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Meditation for Fibromyalgia: Yea or Nay?
Abstract and Commentary
By Nancy 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.
Synopsis: Mindfulness-based stress reduction (MBSR) was investigated as an intervention for fibromyalgia patients in a 3-armed randomized controlled trial using health-related quality of life at the end of 2 months as the primary outcome. While the study did not support the efficacy of MBSR for the treatment of FM for this outcome, some secondary outcome variables demonstrated improvement.
Source: Schmidt S, et al. Treating fibromyalgia with mindfulness-based stress reduction: Results from a 3-armed randomized controlled trial. Pain 2011;152:361-369.
Mindfulness-based stress reduction (mbsr) training often is offered as an 8-week structured program as initially created by Jon Kabat-Zinn. The program uses meditation and yoga techniques to help participants develop nonjudgmental awareness and acceptance of emotions and sensory perceptions in the present moment.1 MBSR has been shown to improve psychological and physical symptoms, coping, and quality-of-life measures in a number of chronic conditions.2 Several studies have assessed MBSR alone and in combination with other techniques as an intervention for fibromyalgia. Of these, few have been randomized or controlled, but most have shown some benefit of this meditation training program for fibromyalgia patients.
Based on positive short- and long-term outcomes of a small quasi-randomized trial of mindfulness-based stress reduction (MBSR) for fibromyalgia (FM), the authors of this article decided to replicate and extend their original study.3
Participants in this study were women 18-70 years of age recruited from the community through news media, support groups, and physician practices. All were telephone screened and underwent an intake interview and examination to confirm their diagnoses of FM and their eligibility for this study. The 177 patients included in the trial were randomized to one of three study groups: the MBSR experimental intervention, an active control intervention, and a wait-list control group. In the two intervention arms, patients were told that two innovative treatments would be prepared: one based on mindfulness concepts and the other based on health support techniques.
The MBSR intervention was structured on the original 8-week program created by Kabat-Zinn and others at University of Massachusetts and was taught by two formally trained and experienced MBSR instructors. In addition to class attendance, patients were required to document home practice of the techniques for 30-45 minutes daily. Participants received pre- and post-intervention 1-hour interviews with an instructor to discuss pretreatment expectations and goals and their experiences during the course. Patients also were asked to quantify to what degree goals were met at the end of treatment.
The active control intervention was also an 8-week course consisting of social support, topical education discussions, relaxation training, and gentle stretching exercises. Homework assignments were similar in intensity to the MBSR group. The two instructors, both of whom were psychologists experienced in group therapy and relaxation training, conducted similar pre- and post-treatment interviews for individuals in this active control arm.
Wait-list control patients received no active treatment and were offered a choice of either intervention at the end of the short-term follow-up period.
Primary outcome of the study was chosen to be baseline to post-intervention change on a German Health Related Quality of Life (HRQoL) inventory called "Profile for Chronic Diseases." This validated instrument consists of a self-administered 40-item questionnaire appropriate for patients with chronic but non-life-threatening diseases. Secondary outcome measures were made using the Fibromyalgia Impact Questionnaire (FIQ) and other validated instruments to assess depression, anxiety, sleep quality, pain perception, physical symptoms and self-attribution of mindfulness.
a.l participants also were assessed for periods of 24 hours, while pursuing their normal activities of daily living, wearing a vest-like ambulatory psychophysiologic monitor with sensors for respiration, ECG, and physical activity. The device included a recording display, and patients were required to complete an electronic diary entry at regular intervals while they were awake. The authors intend to report the monitor data in another paper.
a.l data, including the monitor data, were collected at baseline, at the end of the 8-week intervention or wait period, and after an additional 8 weeks for all patients. Results were based on intention-to-treat analyses, and analysis of covariance was performed. Contrast analyses were performed; one contrast compared wait-list control vs. both active treatments and a second contrast compared MBSR vs. the active control group.
HRQoL, the primary outcome, showed a significant positive change over time for the whole cohort and was significant for the MBSR group but not the active control or wait group. The differences in effect size between groups, however, was not statistically significant. Secondary outcome results were positive and significant only for improvement in anxiety and self perception of mindfulness in the MBSR group.
These results were in stark contrast to the large significantly positive effect that the authors noted in their first quasi-randomized study of MBSR for FM and may illustrate some of the difficulties in devising a robust study protocol involving behavioral interventions for some chronic debilitating conditions. It is interesting to note that the pre- and post-interview data collected, which included qualitative and quantitative feedback about perceived improvement, was markedly positive in the MBSR group compared to the active control. The authors postulate that the data collection in this study may have created a large patient burden that was not present in their original study protocol. Patients complained that the in-hospital process of fitting and calibrating the vest-like monitor caused fatigue and was done at the same time they were requested to complete multiple questionnaires. Thus, some patients were allowed to take the questionnaires home and complete them over the following 24 hours during which they also received prompts every 45 minutes from the monitor to fill in the electronic diary.
There are other possible explanations for the different results observed in the two studies. In the earlier study, patients chose the MBSR course based on referral from an often enthusiastic and supportive physician or after reading a positive brochure promoting the course. In the more recent study, patients did not choose their intervention. Thus the powerful effects of patient preferences and motivation may have created different outcomes.
The authors conclude that MBSR cannot be recommended as an effective intervention for FM. However, further studies are needed that attempt to conform to what occurs under more natural conditions and that are designed to carefully consider the patient burden of study participation in this population.
1. Kabat-Zinn J. Full Catstrophe Living: Using the Wisdom of Your Body and Mind to Face Stress, Pain and Illness. New York, NY: Bantam Dell; 1990.
2. Merkes, M. Mindfulness-based stress reduction for people with chronic diseases. Aust J Prim Health 2010; 16:200-210.
3. Grossman P, et al. Mindfulness training as an intervention for fibromyalgia: Evidence of postintervention and 3-year follow up in well-being. Psychother Psychsom 2007;76:226-233.