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 (P05). No obvious adverse reaction was found during and after the treatment with the exception of one case in XFZY group reporting of discomfort in the stomach
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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