Maintenance therapy with colloidal bismuth subcitrate reduces duodenal ulcer relapse.

AIM: To investigate the efficacy and safety of daily low-dose colloidal bismuth subcitrate in reducing duodenal ulcer relapse. DESIGN: Double-blind, double-dummy group comparative clinical trial with random allocation. Healing Phase: colloidal bismuth subcitrate 240 mg twice daily vs ranitidine 150 mg twice daily for up to 12 weeks. Maintenance Phase: nightly, colloidal bismuth subcitrate 120 mg vs ranitidine 150 mg vs placebo for up to 12 months (high-risk patients received active treatment only). ASSESSMENT: clinical, endoscopy, random blood bismuth levels (and rapid urease test for Helicobacter pylori in a subgroup). PATIENTS: 194 with active duodenal ulcer. OUTCOME: Cumulative healing at 12 weeks was 93% on colloidal bismuth subcitrate (of 92 patients) and 97% on ranitidine (of 102 patients). Relapse at 1 year was significantly less on active treatment as follows: placebo (50 patients) 60%; ranitidine (71 patients) 21%; colloidal bismuth subcitrate (64 patients) 33%. This was independent of the results of the rapid urease test which was positive in 78%, 88% and 76% of the patients respectively. Treatment was well tolerated. The highest median blood bismuth level (mcg/L) was 25 in the healing phase and fluctuated between 6 and 10 in the maintenance phase. CONCLUSIONS: Colloidal bismuth subcitrate, 120 mg nightly, is effective in reducing duodenal ulcer relapse and is well tolerated.

Effect of cyclospasmol on early diabetic retinopathy.

A randomized, double-blind, placebo controlled study to investigate the long-term effect of Cyclospasmol (cyclandelate) on the abnormal permeability of the blood-retinal barrier was performed in 26 patients with insulin-dependent diabetes mellitus for at least 1 year and minimal retinopathy. Cyclospasmol 400 mg or placebo capsules were taken 4 times daily for 12 months by equal numbers in both groups. Each patient underwent a routine ophthalmoscopic examination, retinal fluorescein angiography and quantitative vitreous fluorophotometry to assess the permeability of the blood-retinal barrier just before the trial and following 6 and 12 months of therapy. Laboratory tests for determining blood and urine glucose levels and blood HbA1-levels were also carried out at these assessments. Statistically significant changes in diabetic control, in HbA1-levels or in the frequency of retinal microaneurysms could not be shown in either treatment group during the trial, nor were there any significant differences in these parameters between the two groups. Analysis of fluorophotometric data on fluorescein penetration into the left posterior vitreous demonstrated significant reductions in this parameter during the trial compared to the pretreatment level in Cyclospasmol treated diabetics. These changes in the pretreatment level after 6 and 12 months also differed significantly between the two groups. However, this statistically significant beneficial reduction in fluorescein penetration into the left posterior vitreous did not occur in the right eye in the Cyclospasmol group. In placebo treated patients a consistently deleterious trend for this parameter was observed for both eyes during the one year study.(ABSTRACT TRUNCATED AT 250 WORDS)

Cyclandelate in the treatment of multi-infarct dementia. Interim findings from a multicentre study in general practice.

An open, multicentre clinical trial conducted in general practice was undertaken to investigate the effects of treatment with cyclandelate 800 mg twice daily in elderly patients with multi-infarct dementia. Interim findings in 303 patients demonstrate significant improvements after 12 weeks' treatment in mean scores of cognitive functions, orientation, verbal communications, social behaviour and interest in others and in the environment as assessed by the Blessed Dementia Scale and Parkside Behavioural Scale. Although a placebo response cannot be excluded because of the uncontrolled design of the study, these findings appear to warrant further investigation in well-designed controlled clinical trials in patients with multi-infarct dementia.

The efficacy of intra-articularly administered MYC 2095, triamcinolone hexacetonide and placebo in gonarthritis. A combined double-blind clinical trial.

We report the results of a double-blind three-centre study, employing a cross-over design, set up to compare the efficacy of intra-articular injections of Myc 2095 (20 mg), triamcinolone hexacetonide (Lederspan) (20 mg) and placebo in 40 patients with synovitis of the knee joint. Each patient included in the study contributed data on 2 of the 3 treatment variables being compared. Seven clinical parameters were assessed every 6 weeks, while the doctor's and the patient's assessments were scored. Intra articular treatment both with Myc 2095 and triamcinolone hexacetonide proved to be effective. Placebo response was also very high. After the first Myc 2095 injection, improvement in "tenderness", "pain under load" and "swelling and hydrops" was significantly superior to that following placebo treatment. The evaluation of the second injections indicated a marked carry-over effect from the first course. This was also evident from the doctor's and patient's assessments. The importance of including a placebo in the evaluation of anti-phlogistic drugs in clinical trials, emerged from this study.