scholarly journals Nicotine Replacement Combined with a Novel Compound (ProBAN) for Smoking Cessation: A Pilot Study

2001 ◽  
Vol 8 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Richard Leigh ◽  
Norman M Viner ◽  
Gerard Cox ◽  
Jeffrey W Balon ◽  
Douglas MC Wilson ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Pilot Study ◽  
Treatment Group ◽  
Adverse Effects ◽  
Control Group ◽  
Nicotine Gum ◽  
Double Blind ◽  
Nicotine Replacement ◽  
Continuous Abstinence ◽  
To Receive

BACKGROUND: Smoking cessation rates with available pharmacological therapies remain suboptimal. Anecdotal observations with a combination of sublingual pralidoxime and ipratropium (ProBAN) suggested that these agents in combination with nicotine gum improved quit rates.OBJECTIVE: To determine whether ProBAN together with nicotine replacement improves quit rates compared with nicotine replacement alone.DESIGN: A 12-week, prospective, double-blind, randomized, placebo controlled pilot study. SETTING: University-affiliated outpatient clinic.POPULATION STUDIED: Healthy adult smokers were recruited via advertisements. Of 107 subjects seen at the screening visit, 27 were excluded because of comorbid illness or concomitant medication use.INTERVENTIONS: Of 80 eligible subjects, 40 were randomly assigned to receive treatment with ProBAN sub- lingual tablets and nicotine gum (treatment group), and 40 to receive placebo tablets and nicotine gum (control group) for 12 weeks. The primary outcome was complete continuous abstinence of smoking from one through 12 weeks after the quit date.MAIN RESULTS: There were no adverse effects in the treatment group. At one week after the quit date, 35% of ProBAN-treated subjects had quit compared with 18% of control subjects (odds ratio [OR] 2.5, 95% CI 0.9 to 7.2). Corresponding quit rates at four weeks were 28% and 15% (OR 2.1, 95% CI 0.7 to 6.5), at eight weeks were 25% and 13% (OR 2.3, 95% CI 0.7 to 7.6), and at 12 weeks were 23% and 13% (OR 2.0, 95% CI 0.6 to 6.7), respectively.CONCLUSIONS: This pilot study indicated that ProBAN combined with nicotine replacement doubled the continuous sustained quit rate compared with nicotine replacement alone, with no adverse effects. Although not statistically significant due to the size of the study, this result suggests that it may be an effective therapy for smoking cessation, and larger studies are warranted.

scholarly journals Contributions of auriculotherapy in smoking cessation: a pilot study

2014 ◽  
Vol 48 (5) ◽  
pp. 883-890
Author(s):  
Roberta de Paiva Silva ◽  
Erika de Cássia Lopes Chaves ◽  
Sandra Cristina Pillon ◽  
Andréia Maria Silva ◽  
Denis da Silva Moreira ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Pilot Study ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind ◽  
Future Studies ◽  
Randomized Controlled ◽  
And Control ◽  
Experimental Group

Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking) and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research). Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002), in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050) and in not smoking when ill 23.8% (p=0.025). Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

scholarly journals A Standardized Transcutaneous Electric Acupoint Stimulation for Relieving Tobacco Urges in Dependent Smokers

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Caroline Lambert ◽  
Ivan Berlin ◽  
Tat-Leang Lee ◽  
Siew Wan Hee ◽  
Audrey S. L. Tan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Smoking Cessation ◽  
Control Group ◽  
Double Blind ◽  
Standardized Protocol ◽  
Urge To Smoke ◽  
The Difference ◽  
To Receive ◽  
Transcutaneous Electric Acupoint Stimulation ◽  
Acupoint Stimulation

