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The non-specific effects of acupuncture treatment: When and how to control for them

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... Sham Acupuncture-Subjects receive sham acupuncture using superficial needling at non-acupuncture points according to previously established procedures (Birch, Hammerschlag, Trinh, Zaslawski, 2002;Hammerschlag, 1997;Vincent, 1989). These points are 2-3 cm away from the true point location (in predetermined locations that are not on a channel/meridian) with an insertion depth of 1-2 mm, which is just sufficient to make the needle stand vertically, without eliciting a de qi response. ...
... to minimize the non-physiological effects (Birch et al., 2002), and 2) to maintain the psychological impact. ...
... 6d) Sources that justify choice of control: (Birch et al., 2002;Hammerschlag, 1997;Stux & Hammerschlag, 2001, MacPherson et al., 2002Vincent & Lewith, 1995;Vincent, 1989) Anastasi et al. The statement of suitability is specific to the IRB requirements of our academic health science campus. ...
Article
Distal sensory peripheral neuropathy is a common neurological complication experienced by people living with the human immunodeficiency virus (HIV). Traditional Chinese medicine (TCM) may offer effective interventions in the management of its symptoms. To improve the quality and transparency of reporting acupuncture clinical trials, the Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in 1996 and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) recommendations were introduced in 2001. Incorporating international guidelines, this paper describes the development of a RCT including rationale, design, methods, procedures and logistics for a pilot study aimed at evaluating acupuncture and moxibustion for neuropathy associated with HIV. Using STRICTA guidelines as a template, aspects of clinical research design are explored to further optimise future studies of TCM.
... 68,71 Clinical trials testing the specific claims of acupuncture generally have tried to focus on testing the efficacy of applying specific techniques and/or specific points. [72][73][74] However, insertion of needles into the body can stimulate other effects not dependent on the locations of stimulation and are thus nonspecific. Regardless of where the needles are placed, a range of nonspecific mechanisms can be activated. ...
... Regardless of where the needles are placed, a range of nonspecific mechanisms can be activated. 37,[74][75][76][77][78][79][80] These include heterosegmental analgesic mechanisms, 50,81,82 homosegmental analgesic effects, 83 microcirculatory effects, 84 and relaxation response effects. 78,85 One can speculate a cascade of normal physiologic effects involved in prevention of infection and healing of damaged tissues after the insertion of any needles anywhere on the body. ...
... An international group of researchers discussing these effects recently concluded, we cannot be satisfied that a truly inert intervention is possible as the control treatment in acupuncture studies. Therefore the sham intervention cannot be considered equivalent to placebo in the same way that a placebo pill is considered to be an inert intervention in a placebo controlled pharmaceutical trial 74 This is a point raised by others. 11,79,80 However, it has been common for researchers to not separate these different effects and lump them together with any placebo effects. ...
Article
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Researchers examining the efficacy of medical procedures make assumptions about the nature of placebo. From these assumptions they select the sham interventions to be used in their trials. However, placebo is not well defined. A number of definitions are contradictory and sometimes misleading. This leads to problems in sham-controlled studies of medical procedures and difficulties interpreting their results. The author explores some of the contradictory definitions of placebo and assumptions and consequences of these. Principal among these is the assumption that the placebo is inert when it is not, which introduces bias against the tested medical procedures and devices. To illustrate the problem, the author examines the use of sham procedures in clinical trials of the medical procedures surgery and acupuncture in which the sham was assumed to be inert but was not. Trials of surgery and acupuncture should be re-examined in light of this.
... Invasive sham acupuncture (ie, "minimal" acupuncture-shallow needling with no manipulation at nonacupuncture points) is a recommended control for acupuncture trials for treatment of chronic pain. 30 Although invasive sham acupuncture is not physiologically inert and may have analgesic properties, 27,31,32 we hypothesized that acupuncture would be more effective than sham acupuncture in decreasing shoulder pain intensity in people with SCI. area through advertisements and letters. ...
... Noxious stimulus to the skin during sham acupuncture may result in endorphin release through neurophysiologic mechanisms called diffuse noxious inhibitory control (DNIC). 27,31,32 It has been suggested that DNIC has a relatively minor role in acupuncture analgesia and that other systems, mediated by serotonin and noradrenaline, and changes in the autonomic nervous system, are more important. 30 There is evidence that chronic pain is mediated not only through neurotransmitters, but also through the autonomic nervous system. ...
... 48 Various sham acupuncture controls have been described and include: (1) "placebo needles"; (2) superficial needling (minimal acupuncture); and (3) needling at nonacupuncture points. 31 We chose to use superficial needling at nonacupuncture points on the shoulder as our control intervention. Although nonacupoints on the shoulder might be too close to highly effective acupoints, 49 we were concerned that needling at points located elsewhere on the body would not be as convincing as those on the shoulder. ...
Article
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To determine the efficacy of acupuncture in the treatment of chronic musculoskeletal shoulder pain in subjects with spinal cord injury (SCI). Randomized, double blind (participants, evaluator), placebo (invasive sham) controlled trial. Clinical research center. Seventeen manual wheelchair-using subjects with chronic SCI and chronic musculoskeletal shoulder pain. Participants were randomly assigned to receive 10 treatments of either acupuncture or invasive sham acupuncture (light needling of nonacupuncture points). Changes in shoulder pain intensity were measured using the Wheelchair User's Shoulder Pain Index. Shoulder pain decreased significantly over time in both the acupuncture and the sham acupuncture groups (P=.005), with decreases of 66% and 43%, respectively. There was no significant difference between the 2 groups (P=.364). There was, however, a medium effect size associated with the acupuncture treatment. There appears to be an analgesic effect or a powerful placebo effect associated with both acupuncture and sham acupuncture. There was a medium treatment effect associated with the acupuncture, which suggests that it may be superior to sham acupuncture. This observation, along with the limited power, indicates that a larger, more definitive randomized controlled trial using a similar design is warranted.
... The protocols for all three groups are based on principles of TCM acupuncture, including the control regimen, which was designed to be inactive. The control treatment involved needling of non-acupuncture points with minimal stimulation, an ''invasive sham'' acupuncture procedure [48]. To maintain blinding, patients were told in the consent form only that the control treatment used points ''not used to treat hypertension.'' ...
... We used an invasive sham control treatment that involved needling of non-acupuncture points with minimal stimulation. Other invasive sham interventions include needling of acupuncture points that are not expected to affect the clinical problem at hand and needling relevant acupuncture points but at shallower depths and/or with limited stimulation [48,65,78]. Others have argued that control conditions in acupuncture trials should not involve penetration of the skin, referred to as non-or minimally invasive sham acupuncture [48]. ...
... Other invasive sham interventions include needling of acupuncture points that are not expected to affect the clinical problem at hand and needling relevant acupuncture points but at shallower depths and/or with limited stimulation [48,65,78]. Others have argued that control conditions in acupuncture trials should not involve penetration of the skin, referred to as non-or minimally invasive sham acupuncture [48]. Special retractable needles have been developed for research purposes with the goal of delivering a control while keeping the patient blinded [79,80]. ...
Article
Hypertension is a major public health problem with serious medical and financial consequences. Barriers to successful conventional pharmacological treatment include side effects, out-of-pocket expenses, patient noncompliance and insufficient dosages. Acupuncture has been studied as an alternative therapy for controlling blood pressure (BP) but previous studies have serious methodological limitations. This paper describes the design of the Stop Hypertension with the Acupuncture Research Program (SHARP) trial, a pilot randomized clinical trial designed to gather preliminary data regarding the efficacy of traditional Chinese medicine (TCM)-based acupuncture for control of essential hypertension. The design of the SHARP trial balanced rigorous clinical trial methodology with principles of TCM. Eligible participants had systolic BP (SBP) 140-179 mm Hg and diastolic BP (DBP) 90-109 mm Hg in the absence of antihypertensive therapy. Following screening, participants were randomized to one of three groups: individualized, standardized or control acupuncture. Treatments were designed according to principles of TCM; nonspecific effects associated with the interventions were standardized across the randomized groups. For individualized acupuncture, points were tailored to each participant. Standardized acupuncture used a prespecified set of points. The invasive sham control acupuncture regimen was designed to be non-active. Each participant received a "prescription" for individualized acupuncture from an acupuncturist who was masked to treatment assignment, and was subsequently treated by an independent acupuncturist. Patients and those assessing BP were masked to treatment group. Acupuncture was delivered twice a week for 6 weeks. Follow-up visits were every 2 weeks to week 10 and then at months 4, 6, 9 and 12. The primary endpoint will be change in SBP from baseline to 10 weeks. DBP, BP trajectories over the 12-month follow-up and antihypertensive medication requirements will also be examined. Initial contact was documented for 1442 prospective participants from March 2001 to April 2002; 424 provided informed consent and 192 were ultimately randomized.
... Textbooks routinely state that if these sensations are not obtained with needling, then the treatment will not be effective [17,44]. Since the first descriptions of this deqi in Western publications in the early 1970s, researchers have tested acupuncture in controlled trials that attempt to control for placebo effects by varying the locations of the needling and the techniques of needling using what has been called 'sham acupuncture' [10]. In particular, during the last 30 years needling techniques have been used to avoid producing the deqi sensations. ...
