Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2003; 8: 9–13
Fibromyalgia syndrome (FMS) is a condition in which diffuse pain is associated with fatigue, functional impairment and disrupted sleep. It is a diagnosis that is applied to a significant subgroup of patients with chronic widespread musculoskeletal pain – a condition that affects about 12% of the UK population.1 Once this subgroup was found to have a characteristic EEG pattern, suggesting a discrete disease entity, a set of clinical criteria was developed by a consensus group of the American College of Rheumatology in 1990.2 These include pain in the axial region, on both sides of the body and both above and below the waist, for 3 months or more, provided that tenderness can be elicited by palpation at 11 or more of 18 defined tender point sites. The use of these criteria allows fibromyalgia to be diagnosed with a sensitivity of nearly 90% and a specificity of over 80%.2
However, some rheumatologists remain unconvinced that the criteria are clinically useful. This view may be partly a reaction to the vague diagnostic label of ‘fibrositis’. It takes an effort to differentiate fibromyalgia from ‘myofascial pain’ and ‘chronic fatigue syndrome’ (diagnoses that are also distrusted by some). These reservations are supported by the finding of one survey that 60% of patients with chronic widespread pain had fewer than 11 tender points, and that women generally had more tender points than men regardless of pain status.1 Moreover, there is no clear fundamental biological cause for FMS. Changes in various physiological parameters have been observed, and recently it has been established that the condition involves amplification of pain signals. Functional magnetic resonance imaging (MRI) investigations show that the brain’s response to pressure is twice as marked in FMS patients than in healthy controls.3 As has been commented,4 it is possible that these changes may be the result rather than associated with the cause. In addition, one can argue that a diagnostic label serves little useful purpose when there is no effective treatment. Existing treatments are mainly pharmacological, including antidepressants, and are disappointing.
Despite these reservations, the criteria for FMS have been useful for defining homogeneous populations of patients for the purpose of clinical studies. When interpreting trials, failure to always apply the criteria, and problems with generalisability should be borne in mind. The targets of treatment should be management of pain and restoration of function: many studies use muscle tenderness as the endpoint, which has less clear clinical relevance. Function is best assessed by use of the disease-specific Fibromyalgia Impact Questionnaire (FIQ).5
Patients with fibromyalgia commonly use complementary and alternative medicine (CAM). One survey found that 91% had used CAM, compared with 63% for patients with other rheumatic conditions.6 The CAM therapies frequently used include massage, dietary therapies, vitamins and herbs, relaxation and imagery, spirituality/praying, acupressure, acupuncture, biofeedback and meditation.7 Twenty-five RCTs have recently been systematically reviewed8 with an overall comment that the average methodological score was below 50% and the median group size was only 20, which risks missing genuine differences. Many studies compare one unorthodox treatment with another of unknown effectiveness, so no meaningful conclusions can be drawn. Some of the therapies reviewed here are regarded by some people as conventional.
In one good quality RCT,9 70 subjects were randomised to genuine or sham electro-acupuncture (EA). The experimental group was treated at two peripheral points and up to six other points near the most painful sites, and the intensity of the EA was sufficient to cause muscle contraction. Controls received EA at just perceptible levels, to needles inserted superficially into non-points 20 mm away from the points that would have been used in their case. Treatments were given twice weekly for 3 weeks. Evaluation was by questionnaires, including pain scores by region, sleep quality, and morning stiffness, and by a ‘masked’ physician who assessed the overall condition and measured pain threshold. In the EA group, two patients withdrew because of an increase in symptoms, and three because of the unpleasantness of needle insertion. In the control group, four withdrew because of an increase in symptoms and one because of unpleasantness of needle insertion. Patients in the acupuncture group improved significantly on all parameters except morning stiffness; 25% of subjects improved markedly, 50% had satisfactory relief of symptoms and 25% had no benefit. The response in the acupuncture group was significantly superior to that of the placebo group in five out of eight measures. One serious limitation of the study is that there was no follow-up period.
In two other RCTs of acupuncture, neither patients nor assessor were blinded. One study of 42 patients used three groups: acupuncture, antidepressants and both treatments.10 Patients in the acupuncture group showed significant improvements in pain relief, pain threshold and depression but not sleep quality. The combined group improved on all measures. No between-group comparison was performed. The benefit was maintained, although diminished, after 6 months. A second small study in 37 patients found acupuncture to be significantly superior to a placebo (inactivated laser treatment for pain intensity, localised pain rating and pain threshold).11
A systematic review of the evidence for acupuncture treatment of FMS concluded that the limited amount of evidence suggested that it is effective, although the duration of effect is unknown, but that further high-quality RCTs are needed to provide more robust data.12 These, and other authors refer to the risk that acupuncture may exacerbate symptoms of FMS.
