The status and future of acupuncture clinical research

On November 8-9, 2007, the Society for Acupuncture Research (SAR) hosted an international conference to mark the tenth anniversary of the landmark National Institutes of Health Consensus Development Conference on Acupuncture. More than 300 acupuncture researchers, practitioners, students, funding agency personnel, and health policy analysts from 20 countries attended the SAR meeting held at the University of Maryland School of Medicine, Baltimore, MD. This paper summarizes important invited lectures in the area of clinical research. Specifically, included are: a review of the recently conducted German trials and observational studies on low-back pain (LBP), gonarthrosis, migraine, and tension-type headache (the Acupuncture Research Trials and the German Acupuncture Trials, plus observational studies); a systematic review of acupuncture treatment for knee osteoarthritis (OA); and an overview of acupuncture trials in neurologic conditions, LBP, women's health, psychiatric disorders, and functional bowel disorders. A summary of the use of acupuncture in cancer care is also provided. Researchers involved in the German trials concluded that acupuncture is effective for treating chronic pain, but the correct selection of acupuncture points seems to play a limited role; no conclusions could be drawn about the placebo aspect of acupuncture, due to the design of the studies. Overall, when compared to sham, acupuncture did not show a benefit in treating knee OA or LBP, but acupuncture was better than a wait-list control and standard of care, respectively. In women's health, acupuncture has been found to be beneficial for patients with premenstrual syndrome, dysmenorrhea, several pregnancy-related conditions, and nausea in females who have cancers. Evidence on moxibustion for breech presentation, induction of labor, and reduction of menopausal symptoms is still inconclusive. In mental health, evidence for acupuncture's efficacy in treating neurologic and functional bowel disorder is still inconclusive. For chronic cancer-related problems such as pain, acupuncture may work well in stand-alone clinics; however, for acute or treatment-related symptoms, integration of acupuncture care into a busy and complex clinical environment is unlikely, unless compelling evidence of a considerable patient benefit can be established.     

Relief of chronic neck and shoulder pain by manual acupuncture to tender points--a sham-controlled randomized trial

OBJECTIVES: To compare the effects of real acupuncture to tender points for neck and shoulder pain and stiffness (Japanese: katakori) with those of sham acupuncture. DESIGN: Randomized-controlled trial. METHODS: Thirty-four volunteers from an acupuncture school with complaints of chronic pain and stiffness, who had no arm symptoms and gave informed consent, were randomly allocated to acupuncture or sham groups. Acupuncture or sham acupuncture was applied to the tender points once a week for 3 weeks. In the acupuncture group the acupuncture needle was inserted to the muscle, then the sparrow pecking technique was applied five times. Sham acupuncture was done without insertion of the needle. Dull pain and stiffness were evaluated by visual analog scale (VAS) before, and every 2 days after the first needling for 1 month. Pressure pain threshold on the tender points was measured before and after each treatment. RESULTS: There was no statistical difference of VAS scores between acupuncture and sham groups 9 days after the last treatment. However, the acupuncture group showed significant reduction of VAS scores immediately after and/or 1 day after the real acupuncture treatments (P<0.01). The effect tended to be prolonged after repeated treatment. Pressure pain thresholds tended to increase after real acupuncture treatment but not after sham acupuncture. CONCLUSIONS: Acupuncture applied to tender points appears to have short-term effects on neck and shoulder pain and stiffness, but this study was unable to demonstrate any long-term superiority over sham acupuncture.     

Acupuncture for chronic shoulder pain in persons with spinal cord injury: a small-scale clinical trial

OBJECTIVE: To determine the efficacy of acupuncture in the treatment of chronic musculoskeletal shoulder pain in subjects with spinal cord injury (SCI). DESIGN: Randomized, double blind (participants, evaluator), placebo (invasive sham) controlled trial. SETTING: Clinical research center. PARTICIPANTS: Seventeen manual wheelchair-using subjects with chronic SCI and chronic musculoskeletal shoulder pain. INTERVENTIONS: Participants were randomly assigned to receive 10 treatments of either acupuncture or invasive sham acupuncture (light needling of nonacupuncture points). MAIN OUTCOME MEASURE: Changes in shoulder pain intensity were measured using the Wheelchair User's Shoulder Pain Index. RESULTS: 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. CONCLUSIONS: 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.     

Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis.

Acupuncture has gained increasing attention in the treatment of chronic pain. The lack of a satisfying placebo method has made it impossible to show whether needling is an important part of the method or whether the improvement felt by the patient is due to the therapeutic setting and psychological phenomena. Also, the effectiveness of acupuncture has not been demonstrated sufficiently. We treated 52 sportsmen with rotator cuff tendinitis in a randomised single-blind clinical trial using a new placebo-needle as control. Patients were treated for 4 weeks. The primary endpoint of the trial was the change in the modified Constant-Murley-score from the baseline. Assessment of the treatment outcome was made by experienced orthopaedists not informed of the treatment allocation. Acupuncture with penetration of the skin was shown to be more effective than a similar therapeutic setting with placebo needling in the treatment of pain. The acupuncture-group improved 19.2 Constant-Murley-score points (SD 16.1, range from -13 to 50), the control-group improved 8.37 points (SD 14.56, range from -20 to 41), (P=0.014; C.I. 2.3;19.4). This study showed that needling is an important part of the acupuncture effect in the treatment of chronic shoulder pain in athletes. No conclusions can be derived from this study concerning the importance of choosing points and the rules of Traditional Chinese Medicine. Using the new placebo method as control for other ailments could improve the evidence of specific acupuncture effects beyond pain treatment.     

The effectiveness of dry needling for patients with orofacial pain associated with temporomandibular dysfunction: a systematic review and meta-analysis

Background

Orofacial pain of myofascial origin is often associated with temporomandibular joint dysfunction, affects chewing muscles and may lead to functional limitations. Dry needling is an intervention commonly used for inactivating myofascial pain trigger points.

Effectiveness of acupuncture for migraine: critical literature review

AIM: The aim of this paper is to evaluate previous research studies on acupuncture for migraine with reference to the Standards for Reporting Interventions in Controlled Trials of Acupuncture guidelines. BACKGROUND: It is estimated that around 2-15% of the world's population are affected by migraine headaches. Thirteen per cent of adults in the United Kingdom suffer with chronic pain, migraine headaches accounting for 7% of cases. Migraine pain relief is grounded in pharmacology. Acupuncture for migraine has been widely researched. However, inconsistent and low quality results have been produced. Recently, published Standards for Reporting Interventions in Controlled Randomized Trials of Acupuncture guidelines recommend important information that must be included in research in order to be valid and reliable. METHODS: Searches were conducted between September 2003 and May 2004 using the Ovid Medline 1966-2004, British Medical Journal, Blackwell Synergy, Science Direct, The Lancet and Cochrane Library Issue 1 databases. Searches were limited to the previous 20 years and to publications in the English language only. FINDINGS: Thirteen randomized controlled trials met the inclusion criteria and were critically reviewed for methodological quality, reporting of acupuncture needling details, practitioner background, control interventions and use of a diagnostic criterion. Findings agreed with previous literature reviews that the majority of studies of acupuncture for migraine research are of poor quality, with conflicting results. Few studies met the criteria of the Standards for Reporting Interventions in Controlled Trials of Acupuncture recommendations. Overall, the quality of research in this area must be questioned. CONCLUSIONS: In the light of these findings, practitioners may face a dilemma when considering the use of acupuncture for migraine. Therefore, large, high quality randomized controlled trials of acupuncture for migraine are needed. Until better quality research is published, with verification of the benefits of acupuncture for migraine, provision of this alternative therapy should not be expanded or withdrawn.     

