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PubMedDate not supplied

Treatment of early recurrences of acute purulent otitis media; value of myringotomy.

The present investigation was carried out in order to study the efficacy of oral antibiotics (A) versus oral antibiotics plus acute myringotomy (B) in the treatment of early recurrences of acute purulent otitis media. Seventy-nine children with early recurrences (arisen within 4 weeks of a primary episode) were randomly allocated to one of the two treatment groups (A or B). Eleven of 41 (26.8%) children in group A, and 12/38 (31.6%) in group B had healed at 4 weeks (p greater than 0.1). Seventeen children of both groups had secretory otitis media at 4 weeks and new relapses had occurred in 13 children in group A and 9 in group B. No difference between the groups was noted regarding the number of otitis episodes during the next 5 months. Thus, acute myringotomy could not be proven to affect the clinical course of an early recurrence of acute purulent otitis media as compared with that after treatment with oral antibiotics alone.

Amoxicillin↗

PubMed1985

Ranitidine versus anticholinergic/antacid for duodenal ulcer. A randomized, endoscopically controlled, single-blind multicentre trial.

One hundred and forty-nine patients with endoscopically documented duodenal or prepyloric ulcer were randomly allocated to treatment with ranitidine, 150 mg twice daily (75 patients), or glycopyrrobromide, 2 mg three times daily, and antacid suspension, 60 ml/day, with a buffering capacity of 480 mmol/day (74 patients). The patients underwent a thorough prestudy symptom analysis, and endoscopy was performed by an observer who was unaware of the treatment in use. After 4- and 8-week courses of treatment the patients were re-evaluated. Sixty-nine patients in the ranitidine group and 66 in the anticholinergic/antacid group completed the trial. Complete ulcer healing was obtained in 60 of the 69 patients (87%) in the ranitidine group and in 50 of the 66 patients (76%) in the anticholinergic/antacid group after 4 weeks of treatment and in 65 (94%) and in 61 (92%), respectively, after 8 weeks of treatment. Forty-three patients had troublesome side effects of either anticholinergic or antacid treatment, and three patients had to interrupt the treatment. There were no serious side effects of ranitidine. This study suggests that ranitidine causes faster ulcer healing than the combination of anticholinergic and antacid. The results show that ranitidine is an effective and safe drug for duodenal ulcer healing, with no troublesome side effects.

Antacids↗

PubMed1989

[The rate of injection of succinylcholine and onset of neuromuscular action, serum potassium or myoglobin levels. Studies in men during halothane anesthesia].

Succinylcholine was injected at different speeds to 60 men in halothane anesthesia, to see whether the rate of injection influenced the effects. METHODS. Sixty men (ASA I and II, mean age 28.6 years) undergoing surgery without muscle trauma were studied. They were treated uniformly with respect to premedication, anesthesia, venipuncture (cubital), and concentration (1%) and dosage (1 mg/kg) of succinylcholine (SCh). The only difference lay in the speed of injection of the relaxant: 20 mg/s, 8 mg/s, 4 mg/s, 2 mg/s and 1 mg/s, 12 patients being randomly allocated to each. The injection rate was controlled by a preprogrammed microprocessor pump system (XD 5500, HC Ulrich, D-7900 Ulm, Donau). The neuromuscular transmission was monitored by the adductor pollicis twitch technique using indirect supramaximal stimulation (Accelograph, biometer, DK-5120 Odense). The recorded twitch response allowed determination of the total onset time (TOT) from the beginning of the injection to the maximal twitch depression, its components, latent and manifest onset times (LOT and MOT), and the twitch depression factor ki. Blood samples for measurement of potassium and myoglobin levels (RIA, sensitive to 5 ng/ml) were taken before and 5, 15, and 30 min after SCh administration. For determination of the course (difference between two values before and after SCh), the maximum level up to 30 min was recorded. RESULTS. The twitch depression amounted to 100% in 57 patients and to 93% or 98% in the remaining 3. Reducing the speed of injection led to significant prolongation of TOT and LOT (Table 3) and significant differences in the onset characteristic in regard to twitch depression factor ki (Table 4). No significant influence on the increase in potassium (Table 7) and myoglobin (Table 8) was observed. CONCLUSION. These findings give no cause to inject SCh more slowly than usual in healthy adults.

