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Is low salt dietary advice a useful therapy in hypertensive patients with poorly controlled blood pressure?

In order to decide whether or not to advise a low Na trial routinely in a hypertension clinic, a randomised controlled 'management' trial was conducted to assess dietary compliance, well-being and changes in antihypertensive medication as a result of such a diet. Sixty-five out-patients on drug treatment for hypertension but with diastolic blood pressures greater than 95 mm Hg on two successive occasions were randomly allocated either to an index group on a 1 g Na (44 mmol) daily diet or to a reference group. Dietary advice was given in detail and repeated as necessary to ensure there was no misunderstanding. After three months 28% of the index group still added salt to their cooking and 13% sometimes added salt at the table. The difference between the groups in 24-hour Na excretion averaged 59 mmol at the end of the trial but 55% of the index group had a 24-hour Na excretion greater than 80 mmol. The average blood pressure at the end of the trial was only a 4 mm Hg systolic and 3 mm Hg diastolic lower in the index group. However, this modest benefit was achieved without any obvious deterioration in the quality of the lives of the patients on the low Na diet. The index group enjoyed their food as much as before and tended to require less drug treatment. On the debit side the index group complained more of transient unsteadiness (p less than 0.05) suggestive of postural hypotension. Low salt dietary advice is only marginally effective in patients poorly controlled on drug treatment. Non-compliance limits the usefulness of the advice.

Antihypertensive Agents↗

De-Nol in the treatment of reflux esophagitis.

Twenty-eight patients with histologically proven reflux esophagitis were randomly allocated to receive either De-Nol (tripotassium dicitrate bismuthate) or placebo for three weeks. Significant decreases in symptoms frequency and severity were noted in De-Nol group comparing with placebo group (p less than 0.01). Objective improvement in esophageal endoscopic appearance was obtained in 78.5% of the patients treated with De-Nol and only in 14.2% of those receiving placebo. De-Nol appears to be an effective drug in the treatment of reflux esophagitis, but this should be confirmed by further studies.

Adult↗

A comparison of intracavitary talc and tetracycline for the control of pleural effusions secondary to breast cancer.

Forty-one patients with malignant pleural effusions secondary to breast cancer were randomly allocated to treatment with either intracavitary talc or intracavitary tetracycline. Of 33 evaluable patients, radiological control was achieved in 11/12 (92%) of the talc group compared with 10/21 (48%) of the tetracycline group (P = 0.022). Intracavitary talc provides effective palliation of metastatic pleural effusions secondary to breast cancer.

Breast Neoplasms↗

Effects of precurarization on the blood pressure and heart rate changes induced by suxamethonium facilitated laryngoscopy and intubation.

The effects of precurarization on blood pressure and heart rate increases during laryngoscopy and intubation were studied in 60 surgical patients, who were randomly allocated to four groups, receiving as a pretreatment d-tubocurarine (0.05 mg/kg), alcuronium (0.03 mk/kg) , pancuronium (0.008 mg/kg) or saline in a double-blind fashion. d-Tubocurarine and alcuronium pretreatments seemed to attenuate the blood pressure increase during laryngoscopy and intubation under suxamethonium. Moreover, d-tubocurarine pretreatment protected effectively against high blood-pressure increases. Heart-rate increases were of the same magnitude in all the pretreated groups. d-Tubocurarine pretreatment abolished suxamethonium-induced fasciculations completely, whereas alcuronium pretreatment gave protection in 93% and pancuronium pretreatment in 43% of patients.

Adult↗

Topical prostaglandin E2 in the treatment of acute upper gastrointestinal tract hemorrhage. A prospective, randomized, double-blind study.

We performed a prospective, randomized, double-blind study to assess the efficacy of topical prostaglandin E2 (PGE2) in altering the course of patients with severe upper gastrointestinal tract hemorrhage. Forty-four patients with life-threatening, endoscopically proven hemorrhage were randomly allocated to receive either PGE2 or placebo for seven days. Severity of mucosal injury, determined by endoscopy, was scored both before and after completion of treatment. There were no significant differences between groups in either transfusion requirements or successful outcomes. However, the PGE2 group had significantly improved endoscopic injury scores while the placebo group did not. Therefore, topical PGE2 does not control acute hemorrhage from established upper gastrointestinal tract lesions, but it does result in an accelerated healing of established lesions.

Acute Disease↗

Randomized, prospective study of nail bed ablation for recurrent ingrowing toenails.

