Beclomethasone dipropionate aerosol in childhood asthma: a three- to five-year follow-up.
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Biomedical subjects
Publications and source records attributed to M Tooley.
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Nine normal women were examined in the first 11 days of the puerperium. Serum prolactin, oestradiol and follicle simulating hormone (FSH) levels were measured and the FSH response to 100 mug of intravenously administered follicle stimulating hormone/lutenizing hormone-releasing hormone (LH/FSH-RH) was assessed on day 1 post partum in five subjects and on days 4 (two subjects), 6 and 7 post partum in the other four subjects. Bromocriptine therapy was given to six of these women and four to seven days after the start of such therapy, when prolactin levels had fallen to normal non-pregnant levels, these women were retested. Before bromocriptine treatment, the basal FSH levels were unmeasurable in six and low in one other of the nine subjects. After bromocriptine treatment, the basal FSH levels were measurable in four out of six patients and were higher than in the untreated patients (P less than 0-01). The FSH response to LH/FSH-RH was unmeasurable in eight out of nine before treatment, which is less than the response seen in 26 normal men and women (P less than 0-01). There was also no discernible FSH response to LH/FSH-RH after treatment with bromocriptine. Before treatment with bromocriptine, the serum prolactin levels were elevated in all nine women but were within the normal range for non-pregnant women after three days of bromocriptine therapy. Thus postpartum gonadotrophin suppression seemed to depend on high prolactin levels and at least part of the antigonadotrophic action of prolactin seemed to be at pituitary level.
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A method has been developed for simultaneously comparing the usefulness of many treatments of established value for symptomatic medical conditions. Medical assessment of outcome is not employed. Instead patients are required to assess treatments prescribed during the course of ordinary general practice rather than under the strictly controlled settings of most clinical trials. Outcome incorporates patient compliance and treatment acceptability and is based on patients' subjective judgments of the usefulness of randomly allocated treatments as recorded in self-completed diaries, which are mailed directly to a trial centre. Thus large and more representative samples are achieved through minimizing the efforts required, both of participating doctors and of patients. Although the approach was originally developed and tested for the comparison of hay fever treatment regimens, we believe that it can be adapted to compare many other treatments where patient-reported symptoms validly describe the outcome of interest. The feasibility of the approach was tested in two pilot studies, and it has been employed successfully in a two-year trial comparing seven hay fever treatments. Aspects of analysing such trials are discussed.
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