A behavioural intervention focusing on diverse pain coping skills was compared with an educational control condition in an RCT involving 86 patients; both were given once a week for 10 weeks. Both groups showed statistically significant improvements in self-reported and observed pain behaviour, depression, myalgic score, helplessness and coping but not in pain index or social support.13 A cognitive behavioural stress management package lasting 90 minutes and delivered to 20 patients twice a week was superior to usual care in another group of 20 patients, for the pressure threshold score only. Pain distribution, pain visual analogue scale (VAS), disturbed sleep, lack of energy and depression were no different.14
In one RCT, six patients received 15 sessions of biofeedback and six received sham biofeedback over 5 weeks.15 Significant improvements in tender points, pain intensity and morning stiffness were found in the biofeedback group, and in tender points in the sham group. No statistical between-group comparison was made. Changes persisted for up to 6 months after the treatment.
In another RCT, 119 subjects were divided into four groups.16 Electromyogram biofeedback directed at the trapezius muscle, with relaxation, was compared with exercises, including walking, and with a combination of biofeedback and exercise interventions. A fourth group received a special programme designed as an attention control, which included standard educational material about FMS that was not believed to have any clinical effect. The interventions were given over a 6-week individual training phase and a two-year group maintenance phase. Ten different outcome measures were applied over the 2-year trial period, including disease severity by masked physician, pain scores, pain behaviour or physical activity, and self-efficacy of function, i.e. the belief that one can remain active despite the presence of the condition. Patients in all groups improved, and biofeedback was superior to the control group only in terms of tender points and enhanced self-efficacy. Biofeedback combined with exercise produced benefits that persisted over the 2-year follow-up period. One reviewer concluded that improvements that occur with mind–body interventions appear more likely to be changes in self-efficacy rather than reduction of symptoms.17
Several studies have compared exercise with no additional treatment. In an RCT with 45 patients, two exercise classes combined with group educational sessions were given weekly for 6 weeks, and compared with a waiting list control.18 The exercise group was significantly improved in 6-min walk, well-being (FIQ) and morning fatigue, but not perceived exertion, or other aspects of the FIQ including physical impairment, stiffness and depression. In another RCT involving 69 subjects, pool exercise over 6 months combined with six sessions of education focusing on coping strategies was superior to standard care for a number of outcome measures.19 In a further RCT, aerobic exercise at 60–70% maximum heart rate three times a week for 14 weeks was superior to usual care for pain distribution, pain VAS, pain threshold, work capacity but not depression.14
Patients with FMS may have difficulty complying with strenuous exercise regimes, so some studies have tested less strenuous regimes. An RCT in 25 patients that compared low-impact aerobic dance for 1 h twice weekly for 20 weeks with no additional exercise found significant improvement in aerobic fitness in both groups, with no differences between the groups.20 Another study of mild exercise found that 10 subjects undertaking aerobic walking three times weekly for 8 weeks showed little superiority over nine sedentary controls.21 Two 50-min sessions per week of exercise for strength, flexibility and endurance were not superior to no treatment control in FMS symptoms, in an RCT of 85 patients, although physical fitness was superior in the exercised group.22
Exercise regimes have also been compared with other interventions to control for attention.
A recent, rigorous study randomised 136 highly disabled participants to two groups with twice weekly classes for 12 weeks.23 The intervention group received standardised advice and encouragement and an individualised aerobic exercise programme set by a personal trainer, involving treadmills and exercise bicycles, to the intensity level of sweating slightly but still able to talk comfortably. The control group received training in relaxation and flexibility, for the same duration. The main outcome was the global assessment of change. At 3 months, 35% of participants in the intervention group were much or very much better, compared with 18% of the controls (P = 0.03), but the difference was not significant after a year. The FIQ did not reveal any differences between the groups. The dropout rate in the study was very high, and only 53% of participants attended more than one-third of classes.
