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At least 73 records · Page 4Linked to original sources
PubMed2007

The use of homeopathic combination remedy for dengue fever symptoms: a pilot RCT in Honduras.

A double-blind, placebo-controlled randomized trial of a homeopathic combination medication for dengue fever was carried out in municipal health clinics in Honduras. Sixty patients who met the case definition of dengue (fever plus two ancillary symptoms) were randomized to receive the homeopathic medication or placebo for 1 week, along with standard conventional analgesic treatment for dengue. The results showed no difference in outcomes between the two groups, including the number of days of fever and pain as well as analgesic use and complication rates. Only three subjects had laboratory confirmed dengue. An interesting sinusoidal curve in reported pain scores was seen in the verum group that might suggest a homeopathic aggravation or a proving. The small sample size makes conclusions difficult, but the results of this study do not suggest that this combination homeopathic remedy is effective for the symptoms that are characteristic of dengue fever.

Adolescent↗
PubMed2026

Comparison of short-term clinical outcomes and patient satisfaction between intraoral scanning and conventional impressions for complete-arch implant prostheses: a pilot RCT.

OBJECTIVE: To compare framework passive fit, subjective evaluations, and short-term clinical outcomes between conventional impressions (CI) and intraoral scanning (IOS) for complete-arch implant-supported fixed dental prostheses (CIFDPs). METHODS: In this randomized controlled trial, 22 patients were allocated to the CI or IOS groups. All participants received a definitive one-piece CIFDP. The primary outcome was framework passive fit, assessed using the Vision and Tactile Score (V&T score), which included framework lift-off, the single-screw test, the full-screw test, smoothness of screw insertion, and radiographic gap assessment. Secondary outcomes included operator evaluation, patient satisfaction using a visual analog scale (VAS), early implant survival, marginal bone loss (MBL), modified Plaque Index (mPII), and complications at the 6-month follow-up. RESULTS: Twenty-two patients were enrolled (CI: n = 11; IOS: n = 11), and one patient in the CI group was lost to follow-up. No statistically significant difference in the V&T score was observed between the CI and IOS groups (4.66 &#xb1; 0.17 vs. 4.65 &#xb1; 0.28; P = 0.93). The operator reported greater nervousness during the CI procedure than during IOS (21.82 &#xb1; 15.69 vs. 8.64 &#xb1; 7.47; P < 0.05). Patients in the CI group reported significantly greater discomfort, including nausea and anxiety, than those in the IOS group (P < 0.05). At the 6-month follow-up, the early implant survival rate was 100% in both groups. No significant differences were found between the groups in MBL (0.09 &#xb1; 0.09 vs. 0.06 &#xb1; 0.10 mm; P = 0.43) or mPII (0.10 &#xb1; 0.12 vs. 0.10 &#xb1; 0.28; P = 0.99). CONCLUSION: IOS and CI achieved comparable short-term clinical outcomes in patients who met the predefined inclusion criteria, including controlled implant number, spacing, and angulation. IOS provided a more favorable experience for both operators and patients. CLINICAL SIGNIFICANCE: In complete-arch implant restorations, intraoral scanning may provide clinical outcomes comparable to those of conventional impressions while improving patient comfort.

Humans↗
PubMed2007

Does the presence of sensory hypersensitivity influence outcomes of physical rehabilitation for chronic whiplash?--A preliminary RCT.

Patients with chronic whiplash associated disorders present with varied sensory, motor and psychological features. In this first instance it was questioned whether a multimodal program of physical therapies was an appropriate management to be broadly prescribed for these patients when it was known that some would have sensory features suggestive of a notable pain syndrome. A randomised controlled trial was conducted with 71 participants with persistent neck pain following a motor vehicle crash to explore this question. Participants were randomly allocated to receive either a multimodal physiotherapy program (MPT) or a self-management program (SMP) (advice and exercise). In the randomisation process, participants were stratified according to the presence or not of widespread mechanical or cold hyperalgesia. The intervention period was 10 weeks and outcomes were assessed immediately following treatment. Even with the presence of sensory hypersensitivity in 72.5% of subjects, both groups reported some relief of neck pain and disability (Neck Disability Index) and it was superior in the group receiving multimodal physiotherapy (p=0.04). Post-hoc observations however suggested that relief was marginal in the subgroup with both widespread mechanical and cold hyperalgesia. Further research is required to test the validity of this sub-group observation and to test the effect of the intervention in the long term.

Adolescent↗
PubMed2004

Hyperfractionated accelerated radiochemotherapy (HFA-RCT) with mitomycin C for advanced head and neck cancer.

