Systematic review of harm from case reports and clinical trials of the oral use of Arctostaphylos uva-ursi, Turnera diffusa and Achillea millefolium

Author(s):  
Laura Dwyer ◽  
Ian Breakspear
2018 ◽  
Vol 64 (1) ◽  
pp. 63-70 ◽  
Author(s):  
Gabriella Maria Pitt Gameiro Sales ◽  
Izabel Crystine Pereira Barbosa ◽  
Laura Maia Sampaio Canejo Neta ◽  
Paloma Lopes de Melo ◽  
Raphael de Azevedo Leitão ◽  
...  

Summary Introduction: Chikungunya (CHIK) is a tropical arbovirus, transmitted by the female mosquito Aedes aegypti and Aedes albopictus. In Brazil, there have been cases reported since 2014. The initial manifestations of this virus are sudden onset high fever, headache, chills, rashes, myalgia and intense joint pain. Usually, CHIK presents the acute and chronic phases, the latter characterized by bilateral polyarthralgia, which can last for months or even years. During this period, autoimmune diseases can be triggered, making the picture even more complicated. Method: A systematic review was performed on the PubMed and Scielo databases in January 2017. Clinical trials, cohorts, case-control and case reports were included in the study. Expert opinions, societal consensuses and literary reviews were exclusion criteria. Studies were conducted in English, Spanish and Portuguese. The studies were descriptively analyzed and the data was grouped according to methodological similarity. Results: Twenty-four (24) articles were selected and, in compliance with the inclusion and exclusion criteria, 18 were eliminated, with six studies remaining in the present review: five clinical trials and one case report. Conclusion: When the manifestations of CHIK become chronic and, the longer they last, more complications arise. Polyarthralgia can be immaterial, distancing individuals from their daily-life activities. Anti-inflammatory drugs (either steroid or not), in addition to immunosuppressants, homeopathy and physiotherapy are measures of treatment that, according to the literature, have been successful in relieving or extinguishing symptoms. However, it is fundamental that studies of CHIK treatment be further developed.


2021 ◽  
Author(s):  
Felipe dos Santos Souza ◽  
Alvaro Moreira Rivelli

Introduction: The bobble head syndrome (BHDS) is described in the literature as a complex and rare syndrome with repetitive movements of the anteroposterior head. Furthermore, it is known that this movement disorder is due to the effect of pressure from the third dilated ventricle, which distorts the red dorsomedial nucleus and the dentatorubrotalamic pathways. Objective: to evaluate the number of studies on the syndrome and, added to the findings, describe the manifestations about the Bobble Head Doll Syndrome, elucidating the main neurological exams, treatments used and reported prognoses, in order to make it a potential diagnosis in children who present a compatible clinic. Methodology: a systematic review based on databases (SCIELO <LILACS and PUBMED), using the PRISMA method with the following descriptor: Bobble Head Doll Syndrome. The selection criteria included: studies made available in full, case reports, reviews and clinical trials. Exclusion criteria: articles not available in full, duplicates and works that only touched on the theme. Results: it was found in the scientific literature, PUBMED: 52 studies and SCIELO: 0. SCIELO: 2. Conclusions: the articles selected based on the established criteria showed a significant scientific scarcity around the Bobble Head Doll Syndrome. The dissemination of new studies and documentation of case reports is essential in understanding both the general syndrome and the specific knowledge of the procedures in which neurologists must take it. In this sense, the epidemiology is approximately between 2 and less than 5 years of age in children.


Author(s):  
Pinky Kotecha ◽  
Alexander Light ◽  
Enrico Checcucci ◽  
Daniele Amparore ◽  
Cristian Fiori ◽  
...  

