Tricyclic antidepressants updated on 07-01-2025

Genital 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.
S11052
R40984		 Bérard (Controls unexposed, sick), 2017 Genital organs malformations 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes Monotherapy: TCA only Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 1.12 [0.46;2.72] -/382   -/14,847 - 382
ref
S10937
R40705		 Ban (Controls exposed to SSRIs), 2014 Genital system malformations 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: TCA only 1.15 [0.51;2.59] C
excluded (control group) 		8/2,428   22/7,683 30 2,428
ref
S10938
R40721		 Ban (Controls unexposed, disease free), 2014 Genital system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free excluded Adjustment: Yes Monotherapy: TCA only 0.81 [0.41;1.63]
excluded (control group) 		8/2,428   1,292/325,294 1,300 2,428
ref
S10939
R40743		 Ban (Controls unexposed, sick), 2014 Genital system malformations 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes Monotherapy: TCA only Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 0.62 [0.29;1.30] 8/2,428   67/13,432 75 2,428
ref
S10943
R40772		 Vasilakis-Scaramozza (Controls exposed to SSRIs), 2013 Genital anomalies 1st trimester retrospective cohort exposed to other treatment, sick excluded Adjustment: No Monotherapy: TCA only 0.76 [0.31;1.85] C
excluded (control group) 		8/1,608   12/1,825 20 1,608
ref
S10944
R40780		 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Genital anomalies 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Matched Monotherapy: TCA only 0.50 [0.20;1.10] 8/1,608   60/6,617 68 1,608
ref
S10930
R40607		 Davis, 2007 Congenital anomalies of genital organs 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 0.77 [0.25;2.38] 3/167   1,165/49,669 1,168 167
ref
Total 4 studies 0.70 [0.45;1.08] 1,311 4,585
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), 2017Bérard, 2017 1 1.12[0.46; 2.72]-38224%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, sick), 2014Ban, 2014 2 0.62[0.29; 1.30]752,42834%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Vasilakis-Scaramozza (Controls unexposed, NOS), 2013Vasilakis-Scaramozza, 2013 3 0.50[0.20; 1.10]681,60826%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: moderateROB mesure: moderateROB reporting: moderate Davis, 2007Davis, 2007 0.77[0.25; 2.38]1,16816715%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (4 studies) I2 = 0% 0.70[0.45; 1.08]1,3114,5850.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick; 2: Controls unexposed, sick; 3: Controls unexposed, NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.70[0.45; 1.08]1,3114,5850%NABérard (Controls unexposed, sick), 2017 Ban (Controls unexposed, sick), 2014 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Davis, 2007 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.59[0.30; 1.15]1,2361,7750%NAVasilakis-Scaramozza (Controls unexposed, NOS), 2013 Davis, 2007 2 unexposed, sickunexposed, sick 0.79[0.45; 1.41]752,8100%NABérard (Controls unexposed, sick), 2017 Ban (Controls unexposed, sick), 2014 2 Tags Adjustment   - No  - No 0.77[0.25; 2.38]1,168167 -NADavis, 2007 1   - Yes  - Yes 0.69[0.43; 1.11]1434,4180%NABérard (Controls unexposed, sick), 2017 Ban (Controls unexposed, sick), 2014 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 3 MatchedMatched 0.50[0.21; 1.17]681,608 -NAVasilakis-Scaramozza (Controls unexposed, NOS), 2013 1 Monotherapy   - no or not specified  - no or not specified 0.77[0.25; 2.38]1,168167 -NADavis, 2007 1   - TCA only  - TCA only 0.69[0.43; 1.11]1434,4180%NABérard (Controls unexposed, sick), 2017 Ban (Controls unexposed, sick), 2014 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 3 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.79[0.45; 1.41]752,8100%NABérard (Controls unexposed, sick), 2017 Ban (Controls unexposed, sick), 2014 2 All studiesAll studies 0.70[0.45; 1.08]1,3114,5850%NABérard (Controls unexposed, sick), 2017 Ban (Controls unexposed, sick), 2014 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Davis, 2007 40.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.41.00.6900.000Bérard (Controls unexposed, sick), 2017Ban (Controls unexposed, sick), 2014Vasilakis-Scaramozza (Controls unexposed, NOS), 2013Davis, 2007

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

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 10943, 10937, 10938

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.69[0.42; 1.11]2,5364,2030%NABan (Controls unexposed, disease free), 2014 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Davis, 2007 3 unexposed, sick controlsunexposed, sick controls 0.79[0.45; 1.41]752,8100%NABérard (Controls unexposed, sick), 2017 Ban (Controls unexposed, sick), 2014 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.95[0.52; 1.74]504,0360%NABan (Controls exposed to SSRIs), 2014 Vasilakis-Scaramozza (Controls exposed to SSRIs), 2013 20.510.01.0