CYCLOSPORINE USE IN THE PRECOLECTOMY CHRONIC ULCERATIVE-COLITIS PATIENT - A COMMUNITY EXPERIENCE AND ITS RELATIONSHIP TO PROSPECTIVE AND CONTROLLED CLINICAL-TRIALS
R. Kozarek et al., CYCLOSPORINE USE IN THE PRECOLECTOMY CHRONIC ULCERATIVE-COLITIS PATIENT - A COMMUNITY EXPERIENCE AND ITS RELATIONSHIP TO PROSPECTIVE AND CONTROLLED CLINICAL-TRIALS, The American journal of gastroenterology, 90(12), 1995, pp. 2093-2096
Objective: To define what effect seminal and controlled clinical trial
s have on practice patterns within a gastroenterological community. To
define whether these practice patterns reproduce reported treatment m
ethods and whether results comparable with those reported in such tria
ls are noted within a community practice setting. Methods: Mailed surv
eies, with telephone follow-up, were sent to all members of the Pacifi
c Northwest Gastroenterology Society. Respondents were queried regardi
ng cyclosporin use in the precolectomy chronic ulcerative colitis (CUC
) patient. Data collected included patient demographics, disease durat
ion and extent, pretreatment use of steroids, method, dosage, and dura
tion of cyclosporin therapy, side effects, and short-term and subseque
nt clinical results. Results: Twenty-one percent of 81 respondents had
used cyclosporin for precolectomy CUC, approximately one-half using c
onstant infusion and one-half using parenteral bolus therapy. Side eff
ects attributed to the cyclosporin were noted in eight of 30 patients
(27%), and acute colectomy was avoided in 17 patients (57%). Subsequen
t colectomy was required in an additional nine patients (73% total) wi
thin a 6-month follow-up period, a significantly higher colectomy rate
than that reported in prospective trials. Conclusions: Potential reas
ons precluding cyclosporin use within the gastroenterological communit
y may include lack of knowledge about cyclosporin therapy for CUC, lac
k of opportunity, skepticism, fear of medication side effects, survey
sampling error, or treatment philosophy. Potential reasons for failure
to duplicate the results reported in controlled trials are more compl
ex but may include inadequate treatment duration, the learning curve a
ssociated with use of a new medication, or acceptance of colectomy as
the treatment of choice in patients with acutely or chronically debili
tating disease.