SUMMARY A double-blind controlled clinical trial of crossover design was conducted in 26 volunteers suffering from migraine. Of 20 subjects who completed the trial, 16 had fewer attacks on amitriptyline than on placebo. Amitriptyline was found to have the greatest effect in reducing attacks with a short warning and in which no specific cause could be recognized. It had least effect in attacks with a long warning and recognized as due to fatigue. The drug was effective only in reducing those attacks with shorter duration and its effect was irrespective of severity. A dosage of between 10 and 60 mg, usually taken at night, was found to be adequate.Amitriptyline has been found effective in chronic tension headache (Lance and Curran, 1964) and its beneficial use in migraine has been reported (Friedman, 1968;Mahloudji, 1969).Although its precise mode of action in migraine is uncertain, amitriptyline and the tricyclic antidepressants possess similarities in structure and pharmacological effect to some of the recently introduced prophylactic agents used in this condition.
SELECTION OF SUBJECTSVolunteers were requested via the British Migraine Association and the press. The criteria of migraine used was the presence of intermittent headache with at least three of the following features: unilateral distribution, sensory prodromata, associated nausea; photophobia and throbbing.All subjects were asked to keep a record of their migraine attacks. These showed the information listed in Table 1. The charts were returned and discussed every two months with a statement as to their accuracy. It was indicated that attacks causing no disturbance of daily routine should be recorded as mild; those causing some lack of efficiency as moderate, and those causing complete disruption of usual activities should be recorded as severe.Of 114 volunteers, 94 were excluded as follows. Seventy-five were excluded before or during a 26 week control period. Only those subjects having more than two attacks per month and with over 50% described as at least of moderate severity were
This study compared the efficacy and safety of the fluticasone propionate 125 microg pressurized metered dose inhaler (pMDI) propelled by either hydrofluoroalkane (HFA) 134a or chlorofluorocarbon (CFC) propellants, in adult patients with asthma. HFA 134a is a non-ozone depleting propellant used as a replacement for the CFC propellants 11 and 12 which are being phased out in accordance with the Montreal Protocol. Three hundred and eighty patients with mild to moderate asthma and 'room for improvement' in their treatment were randomized to receive fluticasone propionate 250 microg twice daily via pMDIs propelled by either CFC propellants 11 and 12 (n = 195) or HFA 134a (n = 185). Fluticasone propionate significantly improved lung function over the 4-week treatment period in both treatment groups. The improvement in mean morning peak expiratory flow (PEF) after 7 days of treatment was approximately 12 l min(-1) in both groups, rising to approximately 22 l min(-1) at the end of the 4-week treatment period. The adjusted mean difference between the two formulations over weeks 1-4 was -1 l min(-1) (90% confidence interval: -7, 5 l min(-1)), confirming their equivalence. Clinical comparability was also demonstrated with respect to secondary efficacy variables, including daily symptom scores, evening PEF and clinic visit expiratory measurements. There were no clinically relevant differences in adverse events or serum cortisol levels between the two groups. The fluticasone propionate 125 microg HFA 134a pMDI is an effective and well tolerated product and is a suitable replacement for the fluticasone propionate 125 microg CFC pMDI at a microgram equivalent dose.
The purpose of this pilot study was to investigate selected stress, immune, and growth consequences of maternal separation and separation with supplemental stroking in neonatal BALB/c infant mice and their dams. Three groups of 5 litters each (7 pups per litter) were studied. Control litters were undisturbed. Separated litters experienced 3 h of daily maternal deprivation on postnatal days 6 to 10. Separated/stroked litters were separated also, but for 2 h, which was then followed by 1 h of stroking with a wet paintbrush to simulate maternal tactile stimulation. After the experimental period, all animals were returned to the nest and left undisturbed for 5 additional days. One pup fromeac h litter was sacrificed on postnatal days 6, 8, 10, and 15. Spleens and thymuses were removed, weighed, and homogenized for cell sorting, cytokine analysis, and proliferation studies. Blood was drawn for corticosterone levels and hematocrit. Hematocrits and thymus weights were lower in separated mice, suggesting decreased growth and protein synthesis. Separated/stroked pups had increased splenic proliferation responses to conconavalin A and phytohemagglutinin at day 15. Separated dams’ proliferative response to Con A was lower than control dams at day 15. Day 15 decreases in thymic CD8 cells occurred in pups, with an increased thymic H:S ratio in separated pups. CD90 cells were higher at day 15 in separated/stroked pups as were CD25s at day 10 in spleen and thymus. However, gene expression of cytokines was not measurable in spleen and thymic cells, with the exception of-IFN in separated/stroked animals. Pooled organ homogenates were used in this preliminary work, and further studies are needed to more precisely analyze the stress, immune, and growth effects of these interventions.
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