Treatment of sex offenders with imaginal desensitization and/or medroxyprogesterone

An early Cochrane review identified only one small trial (n = 21) that compared antiandrogen medication (MPA) plus a psychological intervention versus the same psychological intervention and identified no significant difference between the two groups.

“The older review identified only one small trial (n = 21) that compared antiandrogen medication (MPA) plus a psychological intervention versus the same psychological intervention and identified no significant difference between the two groups (McConaghy 1988).”

For McConaghy 1988, a high level of dropout in the two drug intervention arms is reported (25% - five of 20 - did not complete their course of medication).

“For McConaghy 1988, a study in which a high level of dropout in the two drug intervention arms is reported (25% - five of 20 - did not complete their course of medication), the method of dealing with incomplete data is not given for all outcomes although results for all participants appear to be reported.”

McConaghy 1988 was assessed as having a high risk of bias because no attempt was made to blind outcome assessors.

“We also assessed the remaining study, McConaghy 1988, as having a high risk of bias (in contrast to previous work by the same authors, McConaghy 1985) because no attempt was made to blind outcome assessors.”

McConaghy 1988 was assessed as high risk of bias because the conduct of one component of the intervention (imaginal desensitisation) could not be blinded.

“We assessed McConaghy 1988 as being at high risk of bias as the conduct of one component of the intervention (imaginal desensitisation) could not be 'blinded' to anyone involved in the study.”

Only two included studies formally measured recidivism by reports of being charged for sexual offences (Langevin 1979; McConaghy 1988).

“Only two studies formally measured recividism by reports of being charged for sexual offences (Langevin 1979; McConaghy 1988).”

Personal communication with an author from McConaghy 1988 clarified the method of randomisation, and in these three cases, the risk of bias for sequence generation was assessed as low.

“personal communication with an author from McConaghy 1988 provided information that clarified the method of randomisation (Blaszczynski 2011), and in these three cases, we have assessed the risk of bias for this criterion to be low.”

McConaghy 1988 compared medroxyprogesterone (MPA, intramuscular) with imaginal desensitisation versus imaginal desensitisation alone.

“McConaghy 1988 compared medroxyprogesterone (MPA, intramuscular) with imaginal desensitisation versus imaginal desensitisation alone.”

Personal communication with an author involved in McConaghy 1988 led to an assessment of 'high' risk of bias for allocation concealment.

“personal communication with an author involved in McConaghy 1988 led to an assessment of 'high' risk of bias for one study, as it was confirmed that no method of concealment was employed.”

For McConaghy 1988, the method of dealing with incomplete data is not given for all outcomes although results for all participants appear to be reported.

“the method of dealing with incomplete data is not given for all outcomes although results for all participants appear to be reported.”

Patients' STAI state and anxiety scores were significantly lower following than preceding all 3 treatments.

“Investigators did report that”

Langevin 1979 and McConaghy 1988 feature MPA plus psychological treatment versus psychological treatment alone.

“Whilst some trials are superficially similar (Langevin 1979 and McConaghy 1988 feature MPA plus psychological treatment versus psychological treatment alone), the former trial reports few real data for analysis due to catastrophic dropout”

At two-year follow-up, no participant who received both imaginal desensitisation and medroxyprogesterone had received a charge for sexually anomalous behaviour, whereas one treated with imaginal desensitisation alone relapsed.

“At two-year follow-up, investigators found that no participant who had received both imaginal desensitisation and medroxyprogesterone had received a charge for sexually anomalous behaviour, whereas one who was treated with imaginal desensitisation alone relapsed.”

McConaghy 1988 provided no standard deviations for any of the means provided for continuous data (and data have since been destroyed).

“Finally, one might hope data from the latter trial, McConaghy 1988, might be comparable to data within the trial conducted by Hucker (Hucker 1988), but the former provided no standard deviations (SDs) for any of the means provided for continuous data (and data have since been destroyed).”

Standard deviations are missing from some measures from McConaghy 1988, but there is no reason to suspect these were suppressed; data appear to have been lost (Blaszczynski 2011).

