Is Sham Laser a Valid Control for Acupuncture Trials?

Irnich, Dominik; Salih, N.; Offenbächer, Martin; Fleckenstein, Johannes

doi:10.1093/ecam/neq009

Cited by 69 publications

(54 citation statements)

References 31 publications

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“…However, a quarter of these studies found significant threshold changes also after sham acupuncture, while only one of the included articles reported changes of sensory thresholds after an inert control procedure. These facts go in line with the previously drawn conclusion that there are effects specific to acupuncture, but that sham acupuncture may cause physiological reactions exceeding pure placebo effects [6,108,109]. It can be assumed that this in part explains the clinical effects of sham acupuncture interventions observed in acupuncture randomized controlled trials.…”

Section: Results Interpretationsupporting

confidence: 87%

Effects of Acupuncture on Sensory Perception: A Systematic Review and Meta-Analysis

Baeumler¹,

Fleckenstein²,

Takayama

et al. 2015

Deutsche Zeitschrift für Akupunktur

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Background: The effect of acupuncture on sensory perception has never been systematically reviewed; although, studies on acupuncture mechanisms are frequently based on the idea that changes in sensory thresholds reflect its effect on the nervous system. Methods: Pubmed, EMBASE and Scopus were screened for studies investigating the effect of acupuncture on thermal or mechanical detection or pain thresholds in humans published in English or German. A meta-analysis of high quality studies was performed. Results: Out of 3007 identified articles 85 were included. Sixty five studies showed that acupuncture affects at least one sensory threshold. Most studies assessed the pressure pain threshold of which 80% reported an increase after acupuncture. Significant short-and long-term effects on the pressure pain threshold in pain patients were revealed by two meta-analyses including four and two high quality studies, respectively. In over 60% of studies, acupuncture reduced sensitivity to noxious thermal stimuli, but measuring methods might influence results. Few but consistent data indicate that acupuncture reduces pin-prick like pain but not mechanical detection. Results on thermal detection are heterogeneous. Sensory threshold changes were equally frequent reported after manual acupuncture as after electroacupuncture. Among 48 sham-controlled studies, 25 showed stronger effects on sensory thresholds through verum than through sham acupuncture, but in 9 studies significant threshold changes were also observed after sham acupuncture. Overall, there is a lack of high quality acupuncture studies applying comprehensive assessments of sensory perception.

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Section: Results Interpretationsupporting

confidence: 87%

Effects of Acupuncture on Sensory Perception: A Systematic Review and Meta-Analysis

Baeumler¹,

Fleckenstein²,

Takayama

et al. 2015

Deutsche Zeitschrift für Akupunktur

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“…prepared a randomization schedule (random permuted blocks of 6-12, stratified by acupuncturist). Participants who returned baseline questionnaires were consecutively randomized to receive laser acupuncture, sham laser acupuncture, 17 needle acupuncture, or control (no acupuncture). An investigator (K.N.)…”

Section: Randomization and Maskingmentioning

confidence: 99%

Acupuncture for chronic knee pain: a randomized clinical trial

Hinman¹,

McCrory²,

Pirotta³

et al. 2015

Deutsche Zeitschrift für Akupunktur

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124

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IMPORTANCEThere is debate about benefits of acupuncture for knee pain.OBJECTIVE To determine the efficacy of laser and needle acupuncture for chronic knee pain. DESIGN, SETTING, AND PARTICIPANTSZelen-design clinical trial (randomization occurred before informed consent), in Victoria, Australia (February 2010-December 2012. Community volunteers (282 patients aged Ն50 years with chronic knee pain) were treated by family physician acupuncturists. INTERVENTIONSNo acupuncture (control group, n = 71) and needle (n = 70), laser (n = 71), and sham laser (n = 70) acupuncture. Treatments were delivered for 12 weeks. Participants and acupuncturists were blinded to laser and sham laser acupuncture. Control participants were unaware of the trial. RESULTS At 12 weeks and 1 year, 26 (9%) and 50 (18%) participants were lost to follow-up, respectively. Analyses showed neither needle nor laser acupuncture significantly improved pain (mean difference; −0.4 units; 95% CI, −1.2 to 0.4, and −0.1; 95% CI, −0.9 to 0.7, respectively) or function (−1.7; 95% CI, −6.1 to 2.6, and 0.5; 95% CI, −3.4 to 4.4, respectively) compared with sham at 12 weeks. Compared with control, needle and laser acupuncture resulted in modest improvements in pain (−1.1; 95% CI, −1.8 to −0.4, and −0.8; 95% CI, −1.5 to −0.1, respectively) at 12 weeks, but not at 1 year. Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks (−3.9; 95% CI, −7.7 to −0.2) but was not significantly different from sham (−1.7; 95% CI, −6.1 to 2.6) and was not maintained at 1 year. There were no differences for most secondary outcomes and no serious adverse events. MAIN OUTCOMES AND MEASURES CONCLUSIONS AND RELEVANCEIn patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients.TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12609001001280 JAMA. 2014;312(13):1313-1322. doi:10.1001/jama.2014 Author Audio Interview at jama.com Related article page 1342Supplemental content at jama.com C hronic knee pain affects many people older than 50 years 1 and is the most common pain concern among older people consulting family physicians. 2 It is typically due to osteoarthritis and associated with declines in physical function. Nonpharmacological approaches are central to managing chronic knee pain. 3,4 Patients with joint pain and arthritis frequently use complementary and alternative medicine. 5 Acupuncture is the most popular of alternative medical systems, with use increasing over time. 5 Although traditionally administered with needles, laser acupuncture (low-intensity laser therapy to acupuncture points) is a noninvasive alternative with evidence of benefit in some pain conditions. 6-8 Efficacy of laser acupuncture compared with needles is unknown. Preliminary evidence suggests laser may be superior to needles for myofascial trigger points. 9 A meta-analysis supports needle acupuncture for osteoart...

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“…This was chosen as the control as the inactive device appears to treat acupuncture points with laser light but is inert and does not puncture the skin [9]. The laser probe is rested lightly on the skin and the inactive sham laser will be applied at the same sites for the same duration and order as the acupuncture followed by a rest period of 24 minutes and then a further two minutes of sham radiation to the two acupoints will be administered.…”

Section: Interventionsmentioning

confidence: 99%

Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy

Zaslawski

Berle

Gadau

et al. 2016

Evidence-Based Complementary and Alternative Medicine

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Background. Lateral elbow pain is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1–3%. Methods/Design. This study protocol is for a multisite randomised controlled study and is designed to evaluate the clinical efficacy of acupuncture in the treatment of chronic (over three months' duration) lateral elbow pain. Four study sites, in the People's Republic of China, Hong Kong, Italy, and Australia, will recruit 24 participants each. A total of 96 participants will be randomised to either an acupuncture group or a sham laser control group. The primary outcome measure will be the Disabilities of Arm, Shoulder, and Hand questionnaire with secondary outcome measures of Pain-Free Grip Strength Test, Muscle Tension Test, and a pain visual analogue scale. Discussion. Key features for conducting a multisite international acupuncture randomised clinical trial have been detailed in this protocol. Trial Registration. This trial is registered at Australian and New Zealand Clinical Trial Registry ACTRN12613001138774 on 11 October, 2013.

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Is Sham Laser a Valid Control for Acupuncture Trials?

Cited by 69 publications

References 31 publications

Effects of Acupuncture on Sensory Perception: A Systematic Review and Meta-Analysis

Effects of Acupuncture on Sensory Perception: A Systematic Review and Meta-Analysis

Acupuncture for chronic knee pain: a randomized clinical trial

Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy

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