McConaghy 1988.

Methods	Design: parallel RCT
Participants	Participants: men seeking treatment for anomalous urges and behaviours they felt unable to control Sex: all male Age: mean = 30 years (SD = see note 2, range 16 to 50) Unit of allocation: individual participant Number randomised: 31 (n = 10 M; n = 10 ID; n = 11 M + ID) Number completing: 30 (n = 10 M; n = 10 ID; n = 10 M + ID) Setting: inpatient for duration of ID treatment only; single site; Sydney, Australia Inclusion criteria: male; seeking treatment for anomalous urges and behaviours they felt unable to control Exclusion criteria: active psychosis Baseline characteristics: at recruitment, 17 participants were single, 9 married, 3 separated, and 1 divorced. 22 of the 30 participants met DSM‐III criteria for 1 paraphilia and 8 participants for 2 or more paraphilias. 19 had been convicted for sexual offences; 8 of the remaining 11 who had carried out sexual offences and had not been charged, were paedophiles. 2 participants were of low intelligence and functionally illiterate and a third participant had brain damage as a result of a motor vehicle accident. Another had a chromosomal anomaly and, while rated as normal in terms of IQ score on the WAIS measure (Wechsler 1981), had a lower than normal score on the Wechsler Memory Scale (Wechsler 1945). A 5th participant had schizophrenia in remission and was being treated with fluphenazine decanoate. Ethnicity of participants not reported
Interventions	Three conditions: medroxyprogesterone (M) (n = 10 randomised) imaginal desensitisation (ID) (n = 10 randomised) medroxyprogesterone plus desensitisation (M + ID) (n = 11 randomised, see note 1) Medroxyprogesterone (M): 150 mg by IM injection; total of 8 injections; 4 injections at 2‐week intervals followed by 4 injections at monthly intervals Imaginal desensitisation (ID): based on hypothesis that anomalous behaviours are driven by a sense of tension and excitement that becomes aversive if behaviour not completed; each participant initially trained to relax; then to visualise situation where they have carried out anomalous behaviour in the past but visualise not completing the behaviour while remaining relaxed; 14 sessions: 2 sessions on day 1, 3 sessions on subsequent 4 days; delivered during a 5‐day admission to a psychiatric ward Duration of intervention: ID = 5 days, M = 6 months Duration of trial: 2 years Length of follow‐up: 1 month and 1 year following treatment
Outcomes	Primary outcome Recidivism as measured by reconviction or caution: reports of being charged for sexually anomalous behaviour Secondary outcomes Anomalous urge: participants' report of % reduction in their anomalous urge in response to treatment; independent assessment of change in anomalous desire following treatment; independent assessment of change in anomalous behaviour following treatment Anxiety State: mean scores on State‐Trait Anxiety Inventory (STAI) (Spielberger 1983) Dropping out of treatment Adverse events: side effects of medroxyprogesterone Other outcomes General tension: participants' report of % reduction in their general tension in response to treatment Hormone profiles: plasma testosterone, dihydrotestosterone, LH, FSH, and prolactin
Notes	Initially, 11 participants were randomised to combined treatment. However, "one patient allocated to the combined treatment who was concerned about his low level of normal sexual interest decided not to have M treatment when informed his plasma testosterone was low. He was treated with ID alone and excluded from the study" (p 200, col 1) No standard deviations were reported for any continuous data in this paper. These have been requested from 1 trial investigator, who reported that to his knowledge, no data from the study now survives. The first author, who held all data, is deceased (Blaszczynski 2011)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Insufficient information appeared in the published paper to allow a judgement to be made. Clarification about method of sequence generation was requested from 1 trial investigator, who reported that a random numbers table was used (Blaszczynski 2011)
Allocation concealment (selection bias)	High risk	Insufficient information appeared in the published papers to allow a judgement to be made. Clarification about method of allocation concealment was requested from 1 trial investigator, who reported that the first author made no attempts to conceal allocation (Blaszczynski 2011)
Blinding of participants and personnel (performance bias) All outcomes	High risk	The relevant comparison for this review is between a combined pharmacological plus psychological intervention and a psychological intervention. A placebo was not used for the control condition and it was not possible to blind to allocation
Blinding of outcome assessment (detection bias) All outcomes	High risk	The outcome assessor was not blinded and thus there is a risk of detection bias. This is despite the investigator's observation: "The significant correlations in this study between the assessor's and patients'measures of response and those between both these measures and the patients’ STAI and tension scores further support the validity of the measures of response . . . this suggests that the fact that the assessor in the present study was not blind to the different treatments did not significantly bias his assessments" (p 205, col 1)
Incomplete outcome data (attrition bias) All outcomes	Low risk	At 1 month, 0/10 missing from ID condition; 0/10 missing from M condition; 1/10 (10%) missing* from ID + M condition At 12 months, 0/10 missing from ID condition; 0/10 missing from M condition; 1/10 (10%) missing* from ID + M condition (*1 participant changed his mind after random allocation and withdrew from M treatment) Numbers of missing data are small, and reasons for missing outcome data are likely to be related to true outcome. Investigators emphasise, as in their previous (1985) study, their certainty that solicitors acting for any of their clients would have informed them of any post‐treatment arrests or convictions (p 200)
Selective reporting (reporting bias)	Unclear risk	Study protocol is not available but it seems clear that the published report included all expected outcomes, including those that were pre‐specified. However, neither means nor standard deviations were reported for anxiety (only correlations between participants' and assessors' views). These data have been requested from one trial investigator but do not appear to have survived (Blaszczynski 2011) (see note 2 above)
Other bias	Low risk	No other obvious source of bias