Immediate effects of dry needling and acupuncture at distant points in chronic neck pain: results of a randomized,double-blind,sham-controlled crossover trial

To evaluate immediate effects of two different modes of acupuncture on motion-related pain and cervical spine mobility in chronic neck pain patients compared to a sham procedure. Thirty-six patients with chronic neck pain and limited cervical spine mobility participated in a prospective, randomized, double-blind, sham-controlled crossover trial. Every patient was treated once with needle acupuncture at distant points, dry needling (DN) of local myofascial trigger points and sham laser acupuncture (Sham). Outcome measures were motion-related pain intensity (visual analogue scale, 0-100 mm) and range of motion (ROM). In addition, patients scored changes of general complaints using an 11-point verbal rating scale. Patients were assessed immediately before and after each treatment by an independent (blinded) investigator. Multivariate analysis was used to assess the effects of true acupuncture and needle site independently. For motion-related pain, use of acupuncture at non-local points reduced pain scores by about a third (11.2 mm; 95% CI 5.7, 16.7; P = 0.00006) compared to DN and sham. DN led to an estimated reduction in pain of 1.0 mm (95% CI -4.5, 6.5; P = 0.7). Use of DN slightly improved ROM by 1.7 degrees (95% CI 0.2, 3.2; P = 0.032) with use of non-local points improving ROM by an additional 1.9 degrees (95% CI 0.3, 3.4; P = 0.016). For patient assessment of change, non-local acupuncture was significantly superior both to Sham (1.7 points; 95% CI 1.0, 2.5; P = 0.0001) and DN (1.5 points; 95% CI 0.4, 2.6; P = 0.008) but there was no difference between DN and Sham (0.1 point; 95% CI -1.0, 1.2; P = 0.8). Acupuncture is superior to Sham in improving motion-related pain and ROM following a single session of treatment in chronic neck pain patients. Acupuncture at distant points improves ROM more than DN; DN was ineffective for motion-related pain.     

Acupuncture: an evaluation in the painful crises of sickle cell anaemia

An evaluation of acupuncture for pain relief was made in 10 patients with sickle cell anaemia during 16 pain crises. A model was developed in which the patient served as his own control and in which both patient and examiner were unaware of whether an acupuncture point or a sham site was treated. The results show (1) that pain relief was obtained in 15 of the 16 painful episodes regardless of whether an acupuncture point or a sham site was treated, demonstrating considerable overlap between the effects of needling acupuncture points and sham sites; (2) that needling at acupuncture points for pain relief is not significantly superior to treatment at sham sites; (3) that needling, per se, whether at acupuncture points of at sham sites can be useful for alleviating pain in sickle cell crises. The model could be useful for evaluation of pain relief by needling in other diseases.     

Effects of dry needling on pain,pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis: Secondary analysis of a randomized controlled trial

ObjectiveTo determine the changes produced by dry needling in active myofascial trigger points in hip muscles compared to a sham needling on pain intensity, main pain area, pressure pain threshold and psychological distress in patients with hip osteoarthritis.DesignSecondary analysis of a single-centre, randomized, double-blinded, clinical trial.Intervention30 participants with mild to moderate hip osteoarthritis were randomly assigned to DN group (n = 15) or sham DN group (n = 15). DN group received three sessions of penetrating DN, and sham DN group received three sessions of non-penetrating DN in hip muscles.Main outcome measures: Pain intensity (Visual Analogue Scale), main pain area (body chart), pressure pain threshold (algometry), psychological distress (Hospital Anxiety and Depression Scale) and self-reported improvement (Global Rate of Change) were measured before and after treatment.ResultsDN group showed statistically significant improvements with large effect sizes for pain intensity (p < 0.001; E.S: 2.7), pressure pain thresholds (p < 0.05; E.S: 1.3-1.8) and psychological distress (p = 0.002; E.S: 1.5) compared to sham DN group. The DN group described a self-reported improvement categorised as quite a bit, great or very great deal better (n = 12, 80%). No statistically significant differences were found between baseline and postintervention in the sham DN group in any variable (p > 0.05).ConclusionsThree sessions of dry needling were more effective than sham dry needling for improving pain intensity, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis in the short term.     

