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Results for “Randomized controlled trials”

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At least 253 records · Page 14Linked to original sources

PubMed2001

Oral appliances for the management of severe snoring: a randomized controlled trial.

The aim of this randomized controlled trial was to assess the effectiveness of a mandibular advancement appliance (MAA) in managing severe snoring. Twenty-eight adults with severe snoring and normal overnight oximetry were recruited from sleep disorder clinics. A maxillary placebo appliance and a MAA were worn by each subject for a period of 4-6 weeks each. Questionnaires at baseline and after each appliance period assessed bed partners' reports of snoring severity (loudness and number of nights per week), and patients' records of daytime sleepiness. Twenty-five subjects completed the entire trial. The MAA was significantly more effective than the placebo in reducing the frequency and loudness of snoring, the reported daytime sleepiness and the frequency of morning tiredness. Excessive salivation was the most commonly reported complication. It was concluded that the custom-made MAA was significantly more effective than the placebo in managing the main symptoms of severe snoring. However, not all subjects' partners reported an improvement with the MAA, with 84 per cent reporting a reduction in snoring loudness and 76 per cent reporting snoring on fewer nights per week.

Adult↗

PubMed2005

Effects of bone density feedback and group education on osteoporosis knowledge and osteoporosis self-efficacy in premenopausal women: a randomized controlled trial.

In this 2-yr randomized controlled trial, we examined the effect of bone mineral density feedback and two different educational interventions (an osteoporosis information leaflet and group-based behavioral education [OPSMC]) on osteoporosis knowledge and self-efficacy in 470 women aged 25-44 yr. Osteoporosis knowledge increased across all intervention groups. Women receiving the OPSMC had a greater increase in both short (beta = +1.33, 95% confidence interval [CI] = 0.72-1.94) and long-term (beta = +0.64, 95% CI = 0.0034-1.25) osteoporosis knowledge, compared to those receiving the leaflet. In contrast, a low T-score was associated with a significant increase in long-term (beta = +0.66, 95% CI = 0.0034-1.25) but not short-term (beta = +0.57, 95% CI = -0.036 to 1.17) osteoporosis knowledge, compared to a normal T-score. Changes in osteoporosis self-efficacy were not associated with either low bone mineral density or receiving the OPSMC but were negatively associated with number of children (beta = -0.9, 95% CI = - 1.4 to -0.3) and working more than 20 h per week (beta = -2.7, 95% CI = -4.6 to -0.8). In conclusion, both the OPSMC and bone density feedback increased osteoporosis knowledge but not self-efficacy over 2 yr. Women with children or who worked full time have decreased osteoporosis self-efficacy, suggesting that this group should be a specific target for future interventional strategies.

Adult↗

PubMed2003

A double-blind, placebo-controlled, randomized trial of oral sodium clodronate for metastatic prostate cancer (MRC PR05 Trial).

BACKGROUND: The most frequent site of metastases from prostate cancer is bone. Bisphosphonates reduce excessive bone turnover while preserving bone structure and mineralization in patients with other tumor types. We conducted a double-blind, placebo-controlled, randomized trial to determine whether the first-generation bisphosphonate sodium clodronate could improve bone progression-free survival (BPFS) times among men with bone metastases from prostate cancer. METHODS: Between June 1994 and July 1998, 311 men who were starting or responding to first-line hormone therapy for bone metastases were randomly assigned to receive oral sodium clodronate (2080 mg/day) or placebo for a maximum of 3 years. The primary endpoint of the trial was symptomatic BPFS. Secondary endpoints included overall survival, treatment toxicity, and change in World Health Organization (WHO) performance status. Time-to-event data were analyzed using the log-rank chi-square test and Kaplan-Meier curves. All statistical tests were two-sided. RESULTS: Baseline characteristics were balanced across the two groups. After a median follow-up of 59 months, the sodium clodronate group showed statistically nonsignificant better symptomatic BPFS (hazard ratio [HR] = 0.79, 95% confidence interval [CI] = 0.61 to 1.02; P =.066) and overall survival (HR = 0.80, 95% CI = 0.62 to 1.03; P =.082) than the control group. Patients in the clodronate group were less likely to have a worsened WHO performance status (HR = 0.71, 95% CI = 0.56 to 0.92; P =.008). However, the clodronate group reported more gastrointestinal problems and increased lactate dehydrogenase levels and required more frequent modification of the trial drug dose (HR for any adverse event = 1.71, 95% CI = 1.21 to 2.41; P =.002). Results of subgroup analyses suggested that clodronate might be more effective the sooner after diagnosis of metastatic bone disease it is started. CONCLUSION: These results suggest that further studies of the effect of newer generation bisphosphonates on BPFS in men with metastatic prostate cancer are warranted.

