Sertraline updated on 07-01-2025

Nervous 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
R14840		 Bérard (Controls exposed to non-Sertraline SSRI), 2015 Nervous system malformations 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.35 [0.50;3.61] C
excluded (control group) 		5/366   20/1,963 25 366
ref
S6705
R18924		 Bérard (Controls unexposed, sick), 2015 Nervous 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) 1.67 [0.68;4.13] 5/366   117/14,868 122 366
ref
S5888
R14770		 Ban (Controls unexposed, disease free), 2014 Nervous system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.79 [0.42;7.54] -/757   465/325,294 - 757
ref
S6018
R15580		 Jimenez-Solem (Controls unexposed, NOS), 2012 Malformations of the nervous system 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.85 [0.12;6.07] 1/817   -/843,797 - 817
ref
S7178
R20165		 Colvin, 2011 Nervous system defects 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.08 [0.35;3.38] -/908   289/94,561 - 908
ref
S6244
R16519		 Malm, 2011 Central nervous system 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.35 [0.50;3.64] -/869   -/628,607 - 869
ref
Total 5 studies 1.39 [0.83;2.32] 122 3,717
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 1.67[0.68; 4.13]12236633%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Ban (Controls unexposed, disease free), 2014Ban, 2014 2 1.79[0.42; 7.54]-75713%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Jimenez-Solem (Controls unexposed, NOS), 2012Jimenez-Solem, 2012 3 0.85[0.12; 6.07]-8177%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Colvin, 2011Colvin, 2011 1.08[0.35; 3.38]-90821%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 1.35[0.50; 3.64]-86927%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (5 studies) I2 = 0% 1.39[0.83; 2.32]1223,7170.25.01.0ROB: 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, NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.39[0.83; 2.32]1223,7170%NABérard (Controls unexposed, sick), 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 5 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.27[0.68; 2.38]-3,3510%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 4 unexposed, sickunexposed, sick 1.67[0.68; 4.12]122366 -NABérard (Controls unexposed, sick), 2015 1 Tags Adjustment   - No  - No 1.08[0.35; 3.36]-908 -NAColvin, 2011 1   - Yes  - Yes 1.48[0.83; 2.64]1222,8090%NABérard (Controls unexposed, sick), 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Malm, 2011 4 Monotherapy   - no or not specified  - no or not specified 1.35[0.50; 3.64]-869 -NAMalm, 2011 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.67[0.68; 4.12]122366 -NABérard (Controls unexposed, sick), 2015 1   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.22[0.54; 2.74]-2,4820%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 3 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 1.67[0.68; 4.12]122366 -NABérard (Controls unexposed, sick), 2015 1 All studiesAll studies 1.39[0.83; 2.32]1223,7170%NABérard (Controls unexposed, sick), 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 50.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.42.71.2010.000Bérard (Controls unexposed, sick), 2015Ban (Controls unexposed, disease free), 2014Jimenez-Solem (Controls unexposed, NOS), 2012Colvin, 2011Malm, 2011

Asymetry test p-value = 0.4063 (by Egger's regression)

slope=0.7476 (0.4501); intercept=-0.7374 (0.7652); t=0.9637; p=0.4063

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 5398

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.27[0.68; 2.38]7363,3510%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 4 unexposed, sick controlsunexposed, sick controls 1.67[0.68; 4.12]122366 -NABérard (Controls unexposed, sick), 2015 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.35[0.50; 3.61]25366 -NABérard (Controls exposed to non-Sertraline SSRI), 2015 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Shen (Nervous system malformations)Shen (Nervous system malformations) 1.43[0.88; 2.32]0%-U,GPunexposed (general population or NOS)T11st trimesterstudies TTT5 metaPregmetaPreg 1.39[0.83; 2.32]0%3,717----Bérard (Controls unexposed, sick), 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 50.510.01.0