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Title

Therapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn's Disease: A Randomized Placebo-Controlled Trial.

Author(s)

JP, Bingaman SI, Ruggiero F, Mauger DT, Mukherjee A, McGovern CO, Zagon IS

Institution

Department of Medicine, The Pennsylvania State University, College of Medicine, GI Medicine H-045, 500 University Drive, Hershey, PA, 17033, USA, jsmith2@....

Source

Dig Dis Sci 2011 Mar 8.

Abstract

BACKGROUND: Endogenous opioid peptides have been shown to play a role in the development and/or perpetuation of inflammation. We hypothesize that the endogenous opioid system is involved in inflammatory bowel disease, and antagonism of the opioid-opioid receptor will lead to reversal of inflammation.

AIMS: A randomized double-blind placebo-controlled study was designed to test the efficacy and safety of an opioid antagonist for 12 weeks in adults with active Crohn's disease.

METHODS: Forty subjects with active Crohn's disease were enrolled in the study. Randomized patients received daily oral administration of 4.5-mg naltrexone or placebo. Providers and patients were masked to treatment assignment. The primary outcome was the proportion of subjects in each arm with a 70-point decline in Crohn's Disease Activity Index score (CDAI). The secondary outcome included mucosal healing based upon colonoscopy appearance and histology.

RESULTS: Eighty-eight percent of those treated with naltrexone had at least a 70-point decline in CDAI scores compared to 40% of placebo-treated patients (p = 0.009). After 12 weeks, 78% of subjects treated with naltrexone exhibited an endoscopic response as indicated by a 5-point decline in the Crohn's disease endoscopy index severity score (CDEIS) from baseline compared to 28% response in placebo-treated controls (p = 0.008), and 33% achieved remission with a CDEIS score <6, whereas only 8% of those on placebo showed the same change. Fatigue was the only side effect reported that was significantly greater in subjects receiving placebo.

CONCLUSIONS: Naltrexone improves clinical and inflammatory activity of subjects with moderate to severe Crohn's disease compared to placebo-treated controls. Strategies to alter the endogenous opioid system provide promise for the treatment of Crohn's disease.

Language

ENG

Pub Type(s)

JOURNAL ARTICLE

PubMed ID

21380937

Nola Chris

[low dose naltrexone] New LDN Study is Published!

The LDN study is published. Do anyone have access to this?

Therapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn's Disease: A Randomized Placebo-Controlled Trial

Jill P. , I. Bingaman, Francesca Ruggiero, T. Mauger, Aparna Mukherjee, O. McGovern and Ian S. Zagon

https://springerlink3.metapress.com/content/l80527u3372x0675/resource-secured/?target=fulltext.pdf & sid=tbuozvzn3n0zzr45431bj045 & sh=www.springerlink.com

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Fantastic!  Thanks for keeping on top of this and posting!! Jayne Crocker www.LDNNow.comImportant! Please sign our LDN petition to the European Parliament by clicking heretel: +44 (0) 7877 492 669Dr Steele MBE, talking about LDNLDNNow are a political/pressure group of individuals dedicated to getting Low Dose Naltrexone (LDN) accepted into modern medicine and trialled for the myriad of uses it shows benefit for. . From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of Alan SchachterSent: 12 March 2011 22:42low dose naltrexone Subject: [low dose naltrexone] New LDN Study is Published! The LDN study is published. Do anyone have access to this?Therapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn's Disease: A Randomized Placebo-Controlled TrialJill P. , I. Bingaman, Francesca Ruggiero, T. Mauger, Aparna Mukherjee, O. McGovern and Ian S. Zagonhttps://springerlink3.metapress.com/content/l80527u3372x0675/resource-secured/?target=fulltext.pdf & sid=tbuozvzn3n0zzr45431bj045 & sh=www.springerlink.com===Posted through GrouplyCreate your own group!www.grouply.com.. . .. . .. . .. .. ... .... . . . ... . .. ... . type_D . ... .. . ... . . . .... ... .. .. . .. . .. . ..

