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Journal of Clinical Pharmacy and... Oct 2016Metamizole was withdrawn from the market in the United States and several European countries following reports of fatal agranulocytosis among users, but is still... (Review)
Review
WHAT IS KNOWN AND OBJECTIVE
Metamizole was withdrawn from the market in the United States and several European countries following reports of fatal agranulocytosis among users, but is still available in many countries in Europe, South America and Asia. Over the past several decades, a number of epidemiologic studies have been conducted to quantify the risk of agranulocytosis and other adverse effects associated with metamizole and other non-narcotic analgesics. The objective of this study was to perform a systematic review of the safety of metamizole.
METHODS
Epidemiologic studies published between 1 January 1980 and 15 December 2014 were identified through systematic searches of PubMed and Google Scholar; the reference sections of selected articles were also reviewed to identify potentially relevant studies. Studies included in this review focused on the safety of metamizole, that is on outcomes such as haematologic abnormalities, gastrointestinal bleeding, anaphylaxis and hepatotoxicity. Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to prespecified criteria.
RESULTS AND DISCUSSION
A total of 22 articles met the criteria for evaluation. The majority of studies that evaluated agranulocytosis indicated an increased risk associated with metamizole, with relative risk (RR) estimates ranging from 1·5 (95% CI, 0·8-2·7) to 40·2 (95% CI, 14·7-113·3). Findings of three case-control studies do not suggest an association between metamizole and aplastic anaemia. Of the five case-control studies that evaluated the risk of upper gastrointestinal bleeding, four found a statistically significant increased risk associated with metamizole (RR estimates ranging from 1·4 to 2·7). There is insufficient evidence to determine whether metamizole increases the risk of other outcomes (e.g. hepatic effects, anaphylaxis, congenital anomalies). Few studies evaluated the effects of dose, route of administration or duration of therapy.
WHAT IS NEW AND CONCLUSION
Published studies reported differences in the magnitude of risk of adverse outcomes associated with metamizole use and often had small sample sizes and a number of other limitations that may have biased the results. Further research is needed to better quantify the potential risks associated with metamizole compared to other non-narcotic analgesics.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Dipyrone; Epidemiologic Studies; Europe; Humans; Safety; United States
PubMed: 27422768
DOI: 10.1111/jcpt.12422 -
BMJ Open Feb 2020This review provides insights into the potential for aspirin to preserve bone mineral density (BMD) and reduce fracture risk, building knowledge of the risk-benefit... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
This review provides insights into the potential for aspirin to preserve bone mineral density (BMD) and reduce fracture risk, building knowledge of the risk-benefit profile of aspirin.
METHODS
We conducted a systematic review and exploratory meta-analysis of observational studies. Electronic searches of MEDLINE and Embase, and a manual search of bibliographies was undertaken for studies published to 28 March 2018. Studies were included if: participants were men or women aged ≥18 years; the exposure of interest was aspirin; and relative risks, ORs and 95% CIs for the risk of fracture or difference (percentage or absolute) in BMD (measured by dual energy X-ray absorptiometry) between aspirin users and non-users were presented. Risk of bias was assessed using the Joanna Briggs Institute Critical Appraisal Checklists for observational studies. Pooled ORs for any fracture and standardised mean differences (SMDs) for BMD outcomes were calculated using random-effects models.
RESULTS
Twelve studies met the inclusion criteria and were included in the meta-analysis. Aspirin use was associated with a 17% lower odds for any fracture (OR 0.83, 95% CI 0.70 to 0.99; I=71%; six studies; n=511 390). Aspirin was associated with a higher total hip BMD for women (SMD 0.03, 95% CI -0.02 to 0.07; I=0%; three studies; n=9686) and men (SMD 0.06, 95% CI -0.02 to 0.13, I=0%; two studies; n=4137) although these associations were not significant. Similar results were observed for lumbar spine BMD in women (SMD 0.03, 95% CI -0.03 to 0.09; I=34%; four studies; n=11 330) and men (SMD 0.08; 95% CI -0.01 to 0.18; one study; n=432).
