Sertraline updated on 07-01-2025

Respiratory 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
R14843
Bérard (Controls exposed to non-Sertraline SSRI), 2015 Respiratory system malformations 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.31 [0.02;5.46] C
excluded (control group)
0/366   8/1,963 8 366
ref
S6705
R18927
Bérard (Controls unexposed, sick), 2015 Respiratory system malformations 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 0.25 [0.02;4.01] C 0/366   81/14,868 81 366
ref
S7352
R21553
Wemakor, 2015 Respiratory system anomalies 1st trimester case control unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 2.49 [0.56;10.95] C 2/16   981/18,050 983 16
ref
S5888
R14775
Ban (Controls unexposed, disease free), 2014 Respiratory system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 4.04 [1.00;16.27] -/757   205/325,294 - 757
ref
S6018
R15584
Jimenez-Solem (Controls unexposed, NOS), 2012 Malformations of the respiratory 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, ...) 2.09 [0.52;8.38] 2/817   -/843,797 - 817
ref
S7178
R20169
Colvin, 2011 Respiratory 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, ...) 3.73 [1.18;11.82] -/908   84/94,561 - 908
ref
S6244
R16521
Malm, 2011 Respiratory tract 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.69 [0.10;4.93] -/869   -/628,607 - 869
ref
Total 6 studies 2.30 [1.22;4.35] 1,064 3,733
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 0.25[0.02; 4.01]813665%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Wemakor, 2015Wemakor, 2015 2.49[0.56; 10.95]9831617%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, disease free), 2014Ban, 2014 2 4.04[1.00; 16.27]-75720%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: lowROB mesure: criticalROB reporting: moderate Jimenez-Solem (Controls unexposed, NOS), 2012Jimenez-Solem, 2012 3 2.09[0.52; 8.38]-81720%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Colvin, 2011Colvin, 2011 3.73[1.18; 11.82]-90828%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 0.69[0.10; 4.93]-86910%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (6 studies) I2 = 5% 2.30[1.22; 4.35]1,0643,7330.210.01.0ROB: 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, NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 2.13[0.95; 4.74]813,71724%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 2.49[0.56; 10.95]98316 -NAWemakor, 2015 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.62[1.39; 4.92]9833,3670%NAWemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 5 unexposed, sickunexposed, sick 0.25[0.02; 4.01]81366 -NABérard (Controls unexposed, sick), 2015 1 Tags Adjustment   - No  - No 2.15[0.67; 6.92]1,0641,29036%NABérard (Controls unexposed, sick), 2015 Wemakor, 2015 Colvin, 2011 3   - Yes  - Yes 2.15[0.87; 5.30]-2,4434%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Malm, 2011 3 Monotherapy   - no or not specified  - no or not specified 0.69[0.10; 4.84]-869 -NAMalm, 2011 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.07[0.12; 9.44]1,06438251%NABérard (Controls unexposed, sick), 2015 Wemakor, 2015 2   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 3.23[1.53; 6.82]-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) 0.25[0.02; 4.01]81366 -NABérard (Controls unexposed, sick), 2015 1 All studiesAll studies 2.30[1.22; 4.35]1,0643,7335%NABérard (Controls unexposed, sick), 2015 Wemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 60.110.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.34.21.7030.000Bérard (Controls unexposed, sick), 2015Wemakor, 2015Ban (Controls unexposed, disease free), 2014Jimenez-Solem (Controls unexposed, NOS), 2012Colvin, 2011Malm, 2011

Asymetry test p-value = 0.0059 (by Egger's regression)

slope=3.4994 (0.5113); intercept=-3.5542 (0.6637); t=5.3549; p=0.0059

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) 2.62[1.39; 4.92]1,2543,3670%NAWemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 5 unexposed, sick controlsunexposed, sick controls Out of scale0.25[0.02; 4.01]81366 -NABérard (Controls unexposed, sick), 2015 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls Out of scale0.31[0.02; 5.46]8366 -NABérard (Controls exposed to non-Sertraline SSRI), 2015 10.510.01.0