Administration, Oral↗

PubMed2004

Patient satisfaction with teledermatology: quantitative and qualitative results from a randomized controlled trial.

As part of a randomized controlled trial involving 208 dermatology patients, a quantitative and qualitative study was undertaken to explore patients' satisfaction with a specialist dermatological opinion and further management obtained through either a traditional outpatient consultation (control group) or an asynchronous teleconsultation (telemedicine group). There was a response rate of 71% to the quantitative patient satisfaction survey (148 replies from 208 distributed questionnaires). The responders comprised 80 of the 111 telemedicine patients (72%) and 68 of the 97 control patients (70%). Overall levels of patient satisfaction were high in both groups, and there was no significant difference between them. Ninety per cent of patients in the control group were satisfied with their overall care, compared with 81% in the telemedicine group, and 87% of patients in the control group were satisfied with their overall management, compared with 84% in the telemedicine group. Follow-up qualitative interviews with 30 of the participants also suggested that patients were generally positive about their care and management, regardless of group, age or gender. Receiving a diagnosis, treatment and cure, receiving adequate information and explanations, the need to be taken seriously, the need for individualized personal care, and the importance of a short waiting time for an appointment and treatment were all aspects of care and management most likely to result in patient satisfaction, regardless of modality.

Adolescent↗

PubMed2005

Use of videotaped interactions during pediatric well-child care to promote child development: a randomized, controlled trial.

The authors performed a randomized, controlled trial to assess the impact of the Video Interaction Project (VIP), a program based in pediatric primary care in which videotaped interactions are used by child development specialists to promote early child development. Ninety-three Latino children (51 VIP, 42 control) at risk of developmental delay on the basis of poverty and low maternal education (none had completed high school) were assessed for cognitive and language development at age 21 months. Results differed depending on the level of maternal education; the VIP was found to have a moderate impact on children whose mothers had between seventh and 11th grade education (approximately 0.75 SD for cognitive development, 0.5 SD for expressive language) but little impact on children whose mothers had sixth grade or lower education.

Adult↗

PubMed1998

Effect of two training regimens on bone mineral density in healthy perimenopausal women: a randomized controlled trial.

The aim of this randomized controlled trial was to evaluate the effects of 18 months of calisthenics and endurance training regimens on bone mineral density (BMD) in perimenopausal women. Clinically healthy sedentary female volunteers (n = 105) aged 52-53 years were randomly assigned to a calisthenics (n = 36), endurance (n = 34), or control (n = 35) group. The calisthenics training (2.6 times per week on average, 50 minutes per session) consisted of rhythmic strength-endurance exercises by large muscle groups, and the endurance training (3.2 times per week, 50 minutes) consisted of walking, stair climbing, ergometer cycling, and jogging at a controlled heart rate zone corresponding to 55-75% of the individual maximal oxygen uptake (VO2max) of the subjects. The control subjects performed a light stretching program once a week The BMD of the lumbar spine (L2-L4), right femoral neck, calcaneus, and distal radius was measured by dual-energy X-ray absorptiometry at 0, 4, 8, 10, 14, and 18 months, and the maximal isometric strength during trunk extension and flexion, leg extension, and arm flexion and the VO2max by ergospirometry were evaluated at 0, 8, 10, and 18 months of intervention. The VO2max improved significantly (p = 0.021) in the endurance group. The linear trend of the femoral neck BMD in the endurance group, as determined by generalized linear models, was significantly different (p = 0.043) from that of the control group, the trend indicating a maintenance of the prestudy BMD. In the calisthenics group, the training effect was not significant. However, the distal radius BMD of the endurance group showed a significant negative trend (p = 0.006). These results suggest that multiexercise endurance training maintains the BMD the clinically important femoral neck of perimenopausal women. This form of endurance training proved also to be feasible for healthy perimenopausal women.