To investigate efficacy and feasibility of hyperfractionated accelerated radiotherapy combined with mitomycin C, patients with locally advanced unresectable squamous cell carcinomas of the head and neck region were administered 64-66 Gy in four weeks and mitomycin C (20 mg/m(2)) on day five. Twenty-one consecutive patients were included between November 1997 and June 1999 (median age: 57 years). All tumours were stage T3-4 and 18/21 were N2-3. Eighteen patients experienced grade 3 and three patients grade 2 mucosal toxicity. With median follow up for surviving patients of 42 months, loco-regional control was 55% at three years, overall survival was 33% at three years. This treatment is at the edge of local tolerability, but there is a good curative chance even for very advanced localised tumours, provided a complete remission is induced at primary treatment.

Adult↗
PubMed2004

RCT of a theory-based intervention promoting healthy eating and physical activity amongst out-patients older than 65 years.

A randomised controlled trial was used to evaluate a theory-based health promotion intervention. The intervention, a healthy living booklet, was designed to promote healthy eating and physical activity amongst people aged over 65 years attending hospital out-patient clinics. The booklet employed persuasive arguments targeting the most proximal cognitive antecedents of behaviour specified by the theory of planned behaviour, as well as goal setting prompts. Participants (N = 252, average age=82) were randomly allocated to a control (patient satisfaction questionnaire) or intervention (healthy living booklet) group. Cognitions and behaviour were measured pre-intervention and at a two week follow up. The intervention group made significantly higher gains in perceived behavioural control, intention and behaviour for both target behaviours, suggesting that the intervention was successful. Sixty three of those invited to set goals to eat more healthily (e.g., "to eat five portions of fruit and vegetables a day") did so, and 67% of those who set such goals reported 100% success in acting on them. By contrast, only 34% of intervention participants set an activity goal (e.g., "a five minute walk everyday"), and only 51% reported 100% success in enacting these goals. Results suggest that the observed behavioural effects of the healthy eating booklet could be attributed to goal setting as well as changes in perceived behavioural control and intention.

Aged↗
PubMed1999

A meta-analysis of randomised controlled trials (RCT) among healthy normotensive and essential hypertensive elderly patients to determine the effect of high salt (NaCl) diet of blood pressure.

To examine the effect of chronic NaCl ingestion on blood pressure (BP) in the elderly, a meta-analysis was undertaken of 11 randomised controlled trials of which five included patients > or =60 years of age only and six included patients with a mean age close to 60 years. The following databases were used: Medline, Embase, Current Contents, The Cochrane Library, the AMI and IPA databases. Mean erect systolic and diastolic blood pressures (SBP/DBP) on chronic (> or =9 weeks) high and low NaCl diets were recorded, the pooled mean effect, the pooled standard error and 95% confidence intervals (Cl) were calculated and linear regression was used to evaluate the potential association between NaCl intake and BP. When all trials were pooled, a chronic high NaCl diet significantly increased mean SBP and DBP by 5.58 mm Hg (95%Cl 4.31-6.85) and 3.5 mm Hg (95%Cl 2.62-4.38) respectively. There was a significant association between the level of NaCl intake and SBP (P = 0.05, r2 = 0.37) but not DBP (P = 0.76, r2 = 0.01). When trials were pooled separately, a chronic high NaCl diet increased SBP by 5.46 mm Hg (95%Cl 3.56-7.36) and DBP by 2.63 mm Hg (95%Cl 1.18-4.08) in trials including patients > or =60 years of age only, and increased SBP by 3.27 mm Hg (95%Cl 1.23-5.31) and DBP by 2.69 mm Hg (95%Cl 1.44-3.94) in trials including patients with a mean age close to 60 years. These data suggest that a chronic high NaCl diet in elderly patients with essential hypertension is associated with an increase in SBP and DBP, the association is significant for both SBP and DBP but more marked for SBP than DBP, the effect is more pronounced the older the patient and NaCl dose strongly predicts SBP in older patients.

Aged↗
PubMed1997

To randomise or not to randomise: methodological pitfalls of the RCT design in psychosocial intervention studies.

We are seeing evidence of more studies investigating the effectiveness of psychosocial interventions of cancer patients, predominantly within groups. As roles within cancer and palliative care diversify, specially trained nurses and other health care workers are taking a more active role within psychosocial intervention studies. Frequently, these studies are randomised controlled trials (RCTs). Often, the results of these psychosocial RCTs have been laid open to general criticisms of design, implementation and reporting. The following paper focuses specifically on the general and experimenter problems in conducting RCTs within psychosocial interventions. It highlights the limitations and inherent problems seen with RCTs of psychosocial interventions so that health care workers are aware of these before considering undertaking psychosocial RCTs with cancer patients.

Bias↗
PubMed1999

Operational and resource management of an RCT: some of the pitfalls and lessons learned.

