Acupuncture is the centuries-old practice of inserting needles into predetermined locations. In the traditional Chinese explanation for the efficacy of acupuncture, the movement of chi, or vital energy, along channels called meridians is influenced by the placement of the needles. An imbalance in the flow of chi can be redressed by certain needle placements, depending on the ailment being treated, and may improve health and well-being. In the Western medical tradition, it is recognized that one explanation, although incomplete, of the efficacy of acupuncture may be that needle placement stimulates the production of endogenous opioids. Inadequate understanding of the mechanism of action of acupuncture, however, is not as much of an impediment to systematic study as is the very nature of the intervention. Deciding what an appropriate control is (Can an intervention that does not use needles provide adequate control? Where should control needles be placed? How many? For how long?) has an important bearing on interpretation and comparison of trials. Regardless of the availability of scientific appraisal of acupuncture, about 1 million consumers in the United States seek treatment each year.
Recently, a few blinded randomized trials have been done to assess the efficacy of acupuncture. A study was done that blindly randomized patients with symptomatic knee OA, to two groups (each with 34 patients). One group received acupuncture and the other non-penetrating sham acupuncture; patients who received acupuncture had an improved WOMAC pain score, however, the improvement was short-term only.
Another single blinded study was done in 193 outpatients with OA of the knee. Participants were randomized into four groups: placebo, diclofenac, electroacupuncture and combined electroacupuncture and diclofenac. There was a significant improvement in WOMAC pain index between the combined and placebo group; there was also an improvement in the visual analogue scale between the electroacupuncture group and the placebo group as well as the electroacupuncture group compared to the diclofenac group. Another randomized, controlled, single-blinded trial compared 97 patients split into two groups: one received diclofenac and acupuncture and the other received diclofenac and placebo acupuncture. The WOMAC index presented a greater reduction in the intervention group than in the control group. The same was observed in the pain visual analogue scale. One acupuncture trial randomized 44 patients with rheumatoid arthritis to receive electroacupuncture or autogenic training for 6 weeks. There was a significant improvement in the acupuncture group in the mean weekly pain intensity, disease activity score 28, use of pain medications, pain disability index, clinical global impression, and pro-inflammatory cytokine levels. On the other hand, two larger studies showed different results. One study compared acupuncture with sham acupuncture. Acupuncture was not shown to be superior to sham acupuncture with outcomes targeting pain and WOMAC index. The study involved 455 patients and 72 controls. Acupuncturists were trained to interact in one of two communication styles, high or neutral expectations, and patients were randomized to one of three style groups, waiting list, high, or neutral, and nested within style. The other study was a randomized controlled trial, that included three groups of patients: group one included 116 patients who received advice about OA and exercise program; the second group included 117 patients who received advice, exercise, and true acupuncture; and the last group included 119 patients who received exercise, advice, and non-penetrating acupuncture. Outcomes included WOMAC index; function; pain intensity; unpleasantness of pain at 2 weeks, 6 weeks, 6 months, and 12 months. The addition of acupuncture to advice and exercise for OA of the knee delivered by physiotherapists provided no significant additional improvement in pain scores. One shared weakness in these studies is sample size in addition to study lengths. Encouraging results though should motivate the design of new, large, prospective randomized controlled trials.
No individual trials have been adequately designed to address the efficacy of acupuncture in pain control in rheumatic diseases. However, a huge number of trials have been performed for a wide variety of painful conditions over many decades using many different types of controls. At least eight Cochrane reviews of acupuncture trials for pain have been performed.
