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1.
Chris Burtin Daniel Langer Hans van Remoortel Heleen Demeyer Rik Gosselink Marc Decramer Fabienne Dobbels Wim Janssens Thierry Troosters 《PloS one》2015,10(12)
Background
Pulmonary rehabilitation programs only modestly enhance daily physical activity levels in patients with chronic obstructive pulmonary disease (COPD). This randomised controlled trial investigates the additional effect of an individual activity counselling program during pulmonary rehabilitation on physical activity levels in patients with moderate to very severe COPD.Methods
Eighty patients (66±7 years, 81% male, forced expiratory volume in 1 second 45±16% of predicted) referred for a six‐month multidisciplinary pulmonary rehabilitation program were randomised. The intervention group was offered an additional eight-session activity counselling program. The primary outcomes were daily walking time and time spent in at least moderate intense activities.Results
Baseline daily walking time was similar in the intervention and control group (median 33 [interquartile range 16–47] vs 29 [17–44]) whereas daily time spent in at least moderate intensity was somewhat higher in the intervention group (17[4–50] vs 12[2–26] min). No significant intervention*time interaction effects were observed in daily physical activity levels. In the whole group, daily walking time and time spent in at least moderate intense activities did not significantly change over time.Conclusions
The present study identified no additional effect of eight individual activity counselling sessions during pulmonary rehabilitation to enhance physical activity levels in patients with COPD.Trial Registration
clinicaltrials.gov NCT00948623相似文献2.
Background
It is an inherent assumption in randomised controlled trials that the drug effect can be estimated by subtracting the response during placebo from the response during active drug treatment.Objective
To test the assumption of additivity. The primary hypothesis was that the total treatment effect is smaller than the sum of the drug effect and the placebo effect. The secondary hypothesis was that non-additivity was most pronounced in participants with large placebo effects.Methods
We used a within-subject randomised blinded balanced placebo design and included 48 healthy volunteers (50% males), mean (SD) age 23.4 (6.2) years. Experimental pain was induced by injections of hypertonic saline into the masseter muscle. Participants received four injections with hypertonic saline along with lidocaine or matching placebo in randomised order: A: received hypertonic saline/told hypertonic saline; B: received hypertonic saline+lidocaine/told hypertonic saline; C: received hypertonic saline+placebo/told hypertonic saline+pain killer; D: received hypertonic saline+lidocaine/told hypertonic saline+pain killer. The primary outcome measure was the area under the curve (AUC, mm2) of pain intensity during injections.Results
There was a significant difference between the sum of the drug effect and the placebo effect (mean AUC 6279 mm2 (95% CI, 4936–7622)) and the total treatment effect (mean AUC 5455 mm2 (95% CI, 4585–6324)) (P = 0.049). This difference was larger for participants with large versus small placebo effects (P = 0.015), and the difference correlated significantly with the size of the placebo effect (r = 0.65, P = 0.006).Conclusion
Although this study examined placebo effects and not the whole placebo response as in randomised controlled trials, it does suggest that the additivity assumption may be incorrect, and that the estimated drug effects in randomised controlled trials may be underestimated, particularly in studies reporting large placebo responses. The implications for randomised controlled trials and systematic reviews need to be discussed. 相似文献3.
Purpose
To determine whether oral doxycycline treatment reduces pterygium lesions.Design
Double blind, randomized, placebo controlled clinical trial.Participants
98 adult patients with primary pterygium.Methods
Patients were randomly assigned to receive 100 mg oral doxycycline twice a day (49 subjects), or placebo (49 subjects), for 30 days. Photographs of the lesion were taken at the time of recruitment and at the end of the treatment. Follow-up sessions were performed 6 and 12 months post-treatment. Statistical analyses for both continuous and categorical variables were applied. p values of less than 0.05 were considered to indicate statistical significance.Main Outcome Measures
The primary endpoint was the change in lesion size after 30 days of treatment.Results
The primary endpoint was not met for the whole population but subgroup analysis showed that doxycycline was effective in patients of Caucasian origin while other ethnicities, mostly Hispanic, did not respond to the treatment. Moreover, there was a correlation between age and better response (p = 0.003). Adverse events were uncommon, mild, and in agreement with previous reports on short doxycycline treatments.Conclusions
Oral doxycycline was superior to placebo for the treatment of primary pterygia in older Caucasian patients. These findings support the use of doxycycline for pterygium treatment in particular populations.Trial Registration
European Union Clinical Trials Register EudraCT 2008-007178-39 相似文献4.
