Scarpa 1997.
Methods | DESIGN Within‐patient Participant delivery ALLOCATION Random Method of randomisation: not reported; tubes labelled left or right and with participant ID number and tube ID number Concealment: unclear BLINDING Double‐blind (participant/investigator) WITHDRAWAL/DROPOUT Described | |
Participants | N: 157 Treatment duration: 6 wks; FU: 7 wks LF: 23 (14.6%) BC: yes Age: 49 (15SD; N = 134) Gender (per cent men): 65.6% (N = 157) Severity: TSS (0 to 12) = 7.7 INCLUSION CRITERIA
EXCLUSION CRITERIA
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Interventions |
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Outcomes |
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Notes | The trial did not report sponsorship, but Istituto Gentili SpA provided medications and appeared to have undertaken the randomisation. There was SD imputation (TSS). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | The trial reported insufficient details. |
Blinding (performance bias and detection bias) All outcomes | Low risk | The trial was double‐blind (participant/investigator). |
Randomisation method reported | Unclear risk | The trial did not report this. |
Loss to follow up | Low risk | 14.6% |
Baseline assessments | Low risk | ‐ |
Baseline comparability demonstrated | Low risk | ‐ |