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PubMed1989

Acute gastroenteritis in well nourished infants: comparison of four feeding regimens.

Two hundred well hydrated babies of 6 weeks to 12 months of age who had been fed on formula feeds and who were admitted with acute gastroenteritis were randomly allocated to receive either a standard return to full milk feeds, or immediate full strength feeds with one of three milk formulas, HN25, SMA Gold Cap, or Formula S. There were significant differences in weight change among the four treatment groups at two and five days, with initial weight loss recorded only for the group of babies who were receiving the graded return to full feeding. There was no difference in the duration of diarrhoea after admission, nor in the time to discharge. Eighteen babies were classified as failures of treatment. None had long term complications. Well hydrated infants with acute gastroenteritis may resume full milk feeding immediately.

Acute Disease↗

PubMed1985

Comparison of CAF versus CMFP in metastatic breast cancer: analysis of prognostic factors.

One hundred fifty-five eligible women with metastatic breast cancer were randomly allocated to receive monthly cycles of either CMFP (cyclophosphamide, methotrexate, 5-fluorouracil, prednisone) or CAF (cyclophosphamide, doxorubicin, 5-fluorouracil), and 12 patients were studied to evaluate the effects of additional Corynebacterium parvum immunotherapy. Overall response rates of 53% were seen with CMFP and CAF. CAF was associated with significantly more complete responses than CMFP (17% v 5%). However, CAF therapy was administered for eight months and CMFP for six months. Only 13% of the CAF patients had a complete response during the first six months of chemotherapy, and this was not significantly different from the complete response rate on CMFP. The median response durations (CMFP, 6.3 months; CAF, 11.0 months), times to treatment failure (CMFP, 5.7 months; CAF, 7.8 months), and survival times (CMFP, 15.8 months; CAF, 18.6 months) were not statistically different. Other investigators who have compared CAF to CMF-containing regimens have reported a large advantage in CAF therapy among patients with "good risk" sites of metastases (local-regional recurrence, bone, lung nodules). Such a finding was not confirmed by our study: in multivariate analyses the groups associated with an advantage for CAF tended to have a poorer prognosis than the groups associated with an advantage for CMFP. There was significantly more nausea and vomiting after CAF treatment, and CMFP treatment was associated with significantly more edema, Cushingoid features, fever, and eye symptoms.

Adult↗

PubMed1988

Double-blind comparison of amlodipine and hydrochlorothiazide in patients with mild to moderate hypertension.

Amlodipine, a new long-acting dihydropyridine calcium antagonist, was compared with hydrochlorothiazie (HCTZ) in 145 patients with mild to moderate hypertension. After 4 weeks of single-blind placebo runin, patients were randomly allocated to receive amlodipine (2.5-10 mg once daily, n = 97) or HCTZ (25-100 mg once daily, n = 48). At study week 12 response rates for amlodipine and HCTZ were 61.5 and 60.5%, respectively. There were clinically significant reductions in 24-h postdose blood pressures with both amlodipine (-18/-11 mm Hg supine: -14/-10 mm Hg standing) and HCTZ (-18/-10 mm Hg supine, -18/-9 mm Hg standing). After study week 12, atenolol (50-100 mg once daily) was added to the regimen of those patients whose hypertension was not controlled with monotherapy. Neither amlodipine nor HCTZ produced clinically significant changes in pulse rate, electrocardiogram, or chest x-ray film. Although amlodipine increased and HCTZ decreased the high-density lipoprotein (HDL)/total cholesterol ratio and the HDL/(low-density lipoprotein + very-low-density lipoprotein) ratio, the difference between the two treatments was not statistically significant. The incidence of side effects and the rate of patient withdrawal was comparable in the two groups. The incidence of laboratory abnormalities was 56% with HCTZ (mainly hypokalemia and hyperuricemia) and 16% with amlodipine. Amlodipine was an effective, well-tolerated agent for treatment of mild-to-moderate hypertension in this study, as single-daily-dose monotherapy and in combination with atenolol.

Adolescent↗

PubMed1983

Cisobitan in treatment of prostatic cancer. A prospective controlled multicentre study.

