A Pilot Open Label Study Of Cystoprotek® In Interstitial Cystitis
T.C. Theoharides1 And G.R. Sant2
International Journal Of Immunopathology And Pharmacology Vol. 18, No. 1, 183-188 (2005)
Full Article PDF Version for Download‘, ‘Departments of Pharmacology and Experimental Therapeutics, Biochemistry,and Internal Medicine1, and Urology2, Tufts University School of Medicineand Tufts-New England Medical Center, Boston, Massachusetts 02111, USA
Received November 3, 2004 – Accepted December 1, 2004
Interstitial cystitis (IC) is a disorder of the urinary bladder characterized by urgency, frequency,nocturia and suprapubic pain. IC occurs primarily in women and symptoms are exacerbated by stress,ovulatory hormones and certain foods. IC pathogenesis is unknown, but the most consistent findingsinvolve some dysfunction of the bladder glycosaminoglycan (GAG) protective layer and a high number ofactivated bladder mast cells. There is no effective therapy even through intravesical administration ofdimethylsulfoxide (DMSO) or oral pentosanpolysulfate (PPS) have had variable success. A dietarysupplement, CystoProtek®, was formulated with the natural GAG components chondroitin sulfate andsodium hyaluronate to provide urothelial cytoprotection, together with the flavonoid quercetin that hasanti-inflammatory properties and inhibits activation of mast cells. Thirty-seven female patients diagnosedby the NIDDK criteria who had failed all forms of therapy took six softgel CystoProtek® capsules per dayfor 6 months. Global assessment scale was reduced from 9.0 ± 2.9 to 4.3 ± 2.1 (p <0.05); moreover, theO’Leary/Sant Symptom Index decreased from 16.3 ± 3.1 to 6.9 ± 4.2 (p <0.05) and the Problem Index from13.1 ± 3.7 to 5.4 ± 4.0 (p <0.05). These results are very promising and warrant a larger study that may permitfurther analyses with respect to other, especially atopic, comorbid diseases.’, ‘Full Article PDF Version for Download‘, ‘Research from Dr. Theoharides