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Results for “randomized controlled trials”

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PubMed2001

Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial.

A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size.

Aged↗

PubMed1988

Hepatic arterial embolization in patients with unresectable hepatocellular carcinoma--a randomized controlled trial.

A randomized controlled trial of hepatic arterial embolization was conducted in 63 consecutive patients who had unresectable but still embolizable hepatocellular carcinoma. Patients were randomized into three groups. Patients in group 1 received multiple hepatic arterial embolizations; patients in group 2 were given hepatic arterial embolization once, followed by monthly chemotherapy with high doses of 5-fluorouracil; and patients in group 3 received only monthly chemotherapy with high doses of 5-fluorouracil. Complete response was achieved in only 1 patient who received multiple hepatic arterial embolizations. Partial responses were observed in 13 patients (61.9%) in group 1, 10 patients (47.6%) in group 2, and 2 patients (9.5%) in group 3. The survival rates of patients in group 1 at the end of the ninth, 12th, 15th, 18th, and 21st months were 53.2%, 42.2%, 42.2%, 42.2%, and 42.2%, respectively, which were not significantly different from those of patients in group 2 but were better than the survival rates of patients in group 3. The results suggest that hepatic arterial embolization is an effective palliative treatment that prolongs survival of patients with unresectable hepatocellular carcinoma.

Adult↗

PubMed1989

Coffee, blood pressure and plasma lipids: a randomized controlled trial.

A randomized controlled trial was conducted to examine the effects of coffee (as commonly drunk in Britain) on blood pressure and plasma lipids in healthy subjects. Fifty-four subjects followed three regimens successively, the order being randomized according to a Latin square design: five or more cups of coffee daily for 4 weeks; five or more cups of decaffeinated coffee daily for 4 weeks but no ordinary coffee; no coffee for 4 weeks. Coffee appeared to cause a small rise (of 3 mm Hg) in recumbent systolic blood pressure; this effect was less than, and obscured by, changes induced by posture and mild stress. No consistent changes attributable to coffee were found in diastolic blood pressure or pulse rate. Small changes in the expected directions occurred in plasma high density lipoprotein (HDL) cholesterol and apolipoprotein AI (decrease), and in total cholesterol, non-HDL cholesterol and apolipoprotein B (increase), but none of these were statistically significant. The effect of coffee on risk of heart disease in Britain is probably small.

Adolescent↗

PubMed1995

Prompting for cost-effective test ordering: a randomized controlled trial.

This randomized, controlled trial tests the efficacy of a computerized prompting system for test ordering. The system, makes use of the sensitivity, specificity, positive and negative predictive values of tests. It was tested using clinical vignettes in an academic family medicine center with first and second year residents. We found that there was a 38% decrease in the numbers of tests ordered (p < .01) and a 12% decrease in the costs of tests ordered by using the prompting system. We suggest that when used at the point of the patient encounter, this system has the potential for promoting more appropriate test ordering and for saving considerable health care dollars.

Clinical Laboratory Techniques↗

PubMed1988

Prevention of mite infestation of bedding by means of an impregnated sheet. A randomized controlled trial.

A randomized controlled trial was conducted to test the effect of a sheet impregnated with benzyl benzoate in preventing mite infestation of new bedding. Impregnated sheets were placed on the mattresses of 17 subjects, while 19 subjects received placebo sheets. Over the following 2 years infestation occurred more commonly, and tended to be heavier, in the beds with inactive sheets than in those with impregnated sheets; among the 27 beds with three items of new bedding sampled on four occasions, a mite count of five or more occurred significantly more often where the sheet was inactive than where it was active (11 of 13 and 5 of 14 respectively). The application of a sheet impregnated with benzyl benzoate appears to prevent mite infestation and may be useful for patients with mite allergy who obtain new bedding as part of a mite-avoidance regimen.

Asthma↗

PubMed2005

Patient and provider perspectives on home telecare: preliminary results from a randomized controlled trial.

