Shang 2012.
Study characteristics | ||
Methods | Study design: randomized controlled, parallel‐group trial Setting/country: multi‐institution, China Dates study conducted: May 2011 to May 2012 |
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Participants | Inclusion criteria:
Exclusion criteria:
Number of participants randomized: 80 Group 1 (citalopram 20 mg daily):
Group 2 (placebo):
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Interventions | Group 1: paroxetine 20 mg daily orally Group 2: soda tablets as a placebo orally |
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Outcomes | Primary outcomes:
Safety outcomes:
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Funding sources | NR | |
Declarations of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Did not explicitly state whether investigators were blinded; participants appeared to be blinded. |
Blinding of outcome assessment (detection bias) Participant‐reported outcomes | Low risk | Participants appeared to be appropriately blinded. Quote: "In the control group, oral placebo medication is the same colour and size as treatment group containing starch complexes." |
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes | Unclear risk | Not explicitly described. |
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 | All participants included in analysis. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Low risk | No additional sources of bias identified. |