scholarly journals A systematic review of (pre)clinical studies on the therapeutic potential and safety profile of kratom in humans

2021 ◽  
Author(s):  
Elisabeth Prevete ◽  
Kim Paula Colette Kuypers ◽  
Eef Lien Theunissen ◽  
Ornella Corazza ◽  
Giuseppe Bersani ◽  
...  
Keyword(s):  
Systematic Review ◽  
Safety Profile ◽  
Clinical Studies ◽  
Therapeutic Potential

scholarly journals Safety Evaluation of α-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies

Antioxidants ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. 1011
Author(s):  
Federica Fogacci ◽  
Manfredi Rizzo ◽  
Christoffer Krogager ◽  
Cormac Kennedy ◽  
Coralie M.G. Georges ◽  
...  
Keyword(s):  
Systematic Review ◽  
Lipoic Acid ◽  
Safety Profile ◽  
Clinical Studies ◽  
Severe Renal Impairment ◽  
Meta Analysis ◽  
Smoking Habit ◽  
Safety Evaluation ◽  
Increased Risk ◽  
Pregnancy Status

Alpha-lipoic acid (ALA) is a natural short-chain fatty acid that has attracted great attention in recent years as an antioxidant molecule. However, some concerns have been recently raised regarding its safety profile. To address the issue, we aimed to assess ALA safety profile through a systematic review of the literature and a meta-analysis of the available randomized placebo-controlled clinical studies. The literature search included EMBASE, PubMed Medline, SCOPUS, Google Scholar, and ISI Web of Science by Clarivate databases up to 15th August 2020. Data were pooled from 71 clinical studies, comprising 155 treatment arms, which included 4749 subjects with 2558 subjects treated with ALA and 2294 assigned to placebo. A meta-analysis of extracted data suggested that supplementation with ALA was not associated with an increased risk of any treatment-emergent adverse event (all p > 0.05). ALA supplementation was safe, even in subsets of studies categorized according to smoking habit, cardiovascular disease, presence of diabetes, pregnancy status, neurological disorders, rheumatic affections, severe renal impairment, and status of children/adolescents at baseline.

scholarly journals The Therapeutic Potential of Carnosine/Anserine Supplementation against Cognitive Decline: A Systematic Review with Meta-Analysis

Biomedicines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 253 ◽  
Author(s):  
Giuseppe Caruso ◽  
Justyna Godos ◽  
Sabrina Castellano ◽  
Agnieszka Micek ◽  
Paolo Murabito ◽  
...  
Keyword(s):  
Systematic Review ◽  
Depressive Symptoms ◽  
Cognitive Decline ◽  
Clinical Studies ◽  
Therapeutic Potential ◽  
Meta Analysis ◽  
Preliminary Evidence ◽  
Elderly Subjects ◽  
Neuroprotective Effects ◽  
The Impact

Carnosine is a natural occurring endogenous dipeptide that was proposed as an anti-aging agent more than 20 years ago. Carnosine can be found at low millimolar concentrations at brain level and different preclinical studies have demonstrated its antioxidant, anti-inflammatory, and anti-aggregation activity with neuroprotective effects in animal models of Alzheimer’s disease (AD). A selective deficit of carnosine has also been linked to cognitive decline in AD. Different clinical studies have been conducted to evaluate the impact of carnosine supplementation against cognitive decline in elderly and AD subjects. We conducted a systematic review with meta-analysis, in accordance with the PRISMA guidelines coupled to the PICOS approach, to investigate the therapeutic potential of carnosine against cognitive decline and depressive symptoms in elderly subjects. We found five studies matching the selection criteria. Carnosine/anserine was administered for 12 weeks at a dose of 1 g/day and improved global cognitive function, whereas no effects were detected on depressive symptoms. These data suggest a preliminary evidence of clinical efficacy of carnosine against cognitive decline both in elderly subjects and mild cognitive impairment (MCI) patients, although larger and long-term clinical studies are needed in MCI patients (with or without depression) to confirm the therapeutic potential of carnosine.

scholarly journals Real-World Outcomes of Ivacaftor Treatment in People with Cystic Fibrosis: A Systematic Review

2021 ◽  
Vol 10 (7) ◽  
pp. 1527
Author(s):  
Jamie Duckers ◽  
Beth Lesher ◽  
Teja Thorat ◽  
Eleanor Lucas ◽  
Lisa J. McGarry ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cystic Fibrosis ◽  
Real World ◽  
Safety Profile ◽  
Clinical Trial Data ◽  
Patient Characteristics ◽  
Healthcare Resource Utilization ◽  
Patient Reported ◽  
Clinical Benefits

