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EDITORIAL COMMENTS

The authors describe their experience using an immunoregulator,IPD-1151T, which purportedly suppresses helper T cell mediatedallergic responses. They report using this agent in a single arm trial,which enrolled 14 women who were treated for 1 year and thenfollowed at 4 and 12-month intervals. The authors noted a significantincrease in bladder capacity from pretreatment values as well as asignificant decrease in interstitial cystitis symptoms. IPD-1151T hadno significant side effects, although 2 patients reported a skin rash,and continued therapy for the 12-month duration of the study. Whilethe results of this trial seem promising, a cautionary note should besounded. Interstitial cystitis is a condition that is typified by awaxing and wanning of symptoms as well as a significant placeboeffect during treatment. The authors have shown that this agentappears to be well tolerated for up to 12 months. However, to makeany definitive statement about efficacy, I believe a sufficiently pow-ered, randomized controlled trial must be performed.

Karl J. KrederDepartment of UrologyThe University of IowaIowa City, Iowa

The authors present an interesting pilot study showing improve-ment of interstitial cystitis with IPD-1151T, a new immunoregulatorthat suppresses helper T cell mediated allergic responses, includingIgE production and eosinophilic inflammation. While the study is

small and not placebo controlled, the results are rather dramatic on3 fronts: 1) subjective symptomatic improvement was complete in 10of 14 patients and moderate in 2, 2) objective improvement in blad-der capacity with time increased from 87 to 215 cc, and 3) concomi-tant changes occurred in blood and urine markers indicating animmune system response. Whether the changes in the autoimmuneparameters are directly related to treatment of interstitial cystitis orsimply reflect improvement of associated allergic conditions in 8 ofthe 14 patients so affected is unclear.

We have all seen similar fantastic results with new therapiesduring the last several years, and a high degree of cynicism iswarranted. Nevertheless, the findings cannot be dismissed, and adouble-blind placebo controlled study in a large group of patientswith interstitial cystitis is warranted.

Philip M. Hanno657 Augusta CourtBerwyn, Pennsylvania

As a pilot study the article opens a new line of inquiry. However,it should be noted that there are a number of methodological issuesthat need to be addressed before any conclusions can be drawn fromthis study. The sample size is small with 14 patients, and so gener-alizability of results is in question. There was no control or compar-ison group and no attempt to blind the investigators or at least theevaluation process. Therefore, the chance that results may be dis-torted due to a systematic bias exists and must be assumed to bepresent in this study. Finally, multiple, before and after comparisonswithout any statistical adjustment make the statistical analysisinvalid. This article is clearly a hypothesis generating study andshould contain only descriptive statistics and use preliminary resultsas estimates to recommend a future and larger controlled trial.

G. Keith ChambersClinical Epidemiology and EvaluationVancouver General HospitalVancouver, BCCanada

ORAL IPD-1151T FOR INTERSTITIAL CYSTITIS1920