| Object The study aimed to explore the clinical efficacy and safety of the classic medicated diet immortal porridge which was on the basis of standardizing and improving the production among the suffers with chronic fatigue syndrome(CFS)caused by spleen and kidney yang deficiency.It can lay foundation for the latter mechanism study of CFS,promote the clinical application for CFS patients,as well as provide scientific basis for further development of medicinal products.And the classic diet prescriptions used in clinical practice can promote the therapeutic thought of "zhiweibing",show the characteristics and advantages of the Chinese medicinal diet,in health,health care and prevention,rehabilitation in chronic disease,promoting the development of the TCM of diet.Methods The study was a randomized controlled trail.Accroding to the inclusion criteria,,86 CFS patients caused by spleen and kidney yang deficiency recruited by convenience sampling in Sichuan Provincal hospital of TCM from January 2016 to August 2016 were included.They were randomly divided into experimental group(n=43)and control group(n=43).Before the clinical study,the edible dose,method,course and of the immortal porridge were scientifically adjuste and rationally improved by refercncing a large number of reviews,consulting experts and basing on the pre-experimental results,as well as cooking menthod.The control group was performed health education with individual and collective guidance for a period of eight weeks by using the form of health education instruction manuals,lectures,telephone,QQ.The experimental group was performed immortal porridge for 8 weeks on the baisis of the control group.To evaluate the improvement of clinical symptoms,several scales such as the Fatigue Scale-14(FS-14)?Fatigue Severity Scale(FSS)?Somatic and Psychological Health Report(SPHERE)?Clinical Syndrome of Traditional C hinese Medicine were mearsured in three times which were pre-intervention,the fourth and eighth week after intervention,as well as the Self-rating anxiety scale(SAS)?Self-rating Depression Scale(SDS)and short form 36 questionnaire(SF-36)evaluating the depression,anxiety and quality.The scores calculated in FSS and spleen kidney yang deficiency syndrome before and after intervention were evaluating of the clinical effect of immortal porridge intervention on CFS according to the criteria in the guideline of clinical trials of traditional Chinese medicine.Meanwhile,the whole research period to whether the adverse effects of the occurrence of the object were observed to assess its safety.Result 76 cases finished all the study.The experimental group were 37 cases(four cases lossed,two cases excluded),while the control group 39 cases(three cases lossed,one cases excluded).research results show: 1.Clinical symptom evaluation 1.1 Fatigue evaluation(1)Fatigue symptom: After the intervention,the experimental group at fourth and eighth weeks of FS-14 scores and Physical fatigue and mental fatigue scores were lower than the control group(P<0.05).Repeated measures analysis of variance(ANOVA)showed: the within-subject effect,teated effect and the interactive effect were of significantance(P <0.05).The scores of FS-14 in two groups were lower than the every previous time point(P <0.05)(2)Fatigue severity: the scores of FSS in experimental group after intervention at fourth and eighth weeks were lower than those in the control group(P<0.05).ANOVA showed: the within-subject effect,teated effect and the interactive effect in FSS were of significantance(P <0.05).The scores of FSS in two goups before and after the each time point were lower than the previous time point(P <0.05)1.2 Associated symptoms evaluation.After the intervention,the scores of SPHERE in the experimental group at fourth and eighth weeks were lower than those in the control group(P<0.05).ANOVA showed: the within-subject effect,teated effect and the interactive effect in SPHERE were of significantance(P <0.05).The scores of SPHERE were lower than the previous time point,the difference was of significantance(P <0.05)1.3 Syndrome of deficiency of Spleen Yang and kidney yang evaluation.After the intervention,the total score and nine items of Spleen and kidney yang deficiency Syndromes in experimental group at the fourth week were lower than the control group,among which fatigue poor appetite and abdominal distention between-subjects effects were statistically significant(P <0.05).At the eighth week,the total score and scores of nine items in experimental group were lower than the control group(P<0.05),except waist cold and pain(P >0.05).ANOVA showed: Spleen and kidney yang deficiency syndromes except six items,such as chills,shortness of breath,stomach pain,nocturnal enuresis,lumbago,between-subjects effects were no statistically significant(P >0.05),the within-subject effect,teated effect and the interactive effect in the other three items and total score were of significantance(P <0.05).The total score and the scores of nine items of spleen and kidney yang deficiency syndromes were higher than the previous time point in the experimental group(P <0.05),while in control group the score of shortness of breath comparison at the fourth week with baseline was no statistically significant(P>0.05),the scores of shortness of breath,poor appetite,backache and stool at the eighth week compared with those at the fourth week were no statistically significant(P>0.05),the other items were statistically significant in control group(P <0.05).2.Clinical efficacy evaluation.The experimental group curative effect are better(P <0.05).3.Anxiety and depression Symptom evaluation.The scores of SAS and SDS in the experimental group after intervention at fourth and eighth weeks were lower than those of the control group(P <0.05).ANOVA showed: the within-subject effect,teated effect and the interactive effect in SAS and SDS were of significantance(P <0.05).The scores of SAS and SDS at each time point were lower than the previous time point.(P <0.05)4.Quality of Life evaluation.The scores of eight dimensions in SF-36 in experimental group after the intervention at the fourth week were higher than the same period in the control group,of which only physiological function,overall health,energy with the significantance(P<0.05).At the eighth week,the scores of eight dimensions in experimental group were higher than those of the control group(P <0.05).ANOVA showed: the between-subjects effects in physiological and emotional function were no statistically significant(P >0.05),the interaction between the two groups in overall health and social function were no significant(P >0.05),the within-subject effect,teated effect and the interactive effect in the others were significant(P <0.05).The eight dimensions scores before and after the each time point in experimental group were higher than the previous time poin(P <0.05),while in control group the score of body pain at the fourth week compared befoe intevention was no significant(P >0.05),the comparisons which contained the one between the baseline and the our week,the other one between the fourth and eighth week in social function and emotional function were no of significantance(P>0.05),the comparisons at different point of other dimensions in control goup were statistically significant(P <0.05).5.Safety evaluation.The whole trial period,two cases in experimental group had indigestion,constipation,fever,other discomfort.And the degree was light.Conclusion The immortal porridge can relieve fatigue symptom,accompanied symptoms,spleen and kidney yang deficiency syndrome,anxiety and depression symptoms,and improve the quality of life among CFS caused by spleen and kidney yang deficiency whose curative effect enhanced with time increasing.The immortal porridge was effective in CFS.As a kind of diet therapy with TCM characteristic,it is worth to explore its mechanism in CFS for popularization and application in clinical and community... |
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