AbstractObjectiveThe aim of this systematic review is to evaluate the data currently available regarding the repurposing of different drugs for Covid-19 treatment. Participants with suspected or diagnosed Covid-19 will be included. The interventions being considered are drugs being repurposed, and comparators will include standard of care treatment or placebo.MethodsWe searched Ovid-MEDLINE, EMBASE, Cochrane library, clinical trial registration site in the UK(NIHR), Europe (clinicaltrialsregister.eu), US (ClinicalTrials.gov) and internationally (isrctn.com), and reviewed the reference lists of articles for eligible articles published up to April 22, 2020. All studies in English that evaluated the efficacy of the listed drugs were included. Cochrane RoB 2.0 and ROBINS-I tool were used to assess study quality. This systematic review adheres to the PRISMA guidelines. The protocol is available at PROSPERO (CRD42020180915).ResultsFrom 708 identified studies or clinical trials, 16 studies and 16 case reports met our eligibility criteria. Of these, 6 were randomized controlled trials (763 patients), 7 cohort studies (321 patients) and 3 case series (191 patients). Chloroquine (CQ) had a 100% discharge rate compared to 50% with lopinavir-ritonavir at day 14, however a trial has recommended against a high dosage due to cardiotoxic events. Hydroxychloroquine (HCQ) has shown no significant improvement in negative seroconversion rate which is also seen in our meta-analysis (p=0.68). Adverse events with HCQ have a significant difference compared to the control group (p=0.001). Lopinavir-ritonavir has shown no improvement in time to clinical improvement which is seen in our meta-analyses (p=0.1). Remdesivir has shown no significant improvement in time to clinical improvement but this trial had insufficient power.DiscussionDue to the paucity in evidence, it is difficult to establish the efficacy of these drugs in the treatment of Covid-19 as currently there is no significant clinical effectiveness of the repurposed drugs. Further large clinical trials are required to achieve more reliable findings. A risk-benefit analysis is required on an individual basis to weigh out the potential improvement in clinical outcome and viral load reduction compared to the risks of the adverse events. (1-16)


2015 ◽  
Vol 7 (2) ◽  
Author(s):  
Amir Feily ◽  
Shadi Mehraban

Necrobiosis lipoidica (NL) is a rare inflammatory granulomatous skin disorder closely associated with diabetes mellitus. The aim of this paper is to review and discuss all the treatment modalities proposed and tested for this disease. A systematic review of the existing literature was conducted to investigate all the available data and summarize all the clinical trials, case reports and original articles on NL. Two major databases (PubMed and Google Scholar) were used. We have examined about 70 articles. Numerous treatment modalities have been currently investigated to compare recalcitrant NL. Being rare, most of the studies regarding this disease are case reports or small-scale clinical trials. We have found that, in spite of plentiful investigations carried out during the years, there is no treatment modality that has proved to be utterly satisfactory in treating NL.


2020 ◽  
Vol 10 (1) ◽  
pp. 23
Author(s):  
Renée V. E. Dagenais ◽  
Victoria C. Su ◽  
Bradley S. Quon

Cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies target the underlying cause of cystic fibrosis (CF), and are generally well-tolerated; however, real-world studies indicate the frequency of discontinuation and adverse events (AEs) may be higher than what was observed in clinical trials. The objectives of this systematic review were to summarize real-world AEs reported for market-available CFTR modulators (i.e., ivacaftor (IVA), lumacaftor/ivacaftor (LUM/IVA), tezacaftor/ivacaftor (TEZ/IVA), and elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA)), and to identify ways in which the pharmacist on CF healthcare teams may contribute to mitigating and managing these AEs. The MEDLINE, EMBASE, CINAHL, and Web of Science Core Collection online databases were searched from 2012 to 1 Aug 2020. Full manuscripts or conference abstracts of observational studies, case series, and case reports were eligible for inclusion. The included full manuscripts and conference abstracts comprised of 54 observational studies, 5 case series, and 9 case reports. The types of AEs reported generally aligned with what have been observed in clinical trials. LUM/IVA was associated with a higher frequency of respiratory-related AE and discontinuation in real-world studies. A signal for mental health and neurocognitive AEs was identified with all 4 CFTR modulators. A systematic approach to monitoring for AEs in people with CF on CFTR modulators in the real-world setting is necessary to help better understand potential AEs, as well as patient characteristics that may be associated with higher risk of certain AEs. Pharmacists play a key role in the safe initiation and monitoring of people with CF on CFTR modulator therapies.


2012 ◽  
Vol 2012 ◽  
pp. 1-28 ◽  
Author(s):  
Ori Scott ◽  
Elaine Galicia-Connolly ◽  
Denise Adams ◽  
Soleil Surette ◽  
Sunita Vohra ◽  
...  