Nurses frequently fulfil important functions within a research team involved in clinical trials. This paper describes the challenges inherent in developing and managing a large clinical trial involving the evaluation of homoeopathy and asthma. Teamwork, a clear and comprehensive understanding of the research protocol, marketing the project, and the ability to manage human resources within both a primary and secondary care environment are all essential aspects of clinical research. Our experience in establishing and managing this project has suggested to us that a high standard of clinical research demands an open approach to problem-solving as well as the realization that efficient research is as much about the management of people as it is about scientific rigour.

Adolescent↗
PubMed2003

Propranolol plus placebo versus propranolol plus isosorbide-5-mononitrate in the prevention of a first variceal bleed: a double-blind RCT.

Nonselective beta-blockers are very effective in preventing first variceal bleeding in patients with cirrhosis. Treatment with isosorbide-5-mononitrate (IS-MN) plus propranolol achieves a greater reduction in portal pressure than propranolol alone. The present multicenter, prospective, double-blind, randomized, controlled trial evaluated whether combined drug therapy could be more effective than propranolol alone in preventing variceal bleeding. A total of 349 consecutive cirrhotic patients with gastroesophageal varices were randomized to receive propranolol + placebo (n = 174) or propranolol + IS-MN (n = 175). There were no significant differences in the 1- and 2-year actuarial probability of variceal bleeding between the 2 groups (propranolol + placebo, 8.3% and 10.6%; propranolol + IS-MN, 5% and 12.5%). The only independent predictor of variceal bleeding was a variceal size greater than 5 mm. However, among patients with varices greater than 5 mm (n = 196), there were no significant differences in the incidence of variceal bleeding between the 2 groups. Survival was also similar. Adverse effects were significantly more frequent in the propranolol + IS-MN group due to a greater incidence of headache. There were no significant differences in the incidence of new-onset or worsening ascites or in impairment of renal function. In conclusion, propranolol effectively prevents variceal bleeding. Adding IS-MN does not further decrease the low residual risk of bleeding in patients receiving propranolol. However, the long-term use of this combination drug therapy is safe and may be an alternative in clinical conditions associated with a greater risk of bleeding.

Adrenergic beta-Antagonists↗
PubMed2004

The value of melatonin for sleep disorders occurring post-head injury: a pilot RCT.

PRIMARY OBJECTIVE: Whilst there is data to support the use of Melatonin in treating disorders of the sleep-wake cycle, so far there is little published evidence on the efficacy of Melatonin in treating the prevalent condition of post-TBI sleep disturbance. RESEARCH DESIGN: The present work used a randomized double-blind controlled cross-over trial to compare Melatonin (5 mg) and Amitriptyline (25 mg) in a small sample of TBI patients presenting with chronic sleep disturbance. MAIN OUTCOME AND RESULTS: No differences in sleep latency, duration, quality or daytime alertness were found for either drug compared to baseline using significance testing. However, effect sizes revealed some encouraging changes. Patients on Melatonin reported improved daytime alertness compared to baseline. On Amitriptyline, patients reported increased sleep duration compared to baseline. CONCLUSIONS: The study provides preliminary evidence for the value of Melatonin and Amitriptyline in treating sleep disorder post-TBI. There were no adverse drug effects. Suggestions are made for ongoing investigation for the treatment of this prevalent condition.

Adolescent↗
PubMed2026

F-URS with FANS versus mPCNL for 2-3&#x2009;cm UUTS: a RCT with a subgroup analysis of 2-2.5&#x2009;cm stones.

OBJECTIVE: To evaluate the safety and efficacy of flexible ureteroscopy (f-URS) with a flexible and navigable suction ureteral access sheath (FANS) compared with mini-percutaneous nephrolithotomy (mPCNL) in the treatment of 2-3&#x2009;cm upper urinary tract stones (UUTS), with a prespecified subgroup analysis for stones &#x2265;2 to <2.5&#x2009;cm. METHODS: This randomized controlled trial enrolled 326 patients with 2-3&#x2009;cm UUTS between June 2023 and December 2025. Patients were randomly assigned in a 1:1 ratio to undergo either f-URS with FANS or mPCNL. A prespecified subgroup analysis was conducted for stones measuring &#x2265;2 to <2.5&#x2009;cm. The primary outcomes were the immediate and 1-month stone-free rate (SFR). Secondary outcomes included the operative duration, decrease in haemoglobin, hospital stay, and complication rate. RESULTS: The baseline characteristics were comparable between the two groups. In the overall 2-3&#x2009;cm cohort, the FANS group achieved immediate and 1-month SFRs comparable to those of the mPCNL group. Although the operative time was longer in the FANS group, it was associated with significantly less haemoglobin loss and a shorter hospital stay, with no significant difference in infection-related complications. Notably, in the subgroup of stones &#x2265;2 to <2.5&#x2009;cm, the FANS group demonstrated a non-inferior SFR at both time points, and the operative time was not significantly longer than that of the mPCNL group. CONCLUSION: For 2-3&#x2009;cm UUTS, f-URS with FANS offers a SFR comparable to that of mPCNL, along with the advantages of reduced blood loss and shorter hospitalization. In the &#x2265;2 to <2.5&#x2009;cm subgroup, FANS shows comprehensive benefits over mPCNL. These findings support FANS as an effective alternative to mPCNL for 2-3&#x2009;cm stones and a potentially preferred option for stones measuring 2-2.5&#x2009;cm.

