Oral beclometasone dipropionate in the treatment of extensive and left-sided active ulcerative colitis: a multicentre randomised study.

AIM: To explore the efficacy and safety of the topically acting steroid beclometasone dipropionate (BDP) in an oral controlled release formulation in the treatment of extensive or left-sided ulcerative colitis. METHODS: In a multicentre, randomised, parallel-group, single-blind study, patients with active mild to moderate ulcerative colitis were randomised to a 4-week treatment with BDP 5 mg/day o.d. vs. 5-ASA 0.8 g t.d.s. The primary efficacy variable was the decrease of Disease Activity Index (DAI) (clinical symptoms and endoscopic appearance of mucosa). Safety was evaluated by monitoring adverse events, vital signs, haematochemical parameters and adrenal function. RESULTS: One hundred and seventy-seven patients were enrolled and randomly treated with BDP (n = 90) or 5-ASA (n = 87). Mean DAI score decreased in both treatments groups (P < 0.0001 vs. baseline for both groups). Clinical remission was achieved in 63.0% of patients in the BDP group vs. 62.5% in the 5-ASA group. A significant DAI score improvement (P < 0.05) in favour of BDP was observed in patients with extensive disease. Both treatments were well tolerated. Mean plasma cortisol levels were significantly reduced vs. baseline in BDP recipients, but without signs of pituitary-adrenal function depletion. CONCLUSION: Oral BDP gave an overall treatment result in patients with active ulcerative colitis without signs of systemic side-effects.

Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double-blind placebo-controlled study.

AIM: To evaluate efficacy and safety of oral beclometasone dipropionate (BDP) when added to 5-ASA in the treatment of patients with active ulcerative colitis. METHODS: In a 4-week, placebo-controlled, double-blind study, patients with extensive or left-sided mild to moderate active ulcerative colitis were randomized to receive oral 5-ASA (3.2 g/day) plus BDP (5 mg/day) or placebo. Clinical, endoscopic and histologic features, and haematochemical parameters were recorded at baseline and at the end of the study. RESULTS: One hundred and nineteen patients were enrolled and randomly treated with BDP plus 5-ASA (n = 58) or placebo plus 5-ASA (n = 61). Both treatment groups showed a statistically significant decrease of disease activity index (DAI) and histology score at the end of treatment (P = 0.001, each). DAI score was lower in the BDP group than in the placebo group (P = 0.014), with more patients in clinical remission in the BDP group (58.6% vs. 34.4%, P = 0.008). Serum cortisol levels significantly decreased in BDP group vs. baseline (P = 0.002), but without signs of pituitary-adrenal function depletion. A low incidence of adverse events was observed in both groups. CONCLUSIONS: Oral BDP in combination with oral 5-ASA is significantly more effective than 5-ASA alone in the treatment of patients with extensive or left-sided active ulcerative colitis.

Beclomethasone dipropionate (3 mg) enemas combined with oral 5-ASA (2.4 g) in the treatment of ulcerative colitis not responsive to oral 5-ASA alone.

BACKGROUND/AIMS: Beclomethasone dipropionate is one of the topical corticosteroids which appear to have minimal systemic effects. We evaluated whether combined therapy with Beclomethasone dipropionate enemas and oral 5-aminosalicylic acid could be effective in patients suffering from ulcerative colitis not responsive to oral 5-aminosalicylic acid as monotherapy. PATIENTS: In twenty patients, non responders to 5-aminosalicylic acid treatment (2.4-3.6 g/day) given for at least 6 weeks, Beclomethasone dipropionate enemas (3 mg/60 ml/day) were added for 4 weeks. METHODS: Efficacy of the combination was evaluated before and at the end of the treatment using a clinical, endoscopic and histological score. RESULTS: After a four-week treatment period, a significant clinical improvement in stool frequency (p < 0.01), stool consistency (p < 0.001), blood (p < 0.001) and mucus in stools (p < 0.05), was observed. Endoscopy and biopsy confirmed an improvement in the activity score at the end of the treatment (p < 0.001). Six patients (30%) achieved remission, ten patients showed an improvement (50%) and four (20%) showed no benefits. No adverse event was observed. CONCLUSIONS: Beclomethasone dipropionate enemas combined with oral 5-aminosalicylic acid may be a safe and useful therapeutic approach in the treatment of ulcerative colitis not responsive to oral 5-aminosalicylic acid alone.