... The sham type 3 clinical trial allows us to examine the clinical effectiveness of the proposed sham techniques, while holding placebo equal between the two Tests relative effects of needle techniques a a These two sham models are NOT tests of acupuncture per se, rather they are tests of the relative effects of the places of needling or the techniques of needling [10,84]. Yet they are routinely used as though they were sham acupuncture-1 type studies, as valid tests of acupuncture and then confused further when said to be placebo treatments [72,75]. ...
Chapter
The objective of this chapter is to provide an overview of the problems and solutions of randomized placebo-controlled trials in acupuncture. Studies examining how acupuncture might work cover a broad range of physiological systems, ranging from a single biochemical pathway to the whole biological system. Needling, touch, and pressure occur before skin penetration and then surface receptors/structures are stimulated by both shallow and deeper insertions with additional receptors are further stimulated by deeper insertions. This process raises important questions about the use of penetrating and non-penetrating sham acupuncture techniques and placebo effects. In clinical research the placebo treatment must be inert, and only when the provided randomization and blinding are properly used, a trial comparing the test treatment to the placebo treatment can be said as placebo-controlled. A placebo-controlled trial is an explanatory trial since it tests the known mechanisms associated with the treatment. But in hands-on therapies like acupuncture what can constitute a valid placebo control treatment? Are there predictable mechanisms by which acupuncture works suggesting which valid placebo can be used? Are there any sham acupuncture interventions that can constitute placebo treatments? Are they credible to be sham treatments? If they are not inert or credible, then how can we perform placebo-controlled trials on acupuncture? Are such trials possible? Many forms of sham acupuncture have been tried out in efforts to control placebo effects. In the ‘real’ or ‘test’ acupuncture the ‘real’ technique is applied to the ‘real’ acupoints. Thus, sham acupuncture involves varying the techniques of treatment and the locations of treatment. Given these two variables, three basic variations of sham acupuncture are possible. One of these could possibly act as a placebo control research model, provided that the sham techniques are clinically inert and the sites of their application are clinically inert. The other two models act to compare either treatment sites or treatment techniques. In the latter two models placebo can be held equal between treatment groups, but these models are not capable of acting as placebo-controlled trials. The second and third sham models are often used inadvertently as though they were capable of answering the same question as the first or were placebo-controlled clinical trials like the first. This chapter will give an overview on the current status and problems of placebo-controlled trials in acupuncture trials and suggest possible solutions. We can summarize the evidence: so far no sham acupuncture techniques are inert; they are also clinically effective; and no placebo-controlled trials of acupuncture have ever been performed. Given the evidence, we propose to stop performing sham acupuncture studies since they cannot achieve control for placebo effects. We propose a two-pronged approach to address the issues of mechanisms of action and effectiveness.
... If the control treatment is tested first in a pilot study, one can generate data about the relative effectiveness of the sham acupuncture treatment, which will assist in determining if indeed it is an appropriate sham treatment [36]. Another important issue with all sham treatments is to avoid the mislabelling of the sham treatment as a placebo treatment [37]. All of the sham interventions tested so far are thought to activate physiologic nonplacebo non-specific effects and some activate specific effects [34,37,38]. ...
... Another important issue with all sham treatments is to avoid the mislabelling of the sham treatment as a placebo treatment [37]. All of the sham interventions tested so far are thought to activate physiologic nonplacebo non-specific effects and some activate specific effects [34,37,38]. In this review none of the studies pretested the sham acupuncture points. ...
... While the use of acupuncture controls generates debate, numerous studies have researched "sham" conditions of acupuncture [18]. In our study, subjects received sham acupuncture using superficial needling at non-acupuncture points according to previously established procedures [19,20]. Very few studies have described the use of placebo moxibustion procedures and studies involving moxibustion have been plagued with devising appropriate placebo controls. ...
Article
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Traditional Chinese medicine (TCM) encompasses many different practices, most notably acupuncture and moxibustion. Traditionally, these modalities are used in combination to augment treatment but seldom are they tested together in clinical studies. Numerous acupuncture studies have been conducted in Asia, Europe and the United States but, there have been few randomized controlled trials (RCT) utilizing moxibustion outside of East Asia. Limited studies have described the use of a moxibustion control or placebo procedure. The methods for developing an acupuncture and moxibustion protocol used in a RCT for irritable bowel syndrome, diarrhea predominant (IBS-D) in adults are described here. Our approach conforms to the scientific rigor for a clinical trial and allows fidelity to the foundations of TCM.
... ‘Nonspecific’ psychological—effects that arise concomitantly with the treatment and emanate from a variety of sources including, but not limited to, treatment environment, patient expectations, practitioner intention, patient-provider rapport, and the natural history of the condition (4). ...
Article
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Both hypnosis and acupuncture have gained credibility over the years in their effectiveness for treating various health conditions. Currently, each of these treatments is administered in distinct settings and separate times. That is, even if patients receive both treatments as part of a multidimensional therapeutic program, they would typically receive them separately rather than simultaneously at the same session. This separation however might be undesirable since, at least theoretically, hypnosis and acupuncture could potentially augment each other if administered concomitantly. In this article we outline the rationale for this hypothesis and discuss the potential ramifications of its implementation.
... A design for sham treatment based on penetrating acupuncture is not desirable because the strategy may unwittingly cause activation of nonspecific mechanisms of acupuncture effects, which have nothing to do with stimulation of specific acupoints [66][67][68]. Sham treatments using patch-type electrodes instead of acupuncture may increase the possibility that participants cannot be properly blinded, given that they are able to see electrodes. The conclusion is that there are four articles [27,31,32,34] with a suitable design for sham EA treatment in patients with knee OA. ...
Article
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Purpose. This study aims to verify the effects of electroacupuncture treatment on osteoarthritis of the knee. Methods. MEDLINE/PubMed, EMBASE, CENTRAL, AMED, CNKI, and five Korean databases were searched by predefined search strategies to screen eligible randomized controlled studies meeting established criteria. Any risk of bias in the included studies was assessed with the Cochrane Collaboration’s tool. Meta-analysis was conducted using RevMan version 5.3 software. Results. Thirty-one randomized controlled studies of 3,187 participants were included in this systematic review. Meta-analysis was conducted with eight studies including a total of 1,220 participants. The electroacupuncture treatment group showed more significant improvement in pain due to knee osteoarthritis than the control group (SMD −1.86, 95% CI −2.33 to −1.39, I2 75%) and in total WOMAC score than the control group (SMD −1.34, CI 95% −1.85 to −0.83, I2 73%). Compared to the control group, the electroacupuncture treatment group showed more significant improvement on the quality of life scale. Conclusion. Electroacupuncture treatment can relieve the pain of osteoarthritis of the knees and improve comprehensive aspects of knee osteoarthritis and the quality of life of patients with knee osteoarthritis.
... 11 EA has been shown to relieve frozen shoulder pain and thus promote the exercise range of motion. One review article reported that EA produced a significantly greater reduction in the intensity of pain than placebo EA. 12 However, medium-term follow-up data are lacking, and little evidence has been found to support the medium-term benefits of EA for the treatment of chronic shoulder pain. This randomized, single-blind, shamacupuncture controlled clinical trial was performed to investigate the short-term and medium-term efficacy of EA as a treatment for FSS based on the meridian philosophy of acupuncture point and non-acupuncture point treatment. ...
Article
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Purpose: Frozen shoulder syndrome (FSS) causes pain and reduces the range of motion in the shoulder joint. To investigate the short and medium-term effects of electroacupuncture in people with FSS, we evaluated the therapeutic effects of true and sham electroacupuncture on pain relief and improvement of shoulder function. Methods: In this randomized, single-blind controlled clinical trial, 21 subjects with FSS were randomly assigned to two groups: a true electroacupuncture group (TEAG) and a sham electroacupuncture group (SEAG). The two groups underwent 18 sessions of treatment over approximately 6-9 weeks and were then followed up at 1, 3, and 6 months. Their effectiveness for alleviating the intensity of shoulder pain was evaluated with a visual analog scale (VAS), while improved shoulder mobility was evaluated by the active range of motion (AROM) and passive range of motion (PROM), and shoulder functional ability was evaluated using the Shoulder Pain and Disability Index (SPADI). Results: It demonstrated that the TEAG or SEAG showed lasting effects at 1, 3, and 6 months, although with no significant difference between these two groups in the shoulder functional ability outcomes. However, the decline in the VAS occurred earlier in the TEAG than the SEAG. Also, there was much more improvement in AROM for flexion and abduction in the TEAG than the SEAG. An increase in the abduction angle after electroacupuncture and manual rehabilitation was also apparent. Conclusion: These results suggest that electroacupuncture plus rehabilitation may provide earlier pain relief for patients with FSS and could be applied clinically.
... While Stux and Hammerschlag [94] suggested that all sham acupuncture models are convincing enough to patients to produce clinical equivalent effects, Birch et al. [95] stated that only placebo with needle insertion produces similar effects to those of acupuncture. ...
