| Objective:To observe the clinical efficacy,mental state and quality of life of modified Liangfu Sijunzi decoction on chronic atrophic gastritis with deficiency of cold in the spleen and stomach,so as to clarify the therapeutic effect of modified Liangfu Sijunzi decoction,and provide more reference for guiding clinical treatment.Method:In this study,the eligible subjects were randomly divided into 2 groups,with 30 cases in individual group,and the corresponding treatment plan was given in accordance with the design.The treatment group was given Liangfu Sijunzi decoction,while the control group was given Wenweishu capsule with a treatment course of 3 months.At different observation points,the information was collected(including TCM syndrome score,HAMA/HAMD score and SF-36 quality of life questionnaire score),and the scores were compared within and between groups.The efficacy,safety and long-term effect of Liangfu Sijunzi decoction on chronic atrophic patients with spleen-stomach deficiency cold type were objectively and comprehensively evaluated.Results:1.Total effect of TCM symptoms:The entire effective rate towards TCM symptoms of the treatment group is 86.67%which is more effective than the control group’s:63.33%(P<0.05).Both groups were able to improve the patients’ symptoms.2.Total score of TCM symptom:At 1 month of treatment,the total scores,principal symptom scores and secondary symptom scores of the two groups were markedly fell(P<0.01).The total scores and minor symptom scores in the treatment group decreased compared with those in the control group(P<0.05),and the improvement of the total score and principal symptoms in the two groups reached a plateau(P>0.05).At 3 months of treatment,the total scores,principal symptom scores and secondary symptom scores in both groups were decreased(P<0.01or0.05),and the total scores and secondary symptom scores in the treatment group were decreased sharply compared with those in the control group(P<0.01),the decrease of principal symptoms in the two groups reached a plateau(P>0.05).After 1 month of withdrawal,the three total scores reached a plateau compared with 3 months(P>0.05),but the total scores and the sub-symptom scores of the treatment group were sharply decreased compared with those of the control group(P<0.01),the main symptom score of the treatment group was lower than that of the control group(P<0.01).3.Single symptom score of TCM:At 1 month of treatment,all the symptoms were improved in the treatment group(P<0.01or0.05).The control group was able to improve the symptoms of gastric bloating and pain,warm preference,stagnation,body tiredness and fatigue,and postprandial depression(P<0.05),but the curative effect of body tiredness and fatigue as well as postprandial depression of the treatment group was more dominant than that of the control group(P<0.05).At 3 months of treatment,all the symptoms except for single symptom score of gastric bloating and pain were considerably improved in the experimental group(P<0.05),and the control group could further improve warm and pleasant massage,stagnation,tiredness,as well as postprandial depression(P<0.05).The single symptom score of gastric bloating and pain in the two groups reached a plateau compared with those at 1 month of treatment(P>0.05).The effect of the treatment group was more beneficial than that of the control group in stagnation,tiredness,as well as postprandial depression(P<0.05).At 1 month of withdrawal,the symptoms of the both groups were remained steadily(P>0.05).4.HAMA/HAMD scores:At 3 months of treatment,the scores of HAMA and HAMD in both groups dropped considerably(P<0.01).At 1 month of withdrawal,the scores of HAMA and HAMD in the treatment group reached a plateau(P>0.05),while the scores of HAMA in the control group soared(P<0.01),the scores of HAMD were reached a plateau(P>0.05).The improvement of anxiety and depression in the treatment group was considerably more beneficial than that in the control group(P<0.01).5.SF-36 quality of life score:At 3 months of treatment,the treatment group in 8 dimensions such as physical function,role physical,bodily pain,general health,vitality,social function,role emotion and mental health were considerably improved(P<0.01).In the control group,there was considerable effect in role physical,general health,social function and role emotion(P<0.01),slight effect in physical function,bodily pain,vitality(P<0.05),and no effect in mental health(P>0.05).The treatment group had more beneficial efficacy than the control group in role physical,bodily pain,role emotion and mental health(P<0.01).The health status of the two groups in physical function,general health,vitality and social function were similar(P>0.05).At 1 month of withdrawal,there were no significant changes in 8 dimensions in both groups(P>0.05).The health status of the treatment group in 6 dimensions of role physical,bodily pain,general health,vitality,role emotion,mental health had more beneficial efficacy than that in the control group(P<0.01or0.05).The dimensions in both physical function and social function were comparable(P>0.05).6.Long-term effect:At the follow-up visit after 1-month of drug discontinuation,the recurrence rate of the treatment group is 16.67%which is as effective as the control group’s:26.67%((P>0.05).7.Safety:There were no serious adverse reaction in both groups.Conclusion:The modified Liangfu Sijunzi decoction could improve chronic atrophic gastritis of spleen and stomach deficiency cold syndrome,decrease the score of TCM syndrome,release anxiety and depression,promote the quality of life from the physical and mental well-being.Therefore,the modified Liangfu Sijunzi decoction can bring more clinical benefits to patients. |
PDF Full Text Request