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    2 Comments for this article
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    RE: Acupuncture as Adjunctive Therapy for Chronic Stable AnginaA Randomized Clinical Trial.
    Rajiv Kumar, MBBS, MD. | Faculty, Dept. of Pharmacology, Government Medical College & Hospital, Chandigarh, 160030. India.
    It is revealed from the RCT that,

    1. Primary and secondary outcomes measures of the RCT were both subjective and objective.

    2. Non-acupoint acupuncture (sham acupuncture) in SA group claimed as pre-validated sham acupoints is not as authentic in this study as in migrane.

    3. Acupuncture on acupoint of non-affected meridian (NA study group) was more harmful to the patients.

    4. The benificial effect of acupuncture related intervention as adjunctive therapy with regard to primary outcome was observed in patients with DAM group in early weeks.

    5. Long term benefit of
    acupuncture related intervention as adjunctive therapy in patients of chronic stable angina is doubtful.

    6. There was no observable change in regulation of anxiety and depression in patients of chronic stable angina in all 4 groups.

    The standard antianginal therapy as per guidelines in patients of chronic stable angina remains the cornerstone, The reliability of acupuncture related intervention as adjunctive therapy is not superior as claimed by the authors. In view of the results of the RCT the interpretation by the investigators does not hold up, The study is more like a non-inferiorty trial.

    Regards,
    Dr.Rajiv Kumar,
    Faculty, Dept. of Pharmacology,
    Government Medical College & Hospital, Chandigarh, 160030. India.
    DRrajiv.08@gmail.com
    CONFLICT OF INTEREST: None Reported
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    Acupuncture (or enhanced placebo?) as adjunctive therapy for angina
    Luciana Machado, BAppScPT(Hons), PhD | Faculty of Medicine/University Hospital, Universidade Federal de Minas Gerais, Belo Horizonte - MG, Brazil
    Zhao and colleagues’ trial concluded that acupuncture is efficacious for stable angina and triggered widespread reactions, particularly in light of prior evidence on the inefficacy of other more ‘biologically plausible’ treatments (e.g. PCI). Most reactions listed ineffective participant blinding as a key source of bias. Indications that unblinding was a problem include an unrealistic scenario where Chinese adults (some recruited from acupuncture clinics) were naïve to the sensation elicited by ‘real’ acupuncture, and the lack of explicit strategies to prevent information exchange on observable differences between acupuncture prescriptions, or to minimize (verbal or non-verbal) cues from unblinded therapists. Other less obvious (but no less important) flaws were the exclusion of 6 participants after randomization , poor choice of data imputation (last-observation-carried-forward can underestimate the overall variance) and absence of pre-specified adjustment analyses to account for known acupuncture effect modifiers (e.g. expectations of acupuncture success).
    The novelty of Zhao and colleagues’s finding compared to previous placebo-controlled trials is another indication that some (if not all) of these problems contributed to their ‘implausible’ result. Although the authors attributed this inconsistency to differences in acupuncture prescriptions, there is mounting evidence against the superiority of acupoints based on traditional acupuncture theories compared to other needling locations (or electroacupuncture compared to manual acupuncture) in improving subjective outcomes.1 Additionally, the lower mean frequency of angina attacks at baseline of their trial compared to previous studies would have decreased (not increased, as claimed by the authors) the efficacy of acupuncture, as patients experiencing higher disease severity show more benefit from ‘real’ acupuncture when compared to sham or non-acupuncture controls.2
    The implementation of sham comparisons that are both meaningful and with low risk of bias is infrequent in trials investigating complex interventions such as acupuncture;3 however, there are ongoing efforts to develop protocols that are more consistent and effective in preserving blinding.4 The increasing level of control for multiple factors underlying the totality of effects observed after acupuncture (i.e. regression to the mean/natural history, placebo effects and acupoint specificity) is a major advantage in Zhao and colleagues’ trial, but the failure to properly address important weaknesses in the trial’s conduct/analysis is  disappointing.

    1. Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture for chronic pain: Update of an individual patient data meta-analysis. J Pain. 2018;19(5):455-474.
    2. Witt CM, Vertosick EA, Foster NE, et al. The effect of patient characteristics on acupuncture treatment outcomes: An individual patient data meta-analysis of 20,827 chronic pain patients in randomized controlled trials. Clin J Pain. 2019;35(5):428-434.
    3. Machado LA, Kamper SJ, Herbert RD, Maher CG, McAuley JH. Imperfect placebos are common in low back pain trials: A systematic review of the literature. Eur Spine J. 2008;17(7):889-904.
    4. Braithwaite FA, Walters JL, Li LSK, Moseley GL, Williams MT, McEvoy MP. Blinding strategies in dry needling trials: Systematic review and meta-analysis [published online August 2, 2019]. Phys Ther. doi: 10.1093/ptj/pzz111
    CONFLICT OF INTEREST: None Reported
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    Original Investigation
    July 29, 2019

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

    Author Affiliations
    • 1Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
    • 2Department of Acupuncture, the Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
    • 3Acupuncture and Tuina School, Hunan University of Traditional Chinese Medicine, Changsha, Hunan, China
    • 4Acupuncture and Tuina School, Guiyang University of Traditional Chinese Medicine, Guiyang, Guizhou, China
    • 5Acupuncture and Tuina School, Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China
    • 6Acupuncture and Tuina School, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, China
    • 7Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, China
    • 8School of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
    JAMA Intern Med. 2019;179(10):1388-1397. doi:10.1001/jamainternmed.2019.2407
    Key Points

    Question  What is the efficacy and safety of acupuncture adjunctive therapy to antianginal therapies in reducing the frequency of angina attacks?

    Findings  This randomized clinical trial that included 404 patients with chronic stable angina found that acupuncture on the acupoints in the disease-affected meridian significantly reduced the frequency of angina attacks compared with acupuncture on the acupoints on the nonaffected meridian, sham acupuncture, and no acupuncture.

    Meaning  Adjunctive therapy with acupuncture had a significant effect in alleviating angina within 16 weeks.

    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

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