CAM for Fibromyalgia A Summary of Evidence
By Nancy J. Selfridge, MD. Dr. Selfridge is Associate Professor, Department of Integrated Medical Education, Ross University School of Medicine, Commonwealth of Dominica, West Indies; she reports no financial relationship to this field of study.
Fibromyalgia (FM) continues to present management challenges for patients and their physicians despite a number of new pharmaceuticals promoted for its treatment. The original diagnostic criteria published by Wolfe et al in 1990 formed the basis for patient inclusion in most extant research on FM. These criteria include the presence of chronic widespread pain of at least 3 months' duration and the presence on physical examination of at least 11 out of 18 possible tender points.1 Wolfe recently proposed a new set of criteria for the disorder that allow for better categorization of the disease and its debilitating symptoms. Chronic widespread pain for at least 3 months' duration remains a hallmark in these new criteria. However, the consensus is that the number of tender points is no longer relevant. Instead, a Widespread Pain Index is used to document painful areas and a Symptom Severity Scale Score is used to assess the severity of associated symptoms such as fatigue, cognitive difficulties, and waking unrefreshed.2 (See Table.) It is interesting to note that when the criterion for tender points is eliminated, the marked female predominance of the disorder is reduced.3
Table: Fibromyalgia Diagnostic Criteria
A patient satisfies diagnostic criteria for fibromyalgia (FM) if the following 3 conditions are met:
1) Widespread pain index (WPI) > 7 and symptoms severity (SS) score > 5 or WPI between 3-6 and SS scale score > 9.
2) Symptoms have been present at a similar level for at least 3 months.
3) The patient does not have a disorder that would otherwise explain the pain.
1) WPI: note the number of areas in which the patient has had pain over the last week. Score will be between 0-19.
Shoulder girdle, left Hip (buttock, trochanter), left Jaw, left Neck
Shoulder girdle, right Hip (buttock, trochanter), right Jaw, right Upper
Upper arm, left Upper leg, left Chest Lower back
Upper arm, right Upper leg, right Abdomen
Lower arm, left Lower leg, left
Lower arm, right Lower leg, right
2) SS scale score:
For each of these 3 symptoms, indicate the level of severity over the past week using the following scale:
0 = no problem
1 = slight or mild problems, generally mild or intermittent
2 = moderate, considerable problems, often present and/or at a moderate level
3 = severe; pervasive, continuous, life-disturbing problems
Also, rate somatic symptoms in general using the following scale:
0 = no symptoms
1 = few symptoms
2 = a moderate number of symptoms
3 = a great deal of symptoms
SS scale score is the sum of the severity of fatigue, waking unrefreshed and cognitive symptoms PLUS the extent of somatic symptoms in general. Final score will be between 0-12.
*Somatic symptoms may include but are not limited to: muscle pain, irritable bowel syndrome, muscle weakness, headache, pain/cramps in abdomen, numbness/tingling, dizziness, insomnia, depression, constipation, nausea, nervousness, blurred vision, fever, diarrhea, dry mouth, itching, wheezing, shortness of breath, Raynaud's phenomenon, hives/welts/rashes, tinnitus, vomiting, heartburn, oral ulcers, loss of/change in taste, seizures, dry eyes, loss of appetite, sun sensitivity, hearing difficulties, easy bruising, hair loss, frequent urination, painful urination, bladder spasms
Adapted from: Wolfe F, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptoms severity. Arthritis Care & Research 2010;62:600-610.
FM has long been considered an idiopathic entity and it has been argued that it does not even represent a separate clinical disorder. The result of this debate has been that physicians have treated many patients with significant symptoms dismissively, a stance that potentially is harmful and no longer is tenable. Increasing research evidence supports the hypothesis that the pathophysiology of FM is the result of genetic and biologic factors, environmental triggers, and neurophysiologic abnormalities. Functional magnetic imaging studies provide direct evidence of increased central pain sensitivity and it generally is agreed that this is the result of both central augmentation of sensory input and diminished central pain inhibitory function.4,5 It has been hypothesized that stressful triggers such as an accident, a flulike illness, emotional stress, or overwork that precede the onset of symptoms in many patients may be part of the pathophysiology of central pain sensitization.6 Though the precise role of environment and stress in the pathophysiology of FM is not yet elucidated, they should not be downplayed in the clinical setting. The opportunity to express and think about stressful triggers may provide patients with valuable insights.
