ABSTRACT
Objective To evaluate the efficacy and safety of Shuangyi Qushi Tongluo Capsules (SQTC) for the treatment of knee osteoarthritis (KOA).Methods A multi-center,randomized,parallel-controlled trial was carried out in 240 cases of KOA patients.The patients were divided into trial group (N =120) and control group (N =120),which was given SQTC,Xianlinggubao capsules respectively for 8 weeks.Before treatment,and 2,4 and 8 weeks after treatment,we recorded the scores of clinical symptoms and traditional Chinese medical syndromes,Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores and knee function scores.After treatment,the clinical efficacy and adverse reaction were observed.Results (1) After treatment for 8 weeks,the clinical efficacy of the trial group was superior to that of the control group (P ＜ 0.05).(2) The trial group had better effect on improving the visual analogue scale (VAS) scores of knee pain,VAS scores of limitation of motion and time for morning stiffness than the control group after treatment for 8 weeks(P ＜ 0.05 or P ＜ 0.01).(3) After treatment for 4 and 8 weeks,the trial group had better effect on improving scores of traditional Chinese medical syndromes,WOMAC scores and Japanese Orthopedic Association(JOA) scores than the control group (P ＜ 0.05 or P ＜ 0.01).(4) Before and after treatment,the results of blood,urine and stool routine examination,liver and kidney function,and electrocardiography showed no significant changes.Conclusion SQTC are effective and safe in treating KOA,and can start an effect shortly.
ABSTRACT
Objective To evaluate the effectiveness and safety of Shuangyi Qushi Tongluo Capsules ( SQTC) in treating ankylosing spondylitis (AS), and to explore the synergistic action of SQTC combined with sulfasalazine. Methods A randomized and parallel-controlled trial was carried out in 80 AS patients. The enrolled subjects were evenly randomized into testing group and control group. Both groups were given oral use of sulfasalazine enteric-coated tablets, and the testing group was additionally given oral use of SQTC, which is mainly composed of silky ant (Formica Fusca), black-winged Termitidae, Scorpio, Radix Ginseng, Radix Astragali, Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Flos Carthami, Radix Salviae Miltiorrhizae, Radix Achyranthis Bidentatae, Caulis Spatholobi, Herba Epimedii, and Radix Morindae Officinalis. The treatment for the two groups covered 24 weeks. On treatment week 4, 12, 24, we recorded the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), visual analog scale (VAS) scores of rachialgia, patients’ general assessment (PGA), VAS scores of night pain, spondylitis scores, Bath Ankylosing Spondylitis Functional Index ( BASFI) , Bath Ankylosing Spondylitis Metrology Index ( BASMI) , scores of the quality of life ( QOL) , erythrocyte sedimentation rate ( ESR) , C-reactive protein ( CRP). Moreover, the adverse reaction of the two groups was also monitored. Results ( 1) Compared with the control group, testing group had high ASAS 20 percentage on treatment week 4, 12 and 24 (P0.05). Conclusion SQTC are effective and safe in treating AS, starting an effect shortly and having synergistic effect on salfasalazine for the treatment of AS.