scholarly journals Clinical Efficacy & Safety of Oral Polypodium Leucotomos Extract for Photoprotection: A Systematic Review

2018 ◽  
Author(s):  
Giselle Prado ◽  
Rebeca Teplitz ◽  
Richard Winkelmann ◽  
James Del Rosso ◽  
Darrell Rigel
Keyword(s):  
Systematic Review ◽  
Adverse Effects ◽  
Clinical Efficacy ◽  
Risk Of Bias ◽  
Data Collection Form ◽  
Efficacy And Safety ◽  
Safety And Efficacy ◽  
Collection Form ◽  
Polypodium Leucotomos ◽  
Minimal Evidence

Background: Polypodium leucotomos extract (PLE) is a naturally derived compound from a fern native to South America. PLE has been shown to have antioxidant and photoprotective properties. Several different preparations of PLE are commercially available.Objective: To review the efficacy and safety of PLE for photoprotection in humans.Methods: A systematic review was conducted in 3 databases (Medline, Embase, and Cochrane) for studies that reported on the clinical efficacy and safety of PLE in humans. A data collection form was created for collecting study variables and risk of bias was assessed.Results: Eighteen studies with sample sizes ranging from n=5 to n-61 were included. The most common formulation of PLE studied was Fernblock® (Heliocare, Ferndale Healthcare, Ferndale, MI) in 18 studies. Most studies reported beneficial photoprotective effects of PLE as evidenced by increased MED. No serious adverse effects were reported.Conclusions: Multiple studies have shown the beneficial photoprotective effects and safety of the Fernblock® PLE formulation, but there is minimal evidence to support the safety and efficacy of other formulations. Given that the extraction methodology varies for herbal nutraceuticals and can affect its efficacy, these findings cannot be extrapolated to other formulations of PLE.

scholarly journals CLINICAL EFFICACY AND SAFETY OF HERBAL MEDICINE THERAPY IN RECURRENT APHTHOUS STOMATITIS: A SYSTEMATIC REVIEW

2021 ◽  
pp. 14-20
Author(s):  
NOVIA TRI HASANAH ◽  
WAHYU HIDAYAT
Keyword(s):  
Systematic Review ◽  
Herbal Medicine ◽  
Adverse Effects ◽  
Pain Score ◽  
Clinical Efficacy ◽  
Biological Activities ◽  
Recurrent Aphthous Stomatitis ◽  
Aphthous Stomatitis ◽  
Efficacy And Safety ◽  
Ulcer Size

Recurrent aphthous stomatitis is the most common oral mucous ulcerative lesion with challenging treatment. Herbal medicine therapy can propose clinical efficacy and safety due to its large biological activities. The objective was to review the clinical efficacy and safety of herbal medicine therapy in terms of ulcer size, pain score, healing duration, and adverse effects in recurrent aphthous stomatitis. A systematic was conducted based on the PRISMA statement. The search was performed using four electronic databases, namely PubMed, Cochrane, Science Direct, and Google Scholar for articles published from 2016 until 2021 using specific keywords. The search was limited to randomized controlled trials (RCTs), in English, full text, and study in humans. The main outcome is expected to be ulcer size, pain score, healing duration, and adverse effects. Quality assessment of selected articles was conducted using the Quality Appraisal of Randomized Trials Checklist (Cochrane Risk of Bias tool). The methodology quality of studies was evaluated using the Cochrane Handbook for Systematic Review of Interventions and Rev Man software. Five articles were eligible for analysis. The population of the sample study ranged from 34-70 patients of 15-65 y old. The herbs used were Aloe vera (Aloe barbadensis Miller), curcumin (Curcuma longa), licorice (Glycyrrhiza glabra), tobacco (Nicotiana tabacum L.), and pomegranate (Punica granatum Linn.). This review showed that there is some evidence of the clinical efficacy and safety of herbal medicine therapy in improved outcomes of recurrent aphthous stomatitis treatment with minimum adverse effects.

scholarly journals Comparative efficacy and safety of interventions for treating head lice: a protocol for systematic review and network meta-analysis