Adult↗

PubMed1987

Psychological group counseling for the prevention of ulcer relapses. A controlled randomized trial in duodenal and prepyloric ulcer disease.

The effect of psychological counseling on 1-year ulcer relapse rate of recurrent duodenal and prepyloric ulcer disease was evaluated in 148 patients randomly allocated into three treatment groups; psychological counseling group, maintenance cimetidine (400 mg at bedtime), and placebo cimetidine at bedtime. Ulcer relapses were monitored by endoscopy at 6 and 12 months after inclusion and at symptomatic recurrence. The estimated proportion of relapse-free patients after 12 months follow-up in the psychological counseling group (0.43 +/- 0.08) did not differ significantly from the placebo group (0.47 +/- 0.07), whereas the corresponding value for the cimetidine group (0.70 +/- 0.07) was significantly higher (p less than 0.01). The effect of cimetidine on ulcer recurrence, however, was confined to smokers; relapse risk among nonsmokers did not differ significantly between the treatment groups. The negative outcome of psychological counseling raises doubts as to whether duodenal or prepyloric ulcer recurrences can be prevented by such a therapeutic approach.

Adolescent↗

PubMed1988

Autonomic and somatosensory nerve function after 2 years of continuous subcutaneous insulin infusion in type I diabetes.

Autonomic and somatosensory nerve function was studied in 24 insulin-dependent diabetic subjects (aged 29 +/- 7 yrs, diabetes duration 8 +/- 4 yr) randomly allocated to either continuous subcutaneous insulin infusion (CSII; n = 12) or unchanged conventional insulin therapy (CIT; n = 12). Measures of glycemic control and somatosensory and autonomic nerve function were comparable in the two groups at the start. Glycemic control was significantly improved in the CSII group throughout study, whereas it remained unchanged in the CIT group. In the CIT group, vibratory perception threshold (VPT) of the great toe and the medial malleolus deteriorated, as did heart rate variation (HRV) at rest, at deep breathing (.05 less than P less than .06), and at standing. In contrast, CSII patients retained their VPT and HRV. Comparison of nerve function alterations during the 2-yr trial showed better preservation in CSII than in CIT patients of VPT in the great toe (0.8 +/- 1.7 vs. -1.4 +/- 1.9 V, P less than .01) and the medial malleolus (1.5 +/- 2.9 vs. -1.4 +/- 1.8 V, P less than .05) and of HRV at rest (10 +/- 24 vs. -13 +/- 22 ms, P less than .05) and at standing (-0.01 +/- 0.13 vs. -0.15 +/- 0.16 ms, P less than .05). We conclude that intensified glycemic control can favorably influence parasympathetic and somatosensory nerve function in insulin-dependent diabetes mellitus.

Adult↗

PubMed1985

Comparison of long-term, low-dose pivmecillinam and nitrofurantoin in the control of recurrent urinary tract infection in children. An open, randomized, cross-over study.

Thirty-five children with a history of vesicoureteric reflux or with recurrent urinary tract infections were randomly allocated to low-dose prophylactic treatment with pivmecillinam or nitrofurantoin. After 6-10 months they were crossed over to the alternate drug for another 6 months, but only 24 completed the study because of lack of compliance or intolerance to nitrofurantoin. There was no significant difference in the long-term prophylactic effect between the two drugs, the overall infection rate being 0.7/patient-year. Pivmecillinam was significantly better tolerated than nitrofurantoin (P = 0.01). Nitrofurantoin effected no major change in the faecal flora, and nearly all urinary infections occurring during long-term treatment were caused by Escherichia coli. In contrast, a marked reduction of E. coli and a marked increase in Gram-positive cocci were found in the faecal flora during treatment with pivmecillinam. Seventy per cent of infections were caused by Streptococcus faecalis and only 20% by E. coli during pivmecillinam treatment (P = 0.001).

Adolescent↗

PubMed1988

Transcutaneous electrical nerve stimulation in the management of acute postoperative pain.

