| ObjectiveThe aim of this study was to prospectively explore the clinical efficacy of Wenjing Decoction in the treatment of insomnia in breast cancer patients with TCM syndrome of blood deficiency and cold coagulation,and to preliminary analysis the clinical application symptoms of Wenjing Decoction.MethodsIn this study,a prospective observational study was used.In outpatient of Guangdong Hospital of Traditional Chinese Medicine between September 2019 to January 2020,25 breast cancer patients with insomnia met the criteria of TCM syndrome for blood deficiency and cold coagulation,which were consecutive cases in a single center.Wenjing Decotion were given to these subjects and observe period lasted for four weeks.observational programs:detailed baseline information and the relevant questionnaires survey(including the Pittsburgh Sleep Quality Index questionnaire,Insomnia Severity Index Scale,traditional Chinese medicine symptom integral scale,quality of life in patients with breast cancer evaluation scale)before and after the intervention.ISI scale survey was conducted again after 1 week,2 weeks and 3 weeks of treatment.Results1.Sleep quality evaluation(1)Response rate:The overall response rate of PSQI was 68.0%and the failure rate was 32.0%after 4 weeks of treatment with Wenjing Decoction.(2)The total score and factor score of PSQI:After 4 weeks of treatment with Wenjing Decoction,total score,factor scores of sleep quality,the time to fall asleep,sleep time,sleep efficiency,sleep disorder were significantly lower,the differences between before and after treatment of factor scores above were statistically significant(P<0.05).While factor scores of the hypnotic drug,daytime dysfunction were no obvious change and there was no statistically significant difference between before and after treatment of these two factor scores(P>0.05).(3)ISI scores:There was no significant difference between ISI scores before treatment and 1 week after treatment,but there was significant difference between ISI scores before treatment and after 2 weeks of treatment,3 weeks of treatment and 4 weeks of treatment(P<0.05).There was a negative correlation between the change of ISI score and treatment course,and the improvement of insomnia severity was more obvious with the extension of treatment course.2.Quality of life evaluationThere were statistically significant differences between the total score of FACT-B before and after treatment(P<0.05),and there were statistically significant differences between the factor scores of physical condition,emotional condition,functional condition,and additional problems of FACT-B after treatment compared with that before treatment(P<0.05).There was no significant difference in factor score of social and family status before and after treatment(P>0.05).3.Evaluation of TCM syndromesThe overall scores of TCM symptoms after treatment were statistically significant compared with that before treatment(P<0.05).The main symptoms of the effective group included difficulty falling asleep,superficial sleep,easily wake-up,dreaminess,difficulty to fall asleep after waking up,early awakening.While accompanied symptom included Daytime sleepiness,cold limbs,dry mouth with hobby of hot drinks,dark purple and dry cracked lips,hand and foot chaps,hot flashes and night sweats,dizziness,etc.Tongue and pulse condition mainly included reddish tongue,white greasy moss and pulse string fine.ConclusionWenjing Decoction can obviously improve sleep state and quality of life of the patients in breast cancer insomnia patients with TCM syndrome of blood deficiency and cold coagulation.The accompanying syndromes could be improved at the same time.There is no adverse reaction on the treatment process,so it is an effective method for clinical treatment of the disease.This research has a certain innovation in expanding the clinical application of Wenjing decoction,and makes a beneficial exploration for the TCM treatment of insomnia after breast cancer surgery. |
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