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PubMed1983

The effect of patient 'familiarity' with blood pressure assessment on the accuracy of follow-up readings.

The fall in blood pressure that is commonly observed when groups of hypertensive individuals are followed without treatment is usually ascribed to two sources: regression towards the mean and increasing familiarity of the subject with the assessment process. Any effect of the latter process could bias the results of controlled studies in which one group is more frequently assessed than the other, a common situation in community trials. To assess the effect of familiarity, we randomly allocated 116 untreated, mildly hypertensive subjects to three-monthly or yearly assessments. At an independent, blind, year end assessment, both groups showed statistically significant reductions in diastolic blood pressure (P less than 0.001) of 8.4 +/- 1.2 (s.e.m.) and 7.6 +/- 1.6 mmHg respectively, but the difference between the groups was not significant (P = 0.682). We conclude that 'familiarity' does not play an important role in the reduction of blood pressure in long-term follow-up studies of hypertensive subjects.

Adult↗

PubMed1981

Randomised trial of endoscopic argon laser photocoagulation in bleeding peptic ulcers.

Emergency endoscopy on 332 patients with acute upper gastrointestinal bleeding showed that 178 had peptic ulcers; 28 of these were actively bleeding (spurting) and 108 showed stigmata of recent haemorrhage (vessels or spots in the ulcer base) suggesting a risk of rebleeding. These 136 patients were randomly allocated to Argon laser photocoagulation or to no additional therapy (controls) at the time of initial endoscopy. All patients received conventional management, and the controlling clinicians did not know whether or not the laser had been used in any individual patients. The laser system proved both simple and safe in use. Initial haemostasis was achieved by the laser in 10 of 15 'spurting vessels', but four of 13 'control' spurting vessels also stopped bleeding spontaneously. Overall, there were no statistically significant differences between the laser treated and control groups in terms of rebleeding, the need for surgical intervention, or death. These results require amplification in larger trials, and comparison with other studies using different protocols and other haemostatic methods.

Acute Disease↗

PubMed1986

Randomised trial of compliance with screening for colorectal cancer.

A randomised trial of compliance with screening for colorectal cancer by means of the haemoccult test was conducted in Farnborough and Basingstoke districts. In each of the 14 participating practices (41 general practitioners) 25 852 men and women aged between 40 and 70 years were randomly allocated by household to one of six groups. The group determined the method of invitation to screening: a letter and the test were sent to the patient, or a letter with an appointment to attend the surgery was sent, or during a routine consultation the general practitioner invited patients to participate, and some patients received an educational booklet about bowel disorders and screening. Of the 17 824 people who were offered screening, 7545 (42%) complied. Compliance was significantly affected by the method of invitation, but not by whether an educational booklet was received, and was highest (57%) in the group that was offered the haemoccult test during a routine consultation (the "opportunistic" approach). In this group the compliance rate achieved by individual general practitioners ranged from 26% to 82%. Compliance was significantly higher in Farnborough, in the older (55-70) age group, in women, and in households in which two or more people were offered screening. The higher compliance in Farnborough may be explained by the higher proportion of older people and by the higher proportion of people living in households of two or more in the population that was offered screening. The fact that the screening programme in Farnborough was offered to the whole community and that the researcher may have acted as a facilitator were probably also important. One per cent of the patients screened had a positive test, and 24 (38%) of the 63 patients who were positive and were investigated in hospital had neoplastic disease. The yield was 1.2 cancers and 1.2 benign adenomas (1 cm or larger in size) per 1000 people screened. This low yield is likely to be a consequence of the relatively young age group screened.

Adult↗

PubMed1989

Rectal induction of anaesthesia in children. A comparison between ketamine-midazolam and halothane for induction and maintenance of anaesthesia.

Thirty children were randomly allocated to one of three anaesthetic techniques. Rectal anaesthesia induction with a mixture of ketamine 10 mg.kg-1 BW and midazolam 0.2 mg.kg-1 BW and maintenance of anaesthesia with either intravenous ketamine or halothane were compared to induction and maintenance with halothane. Rectal induction was found reliable and useful. The frequency of side effects, the recovery time, and the time until the child could be discharged were similar in the groups maintained with halothane, whereas recovery was prolonged when intravenous ketamine was used for maintenance.

