Sleep Improvement Research Articles

Sleep alterations in treatment-resistant depression patients undergoing ketamine treatment.

This study examines self-reported sleep alterations in treatment-resistant depression (TRD) inpatients following intravenous ketamine administration. This is a post-hoc analysis of a naturalistic observational study, which enrolled 28 inpatients with treatment-resistant major depressive disorder and analyzed self-reported sleep changes (items 1-4; 'insomnia', 'nighttime restlessness', 'early morning waking', 'hypersomnia') in Inventory of Depressive Symptomatology 30-item (IDS SR-30) in responders and non-responders stratified per Montgomery-Åsberg Depression Rating Scale (MADRS) during short-term ketamine treatment. Responders, as well as non-responders, did not experience significant changes in IDS SR-30 sleep items ('insomnia', 'nighttime restlessness', 'early morning waking', 'hypersomnia') (p's > 0.05) at 7-day follow-up after eight intravenous ketamine infusions as compared to baseline. Neither responders, nor non-responders reported any significant alterations in sleep patterns during ketamine infusions. These findings are not in line with current literature, as so far modest improvements in sleep during ketamine treatment have been reported. Results should be interpreted with caution, primarily due to the small sample size.

Specific therapeutic methods in lumbar facet syndrome tratment: prliminary study

Introduction: Specific therapeutic methods (STM) are manual techniques used to treat tissue blockade.Aim of this research is to determine efficacy of STM in treatment of lumbar facet syndrome (LFS).Patients and methods. The study included 60 patients suffering from LFS (65% women) aged ~47. The patients were treated ~24 days with the following 2-8 procedures: osteopathy, “myofascial release”, acupuncture, acupressure, “cupping”, neurodynamic, proprioceptive neuromuscular facilitation, kinesiotherapy, “kinesio-type taping”, homeopathy and electrotherapy. All patients were evaluated at admission and discharge through: a. pain scale with visual analogue scale (VAS) marked with numbers 1 to 10 (1 being state of no pain, 10 being state of maximum pain); b. disability with so-called Oswestry index (ODI) expressed in percentages (0-20% being minimum, 80-100% being complete disability); c. quality of sleep, rated through modified Pittsburgh index of sleep quality (PSQI) expressed between 0 (very poor) and 4 (very good). The assessment of improvement in pain intensity and level of disability was conducted via subtraction of values noted before treatment from values at the end of treatment, while the assessment of sleep quality improvement was conducted via subtraction of values noted at the end of treatment from the values noted before treatment. Non-parametric statistical analyses were used. Results: significantly lower values of VAS (p<0.0001) and ODI (p?0.0001), significant increase in PSQI (p?0.0001) at the end in relation to the beginning of treatment, as well as significant correlation between decrease in pain and disability (r=0.3292, p=0.0105). No significant difference in pain (p=0.9856) and disability (p=0.9171 decrease was noticed between sexes.Conclusion: STM is efficient in the treatment of pain attacks in patients of both sexes suffering from LBS.

Weighted Blankets as a Sleep Intervention: A Scoping Review.

Sleep disorders are associated with a range of health conditions, with poor sleep often further exacerbating individuals' health, well-being, and ability to participate in daily occupations. Weighted blankets offer a potentially simple nonpharmacological sleep intervention option. To summarize available literature on instrumentation and outcomes associated with overnight use of weighted blankets for therapeutic purpose. A scoping review following the PRISMA review guidelines was conducted. Sources included MEDLINE, Cochrane Library, CINAHL, PsycINFO, Scopus, Embase, and Google. Included studies reported on overnight use of weighted blankets. Critical appraisal of studies was conducted with standardized tools. Eighteen studies met the inclusion criteria. Positive outcomes were reported for adults, including improved sleep, reduction in medication use, and improved mood. Sleep outcomes were mixed for children and adolescents but included improved occupational performance. Methodological quality of included studies regarding effectiveness was variable. Ten studies included details of the intervention, whereas only one study reported on implementation. No specific guidelines for use were included. Weighted blankets are used as a sleep intervention for individuals across the life span experiencing a range of health conditions. Currently, there is more evidence of effectiveness with adults, although parents are favorable regarding weighted blanket use for children. Implementation and recommendation of weighted blankets are typically led by occupational therapists, with knowledge of the intervention facilitating use. This review provides information to inform occupational therapists' clinical decision-making and continued implementation of weighted blankets for individuals with sleep problems. Plain-Language Summary: This scoping review summarizes what is known about the use of weighted blankets as a sleep intervention for people of all ages. There is more evidence for overnight use of weighted blankets for adults, with improvements reported in sleep, mood, medication use, and pain. Although there is little evidence of improvement in sleep for children, some children show improvement in everyday functioning, and parents report positive outcomes from overnight use of weighted blankets. These findings suggest that occupational therapists should consider offering or recommending weighted blankets as a sleep intervention option for people of all ages, alongside consideration of individuals' preferences. Development of practice guidelines that incorporate current research findings is urgently needed to support occupational therapists' use of weighted blankets.

