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PubMed1995

[Clinical evaluation of anticancer effect of methionine-depleting total parenteral nutrition with 5-fluorouracil and/or mitomycin C].

Methionine-depleting total parenteral nutrition (Met-deplete TPN), infusing AO-90 amino acid solution (lacking both L-methionine and L-cysteine) as a sole nitrogen source, showed synergistic effects with several antineoplastics including 5-fluorouracil (5-FU). In the recent multi-center, randomized, controlled study, advanced gastric cancer patients were randomly allocated to RT group and Control group. RT group received AO-90 amino acid solution, while Control group infused Amiparen (commercial methionine and cysteine containing amino acid solution) as protein source for 14 days' TPN with 5-FU and mitomycin C (MMC). The over all clinical response rate (PR+CR) in RT and Control groups were 26.3% and 8.1%, respectively, with significant statistical difference in both values at p = 0.015. Fourteen advanced gastric cancer patients allocated to RT and Control group randomly and received each amino acid as protein source for 7 days TPN with 5-FU administration. All cases were performed gastrectomy without waiting period, and resected material was examined the histological response. In the 7 cases of RT group, grade 2 was seen in 4 cases, grade 1-b in 1, grade 1-a in 1 and grade 0 in 1. In the 7 of Control, 3 cases were grade 1-a and the remaining 4 were grade 0. There were significant differences in both degree and incidence of the histological response at p = 0.016. A stage IV gastric cancer patient with marked liver metastasis received 2 times RT therapy with 5-FU and MMC for 14 days and undertaken gastrectomy after 22 day, waiting period. Resected gastric cancer showed grade 2 to 3 histological response, and the liver metastasis showed marked effect as PR to CR.

Amino Acids↗

PubMedDate not supplied

Placebo-controlled cross-over study of effects of Org OD 14 in menopausal women.

A double-blind cross-over study with Org OD 14 and placebo was performed in 82 menopausal patients presenting with hot flushes and associated symptoms. Patients were randomly allocated to Org OD 14 or placebo as first treatment, and switched to placebo or Org OD 14 as second treatment. Each treatment period lasted for 16 weeks; no wash-out period was introduced. Tablets containing 2.5 mg of Org OD 14 or matched placebo tablets were supplied. Data on the following variables were obtained and analysed by the non-parametric randomization test for paired observations: hot flushes, sweating, dizziness, palpitations, fatiguability, headache, sleeplessness, irritability, breathlessness, backache and loss of libido and, in 16 patients, on circulating levels of FSH, LH, PRL, T3, T4, cortisol (F), SHBG, TBG and CBG. Twenty patients (13 placebo, 7 Org OD 14) withdrew, because their symptoms did not improve and one patient withdrew for reasons unrelated to treatment, so that 61 patients completed the study. The data demonstrated a good clinical effect and statistically significant differences in favour of Org OD 14 for hot flushes and a number of associated symptoms. Many patients reported on a general feeling of well being and a mood-elevating effect following Org OD 14. Org OD 14 significantly suppressed FSH and LH levels, while those of PRL remained unchanged. Although there was slight suppression of TBG and T4 which attained statistical significance, there was no influence on the most important parameter, T3. SHBG levels were slightly suppressed, whereas F and CBG levels were unaffected.

Climacteric↗

PubMed1980

A clinical trial in the management of operable cancer of the breast.

The results of a randomized controlled clinical trial in the management of operable breast cancer are given. Between 1964 and 1971 498 women, aged 35-69 years, were treated within the trial protocol. Those under 60 years of age on entry underwent ovarian ablation, usually by surgery, and were allocated randomly to treatment by either radical mastectomy (RM) or simple mastectomy and postoperative radiotherapy (SM). Follow-up data for the first 12 years are presented and show that survival in the radical mastectomy group is significantly better (P less than 0.05), particularly in clinical stage 1 disease. The pattern of survival once recurrence was detected also showed interesting differences between the two treatment groups. Overall there was a significantly prolonged survival after detection of recurrence in the RM group (P less than 0.05) which was most marked when local recurrence and distant metastases coincided (P less than 0.01). The duration of survival once recurrence had taken place was independent of tumour size, clinical stage of the disease or menstrual status at the time of presentation, but was directly proportional to the duration of the disease-free inerval (P less than 0.01).

Adult↗

PubMed1998

Extreme hypoventilation reduces ventilator-induced lung injury during ventilation with low positive end-expiratory pressure in saline-lavaged rabbits.

