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169 legs with primary varicose veins suitable for sclerotherapy were entered into the trial. At the time of injection they were randomly allocated to be bandaged for three or six weeks; patients allocated to the six-week group had their legs rebandaged after the first three week. Patients were subsequently assessed blind at three months and thereafter at yearly intervals.
Olsalazine (azodisalicylate) is a new drug in which two molecules of 5-aminosalicylic acid are linked by an azo bond. Its role in the treatment of mildly active, distal ulcerative colitis was investigated. Sixty patients were randomly allocated to receive olsalazine 1 g or a placebo as a retention enema nightly for two weeks. Clinical improvement was seen in 19 (66%) and sigmoidoscopic improvement in 17 (59%) of the 29 patients receiving olsalazine compared with 12 (43%) and 11 (39%), respectively, of the 28 in the control group. These differences were not significant. In a second trial 40 patients were randomised to receive oral olsalazine 2 g daily or a placebo capsule for two weeks. Significant clinical and sigmoidoscopic improvement was seen in the patients receiving oral olsalazine compared with the patients receiving placebo capsules. Oral olsalazine may be valuable in the treatment of mildly active ulcerative colitis. Its role in maintaining remission is yet to be determined.
A team of four midwives provided the majority of care during pregnancy, labour and the puerperium to 503 women at low obstetric risk, over a 2-year period. Compared with standard hospital care randomly allocated to 498 women this 'Know Your Midwife' scheme was associated with greater continuity in all phases of maternity care. The scheme appeared very acceptable to women: they spent less time in the antenatal clinic, and overall, felt more satisfied, better prepared and better able to discuss problems. The scheme was characterised by less obstetric intervention particularly in respect of augmentation of labour and intrapartum analgesia; labours tended to be longer. Neonatal outcome was generally similar in the two groups but the size of the trial did not allow a precise assessment of differential effects in these terms. The 'Know Your Midwife' scheme is feasible. It should now be introduced more widely but in a way which allows continuing evaluation.
In a prospective controlled investigation chronic patients, the majority with neurotic conditions, were randomly allocated either to community psychiatric nurses (CPN) as the main therapist or to routine out-patient psychiatrist follow-up. There was no statistically significant difference in the mean public expenditure for the two modes of care. The direct costs of psychiatric care comprised a small proportion of total public expenditure and were initially greater in the nursing group. Subsequently, and over the whole 18-month study period, nursing was the cheaper option in terms of these direct costs. Clinical and social outcomes were comparable in both follow-up groups. Consumer satisfaction was significantly greater among CPN patients. On balance, these results confirm the benefit of community psychiatric nursing for this patient group.
We tested whether anesthesia that includes nitrous oxide (N2O) results in the development of intraoperative and postoperative pulmonary complications, including hypoxemia. We also tested whether aging contributes to the development of such complications, particularly when anesthesia includes N2O. We randomly allocated patients having total hip replacements, carotid endarterectomies, or transsphenoidal hypophysectomies (total n = 270) to an anesthetic regimen with and without N2O (stratified within surgical group). A heat-and-moisture exchanger was included in the anesthetic circuit of all patients. Patients were monitored perioperatively and for 1 wk after surgery using intermittent and continuous pulse oximetry to determine oxyhemoglobin saturation. Intraoperatively, mean oxygen (O2) saturations were lower in patients given N2O, particularly older patients. Hypoxemia (O2 saturation less than 86%) developed in five patients receiving N2O and in one receiving O2. This difference was not significant. Administration of N2O did not decrease postoperative O2 saturation, nor did it alter the incidence of postoperative hypoxemia, cough, or sputum production.
To evaluate the efficacy of wheat bran in preventing constipation, 200 hospitalized patients were randomly allocated to groups receiving either a dietary supplement of 40 g bran daily or no dietary supplement at all. A quarter of the bran group patients refused to take their bran from the very beginning (refusers), one third stopped bran consumption during the study (dropouts), and only 42% of the patients continued on bran until discharge or death (participants). Independent of a previous history of constipation, neither the hospital incidence of constipation nor the average percentage of days on laxatives was significantly different between the bran group and the control group. Only the dropouts were significantly more constipated than the control patients, whereas no such difference could be demonstrated in the refusers or participants. It is concluded that the administration of bran as a prophylactic laxative confers no benefit in patients hospitalized for a relatively short time.
About 2 per cent of adults have active chronic otitis media, the majority being managed by medical means. Previous controlled studies have been unable to show benefit from any medication, including systemic or topical antibiotics, but the effect of the addition of topical steroids to the latter has never been evaluated. One hundred and sixty three adults with active chronic otitis media were randomly allocated to receive either antibiotic/steroid ear drops or placebo therapy over a 4-6 week period. Fifty-two per cent of ears receiving active therapy, as opposed to 30 per cent on placebo therapy (p less than 0.05), became otoscopically inactive if compliance to medication was greater than 70 per cent. However, when there was an open mastoid cavity, active therapy was no more successful than placebo. Though gentamicin was the antibiotic used, there was no evidence of ototoxic inner ear damage. Surprisingly, correlation between clinical activity and patient report of a discharge was poor. Forty per cent of both treatment groups considered that their ear had become dry following therapy and these were not the same patients whose ears had become otoscopically inactive.