Cystic fibrosis (CF) is a rare, progressive, multi-organ genetic disease. Ivacaftor, a small-molecule CF transmembrane conductance regulator modulator, was the first medication to treat the underlying cause of CF. Since its approval, real-world clinical experience on the use of ivacaftor has been documented in large registries and smaller studies. Here, we systematically review data from real-world observational studies of ivacaftor treatment in people with CF (pwCF). Searches of MEDLINE and Embase identified 368 publications reporting real-world studies that enrolled six or more pwCF treated with ivacaftor published between January 2012 and September 2019. Overall, 75 publications providing data from 57 unique studies met inclusion criteria and were reviewed. Studies reporting within-group change for pwCF treated with ivacaftor consistently showed improvements in lung function, nutritional parameters, and patient-reported respiratory and sino-nasal symptoms. Benefits were evident as early as 1 month following ivacaftor initiation and were sustained over long-term follow-up. Decreases in pulmonary exacerbations, Pseudomonas aeruginosa prevalence, and healthcare resource utilization also were reported for up to 66 months following ivacaftor initiation. In studies comparing ivacaftor treatment to modulator untreated comparator groups, clinical benefits similarly were reported as were decreases in mortality, organ-transplantation, and CF-related complications. The safety profile of ivacaftor observed in these real-world studies was consistent with the well-established safety profile based on clinical trial data. Our systematic review of real-world studies shows ivacaftor treatment in pwCF results in highly consistent and sustained clinical benefit in both pulmonary and non-pulmonary outcomes across various geographies, study designs, patient characteristics, and follow-up durations, confirming and expanding upon evidence from clinical trials.

scholarly journals Interferon therapy in patients with SARS, MERS, and COVID-19: A systematic review and meta-analysis of clinical studies

2021 ◽  
pp. 174248
Author(s):  
Kiarash Saleki ◽  
Shakila Yaribash ◽  
Mohammad Banazadeh ◽  
Ehsan Hajihosseinlou ◽  
Mahdi Gouravani ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Studies ◽  
Interferon Therapy ◽  
Meta Analysis

scholarly journals Radiotherapy of oligometastatic prostate cancer: a systematic review

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Paul Rogowski ◽  
Mack Roach ◽  
Nina-Sophie Schmidt-Hegemann ◽  
Christian Trapp ◽  
Rieke von Bestenbostel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
Predictive Factors ◽  
Therapeutic Potential ◽  
Case Series ◽  
Current Evidence ◽  
Oligometastatic Disease ◽  
Psma Pet ◽  
Oligometastatic Prostate Cancer ◽  
Prognostic And Predictive Factors

Abstract Background Due to improved imaging sensitivity, the term “oligometastatic” prostate cancer disease is diagnosed more often, leading to an increasing interest in metastasis-directed therapy (MDT). There are two types of radiation based MDT applied when treating oligometastatic disease: (1) stereotactic body radiation therapy (SBRT) generally used for bone metastases; or (2) SBRT for isolated nodal oligometastases combined with prophylactic elective nodal radiotherapy. This review aims to summarize current evidence data, which may shed light on the optimal management of this heterogeneous group of patients. Methods A systematic review of the Medline database through PubMed was performed according to PRISMA guidelines. All relevant studies published up to November 2020 were identified and screened. Fifty-six titles were included. Besides outcome parameters, different prognostic and predictive factors were assessed, including site of metastases, time between primary treatment and MDT, use of systemic therapies, hormone sensitivity, as well as pattern of recurrence. Findings Evidence consists largely of retrospective case series and no consistent precise definition of oligometastasis exists, however, most investigators seem to acknowledge the need to distinguish between patients presenting with what is frequently called “synchronous” versus “metachronous” oligometastatic disease. Available data on radiotherapy as MDT demonstrate high local control rates and a small but relevant proportion of patients without progressive disease after 2 years. This holds true for both hormone sensitive and castration resistant prostate cancer diseases. The use of 68Ga-PSMA PET/CT for staging increased dramatically. Radiation doses and field sizes varied considerably among the studies. The search for relevant prognostic and predictive factors is ongoing. Conclusions To our best knowledge this review on oligometastatic prostate cancer included the largest number of original articles. It demonstrates the therapeutic potential and challenges of MDT for oligometastatic prostate cancer. Prospective studies are under way and will provide further high-level evidence.

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