Twenty patients undergoing decompressive lumbar laminectomy were randomly allocated, in a double-blind manner, to receive active or inactive transcutaneous electrical nerve stimulation (TENS) as part of the management of their postoperative pain. All patients received the same non-narcotic general anaesthetic. The efficacy of the TENS was assessed by using a patient-controlled analgesia system (PRODAC) which delivered morphine i.v. This system recorded the number of demands for analgesia and the total dose administered in the first 24 h. In addition, plasma morphine concentrations were measured hourly for the first 6 h and again at 24 h. There was no statistical difference between the two groups in the number of patient demands for analgesia, morphine dose or plasma morphine concentration. TENS offered no advantage over a placebo in the management of acute postoperative pain in these patients.

Acute Disease↗

PubMed1986

Efficacy of oral treatment with acyclovir and co-trimoxazole in first episode genital herpes.

Forty patients presenting with first episode genital herpes were randomly allocated to seven day treatment with oral acyclovir alone, placebo alone, oral acyclovir plus co-trimoxazole, or placebo plus co-trimoxazole. Patients receiving acyclovir had significantly shorter periods of viral shedding (p less than 0.001), pain (p = 0.03), and times to lesion healing (p less than 0.05). Averaged over all patients there was no evidence that co-trimoxazole affected any of the variables, though in women cotrimoxazole was associated with a shorter time to lesion healing (p less than 0.01). Furthermore, the combination treatment gave significantly shorter times to lesion healing than acyclovir alone, placebo alone, or placebo and co-trimoxazole (p = 0.01) and good trends elsewhere (external lesions and duration of pain). Neither drug was associated with any adverse events or toxicity or influenced the subsequent recurrence rate.

Acyclovir↗

PubMed1987

Results of MRC (UK) trial of drug therapy for mild hypertension.

The main aim of the trial was to determine whether drug treatment of mild hypertension (phase V diastolic pressure 90-109 mm Hg) reduced the rates of stroke, of death due to hypertension, and of coronary events, in men and women aged 35-64 years. A total of 17,354 patients was recruited, and 85,572 patient-years of observation accrued. Patients were randomly allocated at entry to take bendrofluazide or placebo, or propranolol or placebo. The stroke rate was reduced with treatment (60 strokes, vs 109 in the placebo groups), being 1.4 and 2.6 per 1,000 patient-years of observation, respectively (p less than 0.01), but overall rates of coronary events were not different (222 with treatment and 234 with placebos). The incidence of all cardiovascular events was reduced with treatment (286 events, vs 352 with placebos; p less than 0.05). For rates of mortality from all causes, treatment made no difference. Several post hoc analyses of subgroup results were performed. The all-cause mortality was reduced in men on treatment (157 deaths, vs 181 in placebo groups) but increased in women on treatment (91 deaths, vs 72 with placebos); this difference between the sexes was significant (p = 0.05). The reduction in stroke rate was greater with bendrofluazide than with propranolol (p = 0.002). The rate of strokes was reduced in both smokers and non-smokers taking bendrofluazide, but only in non-smokers taking propranolol; this difference between the drugs was significant (p = 0.03). The coronary-event rate was not reduced by bendrofluazide, whatever the smoking habit, nor in smokers taking propranolol, but it was reduced in non-smokers taking propranolol. (ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1989

Coculture of human zygotes on fetal bovine uterine fibroblasts: embryonic morphology and implantation.

Zygotes from in vitro fertilization patients (n = 116) were randomly allocated to culture in either conventional plastic petri dishes or coculture on a monolayer of fetal bovine uterine fibroblasts. Embryos (n = 288) remained 26 to 32 hours in these culture systems. Video tape recording for later morphological analysis (11 parameters) was performed on 117 conventionally cultured and 104 cocultured embryos, shortly before replacement, by an independent observer, unaware of the culture conditions for each embryo. A significantly greater number of cocultured embryos (52%) had "good" morphology (zero or only one abnormal characteristic) as compared with conventionally cultured embryos (30%). The most outstanding morphological characteristic of cocultured embryos was the expanded appearance of their blastomeres. The incidence of implantation per embryo increased from 13% to 19% when the coculture rather than conventional culture system was used, and the incidence of ongoing pregnancy per patient after coculture doubled to 35%.

