Re: STUDY ** High-Dose Ursodeoxycholic Acid Fails in PSC**

[Guest guest]

My husband just saw Dr. Harnois this past week. We were not very happy

with her. For the past 4 years my husband has gone to Mayo clinic and

has been treated. It seemed like as soon as he saw her she

immediately gave a different prognosis. Something to the extreme of

how he wouldn't get the transplant until there was nothing else that

could be done. This is opposite of what others have said.

She did however mention the Urso and that in a recent study that high

levels caused other issues. The National Liver Conference has

suggested that the dosage be cut back. She checked my husbands levels

and said they should be calculated according to weight. She said many

Dr.'s were giving higher levels than what was recommended.

Patti

>

> Marie, I also had my Urso cut drastically after I went to Mayo, I

ended up sick and also very itchy. After I called Dr Harnois at Mayo

she increased it again, just not quite as high a dose as before. I

have started feeling somewhat better, she said she has had this happen

to others.

>

> Glad you are doing better. I also have a BCIR like Barby. She will

probably tell you all about it .

> Take care,

> Bettyann

>

[Guest guest]

Hi from Marna, Wesley, and Colin,

Again,,,this is an indicator of why Dr. Gene Whitington ( Pediatric

Gastroenterologist with Foundation ), said he see's thousands

and none of them look as good as my son. I have bucked the system and

made my GI and hepatologist mad by listening to a PHD and doing

research on my own and not giving my son Urso.

I amazed them when I cured him of his severe reflux ,,,,took him off

Nexium and put him on Primal Defense Ultra Probiotic. I WILL NEVER

GIVE HIM CIPRO OR FLAGYL which are very damaging chemotherapeutic

agents. ( Just read a little of the quinolones yahoo group ! )

Everything good has come from my research ,,,and everything bad has

come from the gastro's. Sad but true.

IV Glutathione has been a miracle. Wesley highly recommends it ! His

energy has skyrocketed! His liver functions which are typically in

the 500-800's went to normal for the first time in his 12 years of

being diagnosed with PSC/UC at age 3....symptomatic since 1 year old

vaccines.

He also takes 4000mg of folic acid, alpha lipoic acid, B-vitamins,

Lysine, arginine, vitamin D-3 , Vitamin A, Betaine HCl, and has many

churches in the United States, and other countries praying for

him,,,Catholic, Mormon, Baptist, Lutheran, Pentecostal, Assembly of

God, Non-Denominational, Disciples of Christ, etc, etc

This is such a scary disease that everyone has to make decisions for

themselves,,,but, do your own research, don't be afraid to walk off

the beaten path, and NEVER put your doctor in the " God " category.

As this study shows they are having to back up their tracks. The key

to this disease is not masking the symptoms,,,waiting to turn yellow

and having a hoped for transplant. It is doing everything you can to

beat it at the cellular level.

God bless all,

Marna....worried mom since 1998. A lot of what I have worried about

has not come true ,but it doesn't mean I am not scared. He is my baby

and it has been hard to go against some of these Gastro's and

Hepatologist.

>

> In patients with PSC, treatment with high-dose ursodeoxycholic acid

> (UDCA) may cause more harm than good, according to a study reported

> here.

> Consistent with anecdotal reports, UDCA improved liver

biochemistry, but

> did not improve survival and was associated with twice as many

serious

> adverse events as placebo, said Lindor, M.D., of the Mayo

Clinic

> in Rochester, Minn.

> " It led to biochemical improvement. The unanticipated finding was an

> excess of adverse events, clinically significant adverse events.

That

> was really surprising to us. "

> To confirm the benefits observed in small uncontrolled studies,

> investigators enrolled 150 patients with PSC in a randomized

clinical

> trial. Eligible patients had chronic cholestatic disease of at

least six

> months' duration, alkaline phosphatase levels more than 1.5 times

> normal, cholangiographic documentation of PSC, and confirmatory

liver

> biopsy.

> The patients were stratified by stage (I or II versus III or IV),

> presence or absence of varices, and Mayo risk score of less than

1.5, or

> 1.5 or greater.

> The patients received UDCA 28 to 30 mg/kg/day in 250- or 500-mg Urso

> Forte (Axcan) or matching placebo.

> The primary objective was to assess the effects of UDCA on the

endpoints

> of progression to cirrhosis, development of varices,

cholangiocarcinoma,

> transplant, and death.

> Baseline characteristics were similar between the two groups. About

60%

> of patients had stage I-II disease, and the Mayo risk score

averaged 0.3

> in both groups.

> Dr. Lindor reported that 52 patients in the UDCA group and 27 in the

> placebo group met the endpoints, including death (four in the UDCA

group

> versus two with placebo), liver transplant (11 versus four), and

> development of varices (15 versus five).

> In a hazards model that censored at last patient contact, the UDCA

group

> was more than twice as likely to meet an endpoint (HR 2.42,

P=0.004).

> Limiting the analysis to death or transplant, the investigators

found

> that UDCA posed more than twice the hazard of placebo, whether

censoring

> was at date off protocol (HR 2.61, P=0.046) or at last contact (HR

2.80,

> P=0.028).

> The study was terminated upon the recommendation of the data safety

and

> monitoring Board because of futility and concern over adverse

effects.

> The surprising results leave the clinical status of UDCA for PSC in

> limbo.

> " We know that this higher dose shouldn't be used, based on this

study, "

> Dr. Lindor said. " The intermediate doses have not, in other studies,

> showed a survival benefit. They led to biochemical improvement.

> " Three studies have looked at ability of ursodeoxycholic acid to

reduce

> colonic dysplasia, " he added. " About 70% of patients with this liver

> disease have coexisting ulcerative colitis. The risk of colon cancer

> with that combination is quite high.

> " There are some that think the drug may have a place in reducing

that

> risk of cancer. The data supporting that are from retrospective

studies,

> and, in my mind, aren't strong enough to lead us to recommend use

on a

> routine basis for that indication. "

> FULL ARTICLE:

http://www.medpagetoday.com/MeetingCoverage/AASLD/11632

>

> Barb in Texas - Together in the Fight - Whatever it Takes!

> Son Ken (34) UC 91 PSC 99, LTX 6/21 & 6/30 2007 @ Baylor/Dallas

>