Researchers from University Medical Center in Freiburg, Germany, investigated the efficacy of an 8 week MBSR intervention (Mindfulness-Based Stress Reduction, a structured training in developing nonjudgmental awareness of moment-to-moment experience) with mindful yoga exercises, on enhanced well being of fibromyalgia patients.
 
In this 3-armed trial, a total of 177 female patients were randomized to one of the following conditions: (1) MBSR, (2) an active control procedure controlling for nonspecific effects of MBSR, or (3) a wait list.
 
The major outcome sought was for 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.

Eighty-two percent of the patients completed the study. No significant differences were found 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 the MBSR condition yielded 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 only 3, and the wait list in only 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, which may provide explanations for differences.
 
In summary, a 3-armed randomized controlled trial in female patients suffering from fibromyalgia, patients benefited modestly from a mindfulness-based stress reduction intervention.

Citation:  Schmidt S, Grossman P, Schwarzer B, Jena S, Naumann J, Walach H. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial. Pain. 2011 Feb;152 (2): pages 361-9. Epub 2010 Dec 13. [email protected]