Some cruciferous plants may serve as preventive treatments for several medical conditions; our objective was to systematically investigate their safety in humans. Four electronic databases were searched, and, of 10,831 references identified, 50 were included. Data were extracted by two independent reviewers, whereafter the association between interventions and adverse events was assessed. Adverse events in 53 subjects were identified through clinical trials; of these, altered drug metabolism was rated as certainly/likely caused by cruciferous plants. Adverse events in 1247 subjects were identified through observational studies, of which none received high causality ratings. Adverse events in 35 subjects were identified through case reports, of which allergies and warfarin resistance were rated as certainly/likely caused by cruciferous plants. We conclude that cruciferous plants are safe in humans, with the exception of allergies. Individuals treated with warfarin should consult their physician. Further investigation of uses of cruciferous plants in preventative medicine is warranted.


2021 ◽  
pp. 232020682110158
Author(s):  
Shruthi H. Attavar ◽  
Mithra N. Hegde

Aim: The effective delivery of irrigants into the inaccessible areas of the root canal system is the prerequisite for a proper disinfection of the root canal system. Numerous activation devices that can provide effective delivery of the irrigant and aid in the success of the root canal treatment are available. The activation of irrigants has claimed to be effective in in vitro and clinical trials. Hence, the present systematic review aims to analyze the effect of irrigants and irrigating devices in disinfecting the root canal system. Materials and Methods: A literature search was undertaken in PubMed, Cochrane, Web of Science, and Scopus databases. The inclusion criteria included clinical trials, both in vivo and ex vivo. The exclusion criteria included animal studies, textbooks, review articles, and case reports. The patients who required endodontic treatment along with the activation of irrigants were chosen as participants for the review. Result: The search strategy screened around 132 articles, out of which only 10 were selected for the present systematic review. The risk of bias was calculated based on the following scores: 3, high; 2, moderate; and 1, low. In the present systematic review, four articles were categorized into low-risk bias, three articles were classified as moderate risk, and three articles belonged to the high-risk category. Conclusion: The present systematic review concluded that the use of a mechanical activation device along with the irrigant will help in better removal of the smear layer and debris from the root canal system, improving the cleanliness and helping achieve more successful endodontic treatment.


2017 ◽  
Vol 51 (6) ◽  
pp. 496-503 ◽  
Author(s):  
Shaylee C. Peterson ◽  
Tim T. Y. Lau ◽  
Mary H. H. Ensom

Objective: The aim of this systematic review is to review all human trials assessing the efficacy and safety of ampicillin and ceftriaxone for enterococcal endocarditis and to discuss the clinical implications of the findings. Data Sources: MEDLINE (1946-), EMBASE (1974-), CENTRAL, Google Scholar, and the World Health Organization Clinical Trials Registry Platform were searched through January 2017 using the search terms ampicillin, penicillin, ceftriaxone, cephalosporin, enterococ*, and endocarditis. Unpublished studies were eligible for inclusion. Additional references were identified from literature citations. Study Selection and Data Extraction: Clinical trials in humans that reported on clinical efficacy or adverse outcomes with ceftriaxone and ampicillin therapy in patients with enterococcal endocarditis were included. Case reports, nonhuman, and non-English studies were excluded. Data Synthesis: Four observational clinical studies were identified. One examined the effects of ceftriaxone and ampicillin alone, and 3 compared the therapy to the current standard of care, ampicillin and gentamicin. The studies had small sample sizes and were not adequately designed or powered to establish noninferiority or equivalence to the current standard of care. Rates of clinical cure with ampicillin 2 g every 4 hours and ceftriaxone 2 g every 12 hours were similar to those of ampicillin and gentamicin. Ampicillin and ceftriaxone therapy was well tolerated with low rates of renal failure (0%-33%). Conclusion: The evidence to support the use of ampicillin and ceftriaxone for enterococcal endocarditis is not definitive. In the absence of compelling evidence, clinicians may consider ampicillin and ceftriaxone in patients with Enterococcus faecalis infection at high risk for nephrotoxicity or those with aminoglycoside-resistant pathogens.


2021 ◽  
Vol 10 (4) ◽  
pp. 1-7
Author(s):  
Sadeq A. Al-Maweri ◽  
◽  
Rawan Alanazi ◽  
Mohammed Nasser Alhajj ◽  
Ammar Daer ◽  
...  

