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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
  • Published:
Chinese Journal of Integrative Medicine Aims and scope Submit manuscript

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 (P<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 (P<0.05). Pain intensity measured by VAS in HAA group was significantly reduced from 4.06 to 3.02 (P<0.05). While, for PAA group, the VAS was significantly increased (baseline 3.62; post-treatment 3.96; P<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 (P<0.05). The adverse events were also reported.

Conclusion

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

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Availability of Data and Materials

All data generated or analyzed during this study are included in the manuscript. The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgments

The authors acknowledge assistance and contributions from acupuncturists, experts and investigators in each center. They also acknowledge the contributions from patients with CSAP who participated in this trial.

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Authors and Affiliations

  1. Department of Acupuncture and Moxibustion, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China

    De-hua Li

  2. Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China

    Jin Xie, Yu-lan Ren, Hui Zheng, Jun-ling Lyu, Jun-yan Leng, Ling-lin Zhang, Jie Zhang, Hai-long Fan & Fan-rong Liang

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  1. De-hua Li
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  2. Jin Xie
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Contributions

Liang FR and Li DH conceived the research topic and made study protocol. Ren Yl and Zheng H conceived and implemented the analysis plan. Li DH and Xie J drafted the initial and final manuscript. Lyu JL, Leng JY, Zhang LL, Zhang J and Fan HL had contributed to intervention, and accumulated the clinical data. All authors read and approved the final paper.

Corresponding author

Correspondence to Fan-rong Liang.

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The authors declare that they have no competing interests.

Additional information

Supported by the National Basic Research Program of China “973 Program” (No. 2012CB518501) and the Research Program of the Science and Technology Ministry of the Chengdu City (No. 12DXYB215JH002) in China

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Li, Dh., Xie, J., Ren, Yl. 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. Chin. J. Integr. Med. 27, 838–845 (2021). https://doi.org/10.1007/s11655-021-2870-3

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  • DOI: https://doi.org/10.1007/s11655-021-2870-3

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