Anesthesia, Inhalation↗

PubMed1984

[Value of a blood pressure profile in evaluating 2 antihypertensive agents].

Bopindolol (Sandoz) in single daily doses of 1 and 2 mg was compared with atenolol (ICI) in single daily doses of 50 and 100 mg in respect of antihypertensive effect in a population of 33 patients divided by random allocation into 4 groups and treated for 12 months. Statistical analysis of the more than 4000 blood pressure readings obtained with a noninvasive ambulatory blood pressure recorder indicates equivalence of efficacy between bopindolol 1 mg, bopindolol 2 mg and atenolol 100 mg, with atenolol 50 mg less effective. Bopindolol's long duration of effect was reflected in lower morning values and in the absence of hypotension in the circadian profile.

Adrenergic beta-Antagonists↗

PubMed1987

Transurethral incision versus transurethral resection of the prostate for the treatment of benign prostatic hypertrophy. A preliminary report.

Thirty-seven patients with prostatism and an estimated prostatic weight of less than or equal to 20 g were randomly allocated to transurethral incision or resection of the prostate. Both procedures had an 85% success rate as judged by patients' personal evaluation. At 3 and 12 months follow-up a significant and identical improvement was noted in symptom score and uroflowmetry in the two groups. Postoperative catheterization time and hospital stay was only half as long in the incision group as in the resection group. No patients became impotent as a consequence of the procedures. Frequency of retrograde ejaculation was 28% in the incision group versus 100% in resected patients. Incision of the prostate is easy to perform and seems to be followed by less severe complications. It has a high patient acceptability and may cut the cost of transurethral surgery.

Aged↗

PubMed1987

A comparison of a sustained release preparation of tiaprofenic acid with the conventional tablet formulation and a placebo in rheumatoid arthritis.

In a randomized double-blind, multicentre crossover study, the short-term efficacy and tolerance of tiaprofenic acid (TA) conventional tablet 300 mg twice daily was compared with a sustained release preparation of tiaprofenic acid 600 mg once daily and with a placebo in 146 patients with rheumatoid arthritis. After a minimum washout period of three days, patients were randomly allocated to receive each treatment for a period of two weeks each in a crossover fashion. Pain levels, duration of morning stiffness, onset of inactivity stiffness, articular index, and grip strength, were measured at the end of the washout period and at the end of each treatment period. Escape analgesic consumption, patient compliance, patient preference and overall assessment were measured at the end of each treatment period. Side-effects were noted and standard laboratory tests performed. Sustained release TA was shown to be as effective as the conventional tablet TA in the treatment of rheumatoid arthritis, producing significant improvements in efficacy parameters measured. Both preparations were as well tolerated as the placebo.

Adult↗

PubMed1985

Treatment of malignant pleural effusions with intrapleural Corynebacterium parvum or tetracycline.

Thirty two patients with malignant pleural effusion were randomly allocated to treatment with intrapleural Corynebacterium parvum or tetracycline hydrochloride in an attempt to prevent symptomatic recurrence of pleural fluid. Success in preventing recurrence of fluid at one month, using up to 2 doses of each drug, was 14 of 16 cases for Corynebacterium parvum, 5 of 9 for tetracycline given via an intercostal needle, and 6 of 7 for tetracycline given through an intercostal tube. These difference were not statistically significant. Corynebacterium parvum was significantly more likely to produce pyrexia equal or greater than 38 degrees C (P less than 0.001) and pain requiring analgesia (P less than 0.05) than tetracycline hydrochloride. Corynebacterium parvum is a useful agent for the management of malignant pleural effusion, but is associated with more side effects than tetracycline.

Bacterial Vaccines↗

PubMed1988

Randomized comparative study of therapeutic paracentesis with and without intravenous albumin in cirrhosis.

