Jump to content
helplinedonate
Calliope

Off Label Prescriptions Approach to MDS

Recommended Posts

New member here.  My husband had a recent tentative diagnosis, but as I learn more, he has all the first signs, although nothing noticeable except a light hand tremor and minimal arm swing and nothing that bothers him yet.  After reading this forum we decided to try TUDCA which helped everything right away, sleep, arm swing, mood, anxiety.  The tremor is still there but he says it takes the edge off his noticing it which makes all the difference.  Then one day after reading an anecdotal post he tried aloe vera juice from the grocery store just in case it could help.  The tremor stopped immediately.  I looked it up and the aloe vera study on mice seems preventative, in other words it produced recovery having to do with the tyrosine which sounds like it might something that helps stop progression like Ursodiol (UDCA) as opposed to dopa.  The aloe vera only stops the tremor when he takes it with the TUDCA.

So it's very comforting to have at hand the ability to hopefully slow it down from over the counter, but we are going to meet with our first MDS soon.  We would like to see if she is willing to give him ursodiol off label since the end of the study has been slightly delayed to replace the TUDCA.   We would also like to try the isradiprine which is off label, but my husband is already on blood pressure meds and a channel blocker.  So we are hoping we could convince the MDS to switch him to Isradipine instead of the other two meds.

I have read that people here present their doctor with things they print out from the internet which helps the doctor in this type of situation.  Can anyone tell me what kind of info might help them or what approach you might suggest that might make the doctor's decision easier?

 

CAVEAT:  Don't try either of these over the counters including aloe drinks without serious research or talking to a doctor.  Both can be dangerous under certain conditions.

 

 

 

 

 

 

 

Share this post


Link to post
Share on other sites

Hiker,  UDCA or Ursidiol is a drug nearing the end of its trials for Parkinson's that may stop or slow progression.  You can get a very similar compound over the counter called TUDCA, tauroursodeoxycholic acid, which has been found to work as well for some people with Parkinson's.  It's a chemical found in bile and is prescribed for some kind of stones, gall or kidney maybe.  Body builders use the over the counter compound TUDCA as a supplement to help their liver.  It's called TUDCA on the container.  For Parkinson's you can take 1250 mgs a day.  You can take it in five 250 pills throughout the day.  But don't do this on your own without making sure you don't have a condition that the combination could make it harmful for you.  

Share this post


Link to post
Share on other sites
17 hours ago, Calliope said:

Hiker,  UDCA or Ursidiol is a drug nearing the end of its trials for Parkinson's that may stop or slow progression.

That's not accurate. Phase 1 human trials have only just started for UDCA in Parkinson's; the trial is open-label (not placebo-controlled) and small. There have been a couple small human trials of TUDCA, but in patients with ALS and MS, not PD. More here: https://scienceofparkinsons.com/2018/04/16/udca/

UDCA/TUDCA *may* eventually prove to have benefits for people with PD, but it is far too early to say, one way or the other. The vast majority of drugs that show promise in animal models or early human trials fail more rigorous trials.

As miracleseeker suggests, there's at least one UDCA/TUDCA evangelist on these forums. If he turns out to be right, it's because of a lucky guess, not hard data.

Full disclosure: I take isradipine off-label (prescribed by my MDS), because there's a chance it will be shown to slow progression and I didn't qualify for the Phase III trial. But I didn't start taking it until it had already passed Phase II (large-scale testing for safety in PD patients) and Phase III (large-scale testing for efficacy) was underway. Phase III wrapped up last month, and results should be published sometime in 2019. If results are positive, I'll continue taking it; if not, I'll stop immediately and save a couple bucks every month.

Edit to add: It seems unlikely to me that readily-available and widely-used drugs or supplements will be game-changing PD treatments--if they were, we'd already have the data. And there's no reason to think a drug that slows progression will have symptomatic benefit (and vice versa). It's well known temporary improvement in PD symptoms is highly susceptible to placebo effects, hence the reason open-label studies should be viewed cautiously.

Edited by ShopGuy
  • Thanks 1

Share this post


Link to post
Share on other sites

Shop Guy thanks! What do you mean by "off label". And did your neurologist or your Primary Care prescribe it? What dosage do you take?

