Traditional Chinese Medicine (TCM) collaborative care involving acupuncture for axial spondyloarthritis: 6-week exploratory results of a pragmatic randomised controlled trial.

OBJECTIVES

This pragmatic randomised controlled trial aimed to assess the clinical effectiveness and safety of a Traditional Chinese Medicine (TCM) collaborative model of care (TCMCMC) in patients with active axial spondyloarthritis (axSpA). Here, we present the week 6 analysis.

METHODS

Patients with active axSpA (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥4), spinal pain ≥4 and inadequate response to nonsteroidal anti-inflammatory drugs were randomised to receive either usual rheumatologic care (control) or TCMCMC (intervention, ie, usual rheumatologic care with TCM consultations and 10 acupuncture sessions). Spinal pain at week 6 was the primary outcome. Evaluation of other clinical and quality of life outcomes at week 6 was exploratory.

RESULTS

We recruited 139 participants, with 69 and 70 in the control and intervention groups, respectively. Median (IQR) age was 42.0 (33.0-56.0) years and 98 (70.5%) participants were male. Spinal pain and BASDAI scores were 0.75 (95% CI: -1.46, -0.03) and 0.71 (95% CI: -1.30, -0.13) points lower in the intervention than the control group (below the minimal clinically important differences of 1.5-1.6 and 1.3-1.4, respectively). Adjustments for baseline scores did not significantly alter the results. Ankylosing Spondylitis Quality of Life scores were 1.21 (95% CI: -2.30, -0.11) points lower in the intervention after adjusting for baseline scores. 36-item Short Form Health Survey Mental Component Summary was 4.30 (95% CI: -8.03, -0.56) lower in the intervention when unadjusted, but insignificant after adjusting for baseline. Other outcomes were not statistically significant. One adverse event was observed in each group.

CONCLUSIONS

The intervention group had improved spinal pain, disease activity, and disease-specific quality of life, without significant safety risks.