scholarly journals Press needle for the Prevention of Aspiration Pneumonia in Elderly People: Study Protocol for a Randomized Double-Blind Placebo-Controlled trial.

2021 ◽  
Author(s):  
Soichiro Kaneko ◽  
Akiko Kikuchi ◽  
Shin Takayama ◽  
Ryutaro Arita ◽  
Yumika Seki ◽  
...  
Keyword(s):  
Elderly People ◽  
Aspiration Pneumonia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Lower Limbs ◽  
Secondary Outcome ◽  
Swallowing Function ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Investigation Period

Abstract Background: Pneumonia is the fifth most common cause of death among the Japanese, with 97% of deaths occurring among elderly people aged 65 years or older. The incidence ratio of aspiration pneumonia is high for elderly people. Therefore, prophylaxis is important in geriatric medicine. In our previous studies, we reported that stimulation to the acupoints at ST36 and KI3 of the lower limbs with press needle improved the swallowing function of patients with dysphagia. The improvement of swallowing function may prevent aspiration pneumonia. The aim of this study is to investigate the protective efficacy of using press needle stimulation in the lower limbs for aspiration pneumonia.Methods/design: This is a multi-center, randomized double-blind placebo-controlled trial. A total of 140 patients with cerebrovascular disorder with a history of aspiration pneumonia will be recruited from six centers and randomly assigned to either the real press needle group or the sham press needle group in a 1:1 ratio. The press needle will be replaced twice a week. Treatment will be administered bilaterally at acupoints ST36 and KI3. The primary outcome is the frequency of onset of aspiration pneumonia. The secondary outcome is improvement of the latent time of swallowing reflex (LTSR). The investigation period is of 12-month. The primary outcome will be evaluated throughout the period, and secondary outcomes will be assessed at baseline, 1st month, 6th month, and at the end of the investigation period.Discussion: This study will evaluate the effects of press needle on prevention of aspiration pneumonia and improvement of swallowing function of patients. The results of this study will help support the prophylaxis of aspiration pneumonia.Trial registration: UMIN000023123, registered on July 12th, 2016; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026460

scholarly journals Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis

2020 ◽  
Vol 151 (1) ◽  
pp. 65-72
Author(s):  
David Schnadower ◽  
Robert E Sapien ◽  
T Charles Casper ◽  
Cheryl Vance ◽  
Phillip I Tarr ◽  
...  
Keyword(s):  
Acute Gastroenteritis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Interaction Effects ◽  
Secondary Outcome ◽  
Z Score ◽  
Double Blind ◽  
Multicenter Randomized Controlled Trial ◽  
Weight Percentile ◽  
Age And Sex

ABSTRACT Background Gastroenteritis is a common and impactful disease in childhood. Probiotics are often used to treat acute gastroenteritis (AGE); however, in a large multicenter randomized controlled trial (RCT) in 971 children, Lactobacillus rhamnosus GG (LGG) was no better than placebo in improving patient outcomes. Objectives We sought to determine whether the effect of LGG is associated with age, weight z score and weight percentile adjusted for age and sex, or dose per kilogram administered. Methods This was a preplanned secondary analysis of a multicenter double-blind RCT of LGG 1 × 1010 CFU twice daily for 5 d or placebo in children 3–48 mo of age with AGE. Our primary outcome was moderate to severe gastroenteritis. Secondary outcomes included diarrhea and vomiting frequency and duration, chronic diarrhea, and side effects. We used multivariable linear and nonlinear models testing for interaction effects to assess outcomes by age, weight z score and weight percentile adjusted for age and sex, and dose per kilogram of LGG received. Results A total of 813 children (84%) were included in the analysis; 413 received placebo and 400 LGG. Baseline characteristics were similar between treatment groups. There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome. Whereas we found a statistical association favoring placebo at the extremes of adjusted weight z scores for the number of vomiting episodes (P-interaction = 0.02) and vomiting duration (P-interaction = 0.0475), there were no statistically significant differences in other secondary outcome measures (all P-interactions > 0.05). Conclusions LGG does not improve outcomes in children with AGE regardless of the age, adjusted weight z score, and adjusted weight percentile of participants, or the probiotic dose per kilogram received. These results further strengthen the conclusions of low risk of bias clinical trials which demonstrate that LGG provides no clinical benefit in children with AGE. This trial was registered at clinicaltrials.gov as NCT01773967.

