A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women

SLEEP ◽  
2022 ◽  
Author(s):  
Shadab A Rahman ◽  
Margo D Nathan ◽  
Aleta Wiley ◽  
Sybil Crawford ◽  
Aviva Y Cohn ◽  
...  
Keyword(s):  
Therapeutic Option ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Estrogen Therapy ◽  
Severity Index ◽  
Vasomotor Symptom ◽  
Midlife Women ◽  
Chronic Insomnia ◽  
Double Blind ◽  
Insomnia Disorder

Abstract Study Objectives The neuropeptide orexin promotes wakefulness, modulates thermoregulation, increases after menopause, and is normalized in women receiving estrogen therapy, suggesting a role for orexin antagonism as a treatment for vasomotor symptom (VMS)-associated insomnia disorder. We tested the efficacy of the dual orexin receptor antagonist suvorexant for chronic insomnia related to nighttime VMS. Methods In a double-blind, placebo-controlled trial, 56 women with chronic insomnia associated with nighttime VMS, Insomnia Severity Index (ISI) scores ≥15, and >30 minutes of diary-rated wake after sleep-onset (WASO) were randomized to receive oral suvorexant 10-20 mg (n=27) or placebo (n=29) nightly for 4 weeks. Analysis of within-person change in ISI was adjusted for baseline ISI and race. Results Mean baseline ISI scores were 18.1 (95% CI, 16.8-19.4) and 18.3 (95% CI, 17.2-19.5) in the suvorexant and placebo groups, respectively (p=0.81). The average 4-week ISI within-person decrease from baseline was greater on suvorexant [-8.1 (95% CI, -10.2 to -6.0)] compared to placebo [-5.6 (95% CI, -7.4 to -3.9), p=0.04]. Compared to placebo, nighttime diary-rated VMS frequency was significantly reduced with suvorexant (p<0.01). While diary-rated WASO and total sleep time trended toward improvement on suvorexant, findings were not significant after adjustment for multiple comparison. Daytime VMS and other sleep-related outcomes did not differ between groups. Suvorexant was well tolerated. Conclusion These results suggest that suvorexant is likely a well-tolerated and efficacious treatment for VMS-associated insomnia disorder and reduces nighttime VMS. Antagonism of orexin receptors could provide a novel therapeutic option for midlife women with VMS-associated chronic insomnia.

scholarly journals Suan Zao Ren Tangin Combination withZhi Zi Chi Tangas a Treatment Protocol for Insomniacs with Anxiety: A Randomized Parallel-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Lin-lin Hu ◽  
Xin Zhang ◽  
Wen-juan Liu ◽  
Mei Li ◽  
Yong-hua Zhang
Keyword(s):  
Treatment Group ◽  
Sleep Quality ◽  
Pittsburgh Sleep Quality Index ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Treatment Protocol ◽  
Severity Index ◽  
Improve Sleep Quality ◽  
Insomnia Severity

Insomnia is a serious worldwide health problem that is often comorbid with anxiety. The purpose of the present study was to evaluate the efficacy of a Chinese formula containingSuan Zao Ren Tang(SZRT) andZhi Zi Chi Tang(ZZCT; SZR-ZZC) for improving sleep quality and anxiety states with four indices of Polysomnography (PSG), the Insomnia Severity Index (ISI), the Pittsburgh Sleep Quality Index (PSQI), and the Self Rating Anxiety Scale (SAS).Methods.A randomized, parallel-controlled trial compared SZR-ZZC to lorazepam tablet in insomniacs with anxiety. Patients were randomized to the SZR-ZZC treatment group (n=60) and the lorazepam tablet treatment group (n=59).Results. SZR-ZZC significantly improved scores on all four treatment indices. Compared with lorazepam, treatment with SZR-ZZC resulted in a significant reduction in the ISI (P=0.029), the PSQI (P=0.017), and wake after sleep onset (WASO;P=0.008) scores and improved sleep architecture (P=0.000–0.003) after a 4-week treatment period. Only one subject in the SZR-ZZC group experienced adverse side effects.Conclusion. Treatment with SZR-ZZC for 4 weeks appears to be a relatively safe and effective complementary therapeutic option when aiming to improve sleep quality and anxiety in insomniacs with anxiety.

