Is Yoga Associated With Improved Sleep Amongst Breast Cancer Survivors?

BACKGROUND: Breast cancer survivors may experience sleep disturbances that can affect their physical and mental well-being. We sought to determine the association, if any, between yoga and sleep among breast cancer survivors in a population-based cohort. METHODS: The National Health Interview Survey is designed to be representative of the US civilian non-institutionalized population. We evaluated breast cancer survivors in the 2017 cohort to determine the association between yoga and self-reported quality of sleep. RESULTS: Of the 25,905 people surveyed, representing 238,738,039 in the population, 1.59% reported a previous history of breast cancer. Breast cancer survivors were less likely to report having practiced yoga in the preceding 12 months, compared to those without a history of breast cancer (9.98% vs 13.78%, P = .011). In addition, they were more likely to report having had trouble falling asleep (44.64% vs 36.32%, P = .002), staying asleep (53.72% vs 39.43%, P < .001), and using sleep medication on at least 1 day within the previous week (23.80% vs 13.49%, P < .001) than those without breast cancer. Among breast cancer survivors, there were no significant differences in difficulty falling asleep (39.16% vs 44.98%, P = .482), difficulty staying asleep (61.17% vs 52.70%, P = .305), and needing sleep medication (19.03% vs 24.53%, P = .395) between those who practiced yoga and those who did not. Controlling for sociodemographic factors, there remained no association between yoga and difficulty falling or staying asleep among breast cancer survivors. CONCLUSION: There is no direct association between yoga and sleep quality in breast cancer survivors.

Application of Chaihu-Guizhi-Longgu-Muli decoction combined with Liuwei Dihuang Pills in the treatment of menopausal insomnia and its effect on sleep quality.

To explore the application of Chaihu-Guizhi-Longgu-Muli decoction (CGLM) combined with Liuwei Dihuang Pills in the treatment of menopausal insomnia and its effect on sleep quality. The data of 120 menopausal insomnia patients admitted to our hospital from February 2019 to February 2020 were retrospectively analyzed and they were equally divided into the experimental group (n=60) and the control group (n=60) according to the order of admission. All patients were treated with Liuwei Dihuang Pills, and the experimental group was additionally given CGLM. The Pittsburgh Sleep Quality Index (PSQI), estrogen level, negative emotion score, quality of life score, serum ß-endorphin (ß-EP) level, serotonin level (5-HT) and treatment effective rate were compared between the two groups of patients. After treatment, the experimental group obtained markedly lower PSQI scores and negative emotion scores than the control group (P<0.001). The estrogen levels, ß-EP levels and 5-HT levels of the experimental group after treatment were significantly better than those of the control group (P<0.001). Higher quality of life scores and treatment effective rates were observed in the experimental group after treatment than the control group (P<0.001). CGLM combined with Liuwei Dihuang Pills can regulate the serum hormone levels of patients with menopausal insomnia, reduce negative emotions and improve sleep quality and quality of life, which merits clinical promotion.

Chronotherapeutic efficacy of suvorexant on sleep quality and metabolic parameters in patients with type 2 diabetes and insomnia.

AIMS: This study aimed to assess the chronotherapeutic efficacy of suvorexant on subjective sleep parameters and metabolic parameters in patients with type 2 diabetes and insomnia. METHODS: Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14 ± 2 weeks. The following parameters were assessed before and after the treatment: sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake. RESULTS: Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p < 0.05), but did not change HbA1c, CGM parameters, or body weight. Correlation analysis revealed that changes in sSE were associated with those in HbA1c and body weight (r = -0.61 and r = -0.66, respectively; both p < 0.05). CONCLUSIONS: Suvorexant significantly improved sleep quality and obesity-associated parameters in patients with type 2 diabetes in 14 weeks. Improvements in sleep quality were associated with improvements in glycemic control. Sleep disorder treatment using suvorexant may provide metabolic benefits for patients with type 2 diabetes.

High Prevalence of Cannabidiol Use Within Male Professional Rugby Union and League Players: A Quest for Pain Relief and Enhanced Recovery.

