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Controlled clinical trial of complete open surgical drainage and of prednisolone in treatment of tuberculous pericardial effusion in Transkei.

240 patients with active tuberculous pericardial effusion received a 4-drug daily antituberculosis regimen for 6 months and have been studied for 24 months or longer. Those willing were randomly allocated to open pericardial biopsy and complete drainage of pericardial fluid on admission or percutaneous pericardiocentesis as required. All patients were randomly allocated to prednisolone or matching placebo for the first 11 weeks, on a double-blind basis. Complete open drainage on admission abolished the need for pericardiocentesis (p less than 0.01) but did not influence the need for pericardiectomy for subsequent constriction or the risk of death. Among patients who did not have open drainage on admission, 2 (3%) of 76 given prednisolone compared with 10 (14%) of 74 given placebo died of pericarditis (p less than 0.05), 6 (8%) and 9 (12%) respectively required pericardiectomy, 7 (9%) and 17 (23%) repeat pericardiocentesis (p less than 0.05), and 3 (4%) and 7 (9%) open surgical drainage. By 24 months, apart from the 16 who died from pericarditis, all but 3 patients (2%) had a favourable status.

Adolescent

The pain and discomfort experienced during orthodontic treatment: a randomized controlled clinical trial of two initial aligning arch wires.

A randomized controlled clinical trial was performed to compare the nature, prevalence, intensity, and duration of pain related to the use of a relatively recently developed superelastic arch wire and a more traditional multistranded steel arch wire. Other factors likely to influence the pain experience were also investigated. Forty-three subjects participated in the study, the pain response being assessed by each of the visual analogue scales, the questionnaires, and an analgesic consumption record. In 18 of the 43 subjects a standardized preliminary dental extraction procedure was used as a control. Subsequent to the random allocation of an initial arch wire in 43 patients, 22 of them underwent a second arch wire in the opposing arch, the wire again being determined by random allocation. It was found that the prevalence, intensity, and duration of pain after the insertion of the two types of wire was similar but much greater than in the postextraction control phase. The pain score peaked on the morning after the placement of the arch wire, lasting typically for 5 to 6 days. The pain and discomfort experienced after the insertion of the second arch wire was similar to that of the first, no conditioning response being evident. Overall a diurnal variation was found with a tendency to an increase in pain in the evenings and nights, although this did not greatly affect sleep. The pain response was found to be highly and consistently subjective, not related to the dental arch, crowding, sex, or social class; however, a statistically significant association was found between the age and the pain experienced.

Adolescent

Do serotonin uptake inhibitors decrease smoking? Observations in a group of heavy drinkers.

Serotonin uptake inhibitors have been reported to alter several consummatory and drug self-administration behaviors in rats. These observations suggest important therapeutic applications in humans. While evaluating zimelidine and citalopram effects on ethanol intake, we also assessed smoking behavior. Five male heavy drinkers smoking 29.7 +/- 9.0 (mean +/- SD) cigarettes a day were randomly allocated to receive zimelidine (200 mg/day orally) or placebo in a double-blind crossover study. Another 17 male heavy drinkers smoking 21.1 +/- 14.3 (mean +/- SD) cigarettes a day were randomly allocated to receive citalopram (20 or 40 mg/day orally) or placebo in a double-blind crossover study. In both studies, subjects were not trying to modify their smoking or drinking and received no advice or other treatment to do so. Zimelidine had no effects on the number of cigarettes smoked (F1,4 = 1.80, not significant (NS]. Neither citalopram dose had an effect on smoking (citalopram 20 mg: F1,8 = 0.06, NS; citalopram 40 mg: F1,7 = 0.68, NS). Because intrasubject variation is small, this trial was of sufficient size to exclude with 99.99% confidence the possibility that these drugs decrease smoking behavior by 50%. Since serotonin uptake inhibitors can attenuate ethanol intake in humans, these drugs may have differential effects on consummatory behaviors.

Adult

A controlled trial of 3-month, 4-month, and 6-month regimens of chemotherapy for sputum-smear-negative pulmonary tuberculosis. Results at 5 years. Hong Kong Chest Service/Tuberculosis Research Centre, Madras/British Medical Research Council.

