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PubMed1990

A comparison of the efficacy and safety of ceftizoxime with doxycycline versus conventional CDC therapies in the treatment of upper genital tract infection with or without a mass.

It is well known that sexually transmitted infections of the upper genital tract are widespread. A variety of regimens are used to treat these conditions, many of which have not been subjected to randomized, prospective clinical trials (including the 1985 Centers for Disease Control [CDC] Guidelines for the treatment of upper genital tract infections [UGTI]). This investigation was undertaken to compare the 1985 CDC treatment guidelines with different doses of ceftizoxime, a third-generation cephalosporin with an intermediate half-life, plus doxycycline in patients with UGTI. The patients were divided into subgroups, depending on the presence or absence of a pelvic mass. Sixty-seven women participated in the study. They were older than 14 years of age and required hospitalization for the treatment of UGTI. These women had lower abdominal pain and tenderness, cervical motion or adnexal tenderness, and one of the following: temperature greater than 100.4 degrees F orally, leukocytosis greater than 10,500/mm3, or presence of a suspected inflammatory pelvic mass on pelvic examination or by ultrasound. Informed consent was obtained from all patients in a manner approved by the Institutional Review Board. Pelvic examinations and ultrasound evaluations of the pelvic soft tissues were performed on all patients at the time of admission. Those who were found not to have a pelvic mass or who had a pelvic mass less than 4 cm in transverse diameter were randomly allocated to receive either ceftizoxime 2 gm intravenously every 12 hours with doxycycline 100 mg intravenously twice daily (Rx 1, n = 13) or cefoxitin 2 gm intravenously every six hours with doxycycline 100 mg intravenously twice daily (Rx 2, n = 14). Those patients found to have a pelvic mass (greater than 4 cm in transverse diameter) were randomly allocated to receive either ceftizoxime 2 gm intravenously every eight hours with doxycycline 100 mg intravenously twice daily (Rx 3, n = 19) or clindamycin 900 mg intravenously every eight hours with a 2-mg/kg loading dose of gentamicin followed by 1.5 mg/kg intravenously every eight hours, with adjustments as necessary (Rx 4, n = 21). All UGTI patients without a mass treated with either Rx 1 or Rx 2 responded adequately. However, UGTI patients with a mass treated with Rx 4 were more likely than those treated with Rx 3 to require a change in antibiotics or need extirpative surgery in order to obtain a satisfactory clinical response (Fisher's exact test = 0.046, two-sided).(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗

PubMed1992

Effect of suture technique on early healing of intestinal anastomoses in rats.

OBJECTIVE: To see if the site and tension of sutures had any influence on early breaking strength in intestinal anastomoses. MATERIAL: 161 Male Wistar rats. INTERVENTIONS: First experiment: after laparotomy and division of the ileum an inverted end to end anastomosis was made in a single layer with 14 interrupted sutures of 7/0 polypropylene. All sutures were inserted 3 mm from the cut edges. The rats were randomly allocated to one of four groups according to the size of the loop of suture used: tight (n = 38), 0.4 mm (n = 22), 0.9 mm (n = 35), or 2.0 mm (n = 24). Second experiment: the method used was the same except that sutures were placed 1.5 mm from the cut edges and the rats were randomly allocated to one of two groups according to the size of loop of suture--tight (n = 20), or 0.9 mm (n = 22). MAIN OUTCOME MEASURES: Breaking strength measured in a tensiometer (both experiments); and myeloperoxidase activity/g tissue, hydroxyproline content and solubility/biopsy specimen (first experiment only). RESULTS: Breaking strength decreased proportionally the tighter the sutures were tied, and the differences were significantly greater when the sutures were placed closer to the cut edges. Anastomotic myeloperoxidase activity, hydroxyproline content, and soluble: total hydroxyproline ratio were similar in all groups. CONCLUSION: Tight sutures may promote proteolytic tissue degradation by reducing the local availability of circulating proteinase inhibitors.

Anastomosis, Surgical↗

PubMed1986

A comparison of the effects of bisoprolol and atenolol on lipoprotein concentrations and blood pressure.

