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    Originally posted by Myoak View Post
    Low Dose Naltrexone for Treatment of Multiple Sclerosis
    A Retrospective Chart Review of Safety and Tolerability

    Journal of Clinical Psychopharmacology Volume 35, Number 5, October 2015 www.psychopharmacology.com 609

    Quote "Multiple sclerosis (MS) is an autoimmune disease of the central nervous system that afflicts 400,000 people in the United States and more than 4 million individuals worldwide. The most common form of MS is relapsing remitting multiple sclerosis (RRMS), characterized by alternating relapses and remissions for a period of 10 to 15 years followed by steadily progressive deterioration transitioning into secondary progressive MS. Multiple sclerosis is characterized by neurodegeneration of the spinal cord and brain, resulting in a reduction in mobility, reduced quality of life, and increased medical expenditures... Nearly all of the therapies are costly and have side effects that reduce compliance. There remains an unmet medical need for safe, inexpensive therapies that delay MS progression and improve its clinical course.

    A potential alternative or adjunctive therapy for MS is related to knowledge about the endogenous opioid system and its ability to modulate autoimmune diseases using animal models of MS. This novel biological pathway involves an endogenous opioid growth factor, chemically termed methionine enkephalin, and its nuclear-associated receptor, Opioid growth factor receptor. Modulation of this pathway by exogenous administration of opioid antagonists such as naltrexone (NTX) has been shown to mediate cell replication including T lymphocytes, astrocytes, and other glia that are associated with MS inflammation and degeneration...

    Three clinical trials of LDN in MS have been conducted and report that LDN increases the quality of life of MS patients.
    Cree et al concluded from a trial of 8 weeks that 4.5 mg LDN daily was a safe therapy that improved quality of life, whereas
    Sharafaddinzadeh et al reported safety after 17 weeks of treatment and recommended that longer trials be conducted to evaluate efficacy.
    Gironi et al studied primary progressive MS patients treated with LDN for 6 months and reported increased endogenous opioid levels in the patients and improved MS...

    A major symptom of MS is fatigue, which is one of the many characteristics that patients seek to alleviate. Improvement in fatigue was cited in these clinical studies after LDN therapy, which suggests that there is a potential link between upregulated endogenous opioid systems and fatigue. Gironi et al reported elevated β-endorphin levels at 1, 3, and 6 months after the onset of treatment, with β-endorphin levels remaining elevated for an additional month after LDN was discontinued...

    To determine the safety, tolerability, and effectiveness of LDN on fatigue, a retrospective analysis of MS patients prescribed LDN (3.5 mg orally, once daily) by physicians in the Department of Neurology at The Penn State Hershey Medical Center was undertaken... All patients were given the option of receiving LDN with the understanding that medication could be stopped if they experienced side effects. Some patients already receiving disease-modifying therapy (DMT) when started on LDN continued the standard DMT along with adjunctive LDN. Evidence of major drug interactions was monitored but no interactions were reported.

    The medical records of 215 MS patients, aged 18 to 65 years, seen in the MS clinic for a 7-year period (January 01, 2005 to May 31, 2012) and prescribed 3.5 mg LDN, orally, once daily, served as the study group.

    The LDN was provided by a licensed compounding pharmacy and cost the patients between US $30 to $50 monthly.

    Information on LDN safety, tolerance, side effects, reasons for discontinuation, and hospitalizations while taking LDN were evaluated... The number of documented flares after LDN treatment was initiated was recorded, with a clinical flare defined as the appearance of new symptoms/signs or worsening of old symptoms/signs. Finally, in a retrospective manner, information regarding possible LDN effects on fatigue, quality of life, and the effect on MS was obtained from the patient's visit history and a review of symptoms.

    Prescriptions for LDN were provided to 152 female (71%) and 63 male (29%) patients... Clinically, 87% of the patients had RRMS and 10% had secondary progressive MS, with a mean disease duration of 10 years... Seventy seven percent (n = 166) of patients taking LDN for any period of time did not report any side effects. Six percent of the patients had insomnia, whereas 5% of the patients had excessive dreams. There was no evidence of increased side effects related to other immunomodulators when combined with LDN. No abnormal laboratory results were noted... No patient was admitted to the hospital because of side effects of LDN.

    Most of the MS patients began LDN therapy because of fatigue. Nearly 60% (n = 128) of patients receiving LDN for any period of time reported a reduction in fatigue with LDN therapy.

    Fifty of the 215 patients commented that LDN produced no relief from fatigue and 4 patients stated that LDN increased their fatigue levels.

    Regarding their quality of life and the perception of LDN's effects on MS, 130 patients (60%) stated that LDN stabilized or improved their disease and 75% of the patients reported improved or stabilized quality of life.

    Nine patients reported that LDN reduced the quality of life, and 8% of the patients had the perception that their disease increased while on LDN but provided no details.