Designing an acupuncture study: II. The nationwide, randomized, controlled German acupuncture trials on low-back pain and gonarthrosis

BACKGROUND: In the nationwide German Acupuncture Trials (GERAC), verum acupuncture, mirroring the Traditional Chinese Medicine (TCM) acupuncture style, was tested against sham acupuncture and guideline standard therapy for the entities classified in the West as chronic low back pain (LBP) and gonarthrosis (GON). OBJECTIVE: The objective was to develop broadly consensual acupuncture and control protocols for the treatment of LBP and GON in the GERAC trials. METHODOLOGY: Extensive literature study and consultation with acupuncture experts were consulted. Personal interviews, both free and structured, e-mail discussions, and phone conferences were used as well. RESULTS: Broadly consensual acupuncture protocols for LBP and GON for verum and invasive sham acupuncture were developed. They included semistandardized point combinations with clearly described point selection rules based on TCM acupuncture diagnosis. A procedure was developed to help ensure homogenous treatment quality in a large multicenter trial. CONCLUSIONS: With 1162 randomized patients for LBP and 1039 patients for GON, the GERAC study design allowed acupuncture to be tested in a naturalistic environment. The rigorous study design and large number of physician investigators guaranteed a high external validity for the results. The results will help determine the significance of Chinese acupuncture in the context of Western medicine for the treatment of LBP and GON.     

Effectiveness of dry needling techniques in patients with knee osteoarthritis: A systematic review and meta-analysis

BackgroundDry needling has been found to be effective in various myofascial pain syndromes and musculoskeletal conditions. However, there is a need to evaluate the effects of dry needling techniques in patients with knee osteoarthritis. Hence, the objective of this systematic review was to identify and critically review the evidence on the short-term and long-term effects of dry needling techniques in patients with knee osteoarthritis.MethodsDatabases such as Pubmed, Cochrane library, and Scopus were searched from their inception to July 2019 for randomized controlled trials using dry needling as an active intervention against control/sham/placebo treatment in patients with knee osteoarthritis. The quality of the selected studies was analyzed using Cochrane tool for assessment of risk of bias.ResultsOut of 247 studies, 9 studies were included in the review. The qualitative synthesis for myofascial trigger point dry needling showed contradictory results. The mean difference for periosteal stimulation was significant on pain and function immediately post-treatment (p < 0.00001). The mean difference for intramuscular electrical stimulation on pain was significant (p = 0.03), but marked heterogeneity was found among the studies.ConclusionGood quality studies on myofascial trigger point needling and intramuscular electrical stimulation are required to evaluate their effects in patients with knee osteoarthritis. The review demonstrates a moderate-quality evidence on the short-term effect of periosteal stimulation technique on pain and function in knee osteoarthritis. Future studies comparing the effects of various techniques of dry needling with different dosages and long-term follow up need to be conducted.     

Clinical trials of acupuncture: consensus recommendations for optimal treatment,sham controls and blinding

Evidence of effectiveness is increasingly used to determine which health technologies are incorporated into public health provision. Acupuncture is a popular therapy that has been shown to be superior to placebo in the treatment of nausea and dental pain, and promising for migraine and osteoarthritis of the knee. For many other conditions, such as chronic pain, in which acupuncture is often used, the evidence is either insufficient or negative. Misleading results may occur for a number of reasons. False negative results may arise from inadequate treatment schedules and inappropriate control interventions. This consensus document considers these issues with the aim of improving the design of efficacy trials of acupuncture in order that they are more likely to be conclusive and more meaningfully interpreted. Clinical trials of acupuncture must use an optimal form of treatment; this can be defined by examining standard texts, by surveying and consulting experts. There are a great many variables in treatment (such as point selection, form of stimulation) all of which need to be addressed in designing and reporting clinical trials. The control procedure is determined by the precise research question that is being addressed. For efficacy studies, in which the question is whether acupuncture has specific effects (i.e. is superior to placebo), sham forms of acupuncture appear the most appropriate method of controlling for needle penetration. A recent development of blunted, telescopic needles may represent a major advance. Such procedures may produce a therapeutic response so should preferably be recorded as 'sham' procedures rather than true 'placebo' controls. Blinding in clinical trials is an accepted means of reducing bias. Patient blinding in acupuncture studies can be achieved by sham procedures and its success should be measured. While practitioner blinding is difficult, though not impossible, blinding of the observer and the analyst should be considered as the ideal for all studies. A number of recommendations are made which aim to improve the quality of sham-controlled acupuncture studies.     

