Study protocol for a comparative randomized controlled trial of Tai Chi and conventional exercise training on alleviating depression in older insomniacs.

Background: Insomnia and depression are prevalent mental disorders that are often comorbid among older adults. Lifestyle intervention strategies incorporating Tai Chi or conventional exercise have been shown to alleviate symptoms of insomnia and depression. However, the comparative efficacy of these exercise modalities in individuals with both disorders has yet to be determined. Therefore, the aim of this study is to examine the efficacy of Tai Chi and conventional exercise for reducing depressive symptoms in older adults with chronic insomnia and depressive symptoms, when compared to a health education control. Methods: This study is a prospective, assessor-blinded, three-arm, parallel group, randomized controlled trial. Older adults aged ≥60 years with a diagnosis of chronic insomnia and depressive symptoms will be randomly assigned to a Tai Chi, conventional exercise or health education control condition on a 1:1:1 basis. Interventions will last for 3 months, with a 6-month follow-up period. The primary outcome is depressive symptoms, assessed using the Hospital Anxiety and Depression Scale. Secondary outcomes include subjective sleep quality, 7-day actigraphy, 7-day sleep diary, anxiety symptoms, quality of life, medication usage and physical function. All measurements will be conducted at baseline, 3 months and 9 months by outcome assessors who are blinded to group allocation. Discussion: This study will compare the efficacy of Tai Chi and conventional exercise in improving depression outcomes in older adults with chronic insomnia and depressive symptoms. Our results will shed light on the clinical potential of these interventions for combating insomnia and depression in older adults.

Effects of cognitive behavioural therapy and bright light therapy for insomnia in youths with eveningness: study protocol for a randomised controlled trial.

BACKGROUND: Insomnia and eveningness are common and often comorbid conditions in youths. While cognitive behavioural therapy for insomnia (CBT-I) has been suggested as a promising intervention, it remains unclear whether it is sufficient to also address circadian issues in youths. In addition, despite that light has been shown to be effective in phase-shifting one's circadian rhythm, there has been limited data on the effects of bright light therapy and its combination with CBT-I on sleep and circadian outcomes in youths. The current protocol outlines a randomised controlled trial that examines the efficacy of CBT-I and CBT-I plus bright light therapy (BLT) in reducing insomnia severity, improving mood symptoms and daytime functioning (e.g. sleepiness, fatigue, cognitive function), and improving subjective and objective sleep and circadian measures compared to a waitlist control group. METHODS: We will carry out a randomised controlled trial (RCT) with 150 youths aged 12-24 who meet the criteria of insomnia and eveningness. Participants will be randomised into one of three groups: CBT-I with bright light therapy, CBT-I with placebo light, and waitlist control. Six sessions of CBT-I will be delivered in a group format, while participants will be currently asked to use a portable light device for 30 min daily immediately after awakening throughout the intervention period for bright light therapy. The CBT-I with light therapy group will receive bright constant green light (506 lx) while the CBT-I with placebo light group will receive the modified light device with the LEDs emitting less than 10 lx. All participants will be assessed at baseline and post-treatment, while the two active treatment groups will be additionally followed up at 1 month and 6 months post-intervention. The primary outcome will be insomnia severity, as measured by the Insomnia Severity Index. Secondary outcomes include self-reported mood, circadian, daytime functioning, and quality of life measures, as well as sleep parameters derived from actigraphy and sleep diary and neurocognitive assessments. Objective measures of the circadian phase using dim-light melatonin onset assessment and sleep parameters using polysomnography will also be included as the secondary outcomes. DISCUSSION: This study will be the first RCT to directly compare the effects of CBT-I and BLT in youths with insomnia and eveningness. Findings from the study will provide evidence to inform the clinical management of insomnia problems and eveningness in youths. TRIAL REGISTRATION: ClinicalTrials.gov NCT04256915. Registered on 5 February 2020.

Acupuncture for reducing the south to reinforce the north on executive function and sleep structure in patients with chronic insomnia disorder of heart-kidney disharmony. / æ³»å—è¡¥åŒ—æ³•é’ˆåˆºå¯¹å¿ƒè‚¾ä¸äº¤åž‹æ ¢æ€§å¤±çœ éšœç¢æ‚£è€ æ‰§è¡ŒåŠŸèƒ½åŠç¡çœ ç»“æž„çš„å½±å“.

