scholarly journals Evaluation of an Experimental Pain Model by Noncompartmental Analysis of Results from a Randomized Placebo Controlled Trial

2018 ◽  
Vol 1 (21;1) ◽  
pp. 363-372
Author(s):  
France Varin
Keyword(s):  
Active Treatment ◽  
Controlled Trial ◽  
Experimental Pain ◽  
The Elderly ◽  
Pain Tolerance ◽  
Age Group ◽  
Noncompartmental Analysis ◽  
Time Curve ◽  
Pain Model ◽  
Significant Difference

Background: Understanding analgesic pharmacodynamics (PD) in the elderly is key to optimising pain management. Electrically stimulated pain models (ESPM) permit assessment of pain responses in humans. C and Aδ sensory fibres convey pain and respond to low frequency electrical stimulus (5 and 250 Hz, respectively). Human research suggests pain tolerance threshold (PTT) is similar or decreases with age. Objectives: To determine whether an ESPM is able to detect a difference in PTT in elderly (≥ 75 years) and young (20-40 years) subjects after single dose administration of a placebo and tramadol, a low potency analgesic. Study Design: Two-cohort, randomized, placebo-controlled, cross-over study. Methods: A noncompartmental analysis of data at 17 timepoints on 5 Hz and 250 Hz PTT over 24 h. Results: Young (16) and elderly (13) patients showed similar baseline (E0) PTT between active and placebo both overall and by age group in both frequencies. Net drug effect took into account negative and positive changes from E0. In the elderly, net peak effect on PTT produced by active treatment was significantly greater for both 5 Hz (34%) and 250 Hz (30%). Net area under the 24-h effect-time curve during active treatment was significantly higher for both 5 Hz (163 %) and 250 Hz (175%) stimulations in the elderly. No clinically significant difference was observed in the young. Limitations: High variability in young subjects, despite efforts to remove outliers limited our ability to draw conclusions in that age group. Generalizability of results obtained from an experimental pain model in volunteers to treatment of elderly patients may be limited. Conclusion: ESPM can detect a difference for pain tolerance threshold between placebo and tramadol administration in the elderly. Although both 5 Hz and 250 Hz stimulations can detect a difference, the effect size for 5 Hz is larger and seems more precise and reliable, particularly in the elderly. Key words: Electrical pain model, elderly, geriatric, tramadol, placebo, opioid, area under the effect curve, noncompartmental analysis

scholarly journals Overview of hospitalizations by ambulatory care sensitive conditions in the municipality of Cotia, Brazil

2014 ◽  
Vol 48 (spe) ◽  
pp. 137-144
Author(s):  
Renata Laszlo Torres ◽  
Suely Itsuko Ciosak
Keyword(s):  
Heart Failure ◽  
Urinary Tract ◽  
The Elderly ◽  
Cerebrovascular Diseases ◽  
Descriptive Statistics ◽  
Ambulatory Care Sensitive Conditions ◽  
Age Group ◽  
Unified Health System ◽  
Significant Difference ◽  
Sensitive Conditions

Objective To describe the profile of Hospitalizations by Amulatory Care Sensitive Conditions (HACSC), in the Municipality of Cotia, from 2008 to 2012. Method ecological, exploratory, longitudinal study with a quantitative approach. Data on HACSC, by age group and sex, were obtained from the Department of the Unified Health System. For data analysis descriptive statistics were used. Results During the period, there were 46,676 admissions, excluding deliveries, 7,753 (16.61%) by HACSC. The main causes were cerebrovascular diseases, 16.96%, heart failure, 15.50%, hypertension, 10.80% and infection of the kidney and urinary tract, 10.51%. Regarding gender, HACSC occurred predominantly in males. There was a greater number of HACSC at extreme age ranges, especially in the elderly. Conclusion Chronic diseases predominate among the leading causes of HACSC and there was no significant difference between sex.





scholarly journals Randomised Double-Blind Trial of Combination Antibiotic Therapy in Rheumatoid Arthritis

