| Objective: Meta-analysis was used to systematically evaluate the literature of applying TCM Dampness in the intervention of hyperuricemia.Methods: Electronic databases ended March 31, 2014 were retrieved,including the full text of Chinese scientific journals(VIP), Chinese Biomedical Literature Da tabase(CBM), China Academic Journal(CNKI), Chinese important conference papers database, Chinese major newspaper database, C hinese Outstanding Master’s Thesis database, Ph D thesis database, Wanfang database, the US National Library of Medicine(Medline), Cochrane Library.Randomized controlled clinical study was included in the study. The subjects were patients with hyperuricemia or gouts in remission. The treatment group used TCM Dampness intervention,the control group focused on western conventional treatment, placebo, or simulated agents.In accordance with the modified Jadad scale, the included research methodology was appraised,with which the score was over 4 points. The literature of basic information, the object of study,study design,sample size, interventions, treatment, efficacy evaluation indexes, efficacy outcomes and adverse reactions were extracted.Meta-analysis was applied on clinical total efficiency,uric acid and randomized controlled trials with the same efficacy index. The outcome and the fo rest plot were made by using Stata12.0 software.The therapeutic interventions and duration of treatment on patients were analyzed by the method of subgroup analysis and sensitivity analysis. Publication bias was evaluated by the adopted Egger’s test and Begg’s tests.The results:(1) The study included seven RC T of comparative test group( traditional Chinese medicine) and control group( the application of conventional treatment of Western medicine alone,placebo treatment,or mimetic control treatment). All RCT were written in Chinese, of which two were about three sets of parallel control study with 922 cases of patients with hyperuricemia. The improved Jadad scale included in the literature scored equal or over 4 points, and the average score was 5.143.(2) Metaanalysis showed that there were significant differences after treatment in terms of the total efficiency and the drop of uric acid. The experimental group was superior than the control group(z=4.24,p=0.000;z=2.38,p=0.017); A significant difference was shown in the degree of the decline of LDL. The experimental group was inferior than the control group(z=2.44,p=0.015); There was no significant difference between treatment group and the control group in terms of high-density lipoprotein ﹑triglycerides﹑total cholesterol(z=1.78,p=0.076;z=1.82,p=0.069;z=1.05,p=0.296).(3) According to patient treatment time, subgroup analysis was conducted. After treatment, there was a significant difference between the experimental group and the control group in the total clinical efficiency. When the treatment time was equal or less than 30 days, the experimental group was superior than the control group(z=2.55,p=0.011); While the experimental group was significantly different from the control group when the treatment duration was more than 30 days,that was, the experimental group was superior than the control group(z=4.34,p=0.000). After treatment, when the treatment time was equal or less than 30 days, there was no significant difference between test gro up and control group(z=1.08,p=0.281) on the degree of the decline of uric acid; while when the treatment duration was over 30 days,the experimental group and the control group were significantly different,that was,experimental group was inferior than the control group(z=2.65,p=0.008).(4) New discovery was found on interventions by subgroup analysis. When positive drug was used as a control drug,there was no significant difference between experimental group and the control group in the overall clinical e fficiency after treatment(z=1.42,p=0.155;z=0.85,p=0.396). Using placebo or blank mimetic as a control drug,there was a significant difference between the experimental group and the control group after treatment, and experimental group was superior than the control group(z=5.44,p=0.000). In terms of the decreasing degree of uric acid, the positive drug of allopurinol was used as a control group. The treatment group and the control group were significantly different after treatment. The control group was inferior thanthe treatment group(z=2.11,p=0.035). The reason for this outcome could be a small number of included studies. With the increasing number of trials, this result needed to be verified further.There was no significant difference between the test and the positive drug of Benzbromarone(z=1.89,p=0.059). Using placebo or b lank mimetic as a control drug,there was a significant difference between the experimental group and the control group after treatment,and experimental group was inferior than the control group(z=3.30,p=0.001).(5) The sensitivity analysis showed that the results was stable.(6) there was no significant publication bias in the inverted funnel plot.(7) After using the CONSORT for TCM Statement to evaluate the quality of clinic trials, the titles and the outcomes of the literatures which were included didn’t meet the standards of the statement. But they definitely described the introduction,methodology and discussion. There is no one which had set the terminal index, described the subjects compliance, drawn the flowchart and discussed the possibility of the other substantial bias.Conclusions:(1) the use of Chinese medicine Dampness could improve clinical symptoms of hyperuricemia, reduce uric acid, and the incidence of adverse events.(2) Subgroup analysis showed that compared with using blank or mimetic, using TCM Dampness could effectively increase clinical efficiency, with no significant difference of using positive drug.Traditional C hinese Medicine could effectively reduce uric acid levels.There was no obvious advantage over Western medicine. However, in the occurrence of adverse events, Traditional C hinese Medicine treatment had certain advantages.(3) In the control and prevention of other system diseases caused by hyperuricemia, Traditional Chinese Medicine had certain potential advantages. More clinical data was needed for further validation.(4) CONSORT for TCM statement is suggested to using when reporting the quality and reality of the RCTs. |
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