Beclomethasone dipropionate enemas versus prednisolone sodium phosphate enemas in the treatment of distal ulcerative colitis.

AIM: To compare beclomethasone dipropionate 3 mg/60 mL enema (BDP) and prednisolone sodium phosphate 30 mg/60 mL enema (PP) once daily in patients with active distal ulcerative colitis. METHODS: One hundred and fifty-seven patients were enrolled in a multicentre, 4-week, randomized, double-blind trial. Patients were assessed at baseline, 2 and 4 weeks. RESULTS: Both treatment groups showed statistically significant improvement of clinical activity after 2 and 4 weeks. Endoscopy and biopsy showed a reduction in the activity score at the end of the treatment period in both groups. No statistically significant difference was observed between the two treatment groups. After 4 weeks, 29% of patients in the BDP group and 25% in the PP group were considered to be in clinical remission; an improvement was observed in 40% of patients on BDP and in 47% on PP. Mean morning plasma cortisol levels showed a slight but significant reduction in the PP group, while the ACTH test showed that neither drug interfered with the hypothalamic-pituitary-adrenal (HPA) axis function. No significant changes were observed in the laboratory tests. Finally, there was a low incidence of adverse events in both groups. CONCLUSIONS: It is concluded that, in the topical treatment of active distal ulcerative colitis, BDP 3 mg enemas are as efficacious as PP 30 mg enemas, without interference with the HPA axis.

Effects of 1-year treatment with ipriflavone on bone in postmenopausal women with low bone mass.

Ipriflavone (IP) (7-isopropoxyisoflavone), a synthetic isoflavone derivative, is active in both inhibiting bone resorption and enhancing osteoblast function. This property suggested its clinical use in the treatment of involutional osteoporosis, and in the prevention of postmenopausal bone mass loss. Forty postmenopausal women with low bone mineral content were enrolled and randomly treated for 12 months with IP 600 mg/day or placebo (PL), according to a double-blind, parallel group design. All patients wee also given an oral calcium supplementation (1 g/day). Bone mineral density (BMD) was measured at the spine (L2-L4) by dual-energy X-ray absorptiometry and at the distal radius by single-photon absorptiometry. Bone metabolism markers (serum calcium, phosphate, osteocalcin, and alkaline phosphatase, and urinary calcium, phosphate, and hydroxyproline) were assessed at the same times. After 12 months, a reduction of BMD was evidenced in the PL-treated group, at both the spine (-2.2%, P < 0.01 vs baseline) and the forearm (-1.2%). In the IP-treated group, an increase of BMD was obtained (+1.2%, P < 0.01 vs placebo, at the spine; +3%, not significant, at the forearm). Bone markers were in the normal range for postmenopausal women; no statistically significant modifications were observed during the treatment period. Three patients were withdrawn from the treatment in the IP-treated group, and two in the PL-treated group for gastrointestinal disturbances. In the other women, the tolerance of the drug was good and the compliance with the oral treatment was excellent.

Effect of ipriflavone on bone mass in elderly osteoporotic women.

A study in elderly osteoporotic women was performed to assess the effect of one year treatment with ipriflavone (IP) on bone mass and bone biomarkers. Twenty-eight women aged over 65, with diagnosis of osteoporosis and X-ray evidence of at least one vertebral fracture, were treated with IP tablets (600 mg/day) or placebo (PL), according to a randomized, double-blind, parallel-group design. One g/day calcium supplementation was given to all patients. After 12 months a significant increase (+6%, P < 0.05) of bone mineral density (BMD) at the distal radius (DPA) was obtained in the IP-group. Serum osteocalcin (BGP) and urinary HO-proline/creatinine (HOP/Cr) values were reduced in the same group. BMD values did not change (-0.3%) in the placebo group. One woman of the PL-group was withdrawn from treatment because of worsening of pain, due to new vertebral crushes. Side effects (mainly gastrointestinal) arose in 8 IP- and in 5 PL-treated women. The compliance to the oral administration was good.