OBJECTIVES: To observe the efficacy of acupuncture for reducing the south to reinforce the north on executive function, sleep structure and sleep quality in patients with chronic insomnia disorder of heart-kidney disharmony. METHODS: A total of 100 patients with chronic insomnia disorder of heart-kidney disharmony were randomized into an acupuncture group (50 cases, 1 case dropped out) and a western medication group (50 cases, 2 cases dropped out). Acupuncture for reducing the south to reinforce the north was applied at Baihui (GV 20) and bilateral Shenmen (HT 7), Sanyinjiao (SP 6), Shenmai (BL 62), Zhaohai (KI 6), Xinshu (BL 15), Shenshu (BL 23) in the acupuncture group, once a day, 5 days a week. Lorazepam tablet was given orally in the western medication group, 0.5-1 mg a time, once a day. Both groups were treated for 4 weeks. The Stroop color-word test (SCWT) indexes (the time consuming and the correct number of card A, B, C and the Stroop interference effect [SIE]), sleep structure indexes (total sleep time [TST], sleep latency [SL], wake after sleep onset [WASO], sleep efficiency [SE], non-rapid eye movement period 1 [N1], non-rapid eye movement period 2 [N2], non-rapid eye movement period 3 [N3], rapid eye movement period [REM]) and Pittsburgh sleep quality index (PSQI) score were observed before and after treatment in the two groups. RESULTS: After treatment, the time consuming of card B and C, the time consuming and the correct number of SIE, SL, WASO, N1, N2, as well as the sub-item scores and total score of PSQI were decreased (P<0.05, P<0.01), the correct number of card A, B and C, TST, SE, N3 and REM were increased (P<0.01) compared with those before treatment in the acupuncture group; the time consuming of card C and SIE, the correct number of card A and SIE, TST, SE, REM were increased (P<0.05, P<0.01), SL, WASO, N1, as well as the sub-item scores of sleep quality, sleep latency, sleep duration, sleep efficiency, daytime function and total score of PSQI were decreased (P<0.01) compared with those before treatment in the western medication group. After treatment, in the acupuncture group, the time consuming of card C, the time consuming and the correct number of SIE, N1, N2, as well as the sub-item scores of sleep quality, sleep dysfunction, daytime function and total score of PSQI were lower than those in the western medication group (P<0.01), the correct number of card B and C, N3, REM were higher than those in the western medication group (P<0.01). CONCLUSIONS: Acupuncture for reducing the south to reinforce the north can improve the executive function of patients with chronic insomnia disorder of heart-kidney disharmony, adjust the sleep structure, and improve the night sleep quality and daytime body function.

The role of the GABAergic system on insomnia.

Sleep is an essential activity for the survival of mammals. Good sleep quality helps promote the performance of daily functions. In contrast, insufficient sleep reduces the efficiency of daily activities, causes various chronic diseases like Alzheimer's disease, and increases the risk of having accidents. The GABAergic system is the primary inhibitory neurotransmitter system in the central nervous system. It transits the gamma-aminobutyric acid (GABA) neurotransmitter via GABAA and GABAB receptors to counterbalance excitatory neurotransmitters, such as glutamate, noradrenaline, serotonin, acetylcholine, orexin, and dopamine, which release and increase arousal activities during sleep. Several studies emphasized that dysfunction of the GABAergic system is related to insomnia, the most prevalent sleep-related disorder. The GABAergic system comprises the GABA neurotransmitter, GABA receptors, GABA synthesis, and degradation. Many studies have demonstrated that GABA levels correlate with sleep quality, suggesting that modulating the GABAergic system may be a promising therapeutic approach for insomnia. In this article, we highlight the significance of sleep, the classification and pathology of insomnia, and the impact of the GABAergic system changes on sleep. In addition, we also review the medications that target the GABAergic systems for insomnia, including benzodiazepines (BZDs), non-BZDs, barbiturates, GABA supplements, and Chinese herbal medicines.

Bioactive compounds from Ocimum tenuiflorum and Poria cocos: A novel natural Compound for insomnia treatment based on A computational approach.