Rugby is characterized by frequent high-intensity collisions, resulting in muscle soreness. Players consequently seek strategies to reduce soreness and accelerate recovery, with an emerging method being cannabidiol (CBD), despite anti-doping risks. The prevalence and rationale for CBD use in rugby has not been explored; therefore, we recruited professional male players to complete a survey on CBD. Goodness of fit chi-square (χ2) was used to assess CBD use between codes and player position. Effects of age on use were determined using χ2 tests of independence. Twenty-five teams provided 517 player responses. While the majority of players had never used CBD (p < .001, V = 0.24), 26% had either used it (18%) or were still using it (8%). Significantly more CBD use was observed in rugby union compared with rugby league (p = .004, V = 0.13), but player position was not a factor (p = .760, V = 0.013). CBD use increased with players' age (p < .001, V = 0.28), with mean use reaching 41% in the players aged 28 years and older category (p < .0001). The players using CBD primarily used the Internet (73%) or another teammate (61%) to obtain information, with only 16% consulting a nutritionist. The main reasons for CBD use were improving recovery/pain (80%) and sleep (78%), with 68% of players reporting a perceived benefit. These data highlight the need for immediate education on the risks of CBD, as well as the need to explore the claims regarding pain and sleep.

Cannabidiol in sport: Ergogenic or else?

In the sports domain, cannabis is prohibited by the World Anti-Doping Agency (WADA) across all sports in competition since 2004. The few studies on physical exercise and cannabis focused on the main compound i.e. Δ9-tetrahydrocannabinol. Cannabidiol (CBD) is another well-known phytocannabinoid present in dried or heated preparations of cannabis. Unlike Δ9-tetrahydrocannabinol, CBD is non-intoxicating but exhibits pharmacological properties that are interesting for medical use. The worldwide regulatory status of CBD is complex and this compound is still a controlled substance in many countries. Interestingly, however, the World Anti-Doping Agency removed CBD from the list of prohibited substances - in or out of competition - since 2018. This recent decision by the WADA leaves the door open for CBD use by athletes. In the present opinion article we wish to expose the different CBD properties discovered in preclinical studies that could be further tested in the sport domain to ascertain its utility. Preclinical studies suggest that CBD could be useful to athletes due to its anti-inflammatory, analgesic, anxiolytic, neuroprotective properties and its influence on the sleep-wake cycle. Unfortunately, almost no clinical data are available on CBD in the context of exercise, which makes its use in this context still premature.

Complementary and Alternative Medicine for the Treatment of Insomnia: An Overview of Scientific Evidence from 2008 to 2018.

Insomnia is a widespread sleep disorder in the general population, and it is a risk factor for impaired function, the development of other medical and mental disorders, and causes an increase in health care costs. In view of the health hazards of insomnia and the shortcomings of western medicine, Complementary and Alternative Medicine (CAM) should be considered in the management of insomnia. The present overview reports the potential role of herbal medicine and non-pharmacological therapies in the treatment of insomnia and summarizes the scientific evidence reported from 2008 to 2018. PubMed and Web of Science databases were searched for studies published from 2008 to 2018. 17 randomized controlled trials and 22 non-pharmacological therapies were included in this review, and the results showed that CAM had certain advantages in the treatment of insomnia. The safety of CAM for insomnia was acceptable. Meanwhile, based on pre-clinical trial, the possible mechanisms of CAM for insomnia were modulation of circadian rhythm, GABA receptor activation, antagonisms of 5-HT receptors, inhibition of glutamate-mediated pathways, and attenuation of inflammation. CAM for insomnia has made some progress, but high quality evidence-based medical evidence is still needed to provide guidance for clinical application.

Assessing insomnia management in community pharmacy setting in Jordan: A simulated patient approach.

Insomnia is one of the most common minor ailments to which patients seek advice in a community pharmacy setting. Due to the availability of a wide variety of over-the-counter (OTC) products, community pharmacists are in the front line to safe-guard patients looking for self-medication or advice for treatment of insomnia. The purpose of this study was to assess the content of community pharmacists' interactions with patients seeking advice for insomnia in Jordan. A cross-sectional study using a simulated patient methodology was conducted across a stratified convenience sample of community pharmacies in three major cities in Jordan. The visits were evaluated using pre-defined criteria adapted from published literature relating to content and counseling skills. Visits were audio-recorded using a hidden microphone and the simulated patient completed a data collection form immediately after each visit. A total of 67 community pharmacies (response rate = 93.0%) agreed to participate and were all visited once by the simulated patient. The median duration of the visit was 2 minutes (range: 0.2-4 minutes). The majority (86.6%) of visits resulted in the sale of a drug, most commonly a combination product (paracetamol and diphenhydramine) for 30 recommendations (44.8%). This was followed by a natural plant extract combination product, namely valerian and lemon balm (Melissa officinalis L.) for 23 (34.3%). Pharmacists often did not question medical history or other symptoms prior to product sale. Frequently, the recommended dose (49.3%) and administration time (38.8%) were the only information provided to the patient. No information was provided in relation to potential drug interactions or contraindications. No advice was offered on lifestyle or good sleeping hygiene. This study provided evidence that community pharmacists in Jordan in general did not offer adequate counseling for patients seeking advice for insomnia. Exploration of the reasons and factors contributing to this practice and highlighting professional opportunity and responsibility is recommended.

