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Approved cannabinoids for medical purposes - Comparative systematic review and meta-analysis for sleep and appetite.
Spanagel, R, Bilbao, A
Neuropharmacology. 2021;:108680
Abstract
BACKGROUND Cannabinoids are used for numerous disease indications. However, cannabinoids can also produce adverse effects; for example, they can disturb physiological functions such as sleep and appetite. The medical use of cannabinoids refers to a wide variety of preparations and products. Approved cannabinoid products include dronabinol ((-)-trans-Δ9-tetrahydrocannabinol (THC), nabilone (a THC analogue), and cannabidiol (CBD) that differ in their pharmacology and may thus have different adverse effects on sleep and appetite. OBJECTIVES Here we ask if (i) cannabinoids decrease sleep and appetite in somatic patients or patients that suffer from mental illness and if (ii) there is a difference between THC products (nabilone, dronabinol), vs. CBD in disturbing these physiological functions. METHODS In order to answer these two questions, we performed a comparative systematic review (SR) for nabilone, dronabinol, and CBD. For the comparative SR we searched PubMed, Medline, Embase, and PsycINFO for randomized controlled trials (RCTs) and extracted information for adverse side effects or outcomes reporting a negative impact on sleep and appetite. RCT evidence was calculated as odds ratios (ORs) via fixed effects meta-analyses. Evidence quality was assessed by the Cochrane Risk of Bias and GRADE tools. This study is registered at PROSPERO (CRD42021229932). FINDINGS A total of 17 RCTs (n = 1479) and 15 RCTs (n = 1974) were included for sleep and appetite, respectively. Pharmaceutical THC (nabilone, dronabinol) does not affect sleep or appetite. In contrast, there is moderate evidence that CBD decreases appetite (OR = 2.46 [1.74:4.01] but has also no effect on sleep. INTERPRETATIONS Our comparative systematic study shows that approved cannabinoids can decrease appetite as a negative side effect - an effect that seems to be driven by CBD. Approved cannabinoid products do not negatively affect sleep in somatic and psychiatric patients. This article is part of the special Issue on "Cannabinoids".
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Associations of Benzodiazepine With Adverse Prognosis in Heart Failure Patients With Insomnia.
Sato, Y, Yoshihisa, A, Hotsuki, Y, Watanabe, K, Kimishima, Y, Kiko, T, Kanno, Y, Yokokawa, T, Abe, S, Misaka, T, et al
Journal of the American Heart Association. 2020;(7):e013982
Abstract
Background The prognostic impact of benzodiazepines has been unclear in patients with heart failure (HF). Methods and Results This was a historical observational cohort study. A total of 826 patients who had been hospitalized for HF and were being treated for insomnia with either benzodiazepines or Z-drugs (zolpidem, zopiclone, or eszopiclone), were enrolled and divided on the basis of their hypnotics: benzodiazepine group (n=488 [59.1%]) and Z group (n=338 [40.9%]). We compared the patient characteristics and postdischarge prognosis between the groups. The primary end points were rehospitalization for HF and cardiac death. The benzodiazepine group was older (age, 72.0 versus 69.0 years; P=0.010), had a higher prevalence of depression (17.4% versus 8.9%; P<0.001), and showed a higher use of loop diuretics (77.9% versus 67.8%; P=0.001). In the laboratory data, the benzodiazepine group demonstrated lower levels of hemoglobin (12.3 versus 13.0 g/dL; P=0.001), sodium (139.0 versus 140.0 mEq/L; P=0.018), and albumin (3.7 versus 3.9 g/dL; P=0.003). Kaplan-Meier analysis showed that both end points were higher in the benzodiazepine group (rehospitalization for HF, log-rank P=0.001; cardiac death, log-rank P=0.043). Multiple Cox proportional hazard analysis revealed that the use of benzodiazepines was an independent predictor of rehospitalization for HF (hazard ratio, 1.530; 95% CI, 1.025-2.284; P=0.038). Furthermore, rehospitalization for HF was higher in the benzodiazepine group after propensity score matching (log-rank P=0.036). Conclusions Benzodiazepine is associated with higher risk of rehospitalization for HF compared with Z-drugs in patients with HF.
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Efficacy of Violet oil, a traditional Iranian formula, in patients with chronic insomnia: A randomized, double-blind, placebo-controlled study.