Absorptiometry, Photon↗

PubMed1986

Initial antihypertensive drug therapy: alpha blocker or diuretic. Interim report of a randomized, controlled trial.

A two-center, randomized, controlled trial designed to evaluate and compare an alpha blocker and a diuretic as initial antihypertensive drug treatment is currently in progress. Approximately 100 men and women, aged 30 to 69 years, are being randomly assigned to treatment with either of these two agents. If diastolic blood pressure is not reduced to its target level and is 85 mm Hg or higher, the alternate agent is added. The alternate agent is substituted if a patient does not tolerate the assigned agent. This preliminary report presents data concerning 62 patients who completed at least three of the planned 12 months of drug treatment. At that point, the alpha blocker prazosin and the diuretic hydrochlorothiazide were similar in their ability to lower the average diastolic blood pressure to normal levels. Serum total cholesterol and triglyceride levels declined in prazosin-treated patients but increased in hydrochlorothiazide-treated patients, a difference that was statistically significant. No significant weight change, a possible confounding variable, occurred in either group. More patients were unable to tolerate prazosin than were unable to tolerate hydrochlorothiazide (10 of 30 receiving prazosin, compared with three of 32 receiving hydrochlorothiazide). For those able to continue with prazosin, the favorable lipid response appears to be an asset in regard to reducing possible atherogenic effects of treatment.

Adrenergic alpha-Antagonists↗

PubMed2006

Albuterol nebulized in heliox in the initial ED treatment of pediatric asthma: a blinded, randomized controlled trial.

OBJECTIVE: A prospective blinded, randomized controlled trial was undertaken to compare the initial response of albuterol nebulized in heliox or control in the treatment of moderately severe asthma in children presenting to a pediatric ED. METHODS: Patients were randomized to receive heliox (n = 20) or control (n = 21). The primary outcome was to compare a modified dyspnea index score at 10 and 20 minutes after randomization. Secondary outcomes were to determine if heliox decreased admission rates or endotracheal intubation. RESULTS: There was no statistically significant difference found at 10 or 20 minutes after randomization with heliox (P = .169 and P = .062, respectively). No statistical difference in admission rate was found, and no patients required endotracheal intubation in either group. CONCLUSIONS: Our results demonstrate that albuterol nebulized with heliox offered no clinical benefit over standard therapy in the initial treatment of moderately severe asthma in the ED.

Administration, Inhalation↗

PubMed1996

Impact of permethrin impregnated bednets on child mortality in Kassena-Nankana district, Ghana: a randomized controlled trial.

A community-based randomized, controlled trial of permethrin impregnated bednets was carried out in a rural area of northern Ghana, between July 1993 and June 1995, to assess the impact on the mortality of young children in an area of intense transmission of malaria and no tradition of bednet use. The district around Navrongo was divided into 96 geographical areas and in 48 randomly selected areas households were provided with permethrin impregnated bednets which were re-impregnated every 6 months. A longitudinal demographic surveillance system was used to record births, deaths and migrations, to evaluate compliance and to measure child mortality. The use of permethrin impregnated bednets was associated with 17% reduction in all-cause mortality in children aged 6 months to 4 years (RR = 0.83; 95% CI 0.69-1.00; P = 0.05). The reduction in mortality was confined to children aged 2 years of younger, and was greater in July-December, during the wet season and immediately after (RR = 0.79; 95% CI 0.63-1.00), a period when malaria mortality is likely to be increased, than in the dry season (RR = 0.92, 95% CI 0.73-1.14). The ready acceptance of bednets, the high level of compliance in their use and the subsequent impact on all-cause mortality in this study has important implications for programmes to control malaria in sub-Saharan Africa.

Bedding and Linens↗

PubMedDate not supplied

The large loop excision of the transformation zone cut or blend thermal artefact study: a randomized controlled trial.