Animals↗

PubMed1989

A multicentre randomized trial comparing delivery with a silicone rubber cup and rigid metal vacuum extractor cups.

A total of 258 women requiring assisted delivery where vacuum extraction was thought to be suitable were randomly allocated to delivery with a new silicone rubber cup or metal vacuum extractor cups. There was a tendency for the silicone rubber cup to effect delivery more quickly and to cause less scalp trauma, but to fail to effect delivery on more occasions than metal cups. However, none of these differences was statistically significant. There were no statistically significant differences in the rates of birth canal trauma, maternal blood loss, or neonatal jaundice. The silicone rubber cup produced a cosmetically more acceptable chignon than the metal cups. The introduction of vacuum extractors with silicone rubber cups into obstetric units should be encouraged.

Double-Blind Method↗

PubMedDate not supplied

A randomized comparison of Worksite-sponsored smoking cessation programs.

This worksite study assesses the relative effectiveness of three smoking cessation programs. Computerized medical files indicated that 29% of 13,171 employees were current smokers. Of smokers responding to a worksite-wide survey, 79% indicated interest in a smoking cessation program; 402 smokers agreed to participate and were randomly allocated, within their preference for a group or self-help approach, to the three different programs. Overall, 11% of smokers participated, an excellent rate for a large worksite. Participants were followed for 12 months (91% follow-up). Smokers in the group preference had better short-term results than did those following the self-help approach. The Multiple Component Program had 61% who quit, the Relapse Prevention Program had 37%, and the American Cancer Society Quitter's Guide had 12%. Long-term quit rates ranged from 16% to 26%; all groups exceeded the usual spontaneous quit rate of 5%.

Adult↗

PubMed1988

Transcutaneous electrical nerve stimulation after thoracotomy. Pain relief and peak expiratory flow rate--a trial of transcutaneous electrical nerve stimulation.

Forty patients scheduled to undergo thoracotomy were randomly allocated to receive either transcutaneous electrical nerve stimulation with intramuscular papaveretum (20 patients) or intramuscular papaveretum alone (20 patients) for postoperative pain relief. Total intramuscular analgesic requirements in the first 24 hours, time to satisfactory transfer to oral analgesia, antiemetic requirements and length of stay in hospital postoperatively were noted. Peak expiratory flow rate was compared pre- and postoperatively in the two groups. Use of nerve stimulation did not significantly alter the requirements for analgesia although there was a reduction in postoperative nausea and vomiting in the nerve stimulation group. There was no difference between the two groups with respect to changes in peak expiratory flow rate.

Clinical Trials as Topic↗

PubMed1986

The use of a birthroom: a randomized controlled trial comparing delivery with that in the labour ward.

A randomized controlled trial of two environments for delivery was conducted at Queen Charlotte's Maternity Hospital. A total of 253 parous women expecting to have a labour ward delivery were invited to participate in the trial but only 148 agreed. These women were randomly allocated to be delivered either with standard labour ward management (n = 72) or in the birthroom--a small bedroom decorated in a homely manner, without facilities for epidural analgesia or electronic fetal monitoring (n = 76). Eleven women in the birthroom group and 10 in the labour ward group withdrew from the trial before labour and four were transferred from the birthroom to the labour ward when in labour. A questionnaire sent in the postnatal period to the women who completed the trial was returned by 80%. In the birthroom group there was significantly (i) decreased admission-to-delivery interval (ii) less analgesia (iii) more freedom of movement (iv) less suturing (v) increased rooming-in. No difference was found in the assessment of difficulty of labour nor in the method of subsequent infant feeding.

Clinical Trials as Topic↗

PubMed1983

[A randomized controlled study on vindesine and vincristine in combination with prednisolone in the treatment of adult acute lymphocytic leukemia and blastic crisis of chronic myeloid leukemia].