Investigation into the Effect of Emodin-8-O-β-D-glucoside on Sleep Improvement in a Mouse Experimental Model

Investigation into the Effect of Emodin-8-<i>O</i>-β-D-glucoside on Sleep Improvement in a Mouse Experimental Model

Identifying trajectories of change in sleep disturbance during psychological treatment for depression

BackgroundSleep disturbance may impact response to psychological treatment for depression. Understanding how sleep disturbance changes during the course of psychological treatment, and identifying the risk factors for sleep disturbance response may inform clinical decision-making. MethodThis analysis included 18,915 patients receiving high-intensity psychological therapy for depression from one of eight London-based Improving Access to Psychological Therapies (IAPT) services between 2011 and 2020. Distinct trajectories of change in sleep disturbance were identified using growth mixture modelling. The study also investigated associations between identified trajectory classes, pre-treatment patient characteristics, and eventual treatment outcomes from combined PHQ-9 and GAD-7 metrics used by the services. ResultsSix distinct trajectories of sleep disturbance were identified: two demonstrated improvement, while one showed initial deterioration and the other three groups displayed only limited change in sleep disturbance, each with varying baseline sleep disturbance. Associations with trajectory class membership were found based on: gender, ethnicity, employment status, psychotropic medication use, long-term health condition status, severity of depressive symptoms, and functional impairment. Groups that showed improvement in sleep had the best eventual outcomes from depression treatment, followed by groups that consistently slept well. LimitationSingle item on sleep disturbance used, no data on treatment adherence. ConclusionsThese findings reveal heterogeneity in the course of sleep disturbance during psychological treatment for depression. Closer monitoring of changes in sleep disturbance during treatment might inform treatment planning. This includes decisions about when to incorporate sleep management interventions, and whether to change or augment therapy with interventions to reduce sleep disturbance.

Mind-body therapy for treating fibromyalgia: a systematic review.

Fibromyalgia is a chronic and disabling condition that presents management challenges for both patients and healthcare providers. The objective of this systematic review was to summarize current evidence on the effectiveness and safety of mind-body therapies in the treatment and/or management of fibromyalgia. We searched MEDLINE, EMBASE, PsycINFO, AMED, and CINAHL databases from their inception to December 2023. Eligible articles included adults diagnosed with fibromyalgia participating in a mind-body therapy intervention and were published from the beginning of 2012 onwards. We assessed the quality of the studies using the Joanna Briggs Institute Critical Appraisal Checklists. Of 3866 records screened, 27 studies (30 articles) met our inclusion criteria, in which 22 were randomized controlled trials and 5 were quasi-experimental studies. Mind-body therapies included guided imagery (n = 5), mindfulness-based stress reduction (n = 5), qi gong (n = 5), tai chi (n = 5), biofeedback (n = 3), yoga (n = 2), mindfulness awareness training (n = 1), and progressive muscle relaxation (n = 1). With the exception of mindfulness-based stress reduction, all therapies had at least one study showing significant improvements in pain at the end of treatment. Multiple studies on guided imagery, qi gong, and tai chi observed significant improvements in pain, fatigue, multidimensional function, and sleep. Approximately one-third of the studies reported on adverse events. This review suggests that mind-body therapies are potentially beneficial for adults with fibromyalgia. Further research is necessary to determine if the positive effects observed post-intervention are sustained. Open Science Framework (https://osf.io) (September 12, 2023; https://doi.org/10.17605/osf.io/6w7ac).

Helping athletes to select botanical supplements for the right reasons: A comparison of self-reported reasons for use versus evidence-based supplement claims.

