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We conducted a systematic literature review to assess the adverse event AE profile of paracetamol. Methods We searched Medline and Embase from database inception to 1 May We screened for observational studies in English, which reported mortality, cardiovascular, gastrointestinal GI or renal AEs in the general adult population at standard analgesic doses of paracetamol.
Pooled or adjusted summary statistics were presented for each outcome. Results Of studies retrieved, 8 met inclusion criteria, and all were cohort studies.
Comparing paracetamol use versus no use, of two studies reporting mortality one showed a dose—response and reported an increased relative rate of mortality from 0. Of four studies reporting cardiovascular AEs, all showed a dose—response with one reporting an increased risk ratio of all cardiovascular AEs from 1.
Discussion Given the observational nature of the data, channelling bias may have had an important impact. However, the dose—response seen for most endpoints suggests a considerable degree of paracetamol toxicity especially at the upper end of standard analgesic doses.
Epidemiology, Outcomes research, Osteoarthritis Introduction Paracetamol is the most widely used over-the-counter and prescription analgesic worldwide.
The analgesic benefit of paracetamol has recently been called into question in the management of one chronic painful condition, osteoarthritis OA. We therefore conducted a systematic review of studies investigating the association between paracetamol and major adverse events AEs in the general adult population to provide a clinically informative toxicity profile.
The full search strategy was limited to only identify observational studies and can be found in the online supplementary material.
All relevant references were checked for additional citations. Randomised controlled trial RCT -level evidence was not considered a meaningful way of capturing AE data because of the short-term follow-up of RCT trial participants as well as strict eligibility for trial entry, meaning that the general population would not be represented.
If cohort-level evidence was found for an AE outcome, case—control evidence was not considered. Studies were eligible for inclusion if they met the predefined protocol: Outcomes The main outcomes investigated were all-cause mortality, cardiovascular AEs specifically incidence of myocardial infarction, cerebrovascular accidents and hypertensiongastrointestinal GI AEs specifically incidence of GI bleeding and renal AEs specifically reductions in estimated glomerular filtration rate eGFRincreases in serum creatinine concentration and the need for renal replacement therapy.
We first screened titles and abstracts, and one reviewer SB screened relevant full-text articles. Each outcome is given a quality rating of high, moderate, low or very low based upon risk of bias, inconsistency, indirectness and imprecision. Risk of bias for each outcome was assessed using checklists for observational studies, which are based on the Strengthening the Reporting of Observational Studies in Epidemiology statement.
In instances where data were unable to be pooled, due to difference in outcome or paracetamol dosage reporting, individual adjusted summary statistics were presented for each outcome per study. Results The search process identified records.
Eight studies met the inclusion criteria, all of which were cohort studies. As all prespecified outcomes were found from these eight cohort studies, no case—control evidence was considered.
The quality of evidence varied between outcomes and was graded as low or very low across all outcomes. Due to the non-comparable nature of outcomes and different paracetamol dosage definitions reported by individual studies, meta-analysis was only possible for a singular outcome; the incidence of hypertension.
For all other outcomes, individual adjusted summary statistics are presented by AE category.The aim of this study was to conduct a systematic review of observational studies to evaluate the economic impact of preventable ADRs. Areas covered: Published observational research investigating the cost of preventable ADRs in Western.
Literature Review: a “critical analysis of a segment of a published body of knowledge through summary, classification, and comparison of prior research studies, reviews of literature, and theoretical articles” (do not confuse this with an annotated bibliography).
Mar 02, · SL provided management support to research fellow staff and contributed to the writing of this article. MC contributed to the study design, analysed data and edited the manuscript. PM conducted the search for the systematic review and complied the references for the manuscript.
Department of Statistics, Unit of Biostatistics and Epidemiology, University of Milano–Bicocca, Milan, Italy JC, AP, LS, MS, and SPG oversaw the design of the study and helped to draft the manuscript.
All coauthors participated in the writing of the manuscript and approved the . Systematic review methodology can be applied to any type of literature – epidemiological, randomised trials, observational studies, diagnostic tests, etc – the principals are the same although the search.
Meta-analysis of Observational Studies in Epidemiology A Proposal for Reporting David Moher, MSc Betsy J. Becker, PhD Theresa Ann Sipe, PhD Stephen B. Thacker, MD, MSc for the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) Group B ECAUSE OF PRESSURE FOR TIMELY Evidence We conducted a systematic review of the published.