From MedscapeCME Rheumatology
Lesley M. Arnold, MD
Introduction
Fibromyalgia is a common chronic widespread pain disorder that is often linked to other symptoms, including fatigue, sleep disturbances, cognitive impairment, depression, and anxiety.[1] This condition is also associated with a substantial compromise in quality of life, self-reported loss of function, work disability, and increased work absenteeism, as well as a higher use of healthcare services.[1] Although recent developments in pharmacologic and nonpharmacologic therapies have led to improvements in the care of patients with fibromyalgia, lack of adherence represents an issue that may limit the effectiveness of these treatment approaches. Assessing and improving treatment adherence is therefore a critical aspect in the management of fibromyalgia. The problem of treatment nonadherence in some patients with fibromyalgia is not unique to this condition. Nonadherence is a main concern in the management of many medical disorders. Importantly, there is now evidence about possible reasons for treatment nonadherence in some patients with fibromyalgia, and based on patients' experiences, treatment approaches that may enhance compliance are being developed.
The goals of this article are to review evidence about nonadherence to fibromyalgia treatments and the potential consequences on patient outcomes, and to present approaches to assess and manage this issue in patients with fibromyalgia.
Nonpharmacologic Treatments for Fibromyalgia
Exercise
The use of exercise as a therapy for fibromyalgia has been supported by multiple studies. The Cochrane review evaluating exercise trials in fibromyalgia published up to 2005 concluded that moderate-intensity aerobic training may improve overall well-being and physical function, with little or no difference in pain or tenderness.[2] However, attrition rates were high in most studies (range: 13%-44%), and there were some indications that adherence to both exercise intensity and frequency was poor.[2] For example, 132 patients with fibromyalgia who entered a randomized, controlled trial of a community-based exercise program were randomly assigned to either graded aerobic exercise or relaxation twice weekly for 12 weeks.[3] At the end of the intervention, a significantly higher number of patients in the exercise arm (35% [24/69]) felt much better or very much better, compared with those in the relaxation arm (18% [12/67]). At 12 months follow-up, these benefits were maintained in 38% (26/69) and 22% (15/67) of the participants, respectively (difference not significant). The study, however, was limited by adherence issues, as only 53% of the total group attended more than one third of the classes. The reasons for low adherence included initial increases in pain and stiffness immediately after exercise and the patients' belief that exercise worsened their condition, suggesting that strategies such as education and cognitive behavior therapy may improve adherence to exercise.
Education and Exercise
Recent fibromyalgia trials have explored the possibility that education in combination with exercise may help to improve patient outcomes. The effects of exercise and education were separately evaluated in a 12-week study of a supervised aerobic exercise program, a self-management education program, and the combination of exercise and education in 152 women with fibromyalgia.[7] The program -- based on the American College of Sport Medicine (ACSM) recommendations for maintaining and developing cardiorespiratory fitness in healthy adults -- required patients to meet 3 times a week for an average duration of 20-40 minutes per session, and included walking, pool exercise, or low-impact aerobics, as well as heart rate monitoring and ratings of perceived exertion. Patients were instructed to begin at a comfortable level and strive to increase exercise intensity and duration to meet the ACSM guidelines. The education group, based on principles of self-management, met once a week for 1.5-2 hours per session. The control group was given written instructions for basic stretches and general coping strategies, and patients were contacted once or twice throughout the 12-week period to ensure that they were completing a logbook that documented the course of fibromyalgia and weekly goals (also given to treatment groups) and to answer questions about their condition. At the end of the program, significant differences were seen among the groups only when adherence was taken into consideration. For patients who adhered to the protocol (only about half of the total group), the combination of supervised exercise and group education improved self-efficacy to cope with some symptoms compared with the control group, although this significant difference was lost at the sixth-month follow-up evaluation. The high dropout rate suggested that patients with fibromyalgia may have difficulty adhering to treatments that involve exercise and behavior modification. Alternatively, patients may have dropped out because of preprogram beliefs about exercise and education that were not addressed in the study. The study did not identify comorbid depression or anxiety among the participants, and could not assess the possible role of comorbid mood symptoms on outcomes. These results suggest that encouragement to adopt or enhance a physically active lifestyle instead of promoting exercise may be a more appropriate approach to treatment programs in some patients with fibromyalgia.
In summary, studies to date support the role of exercise with or without education in the treatment of fibromyalgia. Based on the evidence presented, Table 1 summarizes strategies to improve adherence to these potentially effective nonpharmacologic approaches to fibromyalgia management.
