2017
Continued midazolam versus diphenhydramine in difficult-to-sedate patients: a randomized double-blind trial
Sachar H, Pichetshote N, Nandigam K, Vaidya K, Laine L. Continued midazolam versus diphenhydramine in difficult-to-sedate patients: a randomized double-blind trial. Gastrointestinal Endoscopy 2017, 87: 1297-1303. PMID: 28159539, PMCID: PMC5537051, DOI: 10.1016/j.gie.2017.01.028.Peer-Reviewed Original ResearchConceptsDouble-blind trialAdequate sedationStudy medicationModerate sedationAlertness/Sedation scoreAdequacy of sedationStudy medication dosePsychiatric medication useModified Observer's AssessmentMOAA/SAdditional medicationElective colonoscopyPrimary endpointOpioid combinationsOpioid useMedication useMore patientsSedation scoreSuch patientsMedication doseUsual dosesBenzodiazepine useCurrent guidelinesSedate patientsSedation
2011
Double-Blind Randomized Trials of Single-Tablet Ibuprofen/High-Dose Famotidine vs. Ibuprofen Alone for Reduction of Gastric and Duodenal Ulcers
Laine L, Kivitz AJ, Bello AE, Grahn AY, Schiff MH, Taha AS. Double-Blind Randomized Trials of Single-Tablet Ibuprofen/High-Dose Famotidine vs. Ibuprofen Alone for Reduction of Gastric and Duodenal Ulcers. The American Journal Of Gastroenterology 2011, 107: ajg2011443. PMID: 22186979, PMCID: PMC3321505, DOI: 10.1038/ajg.2011.443.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsChi-Square DistributionDouble-Blind MethodDrug CombinationsDuodenal UlcerEndoscopy, GastrointestinalFamotidineFemaleHumansIbuprofenMaleMiddle AgedProportional Hazards ModelsRisk FactorsStomach UlcerTreatment OutcomeConceptsPrimary end point analysisNon-steroidal anti-inflammatory drugsUpper GI ulcersDuodenal ulcerGI ulcersGastric ulcerEnd-point analysisDaily non-steroidal anti-inflammatory drugsH. pylori stool testDouble-blind randomized trialsMultiple potential risk factorsReduction of gastricSingle-tablet combinationUpper gastrointestinal ulcersDouble-blind trialProportional hazards analysisPotential risk factorsAnti-inflammatory drugsBaseline endoscopyREDUCE studyStudy endoscopyTablets thriceUlcer complicationsStool testRandomized trials
2010
Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate‐to‐severe erosive oesophagitis – the results of two double‐blind studies
Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate‐to‐severe erosive oesophagitis – the results of two double‐blind studies. Alimentary Pharmacology & Therapeutics 2010, 33: 203-212. PMID: 21114792, DOI: 10.1111/j.1365-2036.2010.04516.x.Peer-Reviewed Original ResearchConceptsHeartburn resolutionErosive oesophagitisExtended releaseLA grade CSevere erosive oesophagitisDouble-blind trialDouble-blind studyPossibility of benefitCurrent PPIsD oesophagitisSevere oesophagitisGERD patientsSecondary endpointsPrimary endpointSymptomatic resolutionAcid suppressionSubgroup analysisDrug exposureClinical trialsOesophagitisGrade DGrade CFurther evaluationEsomeprazoleAcid inhibition
2009
How Common Is Diclofenac-Associated Liver Injury? Analysis of 17,289 Arthritis Patients in a Long-Term Prospective Clinical Trial
Laine L, Goldkind L, Curtis SP, Connors LG, Yanqiong Z, Cannon CP. How Common Is Diclofenac-Associated Liver Injury? Analysis of 17,289 Arthritis Patients in a Long-Term Prospective Clinical Trial. The American Journal Of Gastroenterology 2009, 104: ajg2008149. PMID: 19174782, DOI: 10.1038/ajg.2008.149.Peer-Reviewed Original ResearchConceptsLiver-related hospitalizationsNon-steroidal anti-inflammatory drugsMonths of therapyAminotransferase elevationLiver eventsClinical trialsLong-term prospective clinical trialsLarge double-blind trialDeath/transplantHepatotoxicity of diclofenacTransplant/deathDouble-blind trialPrescribed non-steroidal anti-inflammatory drugsProspective clinical trialsAdverse hepatic effectsALT/ASTRates of laboratoryAnti-inflammatory drugsProspective trialArthritis patientsLiver injuryRheumatoid arthritisClinical eventsHepatic diseaseCausality assessment
