The paper should be out soon. It was reportedly accepted. Here is the May 2012 abstract.
Safety and Efficacy of Naltrexone Therapy in Children With Moderate to Severe Crohn's Disease: Pilot Study
Jill P. Smith, Douglas Field, Sandra I. Bingaman, Robert Evans, David T. Mauger
Objectives: The opioid receptor antagonist naltrexone improved clinical activity and pro- moted mucosal healing in adult patients with Crohn's disease. The aims of this study were to evaluate the safety, clinical benefit, and quality of life of naltrexone in children with Crohn's disease.
Methods: A prospective double blind placebo pseudo-cross over controlled pilot trial was conducted in children with moderate to severe Crohn's disease. Children were randomized to placebo or naltrexone 0.1 mg/kg orally for 8 weeks followed by 8 additional weeks of naltrexone. Safety and toxicity, clinical activity by the PCDAI (Pediatric Crohn's Disease Activity Index) and Harvey Bradshaw Index, and quality of life by the Impact III survey were monitored.
Results: Fourteen subjects with a mean age of 12.3 years (8-17, range) were enrolled. PCDAI scores significantly decreased from pretreatment (34.2±3.3) to eight-week scores (21.7±3.9) with naltrexone therapy (p=0.005). Only the naltrexone and not placebo-treated subjects had PCDAI scores less than 30 during the first 8 weeks and improvement in the Harvey Bradshaw activity index (p=0.03). Systemic and social quality of life improved (p=0.035), and no serious side effects were noted. Twenty- five percent were considered in remission (score < 10) and 50% had improved with mild disease activity (< 30) at the end of the study.there were no increases in the liver transaminases, electrolyte, renal or glucose abnormalities noted. Prealbumin levels improved 2.5-fold more in naltrexone treated patients over placebo control, suggesting improved nutritional status. ESR values decreased 2.4 more in naltrexone treated patients compared to placebo treated patients during the first eight weeks of the study.Additionally, other parameters of inflamma- tion (white blood count and C-reactive protein) also improved, but either due to the small cohort or the inclusion of data from the subject who flared by intent-to-treat analysis, these differences were not significant.
Conclusions: Naltrexone therapy appears safe when given to children with Crohn's disease and may improve disease activity. Larger studies are need to prove efficacy.
Safety and Efficacy of Naltrexone Therapy in Children With Moderate to Severe Crohn's Disease: Pilot Study
Jill P. Smith, Douglas Field, Sandra I. Bingaman, Robert Evans, David T. Mauger
Objectives: The opioid receptor antagonist naltrexone improved clinical activity and pro- moted mucosal healing in adult patients with Crohn's disease. The aims of this study were to evaluate the safety, clinical benefit, and quality of life of naltrexone in children with Crohn's disease.
Methods: A prospective double blind placebo pseudo-cross over controlled pilot trial was conducted in children with moderate to severe Crohn's disease. Children were randomized to placebo or naltrexone 0.1 mg/kg orally for 8 weeks followed by 8 additional weeks of naltrexone. Safety and toxicity, clinical activity by the PCDAI (Pediatric Crohn's Disease Activity Index) and Harvey Bradshaw Index, and quality of life by the Impact III survey were monitored.
Results: Fourteen subjects with a mean age of 12.3 years (8-17, range) were enrolled. PCDAI scores significantly decreased from pretreatment (34.2±3.3) to eight-week scores (21.7±3.9) with naltrexone therapy (p=0.005). Only the naltrexone and not placebo-treated subjects had PCDAI scores less than 30 during the first 8 weeks and improvement in the Harvey Bradshaw activity index (p=0.03). Systemic and social quality of life improved (p=0.035), and no serious side effects were noted. Twenty- five percent were considered in remission (score < 10) and 50% had improved with mild disease activity (< 30) at the end of the study.there were no increases in the liver transaminases, electrolyte, renal or glucose abnormalities noted. Prealbumin levels improved 2.5-fold more in naltrexone treated patients over placebo control, suggesting improved nutritional status. ESR values decreased 2.4 more in naltrexone treated patients compared to placebo treated patients during the first eight weeks of the study.Additionally, other parameters of inflamma- tion (white blood count and C-reactive protein) also improved, but either due to the small cohort or the inclusion of data from the subject who flared by intent-to-treat analysis, these differences were not significant.
Conclusions: Naltrexone therapy appears safe when given to children with Crohn's disease and may improve disease activity. Larger studies are need to prove efficacy.
