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PubMed1988

A comparative study of aztreonam and procaine penicillin/probenecid in the treatment of uncomplicated gonorrhoea.

236 patients with uncomplicated gonorrhoea were randomly allocated to receive either aztreonam or procaine penicillin plus probenecid. 115 patients (50 men and 65 women) with uncomplicated gonorrhoea were treated with 1 g aztreonam as a single intramuscular injection. The success rate among those who attended at least one follow up examination after treatment was 99%. The antibiotic was well tolerated and there were no side effects. The observed minimum inhibitory concentrations (MICs) of aztreonam in vitro were very much lower than obtainable serum concentrations. The penicillin treated patients who were evaluable showed a failure rate of 12.8%. We conclude that aztreonam is effective against Neisseria gonorrhoeae, including penicillinase-producing strains, both in vivo and in vitro.

Aztreonam↗

PubMed1989

Comparative study of functional bracing and plaster cast treatment of stable lateral malleolar fractures.

In a prospective, randomized study, the use of the Aircast pneumatic air stirrup was compared with a standard below-knee walking cast in the management of Lauge-Hansen supination-eversion, stage II ankle fractures. Forty patients were randomly allocated to the two treatment groups. The use of the air stirrup led to a significant improvement in early patient comfort, post-fracture swelling, range of ankle motion at union, and time to full rehabilitation. We advocate the use of pneumatic air stirrup in the cost-effective management of stable ankle fractures.

Ankle Injuries↗

PubMed1987

Stratified duration of prophylactic antimicrobial treatment in emergency abdominal surgery. Metronidazole-fosfomycin vs. metronidazole-gentamicin in 381 patients.

Consecutive adult patients requiring emergency abdominal surgery were randomly allocated to preoperative treatment with metronidazole-gentamicin (M-G) or metronidazole-fosfomycin (M-F). Postoperative continuation of antibiotics depended on the estimated risk of septic complications. Peroperatively the cases were stratified as group A, acute inflamed appendicitis, or absence of septic disorder--no postoperative antibiotics, group B, gangrenous appendicitis or cholecystitis or intestinal obstruction without resection, or operations with contamination regarded as minor (gastrotomy or enterotomy)--three further doses of antibiotics, or group C, perforated appendicitis, perforation of the alimentary tract, generalized peritonitis or gross contamination--antibiotics continued for 5 days. Assessment for septic complications was made in 381 patients (191 M-G, 190 M-F). The total incidence was 4.8% (M-G 7.8%, M-F 1.6%, p less than 0.01). The difference was mainly due to higher infection rate in patients stratified to group C and randomized to M-G. Stratification thus permitted restricted duration of antibiotic treatment with a low septic complication rate, significantly less with M-F than with M-G regimen.

Abdomen, Acute↗

PubMed1983

Randomized controlled trial of adjuvant chemoimmunotherapy with DTIC and BCG after complete excision of primary melanoma with a poor prognosis or melanoma metastases.

A clinical study was undertaken in 57 patients with completely excised nodular or superficial spreading melanoma invasive to Clark's level 3, 4 or 5 (stage I) and 37 patients with completely resected in transit or lymph node metastases (stage III). The patients were randomly allocated to either a treatment group or a control group. Those in the treatment group received dimethyltriazeno imidazole carboxamide (DTIC) and bacille Calmette-Guérin (BCG). Those in the control group received only careful observation--the same periodic clinical and laboratory investigation that the treatment group underwent. Among the patients in the treatment group a delay in recurrence and an increase in survival were noted only in those with stage III disease, and the improvement was not statistically significant. The survival rates of the control subjects were much higher than those suggested from previously reported studies involving historical or nonrandomized control subjects, and they provide a basis on which to estimate the number of patients required for further trials of adjuvant treatment in melanoma.

Antineoplastic Agents↗

PubMed1983

Abdominal drainage following cholecystectomy: high, low, or no suction?