Intraoperative Fluid Restriction in Pancreatic Surgery: A Double Blinded Randomised Controlled Trial
Ganapathy van Samkar Wietse J. Eshuis Roelof J. Bennink Thomas M. van Gulik Marcel G. W. Dijkgraaf Benedikt Preckel Stefan de Hert Dirk J. Gouma Markus W. Hollmann Olivier R. C. Busch 《PloS one》2015,10(10)
Background
Perioperative fluid restriction in a variety of operations has shown improvement of: complications, recovery of gastrointestinal function and length of stay (LOS). We investigated effects of crystalloid fluid restriction in pancreatic surgery. Our hypothesis: enhanced recovery of gastrointestinal function.Methods
In this double-blinded randomized trial, patients scheduled to undergo pancreatoduodenectomy (PD) were randomized: standard (S:10ml/kg/hr) or restricted (R:5ml/kg/hr) fluid protocols. Primary endpoint: gastric emptying scintigraphically assessed on postoperative day 7.Results
In 66 randomized patients, complications and 6-year survival were analyzed. 54 patients were analyzed in intention to treat: 24 S-group and 30 R-group. 32 patients actually underwent a PD and 16 patients had a palliative gastrojejunostomy bypass operation in the full protocol analysis. The median gastric emptying time (T½) was 104 minutes (S-group, 95% confidence interval: 74–369) versus 159 minutes (R-group, 95% confidence interval: 61–204) (P = 0.893, NS). Delayed gastric emptying occurred in 10 patients in the S-group and in 13 patients in the R-group (45% and 50%, P = 0.779, NS). The primary outcome parameter, gastric emptying time, did not show a statistically significant difference between groups.Conclusion
A fluid regimen of 10ml/kg/hr or 5ml/kg/hr during pancreatic surgery did not lead to statistically significant differences in gastric emptying. A larger study would be needed to draw definite conclusions about fluid restriction in pancreatic surgery.Trial registration
ISRCTN62621488 相似文献5.
Dan Bagger-Sj?b?ck Karin Str?mb?ck Pierre Hakizimana Jan Plue Christina Larsson Malou Hultcrantz Georgios Papatziamos Henrik Smeds Niklas Danckwardt-Lilliestr?m Sten Hellstr?m Ann Johansson Bo Tideholm Anders Fridberger 《PloS one》2015,10(3)
Background
Otosclerosis is a disorder that impairs middle ear function, leading to conductive hearing loss. Surgical treatment results in large improvement of hearing at low sound frequencies, but high-frequency hearing often suffers. A likely reason for this is that inner ear sensory cells are damaged by surgical trauma and loud sounds generated during the operation. Animal studies have shown that antioxidants such as N-Acetylcysteine can protect the inner ear from noise, surgical trauma, and some ototoxic substances, but it is not known if this works in humans. This trial was performed to determine whether antioxidants improve surgical results at high frequencies.Methods
We performed a randomized, double-blind and placebo-controlled parallel group clinical trial at three Swedish university clinics. Using block-stratified randomization, 156 adult patients undergoing stapedotomy were assigned to intravenous N-Acetylcysteine (150 mg/kg body weight) or matching placebo (1:1 ratio), starting one hour before surgery. The primary outcome was the hearing threshold at 6 and 8 kHz; secondary outcomes included the severity of tinnitus and vertigo.Findings
One year after surgery, high-frequency hearing had improved 2.7 ± 3.8 dB in the placebo group (67 patients analysed) and 2.4 ± 3.7 dB in the treated group (72 patients; means ± 95% confidence interval, p = 0.54; linear mixed model). Surgery improved tinnitus, but there was no significant intergroup difference. Post-operative balance disturbance was common but improved during the first year, without significant difference between groups. Four patients receiving N-Acetylcysteine experienced mild side effects such as nausea and vomiting.Conclusions
N-Acetylcysteine has no effect on hearing thresholds, tinnitus, or balance disturbance after stapedotomy.Trial Registration
ClinicalTrials.gov NCT00525551 相似文献6.
7.