Insomnia, a widespread public health issue, is associated with substantial distress and daytime functionality impairments and can predispose to depression and cardiovascular disease. Cognitive Behavioral Anti-insomnia therapies including benzodiazepines often face limitations due to patient adherence or potential adverse effects. This study focused on identifying novel bioactive compounds from medicinal plants, aiming to discover and develop new therapeutic agents with low risk-to-benefit ratios using computational drug discovery methods. Through a systematic framework involving compound library preparation, evaluation of drug-likeness and pharmacokinetics, toxicity prediction, molecular docking, and molecular dynamic simulations, two natural compounds such as 2-(4-hydroxy-3-methoxyphenyl)-8-methoxy-6-prop-2-enyl-3,4-dihydro-2H-chromen-3-ol from Ocimum tenuiflorum and 7-(2-hydroxypropan-2-yl)-1,4a-dimethyl-9-oxo-3,4,10,10a-tetrahydro-2H-phenanthrene-1-carboxylic acid from Poria cocos exhibited high binding affinity with orexin receptor type 1 (OX1R) and type 2 (OX2R), surpassing commercial drugs used in insomnia treatment. Additionally, they showed interactions with critical amino acid residues within the receptors that play crucial roles in competitive inhibitor activity, like commercial drugs such as Suvorexant, Lemborexant, and Daridorexant. Further, molecular dynamics simulations of the protein-ligand complexes under conditions that mimic the in vivo environment revealed both compounds' sustained and robust interactions with the OX1R and OX2R, reinforcing their potential as effective therapeutic candidates. Furthermore, upon evaluating both compounds' drug-likeness, pharmacokinetics, and toxicity profiles, it was discerned that they displayed considerable drug-like properties and favorable pharmacokinetics, along with diminished toxicity. The research provides a solid foundation for further exploring and validating these compounds as potential anti-insomnia therapeutics.

Factors associated with insomnia and fatigue symptoms during the outbreak of Oct.7th war on Gaza: A study from Jordan.

Objective: The Jordanian and the Palestinian communities are tightly related, hence, the current war on Gaza also has social and psychological impacts on Jordanians. Therefore, this study aims to identify the factors associated with severe insomnia and fatigue symptoms in a cohort of Jordanians during the Gaza War outbreak. Methods: This is a cross-sectional web-based questionnaire study. The Insomnia Severity Index-Arabic version (ISI-A), and the Brief Fatigue Inventory-Arabic (BFI-A) were employed, binary logistic and linear regression analyses was performed to identify predictors to severe insomnia and fatigue respectively. Data were collected between December 2023 and January 2024. Results: Data were analyzed from 477 participants, of which 315 (66 %) were females, 107 (22.4 %) reported having a family relative or a friend residing in Gaza, 365 (76.5 %) reported not using any sleep aid, 78 (16.4 %) reported using homeopathy herbal remedies for sleep, and only 52 (10.9 %) reported using over-the-counter sedating antihistamines. Severe insomnia was significantly associated with participants "younger than 30 years old" (OR = 1.81, 95 %CI = 1.22-2.66, p = 0.003), participants "using over-the-counter sedating antihistamines" (OR = 2.78, 95 % CI = 1.27-6.06, p = 0.01). Severe fatigue was significantly associated with "females" (B = 5.87, t = 2.78, p = 0.006), and "smokers" (B = 5.09, t = 2.52, p = 0.01). On the other hand, "not using sleep aids" demonstrated significantly lower odds for severe insomnia (OR = 0.41, 95 % CI = 0.24-0.68, p = 0.001), and fatigue (B = -10.84, t = -4.81, p < 0.001). Conclusions: Addressing modifiable risk factors such as smoking and sleep self-medications is essential to improve insomnia and fatigue symptoms.

Acupuncture for insomnia symptoms in hypertensive patients: a systematic review and meta-analysis.

