Ammo needed on budesonide tapering to prepare for GI doc visit

[MomLady]

Hi there,

It's been many months since I posted, and I am hoping to get some advice on how long to be on budesonide, and how to make a case for that with my doc. I am preparing for my second meeting with my GI doc on Wed - last meeting was pretty unpleasant, as she was dismissive of my dietary efforts, research efforts, etc. But hey, she's head of GI at the local hospital, so who am I to argue? (Insert SARCASM alert here). I would love to have some scientific studies to point to that would shore up my intended argument that I should perhaps be on full 9 mg dose of budesonide longer, and do a really long taper. Frankly, I don't even know WHAT exact treatment path I should be arguing for. I just know that from reading this forum and Tex's book, and other research studies besides, the standard operating procedure for budesonide treatment has a high relapse rate (9 mg for around 6-8 weeks, taper for a few weeks after that, and you still get something like a 70% or more relapse rate). I also recall reading there are "penalties" for going on and off budesonide, in terms of effectiveness and other side effects (e.g. increased risk for osteoporosis, I think it was). Does anyone have some good ammo I can bring to this Wednesday appt?

One study I found was this: https://gut.bmj.com/content/65/1/47

Short background summary on my MC path (if you want details, you could probably search on my earlier posts):
- dx'd MC in Jan 2019, symptoms not too bad
- By spring 2020, decided having occasional urgency and 3+ pudding-like stools a day was indicative of a problem, I "got serious" and decided to take action. Did Enterolab, got terrible results (aka, you react to everything, good luck on your new Air Diet). Went GF, DF, Chicken Egg-Free, and SF July 4, 2020. Independence Day indeed, but darker.
- despite a super strict diet of a very short list of safe foods, prepared by me, and careful food prep (and no loose flour in house, either) to avoid gluten contamination, I didn't improve. About twice (?) I had a short period of improvement for no apparent reason, then back to the pits.
- Tried cholestyramine twice, even at high dose, no good
- lost 12 lbs (alas, some was muscle, I fear)
- just got worse and worse til I was at 10-20 stools a day, watery, urgency, and it was hard to have any life at all, especially to take care of my kids
- finally relented, went to GI doc spring 2021, who thought I was ridiculous for staying on my strict diet so long if it wasn't working. She ordered a SIBO test, which turned out negative.
- Later at my urging, she agreed to put me on 9 mg budesonide. That has been a MIRACLE. Within a day and a half, I had Bristol 4's, toileting 2-4x a day, no urgency, no gurgling gas. I have a life back. No side effects that I can see. (I realize long term use can be bad for osteoporosis, etc.). Still on limited diet, maybe not quite as strict, but still GF, DF, SF, CF.

[tex]

Hi,

Sorry for the late response, but a response to your post couldn't be made in a few minutes, so I had to wait until I had more time available. First off, regarding this comment:

maybe not quite as strict

Anything less than 100 % strict, will not work for most of us. The word "almost", and the words "not quite", are not parts of \our vocabulary, if we intend to control our symptoms by diet alone.

Secondly, before I forget it, I'd like to point out that colestyramine usually won't work early on in an MC recovery program, because there are way too many food issues at that point. After you've carefully selected a safe diet, and followed it long enough to achieve remission, if your symptoms refuse to submit to the diet, then the remaining issue is often BAM, which will indeed respond to colestyramine, if the proper dose can be found, because the food issues should be resolved by the time you reach this point. In other words, I'm suggesting that you try colestyramine again, now that your food issues have been addressed.

Regarding the issue of attempting to educate gastroenterologists, for most of us, that tends to be a frustrating experience, because they consider themselves to be experts on digestive system diseases. Because of that, they can be as stubborn as mules (note my tagline). As we're all aware, that claim of expertise is generally without merit, with regard to the successful treatment of MC. Open-minded gastroenterologists do exist, but trying to locate one who is willing to learn from a patient, is almost as difficult as searching for the holy Grail.

That said, I've listed a few links to articles that you can print out or reference, to support your position. The first one is from my first book, and the other two are from my second book. Note that there are a number of research references that show varying rates of relapse for MC patients when their budesonide treatments are ended, but most show over an 80 % relapse rate. I've only listed two of those references.

6. Bonderup, O. K., Hansen, J. B., Birket-Smith, L., Vestergaard, V., Teglbjaerg, P. S., & Fallingborg, J. (2003). Budesonide treatment of collagenous colitis: A randomised, [sic] double blind, placebo controlled trial with morphometric analysis. Gut, 52(2), 248–251. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/12524408/

197 Park, T., Cave, D., & Marshall, C. (2015). Microscopic colitis: A review of etiology, treatment and refractory disease. World Journal of Gastroenterology, 21(29), 8804–8810. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4528022/

I'm not aware of any research to support long-term treatment at 9 mg per day (beyond 8 weeks) but reduced doses after that are definitely recommended. The article at the link below (the last one) supports the safety and efficacy of long-term (a year or more) treatment using budesonide at half that rate (4.5 mg per day). I believe the standard labeled rate is 9 mg for 8 weeks. You can verify that with the next reference, which is a copy of the label for Entocort EC, on file at tne FDA. Budesonide is not labeled for MC use — it's only labeled for Crohn's disease and UC. So treating MC with it is an off-label use, anyway. There are no drugs labeled for the treatment of MC.

