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Suvorexant for Primary Insomnia: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

ABSTRACT: We performed a systematic review and meta-analysis of double-blind, randomized, placebo-controlled trials evaluating suvorexant for primary insomnia.Relevant studies were identified through searches of PubMed, databases of the Cochrane Library, and PsycINFO citations through June 27, 2015. We performed a systematic review and meta-analysis of suvorexant trial efficacy and safety outcomes. The primary efficacy outcomes were either subjective total sleep time (sTST) or subjective time-to-sleep onset (sTSO) at 1 month. The secondary outcomes were other efficacy outcomes, discontinuation rate, and individual adverse events. The risk ratio, number-needed-to-treat/harm, and weighted mean difference (WMD) and 95% confidence intervals (CI) based on a random effects model were calculated.The computerized literature database search initially yielded 48 results, from which 37 articles were excluded following a review of titles and abstracts and another eight review articles after full-text review. Thus, we identified 4 trials that included a total of 3,076 patients. Suvorexant was superior to placebo with regard to the two primary efficacy outcomes (sTST: WMD = -20.16, 95% CI = -25.01 to -15.30, 1889 patients, 3 trials, sTSO: WMD = -7.62, 95% CI = -11.03 to -4.21, 1889 patients, 3 trials) and was not different from placebo in trial discontinuations. Suvorexant caused a higher incidence than placebo of at least one side effects, abnormal dreams, somnolence, excessive daytime sleepiness/sedation, fatigue, dry mouth, and rebound insomnia.Our analysis of published trial results suggests that suvorexant is effective in treating primary insomnia and is well-tolerated.

SUBMITTER: Kishi T

PROVIDER: S-EPMC4552781 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Suvorexant for Primary Insomnia: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

Kishi Taro T Matsunaga Shinji S Iwata Nakao N

PloS one 20150828 8

<h4>Objective</h4>We performed a systematic review and meta-analysis of double-blind, randomized, placebo-controlled trials evaluating suvorexant for primary insomnia.<h4>Methods</h4>Relevant studies were identified through searches of PubMed, databases of the Cochrane Library, and PsycINFO citations through June 27, 2015. We performed a systematic review and meta-analysis of suvorexant trial efficacy and safety outcomes. The primary efficacy outcomes were either subjective total sleep time (sTS ...[more]

PMID: 26317363

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Project description:BackgroundInsomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people's insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia.MethodsA systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions.ResultsTwelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information.ConclusionsDespite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed.

Project description:Background: Parkinson's disease (PD) is a debitlitating, chronic, progressive neurodegenerative disorder without modifying therapy. Here, we aimed to evaluate the available evidence of herbal medicine (HM) formulas for patients with PD according to randomized double-blind placebo-controlled clinical trials. Methods: HM formulas for PD were searched in eight main databases from their inception to February 2018. The methodological quality was assessed using Cochrane Collaboration risk of bias tool. Meta-analysis was performed using RevMan 5.3 software. Results: Fourteen trials with Seventeen comparisons comprising 1,311 patients were identified. Compared with placebo groups, HM paratherapy (n = 16 comparisons) showed significant better effects in the assessments of total Unified Parkinson's Disease Rating Scale (UPDRS) (WMD: -5.43, 95% CI:-8.01 to -2.86; P < 0.0001), UPDRS I (WMD: -0.30, 95% CI: -0.54 to -0.06; P = 0.02), UPDRS II (WMD: -2.21, 95% CI: -3.19 to -1.22; P < 0.0001), UPDRS III (WMD: -3.26, 95% CI:-4.36 to -2.16; P < 0.00001), Parkinson's Disease Quality of Life Questionnaire (p < 0.01) and Parkinson's Disease Questionnaire-39 (WMD: -7.65, 95% CI: -11.46 to -3.83; p < 0.0001), Non-motor Symptoms Questionnaire (p < 0.01) and Non-Motor Symptoms Scale (WMD: -9.19, 95% CI: -13.11 to -5.28; P < 0.00001), Parkinson's Disease Sleep Scale (WMD: 10.69, 95% CI: 8.86 to 12.53; P < 0.00001), and Hamilton depression rating scale (WMD: -5.87, 95% CI: -7.06 to -4.68; P < 0.00001). The efficiency of HM monotherapy (n = 1 comparison) was not superior to the placebo according to UPDRS II, UPDRS III and total UPDRS score in PD patients who never received levodopa treatment, all P > 0.05. HM formulas paratherapy were generally safe and well tolerated for PD patients (RR: 0.41, 95% CI: 0.21 to 0.80; P = 0.009). Conclusion: The findings of present study supported the complementary use of HM paratherapy for PD patients, whereas the question on the efficacy of HM monotherapy in alleviating PD symptoms is still open.