Cisobitan, an organosilicon compound with estrogenic and antigonadotropic properties has been evaluated clinically in comparison with an estrogen preparation. In a multicenter study a total of 140 patients with well and moderately well differentiated prostatic cancer were randomly allocated to treatment with Cisobitan or Estradurin/Etivex, 70 to each group. Of 34 patients with poorly differentiated prostatic cancer 18 were given Cisobitan--and 16 were given Estracyt-treatment. Among the patients with well and moderately well differentiated prostatic cancer there were, disregarding mortality, no major differences in subjective, objective or laboratory response to the two kinds of treatment. The pattern of side effects was similar, but oedema requiring diuretics occurred more often in the estrogen treated group. There was a significant difference in mortality at 12 months between the groups, two in the Cisobitan group and ten in the estrogen treated group. Cancer was the cause of death in two patients in the estrogen treated group. All other patients succumbed in cardiovascular diseases. At 24 months the difference in mortality rate was less pronounced: Another ten patients had died in the Cisobitan treated group and seven among the estrogen treated patients. Cancer was responsible for the deaths in seven of the Cisobitan patients compared to four of the estrogen treated patients. Within three years one more patient in both groups had died. Of the 34 patients with poorly differentiated cancer, twelve were alive at the 24 months' follow up, six in the Cisobitan group and six in the Estracyt group.

Clinical Trials as Topic↗

PubMed1988

Can general practitioners use training in relaxation and management of stress to reduce mild hypertension?

To see whether general practitioners could effectively carry out training in relaxation and management of stress to reduce mild hypertension a study was carried out with a subsample of phase 2 of the Medical Research Council's treatment of mild hypertension trial. In the main mild hypertension trial patients had been receiving either an active drug or placebo for six years. In phase 2 a subsample of these patients were randomly allocated either to continue or to stop receiving the active drug or placebo. In a further subsample patients were again randomised to receive or not to receive relaxation therapy. This factorial design presented an additional opportunity to assess whether patients controlled with active drugs might have their blood pressure maintained by this behavioural therapy once drug treatment was stopped and to assess whether blood pressure might be further reduced by this therapy in patients who had been under regular medical supervision for as long as six years and who had already received non-pharmacological advice. The therapy was conducted by general practitioners in group sessions once a week for eight weeks. The training in relaxation was accompanied by galvanic skin resistance biofeedback. At one year follow up blood pressure in the relaxation subgroups was either maintained (in the group who had stopped receiving drugs) or reduced further (in the group who had continued receiving drugs and in both placebo groups), while in the control group it had increased in all the subgroups, but particularly in those who had stopped receiving drugs. Differences in changes in blood pressure between the relaxation and control groups were significant. There were five new cardiovascular events, including evidence of myocardial ischaemia in blindly coded electrocardiograms in the control group, compared with one in the treatment group. General practitioners, if motivated, can successfully apply this technique of training those with mild hypertension in relaxation and management of stress.

Adult↗

PubMed1986

Electrophysiologic effects of cibenzoline in humans related to dose and plasma concentration.

The electrophysiologic effects of a new antiarrhythmic agent, cibenzoline, were investigated in 25 patients with an average age of 62 years. The compound was administered intravenously, as a bolus given over 2 minutes, then as a slow infusion over 40 minutes. Each subject was randomly allocated to receive one of the following four doses: 1.55 mg/kg (six patients), 1.8 mg/kg (six patients), 2.2 mg/kg (six patients), or 2.6 mg/kg (seven patients). Plasma cibenzoline concentrations at these doses were 378 +/- 80,525 +/- 194, 618 +/- 72, and 731 +/- 196 ng/ml, respectively. Administration of 1.55 mg/kg cibenzoline significantly shortened the sinus cycle (60 msec on average; p less than 0.025) and increased intraatrial (+8 msec; p less than 0.05) and His-Purkinje conduction times (HV interval + 13 msec; p less than 0.001). At 1.80 mg/kg, prolongation occurred in the HV interval (+9 msec; p less than 0.02), the duration of the QRS complex (+20 msec; p greater than 0.05), and the QT interval (+18 msec; p less than 0.025). At the higher doses these changes became more marked (maximum increase: HV = +16 msec, p less than 0.001; QRS + 25 msec; p less than 0.001; QT + 26 msec, p less than 0.05), and additional effects on atrioventricular nodal conduction time (AH interval + 17 msec; p less than 0.05) and atrial (+20 msec; p less than 0.05) and ventricular (+10 msec; p greater than 0.05) effective refractory periods were observed. Prolongation of the QRS duration was the effect that correlated best with plasma cibenzoline levels (r = 0.47; p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1986

Relative importance of antibiotic and improved clearance in topical treatment of chronic mucopurulent rhinosinusitis. A controlled study.

