OBJECTIVETo evaluate the efficacy and safety of Bushen Qiangji Granule (BQG) in treating ankylosing spondylitis (AS) patients with Shen-deficiency and blood-stasis syndrome.

METHODSA randomized controlled and single-blinded prospective clinical trial was carried out on 68 patients, who were randomly assigned into the BQG group treated with BQG alone and the combined treated (CT) group treated with BQG and sulfasalazine, six-month medication was successively applied to both groups. The therapeutic effects were evaluated before treatment and at the end of the 1st, 3rd and 6th month of the treatment.

RESULTSThe total effective rate was 81.82% in the BQG group and 86.82% in the CT group after 6 months of treatment, showing no significant difference between the two groups, but that after 1 months of treatment in the BQG group was lower than that in the combined group (15.15% vs. 27.59%, P < 0.01). Bath AS disease activity index (BASDAI), Bath AS function index (BASFI), and clinical symptoms such as ache and morning stiffness, as well as indexes of Schober test, activity of thoracic cage, finger-ground distance, erythrocyte sedimentation rate (ESR) and Creactive protein (CRP) in both groups were improved remarkably. BQG showed a time-dependant' effect, the therapeutic effect intensified as the time went by (P < 0.05 or P < 0.01). Moreover, the effect initiating time was earlier in the CT group than that in the BQG group.

CONCLUSIONBQG has satisfactory efficacy, good safety and compliance, and is convenient for administering, therefore, it has broad applying prospect with high exploiting value.