Study finds limited benefit from two oral drugs.

2003 SEP 4 - (NewsRx.com & NewsRx.net) -- 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 2003 issue of the Journal of Urology.

The first in a series of treatment studies planned by the IC Clinical Trials Group tested the effectiveness of pentosan polysulfate sodium (Elmiron; Alza Pharmaceuticals) and hydroxyzine hydrochloride (Atarax; UCB Pharma Inc.) 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 U.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) initiated 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 oral drug approved by the U.S. Food and Drug Administration for IC. Doctors do not know exactly how it works, but one hypothesis is that it may repair defects 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 ...