTs (1.7%) provided the record of follow-up ,1 RCT (0.9%) reported negative outcome ,25 RCTs (21.8%) described adverse events, no RCT described how the sample size was estimated , and how an intent-to-treat (ITT) analysis and correlation analysis were reported, 1 RCT (0.9%) was multi-center, no RCT completed ethical approval and informed consent, 27 RCTs (23.5%) described syndrome type of TCM. Conclusion Currently, the methodology and reporting of studies on CSP for angina pectoris are not good enough to provide reliable evidence for clinical practice.