| Background:According to the epidemio logical studies of recent20years,nearly half of the heart failure patients have diastolic heart failure (DHF) and the morbidity of DHF is rising yearly as the mortality of DHF close to systolic heart failure (SHF). Meanwhile, DHF is prevalent among elderly. With the development of aging society, the number of patients and death of DHF could exceed SHF in the future and the prevention and treatment of DHF could not be optimistic. Although researchers have already published a series of clinical trials of the treatment of DHF in the recent20years, there is not any treatment regimen which could reverse the process and result of the DHF patients based on EBM.The beneficial effect of drugs on chronic heart failure seem to be limited to SHF,and DHF patients could not benefit from them, so it is imperative to strengthen clinical research.In recent10years, the treatment of oral TCM could not only relieve symptoms, improve prognosis,but also prolong the survival time and improve the living quality of DHF patients, which means oral TCM has advantages and characteristics in the treatment of DHF. However, the quality and efficacy of these studies has not been evaluated systematically and the absence of clinical trail evidence meeting the requirements of EBM has affected the promotion and application of TCM.Object ive:To evaluate the effect of oral TCM in the RCTs of DHF systematically, provide reliable evidence of EBM about the efficacy and safety of oral TCM treatment of DHF and provide guidance and reference for the clinical research in this field.Methods:CENTRAL, MEDLINE,CNKI,CBM, VIP and Wan fang Database were searched from bui lding datc to Dec31,2012,without language l imit.The type of rev i ewed studies was RCT and the object was the patients accorded with DHF diagnostic standard.The interventions for the experimental group included taking single Chinese herb,Chinese herbal compound,Chinese patent medicine or combinations of above, as for the control group include taking placebo,no treatment, routine treatment or combined treatment in which the two groups given the same treatment or medication, treatment for at least4weeks.The main outcome evaluation indicators and the Surrogate outcome evaluation indicators were identified. Modified Jadad scale and Cochrane risk bias evaluation criteria were used respectively to evaluate the quality of reviewed studies.A meta analysis was performed by RevMan5.2to evaluate the intervention effect of reviewed studies.The efficient rate of categorical variable was described by RR or OR and the data of continuous variable was described by SMD with a95%confidence interval.Q test and calculation of I2were used to analyse the heterogeneity between studics,which was described by random effect model merge effect va1ue. Sub-group analysis was proposed by the heterogeneity factors. Sensitivity analysis was used to assess the stability of the results.A funnel chart was made to analyse if there was publication bias.Results:(1)This study included22RCTs which compared the combined treatment of TCM and drugs (experimenta1group)with the routine treatment alone (control group), the baseline was comparable between groups.These trials were performed by one center and all published in Chinese.(2) As the result of modified Jadad scale, there were6studies in high quality (4points),16studies in1ow-qua1ity (2-3points); According to Cochrane risk bias evaluation, all of the studies had high risk of bias.(3) According to the main outcome indicators, only1study reported a death case in control group, which made it difficult to evaluate the effcct of interventions on dcath.6trials reported adverse reaction in the process of test, which indicated that neither experimental group nor control group could induce serious adverse reactions. According to the meta analysis of the trails evaluating curative effect by Minnesota Living with Heart Failure Questionnaire, the effect of the experimental group is superior to the control group (P<0.0001).(4) According to the meta analysis of surrogate outcome indicators, compared with the control group, B/A ratio, I VRT, LAD,NY HA heart function and6MWT of the experimental group were improved significantly (P=0.003, P=0.0002, P=0.02, P<0.00001, P<0.00001). The difference of NT-BNP level between the experimental group and control group was not statistically significant (P=0.11), but the decline of BNP level of experimental group was more than that of control group (P=0.0001). Sensitivity analysis indicated that above results were relatively stable. According to the sub-group analysis, there was no statistical difference of E/A ratio between the experimental group and the control group for1month (P=0.63). The experimental group for2months increased more E/A ratio than the control group (P=0.01). The experimental group for3,6months increased more E/A ratio than the control group significantly (P=0.006, P<0.00001). According to the sub-group analysis based on LAD, compared to the control group, the effect of the experimental group for2,3months had no statistical difference (P=0.35, P=0.22), but the effect of the experimental group of6months was significantly decreased (P<0.0001). The funnel chart suggested there was publication bias.Conelus ion:Overall,.the report about TCM treatment of DHF is not normative and a mount of quality problems exist, which affects the reliability of conclusion. Studies suggest that the treatment combined with TCM and western medicine could improve patient.s with diastolic function indexes, symptoms and signs, exercise endurance, BNP level and living quality better than the western medicine routine treatment. Besides, with the course extending, the effect of combined treatment on E/A ratio and LAD is more significant, without any serious adverse reaction. However, based on this system review it is difficult to make a final conclusion in the efficacy and safety of TCM treatment of DHF. More randomized double-blind, placebo-controlled trials are required to be designed, performed and reported normatively to prove its curative effect. |
