Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture.

The nonspecific effects of acupuncture are well documented; we wished to quantify these factors in osteoarthritic (OA) pain, examining needling, the consultation, and the practitioner. In a prospective randomised, single-blind, placebo-controlled, multifactorial, mixed-methods trial, 221 patients with OA awaiting joint replacement surgery were recruited. Interventions were acupuncture, Streitberger placebo acupuncture, and mock electrical stimulation, each with empathic or nonempathic consultations. Interventions involved eight 30-minute treatments over 4 weeks. The primary outcome was pain (VAS) at 1 week posttreatment. Face-to-face qualitative interviews were conducted (purposive sample, 27 participants). Improvements occurred from baseline for all interventions with no significant differences between real and placebo acupuncture (mean difference -2.7 mm, 95% confidence intervals -9.0 to 3.6; P=.40) or mock stimulation (-3.9, -10.4 to 2.7; P=.25). Empathic consultations did not affect pain (3.0mm, -2.2 to 8.2; P=.26) but practitioner 3 achieved greater analgesia than practitioner 2 (10.9, 3.9 to 18.0; P=.002). Qualitative analysis indicated that patients' beliefs about treatment veracity and confidence in outcomes were reciprocally linked. The supportive nature of the trial attenuated differences between the different consultation styles. Improvements occurred from baseline, but acupuncture has no specific efficacy over either placebo. The individual practitioner and the patient's belief had a significant effect on outcome. The 2 placebos were equally as effective and credible as acupuncture. Needle and nonneedle placebos are equivalent. An unknown characteristic of the treating practitioner predicts outcome, as does the patient's belief (independently). Beliefs about treatment veracity shape how patients self-report outcome, complicating and confounding study interpretation.

Meta-analysis of the related nutritional supplements dimethyl sulfoxide and methylsulfonylmethane in the treatment of osteoarthritis of the knee.

Dimethyl sulphoxide and methylsulfonylmethane are two related nutritional supplements used for symptomatic relief of osteoarthritis (OA). We conducted a meta-analysis to evaluate their efficacy in reducing pain associated with OA. Randomized or quasi-randomized controlled trials (RCTs), identified by systematic electronic searches, citation tracking and searches of clinical trial registries, assessing these supplements in osteoarthritis of any joint were considered for inclusion. Meta-analysis, based on difference in mean pain related outcomes between treatment and comparator groups, was carried out based on a random effect model. Seven potential trials were identified of which three RCTs, two DMSO and one MSM (total N = 326 patients) were eligible for inclusion. All three trials were considered high methodological quality. A significant degree of heterogeneity (χ(2) = 6.28, P = .043) was revealed. Two studies demonstrated statistically significant (but not clinically relevant) reduction in pain compared with controls; with one showing no group difference. The meta-analysis confirmed a non significant reduction of pain on visual analogue scale of 6.34 mm (SE = 3.49, 95% CI, -0.49, 13.17). The overall effect size of 1.82 was neither statistically nor clinically significant. Current evidence suggests DMSO and MSM are not clinically effective in the reduction of pain in the treatment of OA. No definitive conclusions can currently be drawn from the data due to the mixed findings and the use of inadequate dosing periods.

Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial.

OBJECTIVES: To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both. METHODS: Exploratory double-blind, randomized placebo-controlled trial conducted from January 2008 to July 2008, in patients with active stable RA receiving conventional therapy. Eighty-three participants from three secondary care UK outpatient clinics were randomized to 24 weeks of treatment with either homeopathic consultation (further randomized to individualized homeopathy, complex homeopathy or placebo) or non-homeopathic consultation (further randomized to complex homeopathy or placebo). Co-primary outcomes: ACR 20% improvement (ACR20) criteria and patient monthly global assessment (GA). SECONDARY OUTCOMES: 28-joint DAS (DAS-28), tender and swollen joint count, disease severity, pain, weekly patient and physician GA and pain, and inflammatory markers. RESULTS: Fifty-six completed treatment phase. No significant differences were observed for either primary outcome. There was no clear effect due to remedy type. Receiving a homeopathic consultation significantly improved DAS-28 [mean difference 0.623; 95% CI 0.1860, 1.060; P = 0.005; effect size (ES) 0.70], swollen joint count (mean difference 3.04; 95% CI 1.055, 5.030; P = 0.003; ES 0.83), current pain (mean difference 9.12; 95% CI 0.521, 17.718; P = 0.038; ES 0.48), weekly pain (mean difference 6.017; 95% CI 0.140, 11.894; P = 0.045; ES 0.30), weekly patient GA (mean difference 6.260; 95% CI 0.411, 12.169; P = 0.036; ES 0.31) and negative mood (mean difference - 4.497; 95% CI -8.071, -0.923; P = 0.015; ES 0.90). CONCLUSION: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA. TRIAL REGISTRATION: Current controlled trials, http://www.controlled-trials.com/, ISRCTN09712705.

