The Elmiron Study discussed

[Paso]

http://www.ichelp.org/pressreleases/PR2003-08-12.html

Nothing new really. Same info as before. I believe people shall continue with Elmiron if they are helped by it. Or am I wrong?

/Paso

[webslave]

Paso, thanks for the quick posting of this link!

I disagree with your conclusion. Why?

... neither the drugs nor the combination therapy produced a statistically significant benefit in patients. ... The NIH press release further states, "Because these treatments proved ineffective for the majority of patients, researchers do not plan to expand the trial, ordinarily the next step if a pilot study is successful.

The ICA webpage is giving the situation the most positive spin possible. Remember, sponsorship by Elmiron's makers is their life-blood.

Who in their right mind would pay over $200 a month to take a chemical proved to be no better than placebo, especially when it could result in baldness and a long list of fairly serious side effects, including the rare but terrifying chance of exsanguinating (bleeding to death)?

Let's be real.

The key thing here is that the scientists themselves scrapped this study at the pilot stage. They have given Elmiron the thumbs down, not me. They have declared that it is not different enough from sugar pills to warrant further study. I think we should listen to them.

[Paso]

Webslave,

You are right. However dont you think that there are some people out there who actually benefit from Elmiron? If not then we should also disregard Atarax who show even lower benefit than Elmiron according to the study. I will think twice however before starting Elmiron thanks to you and this study.

Take care

/Paso

[webslave]

You know, to make me take a medication, you must first prove that more people are helped by it than by plain sugar pills. They cannot do that with Elmiron.

The placebo effect can be very powerful. What's worse, it can be so powerful that the calming effect it can have can itself lead to a real improvement in the patient's condition. Think about it. The placebo effect may be like a form of Wise's "Paradoxical Relaxation" for the patient. So Elmiron, through the placebo effect, may actually cause REAL IMPROVEMENT in some people. When these people tell you they are much better, they are not lying. But give them sugar pills and tell them it is a real medicine, and they will get better too.

---------

Interesting article on the power of the Placebo effect(read article).

[webslave]

Your comment on Atarax: I have already described on this forum how Atarax (hydroxyzine) has antimuscarinic activity that may actually make bladder symptoms worse. In fact, my wife (who does not have IC) gets slight bladder discomfort symptoms when she takes my (discarded) Atarax for her allergic rhinitis, so it's certainly true that it affects smooth muscle, even in controls. This could account for the lack of significant response in the study.

Following the myoneuropathic approach to CPPS, it is clear that antihistamines (and even any accredited quercetin product and ProstaProtek) are only treating the symptoms of a more extensive problem. But by treating those symptoms and relieving pain in target tissues, they may actually allow the neuronal windup to subside, and cause real, profound and long-lasting change.

[webslave]

Dr Theoharides comments (private email communication):

Please read the discussion of the paper (not the abstract) and you will find that the ADDITION of hydroxyzine to Elmiron was the only treatment that came close to being significant and many of the patients were undertreated with hydroxyzine because only a fraction of them reached 50-75 mg per day which is what Dr. Sant and I recommend. The announcement says that 40% were helped on the combination (even though it was not statistically significant), more than either single arm. I believe that if all had reached 50-75 mg hydroxyzine for the whole duration of the trial (they were titrated upwards individually), the combination may have reached significance.

[webslave]

Jill of the ICN has contacted me to say she feels the study was flawed because of the small sample. She feels that the study may be totally invalidated because this small sample does not allow proper statistical analysis. I argue that the results are in line with other Elmiron studies (non-placebo-controlled), so the study seems valid to me. But if you have an opposite view, be sure to post it here. Jill also made the comment that she has spoken to "thousands" of women helped by Elmiron over the years. So, let's see what expert opinions emerge for or against this study in the future ...

So far, one chronic prostatitis / chronic pelvic pain syndrome researcher has said to me that this study does appear underpowered for the design. His comments make me somewhat less sure of my blanket condemnation of Elmiron, but I still feel that it is preferable to take a natural form of GAG replenisher (Cystistat [Hyaluronic Acid], CystaProtek).

Before acting on any of my advice, remember that I am not a doctor, just an opiniated and fairly well-informed layman.

[jd]

This is pretty dramatic news....I feel badly for the women who have grown to depend on Elmiron.

However I don't see it as anything monumental, the power of your own body to bring itself to wellness (through high quality nutrition, skilled relaxation, physical therapy, exercise) far exceeds any pill you can take....

