Posted 08.30.2019 | by AMRA
Fibromyalgia is a chronic disorder affecting approximately 10,000,000 Americans. The disorder presents with symptoms of widespread musculoskeletal pain, fatigue, and mood, sleep, and cognitive difficulties. The cause of fibromyalgia is unknown, and its treatment is largely palliative, consisting of medication to reduce pain and inflammation, graded physical exercise and/or cognitive-behavioral therapy. The disorder incurs a wide variety of costs including high rates of unemployment, sick leave, disability claims, and direct medical care utilization.
Perez-Aranda et al. [Journal of Clinical Medicine] compared the cost-effectiveness and clinical utility of adjunctive Mindfulness-Based Stress Reduction (MBSR) to a previously validated comparator intervention and treatment-as-usual in the treatment of fibromyalgia.
The researchers randomly assigned 225 fibromyalgia patients recruited from a Spanish hospital to one of three treatment interventions: 1) MBSR + treatment-as-usual, 2) FibroQoL + treatment-as-usual, and 3) treatment-as-usual alone. MBSR was delivered using the standard 8-week group protocol with minimal adaptations. FibroQoL is a fibromyalgia intervention with previously demonstrated superiority to treatment-as-usual. It consists of 8 weekly 2-hour group sessions that include fibromyalgia psycho-education, relaxation, and self-hypnosis to help patients control pain and visualize a future pain-free life. Treatment-as-usual involved prescription medications for pain, inflammation, depression, and anxiety, along with recommendations for daily exercise.
Cost-utility data was only available for a final sample of 204 participants (98% female; average age = 53 years). Analyses were performed separately for the full intention-to-treat sample and for 107 patients who attended at least 6 of the 8 intervention sessions and their 12-month follow-up appointments.
Self-ratings of quality-of-life were obtained at baseline and 12 months using the EuroQol EQ-5D to assess disease impingement on mobility, self-care, and activities of daily living, as well as pain, anxiety, and depression. A EuroQol EQ-5D score of “0” indicates a quality of life “as bad as death” and a score of “1.0” indicates “perfect health.”
Direct and indirect costs of fibromyalgia treatment were calculated based on patient medication prescription receipts, patient medication logs, and patient reports of primary care and specialist visits, hospital stays, diagnostic procedures, and sick leave/disability over the past 12 months. MBSR and FibroQoL costs were included in the analyses.
At the 12-month follow-up, average direct and indirect healthcare costs were significantly lower for MBSR ($2,133 USD) than FibroQoL ($2,761 USD) or treatment-as-usual ($3,464 USD) participants. MBSR costs were significantly lower than those of the comparator and control groups primarily due to lower primary care costs and fewer lost workdays.
At 12 months, MBSR participants had the best average quality of life scores (0.57), followed by FibroQoL participants (0.53) and treatment-as-usual participants (0.45). These group differences achieved overall significance.
A cost-utility analysis showed that MBSR was both significantly cheaper and significantly more effective than treatment-as-usual. MBSR was also cheaper than FibroQoL due to fewer sick days, but there was no significant difference between the two in terms of incremental improvement in quality of life.
The results support the cost-utility of add-on MBSR treatment of fibromyalgia compared to an active comparator or treatment-as-usual alone. MBSR led to a savings of $628 per patient compared to the active comparator, and $1331 per patient compared to treatment-as-usual alone.
A significant amount of missing healthcare and follow-up data made the sample size smaller than originally intended. The study’s limitations include reduced sample size due to follow-up loss and direct and indirect costs established by retrospective participant recall rather than healthcare records.
Pérez-Aranda, A., D’Amico, F., Feliu-Soler, A., McCracken, L. M., Peñarrubia-María, M. T., Andrés-Rodríguez, L., . . . Luciano, J. V. (2019). Cost-Utility of mindfulness-based stress reduction for fibromyalgia versus a multicomponent intervention and usual care: A 12-month randomized controlled trial (EUDAIMON study). Journal of Clinical Medicine.