A Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Trial of O-(β-Hydroxyetnyl)-Rutosides in Chronic Arm Oedema Resulting from Breast Cancer Treatment

1995 ◽  
Vol 10 (2) ◽  
pp. 51-55 ◽  
Author(s):  
P. S. Mortimer ◽  
C. Badger ◽  
I. Clarke ◽  
J. Pallett
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Controlled Clinical Trial ◽  
Point Scale ◽  
Carcinoma Of The Breast ◽  
Double Blind ◽  
Parallel Group ◽  
Royal Marsden Hospital ◽  
The Difference

Objective: To assess the efficacy of O-(β-hydroxyethyl)-rutosides (HR) in the treatment of breast-cancer-related lymphoedema. Design: A double-blind, randomized, parallel-group, placebo-controlled clinical trial. Setting: Lymphoedema clinic, Royal Marsden Hospital, London, UK. Patients: Forty-six females with unilateral lymphoedema of the arm secondary to therapy for carcinoma of the breast. Main outcome measures: Arm volume, symptom assessment on a five-point scale. Results: The difference in arm volumes was significantly better for HR than placebo at 6 months, but not at 1–5 months. Conclusion: HR appears to stabilize the patients' condition against increasing lymphoedema in the placebo group.

scholarly journals Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

2020 ◽  
Author(s):  
Fatemeh Roozbeh ◽  
Majid Saeedi ◽  
Reza Alizadeh-Navaei ◽  
Akbar Hedayatizadeh-Omran ◽  
Shahin Merat ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Difference ◽  
Novel Coronavirus ◽  
Loss Of Appetite

Abstract Introduction Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection. Methods This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1. Results Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P < 0.001. Conclusions In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.

scholarly journals Arthritis prevention in the pre-clinical phase of RA with abatacept (the APIPPRA study): a multi-centre, randomised, double blind, parallel group placebo-controlled clinical trial Protocol

2019 ◽  
Author(s):  
Mariam Al-Laith ◽  
Marianna Jasenecova ◽  
Sonya Abraham ◽  
Aisla Bosworth ◽  
Ian N. Bruce ◽  
...  
Keyword(s):  
At Risk ◽  
Controlled Trial ◽  
Hospital Setting ◽  
Placebo Treatment ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Duration Of Treatment ◽  
Double Blind ◽  
Clinical Phase ◽  
Parallel Group

Abstract Trial design: We present a study protocol for a multi-centre, randomised, double blind, parallel group, placebo-controlled trial that seeks to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first-in-class costimulatory blocker abatacept for preventing or delaying the onset of inflammatory arthritis. Methods: The study aimed to recruit 206 male or female subjects from the secondary care hospital setting across the UK and the Netherlands. Participants aged 18 or over who report inflammatory sounding joint pain (clinically suspicious arthralgia) and who are found to be positive for serum autoantibodies associated with RA were eligible for enrolment. All study subjects were randomised to receive weekly injections of investigational medicinal product (IMP), either abatacept or placebo treatment over a 52-week period. Participants were then followed up for a further 52 weeks. The primary endpoint was defined as the time to development of ≥ 3 swollen joints, or to the fulfilment of the 2010 ACR/EULAR classification criteria for RA using swollen but not tender joints, whichever endpoint was met first. In either case, swollen joints were confirmed by ultrasonography. Participants, care givers, and those assessing the outcomes were all blinded to group assignment. Clinical assessors and ultrasonographers were also blinded to each other’s assessments for the duration of the study. Conclusions: There is limited experience of the design and implementation of trials for the prevention of inflammatory joint diseases. We discuss the rationale behind choice and duration of treatment, the challenges associated with defining the “at risk” state, and offer pragmatic solutions in the protocol to enrolling subjects at risk of RA. Trial registration: Current Controlled Trials, ID: ISRCTN46017566. Registered on 04 July 2014.

Management of Hot Flashes in Patients Who Have Breast Cancer With Venlafaxine and Clonidine: A Randomized, Double-Blind, Placebo-Controlled Trial

2011 ◽  
Vol 29 (29) ◽  
pp. 3862-3868 ◽  
Author(s):  
Annelies H. Boekhout ◽  
Andrew D. Vincent ◽  
Otilia B. Dalesio ◽  
Joan van den Bosch ◽  
Joke H. Foekema-Töns ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Group Versus ◽  
Primary Objective ◽  
Double Blind ◽  
Hot Flash ◽  
Double Blind Placebo ◽  
History Of ◽  
The Difference