Forty-two patients (28 men, 14 women, age range 27-65 years) with newly discovered mild to moderate hypertension were randomly allocated to treatment with either bisoprolol or atenolol for a double-blind comparison of these two beta 1-adrenoceptor blocking drugs. Two doses of each drug (10 and 20 mg/d for bisoprolol and 50 and 100 mg/d for atenolol) were given, each dose for a 3-month period, the dose to be given first being decided by random allocation of the patients. During the second 3-month period, the patient received the alternative dose. After treatment for 6 and 12 weeks with each dose, the blood pressure, heart rate, and lipoprotein concentrations were checked. Bisoprolol treatment (both 10 and 20 mg) resulted in a decrease in blood pressure in the supine position from 154/100 to 138/89 mm Hg; and atenolol treatment resulted in decreases from 161/102 to 145/90 mm Hg (50 mg/d) and 146/91 mm Hg (100 mg/d). The drugs and doses did not differ in their effect. The triglyceride content in very low density lipoproteins (VLDL) increased during treatment with bisoprolol (10 mg/d) from 1.04 to 1.31 mmol/l (p less than 0.05); during treatment with atenolol (100 mg/d) it increased from 0.90 to 1.14 mmol/l (p less than 0.05). The cholesterol content in low density lipoproteins did not change, but that in high density lipoproteins (HDL) decreased during treatment with both drugs (from 1.22 to 1.10 mmol/l with bisoprolol 20 mg/d, p less than 0.01: and from 1.21 to 1.13 mmol/l with atenolol 100 mg/d, p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗

PubMedDate not supplied

Pilonidal sinus: a claim for simple track incision.

Ninety-six patients treated surgically for pilonidal sinus were examined in a two-part study. In the first part, 36 patients were randomly allocated according to the surgical techniques employed: marsupialization, incision, and excision without primary closure. Healing times and recurrences a year after operation were studied. The healing times of patients treated by excision were longer in comparison with those treated by incision or marsupialization. The recurrence rates were similar for all techniques used. In the second part of the study 60 patients were randomly allocated according to times of returning to work. Twenty-nine of these patients returned to work before their wound healed; 31 resumed work a week after epithelization of the wound. The wounds healed more quickly in patients who started working before they were closed. Incision of the sinus track, carried out using local anesthesia in the outpatient clinic, allowed the patient to return to work without pain sooner.

Anesthesia, Local↗

PubMed1989

A two-stage trial design for testing treatment, self-selection and treatment preference effects.

We propose a two-stage randomized clinical trial design for separating treatment effects from those resulting from choosing treatment. At the first stage all patients are randomly allocated to one of two groups, the random group and the option group. At the second stage, patients in the random group are randomized a second time to treatment A or B, whereas patients in the option group are given a free choice between the two treatments. If there are differences in treatment response between the random group and the option group, there are two potential sources of bias: self-selection by choosing treatment, and effects of suggestion by receiving the preferred treatment. A linear model is presented to estimate these effects separately along with test statistics which are approximately normally distributed.

Clinical Trials as Topic↗

PubMed1997

Effects at two years of a low-fat, high-carbohydrate diet on radiologic features of the breast: results from a randomized trial. Canadian Diet and Breast Cancer Prevention Study Group.

