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Effect of Xuefu Zhuyu Capsule (血府逐瘀胶囊) on the symptoms and signs and health-related quality of life in the unstable angina patients with blood-stasis syndrome after percutaneous coronary intervention: A Randomized controlled trial

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Abstract

Objective

Compared with Shengmai Capsule (生脉胶囊, SM), the study was conducted to evaluate the efficacy and safety of Xuefu Zhuyu Capsule (血府逐瘀胶囊, XFZY) on the symptoms and signs and health-related quality of life (HR-QOL) in the unstable angina (UA) patients with blood-stasis syndrome (BSS) after percutaneous coronary intervention (PCI).

Methods

A randomized, double-blinded, double-dummy, and placebo-controlled trial was applied. Ninety patients, diagnosed as UA and BSS after successful PCI, were enrolled and equally randomized into three groups, XFZY group, SM group, and placebo group, and administered with the corresponding medications respectively for four weeks. The clinical symptoms and signs (CSS), electrocardiography (ECG), and BSS scores were recorded and compared among groups during and after the treatment. Short-form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QOL in each group before and after the treatment. Safety indexes (blood routine and liver and kidney function tests) were also examined at the beginning and after the treatment.

Results

Eighty-six patients completed the whole study. After the treatment, the total effective rates of the XFZY group in ameliorating CSS and ECG were 76.7% and 60.0%, respectively, which were obviously higher than those in SM (CSS: 53.3%; ECG: 36.7%) and the placebo (CSS: 43.3%; ECG: 30.0%) groups. After one week’s treatment, BSS scores slightly decreased in each group, but no signifificant differences were found among three groups (P>0.05). After four weeks’ treatment, BSS scores in the XFZY group decreased to a lower level compared with SM (P <0.05) and the placebo (P <0.01) groups. After the treatment, the effificacy of XFZY group in improving body pain (BP), general health (GH), vitality (VT), society functioning (SF), role emotional (RE), angina stability (AS), angina frequency (AF), and treatment satisfaction (TS) were better than those in the placebo group (P <0.05,P <0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, and TS were better improved than those in the SM group P <0.05). No obvious adverse reaction was found during and after the treatment except one case in the XFZY group reporting of stomach discomfort.

Conclusions

Compared with SM Capsule treatment, a short-term treatment with XFZY Capsule exhibits better effificacy on CSS and BSS scores, and HR-QOL in UA patients with BSS after PCI. However, its long-term effificacy and safety still needs further investigation.

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Authors and Affiliations

  1. Department of Cardiology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China

    Fu-yong Chu  (褚福永), Jie Wang  (王 阶) & Kui-wu Yao  (姚魁武)

  2. Rescue Center of Emergency, Anzhen Hospital, China Capital University of Medical Science, Beijing 100029, China

    Zhi-zhong Li  (李志忠)

Authors
  1. Fu-yong Chu  (褚福永)
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  2. Jie Wang  (王 阶)
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  3. Kui-wu Yao  (姚魁武)
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  4. Zhi-zhong Li  (李志忠)
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Corresponding author

Correspondence to Jie Wang  (王 阶).

Additional information

Supported by the National Natural Science Foundation of China (No. 90709048) Clinical Trials.

Gov Identifier: NCT00817024

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Chu, Fy., Wang, J., Yao, Kw. et al. Effect of Xuefu Zhuyu Capsule (血府逐瘀胶囊) on the symptoms and signs and health-related quality of life in the unstable angina patients with blood-stasis syndrome after percutaneous coronary intervention: A Randomized controlled trial. Chin. J. Integr. Med. 16, 399–405 (2010). https://doi.org/10.1007/s11655-010-9999-9

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  • DOI: https://doi.org/10.1007/s11655-010-9999-9

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