Targeted Pressure on Abductor Hallucis and Flexor Hallucis Brevis Muscles to Manage Moderate to Severe Primary Restless Legs Syndrome.

CONTEXT: Restless legs syndrome (RLS) treatments have included medications with many adverse effects and limited utility. A noninvasive device would potentially have extensive use where RLS medications may not be appropriate, such as in pregnant or breastfeeding women, people with mild RLS, people who operate machinery or drive occupationally, people with severely impaired renal function, or people who are taking medications contraindicated with RLS medications. OBJECTIVE: To assess the efficacy and safety of a device that produces targeted pressure on the abductor hallucis and the flexor hallucis brevis muscles to reduce the symptoms of moderate to severe RLS, and to compare the current findings with findings from studies of ropinirole use in patients with primary RLS. METHODS: This 8-week single-arm, open-label, clinical trial with a repeated measures design was conducted between April 2009 and August 2012 in 2 offices in Erie, Pennsylvania. Adults with moderate to severe primary RLS were recruited for the study. Mean (SD) follow-up was 15.6 (6) months. Patients wore RLS devices (1 on each foot) for set periods intermittently throughout the course of the study. The primary end point was mean change in the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale from baseline to day 56, and the secondary measure was the Clinical Global Impression scale. A meta-analysis was used to compare the RLS device findings with the findings of 3 historic studies of ropinirole vs placebo. The demographics, disease severity, inclusion and exclusion criteria, and assessment tools were similar among the 4 studies. RESULTS: Thirty patients (22 women, 8 men; mean age, 51.5 years [range, 30-75 years]) participated in the study. Change in mean (SD) IRLSSG score was significantly greater for the RLS device (17.22 [6.16]; P<.001) compared with the ropinirole vs placebo findings (12 [0.86] vs 8.9 [0.86], respectively; P<.05). Sleep loss significantly decreased from 119.5 (61.6) minutes to 22.1 (31.1) minutes per night (P<.001). Global Improvement Scale scores indicated significantly greater improvement with the RLS device compared with ropinirole (27 of 30 [90%] vs 293 of 464 [63%], respectively; P<.05). Mild, transient adverse effects of the device (eg, pain, paresthesia) were reported, but these effects were relieved by loosening the straps. The RLS device demonstrated none of the adverse effects associated with current dopamine agonist therapy, such as augmentation, tolerance, rebound, somnolence, and nausea. CONCLUSION: Producing targeted pressure on the abductor hallucis and flexor hallucis brevis muscles with an external RLS device reduced the symptoms of moderate to severe primary RLS without the adverse effects of medication therapy. (ClinicalTrials.gov number NCT02386423.) J Am Osteopath Assoc.

Leuprolide acetate suppresses pedophilic urges and arousability.

Cognitive-behavioral psychotherapy was compared with cognitive-behavioral psychotherapy augmented by leuprolide acetate (LA) for suppression of pedophilic behavior. Five male pedophiles (M age, 50 years; range, 36-58) were administered LA by Depo injection for 12 months, followed by saline placebo for 12 months. Testosterone levels, sexual interest preference by visual reaction time (Abel Assessment), penile tumescence (Monarch Penile Plethysmography, PPG), as well as strong sexual urges toward children and masturbatory frequency involving thoughts of children (polygraph), were measured every 3 months. On LA, testosterone decreased to castrate levels. Penile tumescence was significantly suppressed compared with baseline, but sufficient response remained to detect pedophilic interest. Pedophilic interest was also detected by visual reaction times. When asked about having pedophilic urges and masturbating to thoughts of children, all subjects self-reported a decrease. Polygraph responses indicated subjects were not deceptive. On placebo, testosterone and physiologic arousal eventually rose to baseline. As noted by polygraph, at baseline and on placebo, subjects were deceptive regarding increased pedophilic urges and masturbatory frequency. Interest preference, as measured by Abel Assessment and Monarch PPG, was generally unchanged throughout the study. Cognitive-behavioral psychotherapy augmented with LA significantly reduced pedophilic fantasies, urges, and masturbation; however, pedophilic interest did not change during 1 year of therapy. Deceptive responses by polygraph suggested that self-report was unreliable. Follow-up utilizing objective measures is essential for monitoring efficacy of treatment in pedophilia. Our study supports the premise that suppression of pedophilic behavior is possible. LA may augment cognitive-behavioral psychotherapy and help break the sequence leading to a re-offense.

The impact of monosymptomatic nocturnal enuresis on attachment parameters.

OBJECTIVE: This study assesses the impact of monosymptomatic nocturnal enuresis (MSNE) on the child's perception of quality of attachment to a caregiver and the caregiver's perception of dissociative behavior. MATERIAL AND METHODS: The study group comprised 47 boys and 63 girls (mean age 11.7 years; range 9-18 years). Subjects were classified into two groups as follows: Group I (normal children without nocturnal enuresis); or Group II (children with MSNE). MSNE was defined as more than three wet episodes per week without day-time enuresis, urge incontinence, frequency or dysuria. The Adolescent Attachment Questionnaire (AAQ) was administered to the children and the Child Dissociative Checklist (CDC) to the caregiver. Comparison groups were divided by gender, feeding method and type of caregiver. The AAQ and CDC scores in each subgroup were compared between the enuretic and non-enuretic groups. RESULTS: Mean scores for attachment pathology were significantly higher in the enuretic (n = 50) than the non-enuretic group (n = 60) (p < 0.05). The most significant attachment pathology was evident for the AAQ Angry Distress dimension in the nocturnally enuretic group. Caregivers' CDC scores did not differ significantly between the two groups. Highest mean dissociation scores were evident for those children whose caregiver was not a biologic parent or grandparent. CONCLUSIONS: MSNE may negatively impact the child's perception of the quality of attachment. Caregivers reported no significant dissociative behavior in nocturnally enuretic children. With prolonged nocturnal enuresis, physicians should be aware of the possibility of anger and distress within the child-caregiver relationship. In such cases, the modified treatment protocol should include psychologic counseling and support.