Purpose: In the realm of pain management, traditional Chinese medicine, specifically acupuncture, has garnered increasing attention. This meta-analysis pioneers the evaluation of acupuncture's effectiveness in treating insomnia among hypertensive patients. Methods: We conducted a comprehensive search across several databases-PubMed, Web of Science, Cochrane Library, WANFANG, China National Knowledge Infrastructure (CNKI), Sinomed, and the Chinese Journal of Science and Technology (VIP). Additionally, forward and backward articles of studies published from the inception of these databases until 10 September 2023, were reviewed. This systematic review and meta-analysis included all randomized controlled trials (RCTs) focusing on acupuncture for insomnia in hypertensive patients, without imposing language or date restrictions. We rigorously assessed all outcome measures reported in these trials. The evidence was synthesized by calculating the difference between mean differences (MD) in symptom change. The quality of the evidence was determined using the Cochrane Risk of Bias tool. This study is registered with PROSPERO under number CRD42023461760. Results: Our analysis included 16 RCTs, comprising 1,309 patients. The findings revealed that acupuncture was significantly more effective than the control group in reducing insomnia symptoms, as indicated by a greater decrease in the PSQI score (MD = -3.1, 95% CI [-3.77 to -2.62], p < 0.00001). Additionally, improvements in both systolic and diastolic blood pressure were more pronounced in the acupuncture group compared to the control group (SBP: MD = -10.31, 95% CI [-16.98 to -3.64], p = 0.002; DBP: MD = -5.71, 95% CI [-8.19 to -3.23], p < 0.00001). These results suggest that acupuncture not only improves sleep quality but also lowers blood pressure in patients suffering from hypertension and insomnia. Further research is warranted to elucidate optimal acupuncture points and the duration of treatment for maximized therapeutic effect.Systematic review registration:https://www.crd.york.ac.uk/prospero, CRD42023461760.

Are Sleep Aids Associated with the Severity of Attention Deficit Hyperactivity Disorder Symptoms in Adults Screened for Insomnia? A Cross-Sectional Study.

(1) Background: Attention Deficit Hyperactivity Disorder (ADHD)-like symptoms and insomnia are closely related. The present study examined whether the use of different sleep aids was related to severe ADHD-like symptoms in Jordanian adults screened for insomnia. (2) Methods: This cross-sectional study used predefined inclusion criteria. The severity of ADHD was assessed using the validated Arabic version of the Adult ADHD Self-Report Scale. (3) Results: Data were analyzed from 244 subjects who met the inclusion criteria for severe insomnia, of which 147 (65.3%) reported not using any sleep aid, 50 (22.3%) reported using homeopathy remedies as sleep aids, and 41 (18.3%) reported using over-the-counter antihistamines as sleep aids. Regression analysis revealed that the use of such sleep aids-namely, "homeopathy herbal remedies" and "over-the-counter antihistamines"-was not associated (p > 0.05) with ADHD-like symptoms. However, "age above 31 years old" was significantly associated (B = -3.95, t = -2.32, p = 0.002) with lower ADHD severity, while the "diagnosis with chronic diseases" was significantly associated (B = 4.15, t = 1.99, p = 0.04) with higher ADHD severity. (4) Conclusions: Sleep aids are not associated with ADHD-like symptoms in adults. More research is required to uncover the risk factors for adult ADHD, especially insomnia.

CHEN Rixin's clinical experience of heat-sensitive moxibustion for Wenyang Yangshen in treatment of insomnia of yang deficiency. / 陈日新热敏灸"æ¸©é˜³å »ç¥ž"æ²»ç–—é˜³è™šå¤±çœ ç—‡ä¸´åºŠç»éªŒæ’·è.

The paper introduces CHEN Rixin's experience and ideas of heat-sensitive moxibustion for Wenyang Yangshen (warming-up yang and nourishing the spirit) in treatment of insomnia of yang deficiency. This type of insomnia is caused by yang insufficiency of the body and malnutrition of the spirit. The treatment focuses on Wenyang Yangshen. Replenishing yang (Shenque [CV 8], Qihai [CV 6] and Guanyuan [CV 4]) is combined with promoting yang circulation (Taiyang [EX-HN 5]). The acupoint combination is optimized through identifying the heat sensitivity. Sparrow-pecking moxibustion and mild moxibustion are used to control the appropriate moxibustion temperature, efficiently stimulate deqi and individually saturate the dose of moxibustion so as to target the principle of treatment and improve the sleep quality.

Zhumian Granules improves PCPA-induced insomnia by regulating the expression level of neurotransmitters and reducing neuronal apoptosis.