It has recently been shown that repeated large-volume paracentesis associated with intravenous albumin infusion is a rapid, effective, and safe therapy of ascites in cirrhosis. To investigate whether intravenous albumin infusion is necessary in the treatment of cirrhotics with large-volume paracentesis, 105 patients with tense ascites were randomly allocated into two groups. Fifty-two patients (group 1) were treated with paracentesis (4-6 L/day until disappearance of ascites) plus intravenous albumin infusion (40 g after each tap), and 53 (group 2) with paracentesis without albumin infusion. After disappearance of ascites, patients were discharged from the hospital with diuretics. Patients developing tense ascites during follow-up were treated according to their initial schedule. Paracentesis was effective in eliminating the ascites in 50 patients from group 1 and in 48 from group 2, with the duration of the hospital stay being approximately 11 days in both groups. Paracentesis plus intravenous albumin did not induce significant changes in standard renal function tests, plasma renin activity, and plasma aldosterone. In contrast, paracentesis without albumin was associated with a significant increase in blood urea nitrogen, a marked elevation in plasma renin activity and plasma aldosterone concentration, and a significant reduction in serum sodium concentration. One patient from group 1 and 11 from group 2 developed renal impairment or severe hyponatremia after treatment, or both (chi 2 = 9.19; p less than 0.01). The development of these complications could not be predicted by clinical and laboratory data before treatment. Although the probability of survival after entry into the study was similar in patients from both groups, a multivariate analysis identified the development of hyponatremia or renal impairment, or both, following the first paracentesis treatment and the occurrence of other complications during the first hospitalization (encephalopathy, gastrointestinal bleeding, and severe infection) as being the only independent predictors of mortality. These results indicate that intravenous albumin infusion is important in avoiding renal and electrolyte complications and activation of endogenous vasoactive systems in cirrhotics with ascites who are treated with repeated large-volume paracentesis. The development of such complications may impair survival in these patients.

Albumins↗

PubMed1986

Vacuum extraction: a randomized controlled comparison of the New Generation cup with the original Bird cup.

A new design of vacuum extractor cup--'the New Generation cup'--has recently been introduced into clinical practice. Its major modification is a traction cord which passes around the rim of the cup for 180 degrees and is free to slide within the rim. Claims that this design 'enables the operator to pull obliquely without causing the cup to tilt' and thereby 'reduces failure rates, reduces the incidence of scalp trauma and increases operator confidence' have been evaluated in a randomized controlled trial. 123 women with singleton pregnancies of 37 completed weeks or more, with a cephalic presentation and for whom a decision to deliver by vacuum extraction had been taken, were randomly allocated to the 'New Generation' cup or BIRD's original vacuum extractor cup; 50 mm anterior and posterior cups were used in both groups as appropriate. The two groups were comparable at entry and delivered by obstetricians of similar status. The two types of cup were similar in respect of number of failures to deliver with the vacuum extractor, correct positioning of the cup, number of pulls required for delivery and time taken to expedite delivery. Cup detachments occurred in nine cases allocated to the 'New Generation' cup compared with four allocated to the original BIRD cup. The babies in the two groups were in similar condition at birth and sustained similar amounts of scalp trauma. Neonatal jaundice, both clinical and biochemical, was more common in babies delivered with the 'New Generation cup' and this was reflected in greater use of phototherapy in this group. Operators were equally divided in their preference of cup.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1982

The use of ranitidine in the management of duodenal ulcer: controlled and open comparison with cimetidine in 59 patients.

Forty patients with duodenal ulcer were randomly allocated either ranitidine 150 mg twice daily or cimetidine 1 g daily on a single blind basis for 4 weeks initially, with an additional month of treatment if endoscopy showed incomplete healing. The endoscopist was unaware of the patients' treatment. After 8 weeks treatment, the healing rate was 85% for ranitidine and 95% for cimetidine; the difference was not statistically significant. An additional 19 patients who did not fulfill the trial criteria, 11 of whom had not responded to cimetidine, were openly treated with ranitidine 150 mg twice daily. In 16 of the patients, the ulcer had healed at 8 weeks (84%), but in one patient, the ulcer perforated after 6 weeks of therapy. Thus, although overall healing rates with ranitidine and cimetidine are similar, ranitidine may be useful in patients where cimetidine has proved ineffective.

