| Background and ObjectiveGlobally,diabetes mellitus(DM)has become one of the major public health problems.According to the International Diabetes Federation(IDF),there are currently 451 million diabetic patients in the world,and more than 90%of them have type 2 diabetes mellitus(T2DM).The number of people with diabetes mellitus worldwide will increase to 693 million by 2045.There is evidence that nearly half of T2DM patients suffer from insomnia.Insomnia causes neuroendocrine disorders in the body,and it is also one of the main reasons for poor blood sugar control in patients with type 2 diabetes.It has been found that insomnia patients have decreased immunity and increased expression of inflammatory factors such as interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)in serological indicators,aggravated insulin resistance and insomnia symptoms in diabetics.In addition,chronic insomnia in diabetics increased the risk of mood disorders,such as anxiety and depression.Effective measures to treat insomnia for diabetics could reduce the risk of anxiety and depression,improve neuroendocrine function as well as reduce the level of inflammatory factors,which is beneficial to control of mood and blood sugar for diabetic patients.Currently,the main treatments for insomnia include non-drug therapy and drug treatments.Repetitive transcranial magnetic stimulation(rTMS)is a new tool developed in recent years to treat sleep disorders.RTMS is effective in improving sleep quality and has the advantages of being non-invasive and safe.Trazodone is commonly used in the clinical treatment of insomnia because of its broad pharmacological effects,short half-life,no hangover and low risk of daytime dysfunction.Trazodone not only inhibits the reuptake of 5-hydroxytryptamine(5-HT),but also antagonizes H1 receptors,α1 receptors,and increases gamma aminobutyric acid(GABA)neuronal effects in the body,reduces wakefulness levels and promote sleep.Some studies have shown that 50 mg of trazodone at night for insomnia could reduce the sleep latency(SL)and number of awakenings(NW)of patients and improve sleep quality.At present,most patients with diabetes mellitus and insomnia are treated with a single therapy to improve their insomnia symptoms,but the efficacy is not good.Therefore,we designed a clinical trial to combine the two treatments.we hope that it could make up for the shortcomings of the single treatment and improve the sleep quality of diabetic patients with insomnia more effectively.The purpose of this study is to observe whether repeated transcranial magnetic stimulation combined with trazodone is better than single treatment for insomnia,and provide a more effective treatment option for patients with diabetes mellitus and insomnia.MethodsPatients diagnosed with type 2 diabetes mellitus combined with chronic insomnia attending the Department of Neurology and Department of Neurorehabilitation of our hospital from March 2019 to March 2021 were collected for the study,a total of 108 patients were included,divided into 3 groups according to the random number table method,and finally 94 patients completed all the experiments according to the experimental criteria.On the basis of conventional diabetes treatment in each group,the rTMS group(n=32)received rTMS treatment;the trazodone group(n=31)received oral trazodone hydrochloride treatment;and the combination group(n=31)was given repeated transcranial magnetic stimulation and trazodone hydrochloride.Patients in each group were treated continuously for 2 weeks.By comparing within and between groups before and after treatment the Pittsburgh sleep quality index(PSQI)scale,selfrating depression scale(SDS)and self-rating anxiety scale(SAS)scores,polysomnography(PSG)indicators:SL,NW,total sleep time(TST)and serological indicators IL-6,TNF-α,fasting plasma glucose,as well as the treatment efficiency and the incidence of adverse reactions in each group,indicate the treatment effect.Results(1)PSQI score:comparison between groups,the scale scores of the combined group after treatment was significantly lower than that in the rTMS group and the trazodone group(P<0.01),and the rTMS group was lower than the trazodone group(P<0.05);PSQI before and after treatment comparison of score difference,PSQI difference score comparison between combined group and rTMS group,the difference was statistically significant(P<0.05),PSQI difference score comparison between combined group and trazodone group or rTMS group and trazodone group,the difference was not statistically significant(P>0.05).In the intra-group comparison,the PSQI scale scores of the 3 groups were significantly reduced after treatment(P<0.01).(2)SDS and SAS scores:comparison between groups,after treatment,the scores of the scales in the combined group were significantly lower than those in the rTMS group and trazodone group(P<0.01),there was no significant difference between the rTMS group and the trazodone group for each scale score(P>0.05);the score difference of each scale before and after treatment was compared,the score difference of each scale of the combined group was compared with the rTMS group and the trazodone group,the difference was statistically significant(P<0.05),the scale score difference between the rTMS group and the trazodone group,the differences were not statistically significant(P>0.05).In the intra-group comparison,the scores of each scale in the 3 groups were significantly reduced after treatment(P<0.01).(3)Polysomnography(PSG)indicators,comparison between groups:After treatment,there were significant differences in the reduction of SL and NW and the increase of TST in the combined group compared with the rTMS group and the trazodone group(P<0.05);the difference between the indicators in the rTMS group and the trazodone group was not statistically significant(P>0.05).In the intra-group comparison,after treatment,the SL and NW of the 3 groups decreased,and the TST increased,,the difference was statistically significant(P<0.05).(4)IL-6,TNF-a and FBG levels,comparison between groups:After treatment,the levels of IL-6,TNF-a,and FBG in the combined group were significantly lower than those in the rTMS group and the trazodone group(P<0.01),but IL-6,TNF-a and FBG levels in the rTMS group and the trazodone group,the differences were not statistically significant(P>0.05).In the intra-group comparison,the levels of IL-6,TNF-a and FBG decreased in the three groups after treatment compared with those before treatment(P<0.01).(5)Effective rate:Comparison between groups:The total effective rate of treatment in the combined group was higher than that in the rTMS group and the trazodone group,the difference was statistically significant(P<0.05).There was no significant difference in the total effective rate of treatment in the rTMS group compared with the trazodone group(P>0.05).(6)Evaluation of adverse reactions:There was no statistically significant difference in the incidence of adverse reactions among the three groups of patients(P>0.05).ConclusionRepetitive transcranial magnetic stimulation combined with trazodone treatment is more efficient in treating insomnia,more beneficial in improving mood levels and controlling blood glucose than rTMS treatment alone or trazodone treatment alone,and it is suitable for clinical use. |