BACKGROUND: The appearance of breast tissue on mammography varies according to its composition. Fat is radiolucent and appears dark on mammography, while stromal and epithelial tissue has greater optical density and appears light. Extensive areas of radiologically dense breast tissue seen on mammography are associated with an increased risk of breast cancer. PURPOSE: The purpose of the present study was to determine whether the adoption of a low-fat, high-carbohydrate diet for 2 years would reduce breast density. METHODS: Women with radiologic densities in more than 50% of the breast area on mammography were recruited and randomly allocated to an intervention group taught to reduce intake of dietary fat (mean, 21% of calories) and increase complex carbohydrate (mean, 61% of calories) or to a control group (mean, 32% of calories from fat and 50% of calories from carbohydrates). Mammographic images from 817 subjects were taken at baseline and compared with those taken 2 years after random allocation by use of a quantitative image analysis system, without knowledge of the dietary group of the subjects or of the sequence in which pairs of images had been taken. The effects of the intervention on the mammographic features of breast area, area of dense tissues in the breast, and the percent of the breast occupied by dense tissue were examined using t tests. Multiple regression was used to examine these effects while accounting for age at trial entry, weight change, and menopausal status. RESULTS: After 2 years, the total area of the breast was reduced by an average of 233.7 mm2 (2.4%) (95% confidence interval [CI] = 106.9-360.6) in the intervention group compared with an average increase of 26.3 mm2 (0.3%) (95% CI = -108.0-160.5) in the control group (P = .01). The area of density was reduced by 374.4 mm2 (6.1%) (95% CI = 235.1-513.8) in the intervention group compared with an average of 127.7 mm2 (2.1%) (95% CI = 8.6-246.7) in the control group (P = .01). Weight loss was associated with a reduction in breast area. The effect of the intervention on breast area was only marginally statistically significant after weight change, menopausal status, and age at trial entry were taken into account (P = .06). Greater weight loss and becoming postmenopausal were associated with statistically significant reductions in the area of density on the mammographic image at 2 years (P = .04 and P<.001, respectively). Age at entry into the trial was marginally significant in the same direction (P = .06). The effect of the intervention on area of density remained statistically significant after controlling for weight loss, age at entry, and menopausal status (P = .03). The change in the percentage of dense tissue in the mammographic image was not significantly different between the two groups (P = .71). CONCLUSIONS AND IMPLICATIONS: These results show that after 2 years, a low-fat, high-carbohydrate diet reduced the area of mammographic density, a radiographic feature of the breast that is a risk factor for breast cancer. Longer observation of a larger number of subjects will be required to determine whether these effects are associated with changes in risk of breast cancer.

Adult↗

PubMed1998

Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer.

BACKGROUND: In phase II trials, irinotecan is active in patients with advanced colorectal cancer, but the survival and clinical benefit of irinotecan compared with second-line fluorouracil by continuous infusion is not known. METHODS: 267 patients who had failed to respond to first-line fluorouracil, or whose disease had progressed after treatment with first-line fluorouracil were randomly allocated irinotecan 300-350 mg/m2 infused once every 3 weeks or fluorouracil by continuous infusion. Treatment was given until disease progression, unacceptable toxic effects, or the patient refused to continue treatment. The primary endpoint was survival, while progression-free survival, response rate, symptom-free survival, adverse events, and quality of life (QoL) were secondary endpoints. FINDINGS: 133 patients were randomly allocated irinotecan and 134 were allocated fluorouracil by continuous infusion. Patients treated with irinotecan lived for significantly longer than patients on fluorouracil (p=0.035). Survival at 1 year was increased from 32% in the fluorouracil group to 45% in the irinotecan group. Median survival was 10.8 months in the irinotecan group and 8.5 months in the fluorouracil group. Median progression-free survival was longer with irinotecan (4.2 vs 2.9 months for irinotecan vs fluorouracil, respectively; p=0.030). The median pain-free survival was 10.3 months and 8.5 months (p=0.06) for irinotecan and fluorouracil, respectively. Both treatments were equally well tolerated. QoL was similar in both groups. INTERPRETATION: Compared with fluorouracil by continuous infusion second-line irinotecan significantly improved survival in patients with advanced colorectal cancer.

Adenocarcinoma↗

PubMed1996

Repeated measurements of non-invasive ambulatory blood pressure: distinction between reproducibility and the proper effect of placebo.

OBJECTIVE: To determine whether non-invasive ambulatory blood pressure is more reproducible and less affected by the placebo treatment than are clinic blood pressure measurements. METHOD: Thirty-four essential hypertensive outpatients were randomly allocated after a 4-week preselection period in two groups in a cross-over study design. One group received placebo for 4 weeks while the other formed the control group (reproducibility), then the treatments were exchanged for another 4 weeks. Clinic and ambulatory blood pressures were measured at three different times for each patient, namely bnefore the random allocation to groups and at the end of each period, using a mercury sphygmomanometer and 24 h non-invasive ambulatory blood pressure monitoring. RESULTS: Administration of placebo was accompanied by a significant reduction in systolic and diastolic clinic blood pressures (by 3.4+/-13 and 3.6+/-8 mmHg, respectively), but not in 24 h, daytime and night-time blood pressures. Circadian hourly blood pressure and heart rate curves were virtually superimposable. In the 13 placebo responder patients selected on the basis of clinic blood pressure, placebo decreased the clinic blood pressure and also reduced systolic and diastolic ambulatory blood pressures, mainly during the day period (by 5.2+/-6.2 and 4.89+/-7.8 mmHg, respectively). This effect is specific and related to the placebo administration because repetition of the measurements without any treatment showed no significant difference. To characterize at baseline the placebo responder patients, comparison with the non-placebo responders showed lower baseline values of ambulatory systolic blood pressure recorded during 24 h daytime and night-time in the placebo responder group. CONCLUSION: The 24 h ambulatory blood pressure average is not affected by placebo in the present group of patients but that a placebo effect occurs mainly during the daytime in patients who decreased their clinic blood pressure under placebo (placebo responders); the placebo-induced reduction in blood pressure is related to a specific effect of placebo and is independent from any alerting reaction or reproducibility hypothesis. This study clearly indicates the necessity of including placebo and ambulatory blood pressure monitoring in the therapeutic and pharmacological trials of antihypertensive drugs.

