scholarly journals Biphasic feature of placebo response in primary insomnia: pooled analysis of data from randomized controlled clinical trials of orexin receptor antagonists

SLEEP ◽  
2019 ◽  
Vol 43 (3) ◽  
Author(s):  
Dongmei He ◽  
Binghu Jiang ◽  
Zhiwei Guo ◽  
Qiwen Mu ◽  
Morgan A Mcclure
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Placebo Response ◽  
Pooled Analysis ◽  
Primary Insomnia ◽  
Subjective Measures ◽  
Receptor Antagonists ◽  
Double Blind

Abstract Objectives The placebo response to orexin receptor antagonists in primary insomnia is little-known. Our aim was, therefore, to conduct a systematic review of placebo-controlled randomized clinical trials to characterize placebo response. Methods We performed a comprehensive literature search for randomized, placebo-controlled, double-blind clinical trials evaluating the efficacy of orexin receptor antagonists addressing primary insomnia. To pool effect size estimates (Cohen’s d) of placebo and orexin receptor antagonists across trials for outcome measures, a meta-analysis was done according to the Cochrane guideline. Results The placebo response was significant and robust to improve the symptoms of insomnia in terms of objective and subjective measures, and the effects (0.70 ± 0.51) in subjective measures were smaller than that (1.10 ± 1.14) in objective measures (p = 0.027). The biphasic feature of placebo response showed an initial short-term increase of placebo effect and subsequent changeless long-term effect. Conclusion The biphasic feature of placebo response is clinically useful, and neuroimaging is essential to clarify the long-term mechanism in the future.

scholarly journals Long-term aspirin use for primary cancer prevention: An updated systematic review and subgroup meta-analysis of 29 randomized clinical trials

2020 ◽  
Vol 11 (21) ◽  
pp. 6460-6473
Author(s):  
Qibiao Wu ◽  
Xiaojun Yao ◽  
Hongwei Chen ◽  
Zhengtang Liu ◽  
Ting Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cancer Prevention ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Primary Cancer

scholarly journals Existing and Emerging Approaches to Treating Chronic Inflammatory Demyelinating Polyneuropathy

US Neurology ◽  
2019 ◽  
Vol 15 (1) ◽  
pp. 33
Author(s):  
Brannagan III Thomas H ◽  
Khosro Farhad ◽  
Inna Kleyman ◽  
Megan Leitch ◽  
Rebecca Traub ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Randomized Clinical Trials ◽  
Chronic Inflammatory Demyelinating Polyneuropathy ◽  
Neurological Diseases ◽  
Demyelinating Polyneuropathy ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Inflammatory Demyelinating Polyneuropathy

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare disabling disease with an incompletely understood autoimmune etiology. Differentiating the condition from other neurological diseases can be challenging and appropriate treatment is often delayed. Intravenous immunoglobulin (IVIg), plasmapheresis, corticosteroids and subcutaneous immunoglobulin (SCIg) have all been demonstrated to be beneficial in placebo-controlled, randomized clinical trials. Corticosteroids, including methylprednisolone and dexamethasone are effective and frequently used in CIDP but their long-term use is limited by side effects. One of the most commonly prescribed treatments for CIDP is IVIg which diminishes inflammatory processes and prevents disease progression. Treatment with IVIg has proven effective in randomized, double blind, placebo controlled, clinical trials and the results support its use in CIDP. For some patients, the benefit of IVIg, is limited by the frequency of infusions and systemic side effects such as flu-like symptoms, headache, and nausea. Other effective treatments for CIDP include corticosteroids that are associated with serious side effects in long-term use and plasmapheresis which requires specialized facilities. More recently, SCIg has been demonstrated in double blind, placebo-controlled studies to be effective for maintenance use in CIDP in patients whose disease has been controlled by IVIg. In a large clinical trial, 0.2 g/kg and 0.4 g/kg body weight doses of 20% SCIg equivalent to 1 mL/kg or 2 mL/kg, respectively, administered weekly, demonstrated efficacy in CIDP and were well tolerated. Immunomodulating treatments such as cyclophosphamide, mycophenolate mofetil and rituximab have also shown efficacy in select populations with CIDP.

scholarly journals Use of levosimendan versus dobutamine when inotropic support is needed in patients with severe acute decompensated chronic heart failure

2021 ◽  
Vol 27 (6) ◽  
pp. 47-60
Author(s):  
M. A. Aristov ◽  
O. M. Melnychuk
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cost Effectiveness Ratio ◽  
Total Cost ◽  
Total Budget ◽  
Cost Of Drugs ◽  
The Cost