    In conclusion, this chart review focused on 215 MS patients who were provided a prescription for oral LDN. The study reports that a significant number of patients found combination therapy of an immunomodulating agent and LDN to be tolerable and possibly beneficial.

    Some patients preferred to take LDN as a monotherapy. The LDN did not cause any unexpected side effects, and those reported were previously noted in the literature. The LDN did not potentiate the side effects of the immunomodulating therapies that the patients were receiving. Any hospitalizations in this study were related to reasons other than MS, and there were no hospitalizations due to LDN...

    data from this retrospective study support future prospective double-blind investigations comparing a combination of LDN plus DMT and DMT alone." End Quote

    ACKNOWLEDGMENT
    The authors thank Marcus Magister, MD, Class of 2015, Penn State University College of Medicine, for the assistance in chart review, data acquisition, and data entry into REDCap.

    AUTHOR DISCLOSURE

    None of the authors have disclosures.

    Anthony P. Turel, MD Department of Neurology The Penn State University College of Medicine Hershey, PA

    Keun Hee Oh, BS Ian S. Zagon, PhD Department of Neural and Behavioral Sciences The Penn State University College of Medicine Hershey, PA

    Patricia J. McLaughlin, MS, DEd Department of Neural and Behavioral Sciences The Penn State University College of Medicine Hershey, PA
    I do not see where you said what LDN did for you. Maybe I'm missing something.

    Comment


      Originally posted by GinnyRuth View Post
      I do not see where you said what LDN did for you. Maybe I'm missing something.
      Hello GinnyRuth!

      Sorry that you were looking for my individual testimony when what I presented was a comprehensive review involving 215 MSers taking LDN during a 7 year period. 215 people carries a great deal more validity than one testimony; even though I do take LDN and am a huge fan of it.


      I don't have MS but take it because it is entirely safe (there is no record of a single serious adverse event in medical literature involving LDN). LDN has a pronounced anti-tumor effect. LDN increases endorphins. I believe feeling good increases my quality of life.


      Some of the highlights from the chart review of 215 MSers taking LDN...

      "The medical records of 215 MS patients, aged 18 to 65 years, seen in the MS clinic for a 7-year period (January 01, 2005 to May 31, 2012) and prescribed 3.5 mg LDN, orally, once daily, served as the study group."

      "Nearly 60% (n = 128) of patients receiving LDN for any period of time reported a reduction in fatigue with LDN therapy."

      "Regarding their quality of life and the perception of LDN's effects on MS, 130 patients (60%) stated that LDN stabilized or improved their disease and 75% of the patients reported improved or stabilized quality of life."

      "There was no evidence of increased side effects related to other immunomodulators when combined with LDN. No abnormal laboratory results were noted."



      The last paragraph is important because many of those trying LDN were taking one of the approved DMT's for MS and, as you can see there were "NO abnormal lab results."


      As far as my personal testimony I have purchased naltrexone from 3 different India internet sites without ever having a problem. The naltrexone is 50mg tabs which I crush and weigh to get the dose I use, which is 2mg per night. Now, since each individual tab of 50mg actually weighs 300mg due to binders and filler, I weigh out 12 mg of the crushed tab (scale and empty caps can be purchased on Amazon) to get 2mg of naltrexone, now called LDN because at 2mg it is low dose naltrexone.


      LDN is not a cure for MS. Will it make your life better if you have MS? Probably, if we believe the 215 people with MS and the researchers at Penn State.

      LDN does not seem to help everyone; even though in my humble opinion it likely helps the great majority of any group taking it and especially those with MS. A great deal of evidence suggests as much.

      Rather than merely state my viewpoint I prefer presenting the results of 215 MSers taking LDN to those who may be interested.

      Thank you for your interest, GinnyRuth. Anything which may help alleviate human suffering is certainly worth talking about and exploring.


      May I add one thought? If you are waiting for your doctors to provide or approve of you taking LDN you may as well wait for hell to freeze over. Its your life, not theirs. If they were in your shoes would they be trying LDN? In a heartbeat! What competent doctor, or any competent human being with MS would not try a demonstrably harmless drug that has a 60% chance of reducing fatigue in MS? And, a 75% chance of stabilizing or improving their quality of life?

      Get support and help outside the doctor's office if you want to try LDN because doctors typically will only discourage and demean efforts to do so. Try LDN on your own. Your doctor doesn't need to know. He sees you what... 20 minutes a couple times a year if you are in remission? Other than that how often does he think about you?


      Seriously, is your doctor concerned enough about your quality of life? To the point where he has thoroughly investigated LDN for possible benefits to people like you with MS? Why not? Obviously, he does not care to. He would if it were his life but it isn't; its your life. Act like it! You have to do it or it won't get done.


      Hopefully, I have not stated my opinions so strongly that I offended someone. That is not my intention. My intention is simple... to let people with MS know they can try LDN knowing it has a 60% chance of improving fatigue and a 100% chance of causing no serious harm. That's all.


      Best to you!

      Comment

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