A prospective trial to assess the effect of suction in an abdominal drain following cholecystectomy was carried out. Three types of closed drainage system were compared: a simple tube drain, a low negative pressure drain, and a high negative pressure drain: 120 consecutive patients undergoing cholecystectomy were randomly allocated to one of the three drainage groups. There was no significant difference in postoperative pyrexia, wound infection, chest infection, or hospital stay. This study failed to demonstrate any clinically useful difference between high negative pressure, low negative pressure, and static drainage system were compared: a simple tube drain, a low negative used, suction is not necessary and a simple tube drain (greater than 6 mm internal diameter) is the most effective form of drainage.

Adult↗

PubMed1988

Double-blind study comparing cimetidine and two doses of a slow release formulation of trimoprostil in duodenal ulcer patients with a 6-month follow-up.

120 adult outpatients with endoscopically proven duodenal ulcer were randomly allocated to three groups of 40, treated in a double-blind manner with cimetidine 400 mg twice daily, trimoprostil 3 mg twice daily and trimoprostil 3 mg at bedtime. Trimoprostil was administered as a slow release formulation. Healing rates after 4 weeks were 78, 74 and 58%, respectively, the difference being not significant (p = 0.12). Similarly there was no significant difference regarding subjective symptoms, side effects and biochemical analysis. Healed patients were followed at bimonthly intervals for 6 months. The relapse rates were 71, 59 and 61% for patients initially treated with cimetidine, trimoprostil 6 or 3 mg, respectively, a difference not statistically significant.

Adolescent↗

PubMed1982

Unnecessary diuretic therapy in the elderly.

The possible beneficial or adverse effects of long-term diuretic use in the elderly were evaluated in 60 males (mean age 80.0 years) and 17 females (mean age 84.3 years). All subjects were found to have no obvious need for diuretics when initially assessed and were not receiving concurrent digoxin therapy. Residents were randomly allocated to placebo or active groups with stratification for prior hypertension or congestive heart failure (CHF) and they were followed for one year in a double-blind design. Mean BP, heart rate and weight at one year were similar to baseline values in both groups. Six active and two placebo subjects developed CHF and two other placebo subjects had a return of BP to hypertensive levels. Serum creatinine, cholesterol, potassium and BUN were significantly improved at one year in the placebo group. Chronic diuretic use did not alter appreciably the occurrence of CHF or hypertension in this elderly population and may not be necessary.

Aged↗

PubMed1987

Prevention of myopic progress by glasses. Study design and the first-year results of a randomized trial among schoolchildren.

We report the design and first-year follow-up results of a randomized trial of three different types of corrective lenses: (1) minus lenses with full correction for continuous use (the reference group); (2) minus lenses with full correction for distant vision only; and (3) bifocal lenses. Two hundred and forty 9- to 11-year-old mildly myopic schoolchildren were randomly allocated to the three treatment groups to be followed up to 3 years. During the first year, 73% of the children were compliant with their treatment. Refraction values after the first year were obtained from all but one child. In the second group (spectacles for distant vision only) myopia had progressed somewhat more than in the reference group. In respect of other values (school achievement, reading habits, and accidents) there were no statistically significant differences between the groups.

Accommodation, Ocular↗

PubMed1981

Double-blind multicentre, between patients comparison of two different doses of indoprofen and one of indomethacin in osteoarthritis.

Patients suffering from osteoarthritis of the large joints or spine randomly allocated to either of two dose levels of indoprofen (IP, 300 or 600 mg/day) or indomethacin (IM, 75 mg/day). 147 patients were admitted to the trial. Drugs were given for one to three months. Controls for effectiveness and safety were carried out weekly during the first month and thereafter at monthly intervals. All three treatments gave significant improvement in the variables considered for effectiveness, and relief was generally evident from the first month. No significant differences were observed between the two doses of indoprofen and indomethacin. Adverse reactions, considered drug related, were reported by 11.6% of patients in the IP 300 group, 12.5% in the IP 600 group, and 18.7% of patients given indomethacin.

Adult↗

PubMed1979

Controlled trial of induction of labor by vaginal suppositories containing prostaglandin E2.