Immune response to influenza vaccination of elderly people. A randomized double-blind placebo-controlled trial

Vaccine ◽  
1994 ◽  
Vol 12 (13) ◽  
pp. 1185-1189 ◽  
Author(s):  
Th.M.E. Govaert ◽  
M.J.W. Sprenger ◽  
G.J. Dinant ◽  
K. Aretz ◽  
N. Masurel ◽  
...  
Keyword(s):  
Immune Response ◽  
Influenza Vaccination ◽  
Elderly People ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Study Protocol ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification Protocol version: Manuscript based on study protocol version 1.3, 1 November 2018.

scholarly journals Primary Prophylaxis to Prevent Tuberculosis Infection in Prison Inmates:A Randomized, Double-Blind, Placebo-Controlled Trial

2019 ◽  
Author(s):  
Roberto Dias de Oliveira ◽  
Andrea da Silva Santos ◽  
Cassia Barbosa Reis ◽  
Alessandra de Cássia Leite ◽  
Flávia Patussi Correia Sacchi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Primary Prophylaxis ◽  
Tuberculosis Infection ◽  
Secondary Outcome ◽  
Double Blind ◽  
Middle Income ◽  
High Exposure ◽  
Double Blind Placebo ◽  
Clinical Benefits

Abstract Background. In many low- and middle-income countries, tuberculosis incidence in prisons is high, exposing incarcerated populations to an elevated risk of tuberculosis infection. Methods. We conducted a randomized, double-blind, placebo-controlled trial among HIV-negative male inmates of a high tuberculosis burden prison to determine whether twice-weekly isoniazid (900 mg) for 12 months prevents tuberculosis infection. The primary outcome was QuantiFERON–TB Gold Plus (QFT) conversion to ≥0.35 IU/ml at 6 months; the secondary outcome was conversion at any time point. Alternative QFT positivity thresholds (≥0.7, ≥2.0, and ≥4.0 IU/ml) were investigated as exploratory endpoints. Results. In total, 467 participants were randomly assigned to isoniazid (N=258) or placebo (N=209). In an interim analysis of participants who had completed six months of follow-up (N=171), QFT conversion occurred in 20.7% (19/92) and 21.5% (17/79) of participants in isoniazid and placebo arms (efficacy: 4.0%; P=0.88). The trial was then stopped for futility, and the remaining participants underwent QFT testing. Among all participants with a second QFT test at 6-months, conversion occurred in 19.7% (26/132) and 30.3% (37/122) of participants in isoniazid and placebo arms (efficacy: 35.1%; P=0.04). Protection was also seen among all individuals with a follow-up QFT (5/132 [3.8%] vs 14/122 [11.5%]; efficacy: 67.0%, P=0.01). In exploratory analyses, the isoniazid arm had significantly lower rates of conversion at ≥2.0 IU/ml (67.0% efficacy, P=0.01), but not at other cutoff values. Discontinuations and losses to follow-up were high in both arms (isoniazid, 126/258 [48.8%]; placebo, 87/209 [41.6%]; P=0.14), due to elective withdrawal (24.0% vs 21.5%; P=0.60) and transfer or release from prison (19.0% vs 18.2%; P=0.92). Conclusions. Our results suggest that 900 milligrams of isoniazid given twice weekly may confer partial protection against QFT conversion in high exposure environments; however, discontinuation rates in both arms were high, which would limit the clinical benefits of this prevention method.

scholarly journals Tranexamic acid for acute gastrointestinal bleeding (The HALT-IT trial): Statistical analysis plan for an international, randomised, double blind, placebo-controlled trial

2019 ◽  
Author(s):  
Amy Charlotte Brenner ◽  
Adefemi Afolabi ◽  
Syed Masroor Ahmad ◽  
Monica Arribas ◽  
Rizwana Chaudhri ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Blood Transfusion ◽  
Tranexamic Acid ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gi Bleeding ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Upper Gi ◽  
Lower Gi Bleeding