Use of food supplements (FS) by athletes is well characterised but there is little information on 'herbal' or 'botanical' FS beyond 'natural'. This study determined, by questionnaire, whether athletes' main self-reported reason for using FS was reflective of what was written on product labels or, when these claims were unavailable, was in accordance with the scientific literature. In 217 elite (n = 55) and amateur (n = 162) athletes living on the island of Ireland, 71% (n = 153) consumed any kind of FS, with 16% (n = 34) of the entire cohort deemed botanical consumers. 'Protein' (21%, n = 46), 'vitamin D' (17%, n = 37) and 'vitamin C' (15% n = 32) were most consumed with the top reasons for use being 'to support health', 'to prevent illness/for immunity purposes' and 'recovery'. There was generally good agreement between approved nutrition and health claims for such products and athletes' main reported reasons for use. Only the amateur athletes in our pool described using botanical supplements, with reasons for use stated as 'sleep improvement' (21%), 'recovery' (14%), 'supporting health' (12%) and 'energy' (12%), resulting in poor agreement with either approved claims or scientific evidence. Only half of amateur athletes knew if their botanical FS were third-party tested. Athletes and practitioners require guidance to avoid consuming supplements for which there is little scientific evidence, and which may risk being contaminated/fraudulent.

Sleep quality and glycemic control in adults with type 2 diabetes mellitus.

Type 2 diabetes mellitus (T2DM) is a common disease that imposes a substantial burden on the healthcare system and patients. Lifestyle modification such as sleep hygiene plays a crucial role in glycemic control. Sleep disorders impact many aspects of health. In this study, we aimed to investigate the correlation between sleep quality and glycemic control in T2DM. Method: This cross-sectional study was performed on 163 T2DM patients, attending Shahid Beheshti Hospital in Hamadan, Iran from March 2020 to 2021. Besides recording the demographic data and HbA1c level of participants, they were asked the Pittsburgh Sleep Quality Index questionnaire for evaluating sleep quality. We employed SPSS ver. 21 for data analysis and considered 0.05 as a significant level. Among all participants, 62 (38%) were female and 30.7% were illiterate. The mean age was 56.67 ± 12.90 years, and HbA1c was 9.03 ± 1.92 mg/dL. Among sleep metrics, mean waking time was 8.74 ± 1.74 hours, and average sleep time was 12.90 ± 4.90 hours. Overall, 58.2% of the participants had poor glycemic control and 44.8% were suffering from poor sleep quality. We found that patients with poor glycemic control exhibited significantly higher levels of sleep disturbances compared to those with good glycemic control (P < 0.001). Sleep quality is associated with glycemic control in patients with T2DM. Sleep disorders are common among diabetic patients. Thus, healthcare providers need to consider sleep quality improvement in their holistic approach to diabetes management.

A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Effectiveness and Safety of Melatonin and Three Formulations of Floraworks Proprietary TruCBN™ for Improving Sleep.

The phytocannabinoid cannabinol (CBN) has a potential mechanism of action as an alternative sleep aid but there is minimal evidence to support its effectiveness. The aim of this randomized, double-blind, placebo-controlled study was to assess the safety and effects of three formulations of a hemp-derived CBN sleep aid, TruCBN™ [25 mg (n = 206), 50 mg (n = 205), 100 mg (n = 203)], on sleep quality (PROMIS Sleep Disturbance 8A), relative to placebo (n = 204). The effectiveness and safety of these formulations relative to 4 mg of melatonin (n = 202) was assessed. Exploratory measures were stress (PROMIS Stress 4A), anxiety (Anxiety 4A), pain (PROMIS™ PEG), and well-being (WHO 5). All groups and the 4 mg melatonin group experienced significant improvement in sleep quality relative to the placebo group with no significant differences between any group and the melatonin group. Participants taking 100 mg showed a larger decrease in stress compared to the placebo group. There were no significant differences in anxiety, pain, well-being, or the frequency of side effects between any group and the placebo group. There was no significant difference in improvements in sleep quality between any of the treatment groups and the 4 mg melatonin group. Orally ingested CBN, at 25 mg, 50 mg, and 100 mg, is a safe and effective alternative for the improvement of sleep.

The effect of massage on cramp frequency, cramp severity, and sleep quality of hemodialysis patients: A randomized controlled trial.

