Placebo response varies between different types of sham acupuncture: A randomized double-blind trial in neck pain patients.

backgroundIn prospective experimental studies of neck pain patients, it is difficult to determine whether responses to sham acupuncture differ from responses to real acupuncture due to the heterogeneous methodologies in control/sham interventions. Here we aim to compare the specific and nonspecific effects of electroacupuncture with four types of sham acupuncture.

methodsIn this double-blind, sham-controlled study, we randomly assigned 175 patients with neck pain to receive 10 sessions of electroacupuncture, shallow puncture, nonacupoint deep puncture, nonacupoint shallow puncture, or nonpenetration acupuncture. We used the Northwick Park Neck Pain Questionnaire (NPQ) as our primary outcome, and Short-form McGill Pain Questionnaire, visual analog scale (VAS), and Pain Threshold as secondary outcomes to measure the changes from baseline to a 3-month follow up.

resultsAll groups, except nonacupoint shallow puncture, had significant improvement in all outcome measurements. Electroacupuncture only showed superior improvements than the shallow puncture, nonacupoint shallow puncture, and nonpenetration groups when compared using the NPQ and VAS scale (*p < 0.001). Interestingly, the nonacupoint shallow puncture produced even less placebo response than nonpenetration acupuncture.

conclusionOur study demonstrates the high variability of placebo response among different types of sham controls depending on the depth of needle insertion and the puncture location. An important implication of our results is nonacupoint deep puncture produced similar analgesic effects as electroacupuncture. Our study may shed a new light on the predominant underlying mechanisms among different types of sham acupuncture controls, which can help with interpreting the effect of acupuncture in other studies.

trial registrationChinese clinical trial registry (ChiCTR-IOR-15006886). SIGNIFICANCE: This study compared the observed specific and nonspecific analgesia effect in four different types of sham acupuncture stimulation with neck pain patients, assessed by four outcomes. Although all of the sham controls produced significant reduction in neck pain, electroacupuncture had superior significant improvement. Importantly, placebo responses differed significantly between the sham controls and responses were inconsistent according to different outcome assessments. This study emphasizes the importance of taking into consideration which sham control and method of outcome measurement were used in a pain research study when evaluating its results.