ETHNOPHARMACOLOGICAL RELEVANCE: Sleep problems, according to Traditional Chinese medicine (TCM) philosophy, are attributed to the imbalance between yin and yang. Zhumian Granules, also known as Sleep-aid Granules or ZG, are a traditional Chinese herbal remedy specifically designed to alleviate insomnia. This formula consists of many components, including Wu Wei Zi (Schisandrae Chinensis Fructus), Suan Zao Ren (Ziziphi Spinosae Semen), and other medicinal plants. According to the pharmacology of Traditional Chinese Medicine (TCM), Wu Wei Zi and Suan Zao Ren have the ability to relax the mind and promote sleep. When taken together, they may balance the opposing forces of yin and yang. Therefore, ZG may potentially be used as a therapeutic treatment for insomnia. AIM OF THE STUDY: This research was specifically developed to establish a strong empirical basis for the subsequent advancement and utilization of ZG in the management of insomnia. This research aimed to gather empirical data to support the effectiveness of ZG, thereby providing useful insights into its potential therapeutic advantages for persons with insomnia. MATERIALS AND METHODS: This study utilized Zhumian Granules (ZG), a traditional Chinese herbal decoction, to examine its sedative and hypnotic effects on mice with PCPA-induced insomnia. The effects were assessed using the pentobarbital-induced sleep test (PIST), Morris water maze test (MWM), and autonomic activity test. The levels of neurotransmitters in each group of mice were evaluated using UPLC-QQQ-MS. The impact of ZG on the quantity and structure of hippocampal neurons was seen in brain tissue slices using immunofluorescence labeling. RESULTS: ZG was shown to possess active sedative properties, effectively lowering the distance of movement and lengthening the duration of sleep. ZG mitigated the sleeplessness effects of PCPA by elevating the levels of 5-hydroxytryptamine (5-HT), 4-aminobutyric acid (GABA), and 5-hydroxyindoleacetic acid (5-HIAA), while reducing the levels of dopamine (DA) and norepinephrine (NE), as well as decreasing neuronal death. CONCLUSIONS: This research confirmed the sedative and hypnotic properties of ZG and elucidated its probable mechanism involving neurotransmitters.

Effect of tuina on sleep quality, psychological state and neurotransmitter level in patients with insomnia: a systematic review and meta-analysis.

Background: Abnormal psychological state and neurotransmitter levels are important factors affecting sleep quality. Numerous studies have shown that tuina can improve the symptoms of sleep disorders in patients with insomnia while relieving anxiety and depression and regulating neurotransmitter levels. However, there have been no meta-analyses on the effect of tuina on psychological states and neurotransmitter levels. Objectives: A meta-analysis was performed to systematically evaluate the effects of massage on sleep quality, psychological state, and neurotransmitter levels in patients with insomnia. Methods: A comprehensive literature search was conducted from inception to July 2023 using eight electronic databases to identify randomized controlled trials (RCTs) on tuina therapy for insomnia. Gray literature was also searched. The methodological quality of the included studies was assessed using the Cochrane Handbook. Reviewer Manager 5.4 and Stata 16.0 were employed for statistical analysis. Results: A total of 23 studies were included, including 1780 patients with insomnia, of whom 892 and 888 were in the experimental and control groups, respectively. Meta-analysis indicated that tuina therapy was superior to other therapies for the treatment of insomnia in increasing the total effective rate [OR = 4.12, 95%CI (2.80, 6.06), p < 0.00001] and 5-hydroxytryptamine (5-HT) level [MD = 16.03, 95% CI (13.40, 18.65), p < 0.00001], while reducing the Pittsburgh Sleep Quality Index score [MD = -2.34, 95% CI (-2.94, -1.74), p < 0.00001], Athens Insomnia Scale score [MD = -2.10, 95% CI (-2.67, -1.52), p < 0.00001], self-rating anxiety scale score [MD = -6.77, 95% CI (-8.34, -5.20), p < 0.00001] and self-rating depression scale score [MD = -6.60, 95% CI (-8.82, -4.37), p < 0.00001]. Subgroup analysis showed that tuina alone or in combination with other therapies was superior to drugs or acupuncture alone in improving all outcomes (p < 0.05). Only two studies reported minor adverse events. Conclusion: Tuina for insomnia has certain therapeutic advantages and can significantly improve sleep quality, relieve anxiety-depressive states, and increase 5-HT levels with high safety. Due to the limitations of the quality of the included studies, additional high-quality clinical trials are required for further verification. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=447839, identifier CRD42023447839.

Non-pharmacological interventions for sleep disruptions and fatigue after traumatic brain injury: a scoping review.