Project description:Gastrointestinal (GI) dysmotility is a common complication in acute, critically ill, postoperative, and chronic patients that may lead to impaired nutrient delivery, poor clinical, and patient-reported outcomes. Several pharmacological and nonpharmacological interventions to treat GI dysmotility were investigated in dozens of clinical studies. However, they often yielded conflicting results, at least in part, because various (nonstandardized) definitions of GI dysmotility were used and methodological quality of studies was poor. While a universally accepted definition of GI dysmotility is yet to be developed, a systematic analysis of data derived from double-blind placebo-controlled randomized trials may provide robust data on absolute and relative effectiveness of various interventions as the study outcome (GI motility) was assessed in the least biased manner.To systematically review data from double-blind placebo-controlled randomized trials to determine and compare the effectiveness of interventions that affect GI motility.Three electronic databases (MEDLINE, SCOPUS, and EMBASE) were searched. A random effects model was used for meta-analysis. The summary estimates were reported as mean difference (MD) with the corresponding 95% confidence interval (CI).A total of 38 double-blind placebo-controlled randomized trials involving 2371 patients were eligible for inclusion in the systematic review. These studies investigated a total of 20 different interventions, of which 6 interventions were meta-analyzed. Of them, the use of dopamine receptor antagonists (MD, -8.99; 95% CI, -17.72 to -0.27; P = 0.04) and macrolides (MD, -26.04; 95% CI, -51.25 to -0.82; P = 0.04) significantly improved GI motility compared with the placebo group. The use of botulism toxin significantly impaired GI motility compared with the placebo group (MD, 5.31; 95% CI, -0.04 to 10.67; P = 0.05). Other interventions (dietary factors, probiotics, hormones) did not affect GI motility.Based on the best available data and taking into account the safety profile of each class of intervention, dopamine receptor antagonists and macrolides significantly improve GI motility and are medications of choice in treating GI dysmotility.

Project description:In 2012, the United States Food and Drug Administration (FDA) issued a warning regarding potential adverse effects of HMG-CoA reductase inhibitors (statins) on cognition, based on the Adverse Events Reporting System and a review of the medical literature. We aimed to synthesize randomized clinical trial (RCTs) evidence on the association between statin therapy and cognitive outcomes.We searched MEDLINE, EMBASE, and Cochrane CENTRAL through December 2012, and reviewed published systematic reviews of statin treatment. We sought RCTs that compared statin treatment versus placebo or standard care, and reported at least one cognitive outcome (frequency of adverse cognitive events or measurements using standard neuropsychological cognitive test scores). Studies reporting sufficient information to calculate effect sizes were included in meta-analyses. Standardized and unstandardized mean differences were calculated for continuous outcomes for global cognition and for pre-specified cognitive domains. The main outcome was change in cognition measured by neuropsychological tests; an outcome of secondary interest was the frequency of adverse cognitive events observed during follow-up.We identified 25 RCTs (all placebo-controlled) reporting cognitive outcomes in 46,836 subjects, of which 23 RCTs reported cognitive test results in 29,012 participants. Adverse cognitive outcomes attributable to statins were rarely reported in trials involving cognitively normal or impaired subjects. Furthermore, meta-analysis of cognitive test data (14 studies; 27,643 participants) failed to show significant adverse effects of statins on all tests of cognition in either cognitively normal subjects (standardized mean difference 0.01, 95% confidence interval, CI, -0.01 to 0.03, p?=?0.42) or Alzheimer's disease subjects (standardized mean difference -0.05, 95% CI -0.19 to 0.10, p?=?0.38).Statin therapy was not associated with cognitive impairment in RCTs. These results raise questions regarding the continued merit of the FDA warning about potential adverse effects of statins on cognition.

