title: A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule in preventing restenosis after percutaneous coronary intervention: a subgroup analysis of senile patients.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of Xiongshao Capsule (XS), consisting of Chuangxiongol and paeoniflorin, in preventing restenosis after percutaneous coronary intervention (PCI) in senile coronary heart disease (CHD) patients.
  
  
  METHODS
  A multi-center, randomized, double-blind, placebo-controlled trial was conducted. A total of 335 CHD patients were randomly assigned to treatment with oral administration of XS, or a placebo for 6 months after successful PCI. A clinical follow-up was performed at 1, 3 and 6 months after PCI and an angiographic follow-up was scheduled at 6 months. The primary endpoint was angiographic restenosis defined as a luminal stenosis ≥ 50% in follow-up. The secondary endpoints were combined incidence of death, target lesion nonfatal myocardial infarction, repeat target-vessel angioplasty, and coronary artery bypass graft surgery (CABG). The follow-up for the above clinical endpoint events was continued to 1 year after PCI.
  
  
  RESULTS
  The subgroup analysis of 152 senile patients (68 cases angiographic follow-up) showed that the restenosis rates tended to reduce in the XS group as compared with that in the placebo group (24.32% vs. 38.71%, P > 0.05), and the minimum lumen diameter (MLD) significantly increased in the follow-up (2.15 ± 0.84 for XS vs. 1.73 ± 0.91 for placebo, P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in the XS group (4.11% and 12.33%) as compared with those in the placebo group (17.72% and 43.04%), but there was no significant difference in the combined incidence of clinical outcomes (6.85% in the XS group vs. 11.39% in the placebo group, P > 0.05). No significant adverse reactions occurred within the 6-month follow-up period in the XS group.
  
  
  CONCLUSIONS
  Administration of XS in addition to standardized Western medication for 6 months is demonstrated to be safe and effective in reducing post-PCI recurrent angina and inhibiting luminal restenosis after PCI in senile CHD patients.
authors: Beijing University of Chinese Medicine, China.
authors: Qing-hua
authors: QH
authors: Shang
authors: Hao
authors: H
authors: Xu
authors: Xiao-yan
authors: XY
authors: Lu
authors: Chuan
authors: C
authors: Wen
authors: Da-zhuo
authors: DZ
authors: Shi
authors: Ke-ji
authors: KJ
authors: Chen
mesh_terms: D000368:Aged; D000787:Angina Pectoris / Q000150:complications / Q000000981:diagnostic imaging / Q000453:epidemiology; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D002214:Capsules; D002681:China / Q000453:epidemiology; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D012008:Recurrence
chemical_list: D002214:Capsules; D004365:Drugs, Chinese Herbal; D010919:Placebos; C528128:xiongshao