OBJECTIVE: The aim of this study was to conduct a scoping review to determine the nature, variety, and volume of empirical evidence on nonpharmacological interventions for sleep disturbances with potential implications for fatigue in adults sustaining a traumatic brain injury (TBI). METHODS: A systematic literature search was conducted across four databases to identify primary studies testing a single non-pharmacological intervention or a combination of non-pharmacological interventions for sleep disturbances and fatigue in community-dwelling adults with TBI. RESULTS: Sixteen studies were reviewed addressing six non-pharmacological interventions for sleep disruptions and fatigue after TBI including light therapy, cognitive-behavioral therapy, warm footbath application, shiatsu, and sleep hygiene protocol. Non-pharmacological interventions involving light or cognitive-behavioral therapy were reported in 75% of the studies. Actigraphy-based estimation of total sleep time and subjective level of fatigue were frequent outcomes. CONCLUSION: While this scoping review has utility in describing existing non-pharmacological approaches to manage sleep and fatigue after TBI, the findings suggest that interventions are often developed without considering TBI individuals' source of motivation and the need for support in self-administration. Future studies may achieve greater sustainability by considering the evolving needs of TBI patients and their families and the drivers and barriers that might influence non-pharmacological intervention use at home.

Does valerian work for insomnia? An umbrella review of the evidence.

Valerian is one of the most used herbal agents (phytotherapeutics) to manage sleep disturbances, in particular, sleep-onset difficulties in young adults. However, the evidence based on primary studies and systematic reviews that supports its use in this domain is weak or inconclusive. In the current study, an umbrella review was performed on the efficacy of valerian for sleep disturbances with a focus on insomnia. As such, only systematic reviews (with or without meta-analysis) were considered for this study. Systematic searches in PubMed, Web of Science, Scopus, Cochrane Database of Systematic Reviews, PROSPERO and CNKI databases retrieved 70 records. Only 8 articles were considered eligible for qualitative analysis. Overall, data suggested that valerian has a good safety profile, however, the results showed no evidence of efficacy for the treatment of insomnia. Moreover, valerian appears to be effective concerning subjective improvement of sleep quality, although its effectiveness has not been demonstrated with quantitative or objective measurements. Despite its widespread use and prescription by general practitioners, psychiatrists and other professionals, valerian does not have empirical support for insomnia. Further studies, in particular high quality randomized controlled trials, are highly recommended since there are scarce studies and the existing ones are quite heterogeneous and with low methodological quality. The implications of our findings for clinical practice are critically discussed.

Effects of the Prolong Life With Nine Turn-Method Qigong on Fatigue, Insomnia, Anxiety, and Gastrointestinal Disorders in Patients With Chronic Fatigue Syndrome: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic fatigue syndrome (CFS) is a debilitating multisystem disorder that can lead to various pathophysiological abnormalities and symptoms, including insomnia, gastrointestinal disorders, and anxiety. Due to the side effects of currently available drugs, there is a growing need for safe and effective nondrug therapies. The Prolong Life With Nine Turn (PLWNT) Qigong method is a system of mind-body exercise with restorative benefits that can alleviate the clinical symptoms of CFS and impart a significant inhibitory effect. Various studies have proven the treatment efficacy of PLWNT; however, the impact on insomnia, gastrointestinal disorders, and anxiety in patients with CFS has not yet been investigated. OBJECTIVE: This study aims to evaluate the efficacy and safety of the PLWNT method in terms of its effects on fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. METHODS: We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention and 8-week follow-up. A total of 208 patients of age 20-60 years will be recruited. The patients will be randomly divided into a PLWNT Qigong exercise group (PLWNT Group) and a control group treated with cognitive behavioral therapy at a ratio of 1:1. Participants from the treatment groups will be taught by a highly qualified professor at the Shanghai University of Traditional Chinese Medicine once a week and will be supervised via web during the remaining 6 days at home, over 12 consecutive weeks. The primary outcome will be the Multidimensional Fatigue Inventory 20, while the secondary outcomes include the Pittsburgh Sleep Quality Index, Gastrointestinal Symptom Rating Scale, Hospital Anxiety and Depression Scale, functional magnetic resonance imaging, gut microbiota, and peripheral blood. RESULTS: The study was approved by the ethics committee of Shanghai Municipal Hospital of Traditional Chinese Medicine in March 2022 (Ethics Approval Number 2022SHL-KY-05). Recruitment started in July 2022. The intervention is scheduled to be completed in December 2024, and data collection will be completed by the end of January 2025. Over the 3-year recruitment period, 208 participants will be recruited. Data management is still in progress; therefore, data analysis has yet to be performed. CONCLUSIONS: This randomized trial will evaluate the effectiveness of the PLWNT method in relieving fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. If proven effective, it will provide a promising alternative intervention for patients with CFS. TRIAL REGISTRATION: China Clinical Trials Registry ChiCTR2200061229; https://www.chictr.org.cn/showproj.html?proj=162803. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53347.