Effectiveness of distant healing for patients with chronic fatigue syndrome: a randomised controlled partially blinded trial (EUHEALS).

BACKGROUND: Distant healing, a form of spiritual healing, is widely used for many conditions but little is known about its effectiveness. METHODS: In order to evaluate distant healing in patients with a stable chronic condition, we randomised 409 patients with chronic fatigue syndrome (CFS) from 14 private practices for environmental medicine in Germany and Austria in a two by two factorial design to immediate versus deferred (waiting for 6 months) distant healing. Half the patients were blinded and half knew their treatment allocation. Patients were treated for 6 months and allocated to groups of 3 healers from a pool of 462 healers in 21 European countries with different healing traditions. Change in Mental Health Component Summary (MHCS) score (SF-36) was the primary outcome and Physical Health Component Summary score (PHCS) the secondary outcome. RESULTS: This trial population had very low quality of life and symptom scores at entry. There were no differences over 6 months in post-treatment MHCS scores between the treated and untreated groups. There was a non-significant outcome (p = 0.11) for healing with PHCS (1.11; 95% CI -0.255 to 2.473 at 6 months) and a significant effect (p = 0.027) for blinding; patients who were unblinded became worse during the trial (-1.544; 95% CI -2.913 to -0.176). We found no relevant interaction for blinding among treated patients in MHCS and PHCS. Expectation of treatment and duration of CFS added significantly to the model. CONCLUSIONS: In patients with CFS, distant healing appears to have no statistically significant effect on mental and physical health but the expectation of improvement did improve outcome.

Should we recruit patients or healthy volunteers for acupuncture studies of chronic pain?

OBJECTIVE: The aim of this study was to compare the results of healthy volunteers with patients in chronic pain, in terms of acupuncture needle sensation. The search for a credible mechanism that underpins the effect of acupuncture in pain has recently involved the use of brain imaging techniques in an attempt to identify the neural correlates involved in pain control. Such studies have usually enrolled healthy participants rather than patients. This practice might be inappropriate as we are unsure if we can generalize from healthy volunteers to patients in chronic pain. METHOD: This paper describes a comparison of data obtained from 2 small randomized controlled studies, 1 involving patients with chronic pain and the other which recruited healthy volunteers. Both studies used real acupuncture and a nonpenetrating "placebo" needle in a crossover design. The outcome studied in this paper was a comprehensive needling sensation questionnaire. RESULTS: There was a difference in the sensations experienced by patients as compared with healthy volunteers. Patients tended to feel much stronger sensation. Neither group differed in distinguishing between real and placebo needling. However, patients were more likely to state that both needles were real, whereas healthy participants were more likely to suggest that neither were real. DISCUSSION: It is concluded that if the nature of the sensation felt is of importance, then it might be inappropriate to recruit healthy volunteers in lieu of patients and a larger study is required to clarify this.

Acupuncture versus placebo for the treatment of chronic mechanical neck pain: a randomized, controlled trial.