You just have to take the initiative to get yourself on the path to wellness in an extremely unhealthy and unnatural world, it's unfortunate that people(and most of the medical establishment for that matter) are conditioned from a young age to not see things in this way.

Part of the blame goes to the pharmaceutical industry, greed rules the world.

[webslave]

Here is the official NIDDK Press Release on the study.

For Immediate Release
August 11, 2003

Title: Interstitial Cystitis Study Finds Limited Benefit in Two Oral Drugs

An 18-month pilot study of two commonly available treatments has shown no significant benefit in patients with interstitial cystitis (IC). The results are reported in the September issue of the Journal of Urology.

The first in a series of treatment studies planned by the Interstitial Cystitis Clinical Trials Group tested the effectiveness of pentosan polysulfate sodium (Elmiron®) and hydroxyzine hydrochloride (Atarax®) in 121 patients with IC. Most volunteers reported experiencing moderate pain, discomfort and urinary frequency for at least a year before entering the study.

IC is a chronic, debilitating condition that affects about a million people, most of them women. Patients suffer pelvic, bladder, or perineal pain and the urge to urinate as often as 18 times a day. Available treatments are limited and not effective for everyone. The National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) initated the Clinical Trials Group in 1998 to identify useful therapies for this devitalizing and difficult disease with no known cause and no cure.

Elmiron® and Atarax® were chosen for early testing because patients prefer oral drugs and each drug has different mechanisms of action. Elmiron® is the only drug approved by the Food and Drug Administration for IC. Doctors do not know exactly how it works, but one theory is that it may repair defects that might have developed in the lining of the bladder. In some patients, mast cells are present in the tissue of the bladder wall, possibly a sign of an allergic or autoimmune reaction. Atarax®, an antihistamine previously untested in a randomized, placebo-controlled trial for IC, reduces mast cell activity. Mast cell activity can cause bladder inflammation and pain, and may play a part in IC.

Patients in the randomized trial received either Elmiron® or Atarax®, a combination of the two, or a placebo. Researchers hoped that a combination treatment might result in faster, more effective symptom relief. However, neither the drugs nor the combination therapy produced a statistically significant benefit in patients. Forty percent of the volunteers who took the combined treatment benefited. Elmiron® alone helped 28 percent of the patients in the trial, while 23% percent had a positive response to Atarax®. [my comment: for some reason this press release does not mention that placebo alone helped about 20 percent]. Side effects were minimal.

"We believe that IC may be caused by many factors," says Leroy M. Nyberg, M.D., NIDDK's Urology Program Director. "That would explain why some treatments work for certain patients but not others. It's also possible that these treatments might work better for IC patients with less severe symptoms than those seen in the volunteers," Nyberg adds.

Because these treatments proved ineffective for the majority of patients, researchers do not plan to expand the trial, ordinarily the next step if a pilot study is successful. They say, however, that they have gained useful information for future clinical trials in IC. The group has already recruited patients for its second treatment study, which is testing whether the bacterium Bacillus Calmette-Guerin (BCG), directly instilled in the bladder, relieves the pelvic pain and frequently urination that are hallmarks of IC.

[faceinthecrowd]

Hi all. I find all this information extremely interesting. I have been on Elmiron for a long time now (since November) and stayed on it because my CP symptoms seemed to improve, and I figured I better just stick with it. But now I seem to have a problem with gastroesophageal reflux disease, and was wondering if anyone knew if Elmiron were implicated in that. I know the elmiron patient info lists indigestion as a side effect, but I never had any problems with this reflux until June, after I had been on the Elmiron for over 6 months. Thanks and hope everyone out there is doing well.

[jori]

I was on Elmiron for over six months. Don't remember the dosage but it was quite high anyway. No positive or negative effects. I had the feeling that Elmiron was bullshit even before I took it and am even more convinced of it now. It's some marketing bluff. I hope the research will turn to other directions now.

[Tomass]

I have been taking chondroitin sulfate for about three months.

Some time ago on the Webslave's webpage https://ucpps.men we could learn that Chondroitin Sulfate is "The poor man's Elmiron®. Chemically similar to Elmiron® yet available without a prescription".

Does this chemical similarity mean that the recent studies on Emiron can be applied to chondroitin sulfate?

BTW as far as I remember Prostaprotec contains chondroitin sulfate.

[webslave]

No. The two chemicals are independent, for instance like different antibiotics can be completely different in side-effects etc.