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Angela Smith ◽  
Caroline Doré ◽  
Peter Charles ◽  
Alena Vallance ◽  
Tara Potier ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Placebo Group ◽  
Active Treatment ◽  
Active Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Good Evidence ◽  
Double Blind ◽  
Acr20 Response ◽  
Significant Difference

Objective. A combination of intravenous clindamycin and oral tetracycline has been used for many years as a treatment for active rheumatoid arthritis (RA), despite the absence of good evidence for its efficacy. A single-blind pilot study of this therapy suggested that a double-blind placebo-controlled trial was warranted.Methods. Patients with active RA were randomised in a 2 : 1 ratio to receive active treatment or placebo for 25 weeks. The active treatment consisted of intravenous clindamycin in a reducing regime, and oral tetracycline twice daily three times a week. 50 patients were to be recruited. The primary outcome measure was the proportion of patients achieving an ACR20 response.Results. An interim statistical analysis was performed after 20 patients had completed the study. Two patients in the active group achieved an ACR20 response, with none in the placebo group (NS). There was a better ESR20 response in the placebo group (P=.02). There were no other significant differences between the groups. The results indicated that it was unlikely that a significant difference in ACR20 response would emerge if the remaining 30 patients were recruited. The trial was therefore halted.Conclusion. This antibiotic regime is unlikely to be a valuable therapy for active rheumatoid arthritis.

scholarly journals Prevalence of osteopenia and osteoporosis among the population of southern Kyrgyzstan - A cross-sectional observational study

Biomedicine ◽  
2021 ◽  
Vol 41 (4) ◽  
pp. 742-746
Author(s):  
Tugolbai Tagaev ◽  
Farida Imanalieva ◽  
Sagynali Mamatov ◽  
Yethindra Vityala ◽  
Altynai Zhumabekova
Keyword(s):  
Observational Study ◽  
Normal Values ◽  
Age Groups ◽  
The Elderly ◽  
Similar Data ◽  
Age Group ◽  
Mineral Density ◽  
Cross Sectional ◽  
Significant Difference ◽  
People Group

Introduction and Aim: Osteoporosis is a skeletal disorder characterized by diminished bone strength that increases the risk of fracture in instances of trivial trauma. The objective was to conduct ultrasound bone densitometry in different age groups (18-60 years and older) in southern Kyrgyzstan, to identify and study the prevalence of osteopenia and osteoporosis.   Materials and Methods: In this cross-sectional observational study a total of 1200 participants were included, where 580 men and 620 women were aged between 18-60 years and older. Based on the age, the participants were divided into three groups. Bone mineral density in participants was measured using a SONOST-3000 densitometer model. The study was conducted among the population of the Osh and Jalal-Abad regions.   Results: Among the population of Osh state in the first group, normal values were found in 65.0%, osteopenia in 26.0%, and osteoporosis in 9.0% of participants. In the second group, values were significantly higher than in the first group. In the third age group, values exceeded significantly compared to the first and second groups. Similar data were obtained from the population of Jalal-Abad state, but a significant difference was found in the elderly people group with a higher percentage of osteopenia and osteoporosis.   Conclusion: The results showed the prevalence of osteopenia and osteoporosis in participants of different age categories of Osh and Jalal-Abad states, and especially in the elderly. Depending on the gender distribution, the prevalence of osteopenia and osteoporosis in our study is significantly higher in women than in men.

scholarly journals PHYSICAL ACTIVITY LEVEL, FUNCTIONAL MOBILITY AND FALL RISK IN THE ELDERLY

2020 ◽  
pp. 1-6 ◽  
Author(s):  
Raesa Andrade da Silva ◽  
Glaudson Sá Brandão ◽  
Anderson Soares Silva ◽  
Jessica Julioti Urbano ◽  
Ezequiel Fernandes de Oliveira ◽  
...  
Keyword(s):  
Physical Activity ◽  
Physical Activity Level ◽  
Execution Time ◽  
Age Groups ◽  
The Elderly ◽  
Functional Mobility ◽  
Activity Level ◽  
Age Group ◽  
Timed Up And Go ◽  
Significant Difference

