A placebo-controlled trial of the antiandrogen cyproterone acetate in deviant hypersexuality

Bradford 1993 and Cooper 1981 compared cyproterone acetate (CPA) with placebo.

“Bradford 1993 and Cooper 1981 compared cyproterone acetate (CPA) with placebo;”

Cooper 1981 was rated as having a high risk of bias because the measures of interest to this review were collected by self report only.

“We rated the sixth study as having a high risk of bias as the measures of interest to this review were collected by self report only (Cooper 1981).”

In Cooper 1981, the authors reported that to compensate for missing data, appropriate corrections were made, and analysis of variance carried out.

“In Cooper 1981, the authors reported that to compensate for missing data, appropriate corrections were made, and analysis of variance carried out.”

Oligospermia (reduction in volume of ejaculate) was remarked upon by all participants during the CPA phase in Cooper 1981.

“The investigator also noted that oligospermia (reduction in volume of ejaculate) was remarked upon by all participants during the CPA phase (p 463).”

The advantage for CPA over the other groups was 0.32, 0.17, and 13.2 respectively.

“Here, the advantage for CPA over the other groups was 0.32, 0.17, and 13.2 respectively (Cooper 1981).”

Even when interventions were identical, the review had concerns regarding differing length of treatment regimes and carry-over effects from cross-over studies, especially between Cooper 1981 and Bradford 1993.

“Even when interventions were identical, we had concerns regarding differing length of treatment regimes and carry-over effects from cross-over studies, especially between Cooper 1981 (where CPA was administered in a 20-week cross-over trial with four-week periods of prescription or four weeks' placebo) and Bradford 1993, where treatment lasted more than a year and was delivered in blocks of”

Cooper et al do not describe asking about recidivism via self report when assessing sexual activity.

“Cooper et al do not describe asking about recidivism via self report when assessing sexual activity (recorded as a simple count of episodes rather than subdivided by type or character); therefore it is assumed no data are available for this outcome from this study (Cooper 1981).”

No participants appeared to have left the study conducted by Cooper et al.

“No participants appeared to have left the study conducted by Cooper et al (Cooper 1981).”

Five different drugs were used: two in head-to-head trials, three against placebo alone, and two where the drug was augmented with a psychological intervention and compared against the psychological intervention on its own.

“Five different drugs were used, two of which were in 'head-to-head' (active treatment comparison) trials (Bancroft 1974; Tennent 1974); three against placebo alone (Cooper 1981; Hucker 1988; Bradford 1993); and two where the drug was augmented with a psychological intervention and compared against the psychological intervention on its own (Langevin 1979; McConaghy 1988).”

CPA was assessed as effective in decreasing capacity for arousal, number of orgasms, and hormone levels (testosterone, LH, FSH), compared to placebo in two studies (Cooper 1981; Bradford 1993).

“CPA was assessed as effective in decreasing capacity for arousal, number of orgasms, and hormone levels (testosterone, luteinising hormone (LH), follicle-stimulating hormone (FSH)), compared to placebo in two studies (Cooper 1981; Bradford 1993).”

Follow-up ran for up to 13 months in the CPA studies.

“follow-up ran for up to 13 months.”

Recidivism data do not appear to have been formally collected in the CPA studies (Cooper 1981; Bradford 1993).

“but recividism data do not appear to have been formally collected (Cooper 1981; Bradford 1993)”

Progestogens, SSRIs, and antipsychotics have similar effects in reducing libido in both sexes.

“(Cooper 1981), SSRIs, and antipsychotics have similar effects in reducing libido in both sexes.”

In other studies, the nature of the sexual offending was such that there was only a possibility of imprisonment (Cooper 1981, p 459), suggesting the behaviours may not have been extreme.

“the nature of the sexual offending in other studies was such that there was only”

Three studies were able to correlate the reductions in sexual interest and arousal to reduced plasma levels of testosterone.

“with three studies being able to correlate this to reduced plasma levels of testosterone (Cooper 1981; McConaghy 1988; Bradford 1993).”

Cooper 1981 participants were men who, except one with marital problems, demonstrated severe sexual acting-out with social and legal implications, including possible imprisonment.

“Participants: men who, with the exception of 1 who had marital problems, demonstrated severe sexual acting-out with social and legal implications, including, in some cases, the possibility of imprisonment”

In Cooper 1981, anxiety or anger were not systematically collected or reported.

“Anxiety or anger: not systematically collected or reported (see note 2)”

Cooper 1981 was an RCT with a cross-over design.

“Design: RCT (cross-over)”

In Cooper 1981, it is unclear whether the sexual activity measured as an outcome included sexual offences, and the primary investigator had not replied.

“It is unclear whether the sexual activity measured as one of the outcomes included sexual offences. The primary investigator has been approached but no reply has been received at the time of preparation of this review”

In Cooper 1981, recidivism was unclear but unlikely, and it was unclear whether the reported sexual activity was of a criminal nature.

“Recidivism as measured by reconviction, caution or self report: unclear but unlikely. It is unclear whether the 'sexual activity' reported is of a criminal nature or not (see note 1)”