Abstract

This research aimed at evaluating the clinical curative effect of Blood Mansion Stasis-Expelling Decoction and its refining prescription on stable angina pectoris through double-blind randomized controlled trial based on doctor and patient reported outcomes. Patients (92) were randomly grouped into Groups A, B, and C, and were separately given Blood Mansion Stasis-Expelling Decoction, refined Blood Mansion Stasis-Expelling Decoction and placebo, and they were evaluated before and after treatment, though, doctor and patient reported outcomes. The results showed that in doctor reported outcomes (DRO) aspect Blood Mansion Stasis-Expelling Decoction and its refining prescription had significant curative effect on angina (P < 0.05) when compared with placebo and reduced the patients’ nitroglycerin consumption (P < 0.01), blood viscosity, platelet adhesion rate (PAR), and serum IL-6 level (P < 0.05 or P < 0.01), and raised their NO level (P < 0.05), while Blood Mansion Stasis-Expelling Decoction could raise the patients’ erythrocyte deformation rate (EDR) and tissue plasminogen activator (t-PA) level (P < 0.05). In patient reported outcomes (PRO) aspect, Blood Mansion Stasis-Expelling Decoction and its refining prescription could improve angina stability of the stable angina pectoris patients, angina frequency and the satisfaction about the whole treatment (P＜0.01 or P＜0.05), and especially, work better on the patients’ angina frequency than placebo (P < 0.05). The result showed that Blood Mansion Stasis-Expelling Decoction and its refining prescription have significant curative effect on stable angina pectoris through reducing inflammatory mediators and improving hemorheology condition and vascular endothelial function. Double-blind randomized controlled trial based on doctor and patient reported outcomes is an effective method to evaluate the curative effect of Chinese herbal formulae.

Key words: Blood Mansion Stasis-Expelling Decoction, patient reported outcomes, doctor reported outcomes, stable angina pectoris, Seattle Angina Questionnaire (SAQ), traditional Chinese medicine, double-blind randomized controlled trial.