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The methodology flaws in Hinman’s acupuncture clinical trial, Part II: Zelen design and effectiveness dilutions .

Click to access S2095-4964(15)60172-8.pdf

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Click to access S2095-4964%2815%2960172-8.pdf

In the October 2014 publication of JAMA, Dr. Hinman and colleagues published the study “Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial,” which concluded that “in patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients[1].” As pointed out in my former article, Part I[2], there were serious flaws in the trial design and statistics, as well as in the interpretation of the results. This article attempts to address problems in the Zelen design used by Hinman et al[1]. There are some advantages to using a Zelen design for a randomized controlled trial (RCT). First, a Zelen design has a post-randomization consent design, which means that consent is only sought for one treatment each time, without the uncertainty of randomization. Researchers can be more comfortable knowing that they have the participants’ consent each time they undergo a treatment. Patients can also be more comfortable with this design because they know which type of treatment they are receiving; unlike traditional RCTs, patients are not ignorant of whether they are receiving the placebo or experimental treatment. Effects such as resentful demoralization and what is known as the “Hawthorne effect” (altered behavior or performance resulting from awareness of being a part of an experimental study) become less of an issue as patients are not weary of being part of a new alternative group, only the “standard” therapy will applies to them. However, it does have some disadvantages, and therefore can cause biases.

1 High drop-out rate:

The drop-out rates were 2.82% (2/71) in the control group; 22.86% (16/70) in the acupuncture group; 18.31% (13/71) in the laser acupuncture group; and 22.86% (16/70) for the sham laser acupuncture group. According to the acceptable standards for an RCT, dropout rates less than 10% are acceptable, drop-out rates between 10% and 20% mean that the resulting data quality is poor, and drop-out rates of more than 20% mean that the data quality is considered very poor and should not be used in analysis. In this trial analysis, the data quality in the acupuncture and sham laser acupuncture groups are very poor as the drop-out rates are over 20%; the authors should not have directly used them in any statistical analysis, unless they had re-adjusted and re-balanced the sample among the groups during the study. As outlined by the National Institutes of Health, if there is a differential drop-out rate of 15% or higher between study arms, such as between the control group and the treatment group in this clinical trial, then there is a very high potential for bias. This is a flaw that can decrease the quality of the study results.

2 The effectiveness in intervention groups was diluted by various factors

The dilution rates should then be 21.87% in the laser acupuncture group, 13.80% in the sham laser acupuncture group, and 31.27% in the acupuncture group (the dilution rate calculations were shown in Tables 1–3). The dilution rate was very significant in the acupuncture group, which causes the effectiveness to be undervalued in the acupuncture group, by almost 1/3.

The effective significance was masked by limited sample size due to the Zelen design of this study.

3.The sample size calculation in this study is questionable.

4 Conclusion The effectiveness of the acupuncture group was diluted 31.27%, and its drop-out rate was 22.86%, much higher than that of the other groups in Hinman’s clinical trial, which constitutes major flaws in how this study is analyzed and interpreted[8]. Based on the bias of Zelen design used in the study, and incorrect sample size calculation, the conclusions drawn from this study are of poor quality, inaccurate, and invalid.

Click to access S2095-4964%2815%2960172-8.pdf

Reference:

1 Hinman RS, McCrory P, Pirotta M, Relf I, Forbes A, Crossley KM, Williamson E, Kyriakides M, Novy K, Metcalf BR, Harris A, Reddy P, Conaghan PG, Bennell KL. Acupuncture for chronic knee pain: a randomized clinical trial. JAMA. 2014; 312(13): 1313–1322.

2 Fan AY. The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation. J Integr Med. 2015; 13(2): 65–68.

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« How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials

via Acupuncture for Chronic Pain is effective -Individual Patient Data Meta-analysis says.

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http://archinte.jamanetwork.com/article.aspx?articleid=1357513

Acupuncture for Chronic Pain Individual Patient Data Meta-analysis

Andrew J. Vickers, DPhil; Angel M. Cronin, MS; Alexandra C. Maschino, BS; George Lewith, MD; Hugh MacPherson, PhD; Nadine E. Foster, DPhil; Karen J. Sherman, PhD; Claudia M. Witt, MD; Klaus Linde, MD ; for the Acupuncture Trialists’ Collaboration
Arch Intern Med. 2012;172(19):1444-1453. doi:10.1001/archinternmed.2012.3654.

Background

Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for four chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain.

Methods

We conducted a systematic review to identify randomized trials of acupuncture for chronic pain where allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible trials, with a total of 17,922 patients analyzed.

Results

In the primary analysis including all eligible trials, acupuncture was superior to both sham and no acupuncture control for each pain condition (all p<0.001). After exclusion of an outlying set of trials that strongly favored acupuncture, the effect sizes were similar across pain conditions. Patients receiving acupuncture had less pain, with scores 0.23 (95% C.I. 0.13, 0.33), 0.16 (95% C.I. 0.07, 0.25) and 0.15 (95% C.I. 0.07, 0.24) standard deviations lower than sham controls for back and neck pain, osteoarthritis, and chronic headache respectively; the effect sizes in comparison to no acupuncture controls were 0.55 (95% C.I. 0.51, 0.58), 0.57 (95% C.I. 0.50, 0.64) and 0.42 (95% C.I. 0.37, 0.46). These results were robust to a variety of sensitivity analyses, including those related to publication bias.

Conclusions

Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.

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