Comparative effectiveness and safety of pharmacological and non-pharmacological interventions for insomnia: an overview of reviews.

BACKGROUND: This review aimed to assess the existing evidence regarding the clinical effectiveness and safety of pharmacological and non-pharmacological interventions in adults with insomnia and identify where research or policy development is needed. METHODS: MEDLINE, Embase, PsycINFO, The Cochrane Library, and PubMed were searched from inception until June 14, 2017, along with relevant gray literature sites. Two reviewers independently screened titles/abstracts and full-text articles, and a single reviewer with an independent verifier completed charting, data abstraction, and quality appraisal. RESULTS: A total of 64 systematic reviews (35 with meta-analysis) were included after screening 5024 titles and abstracts and 525 full-text articles. Eight of the included reviews were rated as high quality using the Assessment of Multiple Systematic Reviews 2 (AMSTAR2) tool, and over half of the included articles (n = 40) were rated as low or critically low quality. Consistent evidence of effectiveness across multiple outcomes based on more than one high- or moderate quality review with meta-analysis was found for zolpidem, suvorexant, doxepin, melatonin, and cognitive behavioral therapy (CBT), and evidence of effectiveness across multiple outcomes based on one high-quality review with meta-analysis was found for temazepam, triazolam, zopiclone, trazodone, and behavioral interventions. These interventions were mostly evaluated in the short term (< 16 weeks), and there was very little harms data available for the pharmacological interventions making it difficult to evaluate their risk-benefit ratio. CONCLUSIONS: Assuming non-pharmacological interventions are preferable from a safety perspective CBT can be considered an effective first-line therapy for adults with insomnia followed by other behavioral interventions. Short courses of pharmacological interventions can be supplements to CBT or behavioral therapy; however, no evidence regarding the appropriate duration of pharmacological therapy is available from these reviews. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017072527.

Using recreational cannabis to treat insomnia: Evidence from over-the-counter sleep aid sales in Colorado.

This study seeks to understand whether people substitute between recreational cannabis and conventional over-the-counter (OTC) sleep medications. UPC-level grocery store scanner data in a multivariable panel regression design were used to compare the change in the monthly market share of sleep aids with varying dispensary-based recreational cannabis access (existence, sales, and count) in Colorado counties between 12/2013 and 12/2014. We measured annually-differenced market shares for sleep aids as a portion of the overall OTC medication market, thus accounting for store-level demand shifts in OTC medication markets and seasonality, and used the monthly changes in stores' sleep aid market share to control for short-term trends. Relative to the overall OTC medication market, sleep aid market shares were growing prior to recreational cannabis availability. The trend reverses (a 236% decrease) with dispensary entry (-0.33 percentage points, 95% CI -0.43 to -0.24, p < 0.01) from a mean market share growth of 0.14 ±â€¯0.97. The magnitude of the market share decline increases as more dispensaries enter a county and with higher county-level cannabis sales. The negative associations are driven by diphenhydramine- and doxylamine-based sleep aids rather than herbal sleep aids and melatonin. These findings support survey evidence that many individuals use cannabis to treat insomnia, although sleep disturbances are not a specific qualifying condition under any U.S. state-level medical cannabis law. Investigations designed to measure the relative effectiveness and side effect profiles of conventional OTC sleep aids and cannabis-based products are urgently needed to improve treatment of sleep disturbances while minimizing potentially serious negative side effects.

Psychotropic effects of L-theanine and its clinical properties: From the management of anxiety and stress to a potential use in schizophrenia.

