Comparative efficacy of Ba-Duan-Jin and pregabalin in the treatment of fibromyalgia: An RCT with an exploratory analysis based on fMRI.

A clinical study used pregabalin as a control to test the effectiveness and safety of Ba-Duan-Jin for fibromyalgia (FM) and explore the relation with brain function. This was a 12-week, prospective, randomized, single-blind trial with 36-week follow-up. A total of 104 FM patients were randomly assigned to Ba-Duan-Jin or pregabalin group. The primary outcome was the pain visual analogue scale score, and the secondary outcome was a series of specialized assessment scales regarding other common FM symptoms. Functional magnetic resonance imaging (fMRI) data of patients before and after treatment were collected. After treatment, both groups showed significant improvements in pain, fatigue, sleep, depression and other aspects, achieving nearly identical results, except that sleep improvement in the Ba-Duan-Jin group was less than that in the pregabalin group at 4 weeks. Most of these improvements were maintained at the 12-week follow-up, with pain and quality of life improvements lasted until 36-week follow-up. The exploratory fMRI results showed elevated degree centrality (DC) values in the parahippocampal gyrus (PHG) of the brain in patients who responded adequately to the treatment with the Ba-Duan-Jin (P < 0.005), and the pre-treatment DC values of the PHG were positively correlated with the improvement in overall symptom severity and sleep quality (P < 0.05) in Ba-Duan-Jin group. In conclusion, aside from insomnia, both Ba-Duan-Jin and pregabalin demonstrated similar improvements in FM. Ba-Duan-Jin may brings new strategies for pain management in FM patients by targeting the PHG, and the DC of PHG may be associated with Ba-Duan-Jin's efficacy. PERSPECTIVE: The results of this study demonstrate that the Ba-Duan-Jin may provide additional option for the multidisciplinary management of fibromyalgia patients.