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PubMed1988

A prospective randomized controlled trial of perioperative antibiotic prophylaxis in renal transplantation.

We have carried out a prospective, randomized controlled trial of perioperative prophylaxis with cefuroxime and piperacillin in 53 recipients of renal allografts. Twenty-seven patients received antibiotic prophylaxis with three doses of cefuroxime 750 mg and piperacillin 4 g, and 26 patients received no prophylaxis. Risk factors for infection were well matched. Infection rates were analysed for the periods 0-5 days and 0-14 days post-transplant. In the first 5 days, patients receiving antibiotics had fewer infections (3 vs. 11, P = 0.04) but by 14 days this difference was no longer apparent (21 vs. 30, P = NS). There was a total of 15 wound infections, which were more common in the control group both at 5 days (1 vs. 5, P = NS) and at 14 days (4 vs. 11, P = 0.027). Urinary infections were unaffected by prophylaxis. We conclude that perioperative antibiotic prophylaxis results in a modest but worthwhile reduction in the incidence of wound infections after renal transplantation.

Adult↗
PubMed2003

Update on progress in the international, multicenter, randomized, controlled trial of corticosteroids after significant head injury (Medical Research Council CRASH Trial).

PURPOSE OF REVIEW: To provide an update on the progress of the multicenter, randomized, controlled trial of corticosteroids after significant head injury (CRASH). RECENT FINDINGS: After a successful pilot phase, the main phase of the CRASH Trial began in March 2001. By June 2002, 107 hospitals from 31 countries were participating in the trial, and together had recruited 3000 patients. Nine hundred patients (30%) had mild head injury, 885 (30%) had moderate head injury, and 1215 (40%) had severe head injury. A total of 1941 (65%) patients were randomized within 3 hours of injury. Outcome at 2 weeks from injury was known for 2933 (98%) patients, of whom 557 (19%) died. At the time of writing, 6-month follow-up for the first 1500 patients was nearly complete. Vital status was known for 1429 (95%) of the 1500 patients, of whom 313 (22%) had died. Functional status based on the Glasgow Outcome Scale was known for 1391 (93%) of the 1500 patients: 22% were dead, 16% were severely disabled, 23% were moderately disabled, and 39% had made a good recovery. SUMMARY: The CRASH Trial is a randomized, placebo-controlled, multicenter trial of a 48-hour corticosteroid infusion after significant head injury and is now the largest head injury trial ever conducted. The efforts of the national coordinators have shown that it is possible to enroll and follow up very large numbers of head-injured patients.

Adolescent↗
PubMed2006

A randomized controlled trial of outreach placement's effect on dental students' clinical confidence.

This randomized controlled trial compared the effects of outreach placement with traditional, exclusively dental school-based clinical experience on students' confidence in providing treatment for patients presenting with common dental problems. Senior dental students (n=49) were allocated at random to existing dental school-based clinics or placement in primary care clinics to work supervised by local dentists. At baseline, students self-rated their global confidence on a five-point scale. These measures were repeated at follow-up, augmented by a transition judgment and a then-test of confidence (asking students to look back and re-rate their pre-placement confidence). Groups were comparable at baseline. Follow-up scores for global confidence were similar between groups. The outreach group scored higher in the transition judgment (mean 3.7, SD 0.9) than the control group (mean 3.1, SD 1.1, P=0.05). In the then-test, on reflection, the outreach group considered their baseline ratings of confidence were overoptimistic (mean then-test scores 3.2, SD 0.9 and baseline 3.7, SD 0.5) while the control group thought theirs were accurate (mean then-test scores 3.8, SD 0.7 and baseline 3.6, SD 0.8, P=0.01). The findings suggest dental outreach training in primary care settings is more effective than dental school training alone in improving students' confidence in tackling clinical situations. The measurement of change in confidence is complicated by shifts in students' internal scales arising from insights gained on outreach.

Attitude of Health Personnel↗
PubMed2004

Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise.

