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Biomedical subjects

B Vernisse

Publications and source records attributed to B Vernisse.

4 recordsLinked to original sources

Randomized, multicentre comparison of sodium alginate and cisapride in the symptomatic treatment of uncomplicated gastro-oesophageal reflux.

AIM: To assess the efficacy and tolerance of sodium alginate compared to cisapride in patients suffering from reflux symptoms, without severe oesophagitis. METHODS: A total of 353 patients with symptoms of reflux oesophagitis (average age 40 years, 51% men, 33% smokers, 43% consumers of alcoholic drinks) were selected at random--180 treated with sodium alginate (4 sachets per day) and 173 treated with cisapride (5 mg four times a day) for 1 month, with a consultation every 2 weeks. Patients with severe oesophagitis or with predominant symptoms of motor dyspepsia were not included. The principal assessment criterion was the change in the severity of the reflux symptoms as evaluated using a visual analogue scale (VAS) at 4 weeks (extremes 0-100). The secondary criteria were the VAS score at 2 weeks, the number of patients considered as treatment failures, the number of episodes of pain, the impact of the reflux on daily activities and on sleep, and an estimate of costs. The statistical analyses were planned without any knowledge of the treatments allocated and on an intention-to-treat basis. RESULTS: There was no difference between the groups at the time of randomization. There were differences in the VAS in favour of the alginate at 2 weeks (29 +/- 22 vs. 35 +/- 25, P = 0.01) at 4 weeks (13 +/- 17 vs. 20 +/- 23, P = 0.001), for the number of episodes at 4 weeks (2 +/- 2 vs. 3 +/- 4, P = 0.001), for pain interfering with daily activities (3% vs. 10%, P = 0.009), for pain disturbing sleep (2% vs. 9%, P = 0.004), and for the proportion of patients considered as treatment failures (11% vs. 24%, P < 0.001). Compliance was similar in the two groups. The average cost for 1 month was lower for alginate (130 fr.) than for cisapride (175 fr.). CONCLUSION: Sodium alginate is more effective, and costs less, than cisapride for the treatment of symptoms presented by patients suffering from reflux without severe oesophagitis.

Adult

Acquired immunodeficiency with intestinal cryptosporidiosis: possible transmission by Haitian whole blood.

A 31-year-old Frenchman had an acquired immunodeficiency syndrome (AIDS) with profound depression of cellular immunity and relative sparing of humoral immunity. The clinical picture included intractable secretory diarrhoea, vomiting, abdominal pain, and weight loss. Gastrointestinal cryptosporidiosis was present and a perfusion technique showed profuse secretion of fluid in the proximal small bowel. The patient also had recurrent Salmonella typhimurium septicaemia, cytomegalovirus infection, and cerebral toxoplasmosis and he died within 13 months. This patient did not belong to any of the groups known to be affected by this type of acquired immunodeficiency (homosexuals, drug addicts, haemophiliacs, Haitians) but had been transfused with Haitian blood 4 years before onset of symptoms. This case supports the notion that some forms of AIDS may be transmitted by blood, with a long incubation period.

Acquired Immunodeficiency Syndrome

[Effect of levamisole on the prevention of developmental flare-ups in quiescent Crohn's disease: a prospective multicenter controlled trial in 155 patients].

The prevention of relapse in quiescent Crohn's disease remains a major therapeutic challenge. The present study is a double blind placebo (P)-controlled, randomized, multicentre cooperative trial designed to test the effectiveness of levamisole (L) in the prophylaxis against flare up in patients with quiescent Crohn's disease. The trial included 2 successive phases: a) phase I:167 patients with inactive disease (but who had not had previous resection of all diseased tissue) were randomly and double blindly assigned to receive either L (150 mg orally once weekly) or P; patients were randomized in 2 strata: those having experienced a recent flare up (within the 3 months preceding their entry into the trial: red strata) versus others (blue strata). Patients were followed up at 3 monthly intervals during 2 years. Initially there was no significant difference between L and P groups as regard to age, sex ratio, duration of disease at the time of randomization, incidence of prior intestinal resection, Crohn's disease topography, clinical activity; biological activity was slightly but significantly higher (P less than 0.05) in the P group. Twelve patients were withdrawn from analysis (lost to follow-up: 2; inadequate respect of the protocol: 10), leaving 155 patients (78 L, 77 P) who completed the study. L did not significantly influence any of the following parameters: incidence of attacks (L: 37 p. 100; P: 35 p. 100), lag time between the entry into the trial and the occurrence of the attack (L: 32.7 +/- 5.2; P: 41.8 +/- 5.8; m +/- SEM; weeks), curves of maintenance in remission (Kaplan-Meier method), outcome rank, severity of attacks. Attempts to analyse separately certain subgroups--subjects with purely colonic (+/- anal) disease, subjects with small bowel localization (+/- anus), patients of the red or blue strata--did not show any statistical difference between L and P. Thirteen patients left the trial for minor intolerance (10 L, 3 P). b) Phase II lasted one further year and involved the patients still in remission and in the trial at the end of phase I (n = 57). Those who had received L during phase I were randomized between continuance of L (L leads to L) vs. a change to P (L leads to P); those who had been on P during phase I were randomized between continuance of P vs. a switch to L.(ABSTRACT TRUNCATED AT 400 WORDS)

Clinical Trials as Topic