Traditional Chinese Medicine as a Complementary Therapy in Patients with Ankylosing Spondylitis: An Open Pilot Study

Objectives: Ankylosing spondylitis (AS) is a chronic inflammatory autoimmune disease involving joints, entheses and spine. Therapies for AS are unsatisfying in some patients because of poor efficacy, adverse reactions, and high cost. Traditional Chinese Medicine (TCM) might have the potential to serve as adjuvant therapies in AS. Hence, we conducted this open pilot clinical trial to explore potential TCM formulae for further randomized controlled studies. Methods: Thirty-four patients with AS and stable background medication for 3 months, were enrolled. Patients received an additional TCM formula for 3 months according to their syndrome patterns in relation to traditional Chinese medicine. Five TCM formulae: Dang Gui Lian Tong Tang (A), Yi Ⅰ Ren Tang (B), Gui Zhi Shao Yao Zhi Mu Tang (C), Huang Qi Wu Wu Tang (D), and Qiang Huo Sheng Shi Tang (E), were chosen for this study. Outcome measurements included ASAS-20 response criteria, Bath AS Disease Activity Index (BASDAI), Functional Index (BASFI), Global Index (BAS-G), IgA, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Intention-To-Treat (ITT) analysis and Wilcoxin Signed Rank Test were used for statistical analyses. Results: Among 34 patients enrolled, 9 patients dropped out, and 9 patients achieved ASAS-20 response criteria. No serious adverse events were reported in this 12-week trial. In patients who received Huang Qi Wu Wu Tang (D), 2 out of 6 (33.3%) reached ASAS-20 response criteria. In 10 patients who received Qiang Huo Sheng Shi Tang (E), 3 (30%) were responders. Conclusions: In this study, Qiang Huo Sheng Shi Tang had potential adjuvant effects in the treatment of AS. Further double blind randomized controlled trials are needed to prove their efficacy.