Clinical Study of Jitongning Capsule in the Treatment of Ankylosing Spondylitis

Objective To evaluate in a large open study if Jitongning capsule is potentially useful in the treatment of ankylosing spondylitis, and observe the safety of Jitongning capsule. Methods Sixty-five patients with ankylosing spondylitis were recruited. Jitongning capsule group were thirty-five patients, using Jitongning capsule at a dose of 4.2 g/d. The control group was using Sulfasalazine. There were thirty patients, using Sulfasalazine at a dose of 2.0 g/d. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), patient’s global assessment, total body pain, spinal pain and night pain, ESR and CRP were measured at 1, 3, 6 months. The primary end point in this study was the proportion of patients with a 20% improvement response according to the ASAS International Working Group criteria (ASAS20 responders) at month 1, 3, 6. Results The study was completed on 56 patients. The treatment group was completed on 33 patients. The control group was completed on 23 patients. Side effects of two groups were uncommon and well tolerated. The ASAS20 was achieved by 66.67% of patients in the treatment group and by 60.86% of patients in the control group at month 6. Conclusion Jitongning capsule can treat the patients of earlier and mid-half ankylosing spondylitis. That is safety and similar to Sulfasalazine.