A randomized controlled trial of home telecare for the management of acute exacerbations of chronic obstructive pulmonary disease has been undertaken in the north-west of England. A videophone was used that communicates via the ordinary telephone network. The intervention period for each participant was two weeks. Participants in the telecare arm of the trial were asked to complete logbooks to record their experiences of each telecare encounter. A simple, self-completed, 10-item questionnaire was used that consisted of a Likert scale, ranging from 1 (totally disagree) to 5 (totally agree). Fourteen nurses completed 150 logbooks and 22 patients completed 145 logbooks. These results demonstrate significant differences in perception between patients and their health-care providers with regard to telecare encounters across all the domains addressed. Participating patients consistently demonstrated more positive views of the telecare encounters than their healthcare providers.

Aged↗

PubMed1976

Psycho-social effects of home care: results of a randomized controlled trial.

A randomized controlled trial was conducted to evaluate the efficacy of the early transfer of hospital in-patients to home care. This paper reports rates of return to normal role functions in work, leisure and household roles for patients who received any of five surgical procedures. With regard to return to work or leisure tasks, no statistically significant differences were observed between groups for any of the procedures. The rates of return to household activities were greater for home care patients than they were for controls in the cases of cholecystectomy and procedures for anal and rectal fistula.

Adult↗

PubMed2002

Reducing STD and HIV risk behavior of substance-dependent adolescents: a randomized controlled trial.

A randomized controlled trial assessed 3 interventions designed to increase safer sex behaviors of substance-dependent adolescents. Participants (N = 161) received 12 sessions of either a health information intervention (I only), information plus skills-based safer sex training (I + B), or the same experimental condition plus a risk-sensitization manipulation (I + M + B). The I + B and I + M + B conditions, as compared with the I only condition, (a) produced more favorable attitudes toward condoms; (b) reduced the frequency of unprotected vaginal sex; and (c) increased behavioral skill performance, frequency of condom-protected sex, percentage of intercourse occasions that were condom protected, and number of adolescents who abstained from sex. The intervention that included the risk-sensitization procedure was more resistant to decay. An unexpected finding was that the I + B and I + M + B conditions produced substantial increases in sexual abstinence.

Acquired Immunodeficiency Syndrome↗

PubMed1982

Alcoholism as a risk factor in methadone maintenance. A randomized controlled trial.

A randomized controlled trial of 625 addicts on methadone maintenance identified 105 (17 percent) as active alcoholics, 47 (8 percent) as inactive alcoholics, and 473 (75 percent) as nonalcoholics. Subjects were followed for up to 29 months (mean 53.7 weeks) to assess the influence of alcoholism on the rehabilitative process. During the study, alcohol consumption significantly decreased (p less than 0.001) in active alcoholics. Indexes of productive activity on entry or during follow-up revealed no significant differences between active alcoholics and other patients with the exception of alcohol-related hospitalizations (p less than 0.001). Behavioral indexes consistently improved with treatment in all patients, being greatest among active alcoholics (p less than 0.01). During the study, 28 (7 percent) of 399 nonalcoholics were recategorized as active alcoholics, and remission from alcoholism was noted in 28 (27 percent) of patients who were initially classified as alcoholic. These findings suggest that alcoholism does not significantly affect rehabilitation from narcotic use and therefore should not be cause for detoxification from methadone maintenance.

Alcoholism↗

PubMed2000

Physical activity, self-esteem, and self-efficacy relationships in older adults: a randomized controlled trial.

A randomized controlled trial examined the growth and form of multidimensional self-esteem over a 12-month period (6-month exercise intervention and 6-month follow-up) in 174 older adults engaged in either a walking or stretching/toning program. The extent to which changes in physical fitness parameters and physical self-efficacy were related to changes in perceptions of attractive body, strength, physical conditioning, and physical self-worth was also determined. Latent growth curve analyses showed a curvilinear pattern of growth in esteem with significant increases at all levels of self-esteem upon completion of the intervention followed by significant declines at 6 months postintervention in both groups. Frequency of activity and changes in physical fitness, body fat, and self-efficacy were related to improvements in esteem perceptions relative to attractive body, strength, and physical condition. Model fitting procedures suggested that the best fit of the data was to a model in which the influence of changes in efficacy and physical parameters on physical self-worth were mediated by perceptions of attractive body and physical condition.

Aged↗

PubMedDate not supplied

The effect of different anthelmintic treatment regimens combined with iron supplementation on the nutritional status of schoolchildren in KwaZulu-Natal, South Africa: a randomized controlled trial.