Leg muscle cramps and compromised sleep patterns are prevalent issues experienced by individuals undergoing hemodialysis treatment. The aim of this study was to assess the impact of massage therapy on hemodialysis patients experiencing cramping, specifically focusing on the frequency and severity of cramps, as well as the quality of sleep. This research involved 36 hemodialysis patients. The intervention group received intradialytic massage targeting the lower extremities, administered three times a week for a total of six sessions over a 2-week period. Data collection utilized a Patient Information Form, the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and a Patient Follow-Up Form. The study revealed a significant reduction in both the frequency and severity of cramps experienced by patients in the intervention group during hemodialysis sessions and at home, from the end of one session to the beginning of the next, compared to the control group (p < 0.05). This effect was observed over the course of six dialysis sessions. Additionally, there was a notable decrease in the mean total score of the Pittsburgh Sleep Quality Index (PSQI) among participants in the intervention group, declining from 9.00 ± 3.79 prior to massage therapy to 5.94 ± 2.84 post-massage (p < 0.001). Conversely, no significant change was observed in the control group, highlighting a notable disparity between the intervention and control groups in terms of sleep quality improvement. The investigation revealed that employing intradialytic massage on the lower extremities led to a reduction in both the frequency and severity of cramps, while also eliciting a positive impact on the sleep quality of patients undergoing hemodialysis.

Effect of Training Load Intensification on the Sleep Pattern of Young Soccer Players

ABSTRACT Purpose: The aim of this study was to examine how intensifying training loads over a week affects the sleep patterns of young soccer players on the nights immediately following the intensified training sessions. Methods: Quasi-experimental study. Fifteen young athletes participants of a team engaged in national level competition, underwent two weeks of training with varying load magnitudes—Week 1: low accumulated training load and Week 2: intensified training loads [40% increase in external training load(ETL)]. To characterize the intensification of the workload, the methods PlayerLoad and RPE-Session were employed to measure ETL and internal training load(ITL), respectively. Total sleep time(TST), total time in bed(TTB), sleep efficiency(SE), sleep latency(SL), and wake after sleep onset(WASO) were obtained using actigraphy and daily sleep log. The variables were compared among the days of week (e.g. Monday of week 1 with Monday of week 2, and so forth). Results: Acute training intensification in week 2 led to significant increases in ETL and ITL on Monday and on Wednesday(p < .05), and ETL(p < .05) on Friday on the second week. Improvements in sleep were observed (Tuesday—TST:+80 min, WASO:-29.3 min, SL:-8 min, SE:+9%; Thursday—TST:+86 min, SL:-4 min, SE:+4%; Saturday—TST:+40 min, SL:+1 min) compared to the same day of the previous week. Correlations between ETL and ITL(r = 0.637), ITL and TST(r = 0.572), ITL and SE(r = 0.548) were found. Conclusion: Intensification of training loads results in alterations in sleep variables, notably an elevated TST and SE in the days subsequent to the acute load increment.

Telehealth-delivered behavioral sleep interventions for Autistic children: An evaluation of an enhanced stepped-care approach

BackgroundSleep problems are common among Autistic children and can have adverse effects on their development, well-being and quality of life. Telehealth offers a cost-effective and accessible model of delivering evidence-based sleep support. This study used a single-case design to evaluate the efficacy of telehealth-delivered behavioral sleep intervention (TDBSI), with intervention phases designed based according to a stepped-care approach. MethodFourteen Autistic children (3–17 years) and their parents participated in a 12-week program consisting of three sequential intervention phases: 1) self-directed online parent education supplemented with individualized intervention tip sheets, 2) group parent coaching via video conferencing, and 3) individualized parent coaching via video conferencing. The appropriateness of parent strategy selection and implementation fidelity was rated throughout. Sleep problem severity (SPS) scores are reported for each child as a measure of effect across intervention phases. The Children's Sleep Habits Questionnaire (CSHQ) and CSHQ-Autism are reported as measures of change from baseline to post-intervention. ResultsOnline parent education and tip sheets facilitated early success in parent strategy selection and implementation fidelity. SPS scores demonstrated large and statistically significant improvements in child sleep following the self-directed phase. Parent implementation fidelity and child sleep outcomes were further improved with group and individualized coaching. Post-intervention, the CSHQ and CSHQ-Autism revealed large and statistically significant improvements across subscales and participants compared to baseline. ConclusionsOnline parent education supplemented with individualized tip sheets demonstrates potential for addressing sleep problems in Autistic children. Therapist-led group and individualized parent coaching via videoconferencing show promise as higher intensity support for parents who do not achieve satisfactory results initially.