“Standard deviations are missing from some measures from another paper (McConaghy 1988), but there is no reason to suspect these were suppressed; data appear to have been lost (Blaszczynski 2011).”

The McConaghy 1988 trial investigators concluded that there were no significant differences in response to the three treatments (medroxyprogesterone, imaginal desensitisation, and combination).

“The trial investigators concluded that there were no significant differences in response to the three treatments.”

In McConaghy 1988, treatment (MPA) significantly reduced anxiety levels.

“where treatment (MPA) significantly reduced anxiety levels”

Medroxyprogesterone acetate (MPA) (intramuscular) appeared effective in the one trial assessing it (McConaghy 1988).

“Medroxyprogesterone acetate MPA (intramuscular) appeared effective in the one trial assessing it (McConaghy 1988)”

There were no reports of recidivism at two-year follow-up in the MPA intramuscular trial (McConaghy 1988).

“with no reports of recividism at twoyear follow-up.”

Four participants ceased injections after three to five episodes due to side effects, though none were reported as having relapsed and they also reported persistence of the therapeutic effect.

“Four participants ceased injections after three to five episodes due to side effects, though none were reported as having relapsed and they also”

MPA was reported to reduce circulating testosterone significantly in one trial in which the drug was administered intramuscularly (McConaghy 1988).

“MPA was also reported to reduce circulating testosterone significantly in one trial in which the drug was administered intramuscularly (McConaghy 1988).”

In McConaghy 1988, there was an average decrease of 70% at one month, which was strengthened to 75% at one year.

“with an average decrease of 70% at one month, which was strengthened to 75% at one year”

Anxiety was formally measured in only one trial (McConaghy 1988).

“Anxiety was formally measured in only one trial (McConaghy 1988)”

In McConaghy 1988, anxiety reduction was formally correlated with a decrease in testosterone levels.

“and was formally correlated with a decrease in testosterone levels as well.”

Combined pharmacological and psychological treatment was examined in only two studies (McConaghy 1988; Bradford 1993).

“this type of combined treatment was only examined in two studies (McConaghy 1988; Bradford 1993).”

One participant left the MPA-only condition of the trial conducted by McConaghy et al (n = 31), due to concerns about his low sexual interest (McConaghy 1988).

“One participant left the MPA-only condition of the trial conducted by McConaghy et al (n = 31), due to concerns about his low sexual interest (McConaghy 1988).”

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).”

Only two of the seven trials described in this report were considered in the Lösel and Schmucker meta-analysis (Langevin 1979; McConaghy 1988), because their inclusion criteria specified recidivism as a prospective outcome.

“Moreover, only two of the seven trials described in this report were considered in their meta-analysis (Langevin 1979; McConaghy 1988), because their inclusion criteria specified recividism as a prospective outcome.”

In McConaghy 1988, selective reporting (reporting bias) was judged at unclear risk.

“Selective reporting (re- porting bias) | Unclear risk”

In McConaghy 1988, incomplete outcome data (attrition bias) for all outcomes was judged at low risk.

“Incomplete outcome data (attrition bias) All outcomes | Low risk”

In McConaghy 1988, allocation concealment (selection bias) was judged at high risk.

“Allocation concealment (selection bias) | High risk”

In McConaghy 1988, no standard deviations were reported for any continuous data.

“No standard deviations were reported for any continuous data in this paper.”

In McConaghy 1988, other bias was judged at low risk.

“Other bias | Low risk”

In McConaghy 1988, one participant allocated to combined treatment was excluded from the study after deciding not to have M treatment.

“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”

In McConaghy 1988, blinding of participants and personnel (performance bias) for all outcomes was judged at high risk.

“Blinding of participants and personnel (perfor- mance bias) All outcomes | High risk”

In McConaghy 1988, random sequence generation (selection bias) was judged at low risk.

“Random sequence genera- tion (selection bias) | Low risk”

In McConaghy 1988, blinding of outcome assessment (detection bias) for all outcomes was judged at high risk.

“Blinding of outcome as- sessment (detection bias) All outcomes | High risk”