Table 1. Strategies to Improve Exercise Adherence in Fibromyalgia
Educate patients about the role of exercise in fibromyalgia treatment
• Given that many patients do not tolerate high-intensity aerobic exercise, low/moderate-intensity graded aerobic exercise may be preferable and may lead to improvements in global well-being and physical function
• A gradual increase in exercise (as tolerated) to reach a goal of 30-60 min of low/moderate-intensity aerobic exercise at least 2-3 times/week for > 10 weeks appears to be associated with maintenance of improvements
Guide patients on exercise initiation and maintenance
• It is recommended that patients initially do less than they think they can accomplish and slowly build endurance. Write a "prescription" for exercise with clear instructions on progression and follow-up based on response
• Encouraging patients to adopt/enhance a physically active wellness lifestyle instead of promoting exercise may be more appropriate for some patients
• Supervised group exercise interventions may be preferable to home-based exercise regimens, especially at the initiation of an exercise program
Address the factors that contribute to low exercise adherence • Discuss any barriers to exercise and develop plans to address these barriers
• Implementing targeted self-management group education programs (ie, Fibromyalgia Self Help Course developed by the Arthritis Foundation) may be helpful in enhancing the effects of exercise
• The addition of cognitive-behavioral therapy may help patients with stress and may help them react less to bodily sensations
• Pharmacologic treatments may help reduce symptoms, improving exercise tolerability
Cognitive-Behavioral Therapy
Although cognitive-behavioral therapy is often recommended to improve adherence to other fibromyalgia treatments, studies indicate that adherence to this therapy is also sometimes problematic. In one study, 145 patients with fibromyalgia were randomly assigned to either standard medical care that included pharmacologic treatment and suggestions for aerobic fitness, or the same standard medical treatment and the addition of 6 group cognitive-behavioral therapy sessions specifically aimed at improving physical function over a 4-week period.[9]
The therapy focused on instruction and practice of 9 skills including the relaxation response, visual imagery techniques, pacing skills, pleasant activity scheduling, communication and assertiveness training, cognitive restructuring principles, stress management, and problem solving. A significantly higher number of patients who completed the cognitive-behavioral therapy protocol (35%) achieved a clinically meaningful and sustained improvement in physical functional status compared with the control group (12%). Despite a low level of adherence to cognitive-behavioral therapy (only 15% of patients consistently reached their stated monthly therapy goals), the study provided some evidence that targeted, brief group cognitive-behavioral therapy in conjunction with standard medical care might improve physical function in some patients with fibromyalgia. In an attempt to improve adherence, this study was designed to offer patients the choice to pursue a personally tailored goal for skill use, or to follow the therapist's recommendations for goal setting. Personalizing the goal, however, did not improve adherence or outcomes. In addition, the pattern of adherence (ie, never meeting goals, sometimes meeting goals, always meeting goals) was not significantly related to improved physical functioning, suggesting that other factors beyond adherence (ie, rapport with the therapist, motivation for change, sense of control over symptoms of fibromyalgia) were more relevant in improving outcomes. Therefore, despite problems with adherence to the treatment plan, patients still reported some benefit from the therapy.
Adherence to a 3-month multimodal program for fibromyalgia that included small group educational sessions, cognitive-behavioral therapy, and exercise demonstrations was adversely affected by patient report of multiple barriers, such as pain, fatigue, stressful events, too much effort, presence of other illness, and lack of time.[10] In addition, pain catastrophizing, a maladaptive coping style that includes rumination about pain and feelings of helplessness, also predicted lower adherence to the treatment program. Based on these findings, patients and their healthcare providers should address problems that may prevent engagement in recommended treatments
There may also be other barriers to cognitive-behavioral therapy that affect adherence, such as availability of cognitive-behavioral therapists and cost of therapy. Less costly self-management programs that provide cognitive-behavioral therapy to a broader group of individuals with fibromyalgia may address some of these barriers. For example, the FibroGuide developed by researchers at the University of Michigan, available online at http://www.fibroguide.com, offers a self-management program that is based in part on cognitive-behavioral principles. Clinicians may also help improve adherence to these Web-based programs by monitoring the patient's progress and reinforcing positive gains.
Pharmacologic Treatments for Fibromyalgia
There are currently 3 medications approved by the US Food and Drug Administration (FDA) for the management of fibromyalgia: the alpha-2-delta ligand, pregabalin, and the serotonin and norepinephrine reuptake inhibitors, duloxetine and milnacipran. Non-FDA-approved medications for which there is evidence supporting their use in fibromyalgia include tricyclic antidepressants, cyclobenzaprine, gabapentin, and others.[1] It is likely that medication options will expand in the future. Although advances in the treatment of fibromyalgia are encouraging, the issue of lack of adherence to pharmacologic therapies persists, and is therefore starting to receive some attention in studies.
