Disodium cromoglycate in the treatment of chronic proctitis.

Abstract

SUMMARY The effect of topical disodium cromoglycate (DSCG) has been examined in 30 patients with chronic active proctitis using a double-blind crossover trial. Each treatment period was four weeks and patients were given DSCG 200 mg by enema twice daily and 100 mg orally three times each day. Twenty-six patients completed the trial successfully, 14 responded to DSCG treatment, two improved with placebo, and 10 responded to neither.Patients who responded to DSCG had significantly more eosinophils in their rectal biopsies than those who failed to respond and in some instances the counts were very high. The findings support the hypothesis that an allergic reaction is important in the pathogenesis of proctitis.Disodium cromoglycate (DSCG) is of proven clinical value in allergic bronchial asthma where it is thought to reduce the degranulation of mast cells in bronchial mucosa (Pepys, Hargreave, Chan, and McCarthy, 1968). Chronic proctitis is an inflammatory condition of unknown aetiology affecting the rectal mucosa. In a related condition, ulcerative proctocolitis, mast cell degranulation is a common feature in rectal biopsies (Bercovitz and Sommers, 1966). It is therefore pertinent to examine whether DSCG, if given topically, would have a beneficial effect in patients with proctitis. Proctitis is a particularly suitable condition to examine because in addition to recording any symptomatic response, the rectal mucosa can be both inspected and biopsied directly. A randomized, double-blind crossover trial was designed to examine the effect of this compound in a group of patients with chronic proctitis. Methods PATIENTSThirty patients with chronic proctitis were included in the trial but four were subsequently withdrawn. All had active symptoms which included rectal bleeding, the passage of mucus, and a change in bowel habit, usually with increased frequency. In all the rectal mucosa was abnormal on sigmoidoscopy. The subsequent details refer to the 26 patients

Controlled trial of disodium cromoglycate in chronic persistent ulcerative colitis.

“…Heatley et al (1975) found that those patients with a high eosinophil count in the rectal biopsy responded more frequently to disodium cromoglycate therapy, but in our patients this feature did not seem to be of prognostic value.…”

“…We chose the oral route of administration in this study because of the inconvenience of rectal treatment, particularly in patients already having regular steroid retention enema therapy. The dose, 800 mg, was selected as it was similar to that used by Heatley et al (1975), with encouraging results in chronic proctitis. It is possible that rectal administration, as used in combination with oral therapy by Heatley and his colleagues in their study, allows more of the drug to come in contact with the inflamed mucosa with an increased therapeutic effect.…”

“…Beneficial effects of disodium cromoglycate have been reported in the treatment of chronic proctitis (Heatley et al, 1975) and the long-term management of patients with slightly active total ulcerative colitis (Mani et al, 1976). There has also been a preliminary report of disodium cromoglycate in the maintenance of remission of ulcerative colitis (Dronfield and Langman, 1977).…”

Inhibition of gastric acid secretion with a mast cell stabiliser, FPL− 52694.

“…They have recently been examined in bowel disease where some patients with ulcerative colitis (Heatley, Calcraft, Rhodes, Owen & Evans, 1975) and allergic enteropathies (Dannaeus, Foucard & Johansson, 1977) appear to benefit. Since histamine is important in normal gastric acid secretion, the administration of a mast cell stabiliser may reduce acid secretion.…”

Assessment of drug therapy in inflammatory bowel disease.

“…(Buckell et al, 1978). Additional data has been generated by the use of diary cards to record bowel frequency by day and night, the amount of rectal bleeding, the degree of urgency, and incontinent episodes (Heatley et al, 1975;Buckell et al, 1978).…”