scholarly journals Changes in biomarkers after 180 days of tobacco heating product use: a randomised trial

2021 ◽  
Author(s):  
Nathan Gale ◽  
Michael McEwan ◽  
Oscar M. Camacho ◽  
George Hardie ◽  
Christopher J. Proctor ◽  
...  
Keyword(s):  
Cigarette Smoking ◽  
Randomised Trial ◽  
Prostaglandin F2α ◽  
Health Impact ◽  
Ambulatory Setting ◽  
Controlled Study ◽  
Control Group ◽  
Biomarkers Of Exposure ◽  
Randomised Controlled Study ◽  
Randomised Controlled

AbstractThe aim of this study was to investigate whether biomarkers of exposure (BoE) and potential harm (BoPH) are modified when smokers switch from smoking cigarettes to exclusive use of a tobacco heating product (THP) in an ambulatory setting. Participants in this randomised, controlled study were healthy volunteer smokers assigned either to continue smoking or switch to a THP, and a control group of smokers who abstained from cigarette smoking. Various BoE and BoPH related to oxidative stress, cardiovascular and respiratory diseases, and cancer were assessed at baseline and up to 180 days. In continuing smokers, BoE and BoPH remained stable between baseline and day 180, while THP users’ levels of most BoE reduced significantly, becoming similar to those in controls abstaining from cigarette smoking. Also at 180 days, significant changes in numerous BoPH, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, 8-epi-prostaglandin F2α type III, fractional concentration of exhaled nitric oxide and white blood cell count, were directionally consistent with lessened health impact. Our findings support the notion that the deleterious health impacts of cigarette smoking may be reduced in smokers who completely switch to using THPs.

scholarly journals Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to the glo Tobacco Heating Product: A Randomized, Controlled Ambulatory Study

2020 ◽  
Author(s):  
Nathan Gale ◽  
Michael McEwan ◽  
Oscar M Camacho ◽  
George Hardie ◽  
James Murphy ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Cigarette Smoking ◽  
Tobacco Product ◽  
Ambulatory Setting ◽  
Controlled Study ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Biomarkers Of Exposure ◽  
Never Smokers

Abstract Introduction Tobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes. Aims and Methods This randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90. Results In continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers. Conclusion glo is a reduced-exposure tobacco product. Implications This clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely. Clinical trial registration ISRCTN81075760.

A Controlled Trial of Home-Based Acute Psychiatric Services

1993 ◽  
Vol 163 (1) ◽  
pp. 49-54 ◽  
Author(s):  
Tom Burns ◽  
Alan Beadsmoore ◽  
Ashok V. Bhat ◽  
Andrew Oliver ◽  
Carola Mathers
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Community Based ◽  
Home Based ◽  
Randomised Controlled Study ◽  
One Year ◽  
Randomised Controlled ◽  
Clinical Measures ◽  
Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

scholarly journals Effects of weekly pain monitoring on back pain outcomes: a non-randomised controlled study

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Alice Kongsted ◽  
Tue Secher Jensen ◽  
Klaus Doktor ◽  
Lise Hestbæk
Keyword(s):  
Back Pain ◽  
Pain Intensity ◽  
Activity Limitation ◽  
Controlled Study ◽  
Group Differences ◽  
Control Group ◽  
Negative Effects ◽  
Randomised Controlled Study ◽  
Pain Outcomes ◽  
Randomised Controlled

Abstract Background Disease monitoring is an important element of self-management of several chronic diseases. Pain monitoring has become very easily available, but the role in musculoskeletal pain conditions is not clear. Awareness of pain might be helpful for people to understand pain, but focusing on pain may on the contrary negatively affect pain experience and behaviours. The objective of this study was to investigate the potential impact of pain monitoring on low back pain (LBP), specifically to determine if pain intensity, activity limitation and pain control, differed between patients with weekly pain monitoring over 12 months and patients with follow-ups at 2 weeks, 3 months and 12 months. Methods This was a non-randomised controlled study embedded in a cohort study with data collection November 1st 2016 to December 21st 2018. Adults seeking care for LBP were enrolled at the first visit to a chiropractor and followed with surveys after 2 weeks, 3 months and 12 months. Those enrolled first, n = 1,623, furthermore received weekly SMS-questions about pain frequency and pain intensity, whereas those enrolled next was the control group, n = 1,269 followed only by surveys. Outcomes at 12-months were compared, adjusting for group differences on baseline parameters. Results LBP intensity (0–10) was slightly lower at 12-months follow-up in the SMS group than the control group (adjusted beta − 0.40 (95% CI: − 0.62; − 0.19)). No relevant between-group differences were observed for activity limitation (0–100) (1.51 (95% CI: − 0.83; 3.85)) or ability to control pain (0–10) (− 0.08 (95% CI − 0.31; 0.15)). Conclusions Frequent pain monitoring did not demonstrate any negative effects of weekly pain monitoring, and it was perhaps even helpful. The role of self-monitoring as part of self-managing LBP should be explored further including optimal frequencies, formats, and methods for feedback. Trial registration The study was not registered as a clinical trial.