Nutraceutical composition (yeast β-glucan, prebiotics, minerals, and silymarin) predicts improvement of sleep quality and metabolic parameters: A randomized pilot study

Background & AimsThe search for integrative and natural therapies that favor homeostasis to boost sleep and diet quality took place for young adult populations as a non-pharmacological strategy for long-term good quality of life. Thus, the present pilot study aims to investigate the effects of 90-day consumption of a nutraceutical composition on the neuro-immune-endocrine axis, providing better sleep quality and health improvement. MethodsFor this, from March 2021 to June 2021, twenty-two Brazilian young adult volunteers (women and men) with BMI between 18.5 to 34.9 kg/m2 were divided into three distinct supplementation groups: NSupple; NSupple plus_S, and NSupple plus. Briefly, the supplement compositions included yeast β-glucan, prebiotics, and minerals in different concentrations associated or not with the herbal medicine silymarin.Neither nutritional nor physical activity interventions were performed during this pilot study period. The anthropometrics measures, questionnaires answer data, and harvest blood for metabolic, inflammatory, and hormonal tests were collected at baseline time (day zero-T0) and day 90 (T90) post-supplementation. ResultsOur results highlight that the supplementation reduced body mass index (BMI), Waist-to-height ratio (WHtR), waist circumference, AST/ALT ratio, alkaline phosphatase, and HbA1c. Post-supplementation the IL-6 and IL-10 levels and the sleep, humor, and quality of life scores were suggested to improve. Sleep quality improvement seems to predict the reduction of adiposity-related body measures. ConclusionIn sum, the nutraceutical supplementation might be related to anthropometric, metabolic, and endocrine parameters after 90 days reflecting on perception of humor, sleep, and life quality enhancement. However, it is important to recognize the limitation of the data presented considering that this was a pilot study. Clinical trial registrationClinicalTrials.gov, identifier NCT04810572 registered on 20th February 2021.

Hot flashes and sleep disruption in a randomized trial in menopausal women

BackgroundHot flashes, common during menopause, affect up to 80% of Western menopausal women and are reported to contribute to sleep disturbances in midlife. Few prospective data are available to confirm the specific role of hot flashes in disrupting sleep in midlife women, however, or confirm whether changes in hot flashes in response to clinical therapies result in improvement in sleep. ObjectiveTo examine the effects of continuous nitroglycerin therapy on sleep quality in peri- and postmenopausal women with frequent hot flashes (pre-specified secondary trial endpoint), and to examine prospective associations between hot flashes and sleep disruption in this population. Study DesignSleep data were analyzed from a randomized, double-blinded, placebo-controlled trial of continuous transdermal nitroglycerin (NTG) therapy to suppress nitric oxide-mediated vasodilation in peri- or postmenopausal women with hot flashes. Participants were randomized to uninterrupted use of transdermal NTG (0.2-0.6 mg/hour) or placebo for 12 weeks. Nocturnal hot flashes awakening participants from sleep were evaluated using 7-day symptom diaries at baseline, 5 weeks, and 12 weeks. Sleep disruption (wake time after sleep onset, WASO) was assessed using validated sleep diaries, and global sleep quality was assessed by the validated Pittsburgh Sleep Quality Index (PSQI: range 0 [best] 21 [worst]) questionnaire. Mixed linear models examined changes in sleep quality and disruption, as well as the strength of associations between nocturnal hot flash frequency and sleep outcomes, over 5 and 12 weeks, adjusting for baseline values, age, race, and ethnicity. ResultsAmong the 141 participants (70 to NTG and 71 to placebo, mean age 54.6 [±3.9] years), the mean baseline hot flash frequency was 10.8 (±3.5) per day, including 2.6 (±1.7) nocturnal hot flashes awakening participants. At baseline, hot flashes were the most commonly reported reason for nocturnal awakening, with 62.6% of participants reporting waking due to hot flashes at least twice nightly. Over 5 and 12 weeks, mean frequency of nocturnal hot flashes causing awakenings decreased in both groups (NTG: -0.9 episodes/night, placebo: -1.0 episodes/night). Sleep disruption as measured by average nightly WASO also decreased (NTG: -10.1 minutes, placebo: -7.3 minutes), and mean PSQI score improved (NTG: -1.3 points, placebo: -1.2 points). No significant between-group differences in change in sleep outcomes were detected from baseline to 5 and 12 weeks, including PSQI sleep quality score as a pre-specified secondary trial endpoint (P ≥ .05 for all). Greater improvement in nocturnal hot flash frequency over 5 and 12 weeks was associated with greater improvement in PSQI sleep quality score (β= -0.30, P=.01) and sleep disruption reflected by WASO (β= -1.88, P=.02) in the combined sample. ConclusionAmong menopausal women in a randomized trial of continuous NTG therapy for hot flashes, hot flashes were the most frequently reported cause of nocturnal awakenings. Compared to placebo, continuous NTG therapy did not result in greater improvements in sleep quality from baseline to 5 and 12 weeks. Based on night-by-night symptom diaries and questionnaires, however, greater improvement in nocturnal hot flash frequency in both groups was associated with greater improvement in sleep quality and disruption.

Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials

Nemolizumab, an interleukin (IL)-31 receptor subunit α antagonist, inhibits the IL-31 pathway of itch and skin inflammation in atopic dermatitis. Two international phase 3 studies were done to assess the efficacy and safety of nemolizumab in atopic dermatitis. In this Article we report results for the 16-week initial treatment period of both trials. ARCADIA 1 and ARCADIA 2 were identical 48-week randomised, double-blind, placebo-controlled phase 3 trials in adult and adolescent participants (aged ≥12 years) with moderate-to-severe atopic dermatitis, associated pruritus, and inadequate response to topical steroids. Participants were enrolled from 281 clinics, hospitals, and academic centres in 22 countries across both trials, and were randomly assigned (2:1) to receive nemolizumab 30 mg subcutaneously (baseline loading dose 60 mg) or matching placebo once every 4 weeks with background topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI; ie, TCS-TCI background treatment). Randomisation was done via interactive response technology and stratified by baseline disease and pruritus severity. Study staff and participants were masked throughout the study, with outcome assessors masked until database lock. Coprimary endpoints at week 16 post-baseline were Investigator's Global Assessment (IGA) success (score of 0 [clear skin] or 1 [almost clear skin] with a ≥2-point improvement from baseline) and at least 75% improvement in Eczema Area and Severity Index score from baseline (EASI-75 response). Outcome rates were compared between groups with the Cochran-Mantel-Haenszel test adjusting for randomisation strata. The key secondary endpoints were the proportion of participants with Peak Pruritus Numerical Rating Scale (PP-NRS) score improvement of at least 4 points at weeks 1, 2, 4, and 16; PP-NRS score below 2 at weeks 4 and 16; Sleep Disturbance Numerical Rating Scale score improvement of at least 4 points at week 16; EASI-75 response plus PP-NRS score improvement of at least 4 points at week 16; and IGA success plus PP-NRS score improvement of at least 4 points at week 16. Efficacy analyses were done on an intention-to-treat basis; safety analyses included all participants who received one dose of nemolizumab or placebo. Both studies are completed (ClinicalTrials.gov: ARCADIA 1, NCT03985943 and ARCADIA 2, NCT03989349). Between Aug 9, 2019, and Nov 2, 2022, 1728 participants were enrolled across both trials: 1142 were allocated to nemolizumab plus TCS-TCI (620 in ARCADIA 1 and 522 in ARCADIA 2) and 586 to placebo plus TCS-TCI (321 in ARCADIA 1 and 265 in ARCADIA 2). ARCADIA 1 included 500 (53%) male participants and 441 (47%) female participants, and ARCADIA 2 included 381 (48%) male participants and 406 (52%) female participants. Mean age ranged from 33·3 (SD 15·6) years to 35·2 (17·0) years across the treatment groups. Both trials met the coprimary endpoints; at week 16, a greater proportion of participants receiving nemolizumab plus TCS-TCI versus placebo plus TCS-TCI had IGA success (ARCADIA 1: 221 [36%] of 620 vs 79 [25%] of 321, adjusted percentage difference 11·5% [97·5% CI 4·7-18·3], p=0·0003; ARCADIA 2: 197 [38%] of 522 vs 69 [26%] of 265, adjusted difference 12·2% [4·6-19·8], p=0·0006) and an EASI-75 response (ARCADIA 1: 270 [44%] vs 93 [29%], adjusted difference 14·9% [7·8-22·0], p<0·0001; ARCADIA 2: 220 [42%] vs 80 [30%], adjusted difference 12·5% [4·6-20·3], p=0·0006). Significant benefits were observed with nemolizumab for all key secondary endpoints including improvement in itch, as early as week 1, and sleep improvement by week 16. The safety profile was similar between nemolizumab plus TCS-TCI and placebo plus TCS-TCI. In the safety sets, 306 (50%) of 616 participants (ARCADIA 1) and 215 (41%) of 519 participants (ARCADIA 2) who received nemolizumab plus TCS-TCI had at least one treatment-emergent adverse event (serious treatment-emergent adverse events in six [1%] and 13 [3%], respectively); and 146 (45%) of 321 (ARCADIA 1) and 117 (44%) of 263 (ARCADIA 2) who received placebo plus TCS-TCI had at least one treatment-emergent adverse event (serious treatment-emergent adverse events in four [1%] and three [1%], respectively). Ten serious treatment-emergent adverse events possibly related to nemolizumab were reported in five (1%) participants in ARCADIA 2. No deaths occurred. Nemolizumab plus TCS-TCI was efficacious and showed statistically and clinically significant improvements in inflammation and itch in adults and adolescents with moderate-to-severe atopic dermatitis. Nemolizumab might offer a valuable extension of current therapies if approved. Galderma.

