A comparison of high- and low-dose lorazepam with amylobarbitone in patients with anxiety states.

A double-blind crossover trial comparing lorazepam at two dosage levels with amylobarbitone supported previous reports of the effective anxiolytic action of the drug. Evaluation of the patients' responses during each week of treatment was based on a physician's weekly rating and on daily self-rating by patients. The results were analyzed by sequential and nonsequential analyses. The main side effect of the drug was drowsiness, which occurred to a clinically significant degree among the high-dose group of patients. The authors emphasize the value of two dosage trials, particularly in devising subsequent flexible individual treatment regimens.

Failure to confirm a vascular cause of muscular dystrophy.

The vascular hypothesis of the cause of muscular dystrophy suggests that ischemia is responsible for the muscle fiber necrosis. A xenon 133 clearance study of muscle blood flow in Duchenne and other muscular dystrophies showed no obvious difference between the response to exercise and arterial occlusion compared with control subjects. Radioautographic study of distribution of 4-125l-antipyrine in skeletal muscle of mice with muscular dystrophy showed no abnormal areas of ischemia. A statistical examination was also made of the grouping of damaged fibers, one of the observations on which the vascular hypothesis was based. Only 0.9% of fibers undergoing phagocytosis occurred in groups of four or more fibers in greater frequency than would have been expected by chance, and 70% of such fibers were isolated. These studies argue strongly against the vascular hypothesis of the cause of muscular dystrophy.

Controlled trial of the effect of cycloalliin on the fibrinolytic activity of venous blood.

Cycloalliin is a natural constituent of onion, sulphur-containing but odourless. It was synthesised for this randomised double-blind study; its effect on fibribolytic activity and platelet aggregability was tested in venous blood from 18 male volunteers. It increased the former to a highly significant degree but had no effect on the latter. It was well tolerated and harmless in the single oral dosage used.

Intention-to-treat analysis: implications for quantitative and qualitative research.

Intention-to-treat analysis is an important aspect of randomized controlled trials of health care interventions. The concept is now widely accepted in theory, but not always implemented in practice. Failure to analyse by intention-to-treat can give misleading and indeed life-threatening interpretations. In some studies, a case is put for estimating the effect that would have been observed if all patients had received the allocated treatment. Situations where this is valid are rare, but an example is given of such an exceptional study. The relevance of the intention-to-treat concept is not always taken into account in qualitative research. Interviews with new mothers who delivered their babies at home in a hypothetical controlled trial of home versus hospital confinement would provide fascinating accounts of the pleasure of successful delivery at home. But by definition the interviews would exclude the hazard and drama of necessary transfers to hospital due to complications in late pregnancy and early labour. The intention-to-treat approach would avoid this bias.

Parathyroid metabolism after operative treatment of hypercalcemic (primary) hyperparathyroidism.

Parathyroidectomy is usually followed by a decrease in serum calcium, a lessening of symptoms, and a normocalcemic state that continues for years. Evaluation of parathyroid gland function after parathyroidectomy over a protracted period showed a continued hypersecretory state in many normocalcemic patients and is reported here for the first time. Patients identified with parathyroid hyperplasia (more than one gland excised) and patients who later developed mild renal failure were excluded. Seventy-seven patients undergoing parathyroidectomy with only one enlarged gland removed and the other normal-sized glands viewed or examined by biopsy were followed up from 5 to 16 years. Two patients developed recurrent hypercalcemia at 4 and 9 years after surgery. Seventy-five patients are considered "cured" and have normal serum calcium values. However, 28 (37%) of these normocalcemic patients have persistent elevations of parathyroid hormone. This increased parathyroid gland function suggests a continuing stimulation of the remaining glands. The rarity of clinical recurrence may be related to effective adaptations that prevent overt hypercalcemia. Many parathyroid adenomas appear to represent nonneoplastic disease.

Complications of inflammatory diseases of the sinuses.

The great majority of cases of sinusitis are uncomplicated. These infections, however, can result in significant morbidity and often mortality. One must be vigilant in detecting orbital or intracranial spread and iatrogenic injury from surgery because manifestations of these complications can be protean. A good knowledge of the anatomy, the clinical signs, and some key laboratory data is crucial to successful treatment of this challenging disease.

Manipulation in treatment of low back pain: a multicentre study.

In a multicentre trial 456 selected patients with low back pain were randomly allocated to one of four treatments-manipulation, definitive physiotherapy, corset, or analgesic tablets. Patients were reassessed clinically after three weeks' treatment and again after a further three weeks. Questionnaires were used to find out the patients' condition three months and one year after admission to the trial. There were never any important differences among the four groups of patients. A few patients responded well and quickly to manipulation, but there was no way of identifying such patients in advance. The response to a corset was slow, but the long-tern effects were at least as good as those of the other treatments. Patients treated only with analgesics fared marginally worse than those on the other three treatments. There is no strong reason, however, for recommending manipulation over physiotherapy or corset.

Nurses and nursing in primary medical care in England.