Vincenzo Libri Andrew P. Brown Giulio Gambarota Jonathan Haddad Gregory S. Shields Helen Dawes David J. Pinato Ethan Hoffman Peter J. Elliot George P. Vlasuk Eric Jacobson Martin R. Wilkins Paul M. Matthews 《PloS one》2012,7(12)
Background
SRT2104 has been developed as a selective small molecule activator of SIRT1, a NAD+-dependent deacetylase involved in the regulation of energy homeostasis and the modulation of various metabolic pathways, including glucose metabolism, oxidative stress and lipid metabolism. SIRT1 has been suggested as putative therapeutic target in multiple age-related diseases including type 2 diabetes and dyslipidemias. We report the first clinical trial of SRT2104 in elderly volunteers.Methods
Oral doses of 0.5 or 2.0 g SRT2104 or matching placebo were administered once daily for 28 days. Pharmacokinetic samples were collected through 24 hours post-dose on days 1 and 28. Multiple pharmacodynamic endpoints were explored with oral glucose tolerance tests (OGTT), serum lipid profiles, magnetic resonance imaging (MRI) for assessment of whole body visceral and subcutaneous fat, maximal aerobic capacity test and muscle 31P magnetic resonance spectroscopy (MRS) for estimation of mitochondrial oxidative capacity.Results
SRT2104 was generally safe and well tolerated. Pharmacokinetic exposure increased less than dose-proportionally. Mean Tmax was 2–4 hours with elimination half-life of 15–20 hours. Serum cholesterol, LDL levels and triglycerides decreased with treatment. No significant changes in OGTT responses were observed. 31P MRS showed trends for more rapid calculated adenosine diphosphate (ADP) and phosphocreatine (PCr) recoveries after exercise, consistent with increased mitochondrial oxidative phosphorylation.Conclusions
SRT2104 can be safely administered in elderly individuals and has biological effects in humans that are consistent with SIRT1 activation. The results of this study support further development of SRT2104 and may be useful in dose selection for future clinical trials in patients.Trial Registration
ClinicalTrials.gov NCT00964340相似文献8.
Dafna Merom Erin Mathieu Ester Cerin Rachael L. Morton Judy M. Simpson Chris Rissel Kaarin J. Anstey Catherine Sherrington Stephen R. Lord Robert G. Cumming 《PLoS medicine》2016,13(8)
BackgroundThe prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i) reducing the number of falls and ii) improving physical and cognitive fall-related risk factors.ConclusionsSocial dancing did not prevent falls or their associated risk factors among these retirement villages'' residents. Modified dance programmes that contain "training elements" to better approximate structured exercise programs, targeted at low and high-risk participants, warrant investigation.
Trial Registration
The Australian New Zealand Clinical Trials Registry ACTRN12612000889853 相似文献9.
Gavin Dreyer Arthur T. Tucker Steven M. Harwood Rupert M. Pearse Martin J. Raftery Muhammad M. Yaqoob 《PloS one》2014,9(7)
Background and Objectives
Vitamin D deficiency and endothelial dysfunction are non-traditional risk factors for cardiovascular events in chronic kidney disease. Previous studies in chronic kidney disease have failed to demonstrate a beneficial effect of vitamin D on arterial stiffness, left ventricular mass and inflammation but none have assessed the effect of vitamin D on microcirculatory endothelial function.Study Design
We conducted a randomised controlled trial of 38 patients with non diabetic chronic kidney disease stage 3–4 and concomitant vitamin D deficiency (<16 ng/dl) who received oral ergocalciferol (50,000 IU weekly for one month followed by 50,000 IU monthly) or placebo over 6 months. The primary outcome was change in microcirculatory function measured by laser Doppler flowmetry after iontophoresis of acetylcholine. Secondary endpoints were tissue advanced glycation end products, sublingual functional capillary density and flow index as well as macrovascular parameters. Parallel in vitro experiments were conducted to determine the effect of ergocalciferol on cultured human endothelial cells.Results
Twenty patients received ergocalciferol and 18 patients received placebo. After 6 months, there was a significant improvement in the ergocalciferol group in both endothelium dependent microcirculatory vasodilatation after iontophoresis of acetylcholine (p = 0.03) and a reduction in tissue advanced glycation end products (p = 0.03). There were no changes in sublingual microcirculatory parameters. Pulse pressure (p = 0.01) but not aortic pulse wave velocity was reduced. There were no significant changes in bone mineral parameters, blood pressure or left ventricular mass index suggesting that ergocalciferol improved endothelial function independently of these parameters. In parallel experiments, expression of endothelial nitric oxide synthase and activity were increased in human endothelial cells in a dose dependent manner.Conclusions
Ergocalciferol improved microcirculatory endothelial function in patients with chronic kidney disease and concomitant vitamin D deficiency. This process may be mediated through enhanced expression and activity of endothelial nitric oxide synthase.Trial Registration
Clinical trials.gov NCT00882401相似文献10.
