Coherence 1/99
PLACEBO AND ACUPUNCTURE
ACUPUNCTURE: A REVIEW OF ITS HISTORY, THEORIES, AND INDICATIONS
Ceniceros S; Brown GR
Department of Psychiatry, East Tennessee State University, James H. Quillen College of Medicine, and James H. Quillen Veterans Administration Medical Center, Johnson City 37614, USA. South Med J, 91(12):1121-5, 1998 Dec.
BACKGROUND: The National Institutes of Health recently recommended acupuncture as an effective tool for the treatment of various health problems. Acupuncture is an old technique but has been popular in the United States only since 1972. Its history, theories, and indications are not well known to the medical community. METHODS: We reviewed the literature to gather information on the history, techniques, physiology, indications, adverse effects, and opposing views to acupuncture. RESULTS: The mechanism by which acupuncture works involves neurotransmitters and adrenocorticotropic hormones. It appears to be effective in the treatment of pain, nausea, and drug detoxification and in stroke victims. Studies suggest acupuncture is no more effective than placebo. Acupuncture side effects have rarely been reported. CONCLUSIONS: Acupuncture appears to be a safe and effective alternative medical therapy for certain health problems. More controlled research is necessary to better understand the range of its clinical application.
A CONTROLLED TRIAL OF ACUPUNCTURE IN PSORIASIS: NO CONVINCING EFFECT
Jerner B; Skogh M; Vahlquist A
Department of Dermatology, Linköping University, Sweden. Acta Derm Venereol, 77(2):154-6, 1997 Mar.
Several uncontrolled studies have suggested that acupuncture is an effective treatment for psoriasis. To test this hypothesis, 56 patients suffering from long-standing plaque psoriasis were randomized to receive either active treatment (electrostimulation by needles placed intramuscularly, plus ear-acupuncture) or placebo (sham, 'minimal acupuncture') twice weekly for 10 weeks. The severity of the skin lesions was scored (PASI) before, during, and 3 months after therapy. After 10 weeks of treatment the PASI mean value had decreased from 9.6 to 8.3 in the 'active' group and from 9.2 to 6.9 in the placebo group (p < 0.05 for both groups). These effects are less than the usual placebo effect of about 30%. There were no statistically significant differences between the outcomes in the two groups during or 3 months after therapy. The patient's own opinion about the results showed no preference for 'active' therapy. It was also clear from the answers that the blinded nature of the study had not been discovered by the patients. In conclusion, classical acupuncture is not superior to sham (placebo) 'minimal acupuncture' in the treatment of psoriasis.
METHODOLOGICAL AND ETHICAL ISSUES IN CLINICAL TRIALS OF ACUPUNCTURE
Hammerschlag R
Yo San University of Traditional Chinese Medicine, Santa Monica, California 90401, USA. J Altern Complement Med, 4(2):159-71, 1998 Summer.
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.
SYMPATHETIC NERVE ACTIVITY AFTER ACUPUNCTURE IN HUMANS
Knardahl S; Elam M; Olausson B; Wallin BG
Department of Clinical Neurophysiology, Sahlgrenska University Hospital, University of Göteborg, Sweden. Pain, 75(1):19-25, 1998 Mar.
The aim of the present study was to determine if acupuncture stimulation inhibits sympathetic nerve activity in humans. Multiunit efferent postganglionic sympathetic activity was recorded with a tungsten microelectrode inserted in a muscle fascicle of the peroneal nerve. Mean arterial pressure, heart rate and skin blood flow were also monitored. Pain thresholds were measured by electrical tooth pain stimulation. After a 30 min rest, acupuncture needles were inserted bilaterally into the Li 11 and the Li 4 acupuncture points, and manipulated until 'chi' cramp-like sensation was reported. Electrical stimulation (2 Hz, 0.6-0.8 ms duration, maximal tolerated stimulation without discomfort) was delivered for 30 min and the physiological recordings were continued for 90 min after the end of acupuncture. In a placebo control experiment, the same procedure was followed, except that acupuncture needles were inserted subcutaneously and no manipulation or stimulation was given. The stimulator delivered pulses to an unconnected channel, hence, the same audiovisual stimuli were experienced as with acupuncture, and care was taken to ask the same questions about sensations in the placebo and the acupuncture groups. Electroacupuncture produced an increase in pain threshold which was paralleled by a transient increase in muscle sympathetic nerve activity. During acupuncture, there was a small increase in heart rate and mean arterial pressure, but there was no post-acupuncture hypotension. The placebo control procedure did not change pain threshold or sympathetic nerve traffic. The findings suggest that electroacupuncture produces moderate hypoalgesia in humans paralleled by a significant increase in muscle sympathetic nerve activity.