50 patients with chronic mucopurulent rhinosinusitis were randomly allocated to treatment with nasal sprays of dexamethasone, tramazoline, and neomycin, dexamethasone and tramazoline with no antibiotic, or matched placebo (propellant alone) four times daily to both nostrils for 2 weeks. The patients were assessed in a double-blind manner for symptomatic response and improvement in nasal mucociliary clearance, nasal airway resistance, sinus radiographs, and intranasal bacteriology and appearance. Both active preparations (with antibiotic 14 of 20 patients responded; without antibiotic 12 of 20 patients responded) were more effective than the placebo (2 of 10 patients responded). There was no significant difference in response between the active preparations with and without antibiotic. Thus, in treatment of chronic mucopurulent rhinosinusitis, reduction of the inflammatory response and decongestion make topical antibiotic unnecessary, probably by allowing host clearance mechanisms to recover.

Administration, Intranasal↗

PubMed1989

[Effect of beta blockers with intrinsic sympathomimetic activity on blood pressure and blood lipids in patients with essential hypertension].

The aim of this study was to compare the effects of a beta-blocker (mepindolol) with intrinsic sympathomimetic activity (ISA) to a beta-blocker (metoprolol duriles) without ISA. Hypertensive patients with more than 50 years of age were selected and randomly allocated to receive either 5 mg/day mepindolol (Group A, 10 patients), or 200 mg/day metoprolol duriles (Group B, 9 patients), or placebo (Group C, 10 patients). They were submitted to clinical exam, stress testing and plasma lipids dosage before and after four weeks of treatment. At rest, there were a significant reduction of systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) in all groups. The mean values for SBP, DBP and HR at rest after treatment were respectively: 154.0, 95.5, 73.7 (Group A); 148.8, 94.4, 70.1 (Group B); 153.0, 96.0, 77.8; (Group C). During stress testing, there were a significant reduction of SBP, HR and double product (DP). The DBP remained unchanged. The mean values for SBP, DBP, HR and DP during stress testing after treatment were respectively; 198.0, 115.5, 124.3, 246.9 (Group A); 198.8, 114.4, 144.6, 283.2 (Group B); 202.2, 119.0, 143.5, 283.4 (Group C). Total cholesterol, HDL-cholesterol, and LDL-cholesterol, have not changed with both beta-blockers. There were a significant increase in plasma triglycerides and VLDL-cholesterol levels after treatment with beta-blockers. In conclusion, both mepindolol and metoprolol were similarly effective in reducing arterial blood pressure of hypertensive patients. There were not significant differences between the beta-blocker with or without ISA in regard to their effects on plasma lipids.

Aging↗

PubMedDate not supplied

Cefuroxime axetil in the treatment of cutaneous infections.

A multicenter clinical trial was conducted in 125 out-patients with skin and skin structure infections due to bacteria in order to compare the safety and efficacy of cefuroxime axetil and cefaclor. Patients with a median age of 32 years were randomly allocated to treatment for 10 days with one of three treatments: cefuroxime axetil 250 mg b.i.d., cefuroxime axetil 500 mg b.i.d., or cefaclor 250 mg t.i.d. Clinical evaluations of each patient were done pre-treatment, 2 to 4 days intra-treatment, and within 3 days post-treatment. One patient discontinued cefuroxime axetil due to severe urticaria and one patient discontinued cefaclor due to a persistent headache and vomiting. Cefuroxime axetil was an effective antibacterial agent for treatment of common skin infections. Clinically beneficial outcome was achieved for 92% (cefuroxime axetil 250 mg b.i.d.), 95% (cefuroxime axetil 500 mg b.i.d.), and 97% (cefaclor 250 mg t.i.d.) of patients. Since the study failed to demonstrate a significant advantage of higher dosage, cefuroxime axetil should be prescribed in a regimen of 250 mg twice a day for patients with skin infections.

Adolescent↗

PubMed1985

Results of the Sherbrooke-Lac Mégantic fluoride varnish study after 20 months.

The purpose of this study was to demonstrate the effectiveness of two fluoride varnishes (Duraphat and Fluor Protector) in the prevention of dental caries in children residing in a non-fluoridated community. At baseline, 787 grade one children (6-7-yr old) were examined and randomly allocated into a control and two treatment groups. At 20 months, 703 children remained in the study. The mean baseline caries experience and the mean number of permanent teeth present at 20 months were not significantly different among the treatment and control groups. The mean DMFS increments after 20 months were 1.70, 1.73 and 2.02 for Fluor-Protector, Duraphat and control groups respectively (% reductions of 15.8 and 14.4 for Fluor-Protector and Duraphat groups). The mean dfs increments for primary molars after 20 months were 1.56, 1.62 and 1.74 for Fluor-Protector, Duraphat and control groups respectively (% reductions of 10 for Fluor-Protector and 7 for Duraphat).

Child↗

PubMed1989

Injections and physiotherapy for the painful stiff shoulder.