Of 1,710 Chinese patients with radiologically active pulmonary tuberculosis but with sputum negative for acid-fast bacilli on four or more initial microscopic examinations who were studied for 5 yr, 592 (35%) had one or more initial sputum cultures positive for Mycobacterium tuberculosis. These 592 patients were randomly allocated to receive streptomycin, isoniazid, rifampin, and pyrazinamide daily for 4 months or 3 times a week for either 4 or 6 months. The remaining 1,118 patients with all their initial cultures negative were randomly allocated to receive the same four drugs daily for 3 months or 3 times a week for either 3 or 4 months. There were no bacteriologic failures during chemotherapy, and the relapse rates for the 4-month regimens during the 5 yr were 2% in 293 patients with drug-susceptible cultures initially (95% confidence limits, 1 to 5%); 8% in 59 patients with cultures resistant to isoniazid, streptomycin, or both drugs, but susceptible to rifampin initially; and 4% in 325 patients with all their cultures negative initially (95% confidence limits, 1 to 7%). The combined relapse rate for the 3-month regimens was 7% in 709 patients with all their cultures negative initially (95% confidence limits, 5 to 9%). In Hong Kong, 4 months of chemotherapy is now used routinely in the treatment of patients with smear-negative pulmonary tuberculosis, whether their initial sputum cultures are positive or negative.

Adolescent

Influence of maternal diet during lactation and use of formula feeds on development of atopic eczema in high risk infants.

OBJECTIVE: To examine the effects of maternal diet during lactation and the use of formula feeds on the development of atopic eczema in infants at risk. DESIGN: Mothers who planned to breast feed exclusively were randomly allocated to either a restricted diet (avoiding milk and other dairy products, eggs, fish, peanuts, and soybeans) or a diet without restrictions. Mothers who did not plan to breast feed were randomly allocated to using one of three formula feeds. SETTING: Child health centre in Canada. SUBJECTS: 97 Mothers who chose to breast feed and 124 mothers who did not. INTERVENTIONS: Restricted diet for 49 mothers who breast fed. Casein hydrolysate formula, soy milk formula, or cows' milk formula for infants not breast fed. MAIN OUTCOME MEASURE: Development of eczema in babies. RESULTS: Infants were followed up over 18 months and examined for eczema. Eczema was less common and milder in babies who were breast fed and whose mothers were on a restricted diet (11/49 (22%) v 21/48 (48%)). In infants fed casein hydrolysate, soy milk, or cows' milk 9/43 (21%), 26/41 (63%), and 28/40 (70%), respectively, developed atopic eczema. CONCLUSIONS: In families with a history of atopic disease [corrected] mothers who breast feed should avoid common allergenic foods during lactation. If they choose not to breast feed a hydrolysate formula should be used.

Bottle Feeding

Effects of varying recall periods on reported food intakes.

A 32-item food frequency questionnaire was administered with different time periods over which intake frequencies were to be recalled. In replicate Studies 1 and 2, 154 students were randomly allocated to six recall periods, ranging from the "the past 3 days" through to "the past year" and "usual intake". Perceived "oftenness" of intake was estimated on seven-point ratings. In Study 3, 78 students were randomly allocated to five short recall periods, e.g. last weekend, the past 5 days. In addition to rating "oftenness", they estimated their frequencies of intake numerically. In the first two studies, recall period was related to "oftenness" ratings in three ways. Responses for some foods (mainly snacks) were unaffected by recall period; others (mainly staples) were monotonically related to the requested duration of the recall; and, for a third set of foods, periods greater than one month (including "usual intake") yielded equivalent ratings but these were greater frequencies than those associated with shorter recall periods. In Study 3, marked differences were seen between frequency ratings over "average" durations and those over recent periods of similar duration. Correlations between numerical frequency estimates and "oftenness" ratings were high. The implications of the results for uses of food frequency methodology in nutritional epidemiology are discussed.

Adult

Guillotine and dissection tonsillectomy compared.

One hundred children and twenty adults were randomly allocated to guillotine or dissection tonsillectomy operations. The study was prospective and double-blind. In the children, the guillotine technique had demonstrable advantages over the dissection technique in terms of duration of operation, blood loss and post-operative pain. There was no significant morbidity in either group. In the adults, the random allocation of patients into these groups was found to be technically unsatisfactory and this arm of the study was abandoned after twenty patients.

Adolescent

Manchester regional breast study. Preliminary results.

