Clinical Efficacy of Modified Yanghe Decoction in Ankylosing Spondylitis: A Randomized Controlled Trial.

BACKGROUND This study evaluated the effects of Modified Yanghe Decoction on pain, disease activity, and functional capacity, and its safety in subjects with ankylosing spondylitis (AS). MATERIAL AND METHODS A randomized, controlled study of subjects with AS was conducted over 8 weeks to compare the efficacy of the Modified Yanghe Decoction to celecoxib-sulfasalazine therapy. Subjects were evaluated at visit 1, and at weeks 4 and 8 of the trial. The Bath ankylosing spondylitis disease activity index (BASDAI), nocturnal back pain (NBP), total back pain (TBP), patient global disease activity (PGDA), the Bath ankylosing spondylitis functional index (BASFI), and the Bath ankylosing spondylitis metrology index (BASMI) were measured at each time point. Safety was monitored throughout the study through blood, urine, and stool samples, along with heart, liver, and kidney function tests. The ASAS 20 improvement criteria were used as efficacy criteria. RESULTS A total of 80 subjects were included. Both treatment groups were effective: 32 subjects (80%) in the Modified Yanghe Decoction group and 34 (85%) in celecoxib-sulfasalazine group met ASAS 20 improvement criteria; no statistically significant difference between groups was observed (P>0.05). Two subjects in the Modified Yanghe Decoction group reported mild diarrhea during the trial. In the celecoxib-sulfasalazine group, 8 subjects experienced upper-abdominal pain; in 3 subjects this was combined with lowered white blood cell count and in 1 subject it was combined with mild proteinuria. This represents a statistically significant difference in safety (P<0.05) between the 2 treatments. CONCLUSIONS This study demonstrates the efficacy and safety of the Modified Yanghe Decoction in AS treatment, especially for patients who have poor clinical responses, severe adverse reactions, or for patients unable to afford the standard clinical options.