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Journal of Chinese Integrative Medicine ›› 2009, Vol. 7 ›› Issue (8): 729-735.doi: 10.3736/jcim20090805

• Original Clinical Research • Previous Articles     Next Articles

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 Chua,Jie Wanga,b,Xiao-wei Suna,Yan-wei Xinga,Kui-wu Yaoa,Shi-han Wanga,Zhi-zhong Lic   

  1. a Department 〇£ Cardiology,Guang’anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China
    b Department of Clinical Basic Science of Chinese Medicine, Hubei Universtiy of Chinese Medicine, Wuhan 430065,Hubei Province,China
    c Rescue Center of Emergency» Beijing Anzhen Hospital, China Capital University of Medical Science^ Beijing 100029, China
  • Received:2009-04-13 Accepted:2009-06-04 Online:2009-08-20 Published:2009-08-15
  • Contact: Jie Wang E-mail:wangjie0103@yahoo.com

Background

With the wide application of percutaneous coronary intervention (PCI) in patients with coronary heart disease (CHD), it is a popularly concerned problem within clinical doctors to promote the patients’ early recovery and improve their health related quality of life (HR-QoL).
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-QoL 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 (SAQ) 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 SAQ 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<0.05). 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-QoL in UA patients with blood-stasis syndrome after PCI. However, its long-term efficacy and safety needs further investigation.

Key words: Xuefu Zhuyu Capsule, Unstable angina, Quality of life, Randomized controlled trial, Double-blind, Double-dummy

Figure 1

Flow diagram of this randomized trial"

Table 1

Baseline characteristics in three groups"

Characteristics Placebo group
(n=29)
SM group
(n=29)
XFZY group
(n=28)
Statistic value P
Male [Cases (%)] 20 (69.0) 15 (51.7) 18 (64.3) 1.95 0.37
Age ($\bar{x}$±s, years) 58.8±8.9 61.6±9.2 61.7±9.6 0.14 0.87
Course of disease ($\bar{x}$±s, years) 6.1±3.4 5.8±3.7 5.2±3.2 0.22 0.65
Body mass index ($\bar{x}$±s, kg/m2) 23.28±3.59 24.07±3.41 23.40±3.54 0.12 0.89
Hypertension [Cases (%)] 12 (41.3) 14 (48.2) 13 (46.4) 0.30 0.86
Hyperlipidemia [Cases (%)] 10 (34.5) 10 (34.5) 11 (39.3) 0.18 0.91
Diabetes mellitus [Cases (%)] 12 (41.4) 11 (37.9) 7 (25.0) 1.86 0.39
Smoking [Cases (%)] 19 (65.5) 15 (51.7) 17 (60.7) 1.18 0.56
Average stent number ($\bar{x}$±s) 1.7±1.2 1.2±0.8 1.9±1.1 1.21 0.31

Table 2

SF-36 scores in 3 groups before and after treatment ($\bar{x}$±s)"

Variable Placebo group (n=29) SM group (n=29) XFZY group (n=28)
Before treatment After treatment Before treatment After treatment Before treatment After treatment
PF 63.18±26.45 68.21±29.60* 64.37±28.60 80.34±18.41** 63.20±27.66 78.36±25.58**
RP 47.45±10.56 48.12±10.24 46.44±12.56 47.72±14.20 47.93±11.41 47.50±15.31
BP 45.28±14.15 49.37±12.20* 44.75±15.16 51.34±16.37* 45.31±16.24 57.40±14.28*△▲
GH 58.61±26.42 63.62±12.28 57.16±25.43 64.21±15.57 57.45±26.30 68.10±23.21*△▲
VT 49.39±14.34 54.29±14.67* 49.10±10.66 54.40±15.35* 48.71±15.73 59.43±16.30*
SF 53.61±14.38 63.78±13.41* 55.20±16.52 63.24±12.45* 55.31±15.03 69.23±15.36*△▲
RE 65.63±11.25 66.61±12.46 63.33±10.54 74.16±11.02* 64.42±19.40 77.56±13.25*
MH 57.20±12.18 59.20±15.52 61.42±14.25 59.27±10.56 55.34±15.39 57.12±16.67
HT 39.67±14.25 39.34±12.56 39.80±16.56 40.32±15.37 40.51±12.89 41.35±21.27

Table 3

SAQ scores in 3 groups before and after treatment ($\bar{x}$±s)"

Group n PL AS AF TS DP
Placebo
Before treatment 29 54.32±15.43 39.32±11.56 56.17±13.64 56.49±10.42 43.18±10.39
After treatment 29 62.70±12.54* 44.17±16.28* 64.25±12.40* 61.29±12.76* 41.80±18.30
SM
Before treatment 29 53.10±15.32 38.65±12.23 55.12±14.16 55.45±12.14 42.19±13.27
After treatment 29 64.20±11.14* 49.10±16.78* 67.43±11.20** 67.12±16.34** 48.89±12.14
XFZY
Before treatment 28 54.17±16.80 39.84±13.51 55.40±14.20 56.52±10.36 43.66±17.12
After treatment 28 64.69±13.76* 56.30±12.49*△▲ 71.31±16.58**△▲ 73.32±9.58**△△▲ 45.21±16.24
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