Autonomic dysfunction is present in FM patients, explaining a number of patient complaints including worsening of symptoms with stress. Several neuroendocrine and immune function alterations have been documented including elevated cerebrospinal fluid levels of substance P, abnormalities in the regulation of cortisol, abnormalities in adrenergic and serotonin systems, and diminished growth hormone secretion with increased levels of proinflammatory cytokines in response to exercise.7,8 Though such alterations may not play a role in the etiology of the FM, they may contribute to persistence of symptoms. Comorbid depression is common in FM and worsens both symptom severity and prognosis. Thus, careful screening for depression and treatment for it when present should be pursued aggressively.
CAM for FM
Current conventional treatment strategies often include recommendations for prescribed medications, exercise, and physical and psychological therapies. Few FM patients achieve high levels of symptom relief even with this multidisciplinary approach. Thus, many patients seek complementary or alternative medicine (CAM) treatment. CAM is defined as a diverse set of diagnostic, treatment, and preventive practices based on philosophies and techniques other than those used in conventional allopathic Western medicine. "Alternative" refers to practices used in place of conventional medicine, whereas "complementary" refers to practices that are used along with conventional medical treatment. Many conventionally trained physicians who use CAM prefer to describe their practices as "integrative": using the best interventions from all practices, tailored to the needs and preferences of each individual patient, and having the greatest potential for good and the least potential for harm. For the sake of this article, CAM will be used to describe interventions that have not been considered part of conventional Western medicine. A Mayo Clinic survey of FM patients referred to a tertiary care program reported 98% had used some form of CAM within the preceding 6 months.9
Evaluating the efficacy of various CAM therapies often is challenging. Though randomized controlled trials (RCT) are considered the strongest research basis for clinical recommendations, many CAM therapies focus on an individualized patient approach as part of the healing process. Thus, standardization of the therapy and blinding of the patient and the practitioner may be impossible in an optimal therapeutic setting. Still, some evidence-based support exists for certain CAM therapies in the treatment of FM.
Nutrition and Supplements
An RCT comparing a 6-week course of vegetarian diet to amitriptyline demonstrated some pain reduction in the diet group compared to baseline, but more overall improvement in the amitriptyline group.10 Evidence of efficacy for most supplements and botanicals is lacking, though patients often try various natural medicines in their quest for help. Topical 0.025% capsaicin cream applied to tender points was shown to reduce FM pain after 4 weeks in one double-blind study of 45 patients. Topical capsaicin cream often causes a burning sensation on initial application, which can be problematic for patients already quite sensitive to pain stimuli.11 Although St. John's wort may be effective for depression and is often tried by FM patients based on its purported effects on neurotransmitter levels, it has not been studied specifically for FM. Further, it is a potent inducer of cytochrome P450 and can reduce the effectiveness of many drugs, including oral contraceptives. Patients considering its use should be counseled about its lack of proven benefit and the potential for drug interactions. Oral SAMe (S-adenosylmethionine) may have beneficial effects for FM patients. A double-blind, controlled crossover study of 17 patients showed improvement in number of painful sites (P < 0.02) and in depression scores (P < 0.05) with SAMe treatment but not with placebo.12 In a 6-week double-blind, placebo-controlled study of 44 patients taking SAMe at 800 mg daily, the greatest improvements occurred for pain (P = 0.002) and for mood (P = 0.006) for the treatment group compared to controls.13 Oral SAMe at this dose is considered generally well tolerated, but it can be expensive. Valerian, passionflower, chamomile, and melatonin often are used to help with the sleep disturbance common in FM patients. All of these substances may have some sedative or sleep-inducing qualities but none have been studied for effectiveness in FM patients. A proprietary combination of magnesium and malic acid (Super Malic) was shown effective in a single randomized, blinded, controlled pilot study of 24 patients, but only at a dose of 6 tablets daily.14 Magnesium and malic acid have not been studied alone. 5-HTP showed promise in an open 90-day study of 50 patients with significant improvement in all clinical variables compared to baseline measures (P < 0.001).15 Cases of eosinophila myalgia syndrome associated with the use of 5-HTP were traced to a contaminated synthetic L-tryptophan from a single manufacturer. There have been no definitive cases of toxicity linked to 5-HTP use worldwide in the last 20 years. Combining the use of 5-HTP with serotonergic antidepressants may increase the risk of serotonin syndrome.16,17
A 2008 systematic review concluded that aerobic exercise has a beneficial effect on improving physical function and decreasing some symptoms in FM patients.18 It is not uncommon for exercise to cause an increase in FM symptoms initially, and adherence and attrition have been a problem in research studies on exercise for FM. Tai chi, yoga, and cumulative daily 30 minutes of self-selected lifestyle physical activity were reported to be beneficial for some FM symptoms in recent small trials and may be associated with less exacerbation of symptoms on initiation of the activity.19-21
A recent qualitative review concluded that acupuncture may be helpful for FM and highlighted the different study designs that hinder comparisons and conclusions.22 Some studies have used standardized acupuncture treatment protocols and others have used individualized treatments deemed more appropriate for the heterogeneity of symptoms presented by FM patients. Sham treatments, both insertive and non-insertive, have been used as placebo-control treatments, but it has been postulated that any kind of needling may produce a nonspecific effect on FM symptoms. Any final conclusions about acupuncture effectiveness for FM will have to wait for more high-quality RCTs with comparable designs and long-term follow-up.