The objective of this randomized controlled trial was to determine whether the pure cut setting results in less thermal artefact than the traditional blend setting when performing a large loop excision of the transformation zone (LLETZ). Forty-nine consenting women were randomized to undergo an LLETZ procedure using either the pure cut or the blend setting. Two histopathologists, who were blind to the randomization, examined the specimens and then graded and measured the degree of thermal artefact. No significant difference was noted at the epithelial margin. At the deep stromal margins, in the blend group, the mean thickness of thermal artefact was 0.382 mm (95% CI, 0.350-0.414) and in the cut group 0.325 mm (95% CI, 0.297-0.353). This was statistically significant. No significant difference was detected in terms of grading of thermal artefact, the presence of dysplasia at the specimen margins, or in positive follow-up smears. Although there was less thermal artefact at the deep stromal margin, cautery at this margin does not generally interfere with pathological assessment of the specimen and the pure cut setting does not produce a clinically significant decrease in the degree of thermal artefact.

Adult↗

PubMed2005

Stress reduction and analgesia in patients exposed to calming music postoperatively: a randomized controlled trial.

BACKGROUND AND OBJECTIVES: This randomized controlled trial was designed to evaluate, first, whether intra- or postoperative music therapy could influence stress and immune response during and after general anaesthesia and second, if there was a different response between patients exposed to music intra- or postoperatively. METHOD: Seventy-five patients undergoing open hernia repair as day care surgery were randomly allocated to three groups: intraoperative music, postoperative music and silence (control group). Anaesthesia and postoperative analgesia were standardized and the same surgeon performed all the operations. Stress response was assessed during and after surgery by determining the plasma cortisol and blood glucose levels. Immune function was evaluated by studying immunoglobulin A (IgA) levels. Patients' postoperative pain, anxiety, blood pressure (BP), heart rate (HR) and oxygen saturation were also studied as stress markers. RESULTS: There was a significantly greater decrease in the level of cortisol in the postoperative music group vs. the control group (206 and 72 mmol L(-1) decreases, respectively) after 2 h in the post anaesthesia care unit. The postoperative music group had less anxiety and pain and required less morphine after 1 h compared with the control group. In the postoperative music group the total requirement of morphine was significantly lower than in the control group. The intraoperative music group reported less pain after 1 h in the post anaesthesia care unit. There was no difference in IgA, blood glucose, BP, HR and oxygen saturation between the groups. CONCLUSION: This study suggests that intraoperative music may decrease postoperative pain, and that postoperative music therapy may reduce anxiety, pain and morphine consumption.

Adult↗

PubMed1995

Comparison of dynamic hip screw and gamma nail: a prospective, randomized, controlled trial.

We report a prospective, randomized, controlled trial, comparing the results of treatment with a dynamic hip screw (DHS) and a gamma nail in 95 consecutive patients with peri-trochanteric fractures of the femur. The DHS was used in 48 patients, the gamma nail in 47. Clinical and radiological outcomes were similar, but the gamma nail was associated with a higher incidence of complications, in particular fracture of the femur below the implant in eight cases. This is consistent with previous reports, and we do not recommend the gamma nail for the treatment of peri-trochanteric femoral fractures.

Aged↗

PubMed1998

Comparison of AIK-C measles vaccine in infants at 6 months with Schwarz vaccine at 9 months: a randomized controlled trial in Ghana.

In a randomized controlled trial in a measles endemic area, standard-dose (4.0 log10pfu) AIK-C measles vaccine administered at 6 months of age was compared to standard-dose Schwarz vaccine (3.7log10pfu) given at 9 months. Seroconversion rates at 3 and 6 months after immunization in the two groups were comparable and similar. The geometric mean titres achieved were, however, significantly higher in the Schwarz group (P < 0.05). No immediate serious side-effects were observed with either vaccine. We conclude that standard-dose AIK-C measles vaccine can be recommended for measles immunization in children below 9 months of age, especially in highly endemic and high-risk areas in developing countries.

Age Factors↗

PubMed2001

A cost-minimization analysis of the societal costs of realtime teledermatology compared with conventional care: results from a randomized controlled trial in New Zealand.