STUDY DESIGN: A single blind randomized controlled trial comparing two models of care for patients with acute simple low back pain. OBJECTIVES: To compare two research-based models of care for acute low back pain and investigate the effect of the timing of physical intervention. SUMMARY OF BACKGROUND DATA: National guidelines offer conflicting information on the delivery of physical treatment in the management of acute low back pain. The guidelines suggest two different models of care. Direct comparisons between these models are lacking in the literature. The present study aims to compare these approaches to the management of acute low back pain. METHODS: Among 804 referred patients, 102 subjects met the specific admission criteria and were randomly assigned to an "assess/advise/treat" group or an "assess/advise/wait" group. The intervention consisted of biopsychosocial education, manual therapy, and exercise. Assessment of short-term outcome enables comparison to be made between intervention and advice to stay active. Assessment of long-term outcome enables comparison to be made between early and late intervention. Study outcomes of reported pain (Visual Analogue Scale), functional disability (the Roland and Morris Disability Questionnaire), mood (Modified Zung Self Rated Depression Score, Modified Somatic Perception Questionnaire, State-Trait Anxiety Inventory), general health (Euroqol), and quality of life (Short Form 36) were assessed at baseline, 6 weeks, 3 months, and 6 months. RESULTS: At 6 weeks, the assess/advise/treat group demonstrated greater improvements in disability, mood, general health, and quality of life than patients in the assess/advise/wait group (P < 0.05). Disability and pain were not significantly different between the groups at long-term follow up (P > 0.05). However, mood, general health, and quality of life remained significantly better in the assess/advise/treat group (P < 0.05). CONCLUSIONS: At short-term, intervention is more effective than advice on staying active, leading to more rapid improvement in function, mood, quality of life, and general health. The timing of intervention affects the development of psychosocial features. If treatment is provided later, the same psychosocial benefits are not achieved. Therefore, an assess/advise/treat model of care seems to offer better outcomes than an assess/advise/wait model of care.

Adult↗
PubMed1997

Treatment of chronic hepatitis C with consensus interferon: a multicenter, randomized, controlled trial. Consensus Interferon Study Group.

This multicenter, randomized, controlled, double-blind, phase III study in 704 patients with chronic hepatitis C infection compared treatment with consensus interferon (CIFN), a non-natural recombinant type-1 interferon, with a standard regimen of recombinant interferon alfa-2b (IFN-alpha2b). Patients were randomized to receive CIFN at doses of 3 microg or 9 microg, or 15 microg IFN-alpha2b (3 million units), subcutaneously three times weekly for 24 weeks, followed by 24 weeks of observation. Efficacy was assessed by normalization of serum alanine transaminase (ALT) concentration and decrease in serum hepatitis C virus (HCV) RNA concentration below the limit of detection by reverse-transcription polymerase chain reaction (RT-PCR) (100 copies/mL). The beneficial effect of CIFN was greater with the 9-microg dose than the 3-microg dose. The sustained ALT and HCV RNA response rates were 20.3% and 12.1%, respectively, in the 9-microg CIFN cohort and 19.6% and 11.3%, respectively, in the 15-microg IFN-alpha2b cohort. However, patients receiving 9 microg of CIFN had a greater reduction in serum HCV RNA concentrations compared with patients receiving 15 microg IFN-alpha2b over the course of treatment (P < .01). Similarly, analysis of patients infected with HCV genotype 1 showed a greater reduction in serum HCV RNA concentration over the course of treatment for the 9-microg CIFN group when compared with the 15-microg IFN-alpha2b group (P < .01). In addition, a greater percentage of patients infected with HCV genotype 1 treated with 9 microg CIFN had undetectable HCV RNA concentrations when compared with patients in the 15-microg IFN-alpha2b cohort at the end of treatment (24% vs. 15%; P = .04). Improvements in liver histology were noted in all three treatment groups; 52% to 55% of the patients in the three cohorts had at least a 2-unit improvement in the Knodell score at the end of the posttreatment period. The adverse-events profiles were characteristic of treatment with type-1 interferon, and the incidences of anti-interferon antibody formation did not significantly differ among the three treatment groups. These results show that administration of 9 microg CIFN three times weekly for 6 months is safe and is effective in reducing serum HCV RNA concentration.