Anxiety disorders are highly prevalent in modern societies, and are ranked the sixth most important contributor of non-fatal negative health outcomes. L-theanine is an amino acid naturally found in green tea (Camellia sinensis) and some other plant extracts, and recent clinical studies have proposed promising adjuvant effects of L-theanine for the negative impact of anxiety and psychological stress on health. In this integrative narrative review, we aimed to appraise and further discuss the effects of L-theanine administration on anxiety disorders and psychological stress. Published data suggests that L-theanine administered at daily doses ranging from 200 to 400 mg for up to 8 weeks are safe and induce anxiolytic and anti-stress effects in acute and chronic conditions. L-theanine at doses lower and higher than these may also show promising therapeutic potential; however, a more thorough investigation through randomized double-blind placebo-controlled crossover clinical trials are necessary to elucidate its effects for longer periods, providing further insights for meta-analyses and the development of recommendation guidelines. Additionally, animal studies investigating a higher dosage, its combination with other pharmacological compounds and associated metabolic comorbidities are recommended, as cases of hepatotoxicity associated with the consumption of green tea extract have been reported.

Efficacy of Polygonatum sibiricum on Mild Insomnia: A Randomized Placebo-Controlled Trial.

Polygonatum sibiricum (PS) rhizome, which contains glyceryl-1-monolinoleate as its primary active component, has been shown to improve insomnia in animal models. Based on these findings, we aimed to investigate the safety and efficacy of PS rhizome extract in improving sleep quality in individuals with mild insomnia. Eighty individuals with mild insomnia were enrolled in a four-week, randomized, double-blind, placebo-controlled trial of PS rhizome extract (500 mg/day, n = 40, PS group) or placebo (n = 40, placebo group). The primary outcome measure was change in total score on the Athens Insomnia Scale (AIS) to indicate sleep quality. The secondary outcome measures included change in actigraphy data and perfusion levels in the brain regions within the default mode network (DMN), which is known to play a key role in insomnia. The PS group showed greater improvement in the total AIS score with a significant increase in total sleep time, relative to the placebo group. In addition, significant group-by-visit interactions were observed in the perfusion level of the medial prefrontal cortex within the DMN. Findings of the current study provide first evidence that PS rhizome extract could be an effective natural ingredient for improving sleep in mild insomnia using a human model.

Factors Associated With Delirium in Surgical Intensive Care Unit Patients Treated With Supplemental Melatonin: A Case-Cohort Study.

OBJECTIVES: Intensive care unit (ICU) delirium is a common neuropsychiatric syndrome that confers significant morbidity and mortality. Melatonin is an endogenous neurohormone involved with regulating sleep-wake cycles and has been found to be disturbed in ICU delirium. We hypothesized that there are independent factors that predict delirium in a cohort of patients on melatonin in the surgical ICU (SICU). METHODS: A retrospective, observational case-cohort analysis of adult SICU patients was conducted. Cases were defined by testing positive on the Confusion Assessment Method for the ICU (CAM-ICU). Delirioprotective and deliriogenic factors were assessed prior to the studied melatonin administration. RESULTS: Forty-one CAM-ICU-positive cases and 59 CAM-ICU-negative controls were included. Higher mean Acute Physiology and Chronic Health Evaluation II scores were associated with delirium in univariable analysis. Stratified analysis found a higher incidence of delirium in baseline CAM-ICU-positive patients who experienced emergency surgery within 24 hours of admission compared with baseline CAM-ICU-negative patients after melatonin administration. CONCLUSIONS: This study describes the use of melatonin in the SICU and characterizes the patients who receive it. Further research is needed to determine the role of melatonin in deliriogenesis and to clarify its utility as a delirioprotectant for postsurgical, critical care patients.

Sleep Disorders.

Sleep disorders are frequent and can have serious consequences on patients' health and quality of life. While some sleep disorders are more challenging to treat, most can be easily managed with adequate interventions. We review the main diagnostic features of 6 major sleep disorders (insomnia, circadian rhythm disorders, sleep-disordered breathing, hypersomnia/narcolepsy, parasomnias, and restless legs syndrome/periodic limb movement disorder) to aid medical practitioners in screening and treating sleep disorders as part of clinical practice.

Efficacy of melatonin for sleep disturbance following traumatic brain injury: a randomised controlled trial.

