The design and reporting of sham acupuncture and its association with the efficacy in acupuncture randomized controlled trials for migraine.

BACKGROUND

In current trials of acupuncture for migraine treatment, the heterogeneity in therapeutic outcomes has been noted, which may be closely tied to the use of diverse sham acupuncture designs. This paper aims to evaluate the reporting quality of sham acupuncture and assess the potential impact of the consistency for intervention procedure between sham and true acupuncture groups on efficacy size in randomized controlled trials (RCTs) for migraine.

METHODS

RCTs with sham acupuncture as a control in migraine were searched in four English and four Chinese databases from inception to May 2024. Based on the SHARE checklist, the distribution of reported items and reporting rates were investigated. The meta-regressions were conducted to assess the potential impact of the consistency of intervention procedures between sham and true acupuncture groups on efficacy size of acupuncture for migraine.

RESULTS

Evaluation of the 46 included studies revealed that a significant proportion of item descriptions were incomplete, such as the information informed or explained to patients (Item 5, 4(8.70%)), relevant operation training information (Item 6.2, 6(13.04%)) and Communication between practitioner and patient (Item 3.3, 8(17.39%)). Meanwhile, the Basic manipulation techniques (β=-0.76), Times of manipulation (β=-0.34), Time point of manipulation (β=-0.34), Frequency of manipulation (β=-0.34) and Duration of manipulation per time (β=-0.34) significantly impact efficacy of acupuncture on migraine.

CONCLUSIONS

The reporting quality of sham acupuncture in the acupuncture RCTs focusing on migraine was inadequate. Some details and context factors of sham acupuncture were often not reported. The differences of manipulation between sham and true acupuncture may be significant factors affecting the effect of acupuncture for migraine. In future acupuncture trials, the manipulation-related factors should be considered in the design of sham acupuncture and the specific reporting guidelines for sham acupuncture like SHARE should be adopted.