2008
Lower Gastrointestinal Events in a Double-Blind Trial of the Cyclo-Oxygenase-2 Selective Inhibitor Etoricoxib and the Traditional Nonsteroidal Anti-Inflammatory Drug Diclofenac
Laine L, Curtis SP, Langman M, Jensen DM, Cryer B, Kaur A, Cannon CP. Lower Gastrointestinal Events in a Double-Blind Trial of the Cyclo-Oxygenase-2 Selective Inhibitor Etoricoxib and the Traditional Nonsteroidal Anti-Inflammatory Drug Diclofenac. Gastroenterology 2008, 135: 1517-1525. PMID: 18823986, DOI: 10.1053/j.gastro.2008.07.067.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnti-Inflammatory Agents, Non-SteroidalConfidence IntervalsCyclooxygenase InhibitorsDiclofenacDose-Response Relationship, DrugEtoricoxibFemaleFollow-Up StudiesGastrointestinal HemorrhageHumansIncidenceMaleMiddle AgedOdds RatioOsteoarthritisProspective StudiesPyridinesRisk FactorsSulfonesTreatment OutcomeConceptsLower GI eventsClinical eventsGI eventsRisk factorsCOX-2 selective inhibitorsBlinded adjudication committeeLower Gastrointestinal EventsTraditional NSAID diclofenacUpper GI eventsDouble-blind trialSignificant risk factorsMajor risk factorAnti-inflammatory drugsSelective inhibitorNonsteroidal anti-inflammatory drug diclofenacGastrointestinal eventsNSAID useProspective trialMultivariable analysisRheumatoid arthritisAdjudication committeeMean durationCyclo-oxygenaseNSAID diclofenacAbstractText
2006
Clinical trial design and patient demographics of the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Study Program: Cardiovascular outcomes with etoricoxib versus diclofenac in patients with osteoarthritis and rheumatoid arthritis
Cannon CP, Curtis SP, Bolognese JA, Laine L, Committee F. Clinical trial design and patient demographics of the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Study Program: Cardiovascular outcomes with etoricoxib versus diclofenac in patients with osteoarthritis and rheumatoid arthritis. American Heart Journal 2006, 152: 237-245. PMID: 16875903, DOI: 10.1016/j.ahj.2006.05.024.Peer-Reviewed Original ResearchMeSH KeywordsAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidAspirinCyclooxygenase InhibitorsDiclofenacDouble-Blind MethodEtoricoxibFemaleHumansMaleMiddle AgedMulticenter Studies as TopicOsteoarthritisPatient SelectionPyridinesRandomized Controlled Trials as TopicResearch DesignRisk AssessmentSulfonesTreatment OutcomeConceptsNonsteroidal anti-inflammatory drugsAnnual event rateThrombotic cardiovascular eventsRheumatoid arthritisCardiovascular eventsEvent ratesHazard ratioTraditional nonsteroidal anti-inflammatory drugsCyclooxygenase-2 selective inhibitorCOX-2 selective inhibitorsTraditional NSAID diclofenacDouble-blind trialCardiovascular event ratesTreatment of patientsAnti-inflammatory drugsClinical trial designSelective inhibitorLong-term useMultinational EtoricoxibCardiovascular outcomesCardiovascular riskPatient demographicsNoninferiority criteriaControl armCOX-2
2005
Randomized, double-blind comparison of immediate-release omeprazole oral suspension versus intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients
Conrad SA, Gabrielli A, Margolis B, Quartin A, Hata JS, Frank WO, Bagin RG, Rock JA, Hepburn B, Laine L. Randomized, double-blind comparison of immediate-release omeprazole oral suspension versus intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients. Critical Care Medicine 2005, 33: 760-765. PMID: 15818102, DOI: 10.1097/01.ccm.0000157751.92249.32.Peer-Reviewed Original ResearchConceptsUpper gastrointestinal bleedingSignificant upper gastrointestinal bleedingGastrointestinal bleedingIll patientsIntravenous cimetidineOmeprazole suspensionMedian gastricChronic Health Evaluation (APACHE II) scoreTrial daysOral suspensionCimetidine treatment groupsDouble-blind trialPrimary end pointDouble-blind comparisonIntensive care unitAdditional risk factorsAcute PhysiologyProtocol populationCimetidine treatmentMedication dosesOrogastric tubeSignificant bleedingCare unitMechanical ventilationGastric aspirates
2004
Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: A double-blind trial
Laine L, Maller ES, Yu C, Quan H, Simon T. Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: A double-blind trial. Gastroenterology 2004, 127: 395-402. PMID: 15300570, DOI: 10.1053/j.gastro.2004.05.001.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnti-Inflammatory Agents, Non-SteroidalAspirinCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDouble-Blind MethodDrug Therapy, CombinationFemaleGastric MucosaHumansIbuprofenIncidenceIsoenzymesLactonesMaleMembrane ProteinsMiddle AgedOsteoarthritisProstaglandin-Endoperoxide SynthasesRisk FactorsStomach UlcerSulfonesTablets, Enteric-CoatedConceptsNonselective nonsteroidal anti-inflammatory drugsLow-dose aspirinCOX-2 selective inhibitorsDouble-blind trialUlcer incidenceNonselective NSAIDsLow-dose enteric-coated aspirinLow-dose aspirin usersCyclooxygenase-2 selective inhibitorSelective inhibitorNonsteroidal anti-inflammatory drugsEnteric-coated aspirinGastrointestinal mucosal injuryNumber of erosionsRisk of ulcerAnti-inflammatory drugsCOX-2 selective inhibitionYears of ageBaseline endoscopyAspirin usersDose aspirinErosive esophagitisCumulative incidenceMucosal injuryRepeat endoscopy
2000
Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials
Laine L, Fennerty M, Osato M, Sugg J, Suchower L, Probst P, Levine J. Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials. The American Journal Of Gastroenterology 2000, 95: ajg20001583. PMID: 11151867, DOI: 10.1111/j.1572-0241.2000.03349.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAmoxicillinClarithromycinDouble-Blind MethodDrug Administration ScheduleDrug Resistance, MicrobialDrug Therapy, CombinationDuodenal UlcerEsomeprazoleFemaleHelicobacter InfectionsHelicobacter pyloriHumansMaleMiddle AgedPenicillin ResistancePenicillinsProspective StudiesProtein Synthesis InhibitorsProton Pump InhibitorsConceptsEradication rateClarithromycin resistanceDaily esomeprazoleTriple therapyDuodenal ulcerProton pump inhibitor-based triple therapyTen-day triple therapyHelicobacter pylori eradication therapyEmergent resistanceH. pylori-positive patientsInhibitor-based triple therapyDouble-blind trialTreat eradication ratesCompletion of therapyPylori eradication therapyPylori-positive patientsSeparate randomized trialsAntibiotic resistanceDaily amoxicillinUS multicenterEradication therapyRandomized trialsHelicobacter pyloriTherapyEsomeprazoleEndoscopic biopsy requirements for post-treatment diagnosis of Helicobacter pylori
Laine L, Sugg J, Suchower L, Neil G. Endoscopic biopsy requirements for post-treatment diagnosis of Helicobacter pylori. Gastrointestinal Endoscopy 2000, 51: 664-669. PMID: 10840297, DOI: 10.1067/mge.2000.105776.Peer-Reviewed Original ResearchConceptsTriple therapyH pylori infectionBody biopsyAntral biopsiesHistologic examinationPylori infectionBiopsy testsDiagnostic yieldProton pump inhibitor-based triple therapyMulticenter double-blind trialInhibitor-based triple therapyDouble-blind trialPost-treatment sensitivityTriple therapy groupDual antibiotic therapyH pylori statusRapid urease testEndoscopic biopsy testsPost-treatment diagnosisHelicobacter pylori diagnosisPretreatment sensitivityEradication therapyUntreated patientsAntibiotic therapyDual therapyH. pylori antibiotic resistance, eradication, and emergent resistance in U.S. double-blind trials of esomeprazole, clarithromycin, and amoxicillin