CONCLUSIONS
While the benefits of reduced fracture risk and higher BMD from aspirin use may be modest for individuals, if confirmed in prospective controlled trials, they may confer a large population benefit given the common use of aspirin in older people.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Bone Density; Bone Density Conservation Agents; Fractures, Bone; Humans; Risk Assessment
PubMed: 32086348
DOI: 10.1136/bmjopen-2018-026876 -
International Journal of Environmental... Feb 2022Paracetamol is the most commonly used antipyretic and analgesic in pregnancy. It is also increasingly used off-label in the neonatal intensive care unit. Despite the... (Review)
Review
INTRODUCTION
Paracetamol is the most commonly used antipyretic and analgesic in pregnancy. It is also increasingly used off-label in the neonatal intensive care unit. Despite the frequent use of paracetamol, concerns have been raised regarding the high variability in neonatal dosing regimens and the long-term safety of early life exposure.
OBJECTIVE
To investigate the available evidence on the long-term safety of prenatal and neonatal paracetamol exposure.
METHODS
We conducted a systematic search of the electronic databases Ovid Medline, Ovid Embase and Web of Science from inception to August 2021 for original research studies of any design that described the use of paracetamol in the prenatal or neonatal (within the first four weeks of life) periods and examined the occurrence of neurodevelopmental, atopic or reproductive adverse outcomes at or beyond birth.
RESULTS
We identified 1313 unique articles and included 30 studies in the final review. Of all studies, 27 (90%), two (7%) and one (3%) were on the long-term safety of prenatal, neonatal and both prenatal and neonatal exposure, respectively. Thirteen (46%), 11 (39%) and four (15%) studies examined neurodevelopmental, atopic and reproductive outcomes. Eleven (100%), 11 (100%), and three (27%) studies on prenatal exposure reported adverse neurodevelopmental, atopic and reproductive outcomes. Only one study found a possible correlation between neonatal paracetamol exposure and long-term adverse outcomes.
CONCLUSIONS
The available evidence, although limited, suggests a possible association between prenatal paracetamol exposure and an increased risk of neurodevelopmental, atopic and reproductive adverse outcomes. There is an immediate need for robust data on the long-term safety of paracetamol exposure in the prenatal and neonatal periods.
Topics: Acetaminophen; Female; Humans; Infant, Newborn; Intensive Care Units, Neonatal; Pregnancy; Vitamins
PubMed: 35206317
DOI: 10.3390/ijerph19042128 -
The Cochrane Database of Systematic... Jul 2014The original authors of this review are unable to update it. The Cochrane Pain, Palliative and Supportive Care Review Group (PaPaS) is seeking new authors to update and... (Meta-Analysis)
Meta-Analysis Review
The original authors of this review are unable to update it. The Cochrane Pain, Palliative and Supportive Care Review Group (PaPaS) is seeking new authors to update and split the review into two separate reviews on migraine and tension‐type headache. If you are interested, please contact the Managing Editor of PaPaS (contact details provided under 'Contact Person'). At July 2014, this review has been withdrawn. This review is out of date although it is correct as of the date of publication. The latest version is available in the ‘Other versions’ tab on The Cochrane Library, and may still be useful to readers. The editorial group responsible for this previously published document have withdrawn it from publication.
Topics: Acute Disease; Adult; Analgesics, Non-Narcotic; Dipyrone; Headache Disorders, Primary; Humans; Randomized Controlled Trials as Topic
PubMed: 25019294
DOI: 10.1002/14651858.CD004842.pub3 -
Heart (British Cardiac Society) Jul 2015There is limited evidence to support decision making on antiplatelet therapy following transcatheter aortic valve implantation (TAVI). Our aim was to assess the efficacy... (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
There is limited evidence to support decision making on antiplatelet therapy following transcatheter aortic valve implantation (TAVI). Our aim was to assess the efficacy and safety of aspirin-only (ASA) versus dual antiplatelet therapy (DAPT) following TAVI.
METHODS
We performed a systematic review and pooled analysis of individual patient data from 672 participants comparing single versus DAPT following TAVI. Primary endpoint was defined as the composite of net adverse clinical and cerebral events (NACE) at 1 month, including all-cause mortality, acute coronary syndrome (ACS), stroke, life-threatening and major bleeding.
