The Study On Acupuncture Treatment Based On The Liver Regulation And Original Consolidate Therapy For Post-stroke Depression

ObjectiveTo objectively evaluate the safety and efficacy of the acupuncture treatment based on the liver regulation and original consolidate therapy for Post-Stroke-Depression (PSD), and provide a valuable clinical reference.Methods1. LiteratureThe searching method includes the electronic and manual retrieval, retrieve the PSD literature at home and abroad in recent10years of acupuncture treatment, and do literature evaluation of the quality criteria according to the Cochrane Review Handbook5.0. And a meta-analysis was used for providing theoretical evidences to the clinical research.2. Clinical Researches2.1According to the principle of RCT and the acupuncture clinical features,123patients were recruited and randomly allocated to the acupuncture group of42cases, drug group of40cases and the combined group of41cases. The acupuncture group were treated by the liver regulation and original consolidate therapy, the drug group were treated by paroxetine, while the combine group were treated with both the acupuncture and paroxetine, all three groups were treated for4weeks and have a3-month-long follow-up.2.2Single-blind method and the third party evaluation are used of clinical efficacy evaluation. The Hamilton rating scale for depression(HAMD) was applied as the primary outcome of the study, and Activities of Daily Living(Barthel index), the World Health Organization Quality of Life-BREF(WHOQOL-BREF on) were applied as the secondary outcomes; the TCM syndrome scale of spleen and stomach scale were applied as TCM syndromes outcomes; the Treatment Emergent Symptom Scale(TESS) as the safety outcome; the modified Rankin scale as the mobility outcome, along with the mortality rate and the relapse rate, the efficacy of the study was out coming.Results1. Literature study resultsSystematic reviews included23RCTs, with a total of2435patients, which are mostly small sample RCTs, when only one multicenter trial, and12trials only referred the word "random", all the tests were not mentioned the implementation of allocation concealment,3of the trials did not describe the baseline situations. Beside the adverse reactions, meta-analysis indicated that it was uncertain whether acupuncture treatment for PSD is better than drugs or not.2. The results of the RCT2.1BaselineBy analyzing the general information, HAMD, Barthel, WHOQOL-BREF, TCM syndrome scale of spleen and stomach scale, there was no statistically significant difference(P)0.05) among three groups, which indicates that the baseline among all three groups are equal.2.2HAMD scoreDifferences in scores among the three groups at each observation point were statistically significant (P<0.05).15days after treatment, the HAMD score of the acupuncture group and the combined group improve-rate was similar (P>0.05), but the two groups were significantly better than the drug group (P<0.01).30days after treatment, the differences among HAMD scores of three groups were statistically significant (P<0.05), but the cure rate between every two groups was not significantly different (P>0.05). The figure of HAMD outline showed the efficacy of three groups:Combined Group> acupuncture group>drug group.2.3WHOQOL-BREF scaleThe scores of physical, psychological and environmental aspect of the acupuncture group and the combined group were increased (P<0.05), and their efficacy were equivalent (P>0.05). Both the two groups has better efficacy than the drug group during the trial (P<0.05). There were no difference inter-and intra-three groups in the social aspect (P>0.05).2.4The TCM syndrome scale of spleen and stomachDuring the treatment, the scores of acupuncture group and combined group indicated that the patients'taste were improved (P<0.05), but the intra-group effect was equivalent (P>0.05), when the drug group didn't show obvious improvement (P>0.05).2.5Barthel indexAfter treatment, Barthel index scores of three groups increased (P<0.05). The Barthel improvement of the acupuncture group and the combined group was resembled (P>0.05), and were better than the drug group (P<0.05).2.6TESSAfter treatment, the results showed that there were less side effects on the acupuncture group and the combined group than the drug group(P<0.01).2.7Comparison of end-point(1) Follow-up end of mortality and disability ratesTelephone follow-up at three months after treatment, there were no deaths; the acupuncture group has11disability (26%), drug group has16cases disability (40%) and combined group has9cases (23%), with chi-analysis, there were no significant difference(P>0.05).(2) The relapse rateAfter the3-month-followup, relapse in the acupuncture group was6(14.3%), while the drug group was9(22.5%), and the combined group was5(12.2%), with chi-analysis, there showed no difference (P>0.05).(3) The incidence of adverse events2(4.5%) patients in the acupuncture group and3(6.8%) in the combined group had intolerable pain, while the drug group had3(9.1%) with complications.(4) Compliance analysis2people in the acupuncture group and3patients in the combined group quit because of the intolerable pain,3people in the drug group withdrew from the study because of the complications, and one was asked to take the initiative quit. All these cases have been counted in the10%drop-offs.Conelusion1. Meta-analysis results showed that the collected trials were mostly small randomized controlled trials, and the acupuncture treatment was probably equivalent, which more high quality needs randomize controlled trials to further confirm.2. Acupuncture treatment based on the liver regulation and original consolidate therapy for PSD has a curative and no worse efficacy to the drug treatment.3. The liver regulation and original consolidate therapy was clearly established the criteria and safety of acupuncture treatment for PSD, and the points and operation is fixed, which improve the patients'life quality.