Abstract Background: Acute gastrointestinal (GI) bleeding is an important cause of mortality worldwide. Bleeding can occur from the upper or lower GI tract, with upper GI bleeding accounting for most cases. The main causes include peptic ulcer / erosive mucosal disease, oesophageal varices and malignancy. The case fatality rate is around 10% for upper GI bleeding and 3% for lower GI bleeding. Rebleeding affects 5-40% of patients and is associated with a four-fold increased risk of death. Tranexamic acid (TXA) decreases bleeding and the need for blood transfusion in surgery and reduces death due to bleeding in patients with trauma and postpartum haemorrhage. It reduces bleeding by inhibiting the breakdown of fibrin clots by plasmin. Due to the methodological weaknesses and small size of the existing trials, the effectiveness and safety of TXA in GI bleeding is uncertain. The HALT-IT trial aims to provide reliable evidence about the effects of TXA in acute upper and lower GI bleeding. Methods: The HALT-IT trial is an international, randomised, double blind, placebo-controlled trial of tranexamic acid in 12,000 adults (increased from 8,000) with acute upper or lower GI bleeding. Eligible patients are randomly allocated to receive tranexamic acid (1g loading dose followed by 3g maintenance dose over 24 hours) or matching placebo. The main analysis will compare those randomised to tranexamic acid with those randomised to placebo on an intention-to-treat basis, presenting the results as effect estimates (relative and absolute risks) and confidence intervals. The primary outcome is death due to bleeding within 5 days of randomisation and secondary outcomes are rebleeding, all-cause and cause-specific mortality, thromboembolic events, complications, endoscopic, radiological and surgical interventions, blood transfusion requirements, disability (defined by a measure of patient’s self-care capacity) and number of days spent in intensive care or high dependency units. Subgroup analyses for the primary outcome will consider time to treatment, location of bleeding, cause of bleed and clinical Rockall score. Discussion: We present the statistical analysis of the HALT-IT trial. This plan was prepared and submitted for publication before the treatment allocation was un-blinded. Trial Registration: Current Controlled Trials ISRCTN11225767 (3/07/2012); Clinicaltrials.gov NCT01658124 (26/07/2012). Keywords: Gastrointestinal haemorrhage, tranexamic acid, clinical trial, statistical analysis.

scholarly journals A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Huang Qi Gui Zhi Wu Wu Tang granules in patients with rheumatoid arthritis

2018 ◽  
Author(s):  
Yang Liu ◽  
Yi-Ru Wang ◽  
Zhi-jie Xi ◽  
Yang Yu ◽  
Li Liu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Decision Making ◽  
Controlled Trial ◽  
Rate Of Change ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Multicenter Randomized Controlled Trial

Abstract Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling, pain, and synovial damage. Effective methods lack in the treatment of RA. A traditional prescription in use for thousands of years in China, Huang Qi Gui Zhi Wu Wu Tang (HQGZWWT) granule is still chosen to relive pain and prevent joint malformation in RA patients. However, no evidence-based medical research has been organized to assess the effectiveness and safety of HQGZWWT granules for RA. Methods/design: We will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether HQGZWWT granules can relieve pain and protect joints. We will randomly divide 120 patients with active arthritis for 3 months. Main measurements include ratio of 50 of ACR (American College of Rheumatology), change of DAS (28) from baseline to 3 months, and SHARP scores of van der Heijde from baseline to 12 months. SecondarymeasurementsincludeACR20, ACR70, Health Assessment Questionnaire-Disability Index (HAQ-DI), arthritis pain score, and Patient Global Assessment of Arthritis. The time points are set as baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months. In addition, the rate of change (score) in the ACR50 and DAS28 from the baseline to 2-week, 1-month, 2-month, 6-month, and 12-month follow-up are also the secondary outcome measures. Discussion: The findings of this research will elucidate the efficacy and safety of HQGZWWT granules and provide an alternative treatment for RA. In addition, our data will benefit the clinical decision-making on active RA and possibly be incorporated into future guidelines. Trial registration: ClinicalTrials.gov ID: NCT03593837. Keywords: Traditional Chinese medicine, Huang Qi Gui Zhi wu wu granules, placebo, active rheumatoid arthritis, multicenter, randomized controlled trial.