RESULTS
At 30 days a NACE rate of 13% was observed in the ASA-only and in 15% of the DAPT group (OR 0.83, 95% CI 0.48 to 1.43, p=0.50). A tendency towards less life-threatening and major bleeding was observed in patients treated with ASA (OR 0.56, 95% CI 0.28 to 1.11, p=0.09). Also, ASA was not associated with an increased all-cause mortality (OR 0.91, 95% CI 0.36 to 2.27, p=0.83), ACS (OR 0.5, 95% CI 0.05 to 5.51, p=0.57) or stroke (OR 1.21; 95% CI 0.36 to 4.03, p=0.75).
CONCLUSIONS
No difference in 30-day NACE rate was observed between ASA-only or DAPT following TAVI. Moreover, a trend towards less life-threatening and major bleeding was observed in favour of ASA. Consequently the additive value of clopidogrel warrants further investigation.
Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Aortic Valve Stenosis; Aspirin; Cardiac Catheterization; Clopidogrel; Drug Therapy, Combination; Female; Heart Valve Prosthesis Implantation; Hemorrhage; Humans; Male; Odds Ratio; Platelet Aggregation Inhibitors; Risk Assessment; Risk Factors; Stroke; Ticlopidine; Time Factors; Treatment Outcome
PubMed: 25948421
DOI: 10.1136/heartjnl-2014-307053 -
Prevention of pre-eclampsia by low-molecular-weight heparin in addition to aspirin: a meta-analysis.Ultrasound in Obstetrics & Gynecology :... May 2016To estimate the impact of adding low-molecular-weight heparin (LMWH) or unfractionated heparin to low-dose aspirin started ≤ 16 weeks' gestation on the prevalence of... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To estimate the impact of adding low-molecular-weight heparin (LMWH) or unfractionated heparin to low-dose aspirin started ≤ 16 weeks' gestation on the prevalence of pre-eclampsia (PE) and the delivery of a small-for-gestational-age (SGA) neonate.
METHODS
A systematic review and meta-analysis of randomized controlled trials (RCTs) was performed by searching the medical databases PubMed, EMBASE, Web of Science and Cochrane Central. Pregnant women randomized to receive LMWH or unfractionated heparin in addition to low-dose aspirin were compared with those who received low-dose aspirin alone. Outcome measures were PE, severe PE, early-onset PE and SGA. Pooled relative risks (RRs) with 95% CI were calculated using a random-effects model.
RESULTS
Eight RCTs met the inclusion criteria; the indication for recruitment was previous recurrent miscarriage in five studies (three included women with thrombophilia) and a history of severe or early-onset PE in three studies (including women with thrombophilia in one). LMWH was administered in seven studies and unfractionated heparin in one. In women with a history of PE, treatment with LMWH and aspirin, compared with aspirin alone, was associated with a significant reduction in development of PE (three trials (n = 379); RR, 0.54 (95% CI, 0.31-0.92); P = 0.03) and in delivery of SGA neonates (two trials (n = 363); RR, 0.54 (95% CI, 0.32-0.91); P = 0.02). These outcomes were not significantly reduced in women with recurrent miscarriage who received LMWH and aspirin, compared with aspirin alone. The small number of studies precluded sensitivity analyses and the evaluation of publication biases. Blinding to the allocation treatment was absent in all RCTs.
CONCLUSIONS
Based on limited evidence, the addition of LMWH to low-dose aspirin could reduce the prevalence of PE and SGA in women with a history of PE. This observation should be the basis of a well-conducted future trial rather than a recommendation for immediate clinical application. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.
Topics: Aspirin; Drug Therapy, Combination; Female; Heparin, Low-Molecular-Weight; Humans; Pre-Eclampsia; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 26481090
DOI: 10.1002/uog.15789 -
Journal of Dentistry Oct 2022Dental pain is a commonly managed presentation in medicine and dentistry, where oxycodone is often prescribed. The aim of this systematic review and meta-analysis was to... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Dental pain is a commonly managed presentation in medicine and dentistry, where oxycodone is often prescribed. The aim of this systematic review and meta-analysis was to determine and quantify the effectiveness of oxycodone for acute dental pain.