Introduction: Low levels of physical activity and functional mobility lead to greater difficulty in performing activities of daily living and are directly proportional to mortality in the elderly. Thus, there are the need to create mechanisms linked to the maintenance of the functional capacity, which assure the elderly autonomy and self-confidence. Objective: To verify the level of physical activity and functional mobility in the elderly and if this functional mobility suffers interference of the age group and physical activity. Methods: The study involved the elderly aged 60 and over, living in Senhor do Bonfim (BA), in the northeastern region of Brazil, from February to July 2015. The evaluation of the subjects occurred in a single session, with physical and general clinical evaluation, as well as the collection of sociodemographic, anthropometric and self-reported morbidities through the application of questionnaires. It was also carried out the Timed Up and Go test (TUG) to verify the levels of functional mobility and level of physical activity with application of the International Questionnaire of Physical Activity (IPAQ) adapted for the elderly. Results: In this study, 127 patients were studied, predominantly female (87%) and mean age of 68 ± 7 years, and the majority of the elderly corresponded to the age group of 60 to 69 years. The elderly belonging to the group considered inactive (IPAQ up to 150 min/weekly) presented the execution time of TUG higher than the elderly in the group considered active (IPAQ > 150 min/weekly), with averaging time for carrying out the test of 10.5±2 minutes and 8.9±2 minutes respectively, with a statistically significant difference of p<0.01. And the execution time of TUG increased proportionally to the increase of the age group. Conclusion: Elderly with lower level of physical activity and belonging to the higher age groups present a higher risk of falls. Strategies should be developed to stimulate increased physical activity level and functional mobility of this population, especially among the older ones, reducing the incidence of falls and providing greater autonomy.

Full dose versus attenuated dose daunorubicin, cytosine arabinoside, and 6-thioguanine in the treatment of acute nonlymphocytic leukemia in the elderly.

1984 ◽  
Vol 2 (8) ◽  
pp. 865-870 ◽  
Author(s):  
S B Kahn ◽  
C B Begg ◽  
J J Mazza ◽  
J M Bennett ◽  
H Bonner ◽  
...  
Keyword(s):  
Median Survival ◽  
Cytosine Arabinoside ◽  
Controlled Trial ◽  
Intensive Therapy ◽  
Eastern Cooperative Oncology Group ◽  
Early Death ◽  
The Elderly ◽  
Acute Nonlymphocytic Leukemia ◽  
Survival Times ◽  
Significant Difference

Between July 1, 1981 and November 1, 1982, 45 patients with acute nonlymphocytic leukemia (age, greater than or equal to 70 years) were randomly assigned to receive induction chemotherapy using either daunorubicin, cytosine arabinoside, and 6-thioguanine in full dosage (F DAT) or an attenuated schedule of the same drugs (At DAT) as part of an Eastern Cooperative Oncology Group controlled trial. Forty patients were deemed evaluable, 20 on each arm. The overall complete remission (CR) rate for all patients in both arms was 28% (11/40). There was no significant difference in CR rates between the two arms. There were 12 early deaths (less than 60 days) in the F DAT arm compared with only five early deaths on the At DAT arm (P = .05). Due primarily to this early death rate, the median survival for the F DAT group was 29 days v 159 days for the At DAT groups (P = .02). The range of survival of the patients in CR for the At DAT group given either one or two cycles of induction therapy was 121 to 414 days, while the survival range for the F DAT CR patients was 121-186 + days. The median survival for those not achieving CR was 14 days for the F DAT group v 80 days for the At DAT (P less than .02). Fifty-nine percent of the At DAT patients spent greater than 100 days out of the hospital v 12% for the F DAT group. Attenuated chemotherapy with lower doses of DAT is the preferred induction regimen for elderly patients with acute nonlymphocytic leukemia since it causes fewer early deaths, allows a better quality of life, and yields survival times as durable as intensive therapy.

