Schnyder 1998.
Methods | Design: quasi‐randomised controlled trial Allocation method: alternation Blinding: not stated | |
Participants | Diagnosis: primary or secondary vaginismus Criteria: DSM‐III‐R Setting: outpatient clinic Number: 51 but data only on 44 available Age: 28 years, SD = 7.72 (range 19 to 55) Duration of vaginismus: not stated for all participants | |
Interventions | Intervention 1: systematic desensitisation (in vitro)
Number of sessions: until symptoms abated
Duration of sessions: not stated
Therapist level: not stated
Adjunctive interventions: not stated Intervention 2: systematic desensitisation (in vivo) Number of sessions: until symptoms abated Duration of sessions: not stated Therapist level: not stated Adjunctive interventions: not stated |
|
Outcomes | Successful sexual intercourse Drop‐outs | |
Notes | Data on 44 patients from contact with author 7 patients excluded due to insufficient data | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Alternation |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | "Because of insufficient data, particularly subsequent to therapy, 7 women had to be eliminated from the evaluation..." No attempt at ITT analysis reported |
Selective reporting (reporting bias) | Unclear risk | Outcome data provided for all stated outcomes but we have no access to study protocols so cannot be certain other outcomes were not assessed |
Other bias | High risk | Participants were free to change treatments after the initial allocation procedure (2 migrated from the in vivo to the in vitro arm of the trial). This equates with a high risk of selection bias which seriously weakens confidence in the results. Participants kept in treatment until symptoms abated. |