ABSTRACT
BACKGROUND: Total glucosides of paeony, effective component extracted from peony, has good inflammatory and analgesic effect. OBJECTIVE: To investigate the curative effect and side effect of total glucosides of paeony combined with methotrexate and sulfasalazine in the treatment of ankylosing spondylitis. DESIGN: Randomized and controlled observation SETTING: Department of Rheumatology , Guangdong Hospital of Traditional Chinese Medicine PARTICIPANTS: Totally 80 inpatients with ankylosing spondylitis hospitalized in the Clinic of Department of Rheumatology, Guangdong Hospital of Traditional Chinese Medicine from June 2003 to April 2004 were involved. The patients were randomly divided into 2 groups with 40 patients in each group. Informed consent was obtained. METHODS: Experimental group: 2 capsules of total glucosides of peony was taken orally, three times per day; methotrexate 10 mg/time, once per week; sulfasalazine 0.5 g/time, three times per day. Control group:methotrexate and sulfasalazine were taken orally and the dosage and method were the same as those in the experimental group. Two groups all used the same NSAID (Nimesulide) , 0.1 g/time, twice per day. The period of the treatment was 3 months. Evaluation of spinal column function and laboratory examination was performed before treatment and 4, 8 and 12 weeks after treatment. MAIN OUTCOME MEASURES: Primary outcomes: Bath ankylosing spondylitis activity index, Bath ankylosing spondylitis function index [1-2],duration of morning stiffness, systemic pain and spinal pain on a four point Likert scale, overall assessment of patient and physician on a four point scale. Secondary outcomes: ①erythrocyte sedimentation, C-reaction protein,Schober test, chest expansion, Occiput to wall distance and finger to floor distance.② Adverse events and side effects. RESULTS: The observation of 38 patients in the experiemtnal group and 37 patients in the control group was completed. ①Result of Bath ankylosing spondylitis activity index, Bath ankylosing spondylitis function index,duration of morning stiffness, pain and spinal pain on a four point Likert scale, overall assessment of patient and physician on a four point scale:The indices at week 4, 8 and 12 werevmore significantly decreased than those before treatment in each group (P ＜ 0.05); the Bath ankylosing spondylitis activity index, pain and spinal pain on a four point Likert scale,overall assessment of patient and physician on a four point scale at week 4and all the indices at week 8 and 12 were more significantly decreased than those in the control group (P ＜ 0.05). ② Evaluation result of Erythrocyte sedimentation rate (ESR) and C reaction protein, Schober test, chest expansion , occiput to wall distance and finger to floor distance: Each index at week 4, 8 and 12 in the experimental group were significantly decreased than those before treatment (P ＜ 0.05), those at week 8 and 12 in the control group were more significantly decreased than those before treatment (P ＜ 0.05). ESR , C reactive protein (CRP) , chest expansion and finger to floor distance at week 12 in the control group were more significantly decreased . ③ Adverse events and side effects: All adverse reactions occurred transiently during the course of disease in the two groups. Undisposed or after having taken live-protective medicine, all patients recovered.Drug was not withdrawn in any case.The incidence of adverse reaction in the experimental group was lower than that in the control group [10％ (3/30),57％(17/30) ,P ＜ 0.05]. CONCLUSION: Combination of total glucosides of paeony, methotrexate and sulfasalazine has an enhanced effect and better safety without special adverse reaction in the treatment of ankylosing spondylitis.