Are minimal, superficial or sham acupuncture procedures acceptable as inert placebo controls?
TL;DR: Control interventions are equally effective as acupuncture in alleviating pain conditions that are predominantly associated with affective components such as migraine or low back pain, but not those with a more pronounced sensory component, such as osteoarthritis of the knee or lateral epicondylalgia.
Abstract: Most controlled trials of acupuncture have used minimal, superficial, sham, or 'placebo' acupuncture. It has recently been demonstrated that light touch of the skin stimulates mechanoreceptors coupled to slow conducting unmyelinated (C) afferents resulting in activity in the insular region, but not in the somatosensory cortex. Activity in these C tactile afferents has been suggested to induce a 'limbic touch' response resulting in emotional and hormonal reactions. It is likely that, in many acupuncture studies, control procedures that are meant to be inert are in fact activating these C tactile afferents and consequently result in the alleviation of the affective component of pain. This could explain why control interventions are equally effective as acupuncture in alleviating pain conditions that are predominantly associated with affective components such as migraine or low back pain, but not those with a more pronounced sensory component, such as osteoarthritis of the knee or lateral epicondylalgia.
Citations
More filters
TL;DR: There is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care, and available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects.
Abstract: BACKGROUND: Acupuncture is often used for migraine prophylaxis but its effectiveness is still controversial. This review (along with a companion review on'Acupuncture for tension-type headache') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with migraine. SEARCH STRATEGY: The Cochrane Pain, Palliative& Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008. SELECTION CRITERIA: We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (no prophylactic treatment or routine care only), a sham acupuncture intervention or another intervention in patients with migraine. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (outcome of primary interest), migraine attacks, migraine days, headache days and analgesic use. Pooled effect size estimates were calculated using a random-effects model. MAIN RESULTS: Twenty-two trials with 4419 participants (mean 201, median 42, range 27 to 1715) met the inclusion criteria. Sixtrials (including two large trials with 401 and 1715 patients) compared acupuncture to no prophylactic treatment or routine care only. After 3 to 4 months patients receiving acupuncture had higher response rates and fewer headaches. The only study with long-term follow up saw no evidence that effects dissipated up to 9 months after cessation of treatment. Fourteen trials compared a'true' acupuncture intervention with a variety of sham interventions. Pooled analyses did not show a statistically significant superiority for true acupuncture for any outcome in any of the time windows, but the results of single trials varied considerably. Four trials compared acupuncture to proven prophylactic drug treatment. Overall in these trials acupuncture was associated with slightly better outcomes and fewer adverse effects than prophylactic drug treatment. Two small low-quality trials comparing acupuncture with relaxation (alone or in combination with massage) could not be interpreted reliably. AUTHORS' CONCLUSIONS: In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but insufficient. Now, with 12 additional trials, there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of'true' acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.
417 citations
TL;DR: Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits, which raises questions about acupuncture's purported mechanisms of action.
Abstract: Background Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. Methods A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks. Results At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care ( P .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P P P = .02) but not in symptoms ( P > .05). Conclusions Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects. Trial Registration clinicaltrials.gov Identifier:NCT00065585
398 citations
TL;DR: It is concluded that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches with small but statistically significant benefits of acupuncture over sham.
Abstract: Background
Acupuncture is often used for tension-type headache prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for migraine prophylaxis') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library.
Objectives
To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with episodic or chronic tension-type headache.
Search methods
The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008.
Selection criteria
We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another intervention in patients with episodic or chronic tension-type headache.
Data collection and analysis
Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (at least 50% reduction of headache frequency; outcome of primary interest), headache days, pain intensity and analgesic use.
Main results
Eleven trials with 2317 participants (median 62, range 10 to 1265) met the inclusion criteria. Two large trials compared acupuncture to treatment of acute headaches or routine care only. Both found statistically significant and clinically relevant short-term (up to 3 months) benefits of acupuncture over control for response, number of headache days and pain intensity. Long-term effects (beyond 3 months) were not investigated. Six trials compared acupuncture with a sham acupuncture intervention, and five of the six provided data for meta-analyses. Small but statistically significant benefits of acupuncture over sham were found for response as well as for several other outcomes. Three of the four trials comparing acupuncture with physiotherapy, massage or relaxation had important methodological or reporting shortcomings. Their findings are difficult to interpret, but collectively suggest slightly better results for some outcomes in the control groups.
Authors' conclusions
In the previous version of this review, evidence in support of acupuncture for tension-type headache was considered insufficient. Now, with six additional trials, the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches.
276 citations
Indiana University1, North American Menopause Society2, University of Illinois at Chicago3, Group Health Cooperative4, University of Virginia5, University of California, San Francisco6, University of Florida7, University of Toronto8, Harvard University9, Case Western Reserve University10, University of Arkansas for Medical Sciences11, University of Colorado Denver12, Reading Hospital13, University of Massachusetts Amherst14, University of Southern California15
TL;DR: Clinicians need to be well informed about the level of evidence available for the wide array of nonhormonal management options currently available to midlife women to help prevent underuse of effective therapies or use of inappropriate or ineffective therapies.