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Well done Nola – thanks! Jayne Crocker www.LDNNow.comImportant! Please sign our LDN petition to the European Parliament by clicking heretel: +44 (0) 7877 492 669Dr Steele MBE, talking about LDNLDNNow are a political/pressure group of individuals dedicated to getting Low Dose Naltrexone (LDN) accepted into modern medicine and trialled for the myriad of uses it shows benefit for. . From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of smalk50@...Sent: 13 March 2011 00:07alanschachter@...; low dose naltrexone Subject: Re: [low dose naltrexone] New LDN Study is Published! TitleTherapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn's Disease: A Randomized Placebo-Controlled Trial.Author(s) JP, Bingaman SI, Ruggiero F, Mauger DT, Mukherjee A, McGovern CO, Zagon IS InstitutionDepartment of Medicine, The Pennsylvania State University, College of Medicine, GI Medicine H-045, 500 University Drive, Hershey, PA, 17033, USA, jsmith2@....SourceDig Dis Sci 2011 Mar 8.AbstractBACKGROUND: Endogenous opioid peptides have been shown to play a role in the development and/or perpetuation of inflammation. We hypothesize that the endogenous opioid system is involved in inflammatory bowel disease, and antagonism of the opioid-opioid receptor will lead to reversal of inflammation. AIMS: A randomized double-blind placebo-controlled study was designed to test the efficacy and safety of an opioid antagonist for 12 weeks in adults with active Crohn's disease. METHODS: Forty subjects with active Crohn's disease were enrolled in the study. Randomized patients received daily oral administration of 4.5-mg naltrexone or placebo. Providers and patients were masked to treatment assignment. The primary outcome was the proportion of subjects in each arm with a 70-point decline in Crohn's Disease Activity Index score (CDAI). The secondary outcome included mucosal healing based upon colonoscopy appearance and histology. RESULTS: Eighty-eight percent of those treated with naltrexone had at least a 70-point decline in CDAI scores compared to 40% of placebo-treated patients (p = 0.009). After 12 weeks, 78% of subjects treated with naltrexone exhibited an endoscopic response as indicated by a 5-point decline in the Crohn's disease endoscopy index severity score (CDEIS) from baseline compared to 28% response in placebo-treated controls (p = 0.008), and 33% achieved remission with a CDEIS score <6, whereas only 8% of those on placebo showed the same change. Fatigue was the only side effect reported that was significantly greater in subjects receiving placebo. CONCLUSIONS: Naltrexone improves clinical and inflammatory activity of subjects with moderate to severe Crohn's disease compared to placebo-treated controls. Strategies to alter the endogenous opioid system provide promise for the treatment of Crohn's disease.LanguageENGPub Type(s)JOURNAL ARTICLEPubMed ID21380937 Nola [low dose naltrexone] New LDN Study is Published! The LDN study is published. Do anyone have access to this?Therapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn's Disease: A Randomized Placebo-Controlled TrialJill P. , I. Bingaman, Francesca Ruggiero, T. Mauger, Aparna Mukherjee, O. McGovern and Ian S. Zagonhttps://springerlink3.metapress.com/content/l80527u3372x0675/resource-secured/?target=fulltext.pdf & sid=tbuozvzn3n0zzr45431bj045 & sh=www.springerlink.com===Posted through GrouplyCreate your own group!www.grouply.com.. . .. . .. . .. .. ... .... . . . ... . .. ... . type_D . ... .. . ... . . . .... ... .. .. . .. . .. . ..

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Is this what you are looking for??SterlingTherapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn's Disease: A Randomized Placebo-Controlled Trial.

Dig Dis Sci. 2011 Mar 8;

Authors: JP, Bingaman SI, Ruggiero F, Mauger DT, Mukherjee A, McGovern CO, Zagon IS

BACKGROUND: Endogenous opioid peptides have been shown to play a role in the development and/or perpetuation of inflammation. We hypothesize that the endogenous opioid system is involved in inflammatory bowel disease, and antagonism of the opioid-opioid receptor

will lead to reversal of inflammation. AIMS: A randomized double-blind placebo-controlled study was designed to test the efficacy and safety of

an opioid antagonist for 12 weeks in adults with active Crohn's disease. METHODS: Forty subjects with active Crohn's disease were enrolled in the study. Randomized patients received daily oral administration of 4.5-mg naltrexone or placebo. Providers and patients were masked to treatment assignment. The primary outcome was the proportion of subjects in each arm with a 70-point decline in Crohn's Disease Activity Index score (CDAI). The secondary outcome included mucosal healing based upon colonoscopy appearance and histology. RESULTS: Eighty-eight percent of those treated with naltrexone had at least a 70-point decline in CDAI scores compared to 40% of placebo-treated patients (p = 0.009). After 12 weeks, 78% of subjects treated with naltrexone exhibited an endoscopic response as indicated by

a 5-point decline in the Crohn's disease endoscopy index severity score

(CDEIS) from baseline compared to 28% response in placebo-treated controls (p = 0.008), and 33% achieved remission with a CDEIS score <6, whereas only 8% of those on placebo showed the same change. Fatigue was the only side effect reported that was significantly greater

in subjects receiving placebo. CONCLUSIONS: Naltrexone improves clinical and inflammatory activity of subjects with moderate to severe Crohn's disease compared to placebo-treated controls. Strategies to alter the endogenous opioid system provide promise for the treatment of Crohn's disease.

From: Alan Schachter <alanschachter@...>Subject: [low dose naltrexone] New LDN Study is Published!low dose naltrexone Date: Saturday, March 12, 2011, 2:41 PM

The LDN study is published. Do anyone have access to this?

Therapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn's Disease: A Randomized Placebo-Controlled Trial

Jill P. , I. Bingaman, Francesca Ruggiero, T. Mauger, Aparna Mukherjee, O. McGovern and Ian S. Zagon

https://springerlink3.metapress.com/content/l80527u3372x0675/resource-secured/?target=fulltext.pdf & sid=tbuozvzn3n0zzr45431bj045 & sh=www.springerlink.com

===

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