Feyzabadi, Z, Rezaeitalab, F, Badiee, S, Taghipour, A, Moharari, F, Soltanifar, A, Ahmadpour, MR
Journal of ethnopharmacology. 2018;:22-28
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Violet oil is an ancient herbal drug which has been extensively used to treat insomnia in traditional Iranian Medicine clinics. Violet oil is an almond or sesame oil-based extract of Viola odorata, which is administered as nasal drops. This study aimed to evaluate the efficacy of Violet oil in the treatment of insomnia. METHODS AND MATERIALS This study was conducted as a 3-arm double-blind randomized trial. A total of 75 patients with chronic insomnia were enrolled and randomly assigned to three groups in Traditional Iranian Medicine Clinic of Mashhad University of Medical Sciences, Mashhad, Iran. The treatment consisted of intranasal dropping of Violet oil, Almond oil or placebo (1% solution of Carboxymethyl cellulose) in each nostril every night before sleep for 30 days, i.e. three drops of the drug (including either Violet oil or Almond oil) or the placebo was used every night before the sleep. All the patients were asked to complete Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) questionnaires before and after the intervention. RESULTS There were no significant differences between patients in the three groups before the intervention (P > 0.05). However, there were significant differences between the three groups after the intervention in ISI scores (P<0.002) and PSQI scores (p<0.001). When comparing the pre- and post-treatment data, the ISI and PSQI scores improved significantly in all the three groups as follows: Violet oil (P<0.001), Almond oil (P<0.001) and placebo (P<0.001). The results also showed that the Violet oil had the most effect among the three groups. In addition, it was more effective on sleep quality than sleep quantity. CONCLUSION Considering the effects of natural nasal drug on the improvement of sleep quality in insomniac patients, this study has proposed the use of Violet oil as a natural and herbal drug in a non-oral method without serious side effects for treatment of insomnia.
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Characterization of growth hormone disulfide-linked molecular isoforms during post-exercise release vs nocturnal pulsatile release reveals similar milieu composition.
Nindl, BC, Eagle, SR, Matheny, RW, Martin, BJ, Rarick, KR, Pierce, JR, Sharp, MA, Kellogg, MD, Patton, JF
Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society. 2018;:102-107
Abstract
OBJECTIVE To characterize the influence of mode (aerobic/resistance) and volume of exercise (moderate/high) on circulating GH immediately post-exercise as well as following the onset of sleep. DESIGN This study used repeated measures in which subjects randomly completed 5 separate conditions: control (no exercise), moderate volume resistance exercise (MR), high-volume resistance exercise (HR), moderate volume aerobic exercise (MA), and high volume aerobic exercise (HA). METHODS Subjects had two overnight stays on each of the 5 iterations. Serial blood draws began as soon as possible after the completion of the exercise session. Blood was obtained every 20 min for 24-h. GH was measured using a chemiluminescent immunoassay. Pooled samples representing post exercise (PE) and first nocturnal pulse (NP) were divided into two aliquots. One of these aliquots was chemically reduced by adding 10 mM glutathione (GSH) to break down disulfide-linked aggregates. RESULTS No differences were observed when pooling GH response at post-exercise (2.02 ± 0.21) and nocturnal pulse (2.63 ± 0.51; p = .32). Pairwise comparisons revealed main effect differences between controls (1.19 ± 0.29) and both MA (2.86 ± 0.31; p = .009) and HA (3.73 ± 0.71; p = .001). Both MA (p = .049) and HA (p = .035) responses were significantly larger than the MR stimulus (1.96 ± 0.28). With GSH reduction, controls significantly differed from MA (p = .018) and HA (p = .003) during PE, but only differed from HA (p = .003) during NP. CONCLUSIONS This study demonstrated similar GH responses to exercise and nocturnal pulse, indicating that mode and intensity of exercise does not proportionately affect GH dimeric isoform concentration.
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Comparison of the effect of lavender and bitter orange on sleep quality in postmenopausal women: A triple-blind, randomized, controlled clinical trial.
Kamalifard, M, Farshbaf-Khalili, A, Namadian, M, Ranjbar, Y, Herizchi, S
Women & health. 2018;(8):851-865
Abstract
This trial compared the effects of lavender and bitter orange on sleep quality in postmenopausal women. This trial was conducted in 2015. Eligible postmenopausal women were allocated into one of two intervention groups or a control group (n = 52 per group) in a 1:1:1 ratio using a randomized block design. Intervention groups received 500 mg capsules containing only bitter orange or lavender flower powder, and the control group received 500 mg capsules containing starch. The Pittsburgh Sleep Quality Inventory was used before and eight weeks after starting the intervention. Data analyses were based on intention to treat. A one-way ANOVA showed a slightly significant difference in mean sleep score among the three groups before the intervention (p = .045). The general linear model, adjusted for baseline sleep score and confounding factors, showed significant differences among the groups in the mean sleep score after eight weeks of treatment (p < .001). Bitter orange and lavender significantly improved the mean sleep score compared with the control group (p < .001 and p = .003, respectively). The positive effect of bitter orange and lavender on sleep quality in postmenopausal women suggests that they can be used to improve sleep quality in such women.
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Higher-protein diets improve indexes of sleep in energy-restricted overweight and obese adults: results from 2 randomized controlled trials.