Article
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The aim of this review is to provide an overview of the different effects of manual and electroacupuncture on the central nervous system in studies with different neuroimaging interventions. The Database PubMed was searched from 1/1/2000 to 1/6/2014 with restriction to human studies in English language. Data collection for functional magnetic resonance (fMRI) studies was restricted to the period from 1/1/2010 to 1/6/2014 due to a recently published review which included all published randomized and nonrandomized controlled clinical studies as well as observational studies with control groups, no blinding required. Only studies comparing manual or electroacupuncture with sham acupuncture were eligible. All participants were healthy adult men and women. A majority of 25 studies compared manual versus sham, a minority of 7 trials compared electro versus sham and only 1 study compared electro versus manual acupuncture. In 29 out of 33 studies verum acupuncture results were found to present either more or different modulation effects on neurological components measured by neuroimaging and neuromonitoring methods than sham acupuncture. Only four studies reported no effects of verum in comparison to sham acupuncture. Evaluation of the very heterogeneous results shows evidence that verum acupuncture elicits more modulation effects on neurological components than sham acupuncture.
... Sham approaches are not suitable within pragmatic trials, since they are artificial controls that do not model usual practice [27], making it difficult to meaningfully interpret their results [6]. Sham acupuncture approaches are generally problematic since there is evidence that they can produce a physiological effect that may be therapeutic [28,29]. ...
Article
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Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain.
... In addition, participants described a number of important experiential factors in their yoga practice, such as connection with the teacher and other class members, enjoyment, accessibility, and sense of belonging. The importance of ''nonspecific'' factors in complementary and alternative medicine and psychological therapies is well documented, [45][46][47][48] with the role of teacher/therapist appearing key. 47,49,50 However, research into these nonspecific factors in yoga is warranted, particularly on the role of yoga teacher characteristics and their impact on practitioner outcomes and experiences. ...
Article
Introduction:Research is increasingly demonstrating a range of benefits of practicing yoga, such as improved physical and mental health, social connectedness, and self-care. Mechanisms of action are less well understood, but may include both psychological and physiological changes. The aim of this study was to understand more about benefits and mechanisms of yoga practice, using qualitative data collected from a large-scale survey of yoga use in the United Kingdom. Methods: The mixed methods, cross-sectional online survey collected data on yoga use and perceived benefits from 2434 U.K. yoga practitioners. The qualitative survey element used open-ended questions to gain "real life" data regarding practice and perceived benefits. Data were analyzed thematically and deductively. A practice-based model describing yoga practice, mechanisms, and benefits, based on the Khalsa logic model of yoga, was developed to explain the data. Findings: Findings highlighted that a diverse range of yoga practices and nonspecific contextual factors related to practicing yoga, needed to be considered to understand how yoga was benefitting people. These practices encompassed both modern and traditional conceptions of yoga as a deeper lifestyle practice. Key mechanisms for change included improvements in physical strength and flexibility, stress regulation, resilience, equanimity, mind-body awareness, and spiritual/personal growth. These mechanisms resulted in diverse improvements in global health functioning, particularly physical and mental health and well-being. Conclusions: The Khalsa model provided a useful base upon which to guide the new population-practice-based model, to understand participants' "real life" experiences of yoga, how yoga is helping people and why. It provides important information for practitioners, teachers, and those delivering yoga interventions as to the range of skills and potential benefits of yoga practice. In addition, findings indicate directions for future research, by highlighting key yoga mechanisms that researchers may choose to focus on in future studies.
... We included the NIC group to assess the potential placebo effect in the SAA group. 22 Patients from this group were not blinded to the intervention. ...
Article
Introduction: Preoperative anxiety before cesarean section is a major issue. Nonpharmacologic anxiety control is believed to be more suitable in pregnant women. Auricular acupuncture (AA) is an inexpensive, easy-to-use, and validated intervention to reduce anxiety in different surgical settings. We evaluated the effect of AA on preoperative cesarean section anxiety. Methods: In a prospective, blind, controlled trial, pregnant women with a scheduled cesarean section under spinal anesthesia were randomized to receive AA with needle, AA without needle (sham), or usual care (no intervention). Anxiety level was assessed by using a visual analogue scale for anxiety (VAS-A; 0-minimal anxiety, 100-maximal anxiety) at three time points: inclusion (pre-induction room-T0), when entering the operating room (T1), and before incision (T2). The primary outcome was the VAS-A variation (percentage changes) between T0 and T1 in the AAe group compared with that in the sham AA group. The secondary outcomes were the VAS-A variation between T0 and T1 in the AA group compared with that in the control group, and the variation between T0 and T2 compared between the three groups, the effect of AA on parasympathetic tone, and the incidence of adverse effects. Results: In women immediately before anesthesia for cesarean section, the AA produced a 19% decrease of anxiety, compared with a 21% anxiety increase in sham AA, which is significantly different. The effect of AA was more present in women with low initial anxiety. The proportion of patients reaching clinically significant anxiety reduction (>33% from the initial level) was 2.5 times higher in the AA group (p = 0.02) compared with the sham group. No differences in anxiety variations were found compared with the no-intervention group. No effect of AA was noted on parasympathetic tone. Conclusion: Compared with sham, AA decreased maternal anxiety level when arriving in the operation room and just before the beginning of the cesarean section, with a trend toward improvement compared with usual care.
... Among these problems are confusion with the definitions of acupuncture, establishing causality of adverse events, and proper reporting of adverse events. A number of articles have been published discussing clinical research methods in acupuncture trials (Birch, 2003; Birch et al., 2002; Hammerschlag, 1998; Hopwood, Lewith, 2003; Lao et al., 2001; Lewith and Vincent, 1996; Margolin et al., 1998; Sherman and Cherkin, 2003; Vincent and Lewith, 1995; ). Part 2 of this article develops a list of criteria that need to be attended to when conducting controlled clinical trials of acupuncture. ...
Article
Unlabelled: OVERVIEW AND METHODS: This paper discusses those medical conditions in which clinical trials of acupuncture have been conducted, and where meta-analyses or systematic reviews have been published. It focuses on the general conclusions of these reviews by further examining official reviews conducted in the United States, United Kingdom, Europe, and Canada each of which examined available systematic reviews. While all reviews agree that the methodological rigor of acupuncture clinical trials has generally been poor and that higher quality clinical trials are necessary, this has not completely hampered the interpretation of the results of these clinical trials. In some conditions the evidence of efficacy has clearly reached a sufficient critical mass from enough well-designed studies to draw clear conclusions; for the rest, the evidence is difficult to clearly interpret. This paper also examines conclusions from the same international reviews on the safety and adverse effects of acupuncture. Here, conclusions are more easily drawn and there is good agreement about the safety of acupuncture. Results and conclusions: General international agreement has emerged that acupuncture appears to be effective for postoperative dental pain, postoperative nausea and vomiting, and chemotherapy-related nausea and vomiting. For migraine, low-back pain, and temporomandibular disorders the results are considered positive by some and difficult to interpret by others. For a number of conditions such as fibromyalgia, osteoarthritis of the knee, and tennis elbow the evidence is considered promising, but more and better quality research is needed. For conditions such as chronic pain, neck pain, asthma, and drug addiction the evidence is considered inconclusive and difficult to interpret. For smoking cessation, tinnitus, and weight loss the evidence is usually regarded as negative. Reviews have concluded that while not free from serious adverse events, they are rare and that acupuncture is a relatively safe procedure.
Article
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Many jurisdictions have used public funding of health care to reduce or remove price at the point of delivery of services. Whilst this reduces an important barrier to accessing care, it does nothing to discriminate between groups considered to have greater or fewer needs. In this paper, we consider whether active targeted recruitment, in addition to offering a 'free' service, is associated with a reduction in social inequalities in self-reported utilization of the breast screening services in NSW, Australia. Using the 1997 and 1998 NSW Health Surveys we estimated probit models on the probability of having had a screening mammogram in the last two years for all women aged 40-79. The models examined the relative importance of socio-economic and geographic factors in predicting screening behaviour in three different needs groups - where needs were defined on the basis of a woman's age. We find that women in higher socio-economic groups are more likely to have been screened than those in lower groups for all age groups. However, the socio-economic effect is significantly less among women who were in the actively targeted age group. This indicates that recruitment and follow-up was associated with a modest reduction in social inequalities in utilisation although significant income differences remain.
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It would seem that the right way to manage health policy is by basing it on evidence from research according to the Evidence-Based-Medicine (EBM) approach. In the last decades, there have been a number of attempts to plan a health policy with respect to complementary and alternative medicine (CAM) in Israel. Reaching agreements about recognition and regulation of CAM treatments is both lengthy and difficult due to the gap between the desire to base health policy on the best research grounded evidence and the difficulties in obtaining such evidence. In recent years, extensive research has been carried out in an attempt to examine the effects of CAM treatments. Some research has been designed as double-blind randomized controlled trials, while most has involved research types which produce evidence considered less valid. One of the significant reasons for this stems from the very essence of CAM itself, and from the holistic approach at its base. However, despite the difficulties in planning health policy with respect to CAM while lacking satisfactory evidence, it seems unethical to avoid decisions, arguing lack of valid information. Some argue that less evidential research should also be taken into consideration. The contributions of medical research evidence must be understood in a wide and complex context in which judgment and values, understanding of probability and tolerance for uncertainty all play a role. Developments in evidence-based medicine are an aid in making decisions, but not a panacea.
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This is a case presentation of a 10-year old girl with a history of severe allergies and asthma treated with acupuncture, the traditional technique of Gua Sha, and dietary intervention according to East-Asian medicine.