scholarly journals Amisulpride augmentation of clozapine for treatment-refractory schizophrenia: a double-blind, placebo-controlled trial

2018 ◽  
Vol 8 (7) ◽  
pp. 185-197 ◽  
Author(s):  
Thomas R.E. Barnes ◽  
Verity Leeson ◽  
Carol Paton ◽  
Louise Marston ◽  
David P. Osborn ◽  
...  
Keyword(s):  
Clinical Response ◽  
Negative Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Persistent Symptoms ◽  
Cardiac Symptoms ◽  
Increased Risk

Background: A second antipsychotic is commonly added to clozapine to treat refractory schizophrenia, notwithstanding the limited evidence to support such practice. Methods: The efficacy and adverse effects of this pharmacological strategy were examined in a double-blind, placebo-controlled, 12-week randomized trial of clozapine augmentation with amisulpride, involving 68 adults with treatment-resistant schizophrenia and persistent symptoms despite a predefined trial of clozapine. Results: There were no statistically significant differences between the amisulpride and placebo groups on the primary outcome measure (clinical response defined as a 20% reduction in total Positive and Negative Syndrome Scale score) or other mental state measures. However, the trial under recruited and was therefore underpowered to detect differences in the primary outcome, meaning that acceptance of the null hypothesis carries an increased risk of type II error. The findings suggested that amisulpride-treated participants were more likely to fulfil the clinical response criterion, odds ratio 1.17 (95% confidence interval 0.40–3.42) and have a greater reduction in negative symptoms, but these numerical differences were not statistically significant and only evident at 12 weeks. A significantly higher proportion of participants in the amisulpride group had at least one adverse event compared with the control group ( p = 0.014), and these were more likely to be cardiac symptoms. Conclusions: Treatment for more than 6 weeks may be required for an adequate trial of clozapine augmentation with amisulpride. The greater side-effect burden associated with this treatment strategy highlights the need for safety and tolerability monitoring, including vigilance for indicators of cardiac abnormalities, when it is used in either a clinical or research setting.

scholarly journals Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial

2017 ◽  
Vol 45 (2) ◽  
pp. 647-661 ◽  
Author(s):  
Pamela M. Lai ◽  
Agron Collaku ◽  
Kenneth Reed
Keyword(s):  
Ankle Sprain ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Complete Recovery ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Application Site ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Adolescents And Adults

Purpose This study was performed to evaluate topical 1% diclofenac/3% menthol gel in treating ankle sprain. Design In this randomized, double-blind, placebo-controlled trial, adolescents and adults with acute ankle sprain (N = 385) applied 4 g of gel containing 1% diclofenac/3% menthol (n = 117), 1% diclofenac (n = 112), 3% menthol (n = 77), or placebo (n = 75) four times daily. The primary outcome was the area under the curve of pain intensity (PI) on movement [0 (no pain) to 10 (extreme pain)] from 24 to 72 hours post-application (AUC1–3 days). Secondary outcomes included pain relief (PR); PI; time to onset of PR, meaningful PR, cooling, and complete recovery; PI difference; sum of PI difference; total PR; reduction in ankle swelling; and the patient’s global assessment of response to treatment. Results There were no statistically significant differences in AUC1–3 between 1% diclofenac/3% menthol and placebo, diclofenac, or menthol gels and no meaningful advantages of 1% diclofenac/3% menthol for any secondary outcome. There was a higher incidence of skin and application-site events with 1% diclofenac/3% menthol than with placebo or 1% diclofenac. Conclusion No significant improvement was observed with topical 1% diclofenac/3% menthol gel compared with placebo, 1% diclofenac, or 3% menthol gel in treating pain from ankle sprain. ClinicalTrials.Gov Identifier: NCT02100670

scholarly journals Adverse reactions to influenza vaccine in elderly people: randomised double blind placebo controlled trial.

BMJ ◽  
1993 ◽  
Vol 307 (6910) ◽  
pp. 988-990 ◽  
Author(s):  
T M Govaert ◽  
G J Dinant ◽  
K Aretz ◽  
N Masurel ◽  
M J Sprenger ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Elderly People ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo
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