Open Access

ARTICLE

Treatment of refractory interstitial cystitis/ painful bladder syndrome with CystoProtek – an oral multi-agent natural supplement

T. C. Theoharides^1,2,3, D. Kempuraj¹, S. Vakali¹, G. R. Sant⁴

1 Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine and Tufts Medical Center, Boston, Massachusetts, USA
2 Department of Biochemistry, Tufts University School of Medicine and Tufts Medical Center, Boston, Massachusetts, USA
3 Department of Internal Medicine, Tufts University School of Medicine and Tufts Medical Center, Boston, Massachusetts, USA
4 Department of Urology, Tufts University School of Medicine and Tufts Medical Center, Boston, Massachusetts, USA
Address correspondence to Dr. T. C. Theoharides, Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine, 136 Harrison Avenue, Boston, MA 02111, USA

Canadian Journal of Urology 2008, 15(6), 4410-4414.

Abstract

Objectives: Interstitial cystitis/Painful bladder syndrome (IC/PBS) is a chronic bladder condition of unknown etiology and pathogenesis. However, there is evidence of bladder surface mucosal and glycosaminoglycans (GAG) dysfunction in IC/PBS and GAG replacement therapy has been used to treat the condition. The results of an open label, uncontrolled study of a dietary supplement designed to improve GAG mucopolysaccharides integrity (glucosamine sulfate, sodium hyaluronate and chondroitin sulfate) and reduce bladder wall inflammation (quercetin, rutin) are presented herein.
Methods: Two hundred fifty two IC/PBS patients (25 men, 227 women; 18-69 years old), who had failed other treatments, took four CystoProtek capsules/day (mg/capsule: glucosamine sulfate, 120; chondroitin sulfate, 150; hyaluronate sodium, 10; quercetin, 150; rutin, 20). Symptoms were evaluated using a visual analogue scale (VAS) (severity range from 1-10) before and after treatment (< 6, 6-12 or > 12 months). The women were divided into two severity groups - a more severe A group with a baseline mean VAS score greater than or equal to 5 and a less severe B group with a mean score < 5.
Results: Male patients (55.72 ± 9.53 years, n = 25) had a mean VAS score at baseline of 7.6 ± 1.63 which fell 51.8% to 3.94 ± 2.46 (p < 0.0001) after 12.46 ± 8.76 months of treatment. The women (n = 227) experienced a 48.8% reduction in the mean VAS score (p < 0.0001) after 11.2 ± 8.7 months. The mean VAS score in Group A (49.72 ± 11.39 years, n = 207) fell 52.1% from 7.91 ± 1.55 to 3.79 ± 2.37 (p < 0.0001) after 11.06 ± 8.18 months and in Group B (52.40 ± 10.19 years, n = 20) fell 43.5% from 3.15 ± 0.92 to 1.78 ± 1.63 (p = 0.013) after 10.10 ± 5.80 months. Patients in Group A and B were further subdivided into Groups A1, B1 (> 12 months), A2, B2 (6-12 months) and A3, B3 (< 6 months treatment); improvement was statistically significant in all the more severe Group A treatment duration subgroups.
Conclusions: Dietary supplements targeting the bladder GAGs (chondroitin, glucosamine, hyaluronate) and bladder inflammation (quercetin, rutin) are useful in the treatment of refractory IC/PBS. Prospective randomized trials of such supplements are warranted in both treatment refractory and treatment naïve patients.

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