Abstract: Objective:To update and expand The North American Menopause Society's evidence-based position on nonhormonal management of menopause-associated vasomotor symptoms (VMS), previously a portion of the position statement on the management of VMS. Methods:NAMS enlisted clinical and research experts in the field and a reference librarian to identify and review available evidence. Five different electronic search engines were used to cull relevant literature. Using the literature, experts created a document for final approval by the NAMS Board of Trustees. Results:Nonhormonal management of VMS is an important consideration when hormone therapy is not an option, either because of medical contraindications or a woman's personal choice. Nonhormonal therapies include lifestyle changes, mind-body techniques, dietary management and supplements, prescription therapies, and others. The costs, time, and effort involved as well as adverse effects, lack of long-term studies, and potential interactions with medications all need to be carefully weighed against potential effectiveness during decision making. Conclusions:Clinicians need to be well informed about the level of evidence available for the wide array of nonhormonal management options currently available to midlife women to help prevent underuse of effective therapies or use of inappropriate or ineffective therapies. Recommended: Cognitive-behavioral therapy and, to a lesser extent, clinical hypnosis have been shown to be effective in reducing VMS. Paroxetine salt is the only nonhormonal medication approved by the US Food and Drug Administration for the management of VMS, although other selective serotonin reuptake/norepinephrine reuptake inhibitors, gabapentinoids, and clonidine show evidence of efficacy. Recommend with caution: Some therapies that may be beneficial for alleviating VMS are weight loss, mindfulness-based stress reduction, the S-equol derivatives of soy isoflavones, and stellate ganglion block, but additional studies of these therapies are warranted. Do not recommend at this time: There are negative, insufficient, or inconclusive data suggesting the following should not be recommended as proven therapies for managing VMS: cooling techniques, avoidance of triggers, exercise, yoga, paced respiration, relaxation, over-the-counter supplements and herbal therapies, acupuncture, calibration of neural oscillations, and chiropractic interventions. Incorporating the available evidence into clinical practice will help ensure that women receive evidence-based recommendations along with appropriate cautions for appropriate and timely management of VMS.
259 citations
TL;DR: It is hypothesized that acupuncture may mediate its antipain, antianxiety, and other therapeutic effects via this intrinsic neural circuit that plays a central role in the affective and cognitive dimensions of pain as well as in the regulation and integration of emotion, memory processing, autonomic, endocrine, immunological, and sensorimotor functions.
Abstract: Human and animal studies suggest that acupuncture produces many beneficial effects through the central nervous system. However, the neural substrates of acupuncture actions are not completely clear to date. fMRI studies at Hegu (LI4) and Zusanli (ST36) indicated that the limbic system may play an important role for acupuncture effects. To test if this finding applies to other major classical acupoints, fMRI was performed on 10 healthy adults during manual acupuncture at Taichong (LV3), Xingjian (LV2), Neiting (ST44), and a sham point on the dorsum of the left foot. Although certain differences could be observed between real and sham points, the hemodynamic response (BOLD signal changes) and psychophysical response (sensory experience) to acupuncture were generally similar for all four points. Acupuncture produced extensive deactivation of the limbic-paralimbic-neocortical system. Clusters of deactivated regions were seen in the medial prefrontal cortex (frontal pole, pregenual cingulate), the temporal lobe (amygdala, hippocampus, and parahippocampus) and the posterior medial cortex (precuneus, posterior cingulate). The sensorimotor cortices (somatosensory cortices, supplementary motor cortex), thalamus and occasional paralimbic structures such as the insula and anterior middle cingulate cortex showed activation. Our results provide additional evidence in support of previous reports that acupuncture modulates the limbic-paralimbic-neocortical network. We hypothesize that acupuncture may mediate its antipain, antianxiety, and other therapeutic effects via this intrinsic neural circuit that plays a central role in the affective and cognitive dimensions of pain as well as in the regulation and integration of emotion, memory processing, autonomic, endocrine, immunological, and sensorimotor functions.
256 citations
Cites background from "Are minimal, superficial or sham ac..."
...Sham points can be used for comparison with the real points to detect possible similarities and/or differences, but they should not be considered to be inert control [Lund and Lundeberg, 2006]....
[...]
References
More filters
Book•
01 Jan 1999TL;DR: The Feeling of What Happens as mentioned in this paper is a theory of the nature of consciousness and the construction of the self, which is the feeling of what happens-our mind noticing the body's reaction to the world and responding to that experience.