The most recent Cochrane Database Systematic Review of acupuncture for OA involved 16 trials with 3498 participants, most with knee OA. The authors predefined thresholds for clinical relevance in outcome measure and were not able to demonstrate that the studies met them even though the short-term improvements in pain and function reported were statistically significant. In addition, when they restricted their analysis to sham-controlled trials using shams judged most likely to adequately blind participants to treatment assignment (which were also the same shams judged most likely to have physiologic activity), pooled short-term benefits of acupuncture were smaller and non-significant. The authors believe that what little benefit was shown was likely the result of placebo effect due to incomplete blinding. Wait list-controlled trials showed greater improvements due to acupuncture than sham-controlled trials. Acupuncture as an adjuvant to an exercise-based physiotherapy program did not result in any greater improvements than the exercise program alone.
Acupuncture has been used in several trials as a therapy for the pain of fibromyalgia. A systematic review identified seven randomized, controlled trials that treated 385 patients over a mean of nine acupuncture treatments. There was a great variability of the methodologic quality of the studies evaluated. The investigators found that when ascertainment bias and lack of blinding were minimized, acupuncture was less likely to be found to be of analgesic benefit. For instance, trials with individual selection of acupuncture points, with electrostimulation and less than 10 sessions had significant effects on pain at post-treatment, but not studies with standardized selection of acupuncture points, manual stimulation, and more than 10 sessions. Furthermore, no studies supported a role for acupuncture in mitigating fatigue, sleep disturbance, or poor functioning.
Few trials have addressed the use of acupuncture in rheumatoid arthritis. A systematic review of eight available studies in which 536 participants were treated showed that six demonstrated reductions in pain but not stiffness. Though reductions in erythrocyte sedimentation rate were demonstrated in five studies, the mean change was a fall of only 3.9 mm/h. Evidence was judged to be conflicting in the placebo-controlled trials.
Despite the fact that trials in patients with rheumatic diseases have affirmed the safety of acupuncture, occasional adverse events due to acupuncture have been documented and include rare instances of pneumothorax, cardiac tamponade, spinal injuries, septic complications, and hepatitis C. However, a considerable amount of evidence supports the safety of acupuncture. A survey was conducted of preceptors and interns at a Japanese national medical facility at which about 60% of the patients undergo acupuncture. Results were compiled over 55,000 acupuncture treatments, and 64 adverse events were identified. The most frequent was failure to remove the needle after the procedure was completed. Almost as common were dizziness, discomfort, and perspiration thought to be associated with a transient vasovagal episode. Less common side effects were burn injuries due to moxibustion, ecchymoses, and needling site reactions. A systematic review of the literature revealed a similar safety record. Nine prospective surveys encompassing over 250,000 acupuncture treatments were reviewed. Minor side effects were common. These included pain at the site of needling and pain due to aggravation of the presenting condition that occurred in up to half of those undergoing acupuncture. Postprocedure fatigue was noted in up to about 40%; an unusual feeling of relaxation (characterized by some as necessary for efficacy) was seen in over 80%. Minor bleeding was seen in up to about 40% as well. Fainting was reported in less than 0.2%. Serious side effects reported included two cases of pneumothorax and two cases in which needles needed to be retrieved surgically after they fractured.
Tai chi is a centuries-old Chinese form of conditioning exercise based in martial arts traditions and consisting of slow, flowing movements, relaxation, and deep breathing. The aim of the practice is balance of mind and body by stimulating chi. Tai chi involves cognitive, cardiovascular, and musculoskeletal responses that evoke physiologic and psychological changes including maximum oxygen consumption, muscular strength, and flexibility. Early studies encouraged enthusiasm for tai chi as an intervention for geriatric patients since these small trials suggested that improvements in balance and fall prevention could follow training in tai chi. A study of 72 patients with OA showed that a 12-week program held three times weekly improved WOMAC scores for pain and function. On physical fitness testing, subjects demonstrated enhanced balance and abdominal muscle strength. A more recent trial of 40 subjects with a mean age of 65 and a mean body mass index of 30 also noted improvements in pain and function for this group with knee OA. Sixty minutes of tai chi twice weekly for 12 weeks was associated with increased improvements in WOMAC scores, as well as chair stand time and measures of self-efficacy and depression. No serious side effects of tai chi have been reported. In a randomized clinical trial of 152 older patients with chronic and symptomatic hip and knee OA, investigators found that when compared with a waiting list control group, both hydrotherapy and tai chi classes groups provided large sustained improvements both at 12 weeks. Another study was done to evaluate 41 adults with knee OA. This was a tai chi program that is 6 weeks long, followed by 6 weeks of home tai chi. Compared to baseline, the tai chi group showed significant improvements in mean overall knee pain, maximum knee pain, and WOMAC subscales of physical function and stiffness.