The purpose of this study was to investigate the need for and choice of stratification factors, and the effects of blinding
and placebo in a clinical experiment. Eighty dogs with canine hip dysplasia (CHD) were included in a randomized, placebo-controlled
and double blind clinical trial with stratified parallel group design, in which body weight and degree of CHD were used as
stratification factors. Thirty-eight dogs were allocated to gold bead implantation and 42 to placebo. After six months, 33
of the 42 placebo-treated dogs received gold bead implantation in an open study lasting a further 18 months. The main outcome
variable in the study was change in pain signs of CHD as assessed by the owner. No significant difference in the main outcome
variable, regardless of the treatment given, could be detected in the two chosen stratification factors. The only factor to
influence the main outcome variable significantly was age. The blinding procedure used in the study, in which 60% of the owners
correctly guessed the treatment given, was found sufficient. Of those who guessed the treatment erroneously, 88% believed
the treatment given was gold bead implantation. The treatment efficacy after six months in the blinded treatment group was
found to be significantly larger compared to the efficacy obtained in the open study. A significant placebo effect was therefore
detected. Conclusion and Clinical Relevance: The age of the dogs influenced the outcome of the CHD treatment, and is recommended
as a stratification factor. A significant placebo effect has to be expected and an optimal blinding procedure is necessary
in similar clinical studies. 相似文献
11.
Claudia Spies Alawi Luetz Gunnar Lachmann Markus Renius Clarissa von Haefen Klaus-Dieter Wernecke Marcus Bahra Alexander Schiemann Marco Paupers Christian Meisel 《PloS one》2015,10(12)
Purpose
Surgical patients are at high risk for developing infectious complications and postoperative delirium. Prolonged infections and delirium result in worse outcome. Granulocyte-macrophage colony-stimulating factor (GM-CSF) and influenza vaccination are known to increase HLA-DR on monocytes and improve immune reactivity. This study aimed to investigate whether GM-CSF or vaccination reverses monocyte deactivation. Secondary aims were whether it decreases infection and delirium days after esophageal or pancreatic resection over time.Methods
In this prospective, randomized, placebo-controlled, double-blind, double dummy trial setting on an interdisciplinary ICU of a university hospital 61 patients with immunosuppression (monocytic HLA-DR [mHLA-DR] <10,000 monoclonal antibodies [mAb] per cell) on the first day after esophageal or pancreatic resection were treated with either GM-CSF (250 μg/m2/d), influenza vaccination (Mutagrip 0.5 ml/d) or placebo for a maximum of 3 consecutive days if mHLA-DR remained below 10,000 mAb per cell. HLA-DR on monocytes was measured daily until day 5 after surgery. Infections and delirium were followed up for 9 days after surgery. Primary outcome was HLA-DR on monocytes, and secondary outcomes were duration of infection and delirium.Results
mHLA-DR was significantly increased compared to placebo (p < 0.001) and influenza vaccination (p < 0.001) on the second postoperative day. Compared with placebo, GM-CSF-treated patients revealed shorter duration of infection (p < 0.001); the duration of delirium was increased after vaccination (p = 0.003).Conclusion
Treatment with GM-CSF in patients with postoperative immune suppression was safe and effective in restoring monocytic immune competence. Furthermore, therapy with GM-CSF reduced duration of infection in immune compromised patients. However, influenza vaccination increased duration of delirium after major surgery.Trial Registration
www.controlled-trials.com ISRCTN27114642 相似文献12.
Objectives
Deprescribing has been proposed as a way to reduce polypharmacy in frail older people. We aimed to reduce the number of medicines consumed by people living in residential aged care facilities (RACF). Secondary objectives were to explore the effect of deprescribing on survival, falls, fractures, hospital admissions, cognitive, physical, and bowel function, quality of life, and sleep.Methods
Ninety-five people aged over 65 years living in four RACF in rural mid-west Western Australia were randomised in an open study. The intervention group (n = 47) received a deprescribing intervention, the planned cessation of non-beneficial medicines. The control group (n = 48) received usual care. Participants were monitored for twelve months from randomisation. Primary outcome was change in the mean number of unique regular medicines. All outcomes were assessed at baseline, six, and twelve months.Results
Study participants had a mean age of 84.3±6.9 years and 52% were female. Intervention group participants consumed 9.6±5.0 and control group participants consumed 9.5±3.6 unique regular medicines at baseline. Of the 348 medicines targeted for deprescribing (7.4±3.8 per person, 78% of regular medicines), 207 medicines (4.4±3.4 per person, 59% of targeted medicines) were successfully discontinued. The mean change in number of regular medicines at 12 months was -1.9±4.1 in intervention group participants and +0.1±3.5 in control group participants (estimated difference 2.0±0.9, 95%CI 0.08, 3.8, p = 0.04). Twelve intervention participants and 19 control participants died within 12 months of randomisation (26% versus 40% mortality, p = 0.16, HR 0.60, 95%CI 0.30 to 1.22) There were no significant differences between groups in other secondary outcomes. The main limitations of this study were the open design and small participant numbers.Conclusions
Deprescribing reduced the number of regular medicines consumed by frail older people living in residential care with no significant adverse effects on survival or other clinical outcomes.Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12611000370909 相似文献13.
