Low Dose Naltrexone May Alleviate Crohn’s Disease Symptoms

Low Dose Naltrexone May Alleviate Crohn’s Disease Symptoms

Low-Dose NaltrexoneFor patients with incurable diseases such as Crohn’s disease, new treatments to help maintain symptom remission can provide hope for living a more comfortable life. One proposed treatment under investigation for Crohn’s disease is low dose naltrexone (LDN). Its use in treating Crohn’s disease remains controversial due to the small number of studies that have been conducted and their inconclusive results.

Low dose naltrexone, named as such because it is given in 4.5 mg doses, is an off-label use of naltrexone, an opioid receptor antagonist. According to Crohn’s Forum, chronic administration of opioids inhibits the normal immune response and enhances pro-inflammatory cytokine production. Naltrexone can reverse these immunosuppressive effects by blocking opioid receptors.

Since Crohn’s disease is a type of inflammatory bowel disease, researchers have been interested in administering LDN to combat inflammation in patients. An open-label pilot prospective trial published in The American Journal of Gastroenterology, entitled, “Low-Dose Naltrexone Therapy Improves Active Crohn’s Disease,” by a research group led by Jill Smith, MD, and Ian Zagon, PhD, at Pennsylvania State University first investigated the safety and efficacy of LDN in patients with active Crohn’s disease.

Seventeen patients were studied for twelve weeks while using 4.5 mg naltrexone daily. Inflammatory bowel disease questionnaires (IBDQs), short-form (SF-36) quality of life surveys, and Crohn’s disease activity index (CDAI) scores were assessed before the study, every four weeks during the study, and four weeks past the study.

As a result of LDN treatment, CDAI scores decreased significantly and remained lower than baseline at four weeks beyond the study. Nearly all (89%) of the patients responded to treatment, and 67% achieved remission. No adverse events occurred, and the most common side effect was sleep disturbance.

In addition to this study, two randomized controlled trials of LDN were reviewed by an article published in The Cochrane Library entitled, “Low Dose Naltrexone for Induction of Remission in Crohn’s Disease.” One study evaluated 34 adult patients (18 on 4.5 mg/day LDN and 16 on placebo) to identify safety and efficacy of LDN over 12 weeks, and the other study evaluated 12 pediatric patients for eight weeks to determine the safety and tolerability of LDN.

The studies yielded mixed results. On one hand, a significant difference in clinical response rate was observed for adult LDN patients compared to placebo patients, but on the other, there was no significant difference in remission (neither clinical nor endoscopic). For the pediatric patients, 25% of LDN treated patients achieved clinical remission, while none of the placebo treated patients achieved clinical remission. Looking at both adult and pediatric patients, no serious adverse events were reported.

Evidently, there is insufficient information to determine the efficacy of LDN in patients with active Crohn’s disease. GRADE analyses of the two studies suggested low quality of evidence due to small amounts of data.

To mitigate these inadequacies, a clinical trial has been registered by Santa Barbara Cottage Hospital under the official title, “Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease,” but is not recruiting. The primary goal of the phase 4 study is to compare LDN against placebo in patients with inflammatory bowel disease, Crohn’s disease, or ulcerative colitis. Efficacy of treatment will be determined by the IBDQ.

It is vital to continue to investigate LDN in patients with Crohn’s disease to establish the safety and efficacy of this off-label medication. Results so far suggest a potential of LDN, but validation is necessary.

7 comments

  1. M. says:

    I was given LDN 4 years by a Rheumatologist who is aware of my history of Crohn’s and it’s attendant complications. I immediately came out of a flare — despite malnutrition issues left over from surgeries. I am not 100% normal, nor would I expect to be (surgical damage and 24 years of Crohn’s has changed me) but I am much better than I have ever been on any other med. I suffer no side effects and a few side benefits.

    Diet is a key component to helping the LDN to help us. Sadly, while some find improvement even with the worst of a UC flare, many with Crohn’s only get some relief. (this may or may not be due to willingness to alter diet).

    I sincerely hope that the studies will be done and soon! This is what we need to be yelling at our doctor’s about, pushing and pressing. Even without studies, that LDN is safe and offers no risk of serious life changing side effects that other meds to, it should be an option for us.

    There is an IBD LDN group on facebook, and we welcome all interested in learning more about LDN.

  2. Julie says:

    LDN works for me! After over 30 yrs dealing w/ Crohn’s Disease, I had tried everything out there and had had 3 surgeries. Finally found true health and wellness w/ LDN!

  3. Elisabeth Gibson says:

    “May alleviate” Crohn’s Disease symptoms has become “does alleviate” Crohn’s Disease symptoms for my son. Before finding a specialist with the cahones to prescribe LDN, we were being pressured into starting a biologic that has a history of nasty and life-threatening side-effects. Now, my son takes LDN exclusively and is mostly symptom-free. A strong, healthy diet free of most sugars and grains is also part of his regimen. He’s gone from moderate-to-severe in disease classification, to remission.

  4. Michele Esposito says:

    LDN has saved my life and my colon. My last flare was so horrible that the choices were clinical trial or surgery to remove my colon. While waiting for the clinical trial to begin, my gastro prescribed LDN. It began working about 2-3 months after I started and by the 4th month there was no longer any crohns symptoms or bleeding. I’ve been on it now since October of last year and my disease is in total remission. My last Calprotectin showed no signs of inflammation.

  5. Greg says:

    I have proctitis with Hypothyroidism. Would it be possible to try LDN at an even lower dose and have the same benefits without going to the full 4.5 mg? Currently coming down from a flare.

    • Judy says:

      I have read in my research of this, that 1.5 is best to start with as your thyroid might spike and you would need to adjust your thyroid medicine as needed. Frequent blood work for your thyroid would be advised.

  6. Josh says:

    I have been diagnosed with severe complex fistulizing crohns colitis since 2011. The fistulas were tunneling though my body and, when flared, completely incapacitated me for months. I started on LDN about a year and half ago and after a period of adjustment to the drug, my fistulas subsided and I’ve had hardly activity on them since then.

    I’ve avoided the use of steroids and biologics as a result. I use a combination of LDN, Pentasa, clean diet and heavy probiotic / fermented foods use – and this keeps me in 100% remission most of the time. Glad I found LDN – the drugs they are offering are dangerous.

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