OBJECTIVE: To compare the degrees of ventilator-induced lung injury caused by two ventilation protocols. DESIGN: Randomized trial. SETTING: University animal laboratory. SUBJECTS: Sixteen New Zealand white rabbits. INTERVENTIONS: After five sequential saline lung lavages, eight pairs of anesthetized rabbits were allocated randomly to receive either of two ventilation protocols for 4 hrs during neuromuscular blockade. Both groups received 3 cm H2O of positive end-expiratory pressure and 100% oxygen. Control group animals received an estimated tidal volume of 12 mL/kg, an inspiratory time of 0.7 sec, and a ventilatory rate adjusted for a PaCO2 of 35 to 45 torr (4.7 to 6 kPa). Study group animals were ventilated through an intratracheal catheter, with inspiratory time of 1.5 secs, ventilatory rate of 20 breaths/min, and peak inspiratory pressure of 4 to 8 cm H2O, adjusted to maintain PaCO2 at 150 to 250 torr (20 to 33 kPa). MEASUREMENTS AND MAIN RESULTS: Arterial blood gases were measured every 30 mins. After 4 hrs, a final lung lavage was performed. Physiologic parameters, cell counts and protein concentration in the final lavage, and lung histology were compared between groups. The alveolar-arterial oxygen tension gradient was higher in the study group over the first 1.5 hrs, but the time profile showed significantly (p = .001) greater improvement in the study group. After 4 hrs, the mean alveolar-arterial oxygen tension gradient was lower in the study group (94 torr [12.5 kPa] vs. 201 torr [26.8 kPa]). The increase in neutrophil count from the initial to the final lung lavage was lower in the study group (0.27 x 10(7) cells/L vs. 2.01 x 10(7) cells/L, p = .037), as was the absolute value of the neutrophil count in the final lavage (1.33 x 10(7) cells/L vs. 3.02 x 10(7) cells/L, p = .04). The median hyaline membrane score was lower in the study group (0.5 vs. 3.0) but the difference was not statistically significant. CONCLUSION: These findings suggest that a very low tidal volume reduces ventilator-induced lung injury in saline-lavaged rabbits during ventilation at low lung volume.

Animals↗

PubMed1983

An additional basic science for clinical medicine: III. The challenges of comparison and measurement.

The main scientific virtue of randomized allocation of treatment is an unpredictability that reduces susceptibility bias in the groups created when treatments are assigned preferentially according to prognostic differences. Even in randomized trials, however, prognostic analyses are needed for checking imbalances in the randomization, for precise clinical application of results, and for discerning disparate therapeutic effects. Improved methods of prognostic analyses can enhance effectiveness in randomized trials and credibility for nonrandomized therapeutic comparisons. Regardless of randomization, therapeutic comparisons will also be improved with better analysis of proficiency for the main treatments, better attention to identifying "soft" clinical outcome events, and development of new analytic structures for complex problems in logistics. The challenges will require better scientific methods for the two types of clinical measurement: the mensuration with which descriptive expressions are provided for individual observations; and the quantification with which individual descriptions are grouped, summarized, and compared.

Humans↗

PubMed1989

A prospective randomized comparison of fine needle aspiration biopsy and fibreoptic bronchoscopy in the investigation of peripheral pulmonary opacities.

Twenty-nine patients, aged 66(+/- 7) years with a peripheral pulmonary opacity (mean diameter 3.6 +/- 1.8 cm) believed to be a tumor, were randomly allocated to initial investigation by either fibreoptic bronchoscopy or percutaneous fine needle aspiration biopsy, the latter performed under fluoroscopic control. The patients proceeded to the alternative investigation in the event of the first failing to achieve a diagnosis. Malignancy was confirmed by the initial procedure in 14/15 patients randomized to fine needle aspiration biopsy but only in 1/14 patients randomized to fibreoptic bronchoscopy (P less than 0.01). Overall, these figures were 25/28 fine needle aspiration biopsy and 2/15 fibreoptic bronchoscopy (P less than 0.01). These results confirm the clinical suspicion that fine needle aspiration biopsy is far more likely than fibreoptic bronchoscopy to establish the presence of malignancy in peripheral pulmonary opacities.

Aged↗

PubMed1990

The capitation study. 1. Does capitation encourage "supervised neglect'?

Four matched pairs of geographically and socially contrasting areas of Britain were randomly allocated within pairs to either a capitation or fee-for-service payment system for the dental care of children in a 3-year clinical trial. Measurements were made on the dental health of randomly selected 5-6 and 14-15-year-old patients and the views of their parents elicited. Patterns of treatment were also gained from the clinical records of randomly selected patients. In addition, the views of the dentists taking part, of the profession's representatives, and of the administrators of the systems were obtained. No evidence of systematic neglect could be found among the children treated under capitation, but they had fewer fillings, more untreated diseased teeth and similar disease levels to their counterparts treated under fee-for-service. Dentists in capitation carried out fewer fillings, fewer extractions, took fewer radiographs and saw their patients less frequently than their fee-for-service colleagues.

