Traditional Chinese Pestle Needle Combined With Five Notes Treatment For Heart And Spleen Deficiency Pattern Insomnia In The Digestive System Malignant Tumor Patients:a Clinic Trial

Objectives1.To explore the effect on sleep quality for the heart and spleen deficiency pattern insomnia in the digestive system malignant tumor patients after using the traditional Chinese pestle needle combined with five notes treatment.2.To explore the effect on anxiety level and depression level for the heart and spleen deficiency pattern insomnia in the digestive system malignant tumor patients after using the traditional Chinese pestle needle combined with five notes treatment.3.To explore the effect on life quality for the heart and spleen deficiency pattern insomnia in the digestive system malignant tumor patients after using the traditional Chinese pestle needle combined with five notes treatment.4.To explore a proper way of using the traditional Chinese pestle needle combined with five notes treatment for the heart and spleen deficiency pattern insomnia in the digestive system malignant tumor patients based on the clinical findings and the effect evaluation.5.To develop and spread the use of the traditional Chinese pestle needle combined with five notes treatment in the hospital,community and family based on the result of the clinic trial and the basic TCM nursing theories as well as methods.Methods1.In this research,the total randomized number method was used to divide the patients into 3 groups.Total 105 hospitalized patients of the Oncology Department of Sichuan Provincial Hospital of Traditional Chinese Medicine were recruited into the research according to the inclusion,exclusion criteria and the result of informed consent from December 2015 to October 2016.The patients were numbered according to the sequential order,and were divided into three groups: the traditional Chinese pestle needle combined with five notes group,the traditional Chinese pestle needle group and the control group.Each group had 35 patients.2.Intervention way: In the control group,the routine treatment based on the normalnursing intervention was used for the insomnia patients according to the made by the state administration of traditional Chinese medicine in 2006.In the traditional Chinese pestle needle group,the pestle needle therapy was used based on the control group measures.In the traditional Chinese pestle needle combined with five notes treatment group,the pestle needle therapy combined with five notes treatment was used based on the control group measures.3.Evaluation of effect: Evaluation was made before and after the 4-week intervention.The evaluation methods include: Pittsburg sleep quality index scale(PSQI);Hamilton anxiety scale(HAMA);Hamilton's Depression Scale(HAMD 24 item version)for the negative emotions;TCM symptom scaling of the heart and spleen deficiency pattern;Chinese version of EORTC QLQ-C30 for the evaluation of the life quality.Results1.Baseline information: There were no difference in sex,age,marriage status,diagnostics,career,education,monthly salary and KPS score in subjects of each group(P>0.05).There were no difference in PSQI total score and each dimension score,TCM syndrome score,HAMA total score,HAMD score,each dimension score of QLQ-C30 in subjects of each group before the intervention(P>0.05).Therefore the data in the three groups were comparable.2.Intra-group comparison before and after the intervention: PSQI total score and each dimension score,TCM syndrome score,HAMA total score,HAMD score,each dimension score of QLQ-C30 were compared within each group before and after the intervention.The results showed that there were no difference in the aforementioned respects before and after the intervention in the control group(P>0.05),while there were difference in the pestle needle group and the pestle needle plus five-notes regimen group(P<0.05).Therefore it was proved that the therapeutic effects of pestle needle and pestle needle plus five-notes regimen were better than the routine nursing.3.Inter-group comparison before and after the intervention: PSQI total score and each dimension score,TCM syndrome score,HAMA total score,HAMD score,eachdimension score of QLQ-C30 were compared among the three groups before and after the intervention.The results showed that there were difference in the aforementioned respects before and after the intervention in each group(P<0.05).Therefore it was proved that there was difference in therapeutic effects among the three groups.4.Mutiple comparison after the intervention: PSQI total score and each dimension score,TCM syndrome score,HAMA total score,HAMD score,each dimension score of QLQ-C30 were compared with LSD method among the three groups after the intervention.The results showed that there were no difference in HAMA score between the control group and the pestle needle group(P>0.05),while there were difference in other respects among the three groups(P<0.05).Therefore it was proved that the therapeutic effect of pestle needle plus five-notes regimen was better than that of pestle needle,and that of pestle needle was better than that of the control.Conclusions1.In the aspects of the total score and each dimension of PSQI scale,the traditional Chinese pestle needle combined with five notes group got less score than the traditional Chinese pestle needle group and the control group in total score,sleeping quality,total sleeping time,sleeping efficiency and daytime dysfunction,which shown that traditional Chinese pestle needle combined with five notes had a good effect of improving the sleeping condition of the the heart and spleen deficiency pattern insomnia patients with digestive system malignant tumor.2.For the heart and spleen deficiency pattern insomnia patients with digestive system malignant tumor,the improvements of clinic signs and symptoms shows: the general effect of the traditional Chinese pestle needle combined with five notes group was better than the traditional Chinese pestle needle group was and the effect of the traditional Chinese pestle needle group was better than the control group was.3.The traditional Chinese pestle needle combined with five notes treatment can improve the sleeping quality,TCM symptom scaling score,anxiety,depression and other negative emotions of the heart and spleen deficiency pattern insomnia in the digestive system malignant tumor patients and improve the life quality of thosepatients.4.The traditional Chinese pestle needle combined with five notes treatment has no other side effects,and it is safe,acceptable as well as convenient.It is worth of being wide used in the hospital,community and family based on the exact curative effect.