BACKGROUND: The study aimed to determine the efficacy of melatonin supplementation for sleep disturbances in patients with traumatic brain injury (TBI). METHODS: This is a randomised double-blind placebo-controlled two-period two-treatment (melatonin and placebo) crossover study. Outpatients were recruited from Epworth and Austin Hospitals Melbourne, Australia. They had mild to severe TBI (n = 33) reporting sleep disturbances post-injury (mean age 37 years, standard deviation 11 years; 67% men). They were given prolonged-release melatonin formulation (2 mg; Circadin®) and placebo capsules for 4 weeks each in a counterbalanced fashion separated by a 48-hour washout period. Treatment was taken nightly 2 hours before bedtime. Serious adverse events and side-effects were monitored. RESULTS: Melatonin supplementation significantly reduced global Pittsburgh Sleep Quality Index scores relative to placebo, indicating improved sleep quality [melatonin 7.68 vs. placebo 9.47, original score units; difference -1.79; 95% confidence interval (CI), -2.70 to -0.88; p ≤ 0.0001]. Melatonin had no effect on sleep onset latency (melatonin 1.37 vs. placebo 1.42, log units; difference -0.05; 95% CI, -0.14 to 0.03; p = 0.23). With respect to the secondary outcomes, melatonin supplementation increased sleep efficiency on actigraphy, and vitality and mental health on the SF-36 v1 questionnaire (p ≤ 0.05 for each). Melatonin decreased anxiety on the Hospital Anxiety Depression Scale and fatigue on the Fatigue Severity Scale (p ≤ 0.05 for both), but had no significant effect on daytime sleepiness on the Epworth Sleepiness Scale (p = 0.15). No serious adverse events were reported. CONCLUSIONS: Melatonin supplementation over a 4-week period is effective and safe in improving subjective sleep quality as well as some aspects of objective sleep quality in patients with TBI. TRIAL REGISTRATION: Identifier: 12611000734965; Prospectively registered on 13 July 2011.

An improved system for grading and treating tinnitus.

OBJECTIVE: Tinnitus is an auditory sensation that can cause discomfort or even pain. Because patients with tinnitus frequently have psychological problems, self-reporting of the severity of tinnitus is unreliable. We developed a new grading system and practical protocol for the systematic treatment of tinnitus that accounts for its severity, patients' psychological problems, and the frequency of catastrophic episodes. The aim of this study is to employ and validate the new system in patients with tinnitus. METHODS: This study comprised two parts: (i) We identified 113 patients, who were then analyzed in terms of severity of tinnitus, psychological problems, and catastrophic episodes. They were then classified into 5 grades, and the records of their previous treatments were scrutinized. From these records, we designed a practical treatment protocol suitable for each of the 5 grades. (ii) We then identified 82 new patients, and graded and treated them according to the system developed in part (i). Patients were followed-up for at least 6 months; treatment efficacy was evaluated using the pre- and post-treatment scores on the Tinnitus Handicap Inventory (THI) and Hospital Anxiety and Depression Scale (HADS). Psychological status was also assessed with the DSM-IV. RESULTS: (i) The overall patient group was categorized as follows: Grade I, 38 patients, average THI=37.6 points, average HADS=10.9 points, catastrophic episodes=0 points; Grade II, 24 patients, THI=70.6, HADS=13.1, catastrophic episodes=0; Grade III, 5 patients, THI=73.2, HADS=28.4, catastrophic episodes=0; Grade IV, 33 patients, THI=63.5, HADS=18.8, catastrophic episodes=1.0; Grade V, 13 patients, THI=73.2, HADS=22.4, catastrophic episodes=2.2. The treatment records revealed treatment via psychotropic drugs for 40% of Grade III, 45.5% of Grade IV, and 84.6% of Grade V patients; psychiatric consultation was provided for 20% of Grade III, 12.5% of Grade IV, and 53.8% of Grade V patients. (ii) THI scores improved significantly in Grades II, IV, and V after treatment using the new protocol; HADS scores improved significantly in Grades IV and V. Catastrophic episode scores improved significantly in Grades IV and V. CONCLUSION: We found large enough differences in THI and HADS scores to successfully classify patients with tinnitus into 5 distinct grades that accounted for tinnitus severity, psychological problems, and catastrophic episodes. We found significant improvements in tinnitus severity and psychological problems in the higher (more severe) grades when this system was used to guide treatment. This system not only provided a reasonably reliable categorization system, it simplified treatment without sacrificing efficacy.

Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial.