Article
To compare the effects of traditional Chinese acupuncture with sham acupuncture on upper-extremity (UE) function and quality of life (QOL) in patients with chronic hemiparesis from stroke. A prospective, sham-controlled, randomized controlled trial (RCT). Patients recruited through a hospital stroke rehabilitation program. Thirty-three subjects who incurred a stroke 0.8 to 24 years previously and had moderate to severe UE functional impairment. Active acupuncture tailored to traditional Chinese medicine diagnoses, including electroacupuncture, or sham acupuncture. Up to 20 treatment sessions (mean, 16.9) over a mean of 10.5 weeks. UE motor function, spasticity, grip strength, range of motion (ROM), activities of daily living, QOL, and mood. All outcomes were measured at baseline and after treatment. Intention-to-treat (ITT) analyses found no statistically significant differences in outcomes between active and sham acupuncture groups. Analyses of protocol-compliant subjects revealed significant improvement in wrist spasticity (P<.01) and both wrist (P<.01) and shoulder (P<.01) ROM in the active acupuncture group, and improvement trends in UE motor function (P=.09) and digit ROM (P=.06). Based on ITT analyses, we conclude that acupuncture does not improve UE function or QOL in patients with chronic stroke symptoms. However, gains in UE function observed in protocol-compliant subjects suggest traditional Chinese acupuncture may help patients with chronic stroke symptoms. These results must be interpreted cautiously because of small sample sizes and multiple, unadjusted, post hoc comparisons. A larger, more definitive RCT using a similar design is feasible and warranted.
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Unlabelled: We sought to determine whether a novel method of placebo acupuncture can be differentiated by subjects from real acupuncture treatment. A single-blind, randomized, controlled clinical trial with an independent observer was performed. Forty-nine healthy subjects over the age of 18 years were randomly assigned to one of 2 experimental groups: 24 subjects received real acupuncture, and 25 subjects received placebo acupuncture. Placebo acupuncture was performed by administering a blunted acupuncture needle through a foam pad at the Large Intestine 4 acupoint. The blunted needle touched but did not penetrate the skin. Real acupuncture was performed by administering an acupuncture needle through a foam pad at the Large Intestine 4 acupoint. The needle pricked and penetrated the skin to a depth of 10 to 20 mm. A simple questionnaire followed, asking whether the subject believed they received real or placebo acupuncture. Twenty-two (88%) of the 25 subjects who received placebo acupuncture believed they received real acupuncture. Nineteen (79.2%) of the 24 subjects who received real acupuncture correctly determined they received real acupuncture. The Fisher exact test showed an insignificant difference between real and placebo acupuncture treatments (P = .463). Subjects were not able to differentiate between real or placebo acupuncture, thereby validating this novel method of administering placebo acupuncture as a good control for acupuncture-naive patients. Perspective: The method of placebo acupuncture herein described is a valid control for acupuncture research involving acupuncture-naive patients.
Article
There is almost universal agreement that the quality of clinical trials of acupuncture is poor. There is an urgent need to improve their quality. The author develops here a list of 45 criteria important in the design, implementation, and writing up of controlled clinical acupuncture trials. This list has been compiled after examining the quality assessment criteria used in meta-analyses and systematic reviews of acupuncture, general publications on clinical trial designs and methodological considerations specific to acupuncture trials. Each criterion is discussed with recommendations about use and implementation. Additionally, each criterion is discussed relative to their importance in three types of acupuncture trial, acupuncture versus sham acupuncture, acupuncture versus standard therapy and acupuncture versus no treatment or wait-list. It is hoped that this exploration and systematic presentation of the 45 criteria will contribute to improving the quality of clinical trials of acupuncture. Improved trial quality will lead to greater ease interpreting the results of trials, especially in systematic reviews.
Article
The purpose of this pilot study was to assess the effect of an individualized traditional Chinese medicine (TCM) acupuncture and moxibustion (Acu/Moxa) treatment on symptom control in patients with irritable bowel syndrome (IBS) in a preliminary, randomized, sham/placebo-controlled trial. Twenty-nine men and women with IBS were randomized to either individualized Acu/Moxa (treatment group) or sham/placebo Acu/Moxa (control group). All subjects were assessed by a diagnostic acupuncturist for a TCM evaluation and individualized point prescription. Only those subjects assigned to the experimental group received the individually prescribed treatment. The diagnostic acupuncturist did not administer treatments and was blind to treatment assignments. All subjects kept a symptom diary for the duration of the study, enabling measurement of symptom frequency, severity, and improvement. The Clinical Global Impression Scale was administered preintervention to establish baseline severity and on completion of the 4-week, eight-session treatment intervention. After 4 weeks of twice-weekly Acu/Moxa treatment, average daily abdominal pain/discomfort improved whereas the control group showed minimal reduction. This between-group difference adjusted for baseline difference was statistically significant. The intestinal gas, bloating, and stool consistency composite score showed a similar pattern of improvement. The findings indicate that Acu/Moxa treatment shows promise in the area of symptom management for IBS.
Article
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The new discipline of whole systems research (WSR) targets the study of complex CAM therapies as system-level phenomena, as opposed to single-agent or uni-dimensional effects. This article describes the pre-defined goals, issues that were developed, and opportunities that were revealed in a workshop held in Vancouver BC, in which scientists, practitioners, and policy makers met to lay the foundations of WSR. Important issues were identified, such as treatment individualization, problems of diagnosis, patient-practitioner interaction, varying therapeutic contexts, and patient-determined outcome values. Research design issues that were addressed included a variety of challenges to the study of intact systems, in relation to both synergy and emergent behaviors, and the opportunities to innovate the conventional RCT. As the network of CAM scientists and practitioners engaged in WSR expands, a common nomenclature and body of techniques will help us to a better understanding of the ways in which whole systems affect healing.
Article
To investigate the contribution of two principal features that underlie traditional Chinese acupuncture: site specificity and application of needle manipulation. Thirteen volunteers completed a randomised, dual blind (subject and assessor) repeated measures study involving five interventions. Pressure pain threshold (PPT) was measured with an algometer, before and after intervention at 10 sites (acupoints and nonacupoints) across the body. Deep needling, with or without manual needle rotation, applied to the acupoint Large Intestine 4 (LI4) or to a nonacupoint located on the medial side of the second metacarpal. Inactive laser to LI4 was used as a control. All interventions were administered for 21 min. Percentage change in PPT from preintervention baseline at the 10 sites during the 18 min immediately following intervention. Statistically significant increases from preintervention PPT means were obtained at all 10 sites following needling of LI4 with manipulation compared with one site after needling LI4 without manipulation. Needling the nonacupoint led to statistically significant increases at six sites when manipulation was present compared with none in the absence of manipulation. No significant changes in mean PPT followed inactive laser. Needling LI4 with manipulation produced mean increases that were statistically significantly greater than those for the other interventions with one exception: needling the nonacupoint with manipulation was as effective as needling LI4 with manipulation at one measurement site only. Both manipulation and site of needling contributed significantly to the elevation of PPT following acupuncture. Distribution of effects on PPT did not support either neural segmental or Traditional Chinese Medicine channel theories. Psychological and physiological nonspecific effects appeared to play a minimal role in changes to PPT.
Article
The primary aim of this study was to examine whether 1 week of continuous auricular acupuncture could reduce low back and posterior pelvic pain associated with pregnancy. A randomized controlled trial was conducted on pregnant women who have lower back and posterior pelvic pain. These women were randomly assigned into an acupuncture group, a sham acupuncture group, or a waiting list control group. All participants were monitored for 2 weeks. Baseline and day 7 showed significant group differences in pain (F = 15; P < .0001) and in the disability rating index score (F = 7; P < .0001). The participants in the acupuncture group reported a significant reduction of pain and improvement of functional status as compared with those in the sham acupuncture and control groups. One week of continuous auricular acupuncture decreases the pain and disability experienced by women with pregnancy-related low back and posterior pelvic pain.
Article
Several unique methodological challenges exist concerning the choice of the most appropriate comparator or control group for clinical research in complementary and alternative medicine (CAM). This article reviews the four major types of control groups (active control, placebo or sham, no intervention control, and different protocols of the experimental intervention), noting the different questions they answer and the different contexts in which they may be used, and discusses how this framework may be applied to CAM research in an effort to avoid methodologically flawed study designs. The choice of comparator depends on complex factors such as the research question being asked, the most plausible competing rival hypotheses, and logistical considerations related to ethics, methodology and feasibility. For example, for sham to be an effective comparator it must capture the ‘nonspecific’ elements of the treatment without containing those that are ‘specific’ to the research question at hand. However, as demonstrated by the examples of acupuncture and energy medicine, designing such sham intervention is not always easy. Controlling for social interaction between practitioners and subjects, addressing issues around ethics, having good-quality measurement of treatment integrity and intensity, and selecting practitioners of sufficient competence when doing a sham process are other important parts of correct design choices. In the light of these complexities, clinicians and researchers alike need a better match between the research questions and the design employed in order for their research to be both scientifically valid and clinically meaningful.