Journal Article↗

PubMedDate not supplied

Treatment of atopic dermatitis with antihistamines: lessons from a single-patient, randomized clinical trial.

BACKGROUND: Single-patient randomized clinical trials (RCTs) can be utilized to maintain methodologic precision in the analysis of treatment effect in individual patients. We describe the results of a single-patient RCT in a patient with atopic dermatitis and review practical considerations regarding the use of antihistamines. METHODS: Using double-blind, crossover techniques, the patient was randomly allocated to four 2-week treatment periods with the following regimens: chlorpheniramine, 8 mg twice daily; chlorpheniramine, 12 mg twice daily; terfenadine, 120 mg twice daily; and placebo (phase 1). The drug that produced superior results from phase 1 (chlorpheniramine, 8 mg) was subsequently compared with astemizole, 10 mg/d, during phase 2, consisting of four 4-week, double-blind, crossover trial periods with random allocation of study drugs. Daily symptom scores, as well as end of treatment period summary impressions by patient and investigator, were analyzed. RESULTS: In both phases, chlorpheniramine produced the most noticeable positive therapeutic effect on the patient's mild but most disturbing symptoms (pruritus and eye irritation) associated with atopic dermatitis. Drowsiness was reported with chlorpheniramine. Tolerance to this side effect, however, developed quickly. CONCLUSIONS: A single-patient RCT with different antihistamines in a patient with chronic atopic dermatitis was a useful tool in achieving a favorable balance among efficacy, toxicity, and cost of therapy.

Adult↗

PubMed2005

Intracytoplasmic sperm injection as a treatment for unexplained total fertilization failure or low fertilization after conventional in vitro fertilization.

OBJECTIVE: To determine whether IVF or intracytoplasmic sperm injection (ICSI) should be the choice of treatment in case of a previous IVF attempt with unexplained total fertilization failure or low fertilization (<25%). DESIGN: Prospective study. SETTING: Leiden University Medical Center. PATIENT(S): Thirty-eight couples undergoing IVF and ICSI on sibling oocytes after a first IVF attempt with total fertilization failure or with low fertilization (<25%). INTERVENTION(S): Performing IVF and ICSI on sibling oocytes. MAIN OUTCOME MEASURE(S): Fertilization and (ongoing) pregnancy rate. RESULT(S): A total of 271 oocytes were collected in 24 oocyte retrievals in the total fertilization failure group. Hundred nine oocytes were randomly allocated to IVF and 12 were fertilized (11%); 162 sibling oocytes were allocated to ICSI and 78 were fertilized (48%). In 8 of the 24 patients fertilization occurred after IVF. The pregnancy rate after transfer of 1 IVF and 1 ICSI embryo (n = 3) was 67% and after the transfer of 2 ICSI embryos (n = 21) this was 52%. In the low fertilization group 169 oocytes were collected in 14 oocyte retrievals. Seventy-two oocytes were randomly allocated to IVF and 16 were fertilized (22%). Ninety-seven sibling oocytes were allocated to ICSI and 58 were fertilized (60%). In 7 of 14 patients fertilization occurred after IVF. The pregnancy rate after the transfer of 1 IVF and 1 ICSI embryo (n = 5) was 80% and after the transfer of 2 ICSI embryos (n = 9) this was 33%. CONCLUSION(S): Performing ICSI on some oocytes of a cohort may avoid total fertilization failures both in patients with a history of total fertilization failure and in patients with a history of low fertilization, as the percentage of fertilization is higher after ICSI compared to IVF and the recurrence of total fertilization failure and low fertilization is high after IVF treatment.