A consecutive series of 31 recurrent ingrowing toenails, which had previously undergone at least two surgical procedures, were recruited to this study over a 1-year period. Patients were randomly allocated to one of two treatment groups. Group A underwent nail bed excision whilst group B had nail bed phenolization in addition to excision. Patients were reviewed 2 weeks and 1 year after operation. Seven toes (41%) in group A developed postoperative infection compared with only one (7%) in group B (P less than 0.01). Recurrent nail spicules occurred in ten patients (59%) in group A and six patients (43%) in group B 1 year after operation. High failure rates for ablation of recurrent ingrowing toenails should encourage greater efforts towards adequate treatment at the first presentation.

Adolescent↗

Feasibility of a men's health promotion programme in Irish primary care.

BACKGROUND: To assess the feasibility of offering health promotion and preventive medicine initiatives in primary care. AIMS: A pilot study aimed at men in general practice to establish the uptake, acceptability and effectiveness of interventions in health initiatives. METHODS: One thousand men aged 18-65 were selected at random from five general practices in the Western Health Board area. Practices were randomly allocated to one of four brief interventions: cardiovascular screening, cancer screening, stress management or general lifestyle advice. RESULTS: Fifty-five per cent of men responded, with 35.7% actually attending. There were minor but significant short-term changes in health status and behaviours. Participants expressed high levels of satisfaction, but tended to prefer interventions with an explicit clinical component. CONCLUSION: It is at least as feasible to offer health promotion for men in primary care as it is for other demographic groups, but adequate training and resources are required.

Adult↗

Management of pregnancy-induced hypertension with pindolol--comparative study with methyldopa.

Thirty-two consecutive women with pregnancy-induced hypertension of early onset were randomly allocated to treatment with pindolol or methyldopa. There was no difference between the groups in regard to the average time of delivery (36.33 vs. 36.6 weeks) and weight of the newborn (2850 vs. 2870 g). A significant drop in systolic (P less than 0.005) and diastolic (P less than 0.05) blood pressure was observed in the group of patients treated with pindolol as compared with the methyldopa group. In the pindolol group an improvement in renal function was observed as determined by CCT and serum creatinine. There were no side effects from the drugs in the mother or in the newborn.

Adult↗

A randomized study of radiation treatment in small cell bronchial carcinoma treated with two types of four-drug chemotherapy regimens.

Of an unselected series of 133 patients with small cell bronchial carcinoma, 110 patients (54 with extensive disease and 56 with limited disease) were randomly allocated to receive either chemotherapy with cyclophosphamide, doxorubicin, vincristine, and methotrexate, alternating after four cycles with cyclophosphamide, lomustine, vincristine, and methotrexate, or the same chemotherapy combinations together with irradiation at 40 Gy to the primary tumor area and the adjacent mediastinum. In patients with extensive disease the total response rates were 70% and 86% and the median survival 7.6 and 9.2 months, respectively. There were no long-term survivors, and no advantage was gained from radiation combination treatment. The results confirm previously reported findings. In limited disease the complete remission rates were 68% and 64%, the partial remission rates 26% and 28%, and the median survival was 14.8 and 15.4 months, respectively. There were no statistically significant differences favoring either treatment regimen. The disease-free survival exceeding 2 years in the two respective groups was 6.5% and 25%; this difference was not statistically significant. A slight advantage of combined radiation and chemotherapy in the direction of better long-term survival was confirmed by the 4-year disease-free survival rate of 12% as compared with 0% in the nonirradiation group. This difference was statistically significant. There was considerable toxicity with both treatment regimens. The addition of radiation treatment to the chemotherapy most likely benefits patients with limited disease. The overall median survival of all the unselected 133 patients (nonrandomized included) was 10.3 months, and the cure rate was 3%.

Actuarial Analysis↗

Spectacle-use, bifocals and prevention of myopic progression. The two-years results of a randomized trial among schoolchildren.

This paper gives the two-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 to be used for distant vision only; and 3) bifocal lenses. A total of 240 9-11-years old mildly myopic schoolchildren were randomly allocated to the three different treatment groups to be followed up for 3 years. After 2-years follow-up the change in the spherical equivalent was greatest in the distant use group. There were no significant positive correlations between changes in refraction and accommodation or refraction and convergence.

Accommodation, Ocular↗

Prognostic value of serum hormone concentrations in prostatic cancer.

