Lansoprazole updated on 08-08-2023

All congenital malformations (majors, minors, majors and minors, or unspecified)

R analysis
id Study   Lib. in paper Exposition period    Study type  Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S18812
R80052
Broe (Controls unexposed, general pop), 2025 Major congenital malformations (exclusion of chromosomal abnormalities (ICD-10 codes Q90– Q99)) 1st trimester population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: Yes 1.33 [1.14;1.57]
excluded (control group)
172/3,534   17,235/478,736 17,407 3,534
ref
S18816
R80053
Broe (Controls unexposed, sick), 2025 Major congenital malformations (exclusion of chromosomal abnormalities (ICD-10 codes Q90– Q99)) 1st trimester population based cohort retrospective unexposed, sick Adjustment: Yes 1.29 [1.05;1.59] 172/3,534   280/7,148 452 3,534
ref
S18828
R80164
Hongoh, 2025 Major malformations 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: Yes 0.51 [0.07;3.79] 1/96   31/1,669 32 96
ref
S14456
R57402
Choi a, 2023 Major congenital malformations 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes 1.01 [0.89;1.15] 233/6,404   85,900/2,655,676 86,133 6,404
ref
S4448
R13175
Matok, 2012 Major malformations (according to CDC definitions) 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 0.83 [0.48;1.46] 13/233   6,753/110,550 6,766 233
ref
S4410
R13176
Pasternak, 2010 Major birth defects (Exposure during First Trimester) 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.13 [0.77;1.67] 28/794   21,867/837,317 21,895 794
ref
S4429
R28447
Diav-Citrin, 2005 Major anomalies 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No 1.21 [0.28;5.23] C 2/44   30/792 32 44
ref
Total 6 studies 1.08 [0.96;1.21] 115,310 11,105
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Broe (Controls unexposed, sick), 2025Broe, 2025 1 1.29[1.05; 1.59]4523,53427%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Hongoh, 2025Hongoh, 2025 0.51[0.07; 3.79]32960%ROB confusion: seriousROB selection: criticalROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: critical Choi a, 2023Choi a, 2023 1.01[0.89; 1.15]86,1336,40459%ROB confusion: moderateROB selection: lowROB classification: moderateROB missing: unclearROB mesure: NAROB reporting: NA Matok, 2012Matok, 2012 0.83[0.48; 1.46]6,7662334%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Pasternak, 2010Pasternak, 2010 1.13[0.77; 1.67]21,8957949%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Diav-Citrin, 2005Diav-Citrin, 2005 1.21[0.28; 5.23]32441%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (6 studies) I2 = 6% 1.08[0.96; 1.21]115,31011,1050.25.01.0ROB: A: confounding, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.08[0.96; 1.21]115,31011,1056%NABroe (Controls unexposed, sick), 2025 Hongoh, 2025 Choi a, 2023 Matok, 2012 Pasternak, 2010 Diav-Citrin, 2005 6 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.01[0.75; 1.38]28,7251,1670%NAHongoh, 2025 Matok, 2012 Pasternak, 2010 Diav-Citrin, 2005 4 unexposed, sickunexposed, sick 1.13[0.89; 1.43]86,5859,93874%NABroe (Controls unexposed, sick), 2025 Choi a, 2023 2 Tags Adjustment   - No  - No 1.21[0.28; 5.23]3244 -NADiav-Citrin, 2005 1   - Yes  - Yes 1.09[0.94; 1.26]115,27811,06125%NABroe (Controls unexposed, sick), 2025 Hongoh, 2025 Choi a, 2023 Matok, 2012 Pasternak, 2010 5 All studiesAll studies 1.08[0.96; 1.21]115,31011,1056%NABroe (Controls unexposed, sick), 2025 Hongoh, 2025 Choi a, 2023 Matok, 2012 Pasternak, 2010 Diav-Citrin, 2005 60.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.42.51.2220.000Broe (Controls unexposed, sick), 2025Hongoh, 2025Choi a, 2023Matok, 2012Pasternak, 2010Diav-Citrin, 2005

Asymetry test p-value = 0.8404 (by Egger's regression)

slope=0.0855 (0.0930); intercept=-0.1557 (0.7247); t=0.2148; p=0.8404

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 18812

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.25[1.09; 1.45]46,1324,7010%NABroe (Controls unexposed, general pop), 2025 Hongoh, 2025 Matok, 2012 Pasternak, 2010 Diav-Citrin, 2005 5 unexposed, sick controlsunexposed, sick controls 1.13[0.89; 1.43]86,5859,93874%NABroe (Controls unexposed, sick), 2025 Choi a, 2023 20.510.01.0