When regulation ignores evidence: The case of Denmark’s Ashwagandha ban and the Technical University of Denmark’s misguided risk assessment

The recent ban on Ashwagandha (Withania somnifera (L.) Dunal) supplements in Denmark, based on a risk assessment by the Technical University of Denmark (DTU), exemplifies the challenges in regulating traditional herbal medicines within modern frameworks. This article critically examines the DTU report, highlighting methodological flaws including overreliance on animal studies and selective literature review. The report’s disregard for Ashwagandha's long history of traditional use and mischaracterization of its effects, particularly alleged abortifacient properties, contradicts a growing body of scientific evidence supporting its safety and efficacy. The current research demonstrating Ashwagandha's benefits in stress reduction, sleep improvement, and cognitive function further underscores the disparity between scientific findings and the DTU’s conclusions. The ban’s implications extend beyond Denmark, raising questions about regulatory consistency and proportionality in evaluating herbal products globally. The Indian Ministry of Ayush’s critique emphasizes the need for a more comprehensive, evidence-based approach for assessing traditional medicines. This controversy may catalyze the development of integrated evaluation methods, such as the Collaborative Medicine and Science framework, bridging diverse knowledge systems in regulatory decision-making. The case underscores the necessity for a global health paradigm that harmonizes traditional and modern medical approaches, ensuring public safety while preserving access to beneficial traditional remedies.

Improvement in sleep disturbance following arthroscopic rotator cuff repair

Approximately 90% of patients express concerns with sleep shortly after developing shoulder-related symptoms. Previous small cohort studies have demonstrated the impact of rotator cuff repair on sleep, but none have characterized the observed benefits. The purpose of this study is to evaluate sleep improvement after rotator cuff repair including the speed of sleep recovery, the time at which improvement plateaus, and the longer-term maintenance of improved sleep. A retrospective review of our institution's shoulder and elbow repository identified patients who underwent primary arthroscopic rotator cuff repair from 2012 - 2021 and reported sleep disturbance preoperatively. Patients were evaluated using sleep-related questions from the Simple Shoulder Test and American Shoulder and Elbow Surgeons score. Sleep outcomes were compared from a preoperative visit to 3-month, 6-month, 12-month, and most recent follow-ups to evaluate efficacy of treatment, speed of recovery and improvement plateaus. Among 677 RCR patients, 95.7% (648/677) reported sleep disturbance preoperatively. A total of 474 met inclusion criteria with median follow-up of 4.1 years (IQR, 2.1-6.1). At most recent follow-up, 81.8% were able to sleep comfortably and 65.7% were able to sleep on the affected side. A plateau in the ability to sleep comfortably was seen at 6 months while no plateau was observed in the ability to sleep on the affected side. More rapid improvement in the ability to sleep comfortably occurred during the first 3 months and from 3 - 6 months for the ability to sleep on the affected side. The majority of patients with sleep disturbance who undergo RCR, report significant, rapid, and lasting improvement in the ability to sleep comfortably and the ability to sleep on the affected side.