DATA
Randomised controlled trials, controlled trials and comparative studies were included involving patients >12 years, where oxycodone was trialled for dental pain.
SOURCES
Three databases were searched: Medline Ovid, Embase Ovid and Web of Science. Two authors independently screened title and abstracts for relevance, extracted data and performed bias assessments.
STUDY SELECTION
Of 148 potentially relevant studies, 13 articles met the inclusion criteria for the systematic review and of the 13, nine studies were included in the meta-analysis. All studies were single-dose analgesia for surgical third molar extractions.
CONCLUSIONS
Oxycodone produced more effective analgesia in combination with paracetamol. In the meta-analysis, monotherapy etoricoxib and rofecoxib showed significant pain relief compared to combination oxycodone/paracetamol (SPID6 mean difference=-2.13, CI=-3.29, -0.98; TOTPAR6 mean difference=-2.98, CI=-4.90, -1.06). Non-steroidal anti-inflammatory drugs (NSAIDs) were more effective than oxycodone/paracetamol combinations, however, the evidence would become weak in a future study with a similar patient setting due to substantial statistical heterogeneity (SPID6 and TOTPAR6 prediction interval -4.471, 0.207 and -7.28, 1.32 respectively).
CLINICAL SIGNIFICANCE
Non-steroidal anti-inflammatory drugs were superior than oxycodone/paracetamol combinations, although some patient populations may experience similar effects to the combined oxycodone/paracetamol combination.
Topics: Acetaminophen; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Etoricoxib; Humans; Oxycodone; Pain, Postoperative
PubMed: 35977697
DOI: 10.1016/j.jdent.2022.104254 -
Brazilian Journal of Medical and... Nov 2015Cocos nucifera (L.) (Arecaceae) is commonly called the "coconut tree" and is the most naturally widespread fruit plant on Earth. Throughout history, humans have used... (Review)
Review
Cocos nucifera (L.) (Arecaceae) is commonly called the "coconut tree" and is the most naturally widespread fruit plant on Earth. Throughout history, humans have used medicinal plants therapeutically, and minerals, plants, and animals have traditionally been the main sources of drugs. The constituents of C. nucifera have some biological effects, such as antihelminthic, anti-inflammatory, antinociceptive, antioxidant, antifungal, antimicrobial, and antitumor activities. Our objective in the present study was to review the phytochemical profile, pharmacological activities, and toxicology of C. nucifera to guide future preclinical and clinical studies using this plant. This systematic review consisted of searches performed using scientific databases such as Scopus, Science Direct, PubMed, SciVerse, and Scientific Electronic Library Online. Some uses of the plant were partially confirmed by previous studies demonstrating analgesic, antiarthritic, antibacterial, antipyretic, antihelminthic, antidiarrheal, and hypoglycemic activities. In addition, other properties such as antihypertensive, anti-inflammatory, antimicrobial, antioxidant, cardioprotective, antiseizure, cytotoxicity, hepatoprotective, vasodilation, nephroprotective, and anti-osteoporosis effects were also reported. Because each part of C. nucifera has different constituents, the pharmacological effects of the plant vary according to the part of the plant evaluated.
Topics: Analgesics; Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Anticonvulsants; Antihypertensive Agents; Bone and Bones; Cocos; Humans; Hypoglycemic Agents; Phytotherapy; Plant Extracts; Protective Agents
PubMed: 26292222
DOI: 10.1590/1414-431X20154773 -
European Journal of Medical Research Jul 2023Recent studies have shown that aspirin consumption may reduce the risk of hepatocellular carcinoma (HCC), but their correlation is still not fully understood. This... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Recent studies have shown that aspirin consumption may reduce the risk of hepatocellular carcinoma (HCC), but their correlation is still not fully understood. This meta-analysis aimed to investigate the correlation between aspirin consumption and HCC.