Adult↗
PubMedDate not supplied

Branched-chain amino acids metabolic support in surgical patients: a randomized, controlled trial in patients with subtotal or total gastrectomy in 16 Japanese institutions.

A prospective, randomized, controlled trial of nutritional effects of branched-chain-enriched amino acid (BCAA) solution was undertaken in 173 surgical patients with gastric cancer. Eighty-six and 87 patients underwent subtotal and total gastrectomy, respectively. The effects were evaluated in total parenteral nutrition (TPN) in an isocaloric/isonitrogenous setting where the major difference between the group was the amount of BCAA received. Each 80 patients in the control and the BCAA groups completed the trial. The group receiving BCAA-enriched amino acid solution demonstrated a statistically significant improvement on days 2 and 3 in nitrogen balance in patients with total gastrectomy. Three-methyl-histidine excretion gradually decreased after day 1, and the values on day 7 were significantly lower than those on day 1 in the BCAA group in both those receiving subtotal and total gastrectomy. There were no significant differences of serum albumin and rapid turnover proteins between the control and BCAA groups in both those receiving subtotal and total gastrectomy. Plasma BCAA level and BCAA to aromatic amino acid (AAA) ratio were significantly higher, and AAA level was significantly lower in the BCAA group than in the control group. There were no serious complications encountered during the observation period in both groups. These results indicated that a BCAA-enriched amino acid solution can improve metabolism and maintains good nitrogen retention without increasing side effects as compared with a conventional amino acid solution for nutritional support of patients who have received subtotal or total gastrectomy.

Adolescent↗
PubMedDate not supplied

Effectiveness of extracorporeal shock wave therapy in the treatment of previously untreated lateral epicondylitis: a randomized controlled trial.

BACKGROUND: Extracorporeal shock wave therapy is a relatively new therapy used in the treatment of chronic tendon-related pain. Few randomized controlled trials have been performed on it, and no studies have examined the effectiveness of extracorporeal shock wave therapy as a frontline therapy for tendon-related pain. HYPOTHESIS: Subjects treated with active extracorporeal shock wave therapy will have higher rates of treatment success than subjects treated with sham extracorporeal shock wave therapy. DESIGN: Double-blind randomized controlled trial. METHODS: Sixty subjects who had previously untreated lateral epicondylitis for less than 1 year and more than 3 weeks were included in this study. Subjects were randomly allocated to receive 1 session per week for 3 weeks of either sham or active extra-corporeal shock wave therapy. Subjects in the active therapy group received 2000 pulses (energy flux density, 0.03-0.17 mJ/mm(2)). All subjects were provided with a forearm-stretching program. After 8 weeks of therapy, subjects were classified as either treatment successes or treatment failures according to fulfillment of all 3 criteria: (1) at least a 50% reduction in the overall pain visual analog scale score, (2) a maximum allowable overall pain visual analog scale score of 4.0 cm, and (3) no use of pain medication for elbow pain for 2 weeks before the 8 week follow-up. Visual analog scale scores were also collected for pain at rest, during sleep, during activity, at its worst, and at its least, as well as for quality of life (using the EuroQoL questionnaire) and grip strength. RESULTS: Success rates in the sham and active therapy groups were 31% and 39%, respectively. No significant difference was detected between groups (chi(2)(1)= 0.3880, P = .533). Mean change in quality of life over 8 weeks was an increase of 1.3 and 3.3 for sham and active therapy groups, respectively, and mean change in grip strength over 8 weeks was an increase of 7.4 kg and 6.8 kg for sham and active therapy groups, respectively. CONCLUSIONS: Despite improvement in pain scores and pain-free maximum grip strength within groups, there does not appear to be a meaningful difference between treating lateral epicondylitis with extracorporeal shock wave therapy combined with forearm-stretching program and treating with forearm-stretching program alone, with respect to resolving pain within an 8-week period of commencing treatment.