scholarly journals Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) for chronic insomnia disorder (‘CANSLEEP’ trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034421 ◽  
Author(s):  
Anastasia Suraev ◽  
Ronald R Grunstein ◽  
Nathaniel S Marshall ◽  
Angela L D'Rozario ◽  
Christopher J Gordon ◽  
...  
Keyword(s):  
Single Dose ◽  
Brain Mri ◽  
Sleep Onset ◽  
Healthcare Utilisation ◽  
Open Access Journal ◽  
Chronic Insomnia ◽  
Proof Of Concept ◽  
Single Dose Study ◽  
Insomnia Disorder ◽  
Daytime Function

IntroductionInsomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally, cannabis use is frequently reported by consumers to promote sleep. However, there is limited research on the effects of cannabis on sleep and daytime function in people with insomnia disorder using objective measures. This proof-of-concept study will evaluate the effects of a single dose of an oral cannabis-based medicine on sleep and daytime function in participants with chronic insomnia disorder.Methods and analysisA randomised, crossover, placebo-controlled, single-dose study design will be used to test the safety and efficacy of an oral oil solution (‘ETC120’) containing 10 mg Δ9-tetrahydrocannabinol (THC) and 200 mg cannabidiol (CBD) in 20 participants diagnosed with chronic insomnia disorder. Participants aged 35–60 years will be recruited over an 18-month period commencing August 2019. Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit. The primary outcomes are total sleep time and wake after sleep onset assessed via polysomnography. In addition, 256-channel high-density electroencephalography and source modelling using structural brain MRI will be used to comprehensively examine brain activation during sleep and wake periods on ETC120 versus placebo. Next-day cognitive function, alertness and simulated driving performance will also be investigated.Ethics and disseminationEthics approval was received from Bellberry Human Research Ethics Committee (2018-04-284). The findings will be disseminated in a peer-reviewed open-access journal and at academic conferences.Trial registration numberANZCTRN12619000714189.

scholarly journals Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Su Li ◽  
Cang Zhang ◽  
Hong-Ya Zhang ◽  
Meng Zhou ◽  
Si-Nong Wang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Severity Index ◽  
Placebo Treatment ◽  
International Standards ◽  
Physician Global Assessment ◽  
Double Blind ◽  
Objective Evidence ◽  
Multicenter Randomized Controlled Trial ◽  
Heat Syndrome

Introduction. The etiology and pathogenesis of psoriasis are complex. Blood-heat syndrome is the core pathogenesis of psoriasis. Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment. Very few studies have investigated the pharmacological mechanism of the CM HCBC method for treating psoriasis. This multicenter randomized controlled trial will focus on treating psoriasis blood-heat syndrome with the HCBC method using Jueyin granules (JYKL). This will be an objective and standardized evaluation of the efficacy, safety, and reproducibility of the HCBC method to obtain objective evidence meeting international standards that aim to establish a clinical standard suitable for the popular application of CM for treating psoriasis. Methods and Analysis. A five-center randomized double-blind placebo-controlled clinical design will be used in this study. At least 196 participants will be randomly assigned to receive either JYKL or placebo treatment approximately 30 minutes after meals in the morning and evening (one sachet per time, twice daily for 8 consecutive weeks). The study duration will be 17 weeks, including 1 week of screening, 8 weeks of intervention, and 8 weeks of follow-up. The patients will be evaluated every 2 weeks, and the measures will be compared with baseline values. The primary outcome measure will be the psoriasis lesion area severity index. We will also observe the recurrence rate, body surface area, physician global assessment, dermatology life quality index, quality of life index, visual analogue scale score, CM symptom score, combined drug use, and adverse events. This trial is registered with NCT03961230.

scholarly journals Azithromycin for chronic eosinophilic rhinosinusitis with nasal polyp: a placebo-controlled trial