Seventy-eight patients with cytologically and/or histologically confirmed prostatic cancer were randomly allocated to orchidectomy (ORX, n = 37) or combined intramuscular and oral estrogen treatment (ESTR, n = 41). Serum levels of testosterone (T), 17 alpha-hydroxyprogesterone, dehydroepiandrosterone, dehydroepiandrosterone sulfate, total estrone (tE1; sum of unconjugated and conjugated estrone, greater than or equal to 85% estrone sulfate), cortisol, luteinizing hormone, follicle-stimulating hormone, prolactin, growth hormone, sex hormone-binding globulin (SHBG), and albumin were determined prior to treatment and 12, 24, and 36 months after initiation of treatment. Fifty patients responded to treatment or had stable disease, and 28 did not respond (12 in the ORX and 16 in the ESTR group). There was no association between pretreatment hormone or protein levels and outcome of the treatment, neither in the total material nor within either of the two treatment subgroups. Significantly higher pretreatment levels of cortisol and prolactin and significantly lower levels of T, tE1, and albumin and a significantly lower T/SHBG-ratio (index on biologically active T) were found in patients with metastatic disease, compared with the patients without metastases. There was no association between testicular or adrenal androgens, SHBG, T/SHBG, and albumin values during treatment and the clinical outcome. The differences found between metastatic and nonmetastatic disease probably simply reflect the more stressful and catabolic condition and generally poorer health in patients with disseminated malignant disease. Furthermore, the study does not lend any support to the hypothesis that indicates an important role of adrenal "rest androgen" in prostatic cancer tumor growth.

17-alpha-Hydroxyprogesterone↗

Randomized comparative trial of three regimens of itraconazole for treatment of vaginal mycoses.

A randomized comparative study of three treatment regimens with itraconazole was carried out in 60 nonpregnant women with acute vaginal candidosis. Vaginitis was demonstrated by both a positive culture and positive findings on microscopic examination of a vaginal smear as well as by the presence of clinical symptoms. Sixty patients seen over a three-month period were randomly allocated to receive one dose of 200 mg daily for two consecutive days (regimen A), 200 mg twice a day for one day (regimen B), or 200 mg once a day for three consecutive days (regimen C). Each group comprised 20 patients. In group A, 65% were clinically and microbiologically cured, 5% were clinically but not microbiologically cured, and 30% relapsed. In group B, 55% were clinically and microbiologically cured, 10% were clinically but not microbiologically cured, 15% did not respond to treatment, and 20% relapsed. In group C, 75% were clinically and microbiologically cured, 10% did not respond, and 15% relapsed.

Adult↗

Latency of brachial plexus block. The effect on onset time of warming local anaesthetic solutions.

A double-blind study was set up to investigate the effect of warming local anaesthetic solutions on the latency of onset of subclavian perivascular brachial plexus blocks. Twenty-four adult patients were randomly allocated into two equal groups. In group A the local anaesthetic was injected at room temperature, while in group B the local anaesthetic solution was prewarmed to 37 degrees C in a thermostatically controlled heating block. All blocks were performed using 0.5 ml/kg of a solution prepared by mixing equal volumes of 0.5% bupivacaine with adrenaline 1:200,000, and 1% prilocaine. The speed of onset of sensory blockade was significantly increased when the temperature of the local anaesthetic solution was increased to 37 degrees C. There were no adverse side effects in either group.

Anesthetics, Local↗

Comparison of highly purified semi-synthetic insulin and highly purified porcine insulin in the treatment of type I diabetes: interim report of a multi-centre randomised single blind study.

This is an interim report of a long term single-blind study of the effects of changing diabetic patients treated with highly purified porcine insulin to semi-synthetic human insulins of identical formulation. Twenty four insulin dependent diabetics were randomly allocated to continue with porcine insulin (n = 11) or human insulin (n = 13). There were no significant changes within the groups nor differences between the groups in mean preprandial capillary blood glucose, glycosylated haemoglobin or insulin dose during the first 24 weeks of the study. Insulin antibody levels remained low and did not differ between the groups. No local or systemic adverse reactions were observed. In this group of patients conversion to human insulin did not result in a change in diabetic control or insulin dose.

Adolescent↗

Intravenous aminophylline in patients already taking oral theophylline: effect on calculated dose of knowledge of serum theophylline concentration on admission.