The influence of indomethacin on the need for postoperative analgesics was investigated in a double-blind study of 41 patients scheduled for abdominal hysterectomy. The incidence of side effects was evaluated. The patients were randomly allocated to treatment with either indomethacin, 0.8 mg/kg i.v. preoperatively, followed by 100 mg rectally 8-hourly for 3 days (Group I), or placebo (Group P), in both cases supplemented with nicomorphine as needed. Thiopentone was used for induction of anaesthesia, followed by nitrous oxide, enflurane, suxamethonium, and pancuronium. The average nicomorphine requirement during the study was 14.0 mg/24 h lower in Group I than in Group P. The pain score values were slightly lower in Group I when resting, but similar on movement. A significant increase in perioperative blood loss was found in Group I. Beginning the indomethacin treatment with a preoperative i.v. bolus seems to offer few advantages compared to a purely postoperative regime and may increase the risk of bleeding complications.
Over 30 months 9292 consecutive patients admitted to nine coronary care units with suspected myocardial infarction were considered for admission to a randomised double blind study comparing the effect on mortality of nifedipine 10 mg four times a day with that of placebo. Among the 4801 patients excluded from the study the overall one month fatality rate was 18.2% and the one month fatality rate in those with definite myocardial infarction 26.8%. A total of 4491 patients fulfilled the entry criteria and were randomly allocated to nifedipine or placebo immediately after assessment in the coronary care unit. Roughly 64% of patients in both treatment groups sustained an acute myocardial infarction. The overall one month fatality rates were 6.3% in the placebo treated group and 6.7% in the nifedipine treated group. Most of the deaths occurred in patients with an in hospital diagnosis of myocardial infarction, and their one month fatality rates were 9.3% for the placebo group and 10.2% for the nifedipine group. These differences were not statistically significant. Subgroup analysis also did not suggest any particular group of patients with suspected acute myocardial infarction who might benefit from early nifedipine treatment in the dose studied.
The responses of heart rate and blood pressure to passive head-up tilting were assessed twice with an interval of 2 months in 100 healthy, middle-aged men. Then the subjects were randomly allocated into training or non-training groups. The intervention period of 4 months was successfully completed by 85 subjects. Mean, indirectly-determined oxygen uptake capacity increased in the training group only. The amplitude of the change in heart rate from supine to tilting and back again was used as the sign of orthostatic tolerance (OT). OT was similar in the training and non-training groups. When the subjects were grouped according to aerobic fitness, no differences in the OT could be observed. Changes in fitness during the intervention did not induce any changes in orthostatic tolerance. When the whole group was divided according to the OT or change in OT, no significant differences of changes in aerobic fitness were observed. It is concluded that in healthy, ambulatory, middle-aged men orthostatic tolerance and aerobic fitness are not correlated.
Over a 13-month period 85 babies were randomly allocated to one of three groups at birth. Babies in Group A were fed SMA Low Birth Weight, Group B Prematalac and Group C Preaptamil. A fourth group, the control group was fed expressed breast milk (EBM). The babies were studied when they were on full enteral feeds until weight was greater than 2.0 kg. Weight gain was greatest in Group B compared to the other three groups but there was no significant difference in gain of length or occipito-frontal circumference. The babies in Group B had a lower volume of feeds and lower energy intake than the other groups but had a significantly higher sodium intake which was reflected in higher mean sodium levels. This may have accounted for the increased weight gain. There was no significant difference in serum calcium, osmolality, total protein or haematocrit.
Cognitive functions in 53 elderly men who underwent a transurethral prostatectomy were assessed pre-operatively and 4 days and 3 months post-operatively. Thirteen patients had a preference for one particular type of anesthesia, and the remaining 40 were randomly allocated to receive either spinal or general anesthesia. Cognitive function was not different between the groups receiving different types of anesthesia at either time point and did not decrease post-operatively. No pre- or perioperative variable could distinguish the subgroup of patients who had a post-operative decrease of 2 points or more on the Mini-Mental State Examination. No difference in post-operative performance was found in the patient groups with pre-operative Mini-Mental State Examination scores above or under their age-specific norm. It is concluded that neither hospitalization nor the two forms of anesthesia investigated cause a decrease in cognitive function in elderly men.
