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Acupuncture and the Complex Connections Between the Mind and the Body.

Almost 50 years ago, New York Times reporter James Reston had an emergency appendectomy while traveling in China. His subsequent report1 that acupuncture produced substantial relief from his postoperative discomfort is widely credited with launching Western interest in acupuncture, although many Western medical practitioners have remained skeptical. Nevertheless, there has been steady progress in application of the methods of evidence-based medicine and modern neuroscience to these ancient practices, suggesting that acupuncture may have therapeutic benefit. The evaluation involves at least 3 questions: Can acupuncture be studied rigorously? What is known about the benefits (and harms)? What is known about the mechanisms? In this issue of JAMA, 2 reports of acupuncture trials use approaches that meet current standards for rigor and avoidance of bias. In one study, Wu and colleagues2 for the Polycystic Ovary Syndrome Acupuncture and Clomiphene Trial (PCOSAct) report a well-designed trial of 1000 patients with polycystic ovary syndrome, using a 2 × 2 factorial design comparing active acupuncture or control acupuncture and clomiphene or placebo, with 250 women assigned to each treatment group.2 Live birth was the primary outcome measure. Clomiphene had the expected effect on fertility, but active acupuncture, compared with sham acupuncture, had no benefit alone or with clomiphene.2 The live birth rate was significantly higher among women treated with clomiphene than with placebo (135 of 471 [28.7%] vs 70 of 455 [15.4%], respectively; difference, 13.3%; 95% CI, 8.0% to 18.5%) but not significantly different among women treated with active vs control acupuncture (100 of 458 [21.8%] vs 105 of 468 [22.4%], respectively; difference, −0.6%; 95% CI, −5.9% to 4.7%). In another study, Liu and colleagues3 evaluated the effect of electroacupuncture applied to the lumbosacral region among women with stress urinary incontinence (n = 252) compared with sham acupuncture without electrical current as the control (n = 252). At 6 weeks, electroacupuncture showed a clear benefit with less urine leakage as measured by a 1-hour pad test (the primary outcome), with mean decreases from baseline to week 6 in urine leakage of 9.9 g with electroacupuncture vs 2.6 g with sham electroacupuncture (mean difference, 7.4 g; 95% CI, 4.8 to 10.0), along with a reduction in diary reports of episodes of stress urinary incontinence.3 Much of the debate between researchers studying acupuncture and their critics has focused on the appropriate comparison group. Both studies used a sham acupuncture control with study participants apparently effectively blinded.2,3 The sham treatment was designed to provide an experience for the patient as similar as possible to the “real” acupuncture (verum acupuncture). Sham interventions in acupuncture trials have included the use of toothpicks that do not penetrate the skin, or needle placement in sites considered inactive or without electrical stimulation. Sham interventions have sometimes been called minimal acupuncture, reflecting the perspective that these interventions may also have activity—perhaps best labeled active placebo—that conveys some of the contextual effects and counterirritant stimulation contributing to acupuncture benefits.4 Nonetheless, most agree that a sham control is the correct methodological approach when evaluating for evidence of specific effects of acupuncture. Depending on the research question, comparison with a usual care control group also may be relevant. What is the current status regarding evidence for benefits and harms of acupuncture? Acupuncture is widely practiced in Germany, largely delivered by physicians. An important series of studies of acupuncture was funded at the request of German health authorities and sponsored by German health insurance companies, with the goal, in part, to generate evidence that could guide reimbursement decisions. For these studies, benefits compared with usual care were of particular interest. The German acupuncture trials4-7 led to a decision that allowed reimbursement of acupuncture treatment for low back pain. Recommendations for consideration of acupuncture as a therapeutic option are now included in some clinical practice guidelines, most notably the recently issued guidelines of the American College of Physicians for management of low back pain.8 The benefits and harms of acupuncture for a number of other specific indications are the subject of high-quality systematic reviews and meta-analyses, including those of the Cochrane Collaboration9 and the Acupuncture Trialists’ Collaboration.10 Generally, the clinically meaningful benefit of acupuncture is limited to subjective outcomes, particularly conditions associated with pain, with the magnitude of benefit varying widely depending on the condition. The positive outcomes associated with pain relief are particularly important at a time when there is enormous concern about overuse of opioids. Acupuncture also has been reported to improve the nausea and vomiting associated with chemotherapy,11 but available evidence does not support benefit of acupuncture for patients with stroke, asthma, bed-wetting, or shoulder and neck pain. As for harms, in general, acupuncture appears Related articles pages 2493 and 2502 Opinion