Sixty patients with adult acute lymphocytic leukemia (ALL) and 40 patients with blastic crisis of chronic myeloid leukemia (CML . BC) were randomly allocated by envelope method to receive either vindesine (VDS; 2 mg/m2 i.v., twice or once weekly) or vincristine (VCR; 1.2 mg/m2 i.v., once weekly) in combination with prednisolone (Pred; 40 mg/m2 p.o., daily). Out of 100 patients entered, 53 patients with ALL and 34 patients with CML . BC were evaluable. Remissions for ALL were seen in 20 of 25 patients (80.0%; 12 CRs and 8 PRs) treated with VDS regimen, and in 17 of 28 patients (60.7%; 7 CRs and 10 PRs) treated with VCR regimen, respectively. For CML . BC, however, remission rates for VDS regimen (42.1%; 5 CRs and 3 PRs in 19 patients) and for VCR regimen (40.0%; 2 CRs and 4 PRs in 15 patients) were equivalent. Overall remission rates of VDS regimen for both diseases, twice weekly regimen (65.5%; 11 CRs and 8 PRs in 29 patients) and once weekly regimen (60.0%; 6 CRs and 3 PRs in 15 patients) were similar. Patients treated with either regimen experienced high incidence of neurotoxicity. Neurotoxic disturbance appeared severer in patients treated with VCR regimen. Incidence of leukopenia and alopecia was high in patients treated with VDS regimen. These data suggest that VDS in combination with Pred is comparable-rather superior-to VCR in combination with Pred for adult ALL and CML . BC. Less neurotoxic and sufficiently effective dosage of VDS is considered to be 2 mg/m2, once weekly.

Adult↗

PubMed1986

Effects of postnatal aminophylline on the course of respiratory distress syndrome in premature infants.

The effect of postnatally administered aminophylline on the development of respiratory distress syndrome was evaluated in 25 premature infants weighing less than 1,500 gm. By random allocation, 14 infants were treated with aminophylline intravenously, and 11 infants served as controls. In the treated infants, a loading dose of 6 mg/kg of aminophylline was administered on the first day of life, and maintenance dosages of 4 mg/kg/day were given for the next three days. Respiratory distress syndrome developed in seven infants in the treated group and seven infants in the control group. Ten infants in each group required mechanical ventilation. More cases of intraventricular hemorrhage were diagnosed in the control group, but more deaths occurred in the treated group. These findings led to the conclusion that aminophylline administered postnatally did not appreciably modify the course of respiratory distress syndrome.

Aminophylline↗

PubMed1986

The effect of six months continuous subcutaneous insulin infusion on kidney function and size in insulin-dependent diabetics.

Glomerular filtration rate (GFR), renal plasma flow (RPF), kidney volume, and urinary albumin excretion rate were measured in 24 insulin-dependent diabetics, aged 29 +/- 7 years (mean +/- S.D.) of 8 +/- 4 years duration, randomly allocated to either continuous subcutaneous insulin infusion (CSII) (n = 12) or unchanged conventional insulin treatment (CIT) (n = 12). Glomerular filtration rate, renal plasma flow, and kidney volume were identical in the two groups at the start of the study, although significantly increased above normal values. During the 6 months CSII treatment a reduction of the GFR from 145 +/- 21 to 132 +/- 14 ml/min (2p = 2.4%) was seen, no change was observed in the CIT group while in both groups RPF and kidney volume remained unchanged. Urinary albumin excretion rate was normal or near normal in both groups and remained unchanged. Thus improved glycaemic control in insulin-dependent diabetics studied before the onset of microalbuminuria is associated with improved (reduced) GFR. Nephromegaly does not improve with 6 months CSII treatment. Whether it would improve with more prolonged treatment is uncertain.

Adult↗

PubMed1984

Multicentred controlled trial of cervical cerclage in women at moderate risk of preterm delivery.

A total of 506 women at moderate risk of preterm delivery were randomly allocated to either cervical cerclage or a control group. Significantly more women in the group allocated to cerclage were admitted to hospital for reasons other than the operation and more received oral tocolytic drugs. There were also more caesarean sections and more preterm deliveries in the women allocated to cerclage although the differences between the two groups were small and not statistically significant.

Adult↗