Adult↗

PubMed2006

Application of artificial neural networks to establish a predictive mortality risk model in children admitted to a paediatric intensive care unit.

INTRODUCTION: Paediatric risk of mortality and paediatric index of mortality (PIM) are the commonly-used mortality prediction models (MPM) in children admitted to paediatric intensive care unit (PICU). The current study was undertaken to develop a better MPM using artificial neural network, a domain of artificial intelligence. METHODS: The purpose of this retrospective case series was to compare an artificial neural network (ANN) model and PIM with the observed mortality in a cohort of patients admitted to a five-bed PICU in a Hong Kong non-teaching general hospital. The patients were under the age of 17 years and admitted to our PICU from April 2001 to December 2004. Data were collected from each patient admitted to our PICU. All data were randomly allocated to either the training or validation set. The data from the training set were used to construct a series of ANN models. The data from the validation set were used to validate the ANN and PIM models. The accuracy of ANN models and PIM was assessed by area under the receiver operator characteristics (ROC) curve and calibration. RESULTS: All data were randomly allocated to either the training (n=274) or validation set (n=273). Three ANN models were developed using the data from the training set, namely ANN8 (trained with variables required for PIM), ANN9 (trained with variables required for PIM and pre-ICU intubation) and ANN23 (trained with variables required for ANN9 and 14 principal ICU diagnoses). Three ANN models and PIM were used to predict mortality in the validation set. We found that PIM and ANN9 had a high ROC curve (PIM: 0.808, 95 percent confidence interval 0.552 to 1.000, ANN9: 0.957, 95 percent confidence interval 0.915 to 1.000), whereas ANN8 and ANN23 gave a suboptimal area under the ROC curve. ANN8 required only five variables for the calculation of risk, compared with eight for PIM. CONCLUSION: The current study demonstrated the process of predictive mortality risk model development using ANN. Further multicentre studies are required to produce a representative ANN-based mortality prediction model for use in different PICUs.

Adolescent↗

PubMedDate not supplied

A randomized controlled trial of a bicarbonate- and a bicarbonate/lactate-containing dialysis solution in CAPD.

OBJECTIVE: To evaluate the safety and efficacy of bicarbonate- and bicarbonate/lactate-based PD fluids. DESIGN: A randomly allocated prospective controlled trial lasting eight weeks. SETTING: Five renal units in Europe. PATIENTS: Individuals who have been treated by CAPD for at least three months and who have had at least one month's therapy with 40 mmol/L lactate PD fluid. Those with recent infection, diabetes or other serious illness are excluded. Forty-seven individuals have entered the study so far. INTERVENTIONS: Patients are randomly allocated to three groups. Group 1 receive 40 mmol/L lactate dialysate, Group 2 are given 38 mmol/L bicarbonate fluid and Group 3 are tested with a 25 mmol/L bicarbonate and 15 mmol/L lactate dialysate. OUTCOME MEASURES: The primary outcome measure is the plasma bicarbonate level. Adverse events and ease of use of the two-chambered bags used by Groups 2 and 3 are also being assessed. RESULTS: To date, plasma bicarbonate levels have been the same in all treatment groups up to the end of the trial period. There are no differences in serum lactate levels. No side effects are attributable to the test fluids. The patients have managed the two-chambered bags successfully. CONCLUSION: This trial is still ongoing, but to date, neutral bicarbonate based fluids have been as effective as lactate dialysate in treating uremic acidosis.

Adult↗

PubMed2006

Health promotion for frail older home care clients.