Adolescent↗

PubMed1988

Double-blind study with fenticonazole or bifonazole lotions in pityriasis versicolor.

The efficacy of fenticonazole 2% lotion was studied in patients suffering from pityriasis versicolor in a double-blind comparison with bifonazole 1% lotion, both applied once daily for three weeks. Forty-six patients were recruited and randomly allocated to one or other treatment group. Clinical and mycological examinations, performed at baseline and at weekly intervals, have shown an excellent response to both treatments. Two cases of mild transient desquamation were reported in the fenticonazole group. Fenticonazole 2% lotion appears active in the treatment of pityriasis versicolor and its efficacy is comparable to that of bifonazole.

Adolescent↗

PubMed1990

Imipenem versus tobramycin--antianaerobe antibiotic therapy in intra-abdominal infections.

The authors compared broad-spectrum monotherapy with imipenem to an aminoglycoside-based antibiotic regimen for the management of intra-abdominal infections. One hundred and four patients who had intra-abdominal infection were randomly allocated to receive imipenem (52) or tobramycin plus clindamycin or metronidazole (52). Patients treated with imipenem had fewer febrile episodes and occurrences of breakthrough bacteremia, less antibiotic resistance and need for drug change; their hospital stay was shorter. The death rate from sepsis was 4% in patients who received imipenem and 13% in those who received the combined regimen (p = 0.08). Treatment was successful in 79% of patients on imipenem versus 67% of those receiving an aminoglycoside. Patient stratification by the APACHE II system and probability of death calculation using delayed-type hypersensitivity scores predicted a similar death rate for the two treatment groups. Imipenem appears to be a safe and efficacious alternative broad-spectrum antibiotic for treating patients who are seriously ill with intra-abdominal infection.

Abdomen↗

PubMed1986

Premedication with oral and rectal diazepam.

It has been postulated that esophageal retention of diazepam tablets is a problem of clinical significance, and that rectal administration is an advantageous alternative. To test this hypothesis, 100 patients were randomly allocated to premedication with either 15 mg diazepam orally or 10 mg diazepam as a rectal solution. A double dummy technique was used. A sedative effect was seen in 23 (50%) of the patients premedicated by mouth (O-group), but only in eight (20%) of those premedicated rectally (R-group) (P less than 0.05). Four patients (9%) in the O-group and seven (18%) in the R-group were unacceptably anxious before induction (n.s.). The plasma concentrations in the tablet group were nearly twice the concentrations found in the rectal-solution group, but no correlation between premedication effect and plasma concentration was found. Timing of premedication was very inaccurate, and this favored oral administration because of a more prolonged effect. No evidence of persistent esophageal retention was found.

Administration, Oral↗

PubMed1990

Faecal occult blood screening for colorectal neoplasia: a randomized trial of three days or six days of tests.

Haemoccult, a guaiac test for faecal occult blood, detects 56-78 per cent of asymptomatic carcinomas when performed over 3 days. In patients with known colorectal cancer the sensitivity of the test for neoplasia is increased by extending the test period to 6 days. We report the first randomized comparison of 3 day with 6 day testing in asymptomatic individuals. 35,184 age and sex matched individuals were randomly allocated to receive Haemoccult over 3 or 6 days. The tests were completed by 10,176 (57.8 per cent) of the 17,616 offered 3 day Haemoccult and 9461 (53.9 per cent) of the 17,568 offered 6 day Haemoccult, a significant decrease in compliance (P less than 0.001). Of the 3 day Haemoccult tests 131 (1.29 per cent) were positive, significantly fewer than the 160 (1.69 per cent) positive tests after 6 day Haemoccult (0.01 less than P less than 0.02). Investigation of subjects with a positive test revealed 20 carcinomas (1.14 per 1000 offered and 1.97 per 1000 completing the test) in the 3 day group and 24 carcinomas (1.37 per 1000 offered and 2.54 per 1000 completing the test) after 6 day Haemoccult tests (0.5 less than P less than 0.7 for those offered the test and 0.3 less than P less than 0.5 for those completing it). After 3 day Haemoccult 112 adenomas in 76 persons were detected (4.31 per 1000 offered and 7.47 per 1000 completing the test). In the 6 day group 123 adenomas in 83 persons (4.72 per 1000 offered and 8.77 per 1000 completing the test) were detected (0.5 less than P less than 0.7 for those offered the test and 0.3 less than P less than 0.5 for those completing it). Large adenomas were found in 27 individuals after 3 day testing (1.53 per 1000 offered the test and 2.65 per 1000 completing it) and in 35 individuals after 6 day testing (1.99 per 1000 offered the test and 3.70 per 1000 completing it) (0.3 less than P less than 0.5 for those offered the test and 0.1 less than P less than 0.2 for those completing it). This study has not demonstrated a significant increase in the yield of neoplasia in asymptomatic subjects offered Haemoccult over 6 days. However there was a significant decrease in compliance and a higher rate of colonscopy in those offered 6 day testing.