The efficacy of acupuncture in smoking cessation, and its effect on the urge to smoke are unclear. We evaluated the effect of a standardized protocol of transcutaneous electric acupoint stimulations (TEAS) on alleviating the urge to smoke. Ninety-eight smokers were recruited in two double-blind studies. Participants abstained from smoking for 26 h, and were randomized to receive TEAS alternating between 2 and 100 Hz at four acupoints (LI4 and PC8, PC6 and TE5) at four different intensities (10, 5, Intermittent 5 or 0 mA). The urge to smoke was assessed by the Questionnaire of Smoking Urges (QSU-Brief). In Experiment 1, the 10 mA group (n= 20) was compared with the 5 mA group (n= 20); the increase in smoking urges did not differ significantly. Considering the possibility that 5 mA may be an active intervention, in Experiment 2, a true placebo (0 mA), and a proxy of placebo [Intermittent 5 mA (i5 mA)] were compared with 10 mA TEAS. In this experiment, 10 mA (n= 20) TEAS showed a tendency to alleviate smoking urges compared with 0 mA (n= 16), and i5 mA (n= 19) TEAS. Only when the data of smokers with Fagerstöm Test for Nicotine Dependence score ≥5 were analyzed that the difference between the 10 mA group and the control group (0 and i5 mA) became significant. Based on these preliminary findings, we conclude that TEAS applied on the skin may antagonize the increase in urge to smoke in abstinent-dependent smokers. It seems warranted to assess the efficacy of TEAS in smoking cessation clinical trials involving a larger population of dependent smokers.

scholarly journals The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances to Double-Lumen Endotracheal Intubation: A Prospective, Randomized, Double-Blind, and Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8
Author(s):  
Tanyong Pipanmekaporn ◽  
Yodying Punjasawadwong ◽  
Somrat Charuluxananan ◽  
Worawut Lapisatepun ◽  
Pavena Bunburaphong
Keyword(s):  
Blood Pressure ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Rate Pressure Product ◽  
Control Group ◽  
Hemodynamic Responses ◽  
Double Blind ◽  
The Mean ◽  
Mean Differences ◽  
To Receive

The purpose of this study was to determine the effect of dexmedetomidine on hemodynamic responses to DLT intubation compared to placebo and to assess the adverse effects related to dexmedetomidine. Sixty patients were randomly allocated to receive 0.7 μg/kg dexmedetomidine (n=30) or normal saline (n=30) 10 minutes before general anesthesia. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), and rate pressure product (RPP) between groups were recorded. During intubation and 10 minutes afterward (T1-T10), the mean SBP, DBP, MAP, HR, and RPP in the control group were significantly higher than those in the dexmedetomidine group throughout the study period except at T1. The mean differences of SBP, DBP, MAP, HR, and RPP were significantly higher in the control group, with the value of 15.2 mmHg, 10.5 mmHg, 14 mmHg, 10.5 beats per minute, and 2,462.8 mmHg min−1. Four patients in the dexmedetomidine group and 1 patient in the control group developed hypotension, while 2 patients in the dexmedetomidine group had bradycardia. Prophylactic dexmedetomidine can attenuate the hemodynamic responses to laryngoscopy and DLT intubation with minimal adverse effects. This trial is registered with ClinicalTrials.govNCT01289769.

The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

2001 ◽  
Vol 6 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Harald Walach ◽  
Stefan Schmidt ◽  
Yvonne-Michelle Bihr ◽  
Susanne Wiesch
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cognitive Task ◽  
Well Being ◽  
Control Group ◽  
Double Blind ◽  
Main Effect ◽  
The Difference ◽  
Being There ◽  
To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

The effect of midodrine on lactate clearance in patients with septic shock: a pilot study

2021 ◽  
Author(s):  
Effat Davoudi-Monfared ◽  
Mostafa Mohammadi ◽  
Meysam Khoshavi ◽  
Hossein Khalili
Keyword(s):  
Septic Shock ◽  
Pilot Study ◽  
Effect Size ◽  
Critically Ill Patients ◽  
Lactate Clearance ◽  
Control Group ◽  
Large Effect Size ◽  
Group 13 ◽  
Registration Number ◽  
To Receive

Background: The effect of midodrine on lactate clearance has not been assessed in critically ill patients yet. Objective: The goal of this study was to assess the effect of adjunctive midodrine therapy on lactate clearance in patients with septic shock. Materials & methods: Patients with septic shock were assigned to receive either adjunctive midodrine 10 mg three-times a day for 5 days (midodrine group = 15 patients) or not (control group = 13 patients). Results: The lactate clearance was significantly faster in the midodrine group than the control group (p = 0.049) with a large effect size ([Formula: see text] = 0.141). Conclusion: When midodrine was added to intravenous vasopressors, it significantly accelerated lactate clearance in patients with septic shock. Trial registration number: IRCT20100228003449N25 (Clinicaltrials.gov).

