Tricyclic antidepressants updated on 07-01-2025

Eye, ear, face and neck malformations

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
R40980		 Bérard (Controls unexposed, sick), 2017 Eye, ear, face and neck 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) 2.45 [1.05;5.72] -/382   -/14,847 - 382
ref
S10943
R40770		 Vasilakis-Scaramozza (Controls exposed to SSRIs), 2013 Ear, eye, face, and neck anomalies 1st trimester retrospective cohort exposed to other treatment, sick excluded Adjustment: No Monotherapy: TCA only 1.14 [0.16;8.07] C
excluded (control group) 		2/1,608   2/1,825 4 1,608
ref
S10944
R40778		 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Ear, eye, face, and neck anomalies 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Matched Monotherapy: TCA only 0.70 [0.20;3.10] 2/1,608   12/6,617 14 1,608
ref
Total 2 studies 1.48 [0.44;4.93] 14 1,990
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 2.45[1.05; 5.72]-38260%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Vasilakis-Scaramozza (Controls unexposed, NOS), 2013Vasilakis-Scaramozza, 2013 2 0.70[0.20; 3.10]141,60840%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: moderateROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 57% 1.48[0.44; 4.93]141,9900.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

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

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.48[0.44; 4.93]141,99057%NABérard (Controls unexposed, sick), 2017 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.70[0.18; 2.76]141,608 -NAVasilakis-Scaramozza (Controls unexposed, NOS), 2013 1 unexposed, sickunexposed, sick 2.45[1.05; 5.72]-382 -NABérard (Controls unexposed, sick), 2017 1 Tags Adjustment   - Yes  - Yes 1.48[0.44; 4.93]141,99057%NABérard (Controls unexposed, sick), 2017 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 2 MatchedMatched 0.70[0.18; 2.76]141,608 -NAVasilakis-Scaramozza (Controls unexposed, NOS), 2013 1 Monotherapy   - TCA only  - TCA only 1.48[0.44; 4.93]141,99057%NABérard (Controls unexposed, sick), 2017 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 2 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 2.45[1.05; 5.72]-382 -NABérard (Controls unexposed, sick), 2017 1 All studiesAll studies 1.48[0.44; 4.93]141,99057%NABérard (Controls unexposed, sick), 2017 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 20.25.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

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

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 10943

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.70[0.18; 2.76]141,608 -NAVasilakis-Scaramozza (Controls unexposed, NOS), 2013 1 unexposed, sick controlsunexposed, sick controls 2.45[1.05; 5.72]-382 -NABérard (Controls unexposed, sick), 2017 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.14[0.16; 8.07]41,608 -NAVasilakis-Scaramozza (Controls exposed to SSRIs), 2013 10.510.01.0