A group of 84 women at 39-43 weeks of pregnancy were randomly allocated to a blind trial of induction of labor with vaginal suppositories containing inert material or either 0.2 mg or 0.4 mg of prostaglandin E2. The suppositories were self-administered every two hours during waking hours on two successive days until labor started or 15 had been used. Side-effects were absent. Labor was established within 48 hr of insertion of the first suppository in 9.3% of control patients, 65.4% of those treated with 0.2 mg PGE2 and 85.7% of those treated with 0.4 mg PGE2. The mean Apgar scores in the three groups were the same. The mean total dose of PGE2 were 2.0 mg (0.2 mg group) and 2.3 mg (0.4 mg group). It is concluded that vaginal PGE2 is an effective and acceptable method of inducing labor at term.

Clinical Trials as Topic↗

PubMed1988

Zaltidine: an effective but hepatotoxic H2-receptor antagonist.

Zaltidine is a new H2-receptor antagonist. This study compares the safety and efficacy of zaltidine with those of placebo in the short-term treatment of duodenal ulcer. One hundred and thirty-five patients were randomly allocated to 4 weeks' treatment with either 150 mg zaltidine once daily or placebo. Fifty-nine were treated for a full 4 weeks with zaltidine before the trial was stopped. Healing rates after 4 weeks of zaltidine and placebo were 86% and 19%, respectively (p less than 0.001). Five patients in the zaltidine group had increased serum aminotransferase levels at the final (4-week) visit. The values normalized when treatment was stopped. Liver biopsy specimens provide strong evidence of drug-induced injury. Hepatic damage was associated with plasma levels of zaltidine in the upper half of the observed range. Zaltidine appears to be an effective treatment of duodenal ulcer. However, the incidence of hepatic damage (8%) seems higher than with commonly used H2-receptor antagonists.

Chemical and Drug Induced Liver Injury↗

PubMed1981

Psychologically mediated effects of diagnostic tests.

Laboratory tests are purported to affect patients even if they have no diagnostic values. We tested this hypothesis by measuring clinical outcomes of 176 patients thought clinically to have nonspecific chest pain. They were randomly allocated either to have a routine electrocardiogram and serum creatine phosphokinase tests (test group) or to have all diagnostic tests withheld (no-test group). Fewer patients in the tests group (20%) reported short-term disability after the index visit than patients in the no-test group (46%) (p = 0.001). Logistic discriminant analysis confirmed that the use of diagnostic tests was an independent predictor of recovery. Patients in the test group felt that care was "better than usual" more often (57%) than patients in the no-test group (31%) (p = 0.001). After the index visit, the two groups were equally worried about serious disease and equally sparing in their use of other medial care for chest pain.

Consumer Behavior↗

PubMed1985

Somatostatin in treatment of haematemesis and melaena.

630 patients with haematemesis and melaena were randomly allocated to treatment by a constant intravenous infusion of either somatostatin or an apparently identical placebo in a double-blind controlled trial. Rebleeding was less common in treated patients (70 episodes in 315 individuals compared with 89 episodes in 315 controls) but the difference was not significant. Operation rates were virtually identical (35 treated patients and 34 controls), while there were slightly more deaths in the treated group than in the controls (31 and 25, respectively). These results are in clear disagreement with those of other smaller series. Though it is not possible to be completely sure that treatment is not useful in some individuals, earlier claims of marked benefit seem unlikely to be justified.

Clinical Trials as Topic↗

PubMed1988

Effect of prophylactic acetaminophen administration on reaction to DTP vaccination.

The effectiveness of acetaminophen in preventing post-vaccination fever was studied in a double-blind randomized manner. Healthy five-month-old infants vaccinated with diphtheria-tetanus-pertussis (DTP) or DTP-inactivated polio vaccine were randomly allocated to receive either placebo (n = 130) or 75 mg of acetaminophen (n = 133) four hours after the vaccination. Rectal temperatures of the infants were measured in the post-vaccination evening and next morning by the parents. The mean values of rectal temperatures were equal in both groups, i.e. 37.6 degrees C, both in the evening and in the morning. No significant difference was found in the occurrence of other minor adverse reactions. Antibody titres to diphtheria and tetanus toxoids and pertussis bacteria of the placebo (n = 25) and acetaminophen (n = 34) groups did not differ significantly from each other. It is concluded that acetaminophen in a single dose schedule is ineffective in decreasing post-vaccination fever and other symptoms.