scholarly journals Effect of Progressive Head Extension Swallowing Exercise on Lingual Strength in the Elderly: A Randomized Controlled Trial

2021 ◽  
Vol 10 (15) ◽  
pp. 3419
Author(s):  
Jin-Woo Park ◽  
Chi-Hoon Oh ◽  
Bo-Un Choi ◽  
Ho-Jin Hong ◽  
Joong-Hee Park ◽  
...  
Keyword(s):  
Controlled Trial ◽  
The Elderly ◽  
Strength Increase ◽  
Oral Performance ◽  
Swallowing Function ◽  
Optimal Method ◽  
Head Extension ◽  
Strengthening Exercise ◽  
Significant Difference ◽  
Strengthening Exercises

Lingual strengthening training can improve the swallowing function in older adults, but the optimal method is unclear. We investigated the effects of a new progressive resistance exercise in the elderly by comparing with a conventional isometric tongue strengthening exercise. Twenty-nine participants were divided into two groups randomly. One group performed forceful swallow of 2 mL of water every 10 s for 20 min, and a total of 120 swallowing tasks per session at 80% angle of maximum head extension. The other group performed five repetitions in 24 sets with a 30 s rest, and the target level was settled at 80% of one repetition maximum using the Iowa Oral Performance Instrument (IOPI). A total of 12 sessions were carried out by both groups over a 4-week period. Blinded measurements (for maximum lingual isometric pressure and peak pressure during swallowing) were obtained using IOPI before exercise and at four weeks in both groups. After four weeks, both groups showed a significant improvement in lingual strength involving both isometric and swallowing tasks. However, there was no significant difference between the groups in strength increase involving both tasks. Regardless of the manner, tongue-strengthening exercises substantially improved lingual pressure in the elderly with equal effect.

scholarly journals The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0246990
Author(s):  
Marcel O. Bonn-Miller ◽  
Sue Sisley ◽  
Paula Riggs ◽  
Berra Yazar-Klosinski ◽  
Julie B. Wang ◽  
...  
Keyword(s):  
Active Treatment ◽  
Symptom Severity ◽  
Ptsd Symptom ◽  
Controlled Trial ◽  
Military Veterans ◽  
Ptsd Symptoms ◽  
Significant Difference ◽  
Ptsd Symptom Severity ◽  
Stage 1 ◽  
To Receive

Importance There is a pressing need for development of novel pharmacology for the treatment of Posttraumatic Stress Disorder (PTSD). Given increasing use of medical cannabis among US military veterans to self-treat PTSD, there is strong public interest in whether cannabis may be a safe and effective treatment for PTSD. Objective The aim of the present study was to collect preliminary data on the safety and potential efficacy of three active concentrations of smoked cannabis (i.e., High THC = approximately 12% THC and < 0.05% CBD; High CBD = 11% CBD and 0.50% THC; THC+CBD = approximately 7.9% THC and 8.1% CBD, and placebo = < 0.03% THC and < 0.01% CBD) compared to placebo in the treatment of PTSD among military veterans. Methods The study used a double-blind, cross-over design, where participants were randomly assigned to receive three weeks of either active treatment or placebo in Stage 1 (N = 80), and then were re-randomized after a 2-week washout period to receive one of the other three active treatments in Stage 2 (N = 74). The primary outcome measure was change in PTSD symptom severity from baseline to end of treatment in Stage 1. Results The study did not find a significant difference in change in PTSD symptom severity between the active cannabis concentrations and placebo by the end of Stage 1. All three active concentrations of smoked cannabis were generally well tolerated. Conclusions and relevance The present study is the first randomized placebo-controlled trial of smoked cannabis for PTSD. All treatment groups, including placebo, showed good tolerability and significant improvements in PTSD symptoms during three weeks of treatment, but no active treatment statistically outperformed placebo in this brief, preliminary trial. Additional well-controlled and adequately powered studies with cannabis suitable for FDA drug development are needed to determine whether smoked cannabis improves symptoms of PTSD. Trial registration Identifier: NCT02759185; ClinicalTrials.gov.

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