BACKGROUND: Despite substantial increases in its popularity and use, the efficacy of acupuncture for chronic mechanical neck pain remains unproved. OBJECTIVE: To compare acupuncture and placebo for neck pain. DESIGN: A randomized, single-blind, placebo-controlled, parallel-arm trial with 1-year follow-up. SETTING: The outpatient departments of 2 major hospitals in the United Kingdom, 1999 to 2001. PATIENTS: 135 patients 18 to 80 years of age who had chronic mechanical neck pain. Eleven patients withdrew from treatment, and 124 completed the primary end point. MEASUREMENTS: The primary outcome was pain 1 week after treatment, according to a visual analogue scale. Secondary outcomes were pain at other time points, score on the Neck Disability Index and the Short Form-36, and use of analgesic medications. INTERVENTIONS: Patients were randomly assigned to receive, over 4 weeks, 8 treatments with acupuncture or with mock transcutaneous electrical stimulation of acupuncture points using a decommissioned electroacupuncture stimulation unit. RESULTS: Both groups improved statistically from baseline, and acupuncture and placebo had similar credibility. For the primary outcome (weeks 1 to 5), a statistically significant difference in visual analogue scale score in favor of acupuncture (6.3 mm [95% CI, 1.4 to 11.3 mm]; P = 0.01) was observed between the 2 study groups, after adjustment for baseline pain and other covariates. However, this difference was not clinically significant because it demonstrated only a 12% (CI, 3% to 21%) difference between acupuncture and placebo. Secondary outcomes showed a similar pattern. LIMITATIONS: All treatments were provided by 1 practitioner. Although the control was credible, it did not mimic the process of needling. A nonintervention group was not present to control for regression to the mean. CONCLUSIONS: Acupuncture reduced neck pain and produced a statistically, but not clinically, significant effect compared with placebo. The beneficial effects of acupuncture for pain may be due to both nonspecific and specific effects.

The core outcomes for neck pain: validation of a new outcome measure.

STUDY DESIGN: Patients enrolled in a randomized controlled trial were asked to complete various questionnaires, which were then compared to establish validity for a new neck pain questionnaire. OBJECTIVES: To validate a new and brief outcome measure for use with patients with mechanical neck pain. SUMMARY OF BACKGROUND DATA: Neck pain is a very common problem and one that clinicians will be required to treat with some regularity. In today's climate of evidence-based practice and the need to quantify and justify clinical intervention, a quick and easy method to evaluate progress is required. Such a measure has already been produced for those experiencing back pain, but as yet, there is no such measure for neck pain and this needs to be addressed. METHODS: The back pain measure was adapted to enable its use with patients with neck pain. Repeatability was assessed by using a 1-week test/retest on 104 patients who were enrolled in a neck pain trial. Validity was assessed by comparing the new questionnaire against other already well validated measures (i.e., the Neck Disability Index and a Visual Analogue Scale for pain) with 133 patients. RESULTS: The test/retest showed excellent repeatability with high intraclass correlations and P < 0.001 for each question tested. The Core Neck Pain Questionnaire also showed good validity, giving close agreement to the other comparison measures. CONCLUSION: The short Core Neck Pain Questionnaire has been demonstrated to be repeatable and valid as a brief outcome measure for use with patients with mechanical neck pain.

The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trial.

The issue of what constitutes an effective and realistic acupuncture placebo control has been a continuing problem for acupuncture research. In order to provide an effective placebo, the control procedure must be convincing, visible and should mimic, in all respects, apart from a physiological effect, the real active treatment. The 'Streitberger' needle might fulfil these criteria and this paper reports on a validation study. This was a single-blind, randomised, cross-over pilot study. Patients were drawn from the orthopaedic hip and knee, joint replacement waiting list. Intervention consisted of either 2 weeks of treatment with real acupuncture followed by 2 weeks on placebo, or vice versa. The prime outcome was a needle sensation questionnaire and there was a range of secondary outcomes. Thirty-seven patients were randomised and completed treatment. Groups were well balanced at baseline. No significant differences between groups or needle types were found for any of the sensations measured. Most patients were unable to discriminate between the needles by penetration; however, nearly 40% were able to detect a difference in treatment type between needles. No major differences in outcome between real and placebo needling could be found. The fact that nearly 40% of subjects did not find that the two interventions were similar, however, raises some concerns with regard to the wholesale adoption of this instrument as a standard acupuncture placebo. Further work on inter-tester reliability and standardisation of technique is highly recommended before we can be confident about using this needle in further studies.