Traditional Chinese medicine collaborative care in the management of patients with axial spondyloarthritis: long-term outcomes of a pragmatic randomised controlled trial through week 52

Acupuncture has been postulated to have analgesic and anti-inflammatory effects. We report the secondary outcomes through week 52 of a pragmatic randomised controlled trial that evaluated the effectiveness of a Traditional Chinese Medicine (TCM) collaborative model of care (TCMCMC) involving acupuncture in patients with axial spondyloarthritis (axSpA). Primary and exploratory outcomes reported previously showed that the intervention group had improved spinal pain, disease activity and disease-specific quality of life at week 6. Eligible patients with active axSpA were randomised to intervention or control group. The intervention group received TCMCMC (10 TCM consultations and acupuncture over the first five weeks). Both intervention and control groups received usual rheumatologic care. Secondary outcomes through 52 weeks over follow-up time-points at weeks 6, 12, 24 and 52 included spinal pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Patient Global Score (BAS-G), Health Assessment Questionnaire (HAQ), 36-item Short Form survey (SF-36) and Ankylosing Spondylitis Quality of Life (ASQoL). Repeated measures analyses were conducted using linear mixed models. A total of 139 patients were recruited, with 70 and 69 assigned to the intervention and control group respectively. Using a linear mixed model, the average treatment effects across weeks 6, 12, 24 and 52 for spinal pain, BASDAI, BASFI, HAQ, BAS-G, SF-36 Physical Component Summary, SF-36 Mental Component Summary and ASQoL were not statistically significant. The TCMCMC approach showed short-term benefits in spinal pain, disease activity and disease-specific quality of life at week 6 compared to usual rheumatologic care, but benefits were not sustained through 52 weeks. ClinicalTrials.gov, NCT03420404 (registered on 14 February 2018).