1020 patients with early breast cancer were treated between March, 1970, and October, 1975, according to a prospective clinical trial. The results have been recorded after a follow-up of two to seven years. 713 cases of clinical stage-1 cancer were randomly allocated to treatment by simple mastectomy and postoperative radiotherapy, or simple mastectomy alone. There was no statistically significant difference in overall survival or in survival without distant metastases between the two groups. There was a significant reduction in the incidence of local recurrence in those who had received early postoperative radiotherapy compared with those who had not. 307 cases of clinical stage-11 cancer were randomly allocated to treatment by simple mastectomy and postoperative radiotherapy or radical mastectomy alone. There was no statistically significant difference in survival or in the incidence of local recurrence or distant metastases between the two groups.

Adult

[Adjuvant chemotherapy for gastric cancer--the third study. First report: central randomization by telephone method and analysis of patients' background factors].

JFMTC conducted the third adjuvant chemotherapy study for gastric cancer patients after curative surgery from 1982 to 1983. Patients were randomly allocated to one of the three arms by telephone method controlled at the headquarters of the foundation. This method resulted in the marked reduction of ineligible cases (253 cases, 6.0% of 4,236 cases), compared with those in the first study (18.3%). Main reasons of ineligibility were the violation of entry criteria due to the misjudgment of noncancer, duplicate cancers and operative curability. Telephone method for random allocation seems to contribute to the improvement in the data quality of a clinical trial.

Antineoplastic Combined Chemotherapy Protocols

Cefamandole and isoxazolyl penicillins in antibiotic prophylaxis of patients undergoing total hip or knee-joint arthroplasty.

In a prospective comparative clinical efficacy and safety study, 58 patients undergoing total hip or knee arthroplasty were randomly allocated to two groups; one received 29 cefamandole intravenously before operation and then 1 g every 6 h parenterally for 3 days and the other received 29 cloxacillin i.v. every 8 h for 1 day and 29 dicloxacillin perorally every 8 h for 2 days. Concentrations of cefamandole and cloxacillin were measured in the serum of all patients and in the synovial fluid of 28 patients. The serum C-reactive protein (CRP) level was measured in 16 randomly allocated patients preoperatively and daily for 8 days. In serum the concentrations of cefamandole and cloxacillin were high. The great variation in cloxacillin concentration can be due in part to its strong affinity for blood proteins. Cefamandole entered the synovial fluid of the knee joint at high concentrations in 5-15 min; similar concentrations of cloxacillin were measured after 16-30 min. Thus, cefamandole seems to be more recommendable as antibiotic prophylaxis in total hip and knee replacements. The CRP level decreased to below 60 mg/l in all 16 patients on the 6th postoperative day.

Aged

Efficacy of clavulanate-potentiated amoxycillin in experimental and clinical skin infections.

The efficacy of clavulanate-potentiated amoxycillin was compared with amoxycillin alone in experimental staphylococcal infection in dogs and in a controlled trial in clinical cases of skin infection in dogs and cats. The experimental infection was produced by subdermal inoculation with beta-lactamase producing (amoxycillin resistant) staphylococci absorbed in cotton dust. This produced discrete, localised lesions with no systemic involvement. In a cross over study, six animals were randomly allocated to treatment with either amoxycillin alone (10 mg/kg, dosed twice daily) or a formulation of clavulanate-potentiated amoxycillin (12.5 mg/kg, of a 1:4 ratio, dosed twice daily). The lesions of the animals treated with clavulanate-potentiated amoxycillin resolved more quickly than those treated with amoxycillin alone. The difference was significant (P less than 0.05) for both lesion diameter and inflammation score after day 6 of treatment. A trial was carried out in clinical cases of skin disease which were randomly allocated to twice daily treatment with either amoxycillin alone (10 or 20 mg/kg), or with clavulanate-potentiated amoxycillin (12.5 or 25 mg/kg of a 1:4 ratio). The required duration of treatment was shorter (P less than 0.5) for the potentiated amoxycillin treatments, and the success rate (judged by cure or substantial improvement) was higher (P less than 0.05) for this group, especially (P less than 0.01) where amoxycillin resistant organisms were isolated. It was concluded that clavulanate-potentiated amoxycillin was an effective treatment of skin infections both under experimental and clinical conditions.

Amoxicillin

Temporal relationship between the onset of oestrus, the preovulatory LH surge and ovulation in farmed fallow deer, Dama dama.

