OBJECTIVETo observe the clinical effect and safety of modified Bushen Zhuanggu Recipe (BZR) in treating ankylosing spondylitis (AS).

METHODSRecruited were 96 AS outpatients of Shen deficiency induced cold-dampness syndrome (SDCDS) or Shen deficiency dampness-heat syndrome (SDDHS) at clinics of China-Japan Friendship Hospital from May 2010 to May 2011. They were randomly assigned to the traditional Chinese medicine (TCM) treatment group and the Western medicine (WM) treatment group in the ratio of 1:1. Those in the TCM treatment group were syndrome typed as the SDCDS group (group A, 22 cases, treated by Bushen Zhuanggu Quhan Decoction + WM placebos) and the SDDHS group (group B, 26 cases, treated by Bushen Zhuanggu Qinghua Decoction +WM placebos). Those in the WM treatment group were syndrome typed as SDCDS group (group C, 27 cases, treated by SASP + TCM placebos) and the SDDHS group (group D, 21 cases, treated by SASP +TCM placebos). Totally 12 weeks consisted of one therapeutic course. BAS-G, BASFI, BASDAI, spine pain, pain at night, TCM symptom score, distance between occipital and wall, distance between finger and ground, thoracic activity, spine activity, Schober test, ESR, CRP were observed as the observing indices; ASAS20, ASAS50, ASAS70, BASDAI50, and criteria of TCM were explored for clinical evaluation and safety evaluation.

RESULTSIn comparison with the same group before treatment,BAS-G, BASFI, BASDAI, spine pain, pain at night, TCM syndrome score,distance between finger and ground, Schober test, ESR, and CRP were improved after treatment (P < 0.01, P < 0.05). In group A and C, thoracic activity and spine activity were getting better (P < 0.01, P < 0.05). In group B distance between occipital and wall and spine activity were getting better (P < 0.01, P < 0.05). In comparison with group C, BAS-G, BASFI, BASDAI, spine pain, distance between finger and ground,thoracic activity,spine activity, Schober test, ESR, CRP were getting better in group A after treatment (P < 0.01, P < 0.05). In comparison with group D, BASFI, BASDAI, spine pain, pain at night,distance between finger and ground, distance between occipital and wall, spine activity, Schober test, and ESR were getting better in group B after treatment (P < 0.01, P < 0.05). The total effective rate, ASAS20, ASAS50, ASAS70, and BASDAI50 were higher in the TCM treatment group than in the WM treatment group (P < 0.05).

CONCLUSIONModified BZR was more effective than SASP method in relieving clinical symptoms and signs, TCM syndrome scores, and inflammatory activity indicators of AS patients.