In 1974 we sent questionnaires on attachment and employment of nurses to 9214 general practices in England. There were 7863 replies (85%), of which 551 were excluded from the study. A total of 2654 nurses were directly employed by 24% (1774) of the practices, and 68% (4972) had attached nurses. Practices in health centres were larger and had greater nursing resources than those in other premises. We suggest that practices may employ nurses to compensate for ineffective nursing attachments, and we conclude that general-practice-employed nurses are becoming "professionalised".

Pragmatic and explanatory trials in the evaluation of the experimental National Health Service nursing homes.

This paper reviews the issues which arose in the design of a randomized controlled trial of three experimental National Health Service nursing homes. Problems associated with the implementation of the trial included ethical issues, choice of sample size and recruitment of subjects to the trial, choice and validity of measures of outcome, evaluation of outcomes and replicability of findings. The distinction between explanatory and pragmatic trials is shown to overcome some of these problems.

The implementation of a multicentred randomized controlled trial in the evaluation of the experimental National Health Service nursing homes.

This paper reviews the implementation of a pragmatic multicentred randomized controlled trial in the evaluation of three experimental nursing homes. The organization of services for the care of elderly people varied between the three centres, and each used different criteria for selecting subjects for the trial and different methods of seeking informed consent. Data presented show that in each centre two truly randomized samples have been selected. However, differences between centres, in the characteristics of selected subjects, reflect the implementation of the trials in each of the centres. These findings emphasize the importance of good collaboration between health professionals providing the service, an independent research team, and the establishment of rigorous criteria for inclusion and exclusion of subjects at the outset.

Management of the jugular bulb during lateral skull base surgery.

The intraoperative management of a patent jugular bulb presents a formidable challenge during the treatment of lateral skull base lesions. Whether to preserve, partially occlude, or completely sacrifice this critical structure is a decision best made following a multifactorial analysis of preoperative clinicoradiographic data, tumor histopathology, and intraoperative findings. Twenty-six patients with tumors requiring dissection near a patent jugular bulb were reviewed. Ten patients had superior neck tumors, nine had primary temporal bone lesions, and seven presented with recurrent parotid malignancies. The most common clinical manifestations were headache and vocal cord paralysis and the most significant radiographic finding was the presence of a mass at the styloid base. Jugular bulb patency was preserved in six patients, partially maintained in seven, and was sacrificed in 13 individuals. This article focuses on the clinicoradiographic findings in patients with neoplastic jugular foramen encroachment, but preserved jugular blood flow. Surgical technique will be detailed through selected case presentations and the management of lower cranial nerve injuries will be reviewed.

Day-case surgery for hernias and haemorrhoids. A clinical, social, and economic evaluation.

Patients with inguinal hernia or haemorrhoids were randomly allocated to an experimental group expected to stay in hospital for only eight hours after surgery or a control group scheduled for discharge on the fifth or sixth day. There was no difference in clinical outcome between the two groups of hernia patients. However, complications were twice as common in haemorrhoid day-patients as in long-stay haemorhoid patients. The standard postoperative regimen for haemorrhoids has since been changed and the change has been accompanied by a fall in the complication-rate. Day-case surgery appears to have similar social effects on the patient and his family as traditional hospital care. There was no significant difference in either the additional expenditure incurred or patients' perceptions of the disruption associated with their operation and convalescence. In the hospital under study, day-case surgery was saving between 20 pounds and 29 pounds per patient. However, this conclusion should not be extrapolated to the N.H.S. as a whole without taking into account the use to which the resources released by day-case surgery will be put.

Posterior internal auditory canal closure following the retrosigmoid approach to the cerebellopontine angle.

The retrosigmoid approach is utilized in a variety of cerebellopontine angle and internal auditory canal procedures. Drill curettage of the posterior internal auditory canal enhances lateral exposure, however, this step may also increase the patient's risk for postoperative cerebrospinal fluid (CSF) otorrhea. Obliteration of perilabyrinthine air cells is technically difficult and muscle graft displacement frequently occurs. A technique for posterior petrous dural flap stabilization of a temporalis muscle plug has proved successful in decreasing the risk of postoperative CSF fistula following retrosigmoid surgery. Temporal bone air-cell anatomy, as it relates to retrosigmoid, posterior internal auditory canal surgery is reviewed. Our technique for internal auditory canal closure, with bone wax, bone paté, muscle grafts, and petrous ridge dural flaps is outlined.

Double-blind controlled trial of a micronized preparation of flumedroxone (Demigran) in prophylaxis of migraine.

A double-blind cross-over trial of a micronized preparation of flumedroxone, an oral progestogen derivative, and a placebo was undertaken to determine whether this drug had prophylactic value in migraine. No benefit was found in males, or in females with no history of menstrual exacerbation of migraine. In women whose migraine was worse around the time of menstruation flumedroxone resulted in statistically fewer headaches of less severity.With the dose used in this trial (micronized flumedroxone 10 mg. t.d.s.) side-effects were frequent, the commonest being polymenorrhagia, which occurred in half the women of reproductive age.