scholarly journals Galcanezumab in migraine prevention: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 13 ◽  
pp. 175628642091808 ◽  
Author(s):  
Panagiotis Gklinos ◽  
Dimos D. Mitsikostas
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Preventive Treatment ◽  
Phase Iii ◽  
Controlled Trials ◽  
Migraine Prevention ◽  
Randomized Controlled ◽  
The Mean

Background: Galcanezumab, along with three other monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, represents the latest disease-specific and mechanism-based treatment for the prophylaxis of migraine. Galcanezumab shares data also for the prophylaxis of cluster headache. Objective: To provide a pooled safety and efficacy analysis of all phase III randomized controlled trials of galcanezumab in the preventive therapy of migraine. Methods: A computer-based literature search was conducted on MEDLINE and the US National Institutes of Health Clinical Trials Registry for phase III randomized controlled trials of galcanezumab in migraine prevention. The primary outcome was the mean change in monthly migraine days (MMDs). The proportions of patients who reported at least one adverse event (AE), at least one serious adverse event (SAE) or withdrew from the study were used as safety outcomes. Results: Two trials were included in the efficacy meta-analysis and three in the safety meta-analysis. Migraine preventive treatment with subcutaneous galcanezumab, at both 120 mg and 240 mg dosages, was associated with a significantly greater reduction in the mean number of MMDs versus placebo (120 mg, MD = –1.98, 95% CI = –2.33 to –1.63; p < 0.0001) or (240 mg, MD = –1.86, 95% CI = –2.20 to –1.53; p < 0.0001). Galcanezumab was found to be more efficacious in all key secondary outcomes as well. Regarding safety, most of the adverse events were mild to moderate, while drop-out rates and serious adverse events were low. Conclusions: Galcanezumab is an efficacious and well-tolerated preventive treatment for migraine. Larger clinical trials with longer follow-up periods need to be conducted in order to provide more safety data of the above-mentioned drug.

scholarly journals The Effect of Zinc Supplementation on Serum Leptin Levels: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 51 (08) ◽  
pp. 503-510
Author(s):  
Masoud Khorshidi ◽  
Meysam Zarezadeh ◽  
Alireza Sadeghi ◽  
Alireza Teymouri ◽  
Mohammad Reza Emami ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Zinc Supplementation ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Serum Leptin ◽  
Randomized Controlled ◽  
Human Adults ◽  
The Mean

AbstractRecently, obesity has become a common worldwide concern. Leptin, as an adipocytokine, plays a major role in the etiology of obesity. Prior studies have demonstrated that zinc potentially affects serum leptin levels. However, clinical trials carried out in this regard are not consistent. Therefore, current meta-analysis was conducted to ascertain the actual effect of zinc supplementation on serum leptin levels in adults. Databases of PubMed, SCOPUS, and Google Scholar were methodically searched to identify relevant articles up to April 2018. Clinical trials that examined the effect of zinc supplementation on serum leptin concentrations as outcome variables in human adults were included. The mean difference (SD) of leptin changes in the intervention and placebo groups were used to calculate the overall effect size. Totally, 663 articles were identified, of which 6 studies were eligible randomized controlled trials (RCTs) with 7 treatment arms. The analysis suggested that zinc supplementation exerts no significant effect on overall serum leptin (WMD: 0.74 ng/ml; 95% CI: −1.39 to 2.87, p=0.49). Nevertheless, sex and duration of intervention seemed to impact the extent of zinc’s influence. In trials with female subjects, zinc consumption led to a significant decrease in serum leptin level (WMD: −1.93 ng/ml; 95% CI: −3.72 to −0.14, p=0.03) as well as trials that lasted for more than 6 weeks (WMD: −1.71 ng/ml; 95% CI: −3.07 to −0.35, p=0.01), in comparison to the control group. Zinc supplementation did not significantly improve leptin concentrations, but it may result in a decreased circulating leptin level in studies with a duration of more than 6 weeks especially among females.

A systematic review and meta-analysis of propionyl-l-carnitine effects on exercise performance in patients with claudication

2013 ◽  
Vol 18 (1) ◽  
pp. 3-12 ◽  
Author(s):  
Eric P Brass ◽  
David Koster ◽  
William R Hiatt ◽  
Antonino Amato
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Exercise Performance ◽  
Meta Analysis ◽  
Phase Iii ◽  
Walking Distance ◽  
Controlled Trials ◽  
Primary Analysis ◽  
Randomized Controlled