14.
Timothy W. Kenealy Matthew J. G. Parsons A. Paul B. Rouse Robert N. Doughty Nicolette F. Sheridan Jennifer K. Harré Hindmarsh Sarah C. Masson Harry H. Rea 《PloS one》2015,10(3)
Objectives
To assess the effect of telecare on health related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals.Methods
Patients were randomly assigned either to usual care or to additionally entering their data into a commercially-available electronic device that uploaded data once a day to a nurse-led monitoring station. Patients had congestive heart failure (Site A), chronic obstructive pulmonary disease (Site B), or any long-term condition, mostly diabetes (Site C). Site C contributed only intervention patients – they considered a usual care option to be unethical. The study took place in New Zealand between September 2010 and February 2012, and lasted 3 to 6 months for each patient. The primary outcome was health-related quality of life (SF36). Data on experiences were collected by individual and group interviews and by questionnaire.Results
There were 171 patients (98 intervention, 73 control). Quality of life, self-efficacy and disease-specific measures did not change significantly, while anxiety and depression both decreased significantly with the intervention. Hospital admissions, days in hospital, emergency department visits, outpatient visits and costs did not differ significantly between the groups. Patients at all sites were universally positive. Many felt safer and more cared-for, and said that they and their family had learned more about managing their condition. Staff could all see potential benefits of telecare, and, after some initial technical problems, many staff felt that telecare enabled them to effectively monitor more patients.Conclusions
Strongly positive patient and staff experiences and attitudes complement and contrast with small or non-significant quantitative changes. Telecare led to patients and families taking a more active role in self-management. It is likely that subgroups of patients benefitted in ways that were not measured or visible within the quantitative data, especially feelings of safety and being cared-for.Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12610000269033 相似文献15.
Manoj K. Saxena Colman Taylor Laurent Billot Severine Bompoint John Gowardman Jason A. Roberts Jeffery Lipman John Myburgh 《PloS one》2015,10(12)
Background
Strategies to prevent pyrexia in patients with acute neurological injury may reduce secondary neuronal damage. The aim of this study was to determine the safety and efficacy of the routine administration of 6 grams/day of intravenous paracetamol in reducing body temperature following severe traumatic brain injury, compared to placebo.Methods
A multicentre, randomised, blind, placebo-controlled clinical trial in adult patients with traumatic brain injury (TBI). Patients were randomised to receive an intravenous infusion of either 1g of paracetamol or 0.9% sodium chloride (saline) every 4 hours for 72 hours. The primary outcome was the mean difference in core temperature during the study intervention period.Results
Forty-one patients were included in this study: 21 were allocated to paracetamol and 20 to saline. The median (interquartile range) number of doses of study drug was 18 (17–18) in the paracetamol group and 18 (16–18) in the saline group (P = 0.85). From randomisation until 4 hours after the last dose of study treatment, there were 2798 temperature measurements (median 73 [67–76] per patient). The mean ± standard deviation temperature was 37.4±0.5°C in the paracetamol group and 37.7±0.4°C in the saline group (absolute difference -0.3°C; 95% confidence interval -0.6 to 0.0; P = 0.09). There were no significant differences in the use of physical cooling, or episodes of hypotension or hepatic abnormalities, between the two groups.Conclusion
The routine administration of 6g/day of intravenous paracetamol did not significantly reduce core body temperature in patients with TBI.Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12609000444280 相似文献16.