Adult↗
PubMed1992

Histologic changes in liver biopsy specimens produced by recombinant interferon alpha-2b therapy for chronic non-A,non-B viral hepatitis. A randomized controlled trial.

The effects of interferon therapy on liver histologic findings were assessed in a randomized controlled trial consisting of 80 patients with chronic non-A,non-B hepatitis. Twenty-eight patients received 1 million units of recombinant interferon alpha-2b; 25 patients received 3 million units, subcutaneously, three times a week for 24 weeks; and 21 patients were observed as untreated controls; all of them underwent liver biopsy within 6 months from the beginning of the study and on the last day of therapy. Six patients were withdrawn from the study because of inadequate liver biopsy specimens. Alanine aminotransferase levels were determined before, during, and after therapy. For each biopsy, a semiquantitative score of histologic features, the histologic activity index, and the overall histologic assessment were performed. Ninety-five percent of patients tested positive for hepatitis C virus antibody. Portal inflammation, piecemeal and spotty necrosis, and bile duct proliferation were significantly decreased in patients with normalized alanine aminotransferase. The effectiveness of therapy was dose dependent: piecemeal and spotty necrosis and the histologic activity index showed a significant decrease only in 3-million-unit-treated patients. Hepatocellular degeneration and fibrosis did not change significantly after treatment.

Alanine Transaminase↗
PubMed1998

Lactated Ringer's solution versus hydroxyethyl starch for volume replacement in autologous blood donors with cardiovascular disease: a controlled, randomized trial.

BACKGROUND AND OBJECTIVES: The study was designed to evaluate whether volume replacement following blood donation can prevent arterial hypotension in autologous blood donors with cardiovascular disease. MATERIALS AND METHODS: One hundred nineteen autologous blood donors with known cardiovascular disease were randomly allocated to receive, following withdrawal of 500 ml of blood, either no infusion (control group) or a 25 ml/min intravenous infusion of either 1,500 ml of lactated Ringer's solution (LRS) or 500 ml of 6% hydroxyethyl starch (HES). Starting before phlebotomy, arterial blood pressure was measured oscillometrically every 5 min until 90 min after donation. RESULTS: Group means showed little difference between the groups in blood pressure throughout the monitoring period. The proportion of patients who at least once had a > or = 20% decrease from baseline in systolic blood pressure was 3-5 times greater in the control group than in the LRS and the HES group (50 vs. 10 and 15%, respectively; p < 0.001 on chi 2 analysis for a 2 x 3 table). Systolic hypertensive episodes (> or = 20% increase over baseline) were observed more frequently in the LRS group than in the control and the HES group (41 vs. 10 and 18%, respectively; p = 0.003). CONCLUSION: Both LRS and HES, administered at a volume ratio to blood loss of 3:1 and 1:1, respectively, significantly reduced the incidence of systolic hypotensive episodes in autologous blood donors with cardiovascular disease. LRS at a 3:1 volume ratio to blood loss was associated with a high rate of systolic hypertension.

Adult↗
PubMed1994

Randomized controlled trials in surgery.