The presence of a possible correlation between changes in left ventricular mass of hypertensive patients and the degree of blood pressure reduction with different antihypertensive drugs has been investigated in 40 outpatients by M-mode echocardiography. Ten of these, with blood pressure in normal limits with different antihypertensive treatment had their therapy changed in chlorthalidone 25 mg/day without any run-in (Group A); other 30 patients, with a previously uncontrolled blood pressure, after a 14 day run-in, were randomly allocated to chlorthalidone 25 mg/day (Group B), slow release nifedipine 20 mg/day (Group C) or placebo (Group D). At the end of the eight week treatment period a further decrease in systolic blood pressure was observed in Group A without changes in ventricular mass; an highly significant decrease in both systolic and diastolic blood pressure was observed in B and C but only patients on chlorthalidone changed their ventricular mass; no change in both blood pressure and ventricular mass was observed on placebo. As changes in ventricular mass are not correlated with blood pressure reduction, we conclude that other, not well defined factors, apart from the decrease in duration and degree of left ventricular systolic wall tension, may be responsible for reversal of left ventricular hypertrophy.
Newborn infants of mothers who were chronic carriers of hepatitis Bs antigen (HBsAg) were randomly allocated to be treated or not treated with hyperimmune hepatitis B immunoglobulin (HBIg) at birth and six weeks and were then followed up to one year with sequential blood tests. Ninety percent of all untreated infants born of mothers positive for both HBsAg and hepatitis Be antigen became chronic carriers of HBsAg at one year. In contrast only 9% of infants treated with HBIg became HBsAg positive. Mothers who were HBsAg positive but hepatitis Be antigen negative only uncommonly infected their infants, with 6% being HBsAg positive at one year. Nearly all infections were in Pacific Islanders, Maoris or Asians. It is recommended that antenatal testing of these groups most at risk for hepatitis B virus spread, be initiated, followed by passive immunoprophylaxis with HBIg of infants born of HBsAg, HBeAg positive mothers.
The generalization of trial results is based on assumptions regarding the distribution of the unknown disease factors affecting the outcome of the treatment. To minimize the uncertainty which this implies, trials should have rigorous entry requirements and as few exclusions as possible. In surgical trials this cannot be achieved with the design at present in use, in which each surgeon performs the operations to be compared in a random order. The reason is that exclusions are an integral part of this design. Neither can it be achieved by keeping deviants from protocol in the groups to which they are randomized. A different design is therefore proposed. In this design the patients are randomly allocated to two groups of surgeons who perform their operation of choice.
Eighty-eight healthy omnivores with normal blood pressure participated in a randomized, controlled, cross-over trial of the effect on blood pressure of increasing dietary fibre intake. Subjects were randomly allocated to a control group eating a low fibre diet throughout, or to one of two experimental groups eating a high fibre diet for one of two 6-week experimental periods. Changes in body weight, other dietary constituents and lifestyle factors were avoided as far as possible. Twenty-four hour diet records showed a substantial increase in dietary fibre when subjects were on the high fibre diet. There was no consistent effect of change in dietary fibre intake on group mean systoloic or diastolic blood pressures. Adjusting blood pressures for changes in other dietary components, plasma lipids, electrolytes, body weight and other lifestyle variables did not alter this result. These findings do not support the hypothesis that the blood pressure lowering effect of a vegetarian diet is solely due to an increase in fibre intake.
399 patients with early breast cancer were randomly allocated to treatment by either modified radical mastectomy or lumpectomy and radiotherapy. 169 had histologically involved axillary nodes and were randomised to receive either adjuvant cytotoxic chemotherapy (76 patients) or no systemic adjuvant treatment (93 patients). Chemotherapy comprised a combination of oral cyclophosphamide and intravenous methotrexate and 5-fluorouracil (CMF) for 12 cycles over one year. Patients in the mastectomy group received a significantly higher percentage of the planned chemotherapy dose compared with those in the radiotherapy group (median 85% v. 71% p less than 0.05). Patients treated with radiotherapy were more frequently nauseated and developed more severe alopecia, but these differences were not statistically significant. At median follow-up of 37 months the relapse-rate and pattern of relapse were similar in both groups of patients receiving CMF.
Because of conflicting results from studies examining the usefulness of digoxin in congestive heart failure (CHF) patients in sinus rhythm, a cross-over trial was conducted in which 20 patients received 7 weeks of digoxin titrated to a level of 1.54 to 2.56 nmol/liter and 7 weeks of matched placebo. The order of treatments was determined by random allocation and patients, clinicians and research staff were blind to allocation. In patients with deteriorating condition, the treatment period was terminated and outcome measures were obtained. If deterioration occurred during the first period, the patient was crossed over without the code being broken. Seven patients required premature termination of study periods because of increasing symptoms of CHF. All 7 were taking placebo at the time (p = 0.016). Small differences in dyspnea (p = 0.044), walking test score (p = 0.055), clinical assessment of CHF (p = 0.036) and ejection fraction (p = 0.004) favored the digoxin treatment group. Patients with more severe CHF were more likely to benefit from digoxin administration. It was concluded that oral digoxin, in doses titrated to produce a serum level of 1.54 to 2.56 nmol/liter, improved quality of life and functional exercise capacity in some patients with CHF in sinus rhythm.