Article
Analysis of the debate concerning the appropriate way of researching the effects of complementary and alternative medicine (CAM) treatments highlights the controversial issue of the mind–body bond in medical research. The article examines a range of approaches, extending from outright opposition to CAM research, through the demand to employ only rigorous trials, to suggestions to use a hierarchy of evidence, up to practice‐based research proposals. These diverse approaches are analysed using theoretical concepts from the field of sociology of science and knowledge. The article uses the concept of “hybrid knowledge” to denote the knowledge being constructed in late modern CAM discourse—knowledge that hybridises differentiated and even contradictory modern categories of knowledge. The article suggests that the different approaches taken by sociologists of science and knowledge, such as strong anti‐dualism and the assertion that there are differences in our understanding of the natural and the cultural–social terrain, are all useful and are not necessarily mutually exclusive. The article seeks to clarify the debate concerning the appropriate way of researching CAM and to contribute to the ongoing development and application of sociology of knowledge.
Article
Abstract De qi is a concept most often associated with patient experiences during needling in acupuncture treatment. A review of the early historical literature on acupuncture shows that texts tended to describe de qi and its associated concept, qi zhi more in terms of practitioner-based phenomena and that this is something more in the realm of the experienced practitioner (i.e., it is skill based). Many modern authors in Asia and the West also describe the importance of practitioner-based experiences in the de qi of acupuncture, further implying that this may lie at the heart of the treatment effects of acupuncture. A review of scientific studies on de qi shows that qualitative studies have focused almost exclusively on patient-based aspects of de qi while quantitative studies have focused exclusively on them. There thus exists a gap in current research on the phenomenon of de qi that possibly reveals weakness in the wider study of acupuncture. It is important that precise qualitative studies of the practitioner-based aspects of de qi begin soon and as they become better understood, quantitative research also is initiated. This research will not only better inform clinical trials and physiologic research of acupuncture in general but could contribute significantly to rethinking of how to train practitioners.
Chapter
Neurological diseases are a wide range of diseases affecting central and peripheral nervous system. Stroke, Alzheimer’s disease (AD), and Parkinson’s disease (PD) are the most common and challenging neurological diseases which lack effective treatment. Chinese medicine (CM) is an ancient yet still alive medical system widely used by Asian people for preventing and treating diseases. The symptoms of stroke, AD, and PD have been described in CM books as early as 2000 years ago. The causes as well as the treatment principles for these diseases are also mentioned in the classic CM books. According to CM theory, the diseases are caused by disharmony of Yin and Yang, thus the treatment strategy is to restore the balance. Throughout the CM history, the etiology and therapy for stroke, AD, and PD have been continuously developed. Currently, Up to 20–40 % of patients with above-mentioned diseases are receiving CM treatment in China, indicating the wide acceptance of CM for the treatment of neurological diseases (Liu in J Am Med Dir Assoc, 2015 [1]; Rajendran et al. in Neurology 57:790–4, 2001 [2]). The widely used formulas for neurological disease treatment include: “Qi Fu Decoction”, and “Tongqiao Huoxue Decoction” for Dementia; “Zhengan Xifeng Decoction”, “Angong Niuhuang Wan” “Tongqiao Huoxue decoction”, “Taohong Siwu Decoction” for Stroke; “Zhengan Xifeng Decoction”, “Lingjiao Gouteng Decoction”, “Dao Tan Decoction”, “Renshen Yangrong Decoction”, and “Dihuang Yinzi Decoction” for PD. Numerous studies have reported the efficacy of CM in the clinic treatment of stroke, AD, and PD. However, most of the clinical studies lack the experimental supports from diseases models and the reports were mainly written in Chinese, thus limiting the recognition of CM by worldwide researchers. With the modernization of CM during the past decades, the experimental data of CM-originated materials (formula, herb extract, and single compounds) on the stroke, AD, and PD models are accumulating rapidly, providing important scientific evidence for the clinic use of CM for treating neurological diseases. This chapter introduces the basic theory of CM for treating stroke, AD, and PD, lists the currently used experimental diseases models for the evaluation of pharmacological activity of CM, and summarizes the CM-originated materials with protective effects in these disease models.
Article
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Background Trials of acupuncture in the West began before textbooks about acupuncture were generally available. This placed trials at risk of possible faulty assumptions about the practice of acupuncture and adoption of problematic research assumptions and methods. Further, this lack of information has had an influence on the theories of developing a valid and reliable sham control treatment in clinical trials of acupuncture. This commentary explores these issues. Methods Literature review focussing on the time line of developments in the field, developments of sham interventions and use thereof and knowledge of physiological effects of needling. Results Early trials demonstrated a lack of knowledge about acupuncture. As the methodology of trials improved, new sham treatment methods were developed and adopted; however, the sham treatment methods were implemented without physiological studies exploring their potential physiological effects and without examining the broader practice of acupuncture internationally. Discussion Mistaken assumptions about the practice of acupuncture reinforced by paucity of physiological investigations are factors that led to use of inappropriate sham interventions for acupuncture trials. These not only lead to confusing or misleading trial results, they, as far as we can see underestimate the effects of acupuncture leading to bias against acupuncture. Conclusions There are significant problems with sham interventions and how they are applied in trials of acupuncture. Further research is needed to explore the effects of this both for future trials and for interpreting existing evidence.
Article
Unlabelled: We investigated the efficacy and safety of acupuncture for the treatment of tension-type headache by conducting a systematic review and meta-analysis of randomized, controlled trials. The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from inception through August 2007. No search or language restrictions were applied. Eight randomized, controlled trials met our inclusion criteria. Pooled data from 5 studies were used for the meta-analysis. Our primary outcome was headache days per month. We assessed data from 2 time points: During treatment and at long-term follow-up (20-25 weeks). The weighted mean difference (WMD) between acupuncture and sham groups was used to determine effect size, and a validated scale was used to assess the methodological quality of included studies. During treatment, the acupuncture group averaged 8.95 headache days per month compared with 10.5 in the sham group (WMD, -2.93 [95% CI, -7.49 to 1.64]; 5 trials). At long-term follow-up, the acupuncture group reported an average of 8.21 headache days per month compared with 9.54 in the sham group (WMD, -1.83[95% CI, -3.01 to -0.64]; 4 trials). The most common adverse events reported were bruising, headache exacerbation, and dizziness. Perspective: This meta-analysis suggests that acupuncture compared with sham for tension-type headache has limited efficacy for the reduction of headache frequency. There exists a lack of standardization of acupuncture point selection and treatment course among randomized, controlled trials. More research is needed to investigate the treatment of specific tension-type headache subtypes.
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The problem of providing an acupuncture placebo that is indistinguishable from genuine needling has appeared insurmountable. However, the authors have developed an apparatus, the Park sham needle unit, which is intended to match what an acupuncture-naïve subject expects to see and experience with needling, but is intended not to produce the specific needling sensation (deqi) that is felt with true needling. This can still not be regarded as a true placebo since skin contact must be made for verisimilitude and there may thus be some physiological stimulation. Nonetheless this form of sham acupuncture should be considered an advance on all previously used methods. The apparatus consists of a blunted needle, the shaft of which telescopes into the handle when tapped, so that, while the needle appears to have been inserted, it does not actually pierce the skin. The needle is held in place by a standard guide tube contained within a fitted sheath with basal ring that is secured to the skin with double sided sticky tape.
Article
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Tension headache is common, and treatment with acupuncture is frequently recommended, although the evidence of its effectiveness is contradictory. This small, randomised, controlled trial was designed as a pilot to test procedures in preparation for a multi-centre trial investigating the effect of acupuncture as a treatment for tension headache. Ten volunteers suffering from episodic, tension-type headache were recruited by local newspaper articles. Patients were randomised to receive either brief needling to tender areas or selected traditional points (Group A), or pressure from a cocktail stick supported within a guide tube to defined, non-tender and non-acupuncture areas (Group B). The patients’ view of the treatment sites was obstructed so that no indication could be gained as to which form of treatment was being given. Throughout the period of the trial, duration, frequency and intensity of headaches were recorded, from which the mean weekly headache index was calculated. There was no difference between the changes in weekly headache index in the two groups, comparing scores before and after treatment. However, Group A experienced a considerably higher number of headache-free weeks than Group B. The credibility of the two procedures was tested using a standard credibility questionnaire and a “final verdict”. One subject in Group B concluded that she had not received genuine acupuncture, but overall there was no statistical difference between the credibility of treatment in the two groups.
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The effect of naloxone on dental postoperative pain was studied to examine the hypothesis that endorphins mediate placebo analgesia. All patients had extraction of impacted mandibular third molars with diazepam, N2O, and local block with mepivacaine. 3 h and 4 h after surgery naloxone or a placebo was given under randomised, double-blind conditions. Pain was evaluated on a visual analogue scale. Patients given naloxone reported significantly greater pain than those given placebo. Patients given placebo as their first drug was either placebo responders, whose pain was reduced or unchanged, or nonresponders whose pain increased. Naloxone given as a second drug produced no additional increase in pain levels in nonresponders but did increase pain levels of placebo responders. Nonresponders had a final mean pain rating identical to that of responders who received naloxone as their second drug. Thus the enhancement of reported pain produced by naloxone can be entirely accounted for by its effect on placebo responders. These data are consistent with the hypothesis that endorphin release mediates placebo analgesia for dental postoperative pain.