Acupuncture for chronic pain in Japan: a review

Many Japanese reports of acupuncture and moxibustion for chronic pain are not listed in medical databases such as Medline. Therefore, they are not easily accessible to researchers outside of Japan. To complement existing reviews of acupuncture and moxibustion for chronic pain and to provide more detailed discussion and analysis, we did a literature search using 'Igaku Chuo Zasshi Wed' (Japana Centra Revuo Medicina) and 'Citation Information by National Institute of Information' covering the period 1978-2006. Original articles and case reports of acupuncture and moxibustion treatment of chronic pain were included. Animal studies, surveys, and news articles were excluded. Two independent reviewers extracted data from located articles in a pre-defined structured way, and assessed the likelihood of causality in each case. We located 57 papers written in Japanese (20 full papers, 37 case reports). Conditions examined were headache (12 trials), chronic low back pain (9 trials), rheumatoid arthritis (8 trials), temporomandibular dysfunction (8 trials), katakori (8 trials) and others (12 trials). While 23 were described as clinical control trials (CCTs), 11 employed a quasi-random method. Applying the 5-point Jadad quality assessment scoring system, the mean score was 1.5 +/- 1.3 (SD). Eleven (52%) of the CCTs were conducted to determine a more effective procedure for acupuncture; these compared a certain type of acupuncture with another type of acupuncture or specific additional points. In particular, the trigger point acupuncture was widely used to treat chronic low back pain in Japan. Many reports of chronic pain treatment by acupuncture and moxibustion are listed in Japanese databases. From the data, we conclude that there is limited evidence that acupuncture is more effective than no treatment, and inconclusive evidence that trigger point acupuncture is more effective than placebo, sham acupuncture or standard care.     

The Short-Term Effects of Acupuncture on Myofascial Pain Patients After Clenching

Aim: Short‐term pain reduction from acupuncture in chronic myofascial pain subjects was evaluated using an 11‐point (0 to 10) numeric rating scale, visual analog scale (VAS), and pain rating of mechanical pressure on the masseter muscle. Methods: A single‐blind, randomized, controlled, clinical trial with an independent observer was performed. Fifteen chronic myofascial pain subjects over the age of 18 were randomly assigned into groups: nine subjects received real acupuncture; six subjects received sham acupuncture. Each subject clenched his/her teeth for 2 minutes. Acupuncture or sham acupuncture was administered at the Hegu Large Intestine 4 acupoint. Sham acupuncture was conducted by lightly pricking the skin with a shortened, blunted acupuncture needle through a foam pad, without penetrating the skin. The foam pad visually conceals the needle's point of the entry, so that the subject cannot discern which technique is being used. The subjects rated their general pain on a numeric rating scale. A mechanical pain stimulus was applied with an algometer and the subject rated his/her pain on a VAS. Statistical analysis was performed using the repeated measures anova , paired t‐tests, and Fisher's exact test as appropriate. Results: There was a statistically significant difference in pain tolerance with acupuncture (P = 0.027). There was statistically significant reduction in face pain (P = 0.003), neck pain (P = 0.011), and headache (P = 0.015) with perception of real acupuncture. Conclusion: Pain tolerance in the masticatory muscles increased significantly more with acupuncture than sham acupuncture.     