2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Grey Literature ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Head Lice ◽  
Efficacy And Safety ◽  
Randomised Controlled ◽  
Meta Analyses

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.

scholarly journals Cardiovascular Toxicities Secondary to Biotherapy and Molecular Targeted Therapies in Neuroendocrine Neoplasms: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials

Cancers ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2159
Author(s):  
Charalampos Aktypis ◽  
Maria-Eleni Spei ◽  
Maria Yavropoulou ◽  
Göran Wallin ◽  
Anna Koumarianou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Targeted Therapies ◽  
Safety Profile ◽  
Meta Analysis ◽  
Mtor Inhibitors ◽  
Risk Of Bias ◽  
Neuroendocrine Neoplasms ◽  
Controlled Trials

A broad spectrum of novel targeted therapies with prime antitumor activity and/or ample control of hormonal symptoms together with an overall acceptable safety profile have emerged for patients with metastatic neuroendocrine neoplasms (NENs). In this systematic review and quantitative meta-analysis, the PubMed, EMBASE, Cochrane Central Register of Controlled Trials and clinicaltrials.gov databases were searched to assess and compare the safety profile of NEN treatments with special focus on the cardiovascular adverse effects of biotherapy and molecular targeted therapies (MTTs). Quality/risk of bias were assessed using GRADE criteria. Placebo-controlled randomized clinical trials (RCTs) in patients with metastatic NENs, including medullary thyroid cancer (MTC) were included. A total of 3695 articles and 122 clinical trials registered in clinicaltrials.gov were screened. We included sixteen relevant RCTs comprising 3408 unique patients assigned to different treatments compared with placebo. All the included studies had a low risk of bias. We identified four drug therapies for NENs with eligible placebo-controlled RCTs: somatostatin analogs (SSAs), tryptophan hydroxylase (TPH) inhibitors, mTOR inhibitors and tyrosine kinase inhibitors (TKI). Grade 3 and 4 adverse effects (AE) were more often encountered in patients treated with mTOR inhibitors and TKI (odds ratio [OR]: 2.42, 95% CI: 1.87–3.12 and OR: 3.41, 95% CI: 1.46–7.96, respectively) as compared to SSAs (OR:0.77, 95% CI: 0.47–1.27) and TPH inhibitors (OR:0.77, 95% CI: 0.35–1.69). MTOR inhibitors had the highest risk for serious cardiac AE (OR:3.28, 95% CI: 1.66–6.48) followed by TKIs (OR:1.51, 95% CI: 0.59–3.83). Serious vascular AE were more often encountered in NEN patients treated with mTOR inhibitors (OR: 1.72, 95% CI: 0.64–4.64) and TKIs (OR:1.64, 95% CI: 0.35–7.78). Finally, patients on TKIs were at higher risk for new-onset or exacerbation of pre-existing hypertension (OR:3.31, 95% CI: 1.87–5.86). In conclusion, SSAs and TPH inhibitors appear to be safer as compared to mTOR inhibitors and TKIs with regards to their overall toxicity profile, and cardiovascular toxicities in particular. Special consideration should be given to a patient-tailored approach with anticipated toxicities of targeted NEN treatments together with assessment of cardiovascular comorbidities, assisting clinicians in treatment selection and early recognition/management of cardiovascular toxicities. This approach could improve patient compliance and preserve cardiovascular health and overall quality of life.

Evaluating Efficacy and Safety of Intradermal Delivery of Vaccines through Microneedle(s) in Animals: Systematic Review Protocol (Preprint)

2021 ◽  
Author(s):  
Ishumeet Kaur Bajwa ◽  
Navneet Kaur ◽  
Joseph L. Mathew
Keyword(s):  
Systematic Review ◽  
Animal Models ◽  
Risk Of Bias ◽  
Controlled Vocabulary ◽  
Free Text ◽  
Efficacy And Safety ◽  
Systematic Review Protocol ◽  
Intradermal Delivery ◽  
Review Protocol ◽  
Intradermal Route