A study was conducted to determine the timing of ovulation relative to the onset of oestrus and the preovulatory LH surge in fallow deer. Mature fallow does were randomly allocated to two treatments (N = 10 per treatment) designed to synchronize oestrus on or about 17 May. Does assigned to Group 1 (prostaglandin-induced oestrus) each initially received single intravaginal CIDR [Controlled Internal Drug Release] devices for 13 days followed by an i.m. injection of 750 mg cloprostenol on Day 12 (15 May) of the subsequent luteal cycle. Does assigned to Group 2 (progesterone-induced oestrus) each received CIDR devices for 13 days, with withdrawal occurring on 15 May. All does were run with crayon-harnessed bucks (10:1 ratio) from the start of synchronization (18:00 h 15 May). Ten does (5 per group) were blood sampled via indwelling jugular cannulae every 2 h for 72 h from cloprostenol injection or CIDR device withdrawal and the plasma was analysed for concentrations of progesterone and LH by radioimmunoassay. Does within each treatment were randomly allocated to an ovarian examination time of 12, 16, 20 or 24 h after the onset of oestrus. Laparoscopy was repeated at 12-h intervals until ovulation was recorded. The ovaries of does failing to exhibit oestrus were examined 72 and 86 h after cloprostenol injection or CIDR device withdrawal. A total of 17 does were observed to exhibit oestrus at a mean (+/- s.e.m.) interval from treatment of 44.6 +/- 3.6 h for Group 1 (N = 9) and 34.1 +/- 2.5 h for Group 2 (N = 8).(ABSTRACT TRUNCATED AT 250 WORDS)

Animals

Renal scars and parenchymal thinning in children with vesicoureteral reflux: a 5-year report of the International Reflux Study in Children (European branch).

A total of 321 children less than 11 years old with nonobstructive grade III or IV vesicoureteral reflux and with previous urinary tract infection was randomly allocated to medical or surgical treatment in the European branch of the International Reflux Study in Children. (Randomization was stratified for age, sex, grade of reflux, presence of renal scarring, interval since last urinary tract infection and treating hospital). The results of excretory urography are reported for 233 girls and 73 boys treated according to the random allocation, 89% of whom were followed for 5 years. After 5 years in the medical group (155 children) new renal scars were seen in 19 and new renal parenchymal thinning in 11. The proportions were almost identical among 151 children allocated to surgical treatment with 20 new scars and 15 new thinnings. Progression of established scars was also similar in both groups. However, the new scars developed sooner after surgery than during medical treatment. In 6 surgically treated children postoperative obstruction was followed by the development of new scars. In addition, 12 patients showed new scars approximately 6 months after successful surgery, while in only 2 children scars developed more than 6 months after surgery. In 11 children of the medical group new scars were seen more than 6 months after allocation. More new scars developed in the children with parenchymal thinning at entry (23%) than in those with scarred or normal kidneys at entry (10% each) (p < 0.05). The younger the patients at entry, the higher the frequency of new scars (less than 2 years 19.8%) 2 to 4 years 9.8% and 5 years or more 4.6%, p < 0.05).

Child

Efficacy of ivermectin in oral drench and paste formulation against migrating larvae of experimentally inoculated Parascaris equorum.

Twenty-one mixed-breed pony foals, reared and maintained under parasite-free conditions, were used to test the efficacy of ivermectin in oral drench and paste formulations (200 micrograms/kg) against 11-day-old migrating larvae of Parascaris equorum. Three replicates of 4 foals and 3 replicates of 3 foals were formed on the basis of age. Foals in replicates of 4 were randomly allocated to be indicators, or to receive vehicle (control) or ivermectin paste or ivermectin liquid. Foals in replicates of 3 were randomly allocated to receive vehicle or ivermectin paste or ivermectin liquid. The recovery of larvae from the lungs, liver, and small intestines of the indicator foals showed that 99.9% of the larvae were in the lungs 11 days after inoculation (day 0 of treatment). The recoveries of larvae from lungs and small intestines of controls at 25 days after inoculation indicated that all larvae had migrated to the small intestine by this time. The mean length of larvae recovered from the lungs (11 days after inoculation) was 0.87 mm the mean length of those recovered from the small intestine (25 days after inoculation) was 3.65 mm. Using larvae recovered from small intestinal contents for calculations, ivermectin in both formulations was 100% effective against 11-day P equorum (P less than 0.01, compared with control group geometric mean of 1498.4).

