Novel approach for cancer-related fatigue: A double-blind randomized clinical trial.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 234-234
Author(s):  
Claudia Vaz De Melo Sette ◽  
Barbara Bonaparte Ribas de Alcântara ◽  
Felipe Melo Cruz ◽  
Jean Henri Maselli Schoueri ◽  
Daniel de Iracema Gomes Cubero ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chi Square ◽  
Double Blind ◽  
Significance Level ◽  
Paullinia Cupana ◽  
Cancer Related Fatigue ◽  
Institutional Review ◽  
Novel Approach ◽  
Qualitative Variables ◽  
The Difference

234 Background: Fatigue is one side effect of cancer and its treatment, and remains as the most prevalent symptom for those who survived. To date, the search for novel approaches regarding Cancer-Related Fatigue persists. As such, Paullinia cupana – a medicinal plant – has shown promising results for the treatment of chemotherapy-induced fatigue. Methods: We conducted a phase II randomized double-blind clinical trial, in which we compared a standardized dry purified Paullinia cupana extract (PC-18) - in doses of 7.5 mg and 12.5 mg given orally twice a day - to placebo for the treatment of fatigue in women with early breast cancer scheduled to receive their first cycle of adjuvant systemic chemotherapy. Only patients that experienced increase in the score of either BFI, HAD or Chalder fatigue scales following the first cycle of chemotherapy were included. For possible associations between qualitative variables, Chi-square test was used. Poisson regression was used to test for the relationship between the drug used and the outcome regarding the difference assessed in scores aforementioned. The significance level was 5%. The program used was Stata 12.0. This study has been approved by our Institutional Review Board (number: 34327214.1.1001.0082) and participants have all signed informed consent forms. Results: PC-18 on 7.5 mg has not been statistically significant with any improvements on assessed scores when compared to placebo (IRR 0.99 [CI] 0.81 – 1.23, p = 0.958 for BFI; IRR 1.04 [CI] 0.56 – 1.95, p = 0,898 for HAD; IRR 0.95 [CI] 0.75 – 1.19, p = 0.645 for Chalder), while greater dosage (12.5mg) has shown the following outcomes regarding the scores (IRR 0.49 [CI] 0.30 – 0.81, p = 0.005 for BFI; IRR 0.89 [CI] 0.45 – 1.76, p = 0,735 for HAD; IRR 0.99 [CI] 0.80 – 1.23, p = 0.914 for Chalder) in the same comparison. Conclusions: Disregarding preliminary data on previous studies, PC-18 has not shown to be better than placebo. Clinical trial information: 34327214.1.1001.0082.

Effect of chamomile oil on cesarean section pain in primiparous women: a randomized clinical trial

2020 ◽  
Vol 15 ◽  
Author(s):  
Roghayeh Zardosht ◽  
Ameneh Basir ◽  
Amirhossein Sahebkar ◽  
Seyed Ahmad Emami
Keyword(s):  
Clinical Trial ◽  
Cesarean Section ◽  
Pain Intensity ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Chi Square ◽  
Double Blind ◽  
The Difference ◽  
Primiparous Women

Background: Pain after cesarean section can turn the pleasant event of childbirth into an unpleasant experience for the mother. Pain relief through non-pharmaceutical methods, such as aromatherapy, could potentially be a useful intervention. In this study, the analgesic effect of chamomile oil was studied. Purpose: The current research was conducted to study the effect of chamomile oil on cesarean section pain in primiparous women. Materials and methods: This was a randomized double blind clinical trial wherein 128 primiparous pregnant women (who willingly selected cesarean section) took part. In the aromatherapy group, the subjects inhaled one drop of 5% chamomile oil, and in the control group the subjects inhaled one placebo drop. In both groups the subjects inhaled for 15-20 minutes at a distance of 5 cm from the nose at 4, 8, and 12 hours after surgery, and pain intensity was measured before and after half an hour after inhalation using the visual analog scale (VAS). For data analysis, the software SPSS (version 25) and descriptive statistics (frequency, frequency percentage, mean, and standard deviation) were used. In order to determine the significance, inferential statistics (Mann-Whitney, Wilcoxon, independent t-test, and Chi-square) were used. Findings: Data indicated that the intervention and placebo groups were homogeneous in terms of demographic variables. The average weights and heights of women in the intervention group were 86/5± 5/9 and 163/7 ±5/1, respectively. Corresponding values women in the control group were 84/5± 5/7 kg and 163/4± 5/8 cm. The finding of the current research indicates that the intervention and placebo groups showed no significant statistical difference in terms of baseline pain before intervention (p=0.08), while the difference between the two groups was significant in terms of pain 4, 8, and 12 hours after intervention (p<0.01). Therefore, inhalation of chamomile oil reduced pain intensity significantly compared to post-intervention. Conclusion: According to the results of the present study, inhalation of chamomile oil following caesarean section in primiparous women reduced pain and also the need for analgesics. Therefore, the use of aromatherapy with chamomile oil as a simple way without any side effects for the reduction of pain in mothers after cesarean section is recommended.

Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo

2020 ◽  
pp. bmjspcare-2020-002454
Author(s):  
Carlos Centeno ◽  
Rocío Rojí ◽  
Maria Angustias Portela ◽  
Ana De Santiago ◽  
Miguel Angel Cuervo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Advanced Cancer ◽  
Randomised Clinical Trial ◽  
Assessment System ◽  
Double Blind ◽  
Cancer Related Fatigue ◽  
Severe Fatigue ◽  
Registration Number ◽  
The Difference

IntroductionMethylphenidate is a psychostimulant drug used to treat fatigue in patients with advanced cancer, for which there is no gold standard of treatment.ObjectiveTo explore the efficacy of methylphenidate in the relief of fatigue in patients with advanced cancer.Materials and methodsA randomised double-blind placebo-controlled multicentre clinical trial, stratified according to the intensity of fatigue. The treatment was considered effective if the improvement in mean fatigue intensity between baseline values and day 6 was significantly higher in the methylphenidate group than in the placebo group. The responses were measured using the Edmonton Symptoms Assessment System (ESAS) and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scales.Results35 patients received placebo and 42 patients received methylphenidate. The populations of both groups were homogeneous. Patients receiving methylphenidate did not exhibit statistically significant improvement of fatigue in comparison to patients receiving placebo (p=0.52). The mean improvement of fatigue (ESAS) on day 6 was −1.9 (±2.5) in the placebo group, and −2.3 (±2.6) in the methylphenidate group (p=0.52). The results obtained with the FACT-F were congruent with those obtained by the ESAS. The responses in patients with severe fatigue were −2.4 (±2.9) in the placebo group and −3.4 (±2.5) in the methylphenidate group; the difference was not statistically significant (p=0.3).ConclusionMethylphenidate was not more efficient than placebo to treat cancer-related fatigue. Fatigue improved significantly after 3 days of treatment and was stabilised on day 6, both with placebo and methylphenidate. The side effects of methylphenidate were mild and infrequent.Trial registration numberEudraCT Registry (2008-002171-27).

PREEMPTIVE ANALGESIA WITH AMITRIPTYLINE IN WOMEN UNDERGOING ABDOMINAL HYSTERECTOMY: A RANDOMIZED CLINICAL TRIAL

2020 ◽  
pp. 2-5
Author(s):  
Antônio Henriques De França Neto ◽  
Alexandre Magno Nóbrega Marinho ◽  
Eveline Pereira De Arruda Agra ◽  
Priscilla Guimarães Alves ◽  
Josikwylkson Costa Brito ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Pressure Pain Threshold ◽  
Abdominal Hysterectomy ◽  
Tricyclic Antidepressant ◽  
Preemptive Analgesia ◽  
Chi Square ◽  
Double Blind ◽  
Exact Test ◽  
Student’S T

The concept of preemptive analgesia, albeit long-standing, has reemerged. Consequently, recent research has focused on testing a variety of drugs preoperatively to prevent the occurrence of postoperative pain, a major factor of morbidity. Amitriptyline is a tricyclic antidepressant used to treat chronic pain. Because amitriptyline acts on pain transmission pathways, it could theoretically be used as an agent for the prevention of postoperative pain. This study evaluated the effectiveness of amitriptyline in preventing pain in patients submitted to hysterectomy, the most commonly performed gynecological surgery. A randomized, double-blind clinical trial was conducted with 145 patients, 72 of these receiving amitriptyline and 73 placebo. All patients were evaluated at 6, 12, 24 and 48 hours after surgery using a visual analog scale (VAS) for pain and algometry to determine the pressure-pain threshold. Statistical analysis was conducted using the chi-square test of association, Student's t-test, and the Mann-Whitney test, with Fisher's exact test being used whenever appropriate. No statistically signicant difference was found between the two groups with respect to pain at any of the time points evaluated, leading to the conclusion that at a dose of 25 mg, amitriptyline is ineffective in preventing postoperative pain in patients submitted to abdominal hysterectomy

scholarly journals A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Shifu Xiao ◽  
Piu Chan ◽  
Tao Wang ◽  
Zhen Hong ◽  
Shuzhen Wang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Controlled Trial ◽  
Drug Effects ◽  
Disease Assessment ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Difference