In a study of 40 individuals with symptomatic knee OA, patients were randomly assigned to 60 minutes of tai chi group or to an attention control group, both for 12 weeks. The primary outcome was the WOMAC pain score at 12 weeks. The tai chi group showed a significantly better improvement in WOMAC pain, physical function, self-efficacy, depression, and health-related quality of life for knee OA.
One single-blinded study compared the classic Yang-style tai chi with a control intervention consisting of wellness education and stretching in patients with fibromyalgia patients. This study, although small, did show significant improvement in Fibromyalgia Impact Questionnaire score, and the Short-Form Health Survey (SF-36). This result is very exciting and merits a long-term study in a larger sample.
The role of tai chi in patients with rheumatoid arthritis has not been studied extensively. One trial randomized 20 patients to tai chi or attention control in twice-weekly sessions for 12 weeks. At 12 weeks, 50% of patients randomized to tai chi achieved an ACR 20 response compared with 0% in the control group. The tai chi group had a greater improvement in the disability index, vitality subscale of the Medical Outcome Study short form 36, and the depression index. There are no large double-blinded placebo-controlled trials of tai chi in rheumatoid arthritis, although the results of this study should encourage such trial.
Yoga derives from a more than 2000-year-old Indian tradition based on eight branches of practice, including postures (asanas), breathing, and meditation. The aim of hatha yoga, or the practice of asanas, is to prepare the practitioner for the spiritual experience of purifying the body. The ultimate goal of this practice is the achievement of harmony in body, mind, and spirit. A number of studies have attempted to quantify physiologic effects of yoga and found reductions in oxygen consumption, minute ventilation, and heart rate after exercise in persons participating in regular yoga practice.
Small studies have suggested that yoga may be efficacious for a variety of musculoskeletal conditions, but all studies to date have methodologic limitations that reduce their generalizability. Nonetheless, the trials that have been carried out support a role for yoga in reducing pain and increasing function. Persons with carpal tunnel syndrome participated in an 8-week yoga program and had significant improvements in grip strength and pain. A study of the effects of a 10-week course of yoga for symptoms of OA of the hands showed reductions in finger joint tenderness and range of motion and hand pain during activity. A more recent trial has suggested that yoga represents an exercise alternative for even obese patients with OA of the knee who are not regular exercisers. Reductions in pain and functional disability using WOMAC scores were demonstrated in a group who completed an 8-week yoga program.
A study to examine whether the physical function in women with rheumatoid arthritis can be altered through a yoga intervention included sixteen independently living, postmenopausal women with rheumatoid arthritis. The group participated in three 75-minute yoga classes a week over a 10-week period. Results showed significantly decreased Health Assessment Questionnaire (HAQ) disability index, decreased perception of pain and depression, and improved balance.
An ongoing study is evaluating the use of yoga in rheumatoid arthritis patients. This study is comparing 70 patients who are split into two groups: one is randomized to receive a 6 week yoga program and the other group is randomized to a 6-week wait-list control condition. The second group will participate in the yoga program following completion the first arm of the study. Data will be collected quantitatively using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. No serious side effects have been reported in the trials assessing yoga for musculoskeletal complaints. There have been rare reports of reversible compression neuropathy after 6 hours of kneeling and very rare instances of vertebral and basilar artery occlusion after neck standing and prolonged flexion of the cervical spine. There is also a report of isolated rupture of the lateral collateral ligament during yoga practice.
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