Adolescent↗

PubMed1986

A double-blind randomized controlled trial of the effect of a low- versus a middle-tar cigarette on respiratory symptoms--a feasibility study.

A feasibility study of a double-blind, randomized controlled trial of the effect of a low-versus a middle-tar cigarette on respiratory symptoms is described. A smoking questionnaire was sent to 19,366 households. Returned questionnaires (64%) yielded 604 middle-tar cigarette smokers aged 20-44 years; 342 replied to a health warning stating that they did not want to or had failed to stop smoking and of these 183 volunteered for the trial. Thus about every 100 households originally mailed yielded one volunteer. Of the volunteers, 95 men were randomly allocated to be sold a middle-tar cigarette and 88 to be sold a low-tar cigarette of identical appearance. The cigarettes were sold at three different reduced prices and the men were asked to smoke them for five weeks. There was a 22% drop-out and this was unrelated to type of cigarette smoked. A reduction in price of 20% was sufficient incentive for volunteers to participate. Cigarette butts were collected weekly or fortnightly and urine samples were collected initially and after three and five weeks. Compliance with the trial cigarettes was good. The excretion of nicotine metabolites, number of cigarettes smoked and average butt weight for men allocated the low-tar cigarette was not significantly different from that of those allocated the middle-tar cigarette. This suggested that the former compensated for the 37% reduction in the nicotine yield of their cigarette by taking more frequent or deeper puffs from their cigarette. The implications of these results for a large-scale, randomized controlled trial are discussed.

Adult↗

PubMed1998

Protective effect of the angiotensin-converting enzyme inhibitor perindopril on diabetic glomerulopathy in streptozotocin-induced diabetic rats.

OBJECTIVES: To evaluate the protective effect of the angiotensin-converting enzyme inhibitor perindopril on diabetic glomerulopathy in rats with experimentally induced diabetes and explore its possible mechanisms. METHODS: Ninety-two adult male Wistar rats were randomly allocated into diabetes mellitus (DM), diabetes mellitus + perindopril (DMP) and control (C) groups. According to the duration of diabetes or observation (1, 3, 6 months), each group was randomly subdivided into DM1, DM3, DM6; DMP1, DMP3, DMP6; and C1, C3, C6 groups. Diabetes was induced by intraperitoneal injection of streptozotocin. The rats in the DMP groups received perindopril 1 mg.kg-1.d-1, through gastric intubation. Urinary protein excretion rate was determined by the method of Coomassie brilliant blue. Plasma renin activity, renal tissue renin activity, and plasma and renal tissue angiotensin II concentration were assayed by radioimmunoassay (RIA). Renal tissue total RNA was extracted by the Chomezymskis AGPC method. Renal angiotensinogen mRNA expression level was assessed by slot blot hybridization using a full length rat angiotensinogen cDNA probe labelled with 32P-dCTP and a random primer. RESULTS: There was increased activity of the renin angiotensin system in diabetic rats. Perindopril decreased proteinuria and delayed the progression of glomerular basement membrane thickening. However, it did not reduce the expansion of the mesangial matrix (P < 0.05). Renin activity increased and angiotensin II concentration decreased significantly in both plasma and renal tissue in diabetes + perindopril groups (P < 0.05). CONCLUSIONS: Perindopril may help prevent the progression of diabetic glomerulopathy, and the inhibition of renin angiotensin system activity may be a mechanism for this action.

Angiotensin-Converting Enzyme Inhibitors↗

PubMed1989

A randomized study of the sitting position for delivery using a newly designed obstetric chair.

A new obstetric chair has been designed to overcome some of the problems of those currently available commercially. The chair has been used to assess the effects of the sitting position in the second stage of labour on the outcome of delivery in 304 women randomly allocated to be delivered either in the chair or in the conventional dorsal position. Delivery in the chair conferred no benefits to mother or baby and resulted in greater mean blood loss and a higher rate of postpartum haemorrhage.

Delivery, Obstetric↗

PubMed1983

Ethamsylate in vaginal surgery under lumbar epidural anaesthesia.

Sixty patients scheduled for vaginal surgery under lumbar epidural block were randomly allocated into two groups, one of which received ethamsylate intravenously prior to induction of anaesthesia. Ethamsylate did not reduce the blood loss at operation in these patients. The possible factors underlying this observation are discussed.

Adult↗

PubMed1989

Is reperitonealization of the gallbladder bed a ritual or necessity?

Reperitonealization of the gallbladder bed after cholecystectomy is the standard procedure described in many textbooks of surgery. Most surgeons who advocate nondrainage after cholecystectomy also routinely obliterate the gallbladder bed. The theoretic considerations are a decrease in post-operative drainage and avoidance of adhesions to the liver. To evaluate the validity of the first consideration, 88 patients undergoing elective cholecystectomy were randomly allocated into two groups. In the first group, the gallbladder bed was reperitonealized whereas in the second group, the raw surface was left uncovered. No significant difference in the amount of postcholecystectomy drainage could be demonstrated in the two groups of patients studied.