BACKGROUND: The objective was to determine the number of randomized controlled trials (RCT) performed by surgeons, published in surgical journals, or comprising a surgical arm and to assess their characteristics and overall quality. METHODS: RCT in general surgery (including gastrointestinal, breast, surgical oncology, vascular, critical care, and trauma) published in 1990 were retrieved by MEDLINE and analyzed to determine the funding agency, type of therapy, area of surgery, journal published, country of origin, number of centers, and whether a surgeon was the principal author. The completeness of the MEDLINE search was compared to a manual search of the literature. All RCT were assessed with Chalmers' qualitative score. RESULTS: MEDLINE retrieved 202 surgical RCT (46% of those retrieved by a manual search) with a mean score of 0.40 +/- 0.13. However, surgical RCT were performed by surgeons in only one third of trials, compared surgical therapies in only one quarter of trials, and were published in surgical journals in less than one third of trials. Only 22% of surgical RCT were funded by peer reviewed granting agencies. The strongest variables determining the quality of surgical RCT were the type of therapy tested (p = 0.0001), the type of journal published (p = 0.006), and the area of general surgery (p = 0.007). CONCLUSIONS: Although surgical RCT are being performed, there are a relatively low proportion and standard of RCT performed by surgeons as the principal author, published in surgical journals, and comparing surgical therapies. This may reflect a lack of expertise by surgeons in clinical trials, lack of funding for surgical trials, methodologic problems peculiar to surgical trials, or a need for adoption of other research designs to assess surgical therapies.

Authorship↗
PubMed1989

Measurement of outcomes within a multicentred randomized controlled trial in the evaluation of the experimental NHS nursing homes.

This paper reports outcome data from a multicentred randomized controlled trial (RCT) undertaken as part of the evaluation of the experimental NHS nursing homes. A small sample size within centres and differential non-response due to death and physical or mental frailty limits the statistical power of this trial and biases subject-reported outcomes toward the views of elderly people who were less frail. There were no significant differences in survival or personal well-being, or changes in behavioural ability, mental state or perceived health status between propositi and controls. There were significant differences in the views of responding propositi and controls suggesting that the experimental NHS nursing homes were preferred by residents. The results of this pragmatic trial suggest that there is no evidence to conclude that NHS nursing homes should not be provided as NHS continuing-care accommodation. Policy decisions should also take account of the other studies undertaken as part of the evaluation. Further research is needed to develop more appropriate outcome measures for this client group.

Aged↗
PubMed2001

The methodological quality of randomized controlled trials of homeopathy, herbal medicines and acupuncture.

BACKGROUND: To investigate the methodological quality of randomized controlled trials in three areas of complementary medicine. METHODS: The methodological quality of 207 randomized trials collected for five previously published systematic reviews on homeopathy, herbal medicine (Hypericum for depression, Echinacea for common cold), and acupuncture (for asthma and chronic headache) was assessed using a validated scale (the Jadad scale) and single quality items. RESULTS: While the methodological quality of the trials was highly variable, the majority had important shortcomings in reporting and/or methodology. Major problems in most trials were the description of allocation concealment and the reporting of drop-outs and withdrawals. There were relevant differences in single quality components between the different complementary therapies: For example, acupuncture trials reported adequate allocation concealment less often (6% versus 32% of homeopathy and 26% of herb trials), and trials on herbal extracts had better summary scores (mean score 3.12 versus 2.33 for homeopathy and 2.19 for acupuncture trials). Larger trials published more recently in journals listed in Medline and in English language scored significantly higher than trials not meeting these criteria. CONCLUSION: Trials of complementary therapies often have relevant methodological weaknesses. The type of weaknesses varies considerably across interventions.

Acupuncture Therapy↗
PubMed1998

Excessive drinking--brief intervention by a primary health care nurse. A randomized controlled trial.

OBJECTIVE: To evaluate the effect of a nurse-conducted intervention on excessive drinkers. DESIGN: Randomized, controlled trial. SETTING: Vårby Health Centre, Stockholm. INTERVENTION: The intervention group visited a nurse three times during a 12-month period. The controls met once with a general practitioner (GP). PATIENTS: Patients were recruited at a health screening on the basis of a raised gamma-glutamyl transferase (GGT). Of 2338 subjects, aged 25-54 years, 222 had a screening GGT of > or = 0.9 mukat/l. 100 were randomized to the treatment and 122 to the control group. MAIN OUTCOME MEASURES: GGT, self-reported alcohol consumption (g/week), sickness allowance and use of health care. RESULTS: After 2 years a reduction of GGT from 1.52 to 1.21 mukat/l (p = 0.02) had occurred in the treatment group. The controls increased their mean level of GGT from 1.75 to 2.16 mukat/l. Mean weekly alcohol consumption in the intervention group was reduced from 337 to 228 g/week (p = 0.02). The controls did not quantify their alcohol consumption initially, but reported a reduced weekly consumption at follow-up. CONCLUSION: The intervention had an impact on GGT and self-reported consumption. The controls also reported decreased consumption possibly because their appointment with the GP functioned as a very brief intervention.