Purpose Therapies for breast cancer may induce hot flashes that can affect quality of life. We undertook a double-blind, placebo-controlled trial with the primary objective of comparing the average daily hot flash scores in the twelfth week among patients treated with venlafaxine, clonidine, and placebo. Additional analyses of the hot flash score over the full 12 weeks of treatment were performed. Patients and Methods In all, 102 patients with a history of breast cancer were randomly assigned (2:2:1) to venlafaxine 75 mg, clonidine 0.1 mg, or placebo daily for 12 weeks. Questionnaires at baseline and during treatment assessed daily hot flash scores, sexual function, sleep quality, anxiety, and depression. Results After 12 weeks, a total of 80 patients were evaluable for the primary end point. During week 12, hot flash scores were significantly lower in the clonidine group versus placebo (P = .03); for venlafaxine versus placebo, the difference was borderline not significant (P = .07). However, hot flash scores were equal in the clonidine and venlafaxine groups. Over the course of 12 weeks, the differences between both treatments and placebo were significant (P <.001 for venlafaxine v placebo; P = .045 for clonidine v placebo). Frequencies of treatment-related adverse effects of nausea (P = .02), constipation (P = .04), and severe appetite loss were higher in the venlafaxine group. Conclusion Venlafaxine and clonidine are effective treatments in the management of hot flashes in patients with breast cancer. Venlafaxine resulted in a more immediate reduction of hot flash scores when compared with clonidine; however, hot flash scores at week 12 were lower in the clonidine group than in the venlafaxine group.

The efficacy and safety of sc Alniditan vs. sc Sumatriptan in the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial

Cephalalgia ◽  
2001 ◽  
Vol 21 (6) ◽  
pp. 672-679 ◽  
Author(s):  
HC Diener ◽  
P Tfelt-Hansen ◽  
F de Beukelaar ◽  
MD Ferrari ◽  
J Olesen ◽  
...  
Keyword(s):  
Adverse Event ◽  
Controlled Trial ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Recurrence Rates ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Headache Severity ◽  
Parallel Group ◽  
The Difference

This double-blind, placebo-controlled, parallel-group, multicentre, multinational, phase-III trial was designed to assess the efficacy and safety of a single subcutaneous injection of placebo, 2 doses of alniditan (1.4 mg and 1.8 mg) and 6 mg of sumatriptan in subjects with acute migraine. A total of 114 investigators from 13 different countries screened 2021 subjects. In total 924 patients were treated with placebo (157), alniditan 1.4 mg (309), alniditan 1.8 mg (141) and sumatriptan 6 mg (317). The lower number of subjects in the alniditan 1.8 mg group is due to the termination of this trial arm after the incidence of a serious adverse event and a subsequent protocol amendment. The number of subjects who were pain free at 2 h (primary endpoint) was: 22 (14.1%) with placebo, 174 (56.3%) with alniditan 1.4 mg, 87 (61.7%) with alnditan 1.8 mg and 209 (65.9%) with sumatriptan 6 mg. Alniditan 1.4 mg was significantly better ( P < 0.001) than placebo and sumatriptan was significantly better ( P = 0.015) than alniditan 1.4 mg. The number of responders (reduction of headache severity from moderate or severe headache before treatment to mild or absent at 2 h), was 59 (37.8%) on placebo, 250 (80.9%) on alniditan 1.4 mg, 120 (85.1%) on alniditan 1.8 mg, and 276 (87.1%) on sumatriptan. Response was significantly higher ( P < 0.001) with alniditan 1.4 mg than with placebo, and significantly lower ( P = 0.036) with alniditan 1.4 mg than with sumatriptan. Recurrence rates were: 22 (37.3%) with placebo, 87 (34.8%) with alniditan 1.4 mg, 35 (29.2%) with alniditan 1.8 mg and 108 (39.1%) with sumatriptan. Adverse events occurred in 577/924 (62.4%) subjects, i.e. in 62/157 (39.5%) with placebo, 214/309 (69.3%) with alniditan 1.4 mg, 91/141 (64.5%) with alniditan 1.8 mg and 210/317 (66.2%) with sumatriptan 6 mg. Sumatriptan was significantly better than alniditan 1.4 mg for pain free at 2 h. The difference, however, was small and clinically not important. For alniditan, a dose-dependent adverse event relationship was seen. The safety profile of alniditan 1.4 mg was similar to that of sumatriptan.

scholarly journals Efficacy and Safety of Levamisole Treatment in Clinical Presentations of Patients With COVID-19: A Double-Blind, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Amir Roostaei ◽  
Zohre Akhoundi Meybodi ◽  
Seyed Rohollah Mosavinasab ◽  
Iman Karimzadeh ◽  
Adeleh Sahebnasagh ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinical Status ◽  
Clinical Importance ◽  
Routine Care ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Old Patients ◽  
Clinical Presentations ◽  
Clinical Benefits ◽  
The Difference