Propionyl-l-carnitine (PLC) may improve exercise performance in patients with peripheral artery disease, but results from clinical trials have been inconsistent. The safety and efficacy of PLC for treatment of claudication was evaluated by a systematic review and meta-analysis of clinical trials for which data were available through September 2010. Eighty-five studies were identified, of which 13 were randomized controlled trials. Owing to database availability for the six phase III studies carried out with PLC (1 g orally, twice daily), a patient-level meta-analysis was conducted as the primary analysis. Treadmill performance data from these six studies were harmonized to peak walking distance (PWD) on a 7% grade at a speed of 3 km/hour. PLC ( n = 440) was associated with a net 16 meter improvement (95% CI, 8–20 meters) in PWD as compared with placebo ( n = 427) in the primary analysis ( p = 0.002). The effect of PLC was similar in subpopulations defined using clinical and demographic variables, with possible enhanced benefit in patients engaged in an exercise program or enrolled at study sites in Russia. The systematic review of the effect of PLCs on claudication identified seven additional randomized controlled trials for a total of 13 trials, which included 681 patients on placebo and 672 on PLC. This meta-analysis confirmed a 45 meter net improvement on PLC using a random-effects model. In conclusion, oral PLC is associated with a statistically significant increase in PWD in patients with claudication, which may be clinically relevant.

The effect of almond intake on lipid profile: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Omid Asbaghi ◽  
Vihan Moodi ◽  
Amir Hadi ◽  
Elham Eslampour ◽  
Mina Shirinbakhshmasoleh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Lipid Profile ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled

A number of clinical trials have examined the effect of almond intake on the lipid profile in recent years; however, the results remain equivocal.

scholarly journals EXPRESS: The benefit of exercise-based rehabilitation programmes in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
pp. 204589402110078
Author(s):  
Lu Yan ◽  
Wence Shi ◽  
Zhi-hong Liu ◽  
Qin Luo ◽  
Zhihui Zhao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Hypertension ◽  
Randomized Controlled Trials ◽  
Exercise Capacity ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean ◽  
Quality Evidence

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I ² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peak oxygen uptake  was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control group . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.

scholarly journals The Antihypertensive Effects and Safety of LCZ696 in Patients with Hypertension: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 10 (13) ◽  
pp. 2824
Author(s):  
Su-Kiat Chua ◽  
Wei-Ting Lai ◽  
Lung-Ching Chen ◽  
Huei-Fong Hung
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Randomized Controlled Trials ◽  
Diastolic Blood Pressure ◽  
Publication Bias ◽  
Meta Analysis ◽  
Systemic Review ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean

Background: The management of hypertension remains suboptimal throughout the world. Methods: We performed a random-effects model meta-analysis of randomized controlled trials to determine the effectiveness and safety of sacubitril/valsartan (LCZ696) for the treatment of high arterial pressure. Relevant published articles from PubMed, Cochrane base, and Medline were examined, and the last search date was December 2020. Only published randomized controlled trials and double-blind studies were selected for further analysis. The mean reductions in systolic blood pressure (msSBP) and diastolic blood pressure (msDBP) in the sitting position, as well as the mean reductions in ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure (maDBP), were assumed as efficacy endpoints. Adverse events (AEs) were considered as safety outcomes. Results: Ten studies with a total of 5931patients were included for analysis. Compared with placebo, LCZ696 had a significant reduction in msSBP (weight mean difference (WMD) = −6.52 mmHg, 95% confidence interval (CI): −8.57 to −4.47; p < 0.001), msDBP (WMD = −3.32 mmHg, 95% CI: −4.57 to −2.07; p < 0.001), maSBP (WMD = −7.08 mmHg, 95% CI: −10.48 to −3.68; p < 0.001), maDBP (WMD = −3.28 mmHg, 95% CI: −4.55 to −2.02, p < 0.001). In subgroup analysis, only 200 mg and 400 mg LCZ696 showed a significant BP reduction. There was no difference in the AE rate between the LCZ696 and placebo groups (WMD = 1.02, 95% CI: 0.83 to 1.27, p = 0.54). Egger’s test revealed a potential publication bias for msSBP (p = 0.025), but no publication bias for other outcomes. Conclusion: LCZ696 may reduce blood pressure more efficaciously than traditional therapy in hypertensive patients without increasing adverse effects.

scholarly journals Network Meta-Analysis of Different Clinical Commonly Used Drugs for the Treatment of Hypertrophic Scar and Keloid

2021 ◽  
Vol 8 ◽  
Author(s):  
Sha Yang ◽  
Yujia J. Luo ◽  
Cong Luo
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Topical Treatment ◽  
Hypertrophic Scar ◽  
Meta Analysis ◽  
Treatment Strategies ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Silicone Gels

