I'm not sure how many others are on Ursodiol, but I got some rather alarming news from my GI Doctor today.
I'm in the early stages of PSC (after having had Ulcerative Colitis for close to 25 years). One of the drugs I was prescribed after diagnosis of the PSC is Ursodiol. My routine with this drug has been three 500 Mg tablets daily (1.5 tablets twice a day).
After my latest blood test last week, I received the results with all being pretty steady and right around the same levels of my last checkup with the exception of Alkaline Phosphate, which jumped from 279 to 336 (normal range is 37-117).
My Doctor tried to reach me yesterday, but was too busy at work to take his call so he reached me this morning.
His advice was stop Ursodiol immediately! He explained further testing on the drug has shown that in large doses it not only does not help stop or subside PSC from getting worse, but may actually increase the damage to the liver. Pretty alarming.
I've asked him for the links to the studies he informed me of, and will post when I receive them. A little disheartening to think that a drug you thought might be helping you stave off the damage of the disease may have made it worse!
It sounds like you were not on it for very long. We were given the option to try it, advised that it was not showing improvement in PSC but might just mask liver function blood tests to look better on paper. My husband tried it for a few months and found that to be true... and he stopped taking it because white bumps began appearing on his body. The went away soon after he stopped. All the drugs you take have to go through the liver... so it does seem wise to only take what you must for keeping yourself comfortable.
I disagree with you. The AASLD actually recommends to stop giving Urso to PSC patients because of the now famous (infamous) Lindor research. All the PSC patient support groups I am attached to seem to agree that that decision was taken too quickly and that the research was flawed from the beginning. The doctor is not incompetent but follows the AASLD guidelines that you and me disagree with. I keep taking my Urso, and I do so because my LFTs are within the norm with Urso and all over the place whithout Urso.
One of the authors in the study sited below was my husbands gastroenterologist for the last 5 years. In 2010 he allowed my husband to choose whether to try the URSO, but cautioned that the studies appeared to indicate that it did nothing to improve the outcome of PSC, that his liver enzyme tests would look better on paper, and the drug appeared to benefit those with PBC , but not PSC. He tried it and the claim about the enzymes improving was true... but the bumps were a concern along with the iffy outcome. Knowing the physician that was a part of this, *I respect him highly) I'd go with the conclusion stated in the article: not good stuff.
Conclusions
Long-term high-dose UDCA therapy is associated with improvement in serum liver tests in PSC but does not improve survival and was associated with higher rates of serious adverse events.
Wonder what happened to the edit option? Was going to clarify that the CONCLUSION stated below is a quote from the article... not my conclusion... albeit, I agree with it.
The problem with the Lindor research is that the dose was too high and the patients were too sick when starting the research. Here in Israel and in Europe it was decided to lower the dose to ~15 mg/kg body weight, which does not seem to have the adverse effects. It is hard to prove who is right, but for me medium dose Urso works to lower my LFTs, so I would hate to stop using it.
I'm currently on a ~17 mg/kg dose, and my Doc at Mayo is just fine with it. Seems to do a decent job of keeping LFTs down, although it's effect on outcomes is uncertain.
In my case keeping LFTs down is a good thing, as I get to have the FAA review all my records every year.
Recent research also shows that patients with up 1.5 times normal alkalyne phosfatase have a better outcome than the ones with higher ALP. It doesn't seem to matter if the lower ALP is a result of Urso or not.
CJ- what is the FAA? ANd Chaim, can you direct me to that research about the alkalyne phosfatase? I wonder if there is speculation about how the lower dose causing alower alkalyne phosfatase affects the outcome. Interesting. Part of the reason I love this forum is the range of studies and anecdotal stories from so many countries. Thanks again, Chaim.
Dolphin: Federal Aviation Administration. I'm a pilot for a living, and every year I have to have a flight physical, and part of that process is the FAA reviewing all of my records from the past year. I've been told that very high LFT values, even if explained, start to make them worry excessively.
I think it is a lie that Ursodiol does nothing and only mask the blood test samples. Before I took Ursodiol I was literally in pain all the time. I could awaken in the middle of night from heavy waves of pain and just have to lie in bed until it passed. Or I would wake up because of the itchiness under my palms and feet or just my body in general. Yes within that month of when my body had to get Ursodiol it weren't getting any better but then suddenly it worked and thanks to Ursodiol I had no pain, itchiness or night sweat. My liver samples were down to normal as well where in the period before it would level around 2-3 times of what it should and it had been like that for half a year. I haven’t had no problems since and that was in 2012. Hopefully it will continue like that. I did have some changes in my bile ducts however which showed up in MR scan but that was from before I got these real bad pain attacks and before I began to take Ursodiol. I am gonna have a new MR scan this year and hopefully there will be no change from the last year. I get 250mg 3 times a day one in the morning and two in evening. I know there might be a bigger risk of developing cancer yet I think it is worth the risk to at least have a great useable life as long as it last and I damn hell planning on it to last a lifetime with or without my liver and bile ducts saying.
Some patients see an improvement on urso (maybe 10%), some not. I take low dose Urso now for one year and my liver values are back to normal. The study your doctor heard about was a high dose Urso study.
For your PSC you need a specialised doctor, all the others will just make you crazy with partial information.
When my husband was first diagnosed with PSC about 3 years ago he was put on ursodial. His GI doc said studies had showed it "may" helped with the disease. After being on it for about 2 years his doctor took him off because he said new studies had shown it did not help with the progression of the disease, so why bother taking it. I think his dose was 500mg 3x's daily also. It did seem to help my husbands blood tests, but he wasn't really fond of taking it; so after much discussion we decided if it was not going to change the outcome of the disease why bother taking it when it sucked to take. He's been off of it going on a year or so now.
My son is taking a moderate dose of urso. His liver enzymes did come down quite abit, however, it still doesn`t affect the tissue of the liver itself, nor the outcome of the PSC. Interestingly though, my son also has ulcerative colitis, and our specialist feels it has a small benefit as according to some research, offers the possibility of helping to protect the colon from colon cancer. As well, we did talk at length with our specialist about why he would put our son on it, when it was no longer recommended, and he explained that it is his understanding that urso used in HIGH doses has a detrimental effect, but within a particular low to mid range, it does not display those negative effects. As well, he told us the studies that showed urso to have negative effects as it came into use for PSC, there was much question about it, since some of the patients had other complex health issues, and other factors could have brought on negative effects.
That`s what we got out of it. Either way, we sympathize with your disappointment that urso has limited benefits. It is frustrating.
Well since first being diagnosed in 2011 with PSC, most of my Liver Function tests have improved.
Bilirubin is 0.5
ALT was 81 in 2011 now is 57
AST was 71 in 2011 now is 42
Alk Phosphate was 362 in 2011, now is 336 four years later
Guess there is no right or wrong way to look at it. I would prefer not taking the medicine if it will not help in the long run. Real telling point with my coming off the drug this week after a few years on it will be my next set of tests in 3 months.