Humans↗
PubMed2006

Out-of-home day care for families living in a disadvantaged area of London: economic evaluation alongside a RCT.

BACKGROUND: Children born into poverty have lifelong disadvantages compared with those more fortunate; social interventions seek to break this cycle of poverty and deprivation. Early Years Centres are one such intervention. These were established in deprived areas in the UK to provide high quality out-of-home day care. This paper reports the results of an economic evaluation conducted alongside a randomized controlled trial of one of these centres in the Borough of Hackney, London. METHODS: Participants were randomized to receive either high quality day care as provided by the centre or to other child care that they secured for themselves where they chose to do so. Information on resource use (early years education and care, as well as health and social care) was collected over an 18-month period; this was valued using appropriate unit costs. The cost of education, social and health care together with the value of productivity gains and out-of-pocket costs were then compared with the effectiveness of the intervention, increased labour force participant in mothers. RESULTS: From the societal perspective, the value of employment outweighs the costs of health and social services used, and in both groups there are cost savings. These are greater in the intervention group, therefore Early Years day care is an efficient use of resources. However, there is a net cost to the public sector of providing the intervention. The cost of achieving an additional mother in the labour force at 18 months is pound38 550 (85% CI of -pound1273, pound416 172). CONCLUSION: From the societal perspective, over an 18-month period, all child care is cost saving, but high quality day care provided by the Early Years Centre is a cost-effective alternative to day care provided by other local services in Hackney. The public sector, however, incurs added expense from this intervention.

Child Care↗
PubMed2005

Does health assessment improve health outcomes in indigenous people? An RCT with 13 years of follow-up.

OBJECTIVE: To examine the impact of a multi-component health assessment on mortality and morbidity in Kimberley Aboriginal residents during a 13-year follow-up. METHOD: A population-based randomised controlled trial using linked hospital, cancer and death records to evaluate outcomes in 620 intervention and 6,736 control subjects. RESULTS: The intervention group had a higher rate of first-time hospitalisation for any reason (IRR=1.37; 95% CI 1.25-1.50), a higher rate of injury-related hospital episodes (IRR=1.31; 95% CI 1.15-1.48) and a higher notification rate of alcohol-related cancers. There was a smaller difference in the rates of multiple hospitalisations (IRR=1.14; 95% CI 0.75-1.74) and no improvement in overall mortality compared with controls (IRR=1.08; 95% CI 0.91-1.29). CONCLUSIONS: There was no overall mortality benefit despite increased health service contact associated with the intervention. IMPLICATIONS: Although not influencing mortality rates, multi-component health assessment may result in a period of increased health service use in Aboriginal and Torres Strait Islander populations, thus constituting an 'intervention'. However, this should not be confused with systematic and sustained interventions and investment in community development to achieve better health outcomes.

Adolescent↗
PubMedDate not supplied

Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report.

OBJECTIVES: A growing number of prospective clinical trials include economic end points. Recognizing the variation in methodology and reporting of these studies, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) chartered the Task Force on Good Research Practices: Randomized Clinical Trials-Cost-Effectiveness Analysis. Its goal was to develop a guidance document for designing, conducting, and reporting cost-effectiveness analyses conducted as a part of clinical trials. METHODS: Task force cochairs were selected by the ISPOR Board of Directors. Cochairs invited panel members to participate. Panel members included representatives from academia, the pharmaceutical industry, and health insurance plans. An outline and a draft report developed by the panel were presented at the 2004 International and European ISPOR meetings, respectively. The manuscript was then submitted to a reference group for review and comment. RESULTS: The report addresses issues related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members agreed that trials should be designed to evaluate effectiveness (rather than efficacy), should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. Analyses should be guided by an analysis plan and hypotheses. An incremental analysis should be conducted with an intention-to-treat approach. Uncertainty should be characterized. Manuscripts should adhere to established standards for reporting results of cost-effectiveness analyses. CONCLUSIONS: Trial-based cost-effectiveness studies have appeal because of their high internal validity and timeliness. Improving the quality and uniformity of these studies will increase their value to decision makers who consider evidence of economic value along with clinical efficacy when making resource allocation decisions.

Advisory Committees↗