Adult↗
PubMed1995

Biofeedback therapy in poststroke rehabilitation: a meta-analysis of the randomized controlled trials.

OBJECTIVE: To assess the efficacy of biofeedback therapy in poststroke rehabilitation. DESIGN: A meta-analysis of the reported randomized control trials of biofeedback therapy in poststroke rehabilitation was performed. Data were analyzed using the effect size method and pooled using the Der Simonian-Laird Random Effects Model. Study quality was assessed according to the method of Chalmers. SETTING: All included studies were conducted in academically based rehabilitation settings. PATIENTS: Patients were in the rehabilitative phase of their illness. The timing of the intervention from the acute event did vary greatly between and within studies. INTERVENTION: Biofeedback therapy was applied to a paretic limb of patients in the study group. Both treatment and control groups received standard physical therapy. MAIN OUTCOME MEASURE: Change in range of motion of a joint of a paretic limb as a result of treatment was examined. This measure was chosen after the eligible studies were evaluated for combinable end points. RESULTS: A total of eight studies were included in the analysis. The mean effect size for change in lower extremity range of motion as a result of biofeedback therapy was 1.50 (95% confidence interval [CI]: -0.59, 3.59). For the upper extremity the effect size was 2.30 (95% CI: -1.06, 5.66). Both results were not significant at the p < .05 level. Statistical tests showed significant heterogeneity among studies, validating the use of the Random Effects Model. CONCLUSION: Results of pooling available randomized control trials do not support the efficacy of biofeedback in restoring the range of motion of hemiparetic joints. Nevertheless, because the calculated mean effect sizes were large, with associated wide confidence intervals, the possibility of a type II error masking an important clinical benefit needs to be considered in evaluating this result.

Arm↗
PubMed2002

[Analysis of randomized controlled trials on otorhinolaryngological diseases in China].

OBJECTIVE: To evaluate the quality of randomized controlled trials (RCT) in otorhinolaryngology in China and offer evidence for the improvement of RCT. METHODS: Five kinds of Chinese journals of clinical otorhinolaryngology were searched, and RCTs were identified and analyzed according to the standards of Evidence Based Medicine. RESULTS: Two hundred and eighty seven issues were referred to, and eighty-one RCTs were finally identified and analyzed. Of these RCTs, 34.57% (28/81) had definite diagnostic standards, 38.27% (31/81) had including standards and 33.33% (27/81) had excluding standards; only 1.23% (1/81) got the approval of the participants; 40.74% (33/81) had moderate sample size, 3.70% (3/81) had large sample size and non of them mentioned sample size estimation; 81.48% (66/81) didn't report the method of randomization and 38.27% (31/81) had baseline comparison; 18.52% (15/81) didn't define the control interventions and 8.64% (7/81) even didn't explicate the experimental intervention; 32.10% (26/81) used blank comparison; 86.42% (70/81) didn't use blindness; 37.04% (30/81) didn't mention the adverse effects; 23.46% (19/81) used accredited standards to evaluate the outcomes; 11.11% (9/81) mentioned the loss of following-up and only 1.23% (1/81) treated the loss with statistics methods. CONCLUSION: The quantity and quality of otorhinolaryngological RCTs couldn't meet the clinical need. More high quality RCTs are required to improve the level of prevention and cure of otorhinolaryngologic diseases.

China↗
PubMed2006

Effects of low-carbohydrate vs low-fat diets on weight loss and cardiovascular risk factors: a meta-analysis of randomized controlled trials.

