Efficacy and safety of suanzaoren decoction for chronic insomnia disorder in adults: study protocol for randomised, double-blind, double-dummy, placebo-controlled trial

Background Insomnia disorder is defined as a combination of dissatisfaction with sleep quantity or quality and a significant negative impact on daytime functioning. Chronic insomnia disorder refers to clinical symptoms of persistent insomnia at least three nights a week for at least 3 months. Prevalence estimates of insomnia disorder range from 12% to 20% in the adult population, with approximately 50% having a chronic course. The potential side effects of hypnotic medications hinder their clinical application. Thus, traditional Chinese medicine is considered as an alternative option for treating insomnia. Objective To evaluate the efficacy and safety of suanzaoren decoction (SZRD), a classic Chinese herbal prescription, for adult chronic insomnia disorder. Methods/analysis This is a randomised, double-blind, double-dummy, placebo-controlled clinical trial. A total of 150 patients with chronic insomnia disorder are randomised, allocated in a ratio of 1:1:1 to three groups: intervention group, control group and placebo group. The intervention group receives SZRD granule plus zolpidem tartrate (ZT) placebo; the control group receives ZT tablet plus SZRD granule placebo; and the placebo group receives ZT placebo and SZRD granule placebo. The patients receive medicine or placebo for 5 weeks and are followed up at 20 weeks. The primary outcome measures are polysomnography and Pittsburgh Sleep Quality Index. Secondary outcome measures are the Insomnia Severity Inde...
Source: BMJ Open - Category: Journals (General) Authors: Tags: Open access, Complementary medicine, Neurology Protocol Source Type: research

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Publication date: Available online 13 August 2019Source: Integrative Medicine ResearchAuthor(s): Sang-Ho Kim, Jin-Hyung Jeong, Jung-Hwa Lim, Bo-Kyung KimABSTRACTBackgroundInsomnia symptoms are common, affecting almost 30% of the population of the population. many use medications that may be ineffective and cause substantial harm. In complementary and alternative medicine, acupuncture is widely used to manage mental health problems. Acupuncture therapy emphasizes individualized treatment according to TCM pattern diagnosis. Although there are some systematic reviews that acupuncture has the benefit for insomnia, there is no ...
Source: Integrative Medicine Research - Category: Complementary Medicine Source Type: research
This study investigated the effect of a combination of melatonin, vitamin B6 and medicinal plants in patients with mild-to-moderate sleep disorders. DESIGN AND SETTING: This was a 4-week, single-center, single-arm, open-label study conducted in 40 participants with mild-to-moderate insomnia, in Poland. INTERVENTION: Participants received Novanuit® Triple Action (melatonin, vitamin B6, California poppy extract, passionflower extract, and lemon balm extract) capsules per day for two weeks. OUTCOMES: Using a daily electronic sleep diary, information was collected on sleep quality (assessed on a 0-10 scale),...
Source: Complementary Therapies in Medicine - Category: Complementary Medicine Authors: Tags: Complement Ther Med Source Type: research
Conclusions: For chronic insomnia insomniacs, LLLT appears to shorten the sleep latency, decrease the number of awakening events at night, and improve the sleep efficiency. PMID: 31312225 [PubMed]
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Conclusions: The treatment effects of the three procedures were comparable in subjective parameters but not by objective measures using actigraphic monitoring. Longer therapeutic course and more frequent administration of LAT may be considered in future trials to achieve the optimal treatment effect. Trial Registration: This trial is registered with ClinicalTrials.gov: NCT02970695, registered May 2016. PMID: 31239857 [PubMed]
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Authors: Bongartz U, Tan BK, Seibt S, Bothe G, Uebelhack R, Chong PW, Wszelaki N Abstract Objective: The purpose of this study was to explore the clinical benefit and tolerability of IQP-AO-101 in healthy subjects with sleep complaints. Methods: This double-blind, randomized, placebo-controlled trial involved fifty subjects with sleep complaints. Subjects with a Pittsburgh Sleep Quality Index (PSQI) score between 6 and 15 were randomized to receive either IQP-AO-101 or placebo for 6 weeks, following a run-in period of one week. Sleep parameters were assessed at baseline and after 1, 4, and 6 weeks using the mod...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Authors: Chang JS, Liu HP, Cheng J, Chen CJ, Hwang SL, Tseng CC, Hsu LF, Lin WY Abstract In clinical practice in Taiwan, Albizia julibrissin is the most prescribed Chinese herbal medicine for insomnia. Short-term insomnia and hypnotic use both attenuate cognitive functions, especially learning memory. In previous studies, A. julibrissin exhibits sedative activity, antidepressant-like effects, and protection of learning and memory against amnesia. However, whether A. julibrissin ameliorates memory loss caused by short-term sleep deprivation is not clear. We utilized the sleep-deprived Drosophila model and olfactory ...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Abstract 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 increase 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 databas...
Source: Current Vascular Pharmacology - Category: Drugs & Pharmacology Authors: Tags: Curr Vasc Pharmacol Source Type: research
This study evaluated the efficacy and safety of TWBXD for insomnia. Methods: We searched seven main databases including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Chinese Biomedicine Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wan-fang. We identified randomized-controlled trials (RCTs) for insomnia treatment involving TWBXD, TWBXD combined with conventional Western medicine, and conventional Western medicine from their inception to May 2018. The quality of literature was evaluated by Cochrane assessing tool to reduce the risk of bi...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Ryan R. Kelly1,2†, Lindsay T. McDonald1,2†, Nathaniel R. Jensen1,2, Sara J. Sidles1,2 and Amanda C. LaRue1,2* 1Research Services, Ralph H. Johnson VA Medical Center, Charleston, SC, United States 2Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, SC, United States The significant biochemical and physiological effects of psychological stress are beginning to be recognized as exacerbating common diseases, including osteoporosis. This review discusses the current evidence for psychological stress-associated mental health disorders as risk factors for os...
Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
Abstract BACKGROUND: Insomnia is the most common sleep-related complaint associated with impaired day-time functioning, reduced quality of life, increased morbidity and substantial societal cost. We evaluated whether individualized homeopathy (IH) could produce significant effect beyond placebo in treatment of insomnia. METHODS: In this double-blind, randomized, placebo-controlled, two parallel arms trial, 60 patients were randomized to receive either IH/verum or control/placebo (1:1). Patient-administered sleep diary (6 items; 1: latency to fall asleep, 2: minutes awake in middle of night, 3: minutes awake t...
Source: Complementary Therapies in Medicine - Category: Complementary Medicine Authors: Tags: Complement Ther Med Source Type: research
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