Animals

Randomised clinical trial of strategies for improving medication compliance in primary hypertension.

230 Canadian steelworkers with hypertension took part in a randomised trial to see if compliance with antihypertensive drug regimens could be improved. For care and follow-up these men were randomly allocated to see either their own family doctors outside working-hours or industrial physicians during work shifts; the same men were randomly allocated to receive or not receive an educational programme aimed at instructing them about hypertension and its treatment. Surprisingly, the convenience of follow-up at work had no effect upon these men's compliance with antihypertensive drug regimens. Similarly, although men receiving health education learned a lot about hypertension, they were not more likely to take their medicine.

Antihypertensive Agents

Blood glucose control and glomerular capillary basement membrane thickening in experimental diabetes.

Glomerular capillary basement membrane thickness (BMT) was measured in 23 rats which had had streptozocin-induced diabetes for 14 months and in 12 age-matched controls. Diabetic rats were randomly allocated to different groups, either receiving no treatment or treated with a low carbohydrate diet or insulin, or both. Control rats were randomly allocated to a normal or low carbohydrate diet. Among the diabetic rats mean plasma glucose concentrations for the groups ranged from 27-4 mmol/l (494 mg/100 ml) in the untreated rats to 9-8 mmol/l (177 mg/100 ml) in those receiving both a low carbohydrate diet and insulin. A highly significant positive relation was found between BMT and plasma glucose concentration for individual rats. When BMT was corrected for body weight a similar relation was observed.

Animals

Moderate alcohol intake and heart rate variability adaptations to high-intensity interval training in healthy young adults: the BEER-HIIT study.

BACKGROUND: It is unknown whether daily alcohol consumption influences training effects on heart rate variability (HRV). This study investigated: (i) the effects of a 10-week high-intensity interval training (HIIT) on HRV in healthy young adults; and (ii) the effects of daily alcohol consumption on HRV responses to exercise. METHODS: 71 healthy young adults (18-40 years old; 52.1% women) participated in the BEER-HIIT study. We conducted a 10-week (2 days/week) controlled trial (ClinicalTrials.gov ID: NCT03660579). Participants were allocated to 5 groups: a non-training group (N-T) and four HIIT groups. Participants in the training groups chose whether to consume alcohol. Those choosing alcohol were randomly allocated to receive beer (5.4%; T-Beer) or an equivalent amount of alcohol (vodka; T-Ethanol) in sparkling water. Those choosing no alcohol were randomly allocated to receive alcohol-free beer (0.0%; T-Zero) or sparkling water (T-Water). Training comprised eight weight-bearing exercises performed in circuit form. HRV was measured before and after the intervention. RESULTS: No statistically significant between-group differences in HRV outcomes were detected after the intervention (all p&#x2009;>&#x2009;0.05). CONCLUSIONS: Our findings indicate that: (i) no statistically significant differences in HRV responses were detected following a 10-week HIIT program using weight-bearing exercises performed twice per week; and (ii) no statistically significant differences in HRV responses were observed among the assigned beverage intervention groups. These findings should be interpreted cautiously because HRV was a secondary outcome and the study was not specifically powered to detect differences in these parameters.

alcohol

The community management of schizophrenia. A controlled trial of a behavioural intervention with families to reduce relapse.

Schizophrenic patients were recruited into a trial of a prophylactic behavioural intervention with families. Families with at least one high Expressed Emotion (EE) relative were randomly allocated to one of four intervention groups: Behavioural Intervention Enactive; Behavioural Intervention Symbolic; Education Only; Routine Treatment. Patients from low-EE families were randomly allocated to two groups: Education Only or Routine Treatment. Relapse rates over nine months after discharge were significantly lower for patients in the two Behavioural Intervention, compared with Education Only and Routine Treatment groups. There was little difference between the two low-EE groups. Patients returning to high-EE relatives showed significantly higher relapse rates than those returning to low-EE relatives, in groups not receiving active intervention. Changes from high to low EE occurred in the Behavioural Intervention groups, and similar although less extensive changes occurred in the Education Only and Routine Treatment groups. Changes in criticism and marked emotional over-involvement (EOI) occurred generally in high-EE groups but were larger in magnitude in the Enactive and Symbolic groups. Reduction of hostility only occurred in the Behavioural Intervention groups. These results give partial support for the causal role of EE in relapse. There were no significant differences between the groups with respect to contact with the psychiatric services or medication.

Adult