Abstract BackgroundIn late December 2019, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) was identified as the cause of a series of pneumonia cases in China. Levamisole can show clinical benefits in management of COVID-19 by its immunomodulatory effect, but effect in clinical status of patients is unknown. We evaluated the efficacy of levamisole on clinical status of patients with COVID-19 on days 3, 7, and 14.MethodsThis prospective, double-blind, randomized, and controlled clinical trial was performed in 18- to 60-year-old patients with confirmed COVID-19 from late April 2020 to mid-August 2020. Patients were randomly assigned to two groups to receive a 5-day course of levamisole or placebo in combination with routine care. Results50 patients with COVID-19 were analyzed: 25 patients were in each group. More than half of the infected patients was men too (60%). On days 3 and 14, patients in Levamisole group had significantly better cough status distribution compared with Placebo (P=0.034 and 0.005, respectively). The difference in fever status on days 1, 3, 7, and 14 between two groups was not statistically significant (P > 0.05). There was significant differences between two groups in dyspnea over a median follow-up of 7th (P=0.015) and 14th (P=0.010) days after receiving the interventions. ConclusionThe results of the current study have overall demonstrated that patients receiving levamisole had significantly higher odds of having a better clinical status including cough and Dyspnea on day 14 than those receiving placebo, but with an effect-size of unsure clinical importance. The difference in the distribution of fever on days 3, 7, and 14 between two groups was not significant, suggesting that levamisole can efficiently improve the most clinical status of patients with COVID-19 infectious compared to placebo.Trial registrationThe trial was registered as IRCT20190810044500N7 (19/09/2020).

scholarly journals How well do doctors understand a scientific article in English when it is not their first language? A randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e043444
Author(s):  
Martine Rostadmo ◽  
Siri Lunde Strømme ◽  
Magne Nylenna ◽  
Pal Gulbrandsen ◽  
Erlend Hem ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
First Language ◽  
Review Article ◽  
Scientific Article ◽  
Potential Range ◽  
Parallel Group ◽  
The Difference ◽  
Randomised Controlled ◽  
Primary Care Medicine

IntroductionEnglish is the lingua franca of science. How well doctors understand English is therefore crucial for their understanding of scientific articles. However, only 5% of the world’s population have English as their first language.MethodsObjectives: To compare doctors’ comprehension of a scientific article when read in their first language (Norwegian) versus their second language (English). Our hypothesis was that doctors reading the article in Norwegian would comprehend the content better than those reading it in English.Design: Parallel group randomised controlled trial. We randomised doctors to read the same clinical review article in either Norwegian or English, before completing a questionnaire about the content of the article.Setting: Conference in primary care medicine in Norway, 2018.Participants: 130 native Norwegian-speaking doctors, 71 women and 59 men. One participant withdrew before responding to the questionnaire and was excluded from the analyses.Interventions: Participants were randomly assigned to read a review article in either Norwegian (n=64) or English (n=66). Reading time was limited to 7 min followed by 7 min to answer a questionnaire.Main outcome measures: Total score on questions related to the article content (potential range −9 to 20).ResultsDoctors who read the article in Norwegian had a mean total score of 10.40 (SD 3.96) compared with 9.08 (SD 3.47) among doctors who read the article in English, giving a mean difference of 1.32 (95% CI 0.03 to 2.62; p=0.046). Age was independently associated with total score, with decreased comprehension with increasing age.ConclusionThe difference in comprehension between the group who read in Norwegian and the group who read in English was statistically significant but modest, suggesting that the language gap in academia is possible to overcome.

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020

scholarly journals Genomic Risk Prediction for Breast Cancer in Older Women

Cancers ◽  
2021 ◽  
Vol 13 (14) ◽  
pp. 3533
Author(s):  
Paul Lacaze ◽  
Andrew Bakshi ◽  
Moeen Riaz ◽  
Suzanne G. Orchard ◽  
Jane Tiller ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Older Women ◽  
Risk Prediction ◽  
Prediction Models ◽  
Cox Regression ◽  
Susceptibility Genes ◽  
Controlled Clinical Trial ◽  
Polygenic Risk Score ◽  
Double Blind ◽  
Genomic Risk

Genomic risk prediction models for breast cancer (BC) have been predominantly developed with data from women aged 40–69 years. Prospective studies of older women aged ≥70 years have been limited. We assessed the effect of a 313-variant polygenic risk score (PRS) for BC in 6339 older women aged ≥70 years (mean age 75 years) enrolled into the ASPREE trial, a randomized double-blind placebo-controlled clinical trial investigating the effect of daily 100 mg aspirin on disability-free survival. We evaluated incident BC diagnoses over a median follow-up time of 4.7 years. A multivariable Cox regression model including conventional BC risk factors was applied to prospective data, and re-evaluated after adding the PRS. We also assessed the association of rare pathogenic variants (PVs) in BC susceptibility genes (BRCA1/BRCA2/PALB2/CHEK2/ATM). The PRS, as a continuous variable, was an independent predictor of incident BC (hazard ratio (HR) per standard deviation (SD) = 1.4, 95% confidence interval (CI) 1.3–1.6) and hormone receptor (ER/PR)-positive disease (HR = 1.5 (CI 1.2–1.9)). Women in the top quintile of the PRS distribution had over two-fold higher risk of BC than women in the lowest quintile (HR = 2.2 (CI 1.2–3.9)). The concordance index of the model without the PRS was 0.62 (95% CI 0.56–0.68), which improved after addition of the PRS to 0.65 (95% CI 0.59–0.71). Among 41 (0.6%) carriers of PVs in BC susceptibility genes, we observed no incident BC diagnoses. Our study demonstrates that a PRS predicts incident BC risk in women aged 70 years and older, suggesting potential clinical utility extends to this older age group.

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