Mindfulness meditation may be helpful for depression associated with FM, though a recent randomized, three-armed controlled study showed no beneficial effect of meditation training for FM.23,24 In this study, the authors concluded that the design, which included significantly long and intrusive data collection periods, may have created enough of a burden for patients that any benefits of the meditation intervention were negated. A recent RCT of 42 patients using an "Affective Self Awareness" program, consisting of a group intervention including emotional disclosure journaling, meditation, and education about mind and body interactions, showed significant benefit for both FM pain symptoms (P < 0.001) and perceived level of function (P < 0.001) compared to a wait list control group.25
A recent systematic review of RCTs evaluating various CAM therapies for fibromyalgia found some promise for a variety of interventions. Balneotherapy is the use of thermal and mineral baths traditionally offered in various parts of the Middle East and Europe to treat pain and rheumatic disease. The authors of this review concluded that balneotherapy for FM is likely beneficial based on four RCTs, even though the studies varied in the constitution of the mineral baths, the therapy settings, and the control group treatments. One high-quality randomized, placebo-controlled, double-blind trial of individualized homeopathy (n = 62) resulted in significant improvements in pain and quality of life measures in the treatment group. An RCT testing the effects of massage vs. both wait-list and education control groups in 52 subjects showed improvements in pain and Fibromyalgia Impact Questionnaire results in the massage group vs controls, but 90% of the pain-relieving effect was gone at 6-month post-study follow-up.22
To date, studies assessing the efficacy of CAM interventions for the treatment of FM have been fraught with methodological flaws. The few higher quality RCTs that exist for any given therapy vary in design, tend to be small studies, and lack long-term follow-up to assess for sustained improvements. Presently, there appears to be some evidence to support exercise, acupuncture, certain mind-body interventions, massage, homeopathy, and balneotherapy as potentially helpful treatments for FM symptoms. There also is some evidence to support the use of topical capsaicin, 5-HTP, and SAMe for FM. More high-quality, large RCTs addressing previous methodological problems need to be done before firm conclusions can be drawn about CAM therapies and their efficacy in the setting of fibromyalgia.
As a very heterogeneous group of patients, FM sufferers deserve treatment individually tailored to their symptoms and preferences, and the therapeutic benefit of generous listening from their doctors. Many will want to explore CAM therapies to use alone or as an adjunct to prescribed medications for FM and will benefit from their physicians' support and guidance. Exercise can be strongly recommended as helpful. Though patients may experience some increased pain with initiation of an exercise program and will need to be supported through this, those who can persist are likely to reap benefits. Patients may wish to explore tai chi and yoga as exercise modalities. A trial of acupuncture would be rational based on current evidence. Massage, homeopathy, and balneotherapy, and the prudent use of some dietary supplements, can be recommended, though strong evidence of efficacy is still lacking. Meditation training and practice can be suggested and endorsed. When patients are open to the notion of a mind-body connection or note that stress and emotions worsen their symptoms, they may benefit from a formal or informal program of education and emotional disclosure journaling. These CAM therapies are all low risk, except for cost. When patients wish to try natural medicines and supplements, they need to be counseled about potential side effects and interactions with other supplements and prescribed medications.
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