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We often and wrongly equate the response seen in the placebo arm of a clinical trial with the placebo effect. In order to obtain the true placebo effect, other non-specific effects can be identified by including an untreated control group in clinical trials. A review of the literature shows that most authors confuse the perceived placebo effect with the true placebo effect. The true placebo effect is highly variable, depending on several factors that are not fully understood. A distinction between the perceived and the true placebo effects would be helpful in understanding the complex phenomena involved in a placebo response.
Article
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In this review, controlled clinical trials of acupuncture are placed into five categories on the basis of the treatment with which acupuncture is compared. Methodological and ethical issues relevant to each category are discussed. Wait list (or no treatment) controls, which are ethically acceptable for stable, chronic conditions, assess the efficacy of acupuncture relative to the natural history of the condition but do not control for nonspecific treatment effects. Placebo controls, defined here as noninvasive procedures such as inactive transcutaneous electrical nerve stimulation (TENS) or mock needling, assess whether acupuncture has an effect beyond that of the therapeutic milieu. Sham controls, defined as invasive but inappropriate procedures such as shallow needling at nonacupoint sites, assess whether acupuncture efficacy depends on the style and location of needling. Standard care comparisons assess whether acupuncture performs at least as well as a medication, medical device, or physiotherapy. Adjunctive care comparisons assess the efficacy of acupuncture plus standard care relative to standard care alone. From an ethical perspective, active debate surrounds placebo and sham controls. Those who argue against these procedures consider withholding treatment to be improper. They favor the wait list and both standard care designs in which all patients receive treatment. Others argue that testing a treatment prior to demonstrating its efficacy against a placebo is equally improper. From a methodological perspective, it should also be considered that most clinical trials of acupuncture have assessed its efficacy by administering a fixed course of treatment based on biomedical diagnosis. The challenge for future trials is to design conditions that more closely mimic the delivery of acupuncture in clinical practice, as individualized treatment informed by its own diagnostic traditions.
Book
Scientific Bases of Acupuncture summarizes the major scientific advances from 1976 - 1988 on the mechanisms of acupuncture. Outstanding researchers from Western countries, Japan and China report their findings in the format of review articles. The individual reviews summarize each author's personal research while also referring to the overall literature in the field of acupuncture and TENS.
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What is bias?Why does bias in an RCT matter?What are the main types of bias in RCTs?Other important sources of biasMusingsReferences
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In recent years, acupuncture analgesia (AA) in the west has been restricted mainly to the treatment of chronic pain and not used for surgical procedures, except for demonstration purposes. In some Western countries, however, AA is used in combination with nitrous oxide, sufficient N2O being given to render the patient unconscious but not for analgesia [80], or with fentanyl [89]. How could a needle inserted in the hand possibly relieve a toothache? Because such phenomena do not conform to accepted physiological concepts, scientists were puzzled and skeptical. Many explained it by the well-known placebo effect, which works through suggestion, distraction, or even hypnosis [201, 202]. In 1945, Beecher [9] showed that morphine relieved pain in 70% of patients, while sugar injections (placebo) reduced pain in 35% of patients who believed they were receiving morphine. Thus, many medical scientists in the early 1970s assumed that AA worked by this placebo (psychological) effect. However, there were several problems with this idea. How does one explain the use of AA in veterinary medicine over the past 1000 years in China and approximately 100 years in Europe and its growing use on animals in America? Animals are not suggestible and only a very few species are capable of the still reaction (so-called animal hypnosis). Similarly, small children also respond to AA. Moreover, several studies in which patients were given psychological tests for suggestibility did not show a good correlation between AA and suggestibility [101]. Hypnosis has also been ruled out as an explanation, as two studies [6, 58] have shown that hypnosis and AA respond to naloxone differently, AA being blocked and hypnosis being unaffected by this endorphin antagonist.
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Acupuncture has been used and tested in a wide range of health problems [16]. Often there are only one or two studies in a particular area and systematic reviews have thus not yet been possible. This chapter will focus on a number of areas with at least two controlled clinical trials or at least one controlled and one noncontrolled clinical trial. This is not a systematic review; rather it is an overview of the quality of the clinical trials in these areas. It is also not intended to be an exhaustive review but more as an introduction and overview of important areas where as yet limited research has been done. The chapter is thus an overview of potentially promising areas where acupuncture is used and further clinical and scientific work should be focused.
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The recent interest in acupuncture has led to an unprecedented amount of research funding in this area. This chapter presents a systematic, stepwise approach to research. It proposes investigating the efficacy of acupuncture by adapting the U. S. Food and Drug Administration (FDA) approach to clinical trials (Table 1). Two examples, one for chronic osteoarthritic (OA) pain [1, 2] and one for acute postextraction dental pain [1, 3–1, 5] are used to demonstrate how this method can be applied to acupuncture research. The final section discusses ways to integrate Western medicine more closely with traditional Chinese medicine (TCM) in research.
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At first glance, sharp differences exist between medicinal practices originating in the east and in the west. While Western medicine is more technological, relies on quantitative measurements, and is increasingly evidence-based, Eastern medicine is minimally invasive, relies on qualitative assessments, and remains largely experience-based. However, one concept shared by both medical systems is that most if not all physiological functions are regulated by activities posessing opposite effects. To consider only a few examples, blood sugar is decreased by insulin and increased by glucagon, calcitonin and parathyroid hormone act in opposing directions to regulate calcium levels in blood and tissues, and, generally speaking, the sympathetic and parasympathetic systems have contrasting functions in regulating many aspects of our internal environment. These phenomena can be regarded as reflections of the yin-yang balance described in traditional Chinese medicine. Thus, the “homeostasis” of Western medicine has long been recognized as “dynamic balance” in the classical texts of Chinese medicine.
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Acupuncture was commonly performed in China to achieve pain relief before it attracted special interest in the late 1950s as a result of its use for anesthetic purposes in surgical operations. In the excitement aroused by this unexpected new application of the ancient healing technique, numerous scientists were recruited to undertake scientific exploration of its basic mechanisms. At the first “All-China Conference on Acupuncture Anesthesia” held in Shanghai in 1965 more than 100 papers were presented; due consideration was given to the basic phenomenon of acupuncture analgesia (AA) in humans (Research Group of AA, Peking Medical College 1973), attention being drawn to its slow onset (an induction period of 20–30min) and slow decay (half-life of 16min).
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Counterirritation phenomena, i.e., the paradoxical, pain-relieving effects of painful stimulation of heterotopic areas of the body have been known for centuries, and various non-Western (e.g., Chinese) medical procedures still include counterirritation as a pain-relieving technique. In fact, most “popular” methods of practicing medicine include the therapeutic use of counterirritation [95], and it has been repeatedly rediscovered by scientists!
Chapter
In this chapter we review 228 of modern scientific studies on acupuncture. As most research has focused on acupuncture analgesia (AA) this will be the major topic. Two main conclusions are drawn: first that AA is effective in treating chronic pain (working better than placebo), and second that the neurological mechanisms of AA are rapidly becoming apparent. We conclude that acupuncture activates small myelinated nerve fibres in the muscle, which send impulses to the spinal cord, and then activates three centres (spinal cord, midbrain and pituitary-hypothalamus) to cause analgesia. The spinal cord centre uses enkephalin and dynorphin to block incoming painful information. The midbrain centre uses enkephalin to activate the raphe descending system which inhibits spinal cord pain transmission using the monoamines (serotonin and norepinephrine). The third centre is the hypothalamus-pituitary, which releases beta endorphin into the blood and cerebrospinal fluid to cause analgesia at a distance. Thus all three endorphins (enkephalin, beta endorphin, and dynorphin) have a role in AA, and two monamines (serotonin and norepinephrine) are also involved. When high frequency low intensity stimulation is used a non-endorphin type of analgesia occurs. Unfortunately, much less research has been done into the other claims made in addition for acupuncture, and these will be given less coverage (Sects. 1.3 and 1.4). Finally, the specificity of acupuncture points will be discussed in Section 1.5.
Article
This paper reviews some of the recent randomised trials on acupuncture published in the literature, with particular reference to the definition of placebo (control), sham acupuncture and real acupuncture. Response rates of 30, 50 and 70% of placebo, sham and real acupuncture respectively, are suggested for the groups of patients studied. The statistical methodology necessary in the design of acupuncture trials, in order to detect differences of this order of magnitude, is discussed. If the postulated response rate had been envisaged at the onset of the trials here reviewed, then the majority of these trials have very low power at a conventional 5% level of significance. It is emphasised that one cannot necessarily conclude from trials which produce statistically non-significant results that acupuncture (when compared with placebo for example) is ineffective. The paper suggests that meaningful comparisons between alternative treatments may be made by using ‘pain free intervals’ with subsequent analysis using life table techniques. Tables are provided for determining appropriate patient numbers.
Article
A randomised controlled trial comparing true and sham acupuncture was conducted on 30 patients suffering from chronic migraine. Diary measures of headache and medication intake were recorded throughout the study, and measures of headache quality, anxiety, and pain behaviour were taken. The credibility of the true and sham treatment procedures was also assessed. True acupuncture was significantly more effective than the control procedure in reducing the pain of migraine headache. Posttreatment reductions in pain scores and medication of 43 and 38%, respectively, were recorded in the true acupuncture group and were maintained at 4-month and I-year follow-up. (C) Lippincott-Raven Publishers.
