Paroxetine 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.
S7434
R21893		 Bérard, 2017 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) 0.96 [0.54;1.71] -/1,132   -/14,847 - 1,132
ref
S7350
R21502		 Wemakor, 2015 Digestive system anomalies 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.25 [0.54;2.90] 7/34   2,732/19,788 2,739 34
ref
S5886
R14753		 Ban (Controls unexposed, disease free), 2014 Digestive system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.43 [0.03;6.93] C 0/1,200   313/325,294 313 1,200
ref
S6017
R15554		 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, ...) 2.09 [0.52;8.39]
excluded (control group) 		2/568   1,545/843,797 1,547 568
ref
S6022
R15622		 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) 2.84 [0.26;31.45] C 2/568   1/806 3 568
ref
S7180
R20244		 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, ...) 0.31 [0.04;2.20] -/572   534/94,561 - 572
ref
S6243
R16511		 Malm, 2011 Digestive system 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.67 [0.17;2.69] -/968   -/628,607 - 968
ref
S7228
R20763		 Davis, 2007 Other congenital anomalies of digestive system 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 2.11 [0.30;14.82] 1/182   138/49,654 139 182
ref
Total 7 studies 0.99 [0.65;1.51] 3,194 4,656
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, 2017Bérard, 2017 0.96[0.54; 1.71]-1,13252%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Wemakor, 2015Wemakor, 2015 1.25[0.54; 2.90]2,7393425%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, disease free), 2014Ban, 2014 1 0.43[0.03; 6.93]3131,2002%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Jimenez-Solem (Controls unexposed, sick), 2012Jimenez-Solem, 2012 2 2.84[0.26; 31.45]35683%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Colvin, 2011Colvin, 2011 0.31[0.04; 2.20]-5724%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 0.67[0.17; 2.69]-9689%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Davis, 2007Davis, 2007 2.11[0.30; 14.82]1391825%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (7 studies) I2 = 0% 0.99[0.65; 1.51]3,1944,6560.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

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

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.92[0.57; 1.49]4554,6220%NABérard, 2017 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 Davis, 2007 6 case control studiescase control studies 1.25[0.54; 2.90]2,73934 -NAWemakor, 2015 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.96[0.52; 1.79]3,1912,9560%NAWemakor, 2015 Ban (Controls unexposed, disease free), 2014 Colvin, 2011 Malm, 2011 Davis, 2007 5 unexposed, sickunexposed, sick 1.02[0.58; 1.78]31,7000%NABérard, 2017 Jimenez-Solem (Controls unexposed, sick), 2012 2 Tags Adjustment   - No  - No 0.97[0.32; 2.94]4552,5220%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Davis, 2007 4   - Yes  - Yes 1.00[0.64; 1.56]2,7392,1340%NABérard, 2017 Wemakor, 2015 Malm, 2011 3 Monotherapy   - no or not specified  - no or not specified 0.98[0.32; 3.03]1391,1500%NAMalm, 2011 Davis, 2007 2   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.04[0.65; 1.68]2,7391,1660%NABérard, 2017 Wemakor, 2015 2   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.67[0.17; 2.64]3162,3403%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) 1.02[0.58; 1.78]31,7000%NABérard, 2017 Jimenez-Solem (Controls unexposed, sick), 2012 2 All studiesAll studies 0.99[0.65; 1.51]3,1944,6560%NABérard, 2017 Wemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 Davis, 2007 70.110.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.33.31.6990.000Bérard, 2017Wemakor, 2015Ban (Controls unexposed, disease free), 2014Jimenez-Solem (Controls unexposed, sick), 2012Colvin, 2011Malm, 2011Davis, 2007

Asymetry test p-value = 0.8381 (by Egger's regression)

slope=0.0566 (0.3454); intercept=-0.1322 (0.6144); t=0.2152; p=0.8381

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 6017

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.10[0.62; 1.93]5,2633,5240%NAWemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 Davis, 2007 6 unexposed, sick controlsunexposed, sick controls 1.02[0.58; 1.78]31,7000%NABérard, 2017 Jimenez-Solem (Controls unexposed, sick), 2012 20.510.01.0