Clopidogrel as prophylactic treatment for migraine: A pilot randomised, controlled study

Cephalalgia ◽  
2014 ◽  
Vol 34 (14) ◽  
pp. 1163-1168 ◽  
Author(s):  
John B Chambers ◽  
Paul T Seed ◽  
Leone Ridsdale
Keyword(s):  
Treatment Effect ◽  
Randomised Trial ◽  
Placebo Treatment ◽  
Controlled Study ◽  
Atrial Septal Aneurysm ◽  
Significant Treatment ◽  
Headache Severity ◽  
Randomised Controlled Study ◽  
Headache Diary ◽  
Randomised Controlled

Introduction Anecdotal reports suggest that clopidogrel may prevent migraine attacks. We undertook a pilot randomised trial. Method We randomised consecutive migraineurs with four to 15 headache days per 28-day month to receive clopidogrel 75 mg or placebo daily for three months. Headache was primarily assessed with a headache diary. Results There were no statistically significant treatment effects. The number of headache days fell by 1.9 on clopidogrel and 1.6 on placebo (adjusted difference 0.02, CI −2.07 to 2.12). Headache severity rose by 0.14 points (out of 10) on clopidogrel, and fell by 0.63 on placebo; treatment effect 0.7 points (CI −0.11 to 1.57). The main treatment effect did not depend on the presence or absence of migraine with aura at baseline, a patent foramen ovale (PFO) or atrial septal aneurysm. Discussion The evidence is inconclusive, but a multicentre trial would be feasible recruiting from primary care.

A Multicentre Randomised Controlled Study Evaluating the Effect of a Standardised Education Programme on Quality of Life, Disease Severity, and Disease Knowledge in Patients with Moderate-To-Severe Psoriasis: The EDUPSO Study

Dermatology ◽  
2021 ◽  
pp. 1-10
Author(s):  
Fatma Jendoubi ◽  
Stefana Balica ◽  
Marie Aleth Richard ◽  
Christine Chiaverini ◽  
Claire Bernier ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Intervention Group ◽  
Education Programme ◽  
Controlled Study ◽  
Control Group ◽  
Randomised Controlled Study ◽  
Randomised Controlled ◽  
To Receive

<b><i>Background:</i></b> Psoriasis is a chronic inflammatory skin disease that has a profound effect on health-related quality of life (HRQoL). Patient education programmes may help patients to gain life-long control over their chronic disease. <b><i>Objective:</i></b> This multicentre randomised controlled study evaluated whether a standardised multidisciplinary education programme was beneficial to psoriasis patients. <b><i>Methods:</i></b> Adults with moderate-to-severe psoriasis were randomly assigned (1:1) to an intervention group to receive an educational programme or to a control group to receive usual care. Randomization was stratified by previous treatment history. The primary outcome was HRQoL, assessed by scoring the Skindex-29 domains emotion, symptom, and functioning. Psoriasis severity was assessed using the psoriasis area severity index (PASI). Levels of perceived stress, patient knowledge about psoriasis, and patient satisfaction were also assessed. Follow-up evaluations were performed at 3, 6, and 12 months. <b><i>Results:</i></b> A total 142 patients formed the intention-to-treat population: 70 in the control group and 72 in the intervention group. Skindex component scores and the PASI were significantly lower at 3, 6, and 12 months as compared to baseline in both groups, but no significant differences were found between the groups. Knowledge about psoriasis improved significantly during follow-up amongst patients from the intervention group compared to controls (68% of correct answers vs. 56%; <i>p</i> &#x3c; 0.01). Patient satisfaction with psoriasis management and treatment was also better in the intervention group. <b><i>Conclusions:</i></b> The standardised education programme did not improve HRQoL and disease severity in psoriasis, but led to a significant improvement in patient knowledge about the disease and increased patient satisfaction.

