Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial<sup>*</sup>

De-hua LI; Jin XIE; Yu-lan REN; Hui ZHENG; Jun-ling LYU; Jun-yan LENG; Ling-lin ZHANG; Jie ZHANG; Hai-long FAN; Fan-rong LIANG

doi:10.1007/s11655-021-2870-3

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Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*

Acupuncture Research | Updated：2021-11-05

- Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*
- Chinese Journal of Integrative Medicine Vol. 27, Issue 11, Pages: 838-845(2021)
- Affiliations：
  
  1.Department of Acupuncture and Moxibustion, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu(610075), China
  2.Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu (610075), China
- Author bio：
  
  Prof. LIANG Fan-rong, E-mail:acuresearch@126.com
- Funds：
- DOI：10.1007/s11655-021-2870-3
  CLC：
- Published：01 November 2021，
  
  Published Online：13 August 2021，
  
  Accepted：02 April 2020
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De-hua LI, Jin XIE, Yu-lan REN, et al. Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*. [J]. Chinese Journal of Integrative Medicine 27(11):838-845(2021)
DOI：

De-hua LI, Jin XIE, Yu-lan REN, et al. Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*. [J]. Chinese Journal of Integrative Medicine 27(11):838-845(2021) DOI： 10.1007/s11655-021-2870-3.

摘要

目的:

评价冠心苏和丸穴位贴敷治疗慢性稳定型心绞痛患者的临床疗效.

方法:

本研究在中国成都的3家医院进行. 基线评估后

符合纳入标准的患者被随机分配到安慰剂穴位贴敷组 (PAA组) 或中药穴位贴敷组 (HAA组) . HAA组患者给予以冠心苏和丸为主的中药粉末调制的穴位贴敷治疗

PAA组患者给予以荞麦粉为主调制的安慰剂贴敷治疗. 两组均取内关穴 (PC 6) 、膻中穴 (RN 17) 、心俞穴 (BL 15) 和厥阴俞穴 (BL 14) 治疗

每次贴敷均取单侧穴位

两侧交替

每周进行3次穴位贴敷

每次间隔2天

持续4周. 主要评价指标为每周心绞痛发作的次数

次要评价指标包括疼痛视觉模拟量表 (VAS) 测量每次心绞痛疼痛程度、口服硝酸甘油的剂量、西雅图心绞痛问卷量表 (SAQ)

焦虑自评量表 (SAS) 和抑郁自评量表 (SDS) . 以上指标在入组第0、4和8周评定

同时评价冠心苏和丸穴位贴敷治疗慢性稳定型心绞痛的安全性.

结果:

共纳入121例患者

两组的基线特征具有可比性. 治疗后

HAA组的心绞痛发作次数从11.00次减少至4.81次 (

0.05)

PAA组心绞痛发作次数没有显著变化 (基线值10.55; 治疗后11.05)

HAA组的心绞痛发作明显少于PAA组 (

0.05) ; HAA组VAS测量的疼痛强度从4.06降低至3.02 (

0.05)

而PAA组VAS评分增加 (基线3.62

治疗后3.96) (

0.05) ; 口服硝酸甘油的剂量、SAS、SDS和SAQ评分方面

HAA组治疗后的改善优于PAA组 (

0.05) ; 少数患者发生皮肤过敏等轻微不良反应发生.

结论:

冠心苏和丸穴位贴敷是慢性稳定型心绞痛患者安全有效的治疗方法. (临床注册号NCT02029118)

Abstract

Objective:

To assess the clinical effectiveness of acupoint application (AP) of Guan Xin Su He Pill (冠心苏合丸

GXSHP) for patients with chronic stable angina pectoris (CSAP).

Methods:

This study was carried out in 3 local hospitals in Chengdu

China. After baseline evaluation

eligible patients were randomly assigned to the placebo application for acupoints (PAA) group or the herbal application for acupoints (HAA) group. Patients in the HAA group underwent AP with herbal powder

which was mainly GXSHP

and patients in the PAA group underwent AP with sham drugs. For each treatment session

unilateral acupoints including Neiguan (PC 6)

Danzhong (RN 17)

Xinshu (BL 15) and Jueyinshu (BL 14)

were stimulated for both groups. AP was performed 3 times a week with a 2-day interval for 4 weeks. The primary outcome was the frequency of angina pectoris attacks per week

while the secondary outcomes included angina pain intensity measured by the Visual Analogue Scale (VAS)

dose of rescue oral drugs (nitroglycerin)

scores on the Seattle Angina Questionnaire (SAQ)

Self-Rating Anxiety Scale scores (SAS) and Self-Rating Depression Scale scores (SDS). Clinical outcomes were measured at week 0

4 and 8. The safety of AP of GXSHP treatment for CSAP were assessed.

Results:

A total of 121 patients were enrolled. Baseline characteristics were comparable across the 2 groups. After treatment

the angina attack numbers in the HAA group were significantly reduced from 11.00 to 4.81 (

0.05). While

for PAA group

the angina frequency was not significantly improved (baseline 10.55; post-treatment 11.05). The HAA group had significantly fewer angina attacks than the PAA group (

0.05). Pain intensity measured by VAS in HAA group was significantly reduced from 4.06 to 3.02 (

0.05). While

for PAA group

the VAS was significantly increased (baseline 3.62; post-treatment 3.96;

0.05). Clinical outcomes showed better improvement after treatment in the HAA group than in the PAA group in terms of oral administration of rescue drugs

SAS

SDS and SAQ scores (

0.05). The adverse events were also reported.

Conclusion:

AP of GXSHP is a safe and effective treatment for CSAP patients (Registration No. NCT02029118).

关键词

Keywords

acupoint applicationchronic stable angina pectorisclinical efficacy randomized controlled trial

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