Del Mar, Chris B

Gillies, Malcolm

Glasziou, Paul P

Hoffmann, Tammy C

McGuire, Treasure M

Ranakusuma, Anggi

Thorning, Sarah

English

Gillies, M

Ranakusuma, A

Thorning, S

Hoffmann, T

McGuire, T

Glasziou, P

Del Mar, C

University of Queensland eSpace

Quantifying common adverse effects of a drug used for any indication from RCTs: the example of amoxicillin

Bond University Research Portal

Bond UniversityResearch RepositoryQuantifying common adverse effects of a drug used for any indication from RCTs: theexample of amoxicillinGillies, Malcolm; Ranakusuma, Anggi; Thorning, Sarah; Hoffmann, Tammy C; McGuire,Treasure M; Glasziou, Paul P; Del Mar, Chris BPublished: 22/06/2016Document Version:Peer reviewed versionLicence:Free to readLink to publication in Bond University research repository.Recommended citation(APA):Gillies, M., Ranakusuma, A., Thorning, S., Hoffmann, T. C., McGuire, T. M., Glasziou, P. P., & Del Mar, C. B.(2016). Quantifying common adverse effects of a drug used for any indication from RCTs: the example ofamoxicillin. Evidence Live Conference, Oxford, United Kingdom.General rightsCopyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright ownersand it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.For more information, or if you believe that this document breaches copyright, please contact the Bond University research repositorycoordinator.Download date: 18 Jun 2021Quantifying common adverseeffects of a drug used for anyindication from RCTs: the exampleof amoxicillinChris Del MarCentre for Research in Evidence-Based PracticeBond University, Australiacdelmar@bond.edu.auMalcolm GilliesAnggi RanakusumaSarah ThorningTammy HoffmannTreasure McGuirePaul GlasziouChris Del Mar• antibiotic resistance crisis• primary care focus• need to reduce antibiotics for common ARIsapart from resistance, antibiotic… …minimal benefit …have common harms-- but poorly quantifiedamoxicillin +/- clavulinatewhy we did the reviewantibiotic resistance• tonnage antibiotics ¾ in primary care• opportunity for shared decision making• need common harms dataminimalbenefitcommonharmshow AEs are usually measured• secondary outcomes of RCTsBUT rarer events,so underpoweredBUTconfounders…• observational studies– post-marketing surveillance– national AEs voluntary reporting– other observational studiesdealing with confoundingtreatment outcomeconfoundertreatment outcomeinterventioncontrolrandomisationtreating theindication as aconfounderwhat we didPICOP – any patients for any indicationI – amoxicillin / co-amoxiclavC – placeboO – any adverse events (AEs)searchwhat we did• RCT for any indication• MEDLINE; Embase; Cochrane CENTRAL• placebosearch• we discarded all but 45(27 of amoxicillin and 17co-amoxiclav)• 1 trial had both in a 3-arm trialrisk of bias…what we foundlow?under-reporting…butonly 25/45 trials harms datawas reporting better with time?amoxicillinAE = diarrhoeaamoxi-clavamoxicillinAE = thrushamoxi-clav“…diaper-areadermatitis…”AE = nausea; vomitingamoxi-clavamoxicillinamoxicillinnauseavomitingAE = rashamoxi-clavamoxicillinamoxicillinamoxi-clavamoxicillinsearchconclusions 1• RCTs poorly report AEs• evidence of common AEs for amoxicillin (+/- clavulanate)• co-amoxiclav diarrhoea ~ NNT =10, [95%CI 6-17]• Amoxicillin + co-amoxiclav candida NNT = 27 [95%CI 24-42]• if poor reporting, then gross under-estimateGillies M, Ranakusuma A, Hoffmann T, Thorning S, McGuire T, Glasziou P, Del MarC. Common harms from amoxicillin: a systematic review and meta-analysis ofrandomized placebo-controlled trials for any indication. Can Med Assoc J. 2014searchconclusions 2• this method of quantifying AEs depends onproper reporting in RCTs• AEs reporting in RCTs must be improved• data used in Decision Aids• we are currently reviewing a new set ofantibiotics (macrolides and cephalosporins)Gillies M, Ranakusuma A, Hoffmann T, Thorning S, McGuire T, Glasziou P, Del MarC. Common harms from amoxicillin: a systematic review and meta-analysis ofrandomized placebo-controlled trials for any indication. Can Med Assoc J. 2014

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Quantifying common adverse effects of a drug used for any indication from RCTs: the example of amoxicillin

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