To the Editor
The recent article by Garland et al1 revealed positive effects of acupuncture in comparison with allopathic medication when assessing sleep disorders and hot flashes in women with breast cancer. We congratulate the authors for their intention to investigate complementary methods on this clinical condition.
Our research experience shows that methodological features account for a considerable portion of the results on acupuncture trials.2 Three methodological issues require careful examination in Garland et al's study.
First, are the authors aware of STRICTA guidelines?3 This is a reporting guideline, similar to the CONSORT statement, but specifically designed for acupuncture clinical trials. Its use is of major importance to structure these trials, assuring transparency, reliability, and high methodological standards. It is not clear if this tool was used in this report.
Second, the number of appointments within the acupuncture group was remarkably higher than in the gabapentin group. It is known that the more a patient feels safe and cared for, the better their adherence to treatment,4 and their predisposition to placebo effects. We would like to question how the researchers controlled the placebo effect in this study. We know there are other studies comparing sham acupuncture and placebo pills.5 However, we are concerned about how to compare patients who underwent weekly acupuncture session with patients in a gabapentin group, who received much less frequent attention.
Third, the authors describe that a limitation of the study was the absence of objective methods to evaluate sleep. We would like to suggest methods such as polysomnography or actigraphy in association with questionnaires. We know that oncology patients are highly vulnerable to psychosocial stress. The use of subjective methods (questionnaires) to evaluate outcomes potentiates the detection of placebo effects, since they reflect patients’ perceptions.
Thus, we believe that a study is needed, with an equivalent number of appointments between groups, and the presence of sham acupuncture groups to evaluate the placebo effect. However, until this study is conducted, caution should be exercised to the affirmation of the evidence level of this effect.