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Crohn's Disease Forum » Treatment » Low Dose Naltrexone » Jill Smith's LDN in children abstract


11-12-2012, 06:16 PM   #1
xmdmom
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Jill Smith's LDN in children abstract

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 (34.23.3) to eight-week scores (21.73.9) 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.
11-12-2012, 07:02 PM   #2
David
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Thank you so much for posting this! Sounds like pretty darn good results.

The 0.1 mg/kg dosage is interesting to me.

*edit* Copied to the LDN subforum.
11-23-2012, 06:38 PM   #3
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The 0.1 mg/kg is interesting to me as well, Jack takes 4.5mg daily and varies in weight between 77-80lbs so if I remember correctly that would make him approximately 35kg so 3.5mg. I'll have to print out the study and bring it to Jack's doctor when we go although he is doing so well, I would hate to adjust and have a set back and start all over.
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Mom to Jack (18) dx Crohn's 2/2010
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Past meds: Imuran/Azathioprine; allopurinol; methotrexate; LDN; Prednisone; Apriso; Pentasa; EEN

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currently none due to liver issues
11-23-2012, 06:46 PM   #4
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I actually emailed Dr. Zagon a few weeks ago and he said that 4.5mg is too much. He said to use 3mg to 4mg max but I think it was Dr. Bihari who found good results using 4.5 max. I'm not sure.

It's just something else that irritates me about LDN. There are so many conflicting opinions when we're just trying to do it "right". It's a little more than frustrating for me. I'm going to be sticking with 4.5mg for now.
01-02-2013, 01:01 AM   #5
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The full pdf of this study is here.
01-02-2013, 01:14 PM   #6
mnsun
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Yea, if the .1mg/kg is correct, I would need about 6.9mg? Odd. Maybe kids have a faster metabolism concerning such opiate antagonists?
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01-02-2013, 01:31 PM   #7
Jmrogers4
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According to this Jack should be getting 3.6mg/day but he takes 4.5, we've had no side effects or other reason to decrease so I'm going to leave him at 4.5 and talk to his GI next time we see him.
01-02-2013, 05:01 PM   #8
Clash
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I think if you read the study, it states that the dose is .1mg/kg up to 4.5 mg so apparently they dose by weight until it goes over the dose of 4.5 mg at which point they just get 4.5mg
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01-08-2013, 05:42 PM   #9
EthanClark
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Does anyone know how young the youngest child is that has been on LDN? I am doing research on LDN for a possible treatment option for myself but wonder at what age it may be appropriate for my 3 1/2 year old son. Any info is appreciated.
01-08-2013, 05:55 PM   #10
Jmrogers4
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Not sure the youngest in the study was 8. You may want to post the question in the Parents of IBD section, there may be someone there that can answer your question my son has been taking it for 6 months and he is 13
03-09-2013, 11:10 PM   #11
ljelen
 
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I actually emailed Dr. Zagon a few weeks ago and he said that 4.5mg is too much. He said to use 3mg to 4mg max but I think it was Dr. Bihari who found good results using 4.5 max. I'm not sure.

It's just something else that irritates me about LDN. There are so many conflicting opinions when we're just trying to do it "right". It's a little more than frustrating for me. I'm going to be sticking with 4.5mg for now.
When I was in the clinical study we were given a dose of 4.5 mg at night. Supposedly, 3 mg is the suggested dose if you weigh 105 lbs or less. 1.5 mg is supposedly the lowest effective dose for an adult. I've been on 4.5 mg since 2009. From what I read, Dr. Bihari determined that 4.5 mg was the optimum dose for his HIV patients. Dr. Jill Smith now works for the NIH, which puts her in the position of approving her own research. I personally don't want to play with my LDN dosage when 4.5 mg is working so well.

Last edited by ljelen; 03-09-2013 at 11:12 PM. Reason: Title change
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