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M Langman

Publications and source records attributed to M Langman.

25 records · Page 2Linked to original sources

Differing attitudes of industry and academia towards controlled clinical trials.

A consensus conference was held in 1984 on controversial issues concerning controlled clinical trials. Thirty-six individuals working in academic institutions, forty-six in industry and twelve in regulatory authorities participated. Academics accepted and industrial representatives rejected the following: existing regulations cannot cope with the rate at which new treatments develop; drug companies may be reluctant to undertake surveillance programmes because sales will fall if adverse reactions are detected; novel remedies should not be promoted before extensive post-marketing surveillance; third parties should finance trials promising to reduce the costs of illness and trialists should be separated from sponsors in data analysis and interpretation, the investigator owning the data unless stated otherwise. Industrial representatives supported and academics rejected the following: government price control inhibits drug development and a multicentre trial can be justified simply by the wish to speed drug registration.

Attitude↗

Treatment with histamine H2 antagonists in acute upper gastrointestinal hemorrhage. Implications of randomized trials.

Histamine H2 antagonists are widely used in treating patients with hematemesis and melena, despite the lack of reliable evidence of benefit from any of the randomized trials, considered separately. Examination of the data from all 27 available randomized trials, in which over 2500 patients were entered, suggests that treatment may reduce the rates of rebleeding, surgery, and death by about 10, 20, and 30 per cent, respectively, although these results were only marginally significant for surgery and death. Any benefit appeared to be confined to patients with bleeding gastric ulcers, but since this subgroup analysis was prompted by preliminary examination of the data in some of the individual trials reviewed here, it should be treated with particular caution. The implications of this overview are that treatment with histamine H2 antagonists appears to be moderately promising, but its effects on important end points, such as death, still need to be assessed reliably. Prevention of "only" about 20 per cent of all deaths could well be worthwhile, for the condition is common, and the treatment widely practicable. To detect such a moderate effect reliably, however, might require the randomization of 10,000 patients (or more), which would be possible only in an extremely simple multicenter collaborative trial.

Acute Disease↗

Cimetidine and tranexamic acid in the treatment of acute upper-gastrointestinal-tract bleeding.

We studied the effects of tranexamic acid (an antifibrinolytic agent) and cimetidine on acute upper-gastrointestinal-tract bleeding in a double-blind randomized placebo-controlled trial in 775 patients with hematemesis or melena or both. Mortality was significantly reduced in patients receiving either tranexamic acid (mortality, 6.3 per cent) or cimetidine (7.7 per cent), as compared with patients receiving placebo (13.5 per cent) (P = 0.0092 for tranexamic acid vs. placebo, P = 0.045 for cimetidine vs. placebo). Ninety-nine patients were withdrawn before the code was broken, mainly because their primary illness was considered not to be due to acute upper-gastrointestinal-tract bleeding. Mortality among those withdrawn was high (22 per cent), and their exclusion reduced death rates to 4 per cent in those given tranexamic acid, 8 per cent in those given cimetidine, and 11 per cent in those given placebo (P = 0.0072 for tranexamic acid vs. placebo, P greater than 0.50 for cimetidine vs. placebo). The reduced mortality associated with tranexamic acid was detectable at both participating hospitals and in most of the main subgroups of patients classified according to site of bleeding. However, treatment with this agent was not associated with any decrease in the rate of rebleeding or the need for operation.

Acute Disease↗

Two cases of children of homosexuals.

The literautre is reviewed with reference to parental attitudes related to homosexuality, sex role typing, and object choice. Two cases of children of opposite-sexed homosexual parents are presented with projective testing indicating difficulties with gender role identity. It is our impression that the manifestation of sexual conflict in these homosexual parents expressed in attitudes and behavior toward the child is not unique and does not differ significantly from that of the heterosexual parent who has sexual conflicts. More long-term data are necessary to help us to understand the influences of parental homosexuality on the growing child.

Adolescent↗

Cardiovascular surveys in areas with different water supplies.

Cardiovascular surveys were conducted in areas with different water supplies. In two areas with hard water 243 men were seen and in three areas with soft water 357 men were seen. There was no evidence of an important difference between the two areas in blood pressure, serum cholesterol, blood sugar, or packed cell volume. A variety of measurements were made on an E.C.G. The P-R interval was significantly longer in the men in the hard water area, and a 40-complex trace showed ventricular extrasystoles in a significantly higher proportion of these men than in those in the soft water area.

Adult↗

Drug switching patterns among patients taking non-steroidal anti-inflammatory drugs: a retrospective cohort study of a general practitioners database in the United Kingdom.

OBJECTIVE: To examine the frequency and determinants of switching between different non-steroidal anti-inflammatory drugs (NSAIDs) and the relationship with co-prescription of gastro-protective drugs (GPDs). DESIGN: This was an analysis of 30,654 patients receiving a total of 209,140 NSAID prescriptions in the UK from 1 January 1997 to 31 December 1998 identified through the MediPlus database. Analyses examined switching, repeat, termination and GPD co-prescription rates in new and continuing takers according to age and sex. RESULTS: Each patient received an average of 6.8 prescriptions in the year of study. Of the prescriptions 72.2% were for one of three NSAIDs, ibuprofen, diclofenac, or naproxen, and 7.2% of prescriptions were for fixed combination products of an NSAID plus a gastroprotective drug. At least 16.0% of continuing takers, and 28.5% of new takers switched to another NSAID in the review period. On average, new patients switched more frequently than continuing patients (0.39 switches/patient/year versus 0.23 switches/patient/year, p < 0.001). Switching between NSAIDs decreased with age and was less common in women (p < 0.05). Switching was associated with a 24% and 33% increased probability of GPD prescription in new and continuing takers, respectively. DISCUSSION: The frequency of switching, and of GPD co-prescription at switching, suggest that dissatisfaction with NSAIDs is frequent, and that gastrointestinal intolerance is a common feature of this dissatisfaction.

Adult↗