BACKGROUND Microneedles are defined as micron-sized projections that create microscopic holes to the skin on application so that drug molecules can penetrate across the outer layers of the skin into the dermis or deeper. Skin is a natural barrier for defense against invading pathogens. Additionally, the dermis possesses dendritic cells that are efficient for antigen presentation and initiating the cascade of immunogenic responses leading to antibody production. Therefore, intradermal delivery of vaccine antigens could be a safe and less invasive alternative for vaccine delivery compared with conventional intramuscular injection. OBJECTIVE We intend to undertake a systematic review of the literature to evaluate the efficacy and safety of intradermal delivery of vaccines using microneedles in animal models. METHODS In this systematic review, we will consider all study designs evaluating the safety and/or efficacy of intradermal delivery of vaccines using microneedles in animal models. Our search strategy will include free text terms and controlled vocabulary for, “microneedle”, “vaccine”, and “intradermal”. We will search literature through PubMed, Embase, Cochrane, and OpenGrey, and we will not have language or date limits. Two review authors will independently select eligible studies and assess the risk of bias using the SYRCLE’s tool particularly for controlled studies and OHAT Risk of Bias Rating Tool for case studies, case-control studies, non-randomized studies, and cohort studies, and CAMARADES checklist to appraise the quality of the included studies. We will report structured summaries of the included studies and, if possible, conduct meta-analyses. The primary outcome to be measured is the efficacy of vaccine delivered through an intradermal route using microneedle(s) such as parameters of immunogenicity (for example antibody levels), sero-efficacy (for example sero-conversion), protective efficacy, etc. Secondary outcomes would include the safety of vaccines delivered through the intradermal route. This could include parameters to identify and/or quantify the timing and nature of local reactions, bleeding, systemic reactions, and death. Pain response during vaccination delivered through the intradermal route will also be evaluated. RESULTS This is a protocol for a systematic review; therefore, results are not available. CONCLUSIONS This is the first systematic review protocol aiming to assess the evidence on the efficacy and safety of intradermal delivery of vaccines using microneedles in various animal models. The findings will inform the safety and efficacy of intradermal delivery of vaccines in animal models, with the overall goal of considering the method for human vaccination as well. The results of this study will be published in a peer-reviewed journal. CLINICALTRIAL PROSPERO CRD42021236625

scholarly journals Efficacy and Safety of 25% Trichloroacetic Acid Peel Versus 30% Salicylic Acid Peel in Mild-to-Moderate Acne Vulgaris: A Comparative Study

2021 ◽  
pp. 2021063
Author(s):  
Surabhi Dayal ◽  
Satbir Singh ◽  
Priyadarshini Sahu
Keyword(s):  
Salicylic Acid ◽  
Adverse Effects ◽  
Comparative Study ◽  
Clinical Efficacy ◽  
Trichloroacetic Acid ◽  
Acne Vulgaris ◽  
Efficacy And Safety ◽  
Inflammatory Lesions ◽  
Treatment Groups ◽  
Proven Efficacy

Background: Both salicylic acid (SA) and trichloroacetic acid (TCA) have proven efficacy with goodsafety profiles in the treatment of acne vulgaris. Objectives: This study compared the clinical efficacy and safety of 25% TCA and 30% SA peels in thetreatment of mild and moderate acne vulgaris. Methods: Patients with mild or moderate acne vulgaris were randomized into 2 groups of 25 personseach, and treated with either the TCA peel or the SA peel at 2-week intervals for 12 weeks. Evaluationof active acne was done by individual lesion counts (comedones, papules and pustules) and calculationof the Michaelsson acne score (MAS). Results: Both peels led to significant decrease in individual lesion counts and MAS compared to baselinevalues, without significant differences between the treatment groups. Thus, the peels had equivalentefficacy against acne vulgaris. The TCA peel was better in treating non-inflammatory lesions,while the SA peel was better for inflammatory lesions, but the differences were not significant. Noserious adverse effects were recorded, but more patients in the TCA peel group experienced burningand stinging sensations. Conclusion: The efficacy of 25% TCA is comparable to that of 30% SA in mild-to-moderate acnevulgaris, but safety and tolerability were better with the SA peel than TCA peel.