Project description:Introduction Migraine is a frequent neurological condition manifested by several episodes of headache. Calcitonin gene-related peptide (CGRP) has been shown to play a key role in the pathophysiology of migraine. Galcanezumab is a monoclonal antibody that binds CGRP and inhibits its action, without affecting the CGRP receptor. The aim of this study is to carry out a systematic review and meta-analysis of all randomized placebo-controlled trials that evaluated the efficacy of galcanezumab (120 mg or 240 mg) for the management of migraine. Methods We screened four databases (PubMed, SCOPUS, Embase, and Cochrane Central) from inception to October 10, 2020. Studies meeting the following criteria were included: (i) Patients: individuals with migraine, (ii) Intervention: galcanezumab at a dose of 120 mg or 240 mg, (iii) Comparator: placebo, (iv) Outcomes: prespecified efficacy and safety outcomes, and (v) Study design: randomized placebo-controlled trials. Efficacy outcomes included change in migraine headache days (MHDs), change in MHDs with acute medication use, patient global impression of severity (PGI-S) score, migraine-specific quality of life role function-restrictive domain (MSQ RF-R) score, and migraine disability assessment (MIDAS) score. Safety outcomes included frequency of injection-site pain, nasopharyngitis, and upper respiratory tract infection (URTI). Moreover, we used the Cochrane Collaboration's risk of bias tool to assess the risk of bias of the included studies. Review Manager Software, version 5.4.1, was used for statistical analysis. Mean difference and risk ratio with 95% confidence interval were used to analyze continuous and dichotomous outcomes, respectively. We used the fixed-effects and random-effects models to analyze homogeneous and heterogeneous data, respectively. Results A total of six studies comprising 4,023 patients were included in this systematic review and meta-analysis. When compared to placebo, both doses of galcanezumab were highly effective in decreasing MHDs (p<0.001), reducing MHDs with acute medication use (p<0.001), and improving the PGI-S score (p<0.001). On the other hand, MSQ RF-R and MIDAS scores were significantly enhanced only in the 240-mg dose group (p<0.001). With regard to side effects, the rates of injection-site pain and nasopharyngitis did not substantially differ between galcanezumab (inclusive of 120 mg and 240 mg) and placebo groups. Nonetheless, when compared to placebo, galcanezumab 120 mg, but not galcanezumab 240 mg, substantially correlated with a higher rate of URTI. Conclusions Galcanezumab is clinically safe and efficient for the management of migraine, and the use of a higher dose increases its efficacy. Future research directions should be geared toward determining the optimal dose of galcanezumab in the management of patients with migraine. Moreover, head-to-head comparative studies between galcanezumab and other related anti-CGRP receptor monoclonal antibodies are warranted.

Project description:Background:Insomnia 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 systematic review on acupuncture using pattern identification. This review aimed for evaluating acupuncture efficacy using pattern-identification to treat insomnia. Methods:We carried out a comprehensive review of randomized controlled trials (from 2000 to April 12, 2018), using PubMed, Cochrane CENTRAL, EMBASE, CINAHL, PsycINFO, CNKI, and 3 Korean (OASIS, NDSL, RISS4U) databases, comparing acupuncture using pattern identification (only) with medication in primary insomnia. Response rate and the Pittsburgh Sleep Quality Index (PSQI) were the primary outcomes. Risk of bias and publication biases were evaluated, and meta-analyses were conducted. Results:Nineteen RCTs were included (11 manual acupuncture (1079 patients), 8 electro-acupuncture (442 patients)) of low quality. Meta-analyses of all studies reveled that acupuncture improved total effectiveness rate (Risk Ratio [RR]?=?1.23, 95% confidence intervals [CIs]: 1.12-1.35, p?<?0.00001; I2?=?80%) and PSQI (MD?=?-1.92, 95% CI: -2.41-1.42, p?<?0.00001; I2?=?30%) compared to medication. Results of overall risk of bias assessments were unclear or high. Conclusions:Acupuncture using pattern identification led to significantly improved total effectiveness rate compared to medication. With regard to PSQI, as compared to the control group, acupuncture using pattern identification was similar to medication. However, this study has limitations of high risk of bias, not using a standardized pattern-diagnosis-treatment and not comparing with standarized acupuncture without pattern identification.

Dataset Information

Suvorexant for Primary Insomnia: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

Publications

Suvorexant for Primary Insomnia: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

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