Adult↗

PubMed1982

Intra-ocular pressure and premedication with oral diazepam.

Thirty patients scheduled for routine eye surgery were randomly allocated to receive either diazepam 0.2 mg/kg or ascorbic acid 100 mg orally 90 minutes pre-operatively in a double-blind fashion. Diazepam caused no significant change in intra-ocular pressure.

Administration, Oral↗

PubMed1990

Serotonin antagonism reduces the adverse symptoms of beta blockade.

Beta-adrenoceptor antagonists (beta blockers) are a well-established first-line treatment for hypertension, but they have been associated with unwanted symptoms including cold extremities, lethargy, and nightmares. Ketanserin is a serotonin S2-receptor antagonist that has previously been shown to reduce blood pressure in hypertensive patients by reducing systemic vascular resistance. Hypertensive patients whose sitting diastolic blood pressure was greater than or equal to 95 mmHg, despite at least 4 weeks therapy with an optimal dose of beta blocker, were selected for the study. The beta-blocker dose remained constant throughout the study, but patients were randomly allocated to receive ketanserin 20 mg twice daily, ketanserin 40 mg twice daily, or bendrofluazide 5 mg each morning plus placebo at night in addition to the beta-blocker therapy. One hundred and forty two patients completed the symptom questionnaire at randomization and after 12 weeks treatment. The treatment groups were well matched for age, sex, weight, and blood pressure. Blood pressure was reduced significantly by all treatments, and there were no between-group differences. Bendrofluazide adversely affected alertness (p less than 0.05) and concentration (p less than 0.01) whereas ketanserin had no significant effect and the ketanserin 20 mg twice daily group had better concentration than the bendrofluazide group (p less than 0.05). Ketanserin treatment reduced the incidence of nightmares (p less than 0.05 for 20 mg twice daily and 40 mg twice daily) and was an improvement over bendrofluazide treatment in this respect (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗

PubMed2001

An experimental investigation of thought suppression and anxiety in children.

OBJECTIVES: This study aimed to explore the effects of thought suppression in children--in particular, whether trying to suppress a thought leads to an immediate and/or delayed increase in its occurrence. The influence of anxiety on children's performance in the experimental paradigm was also examined. DESIGN: Participants were allocated to conditions in a between-groups experimental design devised on the basis of thought suppression methodologies reported in the adult literature. METHODS: One-hundred and twelve participants were recruited from local primary schools and randomly allocated to four experimental conditions. Children in all conditions monitored the occurrence of a target thought (either neutral or anxiety-provoking) by tapping their hand on a table each time the thought came to mind during two consecutive experimental periods. During the first period, half the children were asked not to think about the target thought, while the remaining half were asked to think about anything. During the second period, all children were instructed to think about anything. RESULTS: No evidence was found for either an immediate or a delayed increase in frequency of target thoughts as a consequence of suppression attempts. State and trait anxiety were, however, found to influence children's performance during these experimental tasks and were associated with increased intrusions under certain conditions. CONCLUSIONS: The results of this study suggest that the experimental thought suppression paradigm is workable with 7-11-year-old children. The methodological, theoretical and clinical implications of these findings are discussed.

Adolescent↗

PubMed1981

Effect of aspirin treatment on chondromalacia patellae.

Twenty-nine patients (21 females and 8 males) with chondromalacia patellae diagnosed by arthroscopy were randomly allocated to receive aspirin or placebo for 3 months. Clinical and arthroscopic examination after 3 months showed no significant change in symptoms, signs, or macroscopic appearances in either group. Surgical treatment was performed in 14 patients for deteriorating symptoms.

Adolescent↗

PubMed1987

Long-term efficacy of coronary artery bypass surgery.

Enhancement of the quality of life concomitant with prolongation of life has become an increasingly important goal in modern health care. Direct correlation of health service investment with qualitative end results of treatment is impeded by lack of scientific measuring methods. The most reliable of the available qualitative parameters are subjective contentment with the results of treatment, subjective well-being, symptoms and capacity to cope with daily living. A series of 100 coronary artery disease patients randomly allocated to surgical or medical treatment was analyzed in these respects. Surgical therapy proved superior.

Consumer Behavior↗

PubMed1987

Prophylactic long-term oral tocolysis of multiple pregnancies.

After admission to hospital for bed rest, 200 women with multiple pregnancies were randomly allocated to receive either 4 mg of salbutamol orally five times daily, or to receive no drug. After an average of 6 weeks treatment, no difference between the experimental groups could be detected with respect to duration of gestation, birthweight or any other of the outcomes of pregnancy observed.

Albuterol↗