title: Comparative efficacy and tolerability of two ointment and suppository preparations ('Uniroid' and 'Proctosedyl') in the treatment of second degree haemorrhoids in general practice.
abstract: A multi-centre general practice, open study was carried out in 89 patients with second degree haemorrhoids to compare the efficacy and tolerability of two antibiotic-corticosteroid combinations ('Uniroid' and 'Proctosedyl') in ointment and suppository formulations. Patients were allocated at random into 4 groups and received treatment with one of the trial preparations for 1, 2 or 3 weeks, as required, with weekly assessments of response. There were no significant differences between the various groups at the start of treatment. Significant improvement occurred in all groups during treatment. Both suppository and ointment formulations were broadly comparable and control of symptoms was achieved from Week 2 onwards, building up to levels in excess of 90% after 3 weeks of therapy. With regard to the symptoms of pain and itching, suppositories gave marginally greater relief in the early stages of treatment, while both ointment and suppositories were associated with similar reduction in bleeding from haemorrhoids. Whereas both suppository formulations were about equal in reducing anal discharge, 'Uniroid' ointment was clinically superior to 'Proctosedyl' ointment in controlling this symptom over the 3-week trial period. No unwanted effects were experienced attributable to treatment. No statistically significant differences between the two ointment and the two suppository formulations were identified in this study and all four preparations were found to be efficacious in the majority of patients studied.
authors.affiliation: Medical Department, Pharmakopius Ltd., Goring-on-Thames, England.
authors.forename: R B
authors.initials: RB
authors.lastname: Smith
authors.forename: J
authors.initials: J
authors.lastname: Moodie
mesh_terms: D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003992:Dibucaine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004338:Drug Combinations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004929:Esculin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005419:Flavonoids / Q000008:administration & dosage*; D005601:Framycetin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006484:Hemorrhoids / Q000188:drug therapy*; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009355:Neomycin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D009824:Ointments; D011112:Polymyxin B / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011113:Polymyxins / Q000008:administration & dosage*; D011897:Random Allocation; D013488:Suppositories
chemical_list: D004338:Drug Combinations; D005419:Flavonoids; D009824:Ointments; D011113:Polymyxins; D013488:Suppositories; C056406:Uniroid; D004929:Esculin; D005601:Framycetin; C056407:Proctosedyl; D009355:Neomycin; D011112:Polymyxin B; D003992:Dibucaine; D006854:Hydrocortisone