Safarinejad 2007.

Study characteristics
Methods	Study design: randomized controlled, parallel‐group trial Setting/country: single institute, Tehran, Iran Dates study conducted: March 2003 to April 2005
Participants	Inclusion criteria: Married men with PE defined as IELT < 2 minutes that occurred in > 90% of sexual intercourse. None of the participants had received other treatment for PE for ≥ 4 weeks before the start of the study No other sexual disorders In a stable relationship with their wives for previous ≥ 6 months and possible sexual intercourse ≥ 1 per week Did not use condoms or topical anesthetics. They were also instructed not to pause during intercourse or to have interrupted intromission No obvious organic cause of PE, possible sexual intercourse ≥ 1 per week, and initiation of the participant to seek medical help for what they considered PE. Exclusion criteria: ED according to IIEF Reduced sexual desire Inhibited male orgasm Chronic psychiatric or physical illness Alcohol or substance abuse Use of medication such as psychotropic medication Organic cause of PE including anatomical abnormalities, genital infection and neurologic disorder; organic illness causing limitation in SSRI use Serious relationship problems Total number of participants randomized: 276 Total length of study: 12 weeks Group 1 (escitalopram): Number of participants randomized: 138 Age (mean): 33.5 (range 21–44) years Baseline IELT: NR Number of participants with primary PE: 87/128 (70%) Group 2 (placebo): Number of participants randomized: 138 Age (mean): 33.3 (range 19–46) years Baseline IELT: NR Number of participants with primary PE: 88/126 (69.8%)
Interventions	Group 1: escitalopram 10 mg daily Group 2: placebo daily
Outcomes	Primary outcomes: IELT How measured: using a stopwatch Time points measured: every 2 weeks Secondary outcomes: Sexual satisfaction How measured: 0–5 scale proposed by Kim and Paick Time points measured: every 2 weeks Safety outcomes: Adverse effects How measured: reported by participants Time points measured: every 2 weeks
Funding sources	None
Declarations of interest	NR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "a randomization table generated by the method of random permuted block. Patient randomization numbers were allocated to each site in ascending sequence in blocks."
Allocation concealment (selection bias)	Low risk	Quote: "Assignment to treatment group was performed using an interactive voice response system."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Likely appropriate blinding. Quote: "Group 2 received a similar regimen of placebo. Placebo and escitalopram tablets were identical in appearance, allowing for blinding of treatment assignment." Randomization was done by an individual separate from the single investigator who assessed each participant.
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Likely appropriate blinding. Quote: "Group 2 received a similar regimen of placebo. Placebo and escitalopram tablets were identical in appearance, allowing for blinding of treatment assignment."
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes	Low risk	Single investigator who was likely blinded interviewed participants at each visit.
Blinding of outcome assessment (detection bias) IELT	Low risk	Objective measurement that was unlikely to be influenced by blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	10/138 in the escitalopram arm and 12/138 in the placebo arm excluded.
Selective reporting (reporting bias)	Unclear risk	No protocol available.
Other bias	Low risk	No additional sources of bias identified.