Date of Award

Spring 5-31-1978

Document Type

Open Access Thesis

Degree Name

Medical Doctor (MD)


Methods and Materials: Twelve children with CIBD (7 with CUC and 5 with Crohn's) entered a trial with Cromolyn Sodium. The patient groups consisted mostly of those who had been treated with steroids over a 1-year period without suppression of disease activity, and in whom steroids could not be tapered without exacerbation. On commencement of Cromolyn therapy, steroid dosages ranged from 5-60 mg. q.d. (mean dose 30 mg. q.d.). Multiple complications of steroid therapy were observed in this group. Linear growth retardation was exhibited by 5 patients, 2 with Crohn's and 3 with CUC. One of the patients with CUC was also a Turner's mosaic. One patient with Crohn's had severe osteoporosis with multiple vertebral collapse. One Crohn's and 3 CUC patients were also Cushingoid. Severe side effects of Azulfidine were noted in 4 patients, 3 of whom developed hemo lytic anemia (1 Crohn's and 2 CUC), and 1 with CUC who developed total body rash. Five others (2 Crohn's and 3 CUC) were currently taking Azulfidine. Just prior to commencement of Cromolyn therapy, 2 patients (1 3 11 Crohn's and 1 CUC" ) developed severe exacerbation of the disease, requiring hospitalization for I.V. ACTH and blood transfusions. Three of 5 patients with Crohn's disease had undergone small and large bowel resections, and all 3 showed recurrences of the disease at the site of the anastomosis. All patients with Crohn's disease had ileocolonic disease with rectal involvement. Four of the 6 with ulcerative colitis had pancolonic disease, and 1 had the disease confined to the rectum. At the onset of 20. the Cromolyn trial, ages ranged from 9 to 20 years, with a mean of 15 years. Sex distribution included 9 females (6 with CUC) and 3 males (2 with Crohn's). All the patients in this study were white. Three patients (2 with CUC and 1 Crohn's) had positive family histories of CIBD. Cromolyn was given in the form of gelatin-coated capsules (20, 50, 100, 150 mg). Patients were instructed to open the capsules and dis solve the contents in warm water. Cromolyn was to be taken 1 hour be fore meals. Dosages varied from 300 to 600 mg daily, divided into 3 or 4 equal doses, according to each patient's convenience. At the time of this writing, duration of the treatment varied from 6 to 18 months. Two patients (1 male and 1 female who had Crohn's) did not respond to the Cromolyn therapy after 3 and 1 month periods respectively, and under went further surgery. Cromolyn was provided by Fisons Corporation, Ltd., Bedford, Mass. Previous drug therapy was continued for all patients (Azulfidine for 5, oral steroids for 7, vitamin supplements, and antidiarrheal agents). Before institution of Cromolyn therapy, the following laboratory data were obtained to rule out any hematologic, renal or hepatic abnormalities: CBC with differential, ESR, serum electrolytes, total protein and albumin, creatinine, liver function tests and urinalysis. A complete physical examination, including sigmoidoscopy and rectal suction biopsy, was also performed. Patients were seen in the Pediatric Gastroenterology Clinic approximately 2 weeks after starting Cromolyn therapy, and at monthly intervals thereafter. Laboratory tests listed in the foregoing were repeated during the monthly visits. Rectal suction biopsy was repeated approxi mately 2 to 3 months following initiation of Cromolyn therapy.