Background: There is no uniform treatment for pathological scars, including keloids and hypertrophic scars, in clinic currently. Previously, multiple randomized controlled trials have examined the clinical efficacy of different treatments. Nonetheless, the results are inconsistent, and many treatments have not been directly compared. This makes it difficult to conclude which approach is more favorable, in terms of efficacy and safety, for the treatment of pathological scarring. This study aimed at evaluating the efficacy of different injection and topical treatment strategies for hypertrophic scar and keloid.Methods: Relevant literature from PubMed, Medline, Embase, Scopus, the Cochrane Central Register of Controlled Trials (CCRCT), and WHO International Clinical Trials Registry Platform (WHO-ICTRP) were searched, from database inception through November 2020. Randomized clinical trials evaluating different treatment strategies of pathological scars, including triamcinolone acetonide (TAC), verapamil (VER), 5-fluorouracil (5-FU), botulinum toxin A (BTA), bleomycin (BLM), and silicone gels were included in the study.Results: The network meta-analysis included a total of 2,009 patients from 29 studies. A network meta-analysis of injection and topical treatment strategies showed that the efficacy of TAC combined with BTA was best in the treatment of pathological scars. Combination therapies of TAC with 5-FU and TAC with BTA significantly improved the clinical efficiency. However, there was no statistically significant difference between other treatment strategies. The order of efficacy predicted by the surface under the cumulative ranking (SUCRA) curve was as follows: TAC+BTA (82.2%) &gt; TAC+5-FU (69.8%) &gt; BTA (67.3%) &gt; 5-FU+silicone (59.4%) &gt; TAC+silicone (58.3%) &gt; 5-FU (49.8%) &gt; BLM (42.0%) &gt; TAC (26.7%) &gt; VER (26.2%) &gt; silicone (18.3%). There was no publication bias revealed based on the funnel diagram.Conclusion: This study recommends intralesional injection of TAC-BTA and TAC-5-FU combined therapies. But for patients who cannot tolerate the side effects, the use of silicone gels in combination with TAC is recommended. However, these conclusions need to be further confirmed by more randomized controlled trials.

Clinical Trials

Anthropology ◽  
2020 ◽  
Author(s):  
Salla Sariola
Keyword(s):  
Clinical Trials ◽  
Global Health ◽  
Randomized Controlled Trials ◽  
Knowledge Production ◽  
Health Research ◽  
Phase Iii ◽  
Controlled Trials ◽  
Care Providers ◽  
Randomized Controlled ◽  
Production Processes

Clinical trials are tests of safety and efficacy for drugs, vaccines, and diagnostics. Methods by with which trials are conducted include randomized controlled trials (RCTs) and equivalence studies. Randomized controlled trials compare an experimental compound with a placebo, or a previously existing drug, seeking to establish safety and/or efficacy. RCTs can also be conducted on social interventions or policies. According to current standards, trials are conducted in phases, cumulatively including more participants. So called phase I trials are “first-in-man” studies, prior to which animal studies have been conducted. Phases II and III include a higher number of study participants, often in thousands across the world. After phase III, marketing permission is sought—phases IV and V are used to promote the products and gather further evidence of side effects. Trials are also conducted to compare the equivalence of existing and remanufactured products, extend patents of the patent holder, and gain a hold of a new market, resulting in what is at times called “me-too”-drugs. Trials are conducted by public/global health researchers, pharmaceutical companies, and public-private partnerships all of which entail a complex web of actors. Anthropological literature exploring clinical trials has increased since the 2000s and the field reflects a global increase of overseas research by various biomedical actors. Clinical trials are not a new phenomenon, but their recent trajectory and shifting geographical locations has rendered them an object of inquiry. The increase is a consequence of multiple processes including global regulatory changes, emergence of new bilateral actors, and the overall development in countries like India and China that have increased their capacity for knowledge production. Within anthropology, the interest has coincided with and compounded research on globalization and global assemblages that has focused on webs and networks of technologies, ethics, and financial actors. Knowledge production processes have also illuminated the “ontological turn” in anthropology that has explored practices that give rise to objects, materiality, and biology. Following practices that construct pharmaceuticals illuminates the ways in which life itself, bodies, and biologies are socially constructed. Such approach, while not always explicitly, takes inspiration from Bruno Latour’s Actor-Network Theory and science and technology studies. Knowledge production processes are not devoid of power, and a major concern in the literature is the potential for exploitation of research participants, researchers, and local research cultures. In sites where global health research is conducted, health systems are often poor, and strongly divided between public and private health-care providers. Anthropology in/of clinical trials has engendered social scientists’ roles in working also in collaboration with medical researchers and thinking about the social relationships and ethics of international research, justice and universality of values, how to promote the interests and concerns of communities, and how indeed research bioethical regulation itself is a product of neoliberalization of health research.

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