AIM: This paper reports a study evaluating the comparative effects and costs of a proactive nursing health promotion intervention in addition to usual home care for older people compared with usual home care services alone. BACKGROUND: An ageing population, budget constraints and technological advances in many countries have increased the pressure on home care resources. The result is a shift in nursing services from health promotion to meet the more pressing need for postacute care. For frail older people with long-term needs, these changes combine to create a fragmented system of health service delivery, characterized by providing nursing on demand rather than proactively. METHODS: A two-armed, single-blind, randomized controlled trial was carried out with older people > or =75 years and eligible for personal support services through a home care programme in Ontario, Canada. Participants were randomly allocated either to usual home care (control) or to a nursing (experimental) group. In addition to usual home care, the nursing group received a health assessment combined with regular home visits or telephone contacts, health education about management of illness, coordination of community services, and use of empowerment strategies to enhance independence. The data were collected in 2001-2002. RESULTS: Of the 288 older people who were randomly allocated at baseline, 242 (84%) completed the study (120 nursing group; 122 control group). Proactively providing older people with nursing health promotion, compared with providing nursing services on-demand, resulted in better mental health functioning (P = 0.009), a reduction in depression (P = 0.009), and enhanced perceptions of social support (P = 0.009) at no additional cost from a societal perspective. CONCLUSIONS: Home based nursing health promotion, proactively provided to frail older people with chronic health needs, enhances quality of life while not increasing the overall costs of health care. The results underscore the need to re-invest in nursing services for health promotion for older clients receiving home care.

Adaptation, Psychological↗

PubMed1994

Cough with angiotensin converting enzyme inhibitors: how much of a problem?

PURPOSE: To review the occurrence of angiotensin converting enzyme (ACE) inhibitor-related cough, and to examine its impact on the quality of life. DATA SOURCES: Data from published reports, postmarketing surveillance studies, hospital case series and randomly allocated controlled trials were reviewed. Data are presented from a nested case-control study examining the effects of ACE inhibitor-related cough in 36 subjects compared with 69 controls on various measures of quality of life. RESULTS: Low rates of ACE inhibitor-related cough were found in postmarketing studies, ranging from 0.1% (early studies) to 3%. Much higher figures were reported from double-blind randomly allocated controlled trials using self-administered questionnaires; the net increase over baseline was between 13 and 25% compared to 2% with the comparator drug. The nested case-control study suggested that the ACE inhibitor-related cough is associated with some deterioration in well-being. During ACE inhibitor treatment the patients tended to be more fatigued (P = 0.1) and depressed (P < 0.05) than controls. Reports of a sore throat increased by 27% (P < 0.01). CONCLUSIONS: Cough is a common side effect of ACE inhibitor treatment, with conservative estimates suggesting that around one in 10 patients treated with an ACE inhibitor will develop a dry persistent cough. Half of these may be withdrawn from treatment. This cough is probably associated with some deterioration in well-being, but larger studies are required to confirm this.

Angiotensin-Converting Enzyme Inhibitors↗

PubMed1996

Pitfalls of patient education. Limited success of a program for back pain in primary care.

STUDY DESIGN: Low back pain patients seen in primary care were allocated randomly to one of two educational interventions or to usual care. OBJECTIVE: To evaluate educational interventions designed to improve the outcomes of primary care for low back pain. SUMMARY OF BACKGROUND DATA: Patients with back pain are frequently dissatisfied with their medical care and identify lack of information as the most insufficient aspect. METHODS: In a large Health Maintenance Organization clinic, 293 subjects were allocated randomly to receive usual care, an educational booklet, or a 15-minute session with a clinic nurse, including the booklet and a follow-up telephone call. Outcome measures included satisfaction with care, perceived knowledge, participation in exercise, functional status, symptom relief, and health care use. Outcomes were assessed 1, 3, 7, and 52 weeks after the intervention. RESULTS: The nurse intervention resulted in higher patient satisfaction than usual care (P < 0.001) and higher perceived knowledge (P < 0.001). Self-reported exercise participation was also higher in the nurse intervention group after a 1-week follow-up period (97% vs. 65% in the other groups; P < 0.0001). There were no significant differences among the three groups in worry, symptoms, functional status, or health care use at any follow-up interval. Differences in self-reported exercise and perceived knowledge were no longer significant after 7 weeks. CONCLUSIONS: These findings challenge the value of purely educational approaches in reducing functional impact or health care use related to back pain and also challenge the value of fitness exercise in the most acute phase of back pain.

Adult↗

PubMed2002

Training symmetry of weight distribution after stroke: a randomized controlled pilot study comparing task-related reach, Bobath and feedback training approaches.