In many of the clinical trials evaluating medication treatment for fibromyalgia, the most common cause for premature discontinuation of medication is treatment-emergent adverse events. In the pivotal fibromyalgia trials of milnacipran, 23%-26% of patients discontinued the drug prematurely because of adverse events, mainly nausea, palpitations, headache, constipation, increased heart rate, increased sweating, vomiting, and dizziness.[13] In the duloxetine pivotal fibromyalgia trials, 19.5 % of duloxetine-treated patients discontinued because of adverse events, most commonly nausea, somnolence, fatigue, and insomnia.[14] Finally, in the pregabalin pivotal fibromyalgia trials, 19% of patients on pregabalin also discontinued early because of adverse events, mostly dizziness, somnolence, fatigue, headache, balance disorders, and weight gain.[15] In a pooled analysis of data from 5 clinical trials of duloxetine treatment of fibromyalgia, the common treatment-emergent adverse events occurred early in treatment and had a relatively rapid resolution. For example, nausea, the most common adverse event, had a median time to onset of 1 day and median time to resolution of 6 days.[16] Similarly, in a recent milnacipran trial, 70% of the episodes of nausea in the treatment groups resolved within 3 weeks after onset.[17] In a trial of pregabalin, the median time to onset for dizziness and somnolence in the pregabalin groups was ≤ 1 day.[18] The median duration of dizziness in patients who did not withdraw from the study was 6 days for patients taking 300 mg/day pregabalin and 15 days in those taking 450 mg/day pregabalin. The median duration of somnolence in patients who did not withdraw from the study was 21 days in those taking 300 mg/day pregabalin and 18 days in those taking 450 mg/day pregabalin.
Educating patients about the possible resolution of side effects over time may help patients adhere to ongoing treatment that is otherwise effective. In addition, a "start low, go slow" dosing strategy may minimize the risk for adverse events early in treatment and may improve medication adherence. For example, it has been shown that duloxetine started at 30 mg/day for the first week of therapy may improve tolerability.[14] A slow titration of milnacipran may also help patients continue therapy. A recent milnacipran study used flexible dose titration to 100 mg/day over 4-6 weeks (rather than 2 weeks as currently recommended), which led to fewer patient withdrawals because of adverse events than previous milnacipran studies.[17] Taking medications associated with gastrointestinal side effects (ie, duloxetine and milnacipran) with food can also improve tolerability.[19] Dosing strategies for pregabalin that appear to improve tolerability but are not FDA-approved, include beginning with a low dose of pregabalin (eg, 50-75 mg) at bedtime, increasing as tolerated at bedtime only, and later adding daytime doses as tolerated to reach the recommended total daily dose of pregabalin for fibromyalgia.
Education about adverse effects that may persist and about ways to manage these adverse events is also important in helping patients adhere to ongoing effective medication treatment. Based on clinical experience, clinicians have found that addressing potential weight gain with pregabalin or other medications at the start of therapy and asking patients to keep a food diary during the early phase of treatment can help increase their awareness of their eating patterns and allow them to take steps to minimize the risk for weight gain. Studies of combination therapy for fibromyalgia are limited; however, in some patients who have difficulty tolerating recommended doses of medication, a trial of combinations of lower doses may improve response.[20] Finally, it is important for most patients to attempt to titrate up to the known effective doses of medication to reduce the possibility of discontinuation due to lack of efficacy. For example, patients with higher duloxetine average daily dose (> 30 mg/day) were more likely to adhere to treatment, possibly because they were experiencing some benefit from the treatment.[21]
Patient-physician discordance on communication and satisfaction has also been found to predict overall nonadherence to medication in patients with fibromyalgia.[22] Predictors of high general adherence to health professionals' recommendations for fibromyalgia treatment included low patient psychological distress and low patient-physician discordance on patient well-being.[23] Discrepancies between the patient's and the physician's views on the patient's well-being might contribute to treatment nonadherence if the physician prescribes treatments that are inconsistent with the patient's view of their illness. Psychological distress may adversely affect adherence by interfering with the patient's ability to recall treatment instructions, disrupt the interpersonal relationship with the healthcare provider, and diminish the patient's motivation to make changes. Thus, it is important to identify and address psychological distress in patients with fibromyalgia.[23] In some cases, distress is a manifestation of comorbid psychiatric problems that also need to be assessed and treated.
The patient-physician relationship is important for medication adherence in fibromyalgia.[22] Continuity of care and more frequent visits at the start of treatment will improve patient-physician rapport and adherence to treatment. The development of an alliance with patients that includes discussion of findings from the evaluation, education about fibromyalgia and treatment options, and involvement of the patient in treatment planning will likely enhance adherence.[23] Table 2 summarizes strategies to improve medication adherence in fibromyalgia.
Table 2. Strategies to Improve Medication Adherence in Fibromyalgia
Involve patients in treatment planning
• Review findings from the evaluation
• Review history of treatment trials, including dose, duration, tolerability, and efficacy
• Discuss treatment options, including risks and benefits
Educate patients about fibromyalgia and discuss risks/benefits of pharmacologic treatment options
• Review strategies to reduce risk for adverse events
• Establish a plan for continuity of care (ie, more frequent follow-up visits during the first months of treatment to address safety and tolerability)
Identify and manage any barriers that may interfere with the implementation of and with patients' understanding of treatment plans
• Assess psychological distress or psychiatric comorbidity
• Determine patients' understanding of and satisfaction with the treatment plan
Summary
Adherence to nonpharmacologic and pharmacologic treatments for fibromyalgia may be problematic for some patients, and may interfere with the effectiveness of available therapies. However, there are several strategies that may be helpful in addressing the problem of nonadherence. Adherence to treatment recommendations is most likely enhanced if the healthcare provider develops a therapeutic alliance with the patient, involving him or her in treatment planning.
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