Specification of interventions and selection of controls in randomized controlled trials of acupuncture: a cross-sectional survey

Abstract

Objective: Specification of interventions and selection of controls are two methodological determinants for a successful acupuncture trial. However, current practice with respect to these two determinants is not fully understood. Thus, we conducted a cross-sectional survey to examine the specification of interventions and selection of controls among published randomized controlled trials (RCTs) of acupuncture. Study design and setting: We searched PubMed for acupuncture RCTs published in core clinical journals and complementary and alternative medicine (CAM) journals from January 2010 to December 2019 (10 years) and included RCTs that assessed treatment effects of acupuncture versus any type of control. We used network meta-analyses to explore whether there were differential treatment effects in patients with chronic pain when using sham acupuncture as a control versus using waiting list or no treatment. Results: Most of the 319 eligible RCTs specified well the style of acupuncture (86.8%), traditional acupuncture point locations (96.2%), type of needle stimulation (90.3%) and needle retention time (85.6%). However, other acupuncture details were less-frequently specified, including response sought (65.5%), needle manipulation (50.5%), number of needle insertions (21.9%), angle and direction of insertion (31.3%), patient posture (32.3%) and co-interventions (22.9%). Sham acupuncture (41.4%) was the most frequently used control, followed by waiting list or no treatment (32.9%). There was no differential treatment effect when using sham acupuncture versus waiting list/no treatment as a control (standardized mean difference = −0.15, 95% confidence interval: −0.91 to 0.62). Conclusion: Over a decade of research practice, important gaps have remained in the specification of acupuncture interventions, including response sought, needle manipulation, and co-interventions. While sham acupuncture has been widely used, waiting list or no treatment may also be considered as an appropriate control.

A Randomized Sham-Controlled Mixed Methods Pilot Study of the Feasibility of Acupuncture for Chemotherapy-Induced Neuropathy: Lessons Learned From Patient Experiences in Integrative Cancer Care

“…8 Previous non-sham controlled studies indicate positive changes in neuropathy symptoms when undergoing acupuncture therapy. [14][15][16][17] However, these studies did not control for non-specific treatment effects, [18][19][20][21]46 sometimes cited as placebo effects. Similar to our study, Greenlee et al and co-workers 22 designed their study to be able to control for non-specific treatment effects.…”

“…The therapist delivered Western medical manual genuine acupuncture bilaterally to traditional acupuncture points located in the face (Stomach 6; ST6), hands (Large intestine 4; LI4, Small Intestine 3; SI3) and feet (Bladder 60; BL60, Kidney 3; KI3), in concordance with previous studies and knowledge regarding areas affected by neuropathy. 1 , 14 - 17 , 20 In line with Western medical acupuncture, it seemed important to consider proposed neurophysiological effect mechanisms when selecting these acupuncture points. 31 Sharp needles in stainless steel (manufactured by DongBang, Korea), diameter 0.25 × length 40 mm, were inserted to a depth of a third to a half body-inch, depending on the location of the acupuncture points.…”

“…The therapist delivered sham acupuncture 33 bilaterally to non-acupuncture points 20 located in the face (2 body-inch proximal to ST6), hands (2 body-inch ulnar to LI4, and 2 body-inch proximal and one body-inch radial to SI3) and feet (the middle point between BL60 and KI3, and 2 body-inch proximal to KI3). The credible 19 non-penetrating telescopic sham needle “Park et al ’s sham device” 33 in stainless steel, 0.25 × 40 mm fully extended length (manufactured by DongBang, Korea) was used.…”

“…15 These studes did not control for non-specific effects surrounding the acupuncture therapy. [18][19][20][21] However, patients receiving genuine electro-acupuncture during their chemotherapy-period reported worse pain-levels than patients receiving sham electro-acupuncture at a 4 month follow-up (n = 48). 22 The psychoneuroimmunological mechanisms of actions during acupuncture for neuropathy are not yet well understood.…”

“… 14 Acupuncture is accordingly based on sensorial stimulation, which induces wellbeing effects by social learning mechanisms. 18 Randomized controlled acupuncture studies are thus warranted to distinguish between effects of the specific ingredients of the acupuncture, that is, skin-penetration at traditional acupuncture points and needle stimulation resulting in the specific needle-sensation, 19 - 21 and the social learned wellbeing effects and contextual effects of the entire treatment procedure. 18 The pathology of sensory neuropathy often involves non-nociceptive sensorial stimuli becoming painful, 25 which hypothetically explains the increased level of neuropathic pain previously seen during electro-acupuncture.…”