A randomized controlled trial was carried out to measure the societal costs of realtime teledermatology compared with those of conventional hospital care in New Zealand. Two rural health centres were linked to a specialist hospital via ISDN at 128 kbit/s. Over 10 months, 203 patients were referred for a specialist dermatological consultation and 26 were followed up, giving a total of 229 consultations. Fifty-four per cent were randomized to the teledermatology consultation and 46% to the conventional hospital consultation. A cost-minimization analysis was used to calculate the total costs of both types of dermatological consultation. The total cost of the 123 teledermatology consultations was NZ$34,346 and the total cost of the 106 conventional hospital consultations was NZ$30,081. The average societal cost of the teledermatology consultation was therefore NZ$279.23 compared with NZ$283.79 for the conventional hospital consultation. The marginal cost of seeing an additional patient was NZ$135 via teledermatology and NZ$284 via conventional hospital appointment. From a societal viewpoint, and assuming an equal outcome, teledermatology was a more cost-efficient use of resources than conventional hospital care.

Cost Savings↗

PubMed1998

Kangaroo mother care for low birthweight infants: a randomized controlled trial in different settings.

A randomized controlled trial was carried out for 1 y in three tertiary and teaching hospitals, in Addis Ababa (Ethiopia), Yogyakarta (Indonesia) and Merida (Mexico), to study the effectiveness, feasibility, acceptability and cost of kangaroo mother care (KMC) when compared to conventional methods of care (CMC). About 29% of 649 low birthweight infants (LBWI; 1000-1999 g) died before eligibility. Of the survivors, 38% were excluded for various reasons, 149 were randomly assigned to KMC (almost exclusive skin-to-skin care after stabilization), and 136 to CMC (warm room or incubator care). There were three deaths in each group and no difference in the incidence of severe disease. Hypothermia was significantly less common in KMC infants in Merida (13.5 vs 31.5 episodes/100 infants/d) and overall (10.8 vs 14.6). Exclusive breastfeeding at discharge was more common in KMC infants in Merida (80% vs 16%) and overall (88% vs 70%). KMC infants had a higher mean daily weight gain (21.3 g vs 17.7 g) and were discharged earlier (13.4 vs 16.3 d after enrolment). KMC was considered feasible and presented advantages over CMC in terms of maintenance of equipment. Mothers expressed a clear preference for KMC and health workers found it safe and convenient. KMC was cheaper than CMC in terms of salaries (US$ 11,788 vs US$ 29,888) and other running costs (US$ 7501 vs US$ 9876). This study confirms that hospital KMC for stabilized LBWI 1000-1999 g is at least as effective and safe as CMC, and shows that it is feasible in different settings, acceptable to mothers of different cultures, and less expensive. Where exclusive breastfeeding is uncommon among LBWI, KMC may bring about an increase in its prevalence and duration, with consequent benefits for health and growth. For hospitals in low-income countries KMC may represent an appropriate use of scarce resources.

Breast Feeding↗

PubMed2006

Growth hormone treatment improves growth and clinical status in prepubertal children with cystic fibrosis: results of a multicenter randomized controlled trial.

CONTEXT: This multicenter, randomized, controlled, crossover trial of prepubertal children with cystic fibrosis (CF) tests the hypotheses that recombinant human GH (rhGH) treatment 1) improves height, weight, lean mass, and bone content irrespective of baseline measures; 2) improves clinical status and quality of life; and 3) has continued effect after cessation after 1 yr of treatment. METHODS: Sixty-one prepubertal subjects (<or=25th percentile for height and weight) were randomized into two groups: daily rhGH treatment or no treatment groups for 1 yr. In yr 2, treatments were crossed over. Outcome measures included serial standardized height and weight, number of hospitalizations and antibiotic courses, random blood glucose levels, lean mass, bone mineral content, pulmonary function, nutritional intake, and CF quality of life questionnaires. RESULTS: Groups were similar at baseline and prepubertal during the entire study. After 1 yr, GH showed significantly greater gain in height, weight, lean mass, and bone mineral content. Gain in height was similar regardless of baseline. There were fewer hospitalizations in the rhGH-treated group and improvement in CF quality of life questionnaires measures of weight and body image. There was no difference in pulmonary function between groups. Results were similar in those treated with rhGH the second year. After cessation of rhGH treatment, there was sustained effect for increased height and weight velocity, as well as accrual of bone mineral. CONCLUSION: rhGH therapy improves height and weight, decreases the number of hospitalizations, and improves quality of life in prepubertal children with CF. These effects are sustained after rhGH is discontinued.