BACKGROUND: Low-carbohydrate diets have become increasingly popular for weight loss. However, evidence from individual trials about benefits and risks of these diets to achieve weight loss and modify cardiovascular risk factors is preliminary. METHODS: We used the Cochrane Collaboration search strategy to identify trials comparing the effects of low-carbohydrate diets without restriction of energy intake vs low-fat diets in individuals with a body mass index (calculated as weight in kilograms divided by the square of height in meters) of at least 25. Included trials had to report changes in body weight in intention-to-treat analysis and to have a follow-up of at least 6 months. Two reviewers independently assessed trial eligibility and quality of randomized controlled trials. RESULTS: Five trials including a total of 447 individuals fulfilled our inclusion criteria. After 6 months, individuals assigned to low-carbohydrate diets had lost more weight than individuals randomized to low-fat diets (weighted mean difference, -3.3 kg; 95% confidence interval [CI], -5.3 to -1.4 kg). This difference was no longer obvious after 12 months (weighted mean difference, -1.0 kg; 95% CI, -3.5 to 1.5 kg). There were no differences in blood pressure. Triglyceride and high-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-carbohydrate diets (after 6 months, for triglycerides, weighted mean difference, -22.1 mg/dL [-0.25 mmol/L]; 95% CI, -38.1 to -5.3 mg/dL [-0.43 to -0.06 mmol/L]; and for high-density lipoprotein cholesterol, weighted mean difference, 4.6 mg/dL [0.12 mmol/L]; 95% CI, 1.5-8.1 mg/dL [0.04-0.21 mmol/L]), but total cholesterol and low-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-fat diets (weighted mean difference in low-density lipoprotein cholesterol after 6 months, 5.4 mg/dL [0.14 mmol/L]; 95% CI, 1.2-10.1 mg/dL [0.03-0.26 mmol/L]). CONCLUSIONS: Low-carbohydrate, non-energy-restricted diets appear to be at least as effective as low-fat, energy-restricted diets in inducing weight loss for up to 1 year. However, potential favorable changes in triglyceride and high-density lipoprotein cholesterol values should be weighed against potential unfavorable changes in low-density lipoprotein cholesterol values when low-carbohydrate diets to induce weight loss are considered.

Blood Glucose↗
PubMed2006

Two-center prospective randomized controlled trial of Blake versus Portex drains after cardiac surgery.

OBJECTIVE: To compare the efficacy of two drain types after cardiac surgery in a randomized controlled trial, with primary outcome measure being depth of pericardial effusion 3 to 5 days after drain removal. METHODS: A prospective randomized controlled trial was conducted at two university hospitals. A total of 199 patients undergoing first-time cardiac procedures were randomized at surgery to receive either small-bore flexible Blake drains (19F) or larger Portex drains (28F). Drains were removed according to the study protocol and patients underwent echocardiography 3 to 5 days after drain removal to measure residual pericardial effusion. RESULTS: Ninety patients received Blake drains and 109 patients received Portex drains. There were no statistically significant differences in preoperative variables between the groups. There was no difference in the number of drains inserted per patient between groups (Blake 2.1 +/- 0.4 vs Portex 2.0 +/- 0.5). Mean difference in size of pericardial effusion between groups was 1.96 mm (95% confidence interval -0.02, 3.95 mm), which did not exceed the predefined non-inferiority margin of 10 mm. There was no significant difference in the mean maximal hourly drainage rate between groups (Blake 94.7 mL vs Portex 123.1 mL; P = .070) or in the total drainage rates (Blake 541 mL vs Portex 679 mL; P = .066). Although the Blake group had a higher percentage of patients with detectable effusion (46.3% vs 27.4%; P = .011) than the Portex group, there was no difference in need for late drainage of pericardial effusions (1.1% vs 1.9%) or insertion of further chest drains (8.8% vs 7.2%). CONCLUSION: The performance of small-bore Blake drains is not inferior to that of standard Portex drains after cardiac surgery.

Aged↗