2010
Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: A randomized trial
Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O’Malley S. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: A randomized trial. Drug And Alcohol Dependence 2010, 111: 200-206. PMID: 20542391, PMCID: PMC3771701, DOI: 10.1016/j.drugalcdep.2010.04.015.Peer-Reviewed Original ResearchConceptsWeight gainSmoking cessationPoint prevalence smoking abstinence ratePre-specified primary outcomesLow-dose naltrexoneOpen-label therapySmoking abstinence ratesPoint prevalence abstinenceReduced weight gainNaltrexone augmentationPlacebo groupNicotine replacementPrimary outcomeQuit dateAbstinence ratesLabel therapyNicotine patchBehavioral counselingNaltrexoneAbstinent participantsSmokersWeight concernsWeeksCessationLower rates
2005
Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia
Woods SW, Gueorguieva RV, Baker CB, Makuch RW. Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia. JAMA Psychiatry 2005, 62: 961-970. PMID: 16143728, DOI: 10.1001/archpsyc.62.9.961.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAntipsychotic AgentsBrief Psychiatric Rating ScaleDouble-Blind MethodDrug Administration ScheduleFemaleHumansMalePlacebosPsychotic DisordersRandomized Controlled Trials as TopicResearch DesignSchizophreniaSchizophrenic PsychologySelection BiasSeverity of Illness IndexSex FactorsTreatment OutcomeConceptsBrief Psychiatric Rating ScalePlacebo-controlled trialPsychiatric Rating ScalePlacebo-controlled studyAtypical antipsychotic medicationsDose-controlled studyMedication trialsAntipsychotic medicationRating ScaleDouble-blind clinical trialNew atypical antipsychotic medicationsDose-controlled trialsTreatment completion ratesPlacebo control groupEnd point changePercentage of menDrug Administration databaseRandom effects analysisIll adultsMedication armClinical trialsNew medicationsNovel medicationsSame drugAverage age
2000
Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial
Silverstein F, Faich G, Goldstein J, Simon L, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal N, Stenson W, Burr A, Zhao W, Kent J, Lefkowith J, Verburg K, Geis G. Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial. JAMA 2000, 284: 1247-1255. PMID: 10979111, DOI: 10.1001/jama.284.10.1247.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalysis of VarianceAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidAspirinCelecoxibCyclooxygenase 1Cyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDiclofenacDouble-Blind MethodFemaleGastrointestinal DiseasesHumansIbuprofenIsoenzymesMaleMembrane ProteinsMiddle AgedOsteoarthritisPeptic UlcerProportional Hazards ModelsProspective StudiesProstaglandin-Endoperoxide SynthasesPyrazolesSulfonamidesConceptsNonsteroidal anti-inflammatory drugsConventional nonsteroidal anti-inflammatory drugsCelecoxib Long-term Arthritis Safety StudyCOX-2-specific inhibitorsUlcer complicationsSymptomatic ulcersAnti-inflammatory drugsRheumatoid arthritisIncidence rateAspirin useLower incidenceChronic GI blood lossToxic effectsAdverse effectsCelecoxib-treated patientsUpper GI toxicityUpper GI ulcersGI blood lossInhibition of cyclooxygenaseGI intoleranceCardiovascular eventsGastrointestinal toxicityGI toxicityImportant toxic effectsStudy drugUpper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo.
Bensen W, Zhao S, Burke T, Zabinski R, Makuch R, Maurath C, Agrawal N, Geis G. Upper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo. The Journal Of Rheumatology 2000, 27: 1876-83. PMID: 10955327.Peer-Reviewed Original ResearchMeSH KeywordsAbdominal PainAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidCelecoxibCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDigestive SystemDouble-Blind MethodDyspepsiaFemaleHumansIsoenzymesMaleMembrane ProteinsMiddle AgedNaproxenNauseaOsteoarthritisProspective StudiesProstaglandin-Endoperoxide SynthasesPyrazolesRisk FactorsSulfonamidesTime FactorsTreatment OutcomeConceptsUpper gastrointestinal tolerabilityUpper GI symptomsSevere abdominal painComposite endpointAbdominal painGastrointestinal tolerabilityGI symptomsIndependent predictorsRheumatoid arthritisRelative riskCOX-2-specific inhibitorsUpper GI tolerabilityTreatment group patientsDose-response relationshipGI tolerabilityPlacebo patientsGroup patientsCumulative incidenceParallel groupClinical trialsPlaceboPatientsCelecoxibTolerabilityEndpoint
1990
A multicenter clinical trial of oral ribavirin in HIV-infected people with lymphadenopathy
Roberts R, Hollinger F, Parks W, Rasheed S, Laurence J, Heseltine P, Makuch R, Lubina J, Johnson K, Group R. A multicenter clinical trial of oral ribavirin in HIV-infected people with lymphadenopathy. AIDS 1990, 4: 67-72. PMID: 1690551, DOI: 10.1097/00002030-199001000-00009.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdolescentAdultAIDS-Related ComplexDouble-Blind MethodFemaleGene Products, gagHIVHIV AntigensHIV Core Protein p24HIV InfectionsHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRibavirinRibonucleosidesRNA-Directed DNA PolymeraseUnited StatesViral Core ProteinsConceptsOral ribavirinPeripheral blood mononuclear cellsPlacebo-controlled trialBlood mononuclear cellsMulticenter clinical trialHIV isolationP24 antigenemiaStudy drugMulticenter trialActive treatmentDaily dosesMononuclear cellsClinical trialsMedical CenterWeek 6HIV activityAdult menRibavirinTrialsLymphadenopathyHIVInterlaboratory variationCritical roleAntigenemiaPlaceboA multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group.
Roberts R, Dickinson G, Heseltine P, Leedom J, Mansell P, Rodriguez S, Johnson K, Lubina J, Makuch R. A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group. JAIDS Journal Of Acquired Immune Deficiency Syndromes 1990, 3: 884-92. PMID: 1974628.Peer-Reviewed Original ResearchMeSH KeywordsAcquired Immunodeficiency SyndromeAdministration, OralAdolescentAdultCD4 AntigensCD4-Positive T-LymphocytesDose-Response Relationship, DrugDouble-Blind MethodEvaluation Studies as TopicHumansImmunoblastic LymphadenopathyLeukocyte CountMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRibavirinRibonucleosidesConceptsOral ribavirinActive treatmentBaseline CD4 cell countMajor protocol violationsCD4 cell countPlacebo-controlled trialMulticenter clinical trialSignificant differencesPlacebo patientsPlacebo groupPlacebo treatmentStudy entryTreat analysisWashout periodDaily dosesClinical trialsKaposi's sarcomaProtocol violationsMedical CenterTreatment superiorityTreatment groupsPlaceboRibavirinPatientsOverall significant difference