| Objective To summarize theory, methods and design of clinical trials literature on TCM for the treatment of Hp and analyze dominant and insufficient position.A systematic review about eradication rate of Hp by TCM combined with standard triple therapy. To evaluate the efficacy and safety of TCM decoction and powder combined with standard triple therapy on improving eradication rate of Hp according to a multiple center RCT. At last, to discuss and expect the theory and clinical trials.Methods Systematic review:Defining scrupulous inclusion and exclusion criteria of literature, Searching fully literature on TCM combined with standard triple therapy treating Hp, then evaluating and preparation by screening, finally Meta-analyzing all the inclusion literature, to evaluating efficacy and safety. Clinical trial:A multi-center randomized control clinical trial design was adopted in the trial. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences. Group A was control group, was given standard triple therapy-omeprazole20mg, amoxicillin1.0g, clarithromycin0.5g, twice a day, lOdays. Group B,C,D were all experiment group, were given respectively TCM powder-twice a day,2weeks combined with standard triple therapy, TCM decoction-twice a day,4weeks combined with standard triple therapy, TCM decoction-twice a day,2weeks combined with standard triple therapy. Patients were examined Hp and some other observation quota at the point that1month after stopping west medicine.Results Systematic review:Finally inclusion literatures for meta-analyzing were7. There were1115subjects in all, among which669were experiment group,446were control group, and57were withdrawed-45were failed visit,6were taken medicine by doctor,6were break off for adverse reaction. Every study reported ordinary circumstance-gender, age and so on of patients, and baseline was comparable. Eradication rate:TCM combined with west medicine and single west medicine had the statistically significant difference (P=0.005, RR=1.12,95%Cl [1.03,1.21]). For PU, the differences were statistically significant between the experimental and control group (P=0.02, RR=1.13,95%Cl [1.02,1.25]). For CG, the differences were not statistically significant between the experimental and control group (P=0.39, RR=1.22,95%Cl [0.78,1.91]). For period of treatment-7days, the differences were not statistically significant between the experimental and control group (P=0.05, RR=1.09,95%Cl [1.00,1.18]). For course of treatment-14days, the differences were not statistically significant between the experimental and control group (P=0.01, RR=1.35,95%Cl [1.08,1.70]). For Chinese patent drug, the differences were not statistically significant between the experimental and control group (P=0.25, RR=1.07,95%Cl [0.95,1.22]). For Chinese decoction medicine, the differences were statistically significant between the experimental and control group (P=0.0009, RR=1.17,95%C1[1.07,1.29]). Adverse reaction:the differences were not statistically significant between the experimental and control group (P=0.14,OR=0.47,95%Cl [0.17,1.27]). For Chinese decoction medicine, the differences were statistically significant between the experimental and control group (P=0.004, OR=0.27,95%Cl [0.11,0.66]). Coalescence rate:the differences were not statistically significant between the experimental and control group (P=0.46, RR=1.16,95%Cl [0.79,1.70]). Clinical trial:768were included, and707were screened for FAS,686were screened for PPS,714were screened for SS. All patients’gender, age, medical history, combined disease, combined medicine, symptom scores, scores of SF-36and scores of PRO didn’t have statistically significant difference at baseline (P>0.05). In FAS, eradication rate of Hp:Group A were67.6%, Group B were76.0%, Group C were78.9%, Group D were81.1%, and there were statistically significant difference in4groups (P=0.0489<0.05), but only Group A and Group C (P=0.0081<0.0083), Group A and Group D (P=0.0065<0.0083) had statistically significant difference in2groups. In PPS, eradication rate of Hp:Group A were67.6%, Group B were76.6%, Group C were78.1%, Group D were80.4%. For FAS, the socres of symptom:the scores after treatment had statistically significant difference from before in every group (P<0.05).But there were not statistically significant difference in4groups (P>0.05). For FAS, the socres of SF-36:the scores after treatment had statistically significant difference from before in every group (P<0.05).Only in body pain, there were statistically significant difference in4groups (P<0.05), and only between Group A and Group D there were statistically significant difference (P<0.05). For FAS, the socres of PRO:the scores after treatment had statistically significant difference from before in every group (P<0.05). Only in regurgitation and dyspepsia, there were statistically significant difference in4groups (P<0.05), and for regurgitation, only between Group A and Group D there were statistically significant difference (P<0.05), for dyspepsia, between Group A and Group C, between Group A and Group D there were both statistically significant difference (P<0.05). There were not any quota change of laboratory test between before and after treatment.23adverse reaction probably relevant with trial medicine happened in the treatment.11events happened in Group A (6%),7events happened in Group B (4%),2events happened in Group C (1.1%),3events happened in Group D (1.7%). There was not any serious adverse reaction happened. There were statistically significant difference in4groups (P<0.05), and only between Group A and Group C, between Group A and Group D there were both statistically significant difference (P<0.0083).Conclusions systematic review:Hp eradication rate:TCM combined with west medicine group was better than single west medicine group, for PU and FD, there were both statistically significant difference between two groups, but for CG, there were not. Eradication rate had nothing to do with course of treatment, and there were both statistically significant difference between two groups in7days and14days. For Chinese patent drugs, there were not statistically significant difference between two groups, but for Chinese decoction medicine, there were. Among7trials,4trials reported the happening of adverse reaction.there were not statistically significant difference between two groups, but adverse reaction happening rate of Chinese decoction medicine combined with west medicine was less, the difference was statistically significant.Clinical trial:Treatment based on syndrome differentiation combined with standard triple therapy group was better than standard triple therapy group in Hp eradication rate, improvement of quality of life and PRO and adverse reaction happening rate. |
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