Abstract
The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.
Highlights
Fibromyalgia (FM) is a disabling syndrome of unknown etiology mainly characterized by widespread musculoskeletal pain and symptoms such as fatigue, stiffness, sleep problems, perceived cognitive dysfunction, and distress [1]
In this study we explored the results of the 41 patients in the mindfulness plus amygdala and insula retraining (MAIR) and relaxation therapy (RT) groups
Note: RT: relaxation therapy; MAIR: mindfulness plus amygdala and insula retraining; M: mean; SD: standard deviation; d: Cohen’s d effect size corrected for repeated measures; B: unstandardized regression coefficient; 95% confidence intervals (95% CI): 95% confidence interval; FIQ: Fibromyalgia Impact Questionnaire; Clinical Global Impression-Severity Scale (CGI-S): Clinical Global Impression Severity Scale; PCS: Pain Catastrophizing Scale; HADS comprises two subscales: anxiety (HADS-A): Hospital Anxiety and Depression Scale-Anxiety; HADS-D: Hospital Anxiety and Depression Scale-Depression; EQ-5D-VAS: Visual Analogue Scale from EuroQol; AAQ-II: Acceptance and Action Questionnaire
Summary
Fibromyalgia (FM) is a disabling syndrome of unknown etiology mainly characterized by widespread musculoskeletal pain and symptoms such as fatigue, stiffness, sleep problems, perceived cognitive dysfunction, and distress [1]. AIR was originally designed for patients with CFS [17] as a method of hypothetically reducing chronic over-sensitization and heightened fear response of the amygdala which may underlie some of the symptoms related to both CFS and FM [17,18] These specific techniques aim to retrain conditioned somatic signaling in the brain which may keep the nervous system and the immune system in a state of heightened arousal. This suggests a potential biological path driving part of the benefits of mind–body interventions in FM Taking this state of the question as its foundation, the objective of this 8 week parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT; [19]) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and BDNF in serum. Our general exploratory hypotheses where that: (a) MAIR would result in significantly superior improvements in primary (i.e., FM functional impact) and secondary clinical variables compared with RT; and (b) MAIR would be related with decreases in pro-inflammatory markers and BDNF levels as well as significantly greater increases in the anti-inflammatory markers in comparison to RT
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