In another RCT with 38 patients, aerobic exercise (to 60–70% maximum heart rate) was compared with a relaxation control over 6 weeks.24 Significant superiority of myalgic score and tender point count was supported by non-significant trends in the FIQ scores and self efficacy. In the biofeedback study already mentioned,16 the exercise arm and combined intervention (exercise and biofeedback) arms fared better than attention control in two outcomes – tender point index, and self-efficacy of function. There were no differences in the other measures, including disease severity and pain intensity. Finally, supervised exercise was not superior to unsupervised exercise in a study involving 74 patients, with the exception that anxiety improved more in the former group.25
The Cochrane Review of exercise for FMS concluded that supervised aerobic exercise training has beneficial effects on physical capacity and FMS symptoms, and that strength training may have benefits on some FMS symptoms.26 Further studies on the long-term benefits is needed, and on muscle strengthening and flexibility.
From one small study (n = 39), there is a suggestion that balneotherapy with plain fresh-water baths reduces pain, and the addition of valerian to the bath may improve other outcomes such as well-being and sleep.27 Forty patients were randomised to receive either balneotherapy (20 min a day for 5 days over 2 weeks) and relaxation or relaxation alone.28 Pain and tender point index were measured but no between-group analyses were conducted. In one RCT, 13 patients received a 5-week programme in progressive (Jacobson) muscle relaxation plus home practice.29 They were compared with 12 others that received 10 hydrogalvanic baths over the same period. Both groups improved in pain intensity, sleep, medication and pain coping but there were no significant differences.
A small (n = 19) pilot RCT found that, although treatment with chiropractic manipulation and soft-tissue massage was associated with improvements in many parameters, such as spinal pain and mobility, the changes were not significantly superior to no treatment in terms of the physical symptoms.30 Outcome measures specific to fibromyalgia were not used. The findings justify a larger study. In an RCT with 55 patients, active taped guided imagery for pleasant scenes was compared with taped imagery for pain control mechanisms (which acted as an ‘attention’ control) and with standard care.31 The pleasant imagery was superior to attention imagery and control for pain VAS. Herbal medicine with topical capsaicin was compared with placebo in a controlled trial involving 45 patients.32 Those receiving capsaicin reported less tenderness and a significant increase in grip strength, but no difference in pain scores.
In one RCT of homoeopathy, 30 patients were selected for inclusion in two stages, first for diagnosis of fibromyalgia and then for matching to the remedy Rhus toxicodendrum.33 The homoeopathy group recorded greater reduction in tender points, pain and sleep disturbance, but global assessment was not different.
In another RCT, 40 patients with fibromyalgia were randomised to receive either hypnotherapy or physical therapy consisting of massage and relaxation for 12 weeks.34 Hypnotherapy was superior for several measures, including pain ratings, sleep disturbance and somatic and psychological discomfort scores, although not physicians’ global assessments.
Magnet sleep pads were compared with sham magnet pads and with usual care in an RCT involving 119 patients.35 The pads were of two types, either whole-body exposure to a low, uniform magnetic field of negative polarity, or a field that varied spatially and in polarity. Outcomes were measured at baseline and 6 months, and included FIQ and pain intensity ratings, and point tenderness assessed by masked observer. The functional pad groups showed a significantly greater reduction in pain intensity. They also showed the greatest improvement in FIQ scores but the differences were not significant. In another RCT, 15 patients slept on a magnetised mattress for 16 weeks, while the control group of 15 slept on a sham magnetised mattress.36 Patients using the magnets showed improvements but the data were not compared with the control group.
Connective tissue massage was compared with no treatment or discussion (attention control) in an RCT involving 52 patients.37 The treated group experienced greater relief of pain and depression, and improvement in quality of life (FIQ), but were not significantly different in other variables including activities, fatigue and sleep. The difference between groups was no longer significant after 3 months.
A cohort study of meditation for 10 weeks in 79 patients with fibromyalgia found improvements in all patients, and moderate or great improvement in 51%.38 A single trial suggested that music therapy was associated with reduced pain and disability in chronic pain patients, including fibromyalgia, compared with untreated controls, but no change in anxiety or depression.39
In summary, exercise appears to have a rather small but definite specific benefit in addition to any effect of the additional attention. Gentle exercise is not sufficient; it needs to be more vigorous. The attrition rate is high and it is not possible to be sure that the benefits are maintained for a year. One good study suggests that acupuncture has promise, and other less good studies support this. There is little definitive evidence on other therapies. It is unlikely that any individual complementary therapy can make any greater impact on fibromyalgia than conventional approaches, but combinations of therapies are often used for fibromyalgia and CAM may have something to offer in this context. For example, the judicious use of oral medications such as antidepressants to deal with pain and insomnia can be usefully combined with biofeedback or (supervised) exercise and perhaps acupuncture.