The aim – to conduct clinical effectiveness, meta-analysis of 30 and 120-days mortality data, pharmacoeconomic evaluation of levosimendan treatment compared with dobutamine in patients with severe acute decompensated chronic heart failure (ADCHF) who require inotropic support. Materials and methods. The PubMed and Cochrane databases were searched for direct randomized clinical trials of levosimendan treatment compared with dobutamine in patients with ADCHF. The clinical efficacy of levosimendan and dobutamine was analyzed. Pharmacoeconomic analysis was carried out using the cost-effectiveness method with an assessment of the incremental cost-effectiveness ratio. A decision tree model of levosimendan or dobutamine treatments was constructed. The efficacy endpoints and impact on the budget were analyzed in terms of long-term effectiveness of levosimendan and dobutamine use. Discounted was conducted with rate of 3 %. Sensitivity analysis was carried out in terms of price changing of drugs, the cost of drugs in mg, the likelihood of re-hospitalization of the patient in a 3-year horizon and survival in the long term.Results and discussion. Analysis of clinical data and meta-analysis of randomized clinical trials found that mortality rates with levosimendan and dobutamine in the 30-day period were 9.6 % and 13.8 %, RR 0.71 (95 % CI 0.53–0.95) and in the 120-day period – 13.5 % and 25.2 %, RR 0.54 (95 % CI 0.32–0.92), respectively. The total cost of the course of treatment, taking into account the price of the drug, medical devices, staff services, diagnostic procedures and treatment of adverse reactions when using levosimendan, was 34 003.02 UAH per patient and 18 787.28 UAH when treated with dobutamine. The weighted average hospital stay was 6.4 days in case of levosimendan treatment and 7.5 days of dobutamine treatment. Extrapolation of the data from clinical trials to the 3-year survival rate of patients allowed us to determine an additional indicator of efficacy – the number of life years saved with levosimendan – 2.64 and 2.37 with dobutamine treatment. A cost-effectiveness analysis found that levosimendan is more efficient but more expensive technology compare to dobutamine. The incremental cost-effectiveness ratio for the additional life year saved of a patient with severe CHF is 43,473.55 UAH, which is 6 times less than the likely threshold of willingness to pay in Ukraine.Conclusions. The multivariate sensitivity analysis detected the model sustainability to the most crucial parameters of the model – drug price; the cost of drugs associated with their actual use in mg, the possibility of re-hospitalization of the patient in a 3-year horizon, and long-term survival, which is associated with the time horizon of the model. The total cost of a cohort of patients with ADCHF in Ukraine when using scenario 1 (100 % distribution of costs for dobutamine treatment) over 5 years is 268 188 351.94 UAH, when using scenario 2 (100 % distribution for treatment with levosimendan) total budget costs will be in amount of 485 393 073.09 UAH, if scenario 3 is applied (gradual 5 % transition in the treatment of patients with ADCHF with dobutamine for treatment with levosimendan within 5 years), the total budget costs will amount to 289 916 431.92 UAH

The effects of garlic supplementation on weight loss: A systematic review and meta-analysis of randomized controlled trials

2019 ◽  
pp. 1-13 ◽  
Author(s):  
Manije Darooghegi Mofrad ◽  
Jamal Rahmani ◽  
Hamed Kord Varkaneh ◽  
Alireza Teymouri ◽  
Seyed Mohammad Mousavi
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Body Weight ◽  
Waist Circumference ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Cochrane Library ◽  
Random Effects Models ◽  
Online Databases

Abstract. Obesity is related to increase in the incidence of morbidity and mortality. Studies have suggested anti-obesity properties of garlic; however, results are inconsistent. This systematic review and meta-analysis is done to summarize the data obtained from available randomized clinical trials on the effect of garlic supplementation on body weight, Body Mass Index (BMI), and Waist Circumference (WC). The online databases of Scopus, PubMed, Google Scholar and Cochrane library were searched until March 2018 for related publications using relevant keywords. Effect sizes of eligible studies were pooled using random-effects models. Cochran’s Q-test and I2 index were used for assessing heterogeneity. We found 1241 records in our initial search, of which 13 randomized clinical trials (RCTs) with 15 treatment arms were included. Pooled analysis showed that garlic administration might significantly decrease WC (Weighed Mean Difference (WMD): −1.10 cm, 95% CI: −2.13, −0.07, P = 0.03, I2 = 0%). However, garlic intervention had no significant effect on body weight (WMD): −0.17 kg, 95% CI: −0.75 to 0.39, P = 0.54, I2 = 0%) and BMI (WMD: −0.17 kg/m2, 95% CI: −0.52, 0.16, P = 0.30, I2 = 44.5%) as compared to controls. From Subgroup analysis, it was ascertained that the effect of garlic supplementation on BMI was significant in trials with duration < 12 weeks (WMD: −0.58 kg/m2, 95% CI: −1.08, −0.08, I2 = 19.8%, P = 0.02) compared to those with higher duration (>12 weeks). The current meta-analysis results suggest that garlic supplementation seems to reduce waist circumference unlike body weight and BMI.

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