Acetaminophen↗

PubMed1987

Prophylactic PUVA and UVB therapy in polymorphic light eruption--a controlled trial.

A double-blind controlled trial of low-dose prophylactic oral psoralen photochemotherapy (PUVA) and ultraviolet-B (UVB) irradiation therapy was undertaken from April to September 1983 in 42 patients with polymorphic light eruption (PLE). Patients were randomly allocated to three groups, PUVA with oral 8-methoxypsoralen (8-MOP), UVB with oral placebo, and control low-dose UVA with oral placebo. The initial dose given to each active treatment group was a third of the predetermined minimal phototoxic or erythema dose, followed three times weekly for 6 weeks by doses incremented by an eighth on each occasion in the PUVA group and by a seventh in the UVB group. Ultraviolet radiation exposure was monitored throughout with polysulphone film lapel badges. Patients recorded their symptoms on a visual analogue scale. Symptoms of rash and itch in patients treated with PUVA and UVB were significantly less affected by increasing exposure to ultraviolet radiation than were these symptoms in control patients.

Clinical Trials as Topic↗

PubMed1982

Cyclosporin a as sole immunosuppressive agent in recipients of kidney allografts from cadaver donors. Preliminary results of a European multicentre trial.

In a multicentre trial conducted in eight European centres, 232 recipients of cadaveric renal allografts were randomly allocated to receive either cyclosporin A (CyA, 117 patients) or azathioprine and steroids (control, 115 patients) for immunosuppression. After a follow-up period of up to 11 months, graft survival probability estimates are 73% in the CyA group and 53% in the control group. Two deaths have occurred in the CyA group and seven in the control group. 82% of the CyA group with functioning grafts are receiving CyA alone, 17% have been changed to azathioprine and steroids, and 1 patient is receiving prednisolone in addition to CyA; 27% have never received steroids. At 6 months post-transplant, renal function is similar in patients receiving CyA and in those receiving azathioprine and steroids. These preliminary results suggest that CyA is more effective than conventional immunosuppression. CyA therapy avoids the necessity of long-term steroid therapy.

Azathioprine↗

PubMed1983

Prospective controlled trial of a Y-connector and disinfectant to prevent peritonitis in continuous ambulatory peritoneal dialysis.

A controlled study in two centres compared the efficacy of the standard continuous ambulatory peritoneal dialysis (CAPD) system with that of a new method consisting of a Y-shaped set filled with sodium hypochlorite during the dwelling time. 62 new CAPD patients were randomly allocated to the standard method (group A: 30 patients; age 55.5 +/- 17.5 years) or to the Y-system (group B: 32 patients; age 55.1 +/- 14.3 years). In group A, there were 31 peritonitis episodes in 17 patients (57%) during a cumulative period of 351 months--1 episode every 11.3 patient-months. In group B, there were 11 peritonitis episodes in 10 patients (31%) during 363 months--1 episode every 33 patient-months. Life-table analysis showed a significant difference between the incidence of peritonitis in the two groups. The Y-system method is simple and economical and the frequency and the severity of side-effects appears to be acceptable.

Adolescent↗

PubMed1982

Does the order of second-line treatment in rheumatoid arthritis matter?

In a prospective study 88 patients, with rheumatoid arthritis who had stopped taking gold, penicillamine, or levamisole were randomly allocated to one of the alternative drugs and followed up for a minimum of one year. Concurrent studies of the effects of gold, penicillamine, and levamisole prescribed in 123 patients as the first second-line drug were used for comparison. No difference in toxicity or efficacy between primary and secondary use of gold or penicillamine was identified. Variation in the toxicity of levamisole could in part be accounted for by changes in the dose regimen over the four years of study. The length of the treatment-free interval between drugs did not influence subsequent development of toxicity. These results suggest that an adverse reaction to one of the three second-line drugs studied should not prejudice the selection of another.

Adult↗