| Objective:To evaluate the clinical efficacy of the herbs-partitioned moxibustion combined with herbs application at Shenque point(CV8)on insomnia patients by observing the score changes of the Pittsburgh Sleep Quality Index(PSQI),SPIEGEL scale,Traditional Chinese Medicine Symptoms,and Sleep Logs before and after the treatment.Methods:Conduct the study using a single blind randomized controlled trial method.A total of 64 patients who met the inclusion criteria but did not meet the exclusion criteria were admitted,including 31 in the experimental group and 33 in the control group.Both groups received sleep guidance as the basic treatment.The experimental group received herbs-partitioned moxibustion combined with herbs application at CV8,while the control group received placebo-partitioned moxibustion combined with placebo application at CV8.During moxibustion,the patient lies flat and exposes their navel.Place a bowl made of flour on the patient’s navel,pour medication or placebo into the navel through the small hole on the bowl,and then light the moxa cone and place it inside the bowl.Replace the moxa cone every 20 minutes for a total of 1 hour of treatment.After treatment,use an empty plaster to keep the powder in the navel for 4-8 hours.Instruct the patient to remove it on their own.Distribute a package of 28 plasters to the patient,instruct them to apply it to the CV8 before going to bed every night,and remove it in the morning.The patient was treated with moxibustion once every other day,with each moxibustion lasting for 1 hour and medication leaving for 4-8 hours.The treatment was performed 3 times a week for a total of 12 times(4 weeks).The patient used a plaster every night for a total of 28 days(4 weeks).Fill out the SPIEGEL,PSQI,and Traditional Chinese Medicine Symptoms on the day of the first and last moxibustion,1 month after the end of all moxibustion,and 2 months after the end of all moxibustion;From 14 days before enrollment until 2 months after treatment,fill out a Sleep Log daily for a total of at least 98 days.SPSS 25.0 and Excel were used to statistically analyze the data obtained,and the efficacy of the two groups in treating insomnia was observed and compared.Result:A total of 64 patients were recruited in this study,including 31 in the experimental group and 33 in the control group.The experimental group had 2 cases of dropout,1 case removed,and 2 cases discontinued,while the control group had 9 cases of dropout,1 case removed,and 1 case discontinued.After data organization,55 cases were included in the analysis,including 28 cases in the experimental group and 27 cases in the control group.1.PSQI:Both the experimental group and the control group can improve the sleep quality of patients(P<0.01),and the experimental group was superior to the control group(P<0.01),especially in improving sleep efficiency,sleep-incubation-period,and daytime function of patients(P<0.05).Moreover,the maintenance effect of both groups after treatment was good(P>0.05).However,Sleep factor analysis showed that there was no significant improvement in sleep medication in both groups(P>0.05).2.SPIEGEL:Both the experimental group and the control group can improve the sleep quality of patients(P<0.01),and the experimental group was superior to the control group(P<0.05).Moreover,both groups had good maintenance effects after the end of treatment(P>0.05).3.Traditional Chinese Medicine Symptoms:Both treatment methods can alleviate patients’symptoms(P<0.01),and both groups had good maintenance effects after the end of treatment(P>0.05),but there was no significant difference in symptom relief between the two groups(P>0.05).4.Sleep Logs:Both groups were able to improve the sleep-incubation-period,times of wake-ups,the sum of time to fall asleep after waking up,sleep duration,and sleep efficiency.The experimental group had better results in terms of sleep-incubation-period,sleep duration,and sleep efficiency than the control group.5.Drug reduction rate:Both groups were able to reduce the dosage of sleeping pills,and the experimental group had better effects than the control group(P<0.01).6.Safety:The main adverse reactions involved in this study are local skin lesions,with the highest incidence being local skin damage caused by plasters.The total incidence of adverse reactions was 32.3%in the experimental group and 27.3%in the control group.There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:The treatment of insomnia in both the experimental group and the control group can improve patients’ PSQI score,SPIEGEL score,Traditional Chinese Medicine Symptom score,and Sleep Log situation,and there is no significant rebound in scores at 1 and 2 months after the end of treatment.It can be seen that both groups have good therapeutic effects on insomnia and have good maintenance effects.The experiment also found that compared with the control group,the combination of herbs-partitioned moxibustion and herbs application at CV8 has a better therapeutic effect on insomnia.However,the incidence of adverse reactions in this trial is relatively high.In future trials and clinical work,it is necessary to choose a suitable plaster and apply it in the correct way,giving the skin sufficient rest time to reduce the incidence of adverse reactions.The combination of herbs-partitioned moxibustion and Herbs application at CV8 had a good effect on insomnia.It was speculated that the mechanism of drug delivery may be related to the continuous activation of transient receptor potential vanilloid(TRPV)family channels,the mediation of moxibustion warm stimulation,the activation of neurons,and the improvement of microcirculation,so that drugs can be easily absorbed through the skin,eliminate the influence of the liver first pass effect,and achieve a lasting and stable effect of drug administration.The combination of drugs and moxibustion may cause changes in the humoral,immune,and nervous systems,thereby achieving the effect of treating insomnia. |
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