OBJECTIVE: To determine (1) the most effective of three treatment approaches to retrain seated weight distribution long-term after stroke and (2) whether improvements could be generalized to weight distribution in standing. SETTING: Inpatient rehabilitation unit. DESIGN: Forty asymmetrical acute stroke subjects were randomly allocated to one of four groups in this pilot study. Changes in weight distribution were compared between the 10 subjects of each of three treatment groups (task-specific reach, Bobath, or Balance Performance Monitor [BPM] feedback training) and a no specific treatment control group. One week of measurement only was followed by two weeks of daily training sessions with the treatment to which the subject was randomly allocated. Measurements were performed using the BPM daily before treatment sessions, two weeks after cessation of treatment and 12 weeks post study. Weight distribution was calculated in terms of mean balance (percentage of total body weight) or the mean of 300 balance points over a 30-s data run. RESULTS: In the short term, the Bobath approach was the most effective treatment for retraining sitting symmetry after stroke (p = 0.004). Training with the BPM and no training were also significant (p = 0.038 and p = 0.035 respectively) and task-specific reach training failed to reach significance (p = 0.26). At 12 weeks post study 83% of the BPM training group, 38% of the task-specific reach group, 29% of the Bobath group and 0% of the untrained group were found to be distributing their weight to both sides. Some generalization of symmetry training in sitting to standing was noted in the BPM training group which appeared to persist long term. CONCLUSIONS: Results should be treated with caution due to the small group sizes. However, these preliminary findings suggest that it might be possible to restore postural symmetry in sitting in the early stages of rehabilitation with therapy that focuses on creating an awareness of body position.

Aged↗

PubMed1996

Separating the environmental and genetic factors that may be causes of bovine spongiform encephalopathy.

The initial cause of the bovine spongiform encephalopathy (BSE) epidemic is generally accepted to have been the feeding of infected animal protein to cattle. The proportion of animals affected in any year in a particular herd has generally been low. This suggests either considerable variation in the extent of challenge of the individual animals or variation in their susceptibility to challenge or both. There is known to be genetic variation in susceptibility in other spongiform encephalopathies, such as scrapie in sheep. However, earlier indications that there may be associations between the incidence of BSE in cattle and polymorphisms and mutations in the PrP gene have not been confirmed (Hunter et al. 1994). Here, we attempt to model the likely extent of challenge of the individual animals in five Holstein Friesian pedigree herds and also the distribution of incubation times to the date of clinical onset. By studying the incidence of the disease in related animals we first found that single locus genetic models fitted the data much better than a non-genetic model. This was the first statistical evidence found of genetic variation in susceptibility to BSE. A check on the model in which individual animals were randomly allocated to 'parents' showed that the result was due to the lack of allowance in the non-genetic model for those animals insufficiently challenged or, for non-genetic reasons, resistant to their level of challenge. Thus there is still no evidence, molecular or statistical, for genetic variation in susceptibility. The importance of checking the attribution of genetic effects in complex models by the random allocation of progeny to parents is clear.

Animals↗

PubMed1990

Influence of humoral and volume factors on altered osmoregulation of normal human pregnancy.

These studies were designed to characterize mechanisms leading to decreased plasma osmolality (Posmol) and osmotic thresholds (T) for arginine vasopressin (AVP) release (TAVP) and thirst (Tthirst) in pregnancy. First, the influence of the pregnancy hormone, human chorionic gonadotrophin (hCG), was tested in six nonpregnant women who received hypertonic saline during the luteal phase of the menstrual cycle on two occasions (randomly allocated), once after 15,000 IU of hCG when Posmol, TAVP, and Tthirst decreased 6, 5, and 5 mosmol/kgH2O, respectively (P less than 0.01). In contrast, hCG pretreatment of males (n = 6) had no significant effect. Next, the role of decreased effective vascular volume (underfilling) was evaluated in seven women undergoing hypertonic saline infusion in the presence and absence of head-out water immersion (randomly allocated) during early and late pregnancy and postpartum. Posmol, TAVP, and Tthirst were not influenced by immersion and remained 10 mosmol/kgH2O lower in pregnancy (P less than 0.01). Central redistribution of intravascular volume consistently lowered hematocrit and rate of rise of PAVP per unit increment in Posmol (P less than 0.01). Although these data failed to support the hypothesis that the osmoregulatory change in human pregnancy is attributable to decrements in effective central volume (underfill), they do suggest that hCG may play a role.

Adult↗