Here's a link to the Entocort® EC (budesonide) Capsules data on file at the FDA:

https://www.google.com/url?sa=t&rct=j&q ... TCyrrCU6a3

And here's a direct quote from that document:

The safety of ENTOCORT EC was evaluated in 233 patients in four long-term clinical trials (52 weeks). A total of 145 patients were treated with ENTOCORT EC 6 mg. A total of 8% of ENTOCORT EC patients discontinued treatment due to adverse events compared with 10% in the placebo group. The adverse event profile in long-term treatment of Crohn’s disease was similar to that of short-term treatment with ENTOCORT EC 9 mg in active Crohn’s disease.

DOSAGE AND ADMINISTRATION
The recommended adult dosage for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon is 9 mg taken once daily in the morning for up to 8 weeks. Repeated 8 week courses of ENTOCORT EC can be given for recurring episodes of active disease.
Following an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI <150), ENTOCORT EC 6 mg is recommended once daily for maintenance of clinical remission up to 3 months. If symptom control is still maintained at 3 months an attempt to taper to complete cessation is recommended. Continued treatment with ENTOCORT EC 6 mg for more than 3 months has not been shown to provide substantial clinical benefit.

Here's a link to a research paper discussing a 12-month trial:

264 Münch, A., Bohr, J., Miehlke, S., Benoni, C., Olesen, M., Öst, Å., . . . Ström, M. (2016). Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial Gut, 65, 47–56. Retrieved from http://gut.bmj.com/content/65/1/47

I hope this helps,

Tex

[brandy]

Hi Mom Lady,

So your purpose of your GI doc visit is to get more budesonide?

I would not mention diet since she is not receptive.

Try the KISS program with her--Keep it Simple Stupid

When you talk with the intake RN mention how well the budesonide is working and you now have
quality of life.

Before bringing up studies I'd mention that your life was h_ll before getting before getting on budesonide.
Over exaggerate that you had WD 20 x per day before getting on budesonide. Mention you finally have
quality of life after many months of struggle.

Use terms like, "What are your thoughts on staying on the budesonide longer since it is working?
(Don't initiate taper discussion unless she mentions it.)

I'd over emphasize that the budesonide is working. If she wants you to stop it I'd be honest and say it
got you quality of life and you are afraid to be off of it.

I wouldn't initiate a taper conversation with her. Keep your studies in your back pocket, you may not need them.

Good luck. She may simply renew your scrip.

PS. I don't have the time to find them but there are some Mayo Clinic studies out there that the Mayo Clinic
is okay with long term use (years) of the 2 pill dosage of budesonide for MC

[MomLady]

Thanks for taking the time to answer my recent posts, Tex. I really appreciate your timeliness and thoroughness. It's reassuring to feel like someone out there both understands and cares. Thanks for mentioning the Mayo Clinic thing - I will have to look that up. (I had earlier found the 2016 BMJ study you mentioned in another post, with patients on 4.5 mg for a year after getting remission, and they seemed to have no terrible side effects.)

Mirabile dictu, I actually had a pretty good meeting with the doc yesterday. Perhaps she was just having a bad day the first time. I went in with the objective of getting agreement that a long slow taper off budesonide (rather than what I gather is the industry standard of 3-4 weeks). I wasn't going to try to convince her the diet advice a la Enterolab was a good idea; plus my lack of success in trying to implement those changes is hardly a good testimonial (setting aside here for the moment I might still somehow be getting glutened or something).

She was surprised that I had had such an immediate and strong positive reaction to the budesonide, considering I'd been in a really bad place for so long (weeks of 10-20x watery explosive D, but by day 2 of the budesonide, I was having maybe two 4's, a freaking miracle). I have no idea why that would be, either. She said she would like to get me off the budesonide eventually if possible, and I could start now to move to 6 mg (I have had a good month at 9 mg. I neglected to ask if i should wait another 2 weeks to cut it down to 6 mg). Then after a month, if all is going pretty well, cut it to 3 mg. She easily agreed to my suggestion that I continue slowly tapering after that, as I have read in your book (e.g. 3 mg every other day, or every third day, etc. ). So I do not get the impression she is going to yank my prescription.

Interestingly, I feel a little stronger in my yoga practice since beginning the budesonide, and the occasional weird skin stuff (described by a dermatologist as "eczematic") in certain patches has gone.

Thanks again!
Janet