Sleep as a predictor of improved response to transcranial magnetic stimulation for depression (SPIRiTeD)

BackgroundTranscranial magnetic stimulation (TMS) is an evidence-based approach to treatment- resistant Major Depressive Disorder (TRD). Sleep dysfunction is associated with poor outcomes in TRD, however, the impacts of sleep dysfunction on TMS treatment has yet to be defined. This study examined the association between sleep dysfunction and improvement in depression symptoms with TMS treatment for TRD. MethodsA retrospective observational cohort study was conducted examining all Veterans receiving TMS treatments through the “VA TMS Clinical Pilot Program” over a three-year period. The Patient Health Questionnaire (PHQ-9) sleep item was utilized to assess sleep dysfunction. The association between sleep dysfunction improvements during TMS treatment with depression outcomes was analyzed. Results94.3 % (N = 778) of Veterans reported baseline sleep dysfunction. Chi-square analysis demonstrated higher rates of depression remission at the completion of TMS treatment for those with sleep improvement at weeks 1, 3 and 6 (all p < .001). ANOVA comparing sleep improvements and end of treatment PHQ-8 score (modified to remove sleep item) found a statistically significant difference in mean improvements of depression scores at all 3 time points. LimitationsLimitations include those that are inherent to retrospective studies, as well as limitations in using the PHQ-9 sleep item as the primary means to assess sleep dysfunction. ConclusionThis study reports on the largest sample size to date examining the relationship between sleep dysfunction and TMS treatment outcomes for MDD, and found that improvement in sleep dysfunction was associated with greater reductions in end of treatment depression symptoms including higher depression remission rates.

Efficacy and Safety of Balneotherapy using Diverse Natural Resources in Lithuania: A Multicenter Study

Background: Balneotherapy or spa therapy, with its multimodal effects, has shown clinical efficacy in treating various pathological conditions. However, further studies are needed to assess its impact on mental health and to evaluate treatment safety. This study aimed to evaluate the effectiveness of different natural resources of the Lithuanian medical spa for stress-related disorders and skin health and to disclose the safety profile of using natural resources. Methodology. We performed a multicenter randomized controlled single-blinded study in 6 Lithuanian medical spas. The 1- 2-week treatment combining mineral water, therapeutic mud, and salt procedures was provided for the 364 participants with moderate stress levels and the effect was evaluated using surveys, instrumental, and laboratory measures. Results. The findings highlighted that the effects of BT using different natural resources significantly improve mental and skin health, as well as contribute to overall health status for up to 6 months. A significant reduction of anxiety, depression, and fatigue as well as improvement in sleep, skin moisture, subjective skin state, and integrative outcomes was achieved in all centers after treatment, while stress and saliva cortisol, working speed, skin oiliness, and elasticity improved in a few centers. A positive result was related to the duration of the treatment, and possibly- to the features of natural resources. Mineral water most commonly caused side effects; it varied among centers, however, they were predominantly local, mild, and transient. Conclusions. Balneotherapy using natural resources is effective for the enhancement of mental and skin health. Further research is necessary for a better understanding of the role of different natural resources on health status and safety profile. Keywords: balneotherapy, health, mental state, mineral water, natural resources, peloids, peloi-dotherapy, safety, spa therapy, skin

Gut microbiome composition and functionality impact the responsiveness to a dairy-based product containing galacto-oligosaccharides for improving sleep quality in adults.

Sleep quality and duration can be impacted by diet, and has been linked to gut microbiota composition and function as the result of communication via the microbiota-gut-brain axis. As one strategy to improve sleep quality could be through the modulation of the gut microbiome, we assessed the effects of a dairy-based product containing whey protein, galacto-oligosaccharides, tryptophan, vitamins and minerals after a 3 weeks intervention on gut microbiota composition and (gut-brain related) functions on basis of 67 healthy subjects with moderate sleep disturbances. Associations of the gut microbiota with sleep quality and with response/non-response to the treatment were revealed by shotgun metagenomics sequencing of faecal DNA samples, and subsequent analyses of microbiota taxonomy and generic functionality. A database of manually curated Gut-Brain Modules (GBMs) was applied to analyse specific microbial functions/pathways that have the potential to interact with the brain. A moderate discriminating effect of the DP treatment on gut microbiota composition was revealed which could be mainly attributed to a decrease in Pseudomonas resinovorans, Flintibacter sp. KGM00164, Intestinimonas butyriciproducens, and Flavonifractor plautii. As interindividual variance in microbiota composition could have given rise to a heterogenous responsiveness of the subjects in the intervention group, we zoomed in on the differences between responders and non-responders. A significant difference in baseline microbiota composition between responders and non-responders was apparent, showing lower Bifidobacterium longum and Bifidobacterium adolescentis, and higher Faecalibacterium prausnitzii relative abundances in responders. The findings provide leads with respect to the effectiveness and potential underlying mechanisms of mode of action in sleep improvement that could support future nutritional interventions to aid sleep improvement.