Laine L, Fennerty M, Suchower L, Probst P, Osato M, Levine J. H. pylori antibiotic resistance, eradication, and emergent resistance in U.S. double-blind trials of esomeprazole, clarithromycin, and amoxicillin. Gastroenterology 2000, 118: a498. DOI: 10.1016/s0016-5085(00)84113-x.Peer-Reviewed Original Research
1998
Accuracy of CLOtest after Helicobacter pylori therapy
Laine L, Suchower L, Johnson E, Ronca P, Neil G. Accuracy of CLOtest after Helicobacter pylori therapy. Gastrointestinal Endoscopy 1998, 47: 250-253. PMID: 9540877, DOI: 10.1016/s0016-5107(98)70321-9.Peer-Reviewed Original ResearchConceptsHelicobacter pylori therapyPylori therapyOmeprazole/amoxicillinCompletion of therapyDouble-blind trialRapid urease testingMore effective therapiesEndoscopic biopsy testsOmeprazole therapyAdditional therapyMost patientsDual therapyUnsuccessful treatmentUrease testingEffective therapyPositive testPatientsH. pyloriTherapyCLOtestBiopsy testsDecreased numberWeeksNegative resultsAmoxicillin
1995
A randomized, double-blind comparison of placebo, etodolac, and naproxen on gastrointestinal injury and prostaglandin production
Laine L, Sloane R, Ferretti M, Cominelli F. A randomized, double-blind comparison of placebo, etodolac, and naproxen on gastrointestinal injury and prostaglandin production. Gastrointestinal Endoscopy 1995, 42: 428-433. PMID: 8566633, DOI: 10.1016/s0016-5107(95)70045-5.Peer-Reviewed Original ResearchConceptsProstaglandin productionWeek 1Gastrointestinal injuryGastric injuryHealthy volunteersDimension of ulcersMucosal prostaglandin productionDouble-blind trialDouble-blind comparisonWeeks of treatmentMean numberProstaglandin E2 productionAnti-ulcer drugsGastroduodenal injuryGastrointestinal symptomsUlcer complicationsPrior endoscopyStandard NSAIDsGastric erosionsGastric ulcerMucosal defectsUlcer scoreWeek 4E2 productionPlaceboInteraction of NSAIDs and Helicobacter pylori on gastrointestinal injury and prostaglandin production: a controlled double‐blind trial
LAINE L, COMINELLI F, SLOANE R, CASINI‐RAGGI V, MARIN‐SORENSEN M, WEINSTEIN WM. Interaction of NSAIDs and Helicobacter pylori on gastrointestinal injury and prostaglandin production: a controlled double‐blind trial. Alimentary Pharmacology & Therapeutics 1995, 9: 127-135. PMID: 7605852, DOI: 10.1111/j.1365-2036.1995.tb00361.x.Peer-Reviewed Original ResearchConceptsNonsteroidal anti-inflammatory drugsH. pylori infectionNSAID ingestionProstaglandin E2 productionHistological injuryWeek 1H. pyloriGastroduodenal injuryPylori infectionNegative subjectsE2 productionWeek 4Prostaglandin productionH. pylori-associated gastritisDouble-blind trialNormal baseline endoscopyAnti-inflammatory drugsBaseline endoscopyChemical gastritisGastroduodenal damagePlacebo b.Gastrointestinal injuryNSAID useGastric histologyNSAID group
1992
Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial.
Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, Squires K, Islam MZ. Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial. Annals Of Internal Medicine 1992, 117: 655-60. PMID: 1308663, DOI: 10.7326/0003-4819-117-8-655.Peer-Reviewed Original ResearchConceptsCandida esophagitisCounty hospital settingFluconazole-treated patientsDouble-blind trialResolution of symptomsOral antifungal agentsEnd of therapyEndoscopic responseRetrosternal painStudy medicationClinical cureEsophageal symptomsSymptomatic improvementTreat analysisImmunodeficiency syndromeEndoscopic cureAntifungal therapyEsophageal brushingsHospital settingPatientsSide effectsWeek 1U.S. CentersEsophagitisTherapy