ACUPUNCTURE AND AMITRIPTYLINE FOR PAIN DUE TO HIV-RELATED PERIPHERAL NEUROPATHY: A RANDOMIZED CONTROLLED TRIAL
Shlay JC; Chaloner K; Max MB; Flaws B; Reichelderfer P; Wentworth D; Hillman S; Brizz B; Cohn DL
Denver Community Programs for Clinical Research on AIDS, Colo, USA. JAMA, 280(18):1590-5, 1998 Nov 11.
CONTEXT: Peripheral neuropathy is common in persons infected with the human immunodeficiency virus (HIV) but few data on symptomatic treatment are available. OBJECTIVE: To evaluate the efficacy of a standardized acupuncture regimen (SAR) and amitriptyline hydrochloride for the relief of pain due to HIV-related peripheral neuropathy in HIV-infected patients. DESIGN: Randomized, placebo-controlled, multicenter clinical trial. Each site enrolled patients into 1 of the following 3 options: (1) a modified double-blind 2 x 2 factorial design of SAR, amitriptyline, or the combination compared with placebo, (2) a modified double-blind design of an SAR vs control points, or (3) a double-blind design of amitriptyline vs placebo. SETTING: Terry Beirn Community Programs for Clinical Research on AIDS (HIV primary care providers) in 10 US cities. PATIENTS: Patients with HIV-associated, symptomatic, lower-extremity peripheral neuropathy. Of 250 patients enrolled, 239 were in the acupuncture comparison (125 in the factorial option and 114 in the SAR option vs control points option), and 136 patients were in the amitriptyline comparison (125 in the factorial option and 11 in amitriptyline option vs placebo option). INTERVENTIONS: Standardized acupuncture regimen vs control points, amitriptyline (75 mg/d) vs placebo, or both for 14 weeks. MAIN OUTCOME MEASURE: Changes in mean pain scores at 6 and 14 weeks, using a pain scale ranging from 0.0 (no pain) to 1.75 (extremely intense), recorded daily. RESULTS: Patients in all 4 groups showed reduction in mean pain scores at 6 and 14 weeks compared with baseline values. For both the acupuncture and amitriptyline comparisons, changes in pain score were not significantly different between the 2 groups. At 6 weeks, the estimated difference in pain reduction for patients in the SAR group compared with those in the control points group (a negative value indicates a greater reduction for the "active" treatment) was 0.01 (95% confidence interval [CI], -0.11 to 0.12; P=.88) and for patients in the amitriptyline group vs those in the placebo group was -0.07 (95% CI, -0.22 to 0.08; P=.38). At 14 weeks, the difference for those in the SAR group compared with those in the control points group was -0.08 (95% CI, -0.21 to 0.06; P=.26) and for amitriptyline compared with placebo was 0.00 (95% CI, -0.18 to 0.19; P=.99). CONCLUSIONS: In this study, neither acupuncture nor amitriptyline was more effective than placebo in relieving pain caused by HIV-related peripheral neuropathy.
INTRODUCING A PLACEBO NEEDLE INTO ACUPUNCTURE RESEARCH
Streitberger K; Kleinhenz J
Clinic of Anesthesiology, University of Heidelberg, Germany. Lancet, 352(9125):
364-5, 1998 Aug 1.
BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: The placebo needle is sufficiently credible to be used in investigations of the effects of acupuncture.
DO CERTAIN COUNTRIES PRODUCE ONLY POSITIVE RESULTS? A SYSTEMATIC REVIEW OF CONTROLLED TRIALS
Vickers A; Goyal N; Harland R; Rees R
Research Council for Complementary Medicine, London, UK. Source Control Clin Trials, 19(2):159-66, 1998 Apr.
OBJECTIVE: To determine whether clinical trials originating in certain countries always have positive results. DATA SOURCES: Abstracts of trials from Medline (January 1966-June 1995). STUDY SELECTION: Two separate studies were conducted. The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo, no treatment, or a nonacupuncture intervention. In the second study, randomized or controlled trials of interventions other than acupuncture that were published in China, Japan, Russia/USSR, or Taiwan were compared to those published in England. DATA EXTRACTION: Blinded reviewers determined inclusion and outcome and separately classified each trial by country of origin. DATA SYNTHESIS: In the study of acupuncture trials, 252 of 1085 abstracts met the inclusion criteria. Research conducted in certain countries was uniformly favorable to acupuncture; all trials originating in China, Japan, Hong Kong, and Taiwan were positive, as were 10 out of 11 of those published in Russia/USSR. In studies that examined interventions other than acupuncture, 405 of 1100 abstracts met the inclusion criteria. Of trials published in England, 75% gave the test treatment as superior to control. The results for China, Japan, Russia/USSR, and Taiwan were 99%, 89%, 97%, and 95%, respectively. No trial published in China or Russia/USSR found a test treatment to be ineffective. CONCLUSIONS: Some countries publish unusually high proportions of positive results. Publication bias is a possible explanation. Researchers undertaking systematic reviews should consider carefully how to manage data from these countries.