scholarly journals The Safety and Efficacy of Phage Therapy for Superficial Bacterial Infections: A Systematic Review

Antibiotics ◽  
2020 ◽  
Vol 9 (11) ◽  
pp. 754
Author(s):  
Angharad Steele ◽  
Helen J. Stacey ◽  
Steven de Soir ◽  
Joshua D. Jones
Keyword(s):  
Systematic Review ◽  
Adverse Effects ◽  
Bacterial Infections ◽  
Chronic Wound ◽  
Phage Therapy ◽  
Data Extraction ◽  
Primary Data ◽  
Burn Wound ◽  
Promising Alternative ◽  
Safety And Efficacy

Superficial bacterial infections, such as dermatological, burn wound and chronic wound/ulcer infections, place great human and financial burdens on health systems globally and are often complicated by antibiotic resistance. Bacteriophage (phage) therapy is a promising alternative antimicrobial strategy with a 100-year history of successful application. Here, we report a systematic review of the safety and efficacy of phage therapy for the treatment of superficial bacterial infections. Three electronic databases were systematically searched for articles that reported primary data about human phage therapy for dermatological, burn wound or chronic wound/ulcer infections secondary to commonly causative bacteria. Two authors independently assessed study eligibility and performed data extraction. Of the 27 eligible reports, eight contained data on burn wound infection (n = 156), 12 on chronic wound/ulcer infection (n = 327) and 10 on dermatological infections (n = 1096). Cautionary pooled efficacy estimates from the studies that clearly reported efficacy data showed clinical resolution or improvement in 77.5% (n = 111) of burn wound infections, 86.1% (n = 310) of chronic wound/ulcer infections and 94.14% (n = 734) of dermatological infections. Over half of the reports that commented on safety (n = 8/15), all published in or after 2002, did not express safety concerns. Seven early reports (1929–1987), described adverse effects consistent with the administration of raw phage lysate and co-administered bacterial debris or broth. This review strongly suggests that the use of purified phage to treat superficial bacterial infections can be highly effective and, by various routes of administration, is safe and without adverse effects.

scholarly journals Efficacy and safety profile of statins in patients with cancer: a systematic review of randomised controlled trials

2020 ◽  
Vol 76 (12) ◽  
pp. 1639-1651
Author(s):  
John P. Thomas ◽  
Yoon K. Loke ◽  
Leo Alexandre
Keyword(s):  
Hepatocellular Carcinoma ◽  
Systematic Review ◽  
Statin Therapy ◽  
Safety Profile ◽  
Randomised Controlled Trials ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Patients With Cancer ◽  
Randomised Controlled

Abstract Purpose A growing body of preclinical and observational research suggests that statins have potential as a therapeutic strategy in patients with cancer. This systematic review of randomised controlled trials (RCTs) in patients with solid tumours aimed to determine the efficacy of statin therapy on mortality outcomes, their safety profile and the risk of bias of included studies. Methods Full-text articles comparing statin therapy versus control in solid tumours and reporting mortality outcomes were identified from Medline and Embase from conception to February 2020. A systematic review with qualitative (primarily) and quantitative synthesis was conducted. This systematic review was prospectively registered (Prospero registration CRD42018116364). Results Eleven trials of 2165 patients were included. Primary tumour sites investigated included lung, colorectal, gastro-oesophageal, pancreatic and liver. Most trials recruited patients with advanced malignancy and used sub-maximal statin doses for relatively short durations. Aside from one trial which demonstrated benefit with allocation to pravastatin 40 mg in hepatocellular carcinoma, the remaining ten trials did not demonstrate efficacy with statins. The pooled hazard ratio for all-cause mortality with allocation to pravastatin in patients with hepatocellular carcinoma in two trials was 0.69 (95% confidence interval CI 0.30–1.61). Study estimates were imprecise. There were no clinically important differences in statin-related adverse events between groups. Overall, included trials were deemed low risk of bias. Conclusion The trial evidence is not sufficiently robust to confirm or refute the efficacy and safety of statins in patients with solid malignant tumours. Study and patient characteristics may explain this uncertainty. The potential role of high-dose statins in adjuvant settings deserves further research.

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