Abstract Background New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China. Methods We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was − 2.15 points (95% confidence interval, − 3.07 to − 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group. Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated. Trial registration ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014

scholarly journals Knowledge and ability to manage medical emergencies among dental students

2021 ◽  
Vol 7 (3) ◽  
pp. 161-166
Author(s):  
Chitturi Prashanthi ◽  
Prashant B Patil ◽  
Vajendra Joshi ◽  
Kiran Kumar K R ◽  
Shilpa R T
Keyword(s):  
Life Support ◽  
Dental Students ◽  
Medical Emergency ◽  
Cross Sectional Survey ◽  
Chi Square ◽  
Cross Sectional ◽  
Significance Level ◽  
Chi Square Test ◽  
Medical Emergencies ◽  
The Difference

: An emergency can be encountered anytime and anywhere. Minimal knowledge about medical emergency and their etiology, primary protocol for management must be known to avoid potential consequences. Hence, the present study was undertaken to compare the knowledge, and ability to handle the medical emergencies among the dental students. A cross-sectional survey was conducted among 100 randomly selected dental students (post-graduate students and interns) comprising of two groups of students those who had underwent training and those who did not. The data obtained was analyzed using the SPSS for windows version 22.0 released 2013. Independent chi square test was used for comparison of responses and independent student t-test was used for the comparison of mean scores. The significance level was set at p&#60;0.001. : The average mean knowledge and ability score was 68% & 61.4% respectively among the participants. On further comparison of mean knowledge & ability scores between the participants with & without basic life support training, participants with BLS training showed better knowledge than those without training and the difference was statistically significant between the two groups (p&#60;0.001%). The study found deficiencies in the knowledge and ability of untrained graduates to deal with medical emergencies as compared to trained.

A Comparative Trial of Opipramol and Chlordiazepoxide in the Treatment of Anxiety

1973 ◽  
Vol 1 (3) ◽  
pp. 145-150 ◽  
Author(s):  
K Jepson ◽  
G Beaumont
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Rating Scale ◽  
Comparative Trial ◽  
Anxiety Score ◽  
Double Blind ◽  
Somatic Anxiety ◽  
Daily Dose ◽  
The Difference

A daily dose of 200 mg of opipramol (Insidon, Geigy) and 30 mg of chlordiazepoxide (Librium, Roche) were compared in a clinical trial in general practice. The trial was double blind and a stratified randomisation technique was employed. Twenty four patients received opipramol and twenty six chlordiazepoxide for four weeks. A total anxiety score and separate ‘psychic’ anxiety and ‘somatic’ anxiety scores were recorded, using a rating scale initially and after two and four weeks treatment. No overall difference in efficacy was found between the two drugs—opipramol producing a 76% improvement and chlordiazepoxide 64% by the end of the study. There was no difference in the relief of psychic anxiety. Although opipramol appeared to give more relief of somatic anxiety, the difference was not statistically significant. Again although opipramol relieved more individual symptoms than chlordiazepoxide, none of the differences were significant. 70% of patients on opipramol and 74% of those on chlordiazepoxide were classified ‘better’ globally by both doctor and patient by the end of the trial. The total number of side effects recorded was similar on both drugs although drowsiness occurred twice as frequently on chlordiazepoxide as it did on opipramol.

Screening cancer patients for clinical trial eligibility: A randomized study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6529-6529
Author(s):  
J. Wright ◽  
T. Whelan ◽  
J. Julian ◽  
M. Simunovic ◽  
M. Levine
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Primary Outcome ◽  
Randomized Study ◽  
Secondary Analysis ◽  
Chi Square ◽  
Ongoing Research ◽  
Number Of Patients ◽  
The Difference

6529 Background: The overall proportion of cancer patients enrolled into clinical trials is undesirably low. Research suggests many aspects of the recruitment process can be improved. The present study was undertaken to evaluate the benefit of identifying potentially eligible (PE) clinical trial patients for physicians. Methods: Consenting physicians were randomized to 26 weeks of screening support or not, and were then crossed-over to the other strategy for a second 26-week time period. A computer program reviewed new patient consultations to identify PE clinical trial patients. Physicians receiving support were provided with written individualized details of patient eligibility for trials prior to their medical consultation. The primary outcome of interest was the difference, by physician, in the number of patients who were approached for consent to enter a clinical trial. Results: Thirty-six physicians participated in the 52-week study. 5051 consultations were screened in a blinded fashion, 2,376 when physicians had support and 2,675 when they did not. 939 of 2,376 (39.5%) consultations were identified as involving PE patients when physicians were receiving support, and 1,061 of 2,675 (39.7%) when without. The primary outcome of the study, by physician, did not demonstrate a statistically significant improvement, with 4.1 patients per physician without vs. 4.7 patients with screening support (p>0.05). Secondary analysis demonstrated that the overall proportion of patients approached with the clinical trial option increased from 149/2,675 (5.6%) to 169/2,376 (7.1%) with screening support (Chi-square, p=0.024) and that the number of patients that entered a clinical trial also increased from 60/2,675 (2.2%) to 83/2,376 (3.5%) (Chi-square, p=0.007). Conclusions: This study suggests that individualized patient screening for clinical trial eligibility may be useful to improve the numbers of patients approached to consider clinical trials. The number of new patients that entered clinical trials remained low, and ongoing research to facilitate improvements is required. No significant financial relationships to disclose.