Measurement of serum theophylline concentration is usually recommended before intravenous aminophylline is given to patients taking oral theophylline. Fifty patients with worsening airflow obstruction, all of whom were taking oral theophyllines and who had no contraindication to the use of parenteral aminophylline, were randomly allocated into two groups before treatment was given. The dose of aminophylline was calculated without (group A) and with (group B) knowledge of admission serum theophylline concentration. In group A a regimen incorporating corrections to account for factors affecting theophylline clearance was used in an attempt to represent a "knowledgeable" approach; in group B a formula incorporating the known serum theophylline concentration at the time of admission was used. All loading doses were given over 30 minutes as "mini infusions." The two groups were well matched for age, blood gas tensions, and severity of airflow obstruction. The results for four patients (one from group A and three from group B) were excluded from analysis after completion of the study. In each group the mean admission serum theophylline concentration measured (group A: 8.4 (SD 6.0)mg/l; group B: 7.2 (5.7)mg/l) and the aminophylline doses used (group A: loading bolus 172 (45.5)mg, infusion 815 (198)mg; group B: loading bolus 233(189)mg, infusion 788(214)mg) were similar. Mean serum theophylline concentrations during 24 hours' aminophylline treatment, number of patients with a serum theophylline concentration greater than 20 mg/l, symptoms of toxicity, and outcome were also similar in the two groups. Although satisfactory use of parenteral aminophylline was achieved for most patients without knowledge of serum theophylline concentration at the time of admission to hospital (with the aid of a "knowledgeable" clinical approach and constant infusion pumps), prompt measurement of serum theophylline concentration at the time of admission identified patients with either suboptimal or potentially hazardous theophylline concentrations.

Administration, Oral↗

A randomized trial comparing cisplatin plus cyclophosphamide versus cisplatin, doxorubicin, and cyclophosphamide in advanced ovarian cancer.

After primary surgery, 125 patients with epithelial ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] 1c + IIb + IIc = 22 patients, FIGO III = 82 patients, FIGO IV = 21 patients) were randomly allocated to receive PC (cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 on day 1 every 28 days) (corrected) or PAC (PC + doxorubicin 45 mg/m2). After six cycles, patients clinically disease-free or with resectable residual disease were submitted to second-look surgery. After restaging, patients in surgical complete response (CR) stopped treatment while those responding partially (PR) received six more courses; patients whose disease progressed were excluded from the study. Among patients with measurable disease, the following clinical response rates were observed: PC = 20% CR, 34.3% PR, 14.3% stable disease, and 31.4% progression; PAC = 40.6% CR, 15.6% PR, 12.5% stable disease, and 31.3% progression. In the 75 patients submitted to second look, the results have been the following: PC = 39.5% CR, 36.8% PR, 7.9% stable disease, and 15.8% progression; PAC = 62.2% CR, 18.9% PR, 10.8% stable disease, and 8.1% progression. The difference in surgical complete response in favor of the PAC regimen is significant (P less than .05). Median survival and progression-free survival were 800 and 400 days, respectively, for PAC arm; median survival and progression-free survival were 680 and 380 days, respectively, for PC. These differences are not significant. Probability of survival was affected by FIGO stage, amount of residual disease, histology, performance status, and response at second look, while no influence was observed according to grade of tumor differentiation and age. Our results demonstrate the usefulness of doxorubicin in terms of surgical CR.

Adult↗

Is nifedipine a suitable first-line treatment for essential hypertension in general practice?

Nifedipine has been used in hypertension, mainly as a third-line drug for rapid blood pressure reduction, for over 10 years. More recently it has been shown to be effective and safe in reducing mild to moderate blood pressure when used alone in a slow release formulation. A placebo-controlled study investigating the efficacy and safety of nifedipine in comparison with cyclopenthiazide-potassium has now been carried out by 4 general practitioners in the Glasgow area. Ninety-four patients were entered into the study. After a 4-week placebo run-in phase, patients were randomly allocated to receive either slow-release nifedipine 20 mg b.d., or cyclopenthiazide 0.25 mg with 8.1 mmol potassium daily. The dose was doubled at week 8 for non-responders, and at week 12 the alternative drug was added if there was still no response. The patients were studied for up to 28 weeks. Nifedipine was found to have similar blood pressure lowering efficacy to cyclopenthiazide-potassium, but withdrawals from nifedipine due to side-effects at an early stage were more common.

Adolescent↗

Early, late, and sequential embryo transfer in in vitro fertilization program: a preliminary report.

The timing of ET was evaluated by transferring four embryos at 44 to 48 hours, 68 to 72 hours, or equally dividing and sequentially transferring at 44 to 48 and 68 to 72 hours after insemination. Fifty-one patients were randomly allocated to one of the above protocols. The mean number of blastomeres of embryos transferred at 68 to 72 hours after insemination was significantly (P less than 0.0001) higher than those transferred at 44 to 48 hours. The number of embryos with good morphology was similar in all study groups. The pregnancy rate was similar in the three protocol groups, 53% at 44 to 48 hours, 59% at 64 to 72 hours, and 47% by sequential transfer. There probably is no advantage in delaying the transfer or dividing the embryos into two sequential transfers. It seems that sequential transfer is not associated with any harmful effect.

Adult↗