Body Height↗

PubMed1998

The clinical utility of randomized controlled trials.

OBJECTIVE: Efficacy studies using randomized controlled trials (RCTs), on which empirically supported treatments are based, are often rejected as having little if any relevance to clinical practice. RCTs are faulted for allegedly excluding poor prognosis patients and therapists and treatments that are unrepresentative of clinical practice. METHODS: Evidence on the generalizability of findings from RCTs to diverse patient populations, different therapists, and varied clinical settings is critically evaluated. RESULTS: Existing research indicates that RCTs commonly include patients with multiple problems and levels of disturbance as severe as patients in clinical settings. DISCUSSION: The applicability of the findings of RCTs to clinical practice will be a changing function of the nature of the particular study and clinical setting to which the results are to be generalized. Future research should address the clinical utility of the findings of efficacy studies across different patient populations, therapists, and treatment methods.

Bulimia↗

PubMed2002

Effectiveness and cost-effectiveness analysis of neuroreflexotherapy for subacute and chronic low back pain in routine general practice: a cluster randomized, controlled trial.

STUDY DESIGN: A cluster randomized, controlled trial was performed. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of adding patients' referral to neuroreflexotherapy intervention to the usual management of subacute and chronic low back pain in routine general practice. SUMMARY OF BACKGROUND DATA: Neuroreflexotherapy consists of the temporary implantation of epidermal devices in trigger points in the back and referred tender points in the ear. The efficacy of this procedure for treating subacute and chronic low back pain has been demonstrated in previous randomized, double-blind, controlled clinical trials. METHODS: Twenty-one primary care physicians working in seven primary care centers of the Spanish National Health Service in Palma de Mallorca, Spain, were randomly assigned to the intervention group (n = 11) or the control group (n = 10). The physicians recruited patients who had low back pain that had lasted for 14 or more days despite drug treatment and who did not meet criteria for surgery. The 45 patients recruited by physicians from the control group were treated according to the standard protocol, whereas the 59 patients recruited by physicians from the intervention group were, in addition, referred to neuroreflexotherapy intervention. The analysis of variables was performed taking into account that physicians, not patients, were randomly assigned. RESULTS: Patients underwent clinical evaluations at baseline and 15, 60, and 365 days later. At baseline, median intensity of pain was higher in patients undergoing neuroreflexotherapy than in control patients (visual analogue scale, 6.07; range, 4.67-8.80 vs. 5.15, range 4.11-8.00) and median duration of pain was also higher (48.1, range 28.4-211.1 vs. 17.5, range 15.0-91.5 days). At the last follow-up visit, patients treated with neuroreflexotherapy showed greater improvement than did control patients in low back pain (visual analogue scale, 5.5; range, 3.7-8.8 vs. 1.9; range, -1.2-3.0; P < 0.001); referred pain (visual analogue scale, 3.6; range, 2.7-7.3 vs. 0.6; range, -1.5-2.0; P = 0.001); and disability (Roland-Morris scale, 8.7; range, 2.0-13.3 vs. 2.0; range, -1.5-6.7; P = 0.007). Moreover, neuroreflexotherapy intervention was associated with a significantly (P < 0.035) lower number of consultations to private or public specialists, fewer indications of radiographs by primary care physicians, lower cost of drug treatment, and less duration of sick leave throughout the follow-up period. There were also differences in favor of neuroreflexotherapy intervention in the cost-effectiveness ratio for pain, disability, and quality of life that persisted in the most optimistic, the most conservative, and the average (break-even case) assumptions. CONCLUSIONS: Referral to neuroreflexotherapy intervention improves the effectiveness and cost-effectiveness of the management of nonspecific low back pain.

Acute Disease↗