Share this post


Link to post
Share on other sites

'Off-label' = prescribed for some use/condition other than that approved by the FDA. It's legal and common for doctors to prescribe drugs off-label, but insurance companies can (and do) refuse to pay for off-label rx. In my case, isradipine was prescribed by my MDS, after we figured out I wouldn't qualify for the STEADY PD-III trial.

Generic isradipine is cheap--my insurance has always covered it, no questions asked. Dose is 10 mg/day: (2) 5 mg capsules, each morning. Based on the Phase III protocol, I should prob. split up the dose, morning and evening, but haven't had any ill effects doing it this way. Edema is a common side effect, but I haven't had any.

Never experienced any effect on symptoms, but wasn't expecting any. Progression has been slow for me, to-date, but I exercise and also have high-normal blood urate levels (there's some evidence higher urate levels are associated with slower progression, and a urate-raising supplement is in Phase III trials). As you probably know, YOPD and tremor-dominance are associated with slower progression, so I tick those boxes, too.

I guess I feel pretty fortunate to have the 'right' kind of PD. Although not quite as fortunate as the other 499 out of 500, who don't have PD at all. (I'm joking--sort of.)

A few other people here are taking isradipine, including one person who was part of the STEADY PD III trial. Search the forums, and you should find more discussion.

  • Thanks 1

Share this post


Link to post
Share on other sites

One more note regarding dosing of TUDCA. If you follow the link in my post above to the Science of Parkinson's blog, you'll find that of the few studies of TUDCA in humans, none of them recommend doses as high as 1250 mg/daily. In fact, one study (in liver patients) found side effects between 1000-1500 mg, and recommended doses of 10 mg/kg body weight for future studies. Under that guideline, 1250 mg would only be appropriate for someone 275 pound or heavier.

If I had ALS, chronic diarrhea from taking an unproven compound might be worth it, for the chance at slowing the progress of a fatal disease. But PD isn't ALS--not even close. 

Share this post


Link to post
Share on other sites
On 12/10/2018 at 9:13 AM, ShopGuy said:

One more note regarding dosing of TUDCA. If you follow the link in my post above to the Science of Parkinson's blog, you'll find that of the few studies of TUDCA in humans, none of them recommend doses as high as 1250 mg/daily. In fact, one study (in liver patients) found side effects between 1000-1500 mg, and recommended doses of 10 mg/kg body weight for future studies. Under that guideline, 1250 mg would only be appropriate for someone 275 pound or heavier.

If I had ALS, chronic diarrhea from taking an unproven compound might be worth it, for the chance at slowing the progress of a fatal disease. But PD isn't ALS--not even close. 

ShopGuy, You're right about the date for the Ursodiol.  I was mixing up the two studies.  But for the TUDCA, I'm confused.  My husband would be about 80 kilograms.  Can you redo the math for that 275 pounds?  I think your numbers may be off.  I am finding most sites say 20/mg/kg TUDC per day is safe and common dosage for fatty liver patients is 1750 mgs/day.  I'm not seeing any warnings or any toxicity at the levels my husband is taking in any studies anywhere.  There is one study that found problems with patients who had PSC, which is a rare chronic liver disease.  They did well on TUDCA until five years, and then they had real problems, but the studies say it seems to be PSC-related. 

Another thing, ShopGuy, that I wanted to mention.  Both times you have replied to my posts you have said something negative about how I am approaching PD, once in this post and once when I originally found out about my husband's diagnosis.  Although you may have been correct, the way you wrote made it sound  as though I was doing something wrong.  Since this has happened twice, I would just suggest that you might want to be a little more careful with how you come across to newcomers. This is a very tough diagnosis, and we're already pretty scared about doing the wrong thing.  

As far as some of the other comments by others on this post directed to members besides me, I would also mention that when we as newcomers hear people being sarcastic or denigrating to other forum members we do not feel we are in a welcome space.  It's actually kind of shocking when you think you have found an oasis of people who understand to hear fellow sufferers talking about other forum members that way.  

If anyone actually has an answer to my original question I would be very appreciative.  The question was what kind of print out would you bring to a doctor to help familiarize them with an off label medication that may be helpful for PD.  

 

  • Confused 1

Share this post


Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now

×