Sertraline updated on 07-01-2025

Digestive system anomalies

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.
S5398
R14856		 Bérard (Controls exposed to non-Sertraline SSRI), 2015 Digestive system malformations 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.17 [0.44;3.09] C
excluded (control group) 		5/366   23/1,963 28 366
ref
S6705
R18928		 Bérard (Controls unexposed, sick), 2015 Digestive system malformations 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 1.13 [0.46;2.77] 5/366   176/14,868 181 366
ref
S7352
R21554		 Wemakor, 2015 Digestive system anomalies 1st trimester case control unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.45 [0.06;3.39] C 1/15   2,738/19,807 2,739 15
ref
S5888
R14772		 Ban (Controls unexposed, disease free), 2014 Digestive system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 2.69 [0.67;10.76] -/757   313/325,294 - 757
ref
S6018
R15576		 Jimenez-Solem (Controls unexposed, NOS), 2012 Congenital malformations of the digestive system 1st trimester population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.43 [0.36;5.74]
excluded (control group) 		2/817   1,545/843,797 1,547 817
ref
S6023
R15630		 Jimenez-Solem (Controls unexposed, sick), 2012 Congenital malformations of the digestive system 1st trimester population based cohort retrospective unexposed, sick Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 1.98 [0.18;21.83] C 2/817   1/806 3 817
ref
S7178
R20170		 Colvin, 2011 Gastrointestinal defects (ICD 749–751) 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.97 [0.40;2.36] 5/908   534/94,561 539 908
ref
S6244
R16524		 Malm, 2011 Digestive system 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.09 [0.35;3.41] -/869   -/628,607 - 869
ref
Total 6 studies 1.16 [0.71;1.88] 3,462 3,732
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 Bérard (Controls unexposed, sick), 2015Bérard, 2015 1 1.13[0.46; 2.77]18136629%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Wemakor, 2015Wemakor, 2015 0.45[0.06; 3.39]2,739156%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, disease free), 2014Ban, 2014 2 2.69[0.67; 10.76]-75712%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Jimenez-Solem (Controls unexposed, sick), 2012Jimenez-Solem, 2012 3 1.98[0.18; 21.83]38174%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Colvin, 2011Colvin, 2011 0.97[0.40; 2.36]53990830%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 1.09[0.35; 3.41]-86918%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (6 studies) I2 = 0% 1.16[0.71; 1.88]3,4623,7320.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick; 2: Controls unexposed, disease free; 3: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.23[0.74; 2.03]7233,7170%NABérard (Controls unexposed, sick), 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 5 case control studiescase control studies 0.45[0.06; 3.39]2,73915 -NAWemakor, 2015 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.13[0.62; 2.06]3,2782,5490%NAWemakor, 2015 Ban (Controls unexposed, disease free), 2014 Colvin, 2011 Malm, 2011 4 unexposed, sickunexposed, sick 1.21[0.52; 2.81]1841,1830%NABérard (Controls unexposed, sick), 2015 Jimenez-Solem (Controls unexposed, sick), 2012 2 Tags Adjustment   - No  - No 0.93[0.43; 2.02]3,2811,7400%NAWemakor, 2015 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 3   - Yes  - Yes 1.34[0.71; 2.50]1811,9920%NABérard (Controls unexposed, sick), 2015 Ban (Controls unexposed, disease free), 2014 Malm, 2011 3 Monotherapy   - no or not specified  - no or not specified 1.09[0.35; 3.40]-869 -NAMalm, 2011 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 0.97[0.43; 2.21]2,9203810%NABérard (Controls unexposed, sick), 2015 Wemakor, 2015 2   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.35[0.66; 2.76]5422,4820%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 3 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 1.21[0.52; 2.81]1841,1830%NABérard (Controls unexposed, sick), 2015 Jimenez-Solem (Controls unexposed, sick), 2012 2 All studiesAll studies 1.16[0.71; 1.88]3,4623,7320%NABérard (Controls unexposed, sick), 2015 Wemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 60.210.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.93.01.4710.000Bérard (Controls unexposed, sick), 2015Wemakor, 2015Ban (Controls unexposed, disease free), 2014Jimenez-Solem (Controls unexposed, sick), 2012Colvin, 2011Malm, 2011

Asymetry test p-value = 0.8142 (by Egger's regression)

slope=0.0023 (0.6053); intercept=0.2496 (0.9946); t=0.2509; p=0.8142

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 6018, 5398

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.17[0.68; 2.03]5,1293,3660%NAWemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 5 unexposed, sick controlsunexposed, sick controls 1.21[0.52; 2.81]1841,1830%NABérard (Controls unexposed, sick), 2015 Jimenez-Solem (Controls unexposed, sick), 2012 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.17[0.44; 3.09]28366 -NABérard (Controls exposed to non-Sertraline SSRI), 2015 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Shen (Digestive system malformations)Shen (Digestive system malformations) 1.23[0.76; 1.98]0%-U,GPunexposed (general population or NOS)T11st trimesterstudies TTT5 metaPregmetaPreg 1.16[0.71; 1.88]0%3,732----Bérard (Controls unexposed, sick), 2015 Wemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 60.510.01.0