An experimental double-blind clinical trial method in homoeopathy

1986 ◽  
Vol 75 (03) ◽  
pp. 142-147 ◽  
Author(s):  
Peter Fisher
Keyword(s):  
Clinical Trial ◽  
Statistical Methods ◽  
Controlled Trials ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Novel Approach ◽  
Double Blind Clinical Trial ◽  
Non Parametric

AbstractA small number of double-blind, placebo-controlled trials of homœopathic treatment in rheumatological conditions have been carried out. These have used differing methodologies, leading to varying results. This paper describes a novel approach in the treatment of fibrositis, a syndrome which lacks a pathological definition, but is defined solely in terms of its symptomatology.24 patients were prescribed for 3 months, according to indication, one of three homœopathic remedies (Arnica, Bryonia, Rhus tox.), each patient remaining on the same remedy throughout. They were followed monthly on the following parameters: pain, number of tender spots and sleep. An ‘indication score’ was allotted to each prescription. The results were analyzed by non-parametric statistical methods, showing that homœopathy produced a statistically significant improvement, but only when the prescribed remedy was well indicated.

scholarly journals The Difference of Lymphocyte, hs-CRP, and Electroencephalogram with and without Simvastatin in Acute Ischemic Stroke

2020 ◽  
Vol 26 (3) ◽  
Author(s):  
Chairil Amin Batubara ◽  
Aldy Safruddin Rambe ◽  
Nindia Sugih Arto
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Epileptic Seizures ◽  
Chi Square ◽  
Double Blind ◽  
Mortality And Morbidity ◽  
Randomized Control Trial Design ◽  
Significant Difference ◽  
The Difference ◽  
Hs Crp

Mortality and morbidity due to stroke rank the highest in Indonesia (15.4%), and most types of stroke are ischemic (87%). Inflammation has a role in the pathophysiology of both ischemic stroke and also inhibits acute symptomatic epileptic seizures (3-6%) in the first 7 days after stroke. Statins have been used for the treatment of dyslipidemia in stroke patients. Some studies showed that statins reduced the inflammatory response after a stroke and prevented the recovery of epileptic seizures. This study aimed to determine the differences in lymphocytes, hs-CRP, Electroencephalogram (EEG) with and without Simvastatin in acute ischemic stroke. This research was an experimental study with a double-blind, randomized control trial design consisting of two groups, a group given Simvastatin 20 mg/day, and a group given a placebo for seven days. The difference in lymphocytes, hs-CRP, EEG, and epileptic seizures between the two groups were then analyzed. The sample was 26 people, consisting of 17 (65.4%) males and 9 (34.6%) females with an average age of 59±5.8 years. Chi-Square and Fisher's test showed a significant difference in hs-CRP (p=0.005) and epileptic seizures (p=0.015), but no significant difference in lymphocytes (p=0.336) and EEG (p=0.42) between groups given Simvastatin 20 mg/day and those given placebo. There was a significant difference in hs-CRP and epileptic seizures, but no significant difference in lymphocyte count and EEG between the two groups with and without Simvastatin administration.

scholarly journals A 36-week Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group, Phase 3 Clinical Trial of Sodium Oligomannate for Mild-to-Moderate Alzheimer's Dementia

2020 ◽  
Author(s):  
Shifu Xiao ◽  
Piu Chan ◽  
Tao Wang ◽  
Zhen Hong ◽  
Shuzhen Wang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Controlled Trial ◽  
Drug Effects ◽  
Disease Assessment ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Difference

Abstract Background: New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide which reconstitutes gut microbiota, reduces neuroinflammation, decreases amyloid deposition, and improves cognition in AD animal models. The first phase 3 clinical trial of GV-971 has been completed in China. Methods: We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results: 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time-point, measurable at the week 4 visit and continuing throughout the trial. The difference between groups in change from baseline was −2.15 points (95% confidence interval, −3.07 to −1.23; P<0.0001; effect size 0.531) after 36 weeks treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group.Conclusions: GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well tolerated. Trial registration: ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014.

Sign in / Sign up

Export Citation Format

Share Document