Acupuncture as Adjunctive Therapy for Chronic Stable Angina: A Randomized Clinical Trial

Abstract

Importance: The effects of acupuncture as adjunctive treatment to antianginal therapies for patients with chronic stable angina are uncertain.

Objective: To investigate the efficacy and safety of acupuncture as adjunctive therapy to antianginal therapies in reducing frequency of angina attacks in patients with chronic stable angina.

Design, setting, and participants: In this 20-week randomized clinical trial conducted in outpatient and inpatient settings at 5 clinical centers in China from October 10, 2012, to September 19, 2015, 404 participants were randomly assigned to receive acupuncture on the acupoints on the disease-affected meridian (DAM), receive acupuncture on the acupoints on the nonaffected meridian (NAM), receive sham acupuncture (SA), and receive no acupuncture (wait list [WL] group). Participants were 35 to 80 years of age with chronic stable angina based on the criteria of the American College of Cardiology and the American Heart Association, with angina occurring at least twice weekly. Statistical analysis was conducted from December 1, 2015, to July 30, 2016.

Interventions: All participants in the 4 groups received antianginal therapies as recommended by the guidelines. Participants in the DAM, NAM, and SA groups received acupuncture treatment 3 times weekly for 4 weeks for a total of 12 sessions. Participants in the WL group did not receive acupuncture during the 16-week study period.

Main outcomes and measures: Participants used diaries to record angina attacks. The primary outcome was the change in frequency of angina attacks every 4 weeks from baseline to week 16.

Results: A total of 398 participants (253 women and 145 men; mean [SD] age, 62.6 [9.7] years) were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 4 groups. Mean changes in frequency of angina attacks differed significantly among the 4 groups at 16 weeks: a greater reduction of angina attacks was observed in the DAM group vs the NAM group (difference, 4.07; 95% CI, 2.43-5.71; P < .001), in the DAM group vs the SA group (difference, 5.18; 95% CI, 3.54-6.81; P < .001), and in the DAM group vs the WL group (difference, 5.63 attacks; 95% CI, 3.99-7.27; P < .001).

Conclusions and relevance: Compared with acupuncture on the NAM, SA, or no acupuncture (WL), acupuncture on the DAM as adjunctive treatment to antianginal therapy showed superior benefits in alleviating angina.

Trial registration: ClinicalTrials.gov identifier: NCT01686230.

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.. Flowchart of Screening, Enrollment, Randomization, and Follow-up

DAM indicates disease-affected meridian; ITT, intention to treat; NAM, nonaffected meridian; SA, sham acupuncture; SAE, serious adverse effect; and WL, wait list.

Figure 2.. Frequency of Angina Attacks Over Time During the Study

DAM indicates disease-affected meridian; NAM, nonaffected meridian; SA, sham acupuncture; and WL, wait list.