Cost effective treatment is needed for common self limiting rheumatological conditions. Periarthritis of the shoulder is an example. There is no consensus for one type of treatment, though local steroids or physiotherapy are conventionally used. Their cost and efficacy were compared in a prospective randomised observer-blind trial--in essence a medical audit of the treatment of a common rheumatological problem. Sixty two consecutive patients presenting with a painful stiff shoulder were studied. Patients with coexistent diseases like cervical spondylosis or a stroke were excluded. They were randomly allocated to receive local steroids, six weeks' physiotherapy, or both. The three groups were of similar age, sex, and disease severity. Assessments of pain and shoulder movement were made initially, at six weeks, and at six months by a 'blinded' observer. Physiotherapy was given by one therapist and injections by one physician. All three groups showed significant improvements by six weeks, with further improvement at six months. Improvements were identical in all three groups. No treatment gave complications. The costs of treatment varied: an injection of triamcinolone cost 2.10 pounds; a six week course of physiotherapy cost 48.50 pounds; combination treatment cost 50.60 pounds. Patients expect treatment for a painful stiff shoulder. The results show that local steroid injections are as effective as physiotherapy alone or a combination. They provide rapid treatment and are less expensive. In the uncomplicated case a local steroid injection is the most cost effective treatment.

Costs and Cost Analysis↗

PubMed1991

Doxycycline tolerance study. Incidence of nausea after doxycycline administration to healthy volunteers: a comparison of 2 formulations (Doryx' vs Vibramycin').

In a randomised, double-blind, 3-way cross-over trial, the incidence of nausea associated with 2 doxycycline 100 mg formulations (Doryx' and Vibramycin') were compared. The original study cohort comprised 103 healthy male volunteers, with 97 subjects completing the trial. Subjects were randomly allocated to 1 of 3 treatment sequences and received a single dose of Doryx', Vibramycin' or placebo, with a 7-day washout prior to cross-over. At half-hourly intervals, from 0 to 2 h post-dose, subjects completed questionnaires to indicate if they felt nauseous. Data were analysed according to a log-linear method for the analysis of cross-over trials with categorical responses. Seventeen, 29 and 11 subjects experienced nausea with Doryx', Vibramycin' and placebo, respectively. A significantly greater number of volunteers indicated a positive response with Vibramycin' vs Doryx' and vs placebo; the positive response frequency was not significantly different for the Doryx' vs the placebo regimen. Treatment sequence had no significant effect on response, although a marked first-dose effect was noted; the first (vs the second and vs the third) regimen was 1.5-2 times more likely to induce a positive response.

Adult↗

PubMed1981

Evaluation of aids and equipment for the bath: II. A possible solution to the problem.

One hundred patients needing bath aids is leaving Leeds hospitals in 1978 were randomly allocated into control and treated groups. The former 50 patients received aids through the usual channels, the latter obtained bath aids immediately on discharge and were instructed in their use at home by the peripatetic occupational therapist. All were assessed independently at three to six months. Prompt, correct prescription of aids and supervision of their use in bathing shortly after discharge by a hospital-based occupational therapist resulted in safe bathing by all treated subjects. In contrast, only 82% of controls bathed, 50% of these from the seated position (compared with 90% of the treated group) and only 39% of controls received their aids within two weeks of discharge (compared with 74% of the treated group).

Adult↗

PubMed1985

One-month versus six-month therapy with oral anticoagulants after symptomatic deep vein thrombosis.

The length of time for which deep vein thrombosis (DVT) should be treated with oral anticoagulants (OA) is controversial. In this study, 135 patients with symptomatic first period DVT (83% with proximal DVT) were randomly allocated to OA for one or six months. The diagnosis of initial and recurrent DVT was confirmed by phlebography or plethysmography and thermography, or by a combination of all these methods. Pulmonary emboli were confirmed by lung scans or at autopsy. The patients were followed for at least one year. One patient had to discontinue OA prematurely because of haemorrhage. Seventeen patients left the project for other reasons, ten during and seven after therapy; in one of these DVT recurred. The recurrence rate during the first year was high (17% symptomatic recurrences) irrespective of whether OA had been given for one or six months.

Adult↗

PubMed1982

[Effect of levamisole in postoperative adjuvant immunochemotherapy of stomach cancer--randomized controlled study of MMC-5-FU combination therapy with or without levamisole. 1].

