A Randomized Double-blinded Controlled Trial of Xuefu Zhuyu Capsule
A randomized double-blinded controlled trial of Xuefu Zhuyu Capsule on short-term quality of life in unstable anginal patients with blood-stasis syndrome after percutaneous coronary intervention
Fu-yong CHU , lie WANG1, 2 , Xiao-wei SUN1 , Yan-wei XINO , Kui-wu YACJ , Shi-han WANG1 , Zhi-zhong LP
1. Department of Cardiology , Guang' anmen Hospital, China Academy of Chinese Medical Sciences , Beijing 100053 , China
2. Department of Clinical Basic Science of Chinese Medicine , Hubei Universtiy of Chinese Medicine , Wuhan 430065 , Hubei
Province , China
3. Rescue Center of Emergency , Beijing Anzhen Hospital , China Capital University of Medical Science , Beijing 100029 , China
Background: With the wide application of percutaneous coronary intervention (PCI) in patients with coronary heart disease (CHO) , it is a popularly concerned problem within clinical doctors to promote the patients' early recovery and improve their health related quality of life (HR-OoL).
Objective: To evaluate the efficacy and safety of Xuefu Zhuyu (XFZY) Capsule , a compound traditional Chinese herbal medicine for activating blood circulation , in improving HR-OoL in unstable angina (UA) patients with blood-stasis syndrome after PCI , and to make a comparison with Shengmai (SM) Capsule.
Design, setting, participants and interventions: The study was performed at Rescue Center of Emergency ,Beijing Anzhen Hospital，China Capital University of Medical Science from March 2008 to February 2009. Using a randomized , double-blinded , double-dummy and placebo controlled study design , ninety patients diagnosed as UA and concomitant blood stasis syndrome after successful PCI therapy were enrolled and randomized into three groups: XFZY group , SM group and placebo group , and the patients were administered with the corresponding medications for 4 weeks.
Main outcome measures: The Short-Form 36 (SF-36) and Seattle Angina Questionnaire (SAO) were applied to assess the HR-QoL in each group before and after the treatment
Results: A total of 90 patients were recruited and 4 cases of them withdrew from the study during the treatment period indicating a 4.4% of dropping rate. After the treatment , several domains of scores in SF-36 and SAO were significantly increased in three groups (P<0.05， P<0. 01). The efficacy of XFZY Capsule in improving body pain (BP) , general health (GH) , vitality (VT) , social function (SF) , role emotional (RE), angina stability (AS) , angina frequency (AF) , as well as treatment satisfaction (TS) was better than that of placebo (P<0.05 , P<0.01). Meanwhile , the dimensions of BP , GH , SF , AS , AF , TS were improved as compared with those in the SM group (P
Conclusion: Compared with SM Capsule, a short-term treatment of XFZY Capsule exhibits better efficacy in improving HR-OoL in UA patients with blood-stasis syndrome after PCI. However, its long-term efficacy and safety needs further investigation.
Trial registration: Clinical Trials.Gov, NCT 00817024
Keywords: Xuefu Zhuyu Capsule; unstable angina; quality of life; randomized controlled trial; double-blind; double-dummy
This article is an Open Access article published in Journal of Chinese Integrative Medicine: 2009; 7(8): 729-735.
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