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.
In a 3-armed randomized controlled trial in female patients suffering from fibromyalgia, patients benefited modestly from a mindfulness-based stress reduction intervention.
aDepartment of Environmental Health Sciences, University Medical Center, Freiburg, Germany
bPsychosomatic Medicine, University of Basel Hospital, Basel, Switzerland
cInstitute for Transcultural Health Studies, European University Viadrina, Frankfurt (Oder), Germany
dSamueli Institute, European Office, Brain, Mind and Healing Programme, Germany
eHeymans Chair of Exceptional Human Experiences, University for the Humanistics, Utrecht, The Netherlands
*Corresponding author. Address: Department of Environmental Health Sciences, University Medical Center Freiburg, Breisacherstr. 115b, 79106 Freiburg, Germany. Tel.: +49 761 270 83050; fax: +49 761 270 83430.
Submitted September 29, 2009; revised September 27, 2010; accepted October 28, 2010.
☆ClinicalTrials.gov Identifier: NCT00106275