Effect of treatment on symptoms and quality of life in patients with ulcerative colitis: comparative trial of hydrocortisone acetate foam and prednisolone 21-phosphate enemas The disability associated with ulcerative colitis and proctitis is considerable and includes decreased working capacity, early rising, increased bowel frequency, fear of incontinence, urgency, and tiredness.' Sexual relationships may be adversely affected. Treatment itself may impose further restrictions on patients with this disease. We have compared the effects of foam and liquid topical corticosteroid preparations on the symptoms and quality of life of patiernts with distal ulcerative colitis. Patients, methods, and results We studied 46 patients (18 men, 28 women) aged 20-64 years with symptomatic relapse of chronic ulcerative colitis. All had histological confirmation of the diagnosis and sigmoidoscopic evidence of current exacerbation. Daily bowel frequency and severity of symptoms were assessed, urgency and lassitude being measured on visual analogue scales. Similar scales were used to assess disturbance of the quality of life caused by the treatment and by the disease, and patients also maintained daily symptom score cards. Treatment with prednisolone 21-phosphate enemas (Predsol; 20 mg prednisolone 21-phosphate in a buffered solution of 100 ml) or hydrocortisone acetate foam (Colifoam; 130 mg hydrocortisone acetate in 5 ml foam) was allocated blindly using a prearranged code. It was applied morning and evening for the first two weeks, then nightly for the next fortnight if responses were satisfactory. If responses were unsatisfactory the alternative treatment was supplied. Sigmoidoscopy was repeated after four weeks or if treatment was changed. Data were analysed non-parametrically using the Mann-Whitney U test (two tailed). Five patients were excluded from analysis. In the enema group two showed poor compliance and one took medication for one week only, and in the foam group one patient was given the wrong medication and another was symptom free at entry. The groups did not differ materially in sex or age distribution, duration of disease or of recent episode, extent of disease, or numbers receiving concomitant sulphasalazine. Treatments were equally effective in reducing bowel frequency, urgency, incontinence, and lassitude, but tenesmus was more completely alleviated at two weeks in those receiving the prednisolone enemas (p < 0.025). Sigmoido-scopic abnormalities improved similarly in both groups. After two weeks of treatment four patients changed from the foam to the enema because of poor response; two had slight symptomatic improvement and two did not. The one patient who changed from liquid treatment to foam did not benefit. No serious adverse reactions were reported. Considerable disturbance of general activities due to the exacerbation of ulcerative colitis was recorded before treatment started. This decreased during treatment in both groups and was significantly reduced from baseline after four weeks. In all seven variabl...