Zhou, J, Kim, JE, Armstrong, CL, Chen, N, Campbell, WW
The American journal of clinical nutrition. 2016;(3):766-74
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Abstract
BACKGROUND Limited and inconsistent research findings exist about the effect of dietary protein intake on indexes of sleep. OBJECTIVE We assessed the effect of protein intake during dietary energy restriction on indexes of sleep in overweight and obese adults in 2 randomized, controlled feeding studies. DESIGN For study 1, 14 participants [3 men and 11 women; mean ± SE age: 56 ± 3 y; body mass index (BMI; in kg/m(2)): 30.9 ± 0.6] consumed energy-restricted diets (a 750-kcal/d deficit) with either beef and pork (BP; n = 5) or soy and legume (SL; n = 9) as the main protein sources for 3 consecutive 4-wk periods with 10% (control), 20%, or 30% of total energy from protein (random order). At baseline and the end of each period, the global sleep score (GSS) was assessed with the use of the Pittsburgh Sleep Quality Index (PSQI) questionnaire. For study 2, 44 participants (12 men and 32 women; age: 52 ± 1 y; BMI: 31.4 ± 0.5) consumed a 3-wk baseline energy-balance diet with 0.8 g protein · kg baseline body mass(-1) · d(-1). Then, study 2 subjects consumed either a normal-protein [NP (control); n = 23] or a high-protein (HP; n = 21) (0.8 compared with 1.5 g · kg(-1) · d(-1), respectively) energy-restricted diet (a 750-kcal/d deficit) for 16 wk. The PSQI was administered during baseline week 3 and intervention weeks 4, 8, 12, and 16. GSSs ranged from 0 to 21 arbitrary units (au), with a higher value representing a worse GSS during the preceding month. RESULTS In study 1, we showed that a higher protein quantity improved GSSs independent of the protein source. The GSS was higher (P < 0.05) when 10% (6.0 ± 0.4 au) compared with 20% (5.0 ± 0.4 au) protein was consumed, with 30% protein (5.4 ± 0.6 au) intermediate. In study 2, at baseline, the GSS was not different between NP (5.2 ± 0.5 au) and HP (5.4 ± 0.5 au) groups. Over time, the GSS was unchanged for the NP group and improved for the HP group (P-group-by-time interaction < 0.05). After intervention (week 16), GSSs for NP and HP groups were 5.9 ± 0.5 and 4.0 ± 0.6 au, respectively (P < 0.01). CONCLUSION The consumption of a greater proportion of energy from protein while dieting may improve sleep in overweight and obese adults. This trial was registered at clinicaltrials.gov as NCT01005563 (study 1) and NCT01692860 (study 2).
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Lamotrigine and GABAA receptor modulators interact with menstrual cycle phase and oral contraceptives to regulate mood in women with bipolar disorder.
Robakis, TK, Holtzman, J, Stemmle, PG, Reynolds-May, MF, Kenna, HA, Rasgon, NL
Journal of affective disorders. 2015;:108-15
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Abstract
OBJECTIVES To examine the occurrence of menstrually-entrained mood cycling in women with treated bipolar disorder as compared to healthy controls, and to explore whether there is a specific effect of lamotrigine in dampening menstrually-entrained cyclicity of mood. METHODS Observational comparison study of daily self-ratings of mood, sleep, and insomnia obtained over a mean of four menstrual cycles in 42 women with bipolar disorder taking lamotrigine as part of their treatment, 30 women with bipolar disorder receiving mood stabilizing regimens without lamotrigine, and 13 healthy controls, all with physiological menstrual cycles. Additional exploratory analysis of interactions between psychopharmacological regimen and hormonal contraceptive use in the group of women with bipolar disorder, with the addition of 19 women with bipolar disorder who were using hormonal contraceptives. RESULTS Women treated for bipolar disorder manifested lower average mood, longer average nightly sleep duration, and greater fluctuations in mood and sleep across menstrual cycle phases than healthy controls. Women with bipolar disorder who were taking lamotrigine had less fluctuation in mood both within and across menstrual cycle phases, and were more similar to the control group than to women with bipolar disorder who were not taking lamotrigine in this respect. In addition, medications with GABA-A receptor modulating effects were found to result in improved mood ratings when combined with hormonal contraceptives. CONCLUSIONS Menstrually-entrained mood fluctuation is present in women treated for bipolar disorder to a greater degree than in healthy controls. Lamotrigine may be of use in mitigating this fluctuation. GABA-A receptor modulators in general may act synergistically with hormonal contraceptives to enhance mood in women with bipolar disorder; this hypothesis merits further study.
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The effect of a supervised exercise training programme on sleep quality in recently discharged heart failure patients.