Article
Chinese medicine is growing in popularity and offers an important alternative or complement to biomedical care, but little is known of who uses it or why they purchase it. This article reports the first in-depth, large-scale (n = 575) survey of United States acupuncture users. An anonymous mixed quantitative-qualitative survey questionnaire assessed user demographics, Chinese medicine modalities used, complaints, response to care, other health-care used, and satisfaction with care in six general-service clinics in five states. The user demographic picture was of mid-age, well-educated, employed, mid-income patients. They sought care for a wide variety of conditions; top uses were for relief of musculoskeletal dysfunction, mood care, and wellness care. A large majority reported "disappearance" or "improvement" of symptoms, improved quality of life, and reduced use of selected measures including prescription drugs and surgery. Respondents reported utilizing a wide array of practices in addition to Chinese medicine, while also expressing extremely high satisfaction with Chinese medicine care. The evidence indicates that these respondents behave as astute consumers within a plural health care system. Part II (in press) details reasons given for satisfaction and situates respondent attitudes within a larger sociocultural framework.
Article
In order to investigate the effects induced by acupuncture on the activity of enkephalinergic neurons in the spinal cord, either the lumbar or the cervico-trigeminal area was perfused with artificial cerebrospinal fluid (CSF) (0.1 ml/min) in halothane-anaesthetized rats, and Met-enkephalin-like material (MELM) was measured in 0.5 ml fractions of the perfusates. The effects of manual acupuncture performed by a traditional Chinese acupuncturist at the 'Zusanli' point on the right hind limb were compared to the effects induced by acupuncture applied at a non-acupoint next to 'Zusanli.' The manipulation of needles either at the 'Zusanli' point or at the non-acupoint had no effect on the release of MELM from the lumbar area but significantly increased the release from the cervico-trigeminal zone. It is concluded that manual acupuncture triggers a heterosegmental activation of enkephalinergic neurones within the spinal cord and that this effect is non-specific in terms of the location of the stimulated point.
Article
A literature search revealed 51 controlled clinical studies on the effectiveness of acupuncture in chronic pain. These studies were reviewed using a list of 18 predefined methodological criteria. A maximum of 100 points for study design could be earned in four main categories: (a) comparability of prognosis, (b) adequate intervention, (c) adequate effect measurement and (d) data presentation. The quality of even the better studies proved to be mediocre. No study earned more than 62% of the maximum score. The results from the better studies (greater than or equal to 50% of the maximum score) are highly contradictory. The efficacy of acupuncture in the treatment of chronic pain remains doubtful.
Article
A randomised controlled trial comparing true and sham acupuncture was conducted on 30 patients suffering from chronic migraine. Diary measures of headache and medication intake were recorded throughout the study, and measures of headache quality, anxiety, and pain behaviour were taken. The credibility of the true and sham treatment procedures was also assessed. True acupuncture was significantly more effective than the control procedure in reducing the pain of migraine headache. Posttreatment reductions in pain scores and medication of 43 and 38%, respectively, were recorded in the true acupuncture group and were maintained at 4-month and 1-year follow-up.
Article
Microcirculatory effects of the application of an acupuncture needle (32-gauge, silver) to the back, corresponding to Geshu (B17) in human beings, were studied in vivo by microscope, using a transparent ear chamber in conscious rabbits. Although no striking findings were obtained during the needle application for a period of 30 minutes, it was clearly observed that the microvascular blood flow increases gradually in parallel with augmenting spontaneous rhythmic fluctuation of the vessel diameter, namely vasomotion, throughout a continuous observation period longer than 2 hours following release from the needle application. Diameters of arterioles and venules at the full-dilating phases of vasomotion reached levels higher than 200% and 250% of the initial values just before application of the needle, respectively. The clinical efficacy of acupuncture was suggested to be explained at least in part by the increased rhythmic microvascular blood flow in parallel with vasomotion, from the physiological point of view based on the previous investigations.
Article
One of the challenges of acupuncture research is designing appropriate control groups. To address this problem, after surgical third molar extractions 19 patients were randomly assigned to an acupuncture group (n = 11) or a placebo acupuncture group (n = 8). The length of time for reaching moderate pain and pain intensity after oral surgery were recorded by standard patient self-report. The results indicated that subjects treated with acupuncture reported longer pain-free duration times (mean, 181 versus 71 minutes; p < or = 0.046) and experienced less pain intensity than those who received placebo acupuncture. This study provides a model for an acupuncture control that could examine the placebo effect in clinical acupuncture research.
Article
Many studies of acupuncture treatment are seriously flawed by methodological problems. Poor design, inadequate measures and statistical analysis, lack of follow-up data and sub-standard treatment are all too common. However, the major problem, which many investigators consider to be still unresolved, is the definition of an appropriate placebo control. The use of inappropriate placebo controls has bedeviled acupuncture research and led to serious misinterpretation of the results of clinical trials. While a number of different solutions have been proposed there is, as yet, no agreed way of assessing the adequacy of control conditions or of deciding which placebo to use in a particular trial. We propose that assessing the credibility of treatments and control conditions may provide a way forward to a more rigorous, consensus approach.
Since 1955, when HK Beecher published his classic "The Powerful Placebo," it generally has been accepted that 35% of patients with any of a wide variety of disorders can be treated with placebos alone. In recent years, average cure rates of 70%, and up to 100%, also have been quoted. Like pharmacological preparations, placebos are credited with possessing time-effect curves; cumulation and carry-over effects; differentiated actions depending on color, size, or packaging; even toxic effects. It has been postulated that placebos can prolong life, that their effects occur in surgery as well as in medicine, and that they are mediated by endorphins. In this article source material that forms the scientific basis for such claims is examined. Analysis shows that the studies on which such ideas are based, except perhaps in bronchial asthma, do not in any way justify the conclusions drawn from them. The truth is that the placebo effect is counterfeited by a variety of factors including the natural history of the disease, regression to the mean, concomitant treatments, obliging reports, experimental subordination, severe methodological defects in the studies, misquotations, etc; even, on occasion, by the fact that the supposed placebo is actually not a placebo, but has to be acknowledged as having a specific action on the condition for which it is being given. A further reason for misjudgment is the lack of clarity of the placebo concept itself. Experimental subordination and conditioning are other areas of insufficient conceptual differentiation. The authors conclude that the literature relating to the magnitude and frequency of the placebo effect is unfounded and grossly overrated, if not entirely false. They pose the question whether the existence of the so-called placebo effect is itself not largely-or indeed totally-illusory.
Article
Placebo is a widespread phenomenon in medicine and biology and its mechanisms are understood only partially. Most of our understanding of placebo comes from studies on pain. In particular, placebo analgesia represents a situation where the administration of a substance known to be non-analgesic produces an analgesic response when the subject is told that it is a pain killer. Several theories try to explain this effect by means of anxiety mechanisms, cognitive processes and classical conditioning. However, the placebo response is bidirectional, i.e. analgesic and algesic. In fact, if a subject is told that the ineffective substance is a hyperalgesic drug, a pain increase may occur. The negative effects of placebo are called nocebo and, in extreme cases, they lead to severe pathological conditions. The neurobiology of placebo was born when some authors discovered that placebo analgesia is mediated by endogenous opioids. This claim comes from the observation that the opioid antagonist naloxone can reverse placebo analgesia. On the basis of the discovery of the anti-opioid action of the neuropeptide cholecystokinin, recent studies demonstrate that the blockade of cholecystokinin receptors potentiates the placebo analgesic response, thus suggesting an inhibitory role of cholecystokinin in placebo analgesia. Thus, by antagonizing the anti-opioid action of cholecystokinin during a placebo procedure, a potentiation of the endogenous opioid systems can be obtained.
Article
The authors reexamine the three areas that have encompassed the major part of clinical research within acupuncture: chronic pain, addiction (particularly smoking cessation), and the treatment of nausea and vomiting. Clarification of the findings, and of the different control conditions that have been used, suggests that point location is an important variable in the treatment of chronic pain and nausea, but not in addiction. These observations can be explained by postulating that different underlying mechanisms are involved in the treatment of different conditions: addictions may be purely mediated by opioid peptides, nausea by the autonomic system, and a combination of both may be involved in chronic pain, together with local trigger point action. A hypothesis is presented that suggests that the closer one gets to a purely endorphin-mediated effect, the less relevant it is to think in terms of point location and the more misleading a real versus sham acupuncture model is in the context of a clinical trial. The hypothesis is necessarily speculative, but it does provide a coherent theoretical framework that integrates neurophysiology, clinical trials, and some aspects of traditional Chinese medicine.
Article
Anthropology is a holistic science with theory, data, and methods that can be of great service to researchers on alternative medicine. In this paper useful models and methodologic stances were identified that can help researchers to deal creatively with the stresses imposed on science by worldview preferences that differ among both scientists and healthcare systems. I have argued that rather than prefer one paradigm over another, researchers should select techniques based on a rationale featuring deep knowledge of the context of the healthcare issue they want to study. This will not only produce the most accurate and useful data, but should also help free science of its current strictures and allow expansion into a wider conversation about human and medical realities.
