| Objectives: To evaluate the efficacy and toxicity of Tripterygium wilfordii HookF (TWHF) extract in the treatment of rheumatoid arthritis (RA).Methods: Relevant randomized trials in any language were sought using thefollowing sources: CENTRAL, PUBMED, EMBASE, CBM (all up to November2010). The reference section of retrieved articles and some health care journalswere handsearched. Two reviewers independently identified studies for inclusion,assessed methodological quality of the included studies and extracted data from thoseincluded trials. RevMan software 5.0 was used for meta-analysis. The primaryoutcomes were ACR20/50/70. The secondary outcomes were tender and swollen jointcount, acute phase reactants such as ESR or C-reactive protein (CRP), radiographicbone changes and so on. The safety outcomes were total number of patients withadverse effects, toxicity-related withdrawals and total number of withdrawals anddrop-outs.Results: Ten studies met the inclusion criteria. The dosage of TWHF ranged from 30mg/d to 360mg/d with the duration of treatment at least for 12 weeks. 3 of themcompared TWHF with placebo, 2 compared TWHF with SSZ, 3 compared TWHFwith MTX, 2 were trials comparing TWHF plus MTX (7.5mg/qw) with MTX(15mg/qw). Those 3 trials comparing TWHF with placebo, one of trials comparingTWHF with SSZ and one of trials comparing TWHF with MTX were of high quality.Others'quality was poor and their sample size was small. Among those trialscomparing TWHF with placebo, the primary outcomes were available only in onestudy. The ACR20 and ACR50 were statistically significantly higher in higher dose ofTWHF (360mg/d) group than in placebo group. ORs were 21.47 (95%CI 4.00-115.20)and 12.88 (95%CI 1.85-89.61). When lower dose of TWHF (180mg/d) was comparedwith placebo, ACR 20 was statistically significantly higher ( OR9.97, 95%CI 1.22–81.60). However, ACR50 was not statistically significantly different(OR 7.39,95%CI0.15-372.38). The meta analysis for secondary outcomes showed that TWHF hadbetter effect than placebo in reducing tender and swollen joint count, duration of morning stiffness and level of ESR and CRP. However there were higher rates of toxicity-related withdrawal and total withdrawal and drop-out. Among trials comparing TWHF with DMARD, only one study reported the primary outcomes which showed ACR20/50/70 were all statistically significantly higher in TWHF than in SSZ group, RRs were 1.98 (1.32, 2.97),6.78 (2.12, 21.62) and 10.17 (1.34, 76.99), respectively. For secondary outcomes, one trial reported Sharp–vander Heijde score (0-440), Change from baseline showing that the score was significantly reduced in TWHF group, compared with SSZ group. Mean difference(MD) was -4.05 (-4.74 to -3.36). Another trial compared TWHF with MTX and found that the score (end point value) was significantly higher in TWHF group. MD was 2.00(1.30,2.70). All the trials which reported the primary outcomes had small sample sizes. Effect size estimation was not precise because of wide range of 95% CI.Conclusion: Compared to placebo or SSZ, TWHF may increased the ACR response rate in RA patients and benefit them at other secondary outcomes. Toxicity-related withdrawal was more frequent than placebo, but less than SSZ group. The efficacy and toxicity of TWHF in the treatment of RA needs sufficient evidence of RCTs with high quality and large sample size.
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