Le 2022.
Study characteristics | ||
Methods | 6 week cross‐over trial of oxytocin versus placebo | |
Participants | Inclusion criteria:
Exclusion criteria:
Location/setting: China Sample size: 41 (21 oxytocin, 20 placebo) Number of withdrawals/dropouts: none were lost to follow‐up in the first phase of the cross‐over trial Gender: male (38), female (3) Mean age: 5.0 years across both groups IQ: not reported Baseline ABC‐I or other BoC scores: not an outcome Concurrent medications: details not provided History of previous medications: details not provided |
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Interventions | Intervention (oxytocin) followed by placebo: oxytocin nasal spray 24 IU every 2nd day for 6 weeks, followed by a 2‐week wash‐out period before starting the 2nd phase of the cross‐over trial Comparator (placebo) followed by oxytocin: equivalent placebo (24 IU) every 2nd day for 6 weeks, followed by a 2‐week wash‐out period before starting the 2nd phase of the cross‐over trial |
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Outcomes | Primary outcomes: AEs Secondary outcomes: not reported Timing of outcome assessments: unclear |
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Notes | Source of funding: University of Electronic Science and Technology of China, UESTC high‐level research fostering project Conflicts of interest: "The authors have no conflicts of interest to declare" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 1:1 computer‐generated randomisation |
Allocation concealment (selection bias) | Unclear risk | Intranasal spay bottles for oxytocin or placebo were identical in appearance and labelling with each having a unique code. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Intranasal spray bottles were labelled and distributed to carers by an individual not involved in any other aspect of the trial who was responsible for finally unmasking the treatment details at the end of the trial. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Intranasal spray bottles were labelled and distributed to carers by an individual not involved in any other aspect of the trial who was responsible for finally unmasking the treatment details at the end of the trial. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 of 21 LTFU in oxytocin group and 1 in 22 in placebo group |
Selective reporting (reporting bias) | Unclear risk | There were no serious AEs in either group but the only other AE that was reported was urination frequency. |
Other bias | Low risk | No differences in age, gender, baseline scores of autism subtype |