Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

Acupoint application with herbal medicine is a kind of external treatment of traditional Chinese medicine and has a long history in China, which is use herbal medicine made of plaster and stick to specific acupoints, using the double effects of acupoints and herb to treat disease. In China, acupoint application with herbal medicine has been used in clinical treatment of angina pectoris, but there is no convincing evidence for the efficacy of acupoint application for angina pectoris, due to low methodologic quality and small sample size. The investigators designed the Randomized, Controlled, Double Blind clinical trial to investigates the efficacy of acupoint application in treating angina pectoris, the purpose of this study is to provide the convincing evidence for acupoint application treatment of angina pectoris.

• Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech) (Drug), also known as Herbal medicine application: Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.
• acupoint (Device), also known as acupuncture point: select acupoint according to traditional Chinese medicine
• Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn. (Drug), also known as basic treatment: foundation treatment

Primary outcomes

• Change from Baseline Number of angina attacks at 12 weeks [at baseline,4, 8weeks after inclusion]: The change frequency of angina attack during every 4-week.

Secondary outcomes

• Change from Baseline the severity of angina ( VAS score) at 12 weeks [at baseline,4, 8weeks after inclusion]: The VAS score evaluation angina pain severity
• Change from Baseline the dosage of nitroglycerin at 12 weeks [at baseline,4, 8weeks after inclusion]: Observed reduction in the dose of nitroglycerin
• Seattle Angina Questionnaire [at baseline,4, 8weeks after inclusion]
• self-rating anxiety scale [at baseline,4, 8weeks after inclusion]
• Self-rating Depression Scale [at baseline,4, 8weeks after inclusion]

Sex: All, ages: 35 Years to 85 Years

Inclusion Criteria:

1.Meet the diagnostic criteria of American College of Cardiology(ACC)/American Heart Association (AHA) angina pectoris of coronary heart disease.

2.35 ≤ age ≤ 85 years, both male and female.

3.The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week.

4.Patients signed the informed consent

Exclusion Criteria:

1. age≤35 or age≥85.
2. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
3. history of diabetes.
4. Co-infection or bleeding, allergic.
5. Currently participating in other clinical trials

• Results publication: Li DH, Xie J, Ren YL, Zheng H, Lyu JL, Leng JY, Zhang LL, Zhang J, Fan HL, Liang FR. Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill () for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial. Chin J Integr Med. 2021 Nov;27(11):838-845. doi: 10.1007/s11655-021-2870-3. Epub 2021 Aug 13. PMID 34387828
• Results publication: Ren Y, Li D, Zheng H, Lv J, Leng J, Zhang L, Zhang J, Fan H, Liang F. Acupoint application in patients with chronic stable angina pectoris: study protocol of a randomized, double-blind, controlled trial. Evid Based Complement Alternat Med. 2014;2014:619706. doi: 10.1155/2014/619706. Epub 2014 Aug 27. PMID 25250055

• Fanrong Liang, Principal investigator, Chengdu University of TCM