Tine K. Grimholt Dag Jacobsen Ole Rikard Haavet Leiv Sandvik Trond Jorgensen Astrid Berge Norheim Oivind Ekeberg 《PloS one》2015,10(12)
Objective
To assess whether systematic follow-up by general practitioners (GPs) of cases of deliberate self-poisoning (DSP) by their patients decreases psychiatric symptoms and suicidal behaviour compared with current practice.Design
Randomised clinical trial with two parallel groups.Setting
General practices in Oslo and the eastern part of Akershus County.Participants
Patients aged 18–75 years admitted to hospital for DSP. We excluded patients diagnosed with psychoses, without a known GP, those not able to complete a questionnaire, and patients admitted to psychiatric in-patient care or other institutions where their GP could not follow them immediately after discharge.Intervention
The GPs received a written guideline, contacted the patients and scheduled a consultation within one week after discharge, and then provided regular consultations for six months. We randomised the patients to either intervention (n = 78) or treatment as usual (n = 98).Main Outcome Measures
Primary outcome measure was the Beck Scale for Suicide Ideation (SSI). Secondary outcomes were Beck Depression Inventory (BDI) and Beck Hopelessness Scale (BHS), self-reported further self-harm and treatment for DSP in a general hospital or an emergency medical agency (EMA). We assessed patients on entry to the trial and at three and six months. We collected data from interviews, self-report questionnaires, and hospital and EMA medical records.Results
There were no significant differences between the groups in SSI, BDI, or BHS mean scores or change from baseline to three or six months. During follow-up, self-reported DSP was 39.5% in the intervention group vs. 15.8% in controls (P = 0.009). Readmissions to general hospitals were similar (13% in both groups (P = 0.963), while DSP episodes treated at EMAs were 17% in the intervention group and 7% in the control group (P = 0.103).Conclusion
Structured follow-up by GPs after an episode of DSP had no significant effect on suicide ideation, depression or hopelessness. There was no significant difference in repeated episodes of DSP in hospitals or EMAs. However, the total number of incidents of deliberate self-harm reported by the patients was significantly higher in the intervention group.Trial registration
Trial registration ClinicalTrials.gov Identifier: NCT01342809相似文献17.
Boubacar Coulibaly Augustin Zoungrana Frank P. Mockenhaupt R. Heiner Schirmer Christina Klose Ulrich Mansmann Peter E. Meissner Olaf Müller 《PloS one》2009,4(5)
Background
With the availability of new preventive and curative interventions, global malaria control has been strengthened significantly in recent years. Drugs effective in reducing malaria gametocytaemia might contribute to local elimination and possible long-term eradication. We here report on the effects of methylene blue (MB)-based malaria combination therapy on gametocytaemia during a randomised-controlled trial in Burkina Faso.Methods
An open-label randomised controlled phase II study in 180 children aged 6–10 years with uncomplicated falciparum malaria was conducted in Nouna, north-western Burkina Faso. Children were randomised to MB–artesunate (AS), MB–amodiaquine (AQ), and AS-AQ (local standard of care). Overall follow-up was for 28 days, follow-up for gametocytaemia was for 14 days.Findings
The treatment groups were similar in baseline characteristics and there was only one loss to follow-up. Compared to AS-AQ, both MB-containing regimens were associated with significantly reduced gametocyte carrier rates during follow-up days 3, 7, and 14. This effect was seen both in patients with and without P. falciparum gametocytaemia at baseline.Interpretation
MB reveals pronounced gametocytocidal activity which appears to act against both existing and developing P. falciparum gametocytes. MB-based combination therapy thus has the potential to reduce transmission of P. falciparum malaria in endemic regions, which has important implications for future elimination and eradication strategies.Trial Registration
ClinicalTrials.gov NCT00354380相似文献18.
19.
Kien Hoa Ly Naira Topooco Hanna Cederlund Anna Wallin Jan Bergstr?m Olof Molander Per Carlbring Gerhard Andersson 《PloS one》2015,10(5)
Background
There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment - including four face-to-face sessions and a smartphone application - was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression.Methods
This was a randomised controlled non-inferiority trial (NCT01819025) comparing a blended treatment (n=46) against a full ten-session treatment (n=47) for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment.Results
Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen’s d=1.35; CI [−0.82, 3.52] to d=1.47; CI [−0.41, 3.35]; between group d=−0.13 CI [−2.37, 2.09] and d=−0.10 CI [−2.53, 2.33]). At the same time, the blended treatment reduced the therapist time with an average of 47%.Conclusions
We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone applica¬tion as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression.Trial Registration
Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025 相似文献20.
Ian Mcgowan Craig Hoesley Ross D. Cranston Philip Andrew Laura Janocko James Y. Dai Alex Carballo-Dieguez Ratiya Kunjara Na Ayudhya Jeanna Piper Florian Hladik Ken Mayer 《PloS one》2013,8(4)