A randomized controlled trial in KwaZulu-Natal (South Africa) of 428 primary-school pupils (stratified into 6 groups by age, sex and intervention) measured the effect of different anthelmintic treatments and iron supplementation regimens provided twice at 6-monthly intervals for 1 year (1996/97). Half the pupils received iron supplementation (ferrous fumarate 200 mg weekly for 10 weeks). Pupils received 2 anthelmintic regimens, either (i) albendazole 400 mg plus praziquantel 40 mg/kg or (ii) albendazole 400 mg on 3 consecutive days plus praziquantel 40 mg/kg or (iii) placebo. Baseline prevalences of Ascaris 55.9%, Trichuris 83.6%, hookworm spp. 59.4%, were reduced after 12 months for single-dose albendazole treatment to Ascaris 17.4% (P < 0.005), Trichuris 61.5% (NS), hookworm spp. 0% (P < 0.005), and for triple-dose albendazole treatment to Ascaris 14.8% (P < 0.005), Trichuris 25.0% (P < 0.01), hookworm 0% (P < 0.005). Schistosoma haematobium 43.4% was reduced among treated groups to 8.3% (P < 0.005). There were no significant changes in the anthropometry of the different treatment groups at either 6 or 12 months post treatment. Twelve months after treatment there was a significant increase in haemoglobin levels (P = 0.02) among pupils receiving triple-dose albendazole, praziquantel and ferrous fumarate; pupils receiving no anthelmintic treatment showed a significant decrease as did pupils who received triple-dose albendazole and praziquantel but no iron. Regular 6-monthly anthelmintic treatment significantly reduced the prevalence of Ascaris, hookworm spp. and S. haematobium infections (P < 0.05). Triple-dose treatment for Trichuris was significantly more effective than a single dose of albendazole 400 mg (P = 0.002). In areas with schistosomiasis, hookworm infection and high prevalence of Trichuris infection, combination treatment with praziquantel, triple-dose albendazole, plus iron supplementation, is likely to improve pupils' health and haemoglobin levels.

Adolescent↗

PubMed1989

Effect of screening and treatment on imported intestinal parasite infections: results from a randomized, controlled trial.

A randomized, controlled trial was undertaken to evaluate the effects of a screening program for intestinal parasite infection in newly arrived Southeast Asian refugees to Montréal, Québec, Canada, during 1982-1983. Families assigned to the screened groups were examined, infected persons were treated and followed until they were infection-free, and all screened families were reexamined at six months. Families assigned to the control groups were examined at six months only. Statistically significant prevalence differences in unadjusted and adjusted estimates over the six-month study period were found between screened persons and controls for each of three groups of refugees from Kampuchea, Laos, and Vietnam, respectively. In general, the greatest prevalence differences ascribed to the screening program were observed in hookworm and Ascaris lumbricoides infections. Continued high levels of Giardia lamblia and Strongyloides stercoralis infection were observed at six months; this raises concerns over the effective therapeutic management of infected persons, the risk of local transmission, and the relevance of screening for intestinal parasites in new arrivals from endemic areas.

Asia, Southeastern↗

PubMed1988

The effects of a three-month exercise programme on neuropsychological function in elderly institutionalized women: a randomized controlled trial.

This randomized controlled trial examined the effect of a 3-month exercise programme on neuropsychological function in a population of very elderly institutionalized women. Baseline neuropsychological testing was performed, and following 3 months of exercise or control intervention, subjects were retested 3-7 days after the completion of the study period. Apart from the Word Fluency Test, there was no significant improvement in any of the neuropsychological test scores. This study may not have shown any significant improvement in neuropsychological function because our exercise programme was too light to improve aerobic fitness, or because neuropsychological tests were repeated 3-7 days after exercise was completed and any acute effects of exercise may have disappeared by that time.

Age Factors↗

PubMed2002

Can warfarin be continued during dental extraction? Results of a randomized controlled trial.

A randomized controlled trial was set up to investigate whether patients who were taking warfarin and had an International Normalised Ratio (INR) within the normal therapeutic range require cessation of their anticoagulation drugs before dental extractions. Of 109 patients who completed the trial, 52 were allocated to the control group (warfarin stopped 2 days before extraction) and 57 patients were allocated to the intervention group (warfarin continued). The incidence of bleeding complications in the intervention group was higher (15/57, 26%) than in the control group (7/52, 14%) but this difference was not significant. Two patients in the study required hospital review for bleeding and all other episodes of bleeding were controlled by patients at home. Continuing warfarin when the INR is < 4.1 may lead to an increase in minor post-extraction bleeding after dental extractions but we found no evidence of an increase in clinically important bleeding. As there are risks associated with stopping warfarin, the practice of routinely discontinuing it before dental extractions should be reconsidered.