METHODS
A systematic literature search was conducted on PubMed, Scopus, Cochrane Library, EMBASE, and Web of Science databases. The search period was from the establishment of the database to July 1, 2022 with no language restrictions.
RESULTS
A total of 19 studies including three prospective studies and 16 retrospective ones with 2,217,712 patients were included. Compared with those who did not take aspirin, those who took aspirin had a 30% lower risk of HCC (hazard ratio [HR] = 0.70, 95% confidence interval [CI] 0.63-0.76, I = 84.7%, P < 0.001). Subgroup analysis showed that aspirin significantly reduced the risk of HCC by 19% in Asia (HR = 0.81, 95% CI 0.80-0.82, I = 85.2%, P < 0.001) and by 33% (HR = 0.67, 95% CI 0.61-0.73, I = 43.6%, P = 0.150) in Europe and the U.S with no significant difference. Moreover, in patients with HBV or HCV infection, aspirin reduced 19% and 24% of the risk of HCC, respectively. However, aspirin administration might increase risks of gastrointestinal bleeding in patients with chronic liver disease (HR = 1.14, 95% CI 0.99-1.31, I = 0.0%, P = 0.712). Sensitivity analysis showed no significant difference of results after excluding individual studies, suggesting that the results were robust.
CONCLUSION
Aspirin may reduce the risk of HCC in both healthy population and patients with chronic liver disease. However, attention should be paid to adverse events such as gastrointestinal bleeding in patients with chronic liver disease.
Topics: Humans; Carcinoma, Hepatocellular; Aspirin; Liver Neoplasms; Prospective Studies; Retrospective Studies; Gastrointestinal Hemorrhage
PubMed: 37422691
DOI: 10.1186/s40001-023-01204-5 -
Chinese Medical Journal Apr 2023Many nutritional supplements and pharmacological agents have been reported to show preventive effects on colorectal adenoma and colorectal cancer (CRC). We performed a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Many nutritional supplements and pharmacological agents have been reported to show preventive effects on colorectal adenoma and colorectal cancer (CRC). We performed a network meta-analysis to summarize such evidence and assess the efficacy and safety of these agents.
METHODS
We searched PubMed, Embase, and the Cochrane Library for studies published in English until October 31, 2021 that fit our inclusion criteria. We performed a systematic review and network meta-analysis to assess the comparative efficacy and safety of candidate agents (low-dose aspirin [Asp], high-dose Asp, cyclooxygenase-2 inhibitors [coxibs], calcium, vitamin D, folic acid, ursodeoxycholic acid [UDCA], estrogen, and progesterone, alone or in combination) for preventing colorectal adenoma and CRC. Cochrane risk-of-bias assessment tool was employed to evaluate the quality of each included study.
RESULTS
Thirty-two randomized controlled trials (278,694 participants) comparing 13 different interventions were included. Coxibs significantly reduced the risk of colorectal adenoma (risk ratio [RR]: 0.59, 95% confidence interval [CI]: 0.44-0.79, six trials involving 5486 participants), advanced adenoma (RR: 0.63, 95% CI: 0.43-0.92, four trials involving 4723 participants), and metachronous adenoma (RR: 0.58, 95% CI: 0.43-0.79, five trials involving 5258 participants) compared with placebo. Coxibs also significantly increased the risk of severe adverse events (RR: 1.29, 95% CI: 1.13-1.47, six trials involving 7109 participants). Other interventions, including Asp, folic acid, UDCA, vitamin D, and calcium, did not reduce the risk of colorectal adenoma in the general and high-risk populations compared with placebo.
CONCLUSIONS
Considering the balance between benefits and harms, regular use of coxibs for prevention of colorectal adenoma was not supported by the current evidence. Benefit of low-dose Asp for chemoprevention of colorectal adenoma still requires further evidence.
REGISTRATION
PROSPERO, No. CRD42022296376.
Topics: Humans; Cyclooxygenase 2 Inhibitors; Calcium; Network Meta-Analysis; Vitamins; Colorectal Neoplasms; Chemoprevention; Aspirin; Adenoma; Vitamin D
PubMed: 37027286
DOI: 10.1097/CM9.0000000000002514