BACKGROUND: Sleep disturbances are often referred to as a hallmark and as core symptoms of post-traumatic stress disorder (PTSD). Untreated sleep disturbances can contribute to the maintenance and exacerbation of PTSD symptoms, which may diminish treatment response and constitute a risk factor for poor treatment outcome. Controlled trials on treatment of sleep disturbances in refugees suffering from PTSD are scarce. The present study aims to examine sleep-enhancing treatment in refugees with PTSD. We aim to assess if add-on treatment with mianserin and/or Imagery Rehearsal Therapy (IRT) to treatment as usual (TAU) for PTSD improves sleep disturbances. We will study the relation between sleep disturbances, PTSD symptoms, psychosocial functioning and quality of life. METHODS: The study is a randomised controlled superiority trial with a 2 × 2 factorial design. The study will include 230 trauma-affected refugees. The patients are randomised into four groups. All four groups receive TAU - an interdisciplinary treatment approach covering a period of 6-8 months with pharmacological treatment, physiotherapy, psychoeducation and manual-based cognitive behavioural therapy within a framework of weekly sessions with a physician, physiotherapist or psychologist. One group receives solely TAU, serving as a control group, while the three remaining groups are active-treatment groups receiving add-on treatment with either mianserin, IRT or a combination of both. Treatment outcome is evaluated using self-administered rating scales, observer ratings and actigraph measurements at baseline, during treatment and post treatment. The primary outcome is subjective sleep quality using the Pittsburgh Sleep Quality Index. Secondary outcome measures are objective sleep length, nightmares, PTSD severity, symptoms of depression and anxiety, pain, quality of life and psychosocial functioning. DISCUSSION: This trial will be the first randomised controlled trial to examine sleep-enhancing treatment in trauma-affected refugees, as well as the first trial to investigate the effect of IRT and mianserin in this population. Therefore, this trial may optimise treatment recommendations for sleep disturbances in trauma-affected refugees. Based on our findings, we expect to discuss the effect of treatment, focussing on sleep disturbances. Furthermore, the results will provide new information regarding the association between sleep disturbances, PTSD symptoms, psychosocial functioning and quality of life in trauma-affected refugees. TRIAL REGISTRATION: EudraCT registration under the name 'Treatment of sleep disturbances in trauma-affected refugees - a randomised controlled trial', registration number: 2015-004153-40 , registered on 13 November 2015. ClinicalTrials.gov, ID: NCT02761161. Registered on 27 April 2016.

Pharmacotherapy of Insomnia and Current Updates.

Insomnia is highly prevalent and is associated with a range of psychological, psychiatric, and medical conditions. Insomnia affects health by influencing cognitive, emotional and social functioning. Circadian and sleep homeostatic processes play an important role in insomnia development and its maintenance. Several efficacious treatments, both pharmacologic and non-pharmacologic, exist for the management of insomnia. Among non-pharmacologic treatments including stimulus control therapy, sleep restriction, relaxation, sleep hygiene and cognitive therapy have been shown to be efficacious. Pharmacological treatment acts as adjuvant to cognitive behavioural treatment. Despite availability of various classes drugs for insomnia treatment, none can be considered as an ideal agent. Novel therapies are still being explored and tested to arrive at a hypnotic that has acceptable side effects and tolerability profile while still being efficacious.

Beneficial effects of Lactobacillus casei strain Shirota on academic stress-induced sleep disturbance in healthy adults: a double-blind, randomised, placebo-controlled trial.

The present study examined whether Lactobacillus casei strain Shirota (LcS) improves sleep quality under psychological stress. A double-blind, placebo-controlled trial was conducted in healthy 4th year medical students exposed to academic examination stress. The trial was repeated over two consecutive years in different groups of students, and the data were pooled. For 8 weeks prior to and 3 weeks after a national standardised examination, a total of 48 and 46 subjects received a daily dose of 100 ml of LcS-fermented milk or non-fermented placebo milk, respectively. Study measures included subjective anxiety, overnight single-channel electroencephalography (EEG) recordings, and the Oguri-Shirakawa-Azumi (OSA) sleep inventory scores of subjective sleep quality. Total OSA scores were significantly lower than baseline on the day before the exam and recovered after the exam, indicating a stress-induced decline in sleep quality. There was a significant positive effect of LcS treatment on OSA factors for sleepiness on rising and sleep length. Sleep latency measured by EEG lengthened as the exam approached in the placebo group but was significantly suppressed in the LcS group. The percentage of stage 3 non-REM (N3) sleep decreased in the placebo group as the exam approached, whereas it was maintained in the LcS group throughout the trial. Delta power during the first sleep cycle, measured as an index of sleep intensity, increased as the exam approached in the LcS group and was significantly higher than in the placebo group. These findings suggest that daily consumption of LcS may help to maintain sleep quality during a period of increasing stress. The observed retention of N3 sleep and increased delta power in the LcS group may have contributed to higher perceived sleep satisfaction.

Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial.

Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6), in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171) were randomized (1:1) to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI) score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs) in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in) and/or short duration of treatment may have masked a potential beneficial effect on sleep quality.