Abstract: The publication of this book is an event in the making. All over the world scientists, psychologists, and philosophers are waiting to read Antonio Damasio's new theory of the nature of consciousness and the construction of the self. A renowned and revered scientist and clinician, Damasio has spent decades following amnesiacs down hospital corridors, waiting for comatose patients to awaken, and devising ingenious research using PET scans to piece together the great puzzle of consciousness. In his bestselling Descartes' Error, Damasio revealed the critical importance of emotion in the making of reason. Building on this foundation, he now shows how consciousness is created. Consciousness is the feeling of what happens-our mind noticing the body's reaction to the world and responding to that experience. Without our bodies there can be no consciousness, which is at heart a mechanism for survival that engages body, emotion, and mind in the glorious spiral of human life. A hymn to the possibilities of human existence, a magnificent work of ingenious science, a gorgeously written book, The Feeling of What Happens is already being hailed as a classic.
5,154 citations
TL;DR: Investigation of the conditions controlling this neurobiological reaction could have theoretical and clinical implications on how neurotransmitters and neuropeptides are regulated by chemical messengers.
928 citations
"Are minimal, superficial or sham ac..." refers background in this paper
...The activity set up by acupuncture is said to result in 1) the activation of descending pain-inhibiting pathways and 2) deactivation of limbic structures; these mechanisms are involved in the sensory and affective component of pain, respectively.(6;7)...
[...]
TL;DR: The authors found that activation of unmyelinated tactile (CT) afferents produced a faint sensation of pleasant touch, which may underlie emotional, hormonal and affiliative responses to skin-to-skin contact between individuals.
Abstract: There is dual tactile innervation of the human hairy skin: in addition to fast-conducting myelinated afferent fibers, there is a system of slow-conducting unmyelinated (C) afferents that respond to light touch. In a unique patient lacking large myelinated afferents, we found that activation of C tactile (CT) afferents produced a faint sensation of pleasant touch. Functional magnetic resonance imaging (fMRI) analysis during CT stimulation showed activation of the insular region, but not of somatosensory areas S1 and S2. These findings identify CT as a system for limbic touch that may underlie emotional, hormonal and affiliative responses to caress-like, skin-to-skin contact between individuals.
837 citations
TL;DR: The placebo needle is sufficiently credible to be used in investigations of the effects of acupuncture, and is tested whether needling with the placebo needle feels any different from real acupuncture.
831 citations
"Are minimal, superficial or sham ac..." refers background in this paper
...The control procedures most commonly used include minimal or superficial acupuncture (needling of the skin), or sham acupuncture (needling of non-acupuncture points), or ‘placebo’acupuncture needles (a blunt tip of a needle touches the skin without penetrating it).(1;2) Acupuncture has been reported to affect the different components of perceived pain, ie to alleviate the sensory discriminative aspect (intensity) as well as to lessen the affective component (unpleasantness) of pain....
[...]
TL;DR: Functional magnetic resonance imaging was used to investigate the effects of acupuncture in normal subjects and to provide a foundation for future studies on mechanisms of acupuncture action in therapeutic interventions, suggesting that acupuncture needle manipulation modulates the activity of the limbic system and subcortical structures.
Abstract: Acupuncture, an ancient therapeutic technique, is emerging as an important modality of complementary medicine in the United States. The use and efficacy of acupuncture treatment are not yet widely accepted in Western scientific and medical communities. Demonstration of regionally specific, quantifiable acupuncture effects on relevant structures of the human brain would facilitate acceptance and integration of this therapeutic modality into the practice of modern medicine. Research with animal models of acupuncture indicates that many of the beneficial effects may be mediated at the subcortical level in the brain. We used functional magnetic resonance imaging (fMRI) to investigate the effects of acupuncture in normal subjects and to provide a foundation for future studies on mechanisms of acupuncture action in therapeutic interventions. Acupuncture needle manipulation was performed at Large Intestine 4 (LI 4, Hegu) on the hand in 13 subjects [Stux, 1997]. Needle manipulation on either hand produced prominent decreases of fMRI signals in the nucleus accumbens, amygdala, hippocampus, parahippocampus, hypothalamus, ventral tegmental area, anterior cingulate gyrus (BA 24), caudate, putamen, temporal pole, and insula in all 11 subjects who experienced acupuncture sensation. In marked contrast, signal increases were observed primarily in the somatosensory cortex. The two subjects who experienced pain instead of acupuncture sensation exhibited signal increases instead of decreases in the anterior cingulate gyrus (BA 24), caudate, putamen, anterior thalamus, and posterior insula. Superficial tactile stimulation to the same area elicited signal increases in the somatosensory cortex as expected, but no signal decreases in the deep structures. These preliminary results suggest that acupuncture needle manipulation modulates the activity of the limbic system and subcortical structures. We hypothesize that modulation of subcortical structures may be an important mechanism by which acupuncture exerts its complex multisystem effects.
683 citations
"Are minimal, superficial or sham ac..." refers background in this paper
...Physiologically, the afferent stimulation of the acupuncture needling has been attributed to the activation of ergo-receptors,(4) conveying their information in A-delta or type II or III afferents into the spinal cord, and then to the sensory cortex, resulting in the perceived sensation of de qi.(5) The activity set up by acupuncture is said to result in 1) the activation of descending pain-inhibiting pathways and 2) deactivation of limbic structures; these mechanisms are involved in the sensory and affective component of pain, respectively....
[...]