[Systematic review and Meta-analysis of efficacy and safety of Shumian Capsules in treatment of insomnia].

This study aims to assess the safety and efficacy of Shumian Capsules in the treatment of insomnia. Randomized controlled trial(RCT) about Shumian Capsules for insomnia were retrieved from databases. RevMan 5.4 was used for statistical analysis. A total of 23 articles were included, involving 2 621 patients. Meta-analysis showed that Shumian Capsules had advantages in the treatment of insomnia(RR=1.07, 95%CI[1.03, 1.10], P=0.000 2) and insomnia with depression(RR=1.13, 95%CI[1.02, 1.25], P=0.02) in terms of total response rate. Shumian Capsules had advantages in the treatment of insomnia(MD=-0.75, 95%CI[-1.33,-0.17], P=0.01) and insomnia with depression(MD=-2.51, 95%CI[-2.96,-2.06], P<0.000 01) in terms of PSQI score. The incidence of adverse events in the Shumian Capsules(RR=0.33, 95%CI[0.24, 0.46], P<0.000 01) and Shumian Capsules + conventional western medicine(RR=0.71, 95%CI[0.54, 0.95], P=0.02) was lower than that in the conventional wes-tern medicine alone. In addition, Shumian Capsules had an advantage in treating insomnia complicated with depression in terms of HAMD score(P<0.000 1) and reducing the serum levels of 5-HT, TSH, T3, and T4 in insomnia patients(P<0.05). The quality of evidence was mostly medium or low. The studies demonstrate that Shumian Capsules is effective and safe for treating insomnia, which may be related to the mechanism of lowering the levels of 5-HT, TSH, T3, and T4 in the serum. In view of the quality of evidence, the application of Shumian Capsules should be considered after comprehensive evaluation in clinical practice.

Efficacy of acupuncture therapy on cancer-related insomnia: a systematic review and network meta-analysis.

Objectives: Cancer-related insomnia (CRI) takes a toll on many cancer survivors, causing distressing symptoms and deteriorating the quality of life. Acupuncture therapy has been used for CRI already. However, it is still uncertain which acupuncture regime is best for CRI. The primary objective of this review is to conduct a comparative evaluation and ranking of the effectiveness of different acupuncture therapies for CRI. Methods: Randomized controlled trials (RCTs) that were published up to July 31, 2023, from 8 databases (PubMed, Embase, Cochrane library, Web of Science, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc) were integrated in this study. Trials that met the inclusion criteria were evaluated the risk of bias. Pittsburgh sleep quality index (PSQI) was used to assess the efficacy of different acupuncture therapies as the primary outcome. Then, STATA 15, R, and OpenBUGS were applied to perform the network meta-analysis. PRISMA statements were followed in this network meta-analysis. Results: A total of 37 studies were included in this review, involving 16 interventions with 3,246 CRI participants. Auriculotherapy + moxibustion [surface under the cumulative ranking curve (SUCRA) 98.98%] and auriculotherapy (SUCRA 77.47%) came out top of the ranking, which were more effective than control, medicine, usual care and sham acupuncture. Conclusion: Auriculotherapy + moxibustion and auriculotherapy + acupuncture emerged as the top two acupuncture regimes for CRI and future studies should pay more attention to CRI. Clinical trial registration: https://clinicaltrials.gov/, identifier INPLASY202210095.

Larger hypothalamic subfield volumes in patients with chronic insomnia disorder and relationships to levels of corticotropin-releasing hormone.

The hypothalamus is a well-established core structure in the sleep-wake cycle. While previous studies have not consistently found whole hypothalamus volume changes in chronic insomnia disorder (CID), differences may exist at the smaller substructural level of the hypothalamic nuclei. The study aimed to investigate the differences in total and subfield hypothalamic volumes, between CID patients and healthy controls (HCs) in vivo, through an advanced deep learning-based automated segmentation tool. A total of 150 patients with CID and 155 demographically matched HCs underwent T1-weighted structural magnetic resonance scanning. We utilized FreeSurfer v7.2 for automated segmentation of the hypothalamus and its five nuclei. Additionally, correlation and causal mediation analyses were performed to investigate the association between hypothalamic volume changes, insomnia symptom severity, and hypothalamus-pituitary-adrenal (HPA) axis-related blood biomarkers. CID patients exhibited larger volumes in the right anterior inferior, left anterior superior, and left posterior subunits of the hypothalamus compared to HCs. Moreover, we observed a positive association between blood corticotropin-releasing hormone (CRH) levels and insomnia severity, with anterior inferior hypothalamus (a-iHyp) hypertrophy mediating this relationship. In conclusion, we found significant volume increases in several hypothalamic subfield regions in CID patients, highlighting the central role of the HPA axis in the pathophysiology of insomnia.