A randomized controlled study by envelope method was carried out with the purpose of evaluating effects and side effects of levamisole in patients with resectable stomach cancer. The patients were randomly allocated to the treatment either with control or levamisole according to the indication of the envelope opened at least 3 days prior to surgery. The control group was treated with Mitomycin C (day 0, 20 mg day 1, 10 mg, one shot i.v.) and 5-FU(150 mg/day, p.o.). The levamisole group was treated with Mitomycin C, 5-FU and levamisole. Levamisole was administered at a daily dose of 150 mg for 3 consecutive days before surgery, and the 3 consecutive days administration schedule was repeated every fortnight for one year after surgery. Four hundred and forty-six patients were entered in this trial. However, with the exclusion of 104 patients as exceptions and dropouts, the total eligible patients were 342, consisting of 167 in the control group and 175 in the levamisole group. The effects were evaluated by comparing the disease-free interval or the survival time of both groups. There was no significant difference in the disease-free interval and survival. In this study, we have not yet reached the conclusion that levamisole is effective in prolonging disease-free interval and survival time, because high survival rates are still maintained in both groups for 2 years after surgery. The final conclusion would be drawn with the follow-up results in the future.

Adjuvants, Immunologic↗

PubMed1983

High-frequency jet ventilation. A prospective randomized evaluation.

Three hundred nine patients were randomly allocated to two ventilatory protocols; 157 patients were supported with a volume-cycled ventilator (VCV) (Bear Medical BEAR 1) and 152 with a high-frequency jet ventilatory (HFJV) developed at our institution. The two ventilators were compared for safety, reliability, ease of use, and efficacy in maintaining gas exchange. On VCV, end points of therapy were: fractional concentration of oxygen in the inspired gas (FIo2) less than or equal to 0.40; arterial oxygen pressure (PaO2) greater than or equal to 70 mm Hg; cardiac index (CI) greater than or equal to 3.5 L/min/sq m; and spontaneous respiratory rate less than or equal to eight breaths per minute. On HFJV, end points were: FIo2 less than or equal to 0.45; arterial oxygen saturation greater than or equal to 0.90; and CI greater than or equal to 3.5 L/min/sq m. Spontaneous ventilation and pulmonary venous admixture reduction were the goals on VCV, with oxygen transport the goal on HFJV, Total duration of use of the ventilators was approximately 800 days with both types of devices; there were no technical failures, and the incidence of barotrauma was less than 5 percent. The end point of mechanical ventilation was reached by a significantly higher percentage of the patients randomized to HFJV. Patients who failed to reach the therapeutic goal within 24 hours were crossed over to the other form of support. Those crossed from VCV to HFJV improved more rapidly and in greater number than those crossed from HFJV to VCV. When survival and total duration of stay in the intensive care unit were considered, there was no difference between VCV and HFJV. Considering data on gas exchange, VCV provided a higher PaO2 at equivalent positive end-respiratory pressure than HFJV. Alveolar ventilation was slightly better on HFJV. Differences were statistically but not clinically significant. On HFJV, oxygenation and ventilation were maintained with lower peak inspiratory pressures and smaller tidal volumes than those required for VCV. This investigation proves that HFJV is a safe and reliable method to provide mechanical support which does not, at this time, offer obvious benefits over VCV.

Female↗

PubMed1985

Routine bed rest is unnecessary after cervical myelography.

After undergoing myelography with iopamidol by either direct puncture (n = 120) or lumbar puncture and run up of the contrast medium (n = 232), the patients were randomly allocated into one of two groups, one group being confined to bed for 24h and the other allowed to be fully ambulant. Questionnaires recording the occurrence and severity of side effects were completed at specific intervals after the myelogram. Adverse reactions experienced were significantly fewer than in our previous direct puncture study using metrizamide. Neither in the direct puncture nor in the run up group were side effects adversely affected by allowing the patients to remain ambulant after the examination. There is, therefore, no necessity to confine patients to bed following cervical myelography.

Bed Rest↗

PubMed1981

Comparison of rubber band ligation and sclerosant injection for first and second degree haemorrhoids-- a prospective clinical trial.

Fifty patients with first or mild second degree haemorrhoids were randomly allocated to sclerosant injection (26) or rubber band ligation (24). One year after treatment 24 injection and 22 rubber band ligation patients were assessed. All patients presented with rectal bleeding; injection relieved 14 and rubber band ligation relieved 17 of this symptom (N.S.). Three of seven patients with prolapsing haemorrhoids who had sclerosant injections and five of seven who had rubber band ligation were relieved of this prolapse. However, a further six patients in the injection group developed prolapse for the first time during the one year follow-up period (p less than 0.05). Rubber band ligation relieved anal pain in 10 out of 14 patients whereas injection relieved only one patient of this symptom (p less than 0.05). Neither treatment influenced pruritus ani or faecal soiling. Although rubber band ligation caused more treatment discomfort, it is an effective management for first and mild second degree haemorrhoids and it should be considered as the procedure of choice.

Adult↗