Adenoma↗

PubMed1988

Treatment of locally unresectable carcinoma of the pancreas: comparison of combined-modality therapy (chemotherapy plus radiotherapy) to chemotherapy alone. Gastrointestinal Tumor Study Group.

Randomized trials of the Gastrointestinal Tumor Study Group have previously demonstrated enhanced survival of patients with locally unresectable pancreatic cancer treated with 5-fluorouracil in combination with radiation therapy compared with that of patients treated with radiation therapy alone. The present study compared the survival of patients treated with multidrug chemotherapy [streptozocin, mitomycin, and 5-fluorouracil (SMF)] versus radiation combined with 5-fluorouracil followed by the same three-drug SMF combination. In 43 patients randomly allocated between these two arms, an improved median survival for the combined-modality therapy (42 weeks) compared with chemotherapy alone (32 weeks) was demonstrated. Overall survival following this combined-modality treatment program (41% at 1 year) was significantly superior to that following SMF chemotherapy alone (19% at 1 year), by a two-tailed log rank test (P less than .02). Serial studies of the Gastrointestinal Tumor Study Group with patients with locally unresectable pancreatic adenocarcinoma have shown that combined-modality therapy is superior to either optimal radiotherapy or chemotherapy alone.

Adenocarcinoma↗

PubMed1988

Antibacterial treatment of otitis and sinusitis with ciprofloxacin and penicillin V--a comparison.

80 adult outpatients suffering from otitis media, sinusitis (maxillaris or frontalis) or peritonsillitis were treated with 500 mg ciprofloxacin b.i.d. (n = 40) or with 2 g penicillin V t.i.d. (n = 40). The patients were randomly allocated. Three groups of patients resulted, clinically and bacteriologically evaluable, or only clinically evaluable because the isolated strains were resistant to ciprofloxacin or penicillin V or because no strains were isolated. Ciprofloxacin was superior to penicillin V; there were fewer resistant strains (one compared to 11), and the eradication rate (57% compared to 43%) as well as the clinical efficacy (60% compared to 48%) of ciprofloxacin were better than those of penicillin V--even in a daily dose of 6.0 g. Both treatments were well tolerated; side effects were neither reported nor found.

Adult↗

PubMed1989

A comparison of the value of hyoscine butylbromide and glucagon on aorto iliac intravenous digital subtraction.

The diagnostic quality of intravenous subtraction aorto-iliac arteriograms was assessed in 60 patients randomly allocated to receive either hyoscine butylbromide or glucagon as an inhibitor of bowel peristalsis. The examinations in patients receiving hyoscine butylbromide showed statistically significantly less artefact due to bowel movement than those receiving glucagon. Furthermore, glucagon is 20 times more expensive than hyoscine butylbromide. Neither drug produced significant ECG changes or side effects. We conclude that intravenous hyoscine butylbromide should be used routinely, except where specifically contra-indicated, in all patients undergoing IV-DSA of the aorto-iliac segments.

Adolescent↗