Acupuncture for Insomnia in Pregnancy – a Prospective, Quasi-Randomised, Controlled Study

2005 ◽  
Vol 23 (2) ◽  
pp. 47-51 ◽  
Author(s):  
João Bosco Guerreiro da Silva ◽  
Mary Uchiyama Nakamura ◽  
José Antonio Cordeiro ◽  
Luiz Kulay
Keyword(s):  
Pregnant Women ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Randomised Controlled Study ◽  
Numerical Rating ◽  
Randomised Controlled

Objective This study was undertaken to test the effects of acupuncture on insomnia in a group of pregnant women under real life conditions, and to compare the results with a group of patients undergoing conventional treatment alone (sleep hygiene). Methods A total of 30 conventionally treated pregnant women were allocated at random into groups with or without acupuncture. Seventeen patients formed the study group and 13 the control group. The pregnant women scored the severity of insomnia using a Numerical Rating Scale from 0 to 10. Women were followed up for eight weeks and interviewed five times, at two-week intervals. Results Eight women dropped out, five in the study group and three in the control group. The study group reported a larger reduction on insomnia rating (5.1) than the control group (0.0), a difference which was statistically significant (P=0.0028). Average insomnia scores decreased by at least 50% over time in nine (75%) patients in the study group and in three (30%) of the control group. Conclusion The results of this study suggest that acupuncture alleviates insomnia during pregnancy and further research is justified.

scholarly journals The effect of planned training given to women with preeclamptic pregnancy on oxidative stress and anxiety levels: non-randomised controlled-study

2021 ◽  
Author(s):  
emel tasci ◽  
serdal ogut ◽  
mehmet özkaya
Keyword(s):  
Oxidative Stress ◽  
Controlled Study ◽  
Control Group ◽  
Randomised Controlled Study ◽  
Significant Difference ◽  
Stress Levels ◽  
Before And After ◽  
Anxiety Levels ◽  
Randomised Controlled ◽  
Experimental Group

This study aimed to studying the effects of planned training given to women with preeclamptic pregnancy on stress-anxiety and oxidative stress levels. A non-randomised controlled-study study, carried out in Gynecology and Obstetrics Clinics of Research and Application Hospital of one university. In the study, 28 preeclamptic patients matching the sampling criteria were taken as the experimental group and 22 other preeclamptic patients who also match the sampling criteria constituted the control group. Questionnaire, scale application and laboratory evaluation for the control group were performed only once. In the experimental group, there is a statistically significant difference between the TAS (mmol trolox equ./L) (t = -9.71 P = 0.00) and the TOS (lmol H2O2 equ./L) (t = 6.56 P = 0.00) measurements before and after the training and there is a statistically significant difference between the State-Trait Anxiety Inventory (t = 3.64 P = 0.00) before and after the training. It has been determined in the study that the planned training given to the pregnant women who received a diagnosis of preeclampsia has decreased their oxidative stress levels and state anxiety levels.

scholarly journals The Effects of Two Intervention Strategies to Reduce the Intake of Salt and the Sodium-To-Potassium Ratio on Cardiovascular Risk Factors. A 4-Month Randomised Controlled Study among Healthy Families

Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1467
Author(s):  
Ulla Toft ◽  
Nanna Louise Riis ◽  
Anne Dahl Lassen ◽  
Ellen Trolle ◽  
Anne Helms Andreasen ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Risk ◽  
Cardiovascular Risk Factors ◽  
Plasma Cholesterol ◽  
Plasma Renin ◽  
Controlled Study ◽  
Control Group ◽  
Randomised Controlled Study ◽  
Group A ◽  
Randomised Controlled

The aim was to examine the effects of two different salt reduction strategies on selected cardiovascular risk factors. The study was a four-month cluster randomised controlled study. Eighty-nine healthy Danish families (309 individuals) were randomly assigned to either (A) gradually salt-reduced bread, (B) gradually salt-reduced bread and dietary counselling to further reduce salt intake and increase potassium intake or (C) standard bread (control). The effect was assessed using linear mixed models. Intention to treat analyses comparing changes in the three groups showed a significant reduction in body fat percent (−1.31% (−2.40; −0.23)) and a borderline significant reduction in total plasma cholesterol (−0.25 mmol/L (−0.51; 0.01) and plasma renin (−0.19 pmol/L (−0.39; 0.00) in group A compared to the control group. Adjusted complete case analyses showed a significant reduction in total plasma cholesterol (−0.29 mmol/L (−0.50; −0.08), plasma LDL cholesterol (−0.08 mmol/L (−0.15; −0.00)), plasma renin (−0.23 pmol/L (−0.41; −0.05)), plasma adrenaline (−0.03 nmol/L (−0.06; −0.01)) and body fat percent (−1.53% (−2.51; −0.54)) in group A compared to the control group. No significant changes were found in group B compared to the control group. In conclusion, receiving sodium reduce bread was associated with beneficial changes in cardiovascular risk factors. No adverse effects were observed.

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