2020 ◽  
Vol 0 (0) ◽  
pp. 0-0
Author(s):  
I.S. De Oliveira ◽  
A.F. Guimaraes ◽  
G.F. Arantes Pêgas ◽  
C.J. Machado ◽  
G.D. Cassali ◽  
...  
Keyword(s):  
Nasal Polyp ◽  
Nasal Polyps ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Subjective Improvement ◽  
Double Blind ◽  
Aspirin Intolerance ◽  
Snot 22

BACKGROUND: Chronic eosinophilic rhinosinusitis with nasal polyps (CRSwNP eosinophilic) is characterised by the formation of benign and bilateral nasal polyps. We aimed to compare the effectiveness of azithromycin as an immunomodulator with the use of a placebo in patients presenting with CRSwNP concomitant with asthma and aspirin intolerance after 3 months of treatment and at a 1-year follow-up. METHODOLOGY: We performed a randomised, double-blind, placebo-controlled trial. Patients received 500 mg azithromycin orally three times/week for 12 weeks. Improvement was evaluated by staging, the Sino-Nasal Outcome Test (SNOT-22), and nasal polyp biopsy. Data collected at pretreatment and 3 months posttreatment were compared. Quality of life was evaluated at the 1-year follow-up. RESULTS: Twenty-seven and 21 patients were treated with azithromycin and a placebo, respectively. The medication was well tolerated overall. Twenty patients (74%) in the azithromycin group and three patients (14%) in the placebo group were not refer- red for surgery at the end of the 3-month treatment. Regarding subjective improvement, there was a median decrease only in the azithromycin group, and the between-group difference was significant. SNOT-22 improvement was maintained in the azithromy- cin group at the 1-year follow-up. CONCLUSIONS: Azithromycin could be considered a therapeutic option for patients presenting with CRSwNP concomitant with asthma and aspirin intolerance.

scholarly journals Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eva V. Vodegel ◽  
Sandra E. Zwolsman ◽  
Astrid Vollebregt ◽  
Ruben G. Duijnhoven ◽  
Judith E. Bosmans ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Estrogen Therapy ◽  
Double Blind ◽  
Pop Surgery ◽  
Vaginal Estrogen ◽  
Vaginal Estrogen Therapy

Abstract Background Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. Methods The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. Discussion This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853. EudraCT: 2017-003144-21; registered: 24-07-2017.

scholarly journals Effects of Acupuncture on the Hypothalamus-Pituitary-Adrenal Axis in Chronic Insomnia Patients: A Study Protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Chengyong Liu ◽  
Shiyu Zheng ◽  
Wenzhong Wu ◽  
Xiaoqiu Wang ◽  
Shan Qin ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Severity Index ◽  
Chronic Insomnia ◽  
Secondary Outcome ◽  
Therapeutic Effects ◽  
Before And After ◽  
Fatigue Severity

Abstract Background : Acupuncture, as an important component of traditional Chinese medicine (TCM), has been widely applied in the treatment of chronic insomnia in China，while there is no clinical study related to its therapeutic mechanism. Methods/design : A single-center, single-blind, randomized, placebo-controlled trial will be conducted at Jiangsu Hospital of Traditional Chinese Medicine. A total of 60 patients will be registered.Eligible participantswill be randomly divided into acupuncture group and shamacupuncture group (n = 30 cases in each group). Patients in both groups will be treated once every other day, 3 times per week for 4 weeks.The primary outcome measures are Pittsburgh Sleep Quality Index (PSQI), concentrations of adrenocorticotropic hormone (ATCH), Corticotrophin-releasing hormone (CRH), and cortisol (CORT). Secondary outcome measures are Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS). Discussion : This study aims to evaluate the therapeutic effects of acupuncture on chronic insomnia by using PSQI, ISI, and FSS. The mechanism of acupuncture on CIPs will be preliminarily discussed by analyzing the changes in concentrations of CRH, ACTH, and CORT before and after treatment.

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