Integrative management of insomnia during cancer chemotherapy: A case report.

INTRODUCTION: Insomnia is common among cancer patients, affecting about 50% undergoing cancer treatment. Insomnia can be due to various reasons, such as physical-pain, psychological-distress and medication side-effects. Insomnia has significant impact on quality of life of cancer patients. Even-though managed with hypnotics and antipsychotic drugs, they cause dependency with various short-term and long-term complications. Presenting a case throwing light on Ayurveda topical intervention as add-on to standard-of-care in insomnia during cancer chemotherapy. METHOD: A 51-year-old female patient with breast-cancer with extensive necrosis extending to subcutaneous areas was due for second cycle chemotherapy and was diagnosed with moderate-insomnia with a score of 21 as per Insomnia Severity Index in the Out-Patient-Department. Quality of sleep was assessed using Pittsburgh-Sleep-Quality-Index. Treated for 14 days during the break between cycle two and cycle three with Shirothalam (applied on the vertex) using Kachuradi Churnam with Kshirabala 101 and Padabhyangam (foot massage) using Kshirabala thailam as add-on to Tab Zolpidem5mg. Assessment was conducted on baseline and after 14 days of intervention. RESULTS: Assessment for insomnia before and after intervention was conducted with Insomnia-Severity-Index. The score improved from 21 to 2. Quality of sleep before and after intervention was assessed using global PSQI. It improved from 20 to 8. DISCUSSION: In Ayurveda, Nidranasam (loss of sleep) results from aggravation of Vata-Pitta (body humors responsible for movement and cognition and digestion, metabolism and heat of body), depletion of Kapha (body humor responsible for structural cohesion of body), derangement of Manasika-Dosa (mental constituents) and other diseases. All these etiological factors are attributed by Tikshna(sharp)- Ushna(hot potency) and Ruksha(dry) chemotherapy regimens. Vata-Pitta-hara (normalising Vata and Pitta) and Indriyaprasadaka (clearing senses) action of medicines used could induce sleep and effectively improve quality of sleep. CONCLUSION: Integrative-intervention was found to be beneficial in improving insomnia and quality of sleep without any reported complications or dependency in this case. After 14 days of ayurvedic intervention, the patient could get sleep even without taking zolpidem 5mg and external therapies. Same protocol could be considered for generalization so that it could modify or reduce usage of hypnotics and antipsychotic-drugs.

Just Let Me Sleep in: Identifying and Treating Delayed Sleep Phase Disorder in Adolescents.

Individuals with delayed sleep phase disorder (DSPD) are unable to naturally fall asleep and awake at conventional times; for this reason, DSPD is often mistaken for insomnia. However, unlike many patients with insomnia, those with DSPD struggle to get up at appropriate times. DSPD is associated with school refusal, academic difficulties, and lower employment rate. DSPD in youth has prevalence as high as 16%, and is often comorbid with other psychiatric disorders. Treatments include appropriate light exposure during the day, melatonin use, developing an evening routine that minimizes arousal-increasing activities, and gradually shifting sleep-wake times toward more functional ones.

When Night Falls Fast: Sleep and Suicidal Behavior Among Adolescents and Young Adults.

Sleep disturbances have been linked to suicidal ideation and behaviors in adolescents. Specifically, insomnia and nightmares are associated with current suicide risk and predict future ideation. Associations between hypersomnia, sleep apnea, and suicide remain inconclusive. Potential biological mechanisms underlying these relationships include executive functioning deficits and hyperarousal. Related psychological factors may include thwarted belongingness, perceived burdensomeness, and negative appraisals. Assessing suicide risk in patients with sleep disturbances, and vice versa, is needed. Therapeutic interventions such as cognitive behavior therapy for insomnia and imagery rehearsal treatment, as well as pharmacologic treatments, show promise in treating sleep disorders and suicidal behavior.