Suna, JM, Mudge, A, Stewart, I, Marquart, L, O'Rourke, P, Scott, A
European journal of cardiovascular nursing. 2015;(3):198-205
Abstract
BACKGROUND Sleep disturbances, including insomnia and sleep-disordered breathing, are a common complaint in people with heart failure and impair well-being. Exercise training (ET) improves quality of life in stable heart failure patients. ET also improves sleep quality in healthy older patients, but there are no previous intervention studies in heart failure patients. AIM: The aim of this study was to examine the impact of ET on sleep quality in patients recently discharged from hospital with heart failure. METHODS This was a sub-study of a multisite randomised controlled trial. Participants with a heart failure hospitalisation were randomised within six weeks of discharge to a 12-week disease management programme including exercise advice (n=52) or to the same programme with twice weekly structured ET (n=54). ET consisted of two one-hour supervised aerobic and resistance training sessions, prescribed and advanced by an exercise specialist. The primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) between randomisation and week 12. RESULTS At randomisation, 45% of participants reported poor sleep (PSQI≥5). PSQI global score improved significantly more in the ET group than the control group (-1.5±3.7 vs 0.4±3.8, p=0.03). Improved sleep quality correlated with improved exercise capacity and reduced depressive symptoms, but not with changes in body mass index or resting heart rate. CONCLUSION Twelve weeks of twice-weekly supervised ET improved sleep quality in patients recently discharged from hospital with heart failure.
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Sleep quality during exam stress: the role of alcohol, caffeine and nicotine.
Zunhammer, M, Eichhammer, P, Busch, V
PloS one. 2014;(10):e109490
Abstract
Academic exam stress is known to compromise sleep quality and alter drug consumption in university students. Here we evaluated if sleeping problems and changes in legal drug consumption during exam stress are interrelated. We used the Pittsburgh Sleep Quality Index (PSQI) to survey sleep quality before, during, and after an academic exam period in 150 university students in a longitudinal questionnaire study. Self-reports of alcohol, caffeine, and nicotine consumption were obtained. The Perceived Stress Questionnaire (PSQ-20) was used as a measure of stress. Sleep quality and alcohol consumption significantly decreased, while perceived stress and caffeine consumption significantly increased during the exam period. No significant change in nicotine consumption was observed. In particular, students shortened their time in bed and showed symptoms of insomnia. Mixed model analysis indicated that sex, age, health status, as well as the amounts of alcohol and caffeine consumed had no significant influence on global sleep quality. The amount of nicotine consumed and perceived stress were identified as significant predictors of diminished sleep quality. Nicotine consumption had a small-to-very-small effect on sleep quality; perceived stress had a small-to-moderate effect. In conclusion, diminished sleep quality during exam periods was mainly predicted by perceived stress, while legal drug consumption played a minor role. Exam periods may pose an interesting model for the study of stress-induced sleeping problems and their mechanisms.
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Sleep architecture following a weight loss intervention in overweight and obese patients with obstructive sleep apnea and type 2 diabetes: relationship to apnea-hypopnea index.
Shechter, A, St-Onge, MP, Kuna, ST, Zammit, G, RoyChoudhury, A, Newman, AB, Millman, RP, Reboussin, DM, Wadden, TA, Jakicic, JM, et al
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine. 2014;(11):1205-11
Abstract
STUDY OBJECTIVES To determine if weight loss and/ or changes in apnea-hypopnea index (AHI) improve sleep architecture in overweight/ obese adults with type 2 diabetes (T2D) and obstructive sleep apnea (OSA). METHODS This was a randomized controlled trial including 264 overweight/ obese adults with T2D and OSA. Participants were randomized to an intensive lifestyle intervention (ILI) or a diabetes and support education (DSE) control group. Measures included anthropometry, AHI, and sleep at baseline and year-1, year-2, and year-4 follow-ups. RESULTS Changes in sleep duration (total sleep time [TST]), continuity [wake after sleep onset (WASO)], and architecture stage 1, stage 2, slow wave sleep, and REM sleep) from baseline to year 1, 2, and 4 did not differ between ILI and DSE. Repeated-measure mixed-model analyses including data from baseline through year-4 for all participants demonstrated a significant positive association between AHI and stage 1 sleep (p < 0.001), and a significant negative association between AHI and stage 2 (p = 0.01) and REM sleep (p < 0.001), whereas changes in body weight had no relation to any sleep stages or TST. WASO had a significant positive association with change in body weight (p = 0.009). CONCLUSIONS Compared to control, the ILI did not induce significant changes in sleep across the 4-year follow-up. In participants overall, reduced AHI in overweight/ obese adults with T2D and OSA was associated with decreased stage 1, and increased stage 2 and REM sleep. These sleep architecture changes are more strongly related to reductions in AHI than body weight, whereas WASO may be more influenced by weight than AHI. CLINICAL TRIAL REGISTRATION NUMBER NCT00194259.