German Acupuncture Trials (gerac) address problems of methodology associated with acupuncture studies

OBJECTIVE: Conflicting or ambivalent findings on the effectiveness of body acupuncture in pain treatment are often attributed to flaws in study methodology. The paper describes the methodology used for the German Acupuncture Trials (gerac), which demonstrates that it is possible to design acupuncture studies in accordance with the standards of good clinical practice. METHOD: Approximately 1000 chronic pain sufferers per indication (migraine, tension-type headache, low back pain (cLBP), or gonarthrosis) are randomly allocated to one of three treatment groups (verum acupuncture, sham acupuncture, or established conservative therapy). Patients are blind to the type of acupuncture. All patients receive ten sessions of treatment (two per week) with an option of adding five more treatments in cases of slight but insufficient improvement (number of headache days or von Korff pain score). Participating physicians are in private practice, representing a variety of specialties. All have completed at least a 140-hour training course in acupuncture. Mandatory and optional verum and sham points are predefined. The point selection is individualized according to the criteria of traditional Chinese medicine (TCM). Primary outcome measures are number of headache days per month, von Korff Graded Chronic Pain Scale or Hannover Functional Ability Questionnaire (cLBP), or WOMAC scores (gonarthrosis). Data are assessed by trained telephone interviewers not involved in treatment and blind to types of acupuncture. PRESENT STATUS: Over 500 participating physicians in ten urban areas of Germany. Patient recruitment for cLBP and gonarthrosis was completed in November 2003 and March 2004 respectively. Recruitment for chronic headaches will be completed in autumn 2004. CONCLUSIONS: The gerac trials prove that it is possible to design and carry out acupuncture studies in accordance to stringent standards of methodology and clinical practice. The results will form a basis for the assessment of acupuncture effectiveness in Germany and abroad.     

The effectiveness of acupuncture in the management of persistent regional myofascial head and neck pain: A systematic review and meta-analysis

Persistent head and neck myofascial pain is among the most frequently reported pain complaints featuring major variability in treatment approaches and perception of improvement. Acupuncture is one of the least invasive complimentary modalities that can optimize conventional treatment. The aim of this review was to determine the evidence for the effectiveness of acupuncture in the management of localized persistent myofascial head and neck pain. Only randomized controlled clinical trials (RCTs) were included. The search was conducted in PubMed, Ovid Medline, Embase, Google Scholar, and Cochrane Library in addition to manual search. The main outcome measure was the comparison of the mean pain intensity score on VAS between acupuncture and sham-needling/no intervention groups. Safety data and adherence rate were also investigated. Six RCTs were identified with variable risk of bias. All included studies reported reduction in VAS pain intensity scores in the groups receiving acupuncture when compared to sham needling/no intervention. Meta-analysis, using a weighted mean difference as the effect estimate, included only 4 RCTs, revealed a 19.04 point difference in pain intensity between acupuncture and sham-needling/no intervention (95 %CI: -29.13 to -8.95). High levels of safety were demonstrated by the low rates of side effects/withdrawal. Inconsistency in reporting of outcomes was a major limitation. In conclusion, moderate-quality evidence suggests that acupuncture may be an effective and safe method in relieving persistent head and neck myofascial pain. Optimizing study designs and standardizing outcome measures are needed for future RCTs.     