Background: Oral lichen planus (OLP) is a chronic inflam-matory disorder with a potential of malignant transformation. Despite the extensive research on the topic, the management of OLP is still quite challenging, with no definitive cure. Objective: The present systematic review assessed the efficacy of topical hyaluronic acid in the management of OLP. Material and Methods: A comprehensive search of PubMed, Scopus, Web of Science and Google Scholar was carried out by two independent investigators. All randomized clinical trials that compared the efficacy of hyaluronic acid with other interventions and/or placebo in the management of OLP and fulfilled the following criteria were included: 1) OLP diagnosis was confirmed clinically and histopathologically, 2) the study included systemically healthy patients aged 15 years and older, 3) a minimum sample size of 10, and 4) reporting the main outcomes including pain, erythema, and ulcer size. Case reports, case series, reviews, animal studies, uncontrolled trials were excluded. Results: Four clinical trials involving 234 patients were included. Two studies compared hyaluronic acid with a topical corticosteroid, and two studies compared it with placebo. Only one of the four included studies was at low risk of bias. Overall, topical hyaluronic acid showed good efficacy in alleviating the signs and symptoms of OLP. Two studies found hyaluronic acid significantly more effective in reducing pain and improving clinical signs of OLP compared to placebo. Compared to topical corticosteroids, one study reported comparable results; and one study found hyaluronic acid to be superior to triamcinolone in reducing pain but inferior to triamcinolone in improving the healing time. Conclusion: The limited available evidence suggests that hyaluronic acid may have some benefits in the management of OLP. Further well-designed studies with adequate follow-up periods are highly recommended.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3629-3629 ◽  
Author(s):  
Janique Dyba ◽  
Francis CF Chan ◽  
Keith K. Lau ◽  
Anthony K.C. Chan ◽  
Howard H.W. Chan

Abstract Introduction Tranexamic acid (TXA) is a reversible lysine analogue that competes with the lysine residues on fibrin for the binding of plasminogen thus inhibiting the fibrinolysis and stabilizing clot. Multiple meta-analysis and randomized controlled trials have demonstrated its role in reducing blood loss for menorrhagia, perioperative bleeding, trauma-associated hemorrhage, and post-dental procedure bleeding. However, some of these situations are known to provoke venous thromboembolism (VTE) and the risk of inducing TXA-associated thromboembolic complication is always a concern for the managing physician. Hereby, we conducted a systematic review of the literature to determine whether the reported thromboembolic incidences were associated with the dosing of TXA. Methods We searched the OVID Medline database for all articles including the terms “tranexamic acid” or “antifibrinolytics” and then refined the search results with the key word “hemorrhage”. The search was limited to humans and English language. We included primary research articles using oral or intravenous tranexamic acid in the treatment or prophylaxis of hemorrhage, including clinical trials, cohort studies, case series, and case reports. Review articles, meta-analyses and in vitro studies were excluded from this study. We categorized the studies into two groups. The first group included all case reports and the narrative citations in which the TXA doses were variable among the patients within the same study. Student t-test was used to compare the TXA dosage for patients with and without VTE. A p-value of 0.05 was considered significant. The second group included randomized trials and the non-randomized studies with fixed TXA dosing for all participating subjects allowing comparison between treatment and control arms. The odds ratio of having VTE for each individual study was analyzed against the dosing information of TXA. Weighted regression analysis was used to determine whether the odds ratio of having VTE was linearly correlated with the TXA dose. Results Two authors independently screened the citations and assessed the full text for potentially relevant publications. The initial search strategy resulted in 1959 articles, of which 149 articles published between 1971 and 2013 had complete data on TXA dose, duration of TXA therapy and VTE events. These included 17 case reports, 45 case cohorts, 8 non-randomized clinical trials and 76 randomized control trials. In the first groups of citations, the total dose of TXA reported for patients complicated by VTE was borderline higher than those without VTE but reached the predefined statistically significance (p= 0.042). In the second groups of studies, vast majority did not show significant increase in VTE events in the TXA treatment arm because the odds ratio was equal to 1. Only a few studies had an odds ratio not equal to 1 but the ratios were not linearly correlated either with the daily dose or total dose of TXA. Conclusion Despite the heterogenous indications for antifibrinolytic therapy, TXA treatment did not consistently increase the event rate of VTE. Our study suggested that both the daily or total dose of TXA were not strong predicting factors for the VTE. Instead, we speculate that patients’ pre-existing thrombophilia conditions and the concurrent procoagulant factors are the confounding variables associated with VTE in patients on TXA. Thus, these factors should be considered and balanced against the potential benefits of TXA in reducing the degree of hemorrhage. Disclosures: No relevant conflicts of interest to declare.


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