Acetaminophen↗

PubMed2006

Effects of whole body vibration training on postural control in older individuals: a 1 year randomized controlled trial.

This randomized controlled trial investigated the effects of a 12 month whole body vibration training program on postural control in healthy older adults. Two hundred and twenty people were randomly assigned to a whole body vibration group (n=94), a fitness group (n=60) or a control group (n=66). The whole body vibration and fitness groups trained three times a week for 1 year. The vibration group performed exercises on a vibration platform and the fitness group performed cardiovascular, strength, balance and stretching exercises. Balance was measured using dynamic computerized posturography at baseline and after 6 and 12 months. Whole body vibration training was associated with reduced falls frequency on a moving platform when vision was disturbed and improvements in the response to toes down rotations at the ankle induced by the moving platform. The fitness group showed reduced falls frequency on the moving surface when vision was disturbed. Thus, whole body vibration training may improve some aspects of postural control in community dwelling older individuals.

Accidental Falls↗

PubMed1992

Social intervention and the elderly: a randomized controlled trial.

A randomized controlled trial was set up in 1985 to test the effect of social intervention over 3 years among elderly people, aged 75 and above, living alone. The sampling frame was the age/sex register of a large group practice of 12 general practitioners serving the town of Melton Mowbray, Leicestershire, England, with a list size of approximately 32,000 patients. A total of 523 elderly people living alone in 1985 were identified, interviewed, and randomized into experimental and control groups. A lay worker offered the experimental group (n = 261) individual packages of support that aimed at enhanced social contacts. The outcome measures, approximately 3 years later in 1988, were mortality; changes in physical status; demand for medical, paramedical, social, and voluntary services; and changes in a number of subjective variables (morale, loneliness, and self-perceived health). No significant differences were found for any of the variables with the exception of self-perceived health status, where the experimental group showed significantly greater improvements than did the control group. More importantly, half the elderly in this sample declined several offers of help.

Activities of Daily Living↗

PubMed1995

Evaluation of antenatal and postnatal support to overcome postnatal depression: a randomized, controlled trial.

This randomized, controlled trial tested the hypothesis that women identified as more vulnerable to developing postnatal depression who attended two specific antenatal groups and one postnatal group have a reduced frequency of postnatal depression from 37 to 15 percent at 6 weeks, 12 weeks, and 6 months postpartum. A modified antenatal screening questionnaire was completed, and women identified as more vulnerable to postnatal depression were stratified by parity and randomly allocated to receive extra support groups or to a control group. The Edinburgh Postnatal Depression Scale (EPDS) was used to detect postnatal depression. Attendance at the support groups was low, 31 percent overall. At six weeks, in the intervention group, 8 (13%) of 64 women scored high (> 12) on the EPDS, compared with 11 (17%) controls. Similarly, at 12 weeks 7 (11%) of 63 versus 10 (15%) of 65 women scored higher than 12, and at 6 months, 9 (15%) of 60 versus 6 (10%) of 64 women scored higher than 12, indicating that the intervention did not reduce postnatal depression. It is possible that the method of applying the intervention, using groups separate from the standard antenatal classes, may have affected attendance. More research is required into ways of reaching and supporting women who may become depressed.

Adult↗

PubMed1990

[How to deal with equivocal subjects in statistical analysis of randomized controlled trials].

In randomized controlled trials, it is likely that several subjects with atypical features are registered. In this paper, it was discussed from a statistical point of view how properly the subjects with the following atypical features could be dealt with; 1) subjects who were found to be not eligible for the trial after randomization, 2) subjects who did not receive the assigned regimen by the treatment protocol, 3) subjects whose outcome was ambiguous as the designated endpoint, and 4) subjects who were ambiguous whether to be regarded as censored cases. It was also emphasized that informations on equivocal subjects should be masked in the committee which is responsible for the statistical judgement. Plausible examples were added to assist the readers to understand the rules discussed here.

Humans↗