Mindfulness-based stress reduction (MBSR) is a structured 8-week group program teaching mindfulness meditation and mindful yoga exercises. MBSR aims to help participants develop nonjudgmental awareness of moment-to-moment experience. Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and insomnia as major symptoms. Efficacy of MBSR for enhanced well-being of fibromyalgia patients was investigated in a 3-armed trial, which was a follow-up to an earlier quasi-randomized investigation. A total of 177 female patients were randomized to one of the following: (1) MBSR, (2) an active control procedure controlling for nonspecific effects of MBSR, or (3) a wait list. The major outcome was health-related quality of life (HRQoL) 2 months post-treatment. Secondary outcomes were disorder-specific quality of life, depression, pain, anxiety, somatic complaints, and a proposed index of mindfulness. Of the patients, 82% completed the study. There were no significant differences between groups on primary outcome, but patients overall improved in HRQoL at short-term follow-up (P = 0.004). Post hoc analyses showed that only MBSR manifested a significant pre-to-post-intervention improvement in HRQoL (P = 0.02). Furthermore, multivariate analysis of secondary measures indicated modest benefits for MBSR patients. MBSR yielded significant pre-to-post-intervention improvements in 6 of 8 secondary outcome variables, the active control in 3, and the wait list in 2. In conclusion, primary outcome analyses did not support the efficacy of MBSR in fibromyalgia, although patients in the MBSR arm appeared to benefit most. Effect sizes were small compared to the earlier, quasi-randomized investigation. Several methodological aspects are discussed, e.g., patient burden, treatment preference and motivation, that may provide explanations for differences.
Fibromyalgia is a frequently diagnosed pain disorder primarily affecting women and showing high comorbidity with other functional somatic disorders and depression [47]. So far, no distinct cause or pathology has been identified. Recent research indicates that fibromyalgia patients may manifest dysfunctional pain processing of central origin [1] and, possibly, impaired cardiovascular autonomic regulation [36]. Pharmacological treatment of the disorder has proved difficult, perhaps because of its nonspecific pathophysiology. Thus, central nervous agents, such as tricyclic antidepressants [25], selective serotonin, and norepinephrine reuptake inhibitors [3] and [41] or pregabalin [16], have been found to be moderately successful, but only for relatively short periods of time [15]. Only a few nonpharmacological interventions appear to confer even moderate benefits, i.e., mainly cardiovascular exercise, cognitive–behavioral therapy and patient education [18], or a combination of these [23]. However many of these benefits are also short-lived.
Another proposed behavioral intervention for fibromyalgia is mindfulness-based stress reduction (MBSR), an 8-week, structured group program using mindfulness meditation techniques and mindful yoga exercises [27]. MBSR aims to help participants to develop nonjudgmental awareness of moment-to-moment experience, importantly within a context of openness, kindness, tolerance, and acceptance of perceptible sensory, mental, and emotional phenomena. A body of evidence indicates that MBSR can improve coping and health-related quality of life (HRQol) in many chronic conditions, including chronic pain [20] and [37].
So far, 8 trials have assessed MBSR, specifically, or mindfulness-based techniques in combination with other educational/behavioral techniques among patients with fibromyalgia. Studies in the latter category were either uncontrolled [14] or did not find significant differences in the primary outcome [4] and [33]. Of the 5 trials directly evaluating MBSR, one showed clinical improvement but was uncontrolled [29]; a later trial with a nonrandomized wait-list control group reported significant differences on several fibromyalgia-related visual analogue scales (VAS), the Fibromyalgia Impact Questionnaire (FIQ, P = 0.05) and the symptom checklist SCL90 (P = 0.0001) [19]. A third randomized investigation with wait-list controls showed significant improvements in depression [42], and a fourth uncontrolled trial study provided indications of significant changes in psychophysiological variables [32]. Finally, the fifth study is the direct forerunner of the current investigation [21]. In a quasi-randomized design, 39 female fibromyalgia patients received MBSR; 13 control patients were assigned to an active control procedure designed to match for nonspecific effects of MBSR. MBSR showed strong effects in comparison to the control group for HRQoL (effect sizes ranged from d = 0.52–1.12), pain (d = 1.10), depression (0.39), anxiety (0.67), and coping abilities (0.34–0.88). In a 3-year observational follow-up, the MBSR group of patients maintained significant improvement in all these variables, compared with preintervention. On the basis of these positive findings, we decided to replicate and extend this study, adding an additional control group.
Health-related quality of life (HRQoL) was chosen in this trial as the primary outcome, because severely impaired HRQoL is a central feature of fibromyalgia for some people, and relatively strong effects on HRQoL have been observed in earlier studies of MBSR and fibromyalgia [21].
