At long last, the results from the University of California at San Francisco study of low dose naltrexone (LDN) in patients with multiple sclerosis (MS) have been released. The data seem to point to the conclusion that LDN can help mental health of people with MS, but has little effect on physical functioning.
Before any die-hard LDN fans get their feathers ruffled over these preliminary findings, I need to point out that the study had some general shortcomings in terms of "proving" or "disproving" anything. For one, the treatment period in this study was short - only 8 weeks of treatment with LDN (this was a crossover study design in which all participants received treatment and placebo for 8 weeks each, separated by a washout period of one week). Also, while 80 participants were originally enrolled, data from only 60 people was evaluated. Furthermore, all data was self-reported, rather than based on any "objective" clinical measures. This, as well as the very nature of the general "buzz" around LDN among people with MS, could lead to several biases in terms of reporting and self-selection of participants.
In my opinion, here are some of the most interesting points of this study:
There was no significant physical functioning improvement reported from LDN according to the primary instrument used to measure outcome, the MSQOLI (the Multiple Sclerosis Quality of Life Inventory, a compilation of various surveys used to determine functioning in different areas of life). However, there was significant improvement in the mental health portion of the data, which included pain measures and cognitive functioning.
Seems to be no difference in effects of LDN if people are taking Copaxone or any of the interferons (Betaseron, Avonex or Rebif). This may indicate that it is not a problem to take LDN concurrently with other disease-modifying therapies, whereas previously it was advised that LDN could not be taken with any immunomodulators (such as the interferons), as there could possibly be interactions between LDN and these drugs (although Copaxone has always been considered okay for concurrent use).
Only real side effect reported was vivid dreaming (however, people taking the placebo also reported this effect).
There was a pretty big "placebo effect" reported here, meaning that improvement was measured in several areas of functioning above baseline (where participants were when study started), in BOTH the LDN treatment group and the placebo group.
Bottom line: Look, folks, this is a good "first try" to do an LDN study. I am very impressed by the fact that this study was funded by people living with MS (ldners.org). Clearly, to make any huge statement about the effectiveness of LDN, the study would have to be much bigger and much longer, meaning much more expensive.
I have a couple of things I would do differently in a future study, but I would primarily be very interested at starting people at a lower dose initially. While 4.5 mg (the dosage used in the study) is ideal for some people, I have heard that it is often too much for others. Certainly my experience with LDN was that my overall feeling of well-being deteriorated when I increased my dosage from 3.0 mg to 4.5 mg. I have heard many people say that gradually increasing (then decreasing if necessary) until optimal dosages are found worked much better than starting at 4.5 mg. Anyway, that is one thing on my "wish list," along with more participants and longer treatment period. Again, all of these things cost money and it would be wonderful to see a more "robust" study conducted in the future, following on the pioneering work done at UCSF by Dr. Cree and his colleagues.
Note: There are doubtless many of you who have very strong opinions on this study and have reviewed the data very closely. I would love to hear your opinions on the research and its conclusions in the comments section below.
Source: Bruce Cree, Elena Kornyeyeva, Douglas S. Goodin. Pilot trial of low dose naltrexone and quality of life in MS. Annals of Neurology. Published online February 19, 2010.
For anyone interested in my journey with LDN, read the full articles/blogs:
Although the study only showed a big increase in mental outlook of the MS patients, for some of us, the biggest improvement was physical. From the first day, things did seem brighter for me, but by the end of the first week, nearly all fatigue was gone. By two months, the numbness and tingling in the fingers and hands had started to disappear and by nine months, even the horrible heat intolerance was starting to go away.
I told myself that I would be happy with each of these steps — no more progression of my MS, then the lifting of the mental fog and fatigue, wow. When the tingling was gone, and you sort of don’t realize a negative until you start to remember what it was like before, I thought, “I can live with the heat intolerance, if I can think, laugh and feel again.” My last dream of being able to go out in the heat without instant exhaustion and long term fatigue, came true before the end of the first year.
As you can see, the length of the test was totally inadequate. The fact that there was improvement in the short term is massive. With no down side, and the possibility of enormous improvements, there is no reason to hesitate in giving LDN a try. I know it is not a cure, but if I don’t have to suffer the symptoms of MS, then it is not very important that I still have MS, right?
There is lots of help getting started in the Yahoo group with more than 8,000 members. Go to groups.yahoo.com and search for lowdosenaltrexone.
SWEET!
I am so happy to read this about LDN.
I have taken it for about 4 yrs? It was hard to convince my neuro to prescribe it, so I when online and Donna from Florida helped me find someone locally. It did have to sign a paper that this was an alternative drug.
However, I have trouble with “drop foot” on my left.
Next week I have an appt w/Hanger. I hope they can help. I need a cane when walking in large spaces.
Thank you for pulling up the articules on bee venum therapy. I was recently selected to be a beekeeper! This is a 2 yr commitment and my 1st class is tomorrow. I’m so excited! The best part is I was funded the $500.00 fee to cover the project.
Now I’m not a fan of bee stings, but if it happens I know it could help me. How aboot that?
hello. i am living in Israel. i did bee sting therapy, after having about almost everything else (steroids, avonex, betaferon,rebiff, immunoglobulin and chemo. nothing ever helped me EXCEPT bee stings. it changed my life!!!