Cost‐effectiveness of Acupuncture for Chronic Nonspecific Low Back Pain

Cost‐effectiveness is a major criterion underpinning decisions in mainstream health care. Acupuncture is increasingly used in patients with chronic lower back pain (LBP), but there is a lack of evidence on cost‐effectiveness. The objective of this study was to assess the cost‐effectiveness of acupuncture in alleviating chronic LBP either alone or in conjunction with standard care compared with patients receiving routine care, and/or sham. To determine effectiveness, we undertook meta‐analyses which found a significant improvement in pain in those receiving acupuncture and standard care compared with those receiving standard care alone. For acupuncture and standard care vs. standard care and sham, a weak positive effect was found for weeks 12 to 16, but this was not significant. For acupuncture alone vs. standard care alone, a significant positive effect was found at week 8, but not at weeks 26 or 52. The main outcome parameters for our cost‐effectiveness analysis were the incremental cost‐effectiveness ratio (ICER) of acupuncture treatment presented as cost (A$) per disability‐adjusted life‐year (DALY) saved. The WHO benchmark for a very highly cost‐effective intervention is one that costs less than gross domestic product per capita per quality‐adjusted life‐year (QALY) gained or DALY averted, or less than around $A52,000 in 2009 (the base year for the analysis). According to this threshold, acupuncture as a complement to standard care for relief of chronic LBP is highly cost‐effective, costing around $48,562 per DALY avoided. When comorbid depression is alleviated at the same rate as pain, cost is around $18,960 per DALY avoided. Acupuncture as a substitute for standard care was not found to be cost‐effective unless comorbid depression was included. According to the WHO cost‐effectiveness threshold values, acupuncture is a cost‐effective treatment strategy in patients with chronic LBP.     

Acupuncture as an adjunctive therapy to pharmacological treatment in patients with chronic pain due to osteoarthritis of the knee: a 3-armed, randomized, placebo-controlled trial

The efficacy of acupuncture as an adjunctive therapy to pharmacological treatment of chronic pain due to knee osteoarthritis was studied with a 3-armed, single-blind, randomized, sham-controlled trial; it compared acupuncture combined with pharmacological treatment, sham acupuncture including pharmacological treatment, and pharmacological treatment alone. A total of 120 patients with knee osteoarthritis were randomly allocated to 3 groups: group I was treated with acupuncture and etoricoxib, group II with sham acupuncture and etoricoxib, and group III with etoricoxib. The primary efficacy variable was the Western Ontario and McMaster Universities (WOMAC) index and its subscales at the end of treatment at week 8. Secondary efficacy variables included the WOMAC index at the end of weeks 4 and 12, a visual analogue scale (VAS) at the end of weeks 4, 8, and 12, and the Short Form 36 version 2 (SF-36v2) health survey at the end of week 8. An algometer was used to determine changes in a predetermined unique fixed trigger point for every patient at the end of weeks 4, 8, and 12. Group I exhibited statistically significant improvements in primary and secondary outcome measures, except for Short Form mental component, compared with the other treatment groups. We conclude that acupuncture with etoricoxib is more effective than sham acupuncture with etoricoxib, or etoricoxib alone for the treatment of knee osteoarthritis.     

Sham interventions in randomized clinical trials of acupuncture--a review

BACKGROUND AND OBJECTIVES: For non-drug interventions such as acupuncture, it is difficult to establish placebo or sham controls that are both inert and indistinguishable. We reviewed sham-controlled clinical trials of acupuncture to investigate (a) which types of sham interventions have been used in the past; (b) in what respects true and sham interventions differed; and (c) whether trials using different types of sham yielded different results. METHODS: 47 randomized controlled trials comparing true and sham acupuncture interventions for pain and a variety of other conditions were identified from systematic reviews and through a search in PubMed. Details of patients, interventions, sham interventions and outcomes were extracted in a standardized manner. RESULTS: In two trials the sham intervention consisted of superficial needling of the true acupuncture points, four trials used true acupuncture points which were not indicated for the condition being treated, in 27 trials needles were inserted outside true acupuncture points, five trials used placebo needles and nine trials used pseudo-interventions such as switched off-laser acupuncture devices. True and sham interventions often differed in a variety of other variables, such as manipulation of needles, depth of insertion, achievement of an irradiating needling sensation (de-chi), etc. There was no clear association between the type of sham intervention used and the results of the trials. CONCLUSION: Randomized trials investigating the specific effects of acupuncture have used a great variety of sham interventions as controls. Summarizing all the different sham interventions as "placebo" controls seems misleading and scientifically unacceptable.