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Many clinical trials concerning acupuncture are flawed by methodological problems. One of the major difficulties is the appropriate selection and use of a placebo control. This article evaluates the use of sham acupuncture as a placebo control and analyzes its credibility as a control treatment. Sixty-four subjects were assessed for their perception of whether they were receiving sham or real acupuncture while participating in a clinical trial of acupuncture. It was found that if used under specific experimental conditions, sham acupuncture can function as a credible control. Specific strategies are suggested to maintain the credibility of sham acupuncture as a placebo control.
Article
A problem acupuncture research has to face is the concept of a control group. If, in control groups, non-acupoint needling is done, physiological acupuncture effects are implied. Therefore the effects shown in this group are often close to those shown in the acupuncture group. In other trials, control groups have received obviously different treatments, such as transcutaneous electrical nervous stimulation or TENS-laser treatment; it is not clear if the effects of acupuncture are due only to the psychological effects of the treatment. We developed a placebo acupuncture needle, with which it should be possible to simulate an acupuncture procedure without penetrating the skin. In a cross-over experiment with 60 volunteers we tested whether needling with the placebo needle feels any different from real acupuncture. Of 60 volunteers, 54 felt a penetration with acupuncture (mean visual analogue scale [VAS] 13.4; SD 10.58) and 47 felt it with placebo (VAS 8.86; SD 10.55), 34 felt a dull pain sensation (DEQI) with acupuncture and 13 with placebo. None of the volunteers suspected that the needle may not have penetrated the skin. The placebo needle is sufficiently credible to be used in investigations of the effects of acupuncture.
Article
This article examines the specific and nonspecific effects of Japanese acupuncture on chronic myofascial neck pain in a randomized single-blind trial. Forty-six patients were randomly assigned to receive relevant acupuncture, irrelevant acupuncture, or no-acupuncture control treatment consisting of nonsteroidal anti-inflammatory medication. The two acupuncture groups underwent comparable light shallow needling. The irrelevant acupuncture group received acupuncture at specific sites not relevant for cervical pain. The study measures included the McGill Pain Questionnaire-Short Form (SF-MPQ), the Short-Form Health Survey (SF-36), the Symptom Checklist 90-Revised (SCL-90-R), medication diary, and physiologic measures. The factors examined as predictors of outcome pain ratings were experience with, beliefs about, and knowledge of acupuncture before treatment; perceived efficacy, credibility, and logic of acupuncture; perceived competence of the acupuncturist; and painfulness of acupuncture. No differences were found among the three groups at baseline, except that the relevant acupuncture group reported having had more previous acupuncture treatments. No significant differences in terms of perceived credibility or perceived effectiveness of treatment were found between the two acupuncture groups. The relevant acupuncture group had significantly greater pre-/posttreatment differences in pain than the irrelevant acupuncture and control groups (p < .05). The nonspecific effects of confidence in the acupuncturist, willingness to try any treatment, mood, and physiologic effect of needling were not predictive of treatment outcome, whereas confidence in the treatment and past experiences with acupuncture did correlate significantly with a decrease in pain. Relevant acupuncture with heat contributes to modest pain reduction in persons with myofascial neck pain. Previous experience with and confidence in treatment help to predict benefit. Measurement of nonspecific effects of alternative therapy is recommended in future clinical trials.
Article
Acupuncture has been incorporated as a treatment component in numerous addiction treatment programs in the United States; however, its efficacy has not been demonstrated in large-scale, controlled clinical trials. In this article we discuss the background and design of the Cocaine Alternative Treatments Study (CATS), a randomized, controlled, multisite study of acupuncture that will enroll 500 cocaine-dependent individuals at 6 sites across the country, and that constitutes the largest controlled trial for the treatment of cocaine addiction undertaken to date. After presenting the background of the study, we discuss the approach taken to address several critical issues, including the choice of appropriate control conditions, point location for needle insertion, degree of blinding, and bias checks. Complementary therapies are used by a significant number of individuals, and the need to evaluate them in controlled clinical trials is an ongoing and urgent issue.
Article
Acupuncture is increasingly being used by the general population and investigated by conventional medicine; however, studies of its effects on pain still lack adequate control procedures. To evaluate the (1) efficacy of Chinese acupuncture in treating postoperative oral surgery pain, (2) validity of a placebo-controlled procedure, and (3) effects of psychological factors on outcomes. Randomized, double-blind, placebo-controlled trial. Dental School Outpatient Clinic, University of Maryland at Baltimore. Thirty-nine healthy subjects, aged 18 to 40 years, assigned to treatment (n=19) and control (n=20) groups. Patients' self-reports of time until moderate pain, time until medication use, total pain relief, pain half gone, and total pain medication consumption. Mean pain-free postoperative time was significantly longer in the acupuncture group (172.9 minutes) than in the placebo group (93.8 minutes) (P=.01), as was time until moderate pain (P=.008). Mean number of minutes before requesting pain rescue medication was significantly longer in the treatment group (242.1 minutes) than in the placebo group (166.2 minutes) (P=.01), as was time until medication use (P=.01). Average pain medication consumption was significantly less in the treatment group (1.1 tablets) than in the placebo group (1.65 tablets) (P=.05). There were no significant between-groups differences on total-pain-relief scores or pain-half-gone scores (P>.05). Nearly half or more of all patients were uncertain of or incorrect about their group assignment. Outcomes were not associated with psychological factors in multivariate models. Acupuncture is superior to the placebo in preventing postoperative dental pain; noninsertion placebo procedure is valid as a control.
Article
Numerous studies have demonstrated that acupuncture and moxibustion induce analgesic effects. This study examined whether diffuse noxious inhibitory controls (DNIC) participated in acupuncture and moxibustion induced-analgesia. Single unit extracellular recordings from neurons in the trigeminal nucleus caudalis of urethane-anesthetized Wistar rats were obtained with a glass micropipette. A total of 52 single units, including 36 wide dynamic range (WDR), 5 nociceptive specific (NS) and 11 low-threshold mechanoreceptive (LTM) units were examined. During noxious test stimulation (cutaneous pinch or electrical stimulation), acupuncture, moxibustion or pinch stimulation was applied as the conditioning stimulus to the remote area of the receptive fields. When the conditioning stimulation induced rapid suppression of noxious receptive field stimulation response, examination revealed that various areas of the entire body were affected and suppression increased in an intensity-dependent manner. These features resemble DNIC phenomena. The suppression was observed on both WDR and NS neurons but not on LTM neurons. Eight of 16 WDR neurons examined were inhibited by acupuncture, five of 14 by moxibustion, and seventeen of 21 by pinching stimulation. Of the NS neurons, one of 2 units examined was suppressed by acupuncture, one of 2 by moxibustion, and two of 3 by pinch stimulation. Pinch stimulation induced the most profound suppression followed by manual acupuncture. Moxibustion induced moderate suppression with a long induction time. These results suggest that DNIC may be involved in the analgesic mechanism of acupuncture and moxibustion.
Article
Partly because of a lack of a conventional, effective treatment for cocaine addiction, auricular acupuncture is used to treat this disorder in numerous drug treatment facilities across the country for both primary cocaine-dependent and opiate-dependent populations. To evaluate the effectiveness of auricular acupuncture for the treatment of cocaine addiction. Eighty-two cocaine-dependent, methadone-maintained patients were randomly assigned to 1 of 3 conditions: auricular acupuncture, a needle-insertion control condition, or a no-needle relaxation control. Treatment sessions were provided 5 times weekly for 8 weeks. The primary outcome was cocaine use assessed by 3-times-weekly urine toxicology screens. Longitudinal analysis of the urine data for the intent-to-treat sample showed that patients assigned to acupuncture were significantly more likely to provide cocaine-negative urine samples relative to both the relaxation control (odds ratio, 3.41; 95% confidence interval, 1.33-8.72; P =. 01) and the needle-insertion control (odds ratio, 2.40; 95% confidence interval, 1.00-5.75; P =.05). Findings from the current study suggest that acupuncture shows promise for the treatment of cocaine dependence. Further investigation of this treatment modality appears to be warranted.
Article
Although the placebo in a clinical trial is often considered simply a baseline against which to evaluate the efficacy of a clinical intervention, there is evidence that the magnitude of placebo effect may be a critical factor in determining the results of a trial. This article examines the question of whether devices have enhanced placebo effects and, if so, what the implications may be. While the evidence of an enhanced placebo effect remains rudimentary, it is provocative and therefore worthy of further study. Suggestions are made, therefore, for how such an effect can be investigated without violating the principles of informed consent.
Research methodologies in complementary medicine: Making sure it works Complementary medicine: an objective appraisal
  • Resch K L Ernst
Resch K.L., Ernst E. Research methodologies in complementary medicine: Making sure it works. In: Ernst E., ed. Complementary medicine: an objective appraisal. Oxford, Butterworth Heinmann, 1996, pp 18–30.
Towards a neurobiology of placebo analgesia The Placebo effect: An interdisciplinary exploration
  • H L Fields
  • D D Price
Fields H.L., Price D.D. Towards a neurobiology of placebo analgesia. In: Harrington A., ed. The Placebo effect: An interdisciplinary exploration. Cambridge, Harvard University Press.
Developing protocols for acupuncture studies: an efficacy trial of low back pain
  • Sherman
Acupuncture and related forms of folk medicine
  • Melzack
Chinese medicine users in the United States. Part 1: Utilization, satisfaction, medical plurality
  • Cassidy
The importance of the placebo effect: A proposal for further research
  • Kleijnen