Foster 2010a.

Study characteristics
Methods	Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: USA
Participants	Pain condition: vulvodynia Population: women with vulvodynia Minimum pain intensity: ≥ 4 on 0‐10 VAS Inclusion criteria Aged 18‐50 3 continuous months of insertional (entryway) dyspareunia, pain, or both with tampon insertion Mean score ≥ 4 out of 10 on NRS of pain intensity Exclusion criteria Physical and mental health comorbidities Total participants randomised: 133 Age in years (mean): 30.4 Gender: 133/133 were female Pain duration in years (range): 4.4‐6.5
Interventions	Placebo n = 33 Inert Placebo tablet and cream to match intervention arms Matched dosing for antidepressant Placebo cream for lidocaine Lidocaine 5% cream n = 33 Topical local anaesthetic Participants also took placebo tablet to match antidepressant arm Desipramine 150 mg n = 33 TCA Fixed dose with forced titration Participants also used placebo cream to match lidocaine arm Desipramine 150 mg and lidocaine 5% cream n = 34 Combined intervention Fixed dose of antidepressant with forced titration
Outcomes	Pain intensity Mood Withdrawal
Missing data methods	ITT with LOCF
Funding source	Non‐pharamaceutical: supported by grant RO‐1 HD040123‐05 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
Conflicts of interest	The study authors did not report any potential CoIs.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised using permuted block randomisation scheme by means of a computer‐based random numbers generator.
Allocation concealment (selection bias)	Low risk	Drug assignments were determined by the Department of Biostatistics.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind, identical‐appearing pills and creams, matched dosing with active drug treatment for both tablets and creams
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias) All outcomes	High risk	ITT with LOCF. 4 x higher number of dropouts in desipramine+lidocaine arm than placebo Attrition Total: 21/133 (15.8%) Placebo: 2/33 (6.1%) Lidocaine 5%: 5/33 (15.2%) Desipramine 150 mg: 6/33 (18.2%) Desipramine 150 mg + lidocaine 5%: 6/34 (17.7%)
Selective reporting (reporting bias)	Low risk	All outcomes listed prospectively on clinicaltrials.gov
Other bias	Low risk	No other sources of bias were identified.