Synthetic Food Colors and Hyperactivity in Children: A Double-Blind Challenge Experiment

PEDIATRICS ◽  
1978 ◽  
Vol 62 (6) ◽  
pp. 975-983
Author(s):  
J. Preston Harley ◽  
Charles G. Matthews ◽  
Peter Eichman
Keyword(s):  
Classroom Behavior ◽  
Matched Control ◽  
Neuropsychological Test ◽  
Control Group ◽  
Comparable Data ◽  
Double Blind ◽  
Multiple Trials ◽  
To Receive ◽  
Male Subjects ◽  
Comparison Measures

Nine hyperactive male subjects, selected on the basis of showing a favorable "response" to the Feingold diet in an earlier study, were maintained on a strict elimination (Feingold) diet for 11 weeks, and were given multiple trials of placebo and challenge food materials. Parental and teacher ratings, classroom behavior observations, and neuropsychological test scores obtained during baseline, placebo, and challenge conditions, in general, were not found to be adversely affected by the artificial color challenge materials. As expected, comparable data gathered on a matched control group showed them to receive substantially better ratings than the hyperactive subjects on the majority of the comparison measures employed. Possible explanations for the discrepancy between the dramatic clinical-anecdotal reports that have been given and the much more equivocal findings from format experimental projects are presented.

scholarly journals Expressive arts therapy for hospitalized children: a pilot study measuring cortisol levels

2013 ◽  
Vol 5 (2) ◽  
pp. 7 ◽  
Author(s):  
Garret Yount ◽  
Kenneth Rachlin ◽  
Jane Siegel
Keyword(s):  
Pilot Study ◽  
Treatment Group ◽  
Expressive Arts ◽  
Control Group ◽  
Hospitalized Children ◽  
Expressive Arts Therapy ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Group A ◽  
Cortisol Levels

This pilot study aimed at assessing the feasibility of capturing physiological evidence of reduced stress for hospitalized children following expressive arts therapy. Twenty-five patients were offered a novel form of expressive arts therapy, termed Healing Sock Creatures, during their stay in the hospital. Saliva samples were collected at two times in the afternoon for the purpose of measuring salivary cortisol levels. The patients were randomly assigned to two groups, a treatment group or a wait-list control group. A trend of decreased cortisol levels was apparent following therapy in the treatment group and concurrent steroid treatment, which is common in intensive care units, does not appear to interfere with the ability to measure decreased cortisol levels following therapy. Our results support the design of a formal study to assess physiological biomarkers of stress in hospital settings. To our knowledge, this is the first in-patient study assessing a biomarker of stress following expressive arts therapy for children

Dropout Prevention for Youth with Disabilities: Efficacy of a Sustained School Engagement Procedure

1998 ◽  
Vol 65 (1) ◽  
pp. 7-21 ◽  
Author(s):  
Mary F. Sinclair ◽  
Sandra L. Christenson ◽  
David L. Evelo ◽  
Christine M. Hurley
Keyword(s):  
Treatment Group ◽  
Dropout Prevention ◽  
School Engagement ◽  
Behavioral Disabilities ◽  
Control Group ◽  
Youth With Disabilities ◽  
Engagement Strategies ◽  
Overall Performance ◽  
And Control ◽  
To Receive

The purpose of this study was to examine the efficacy of a sustained dropout prevention procedure that incorporated monitoring and school engagement strategies. Ninety-four students with learning and emotional/behavioral disabilities received interventions in Grades 7 and 8; half of the students (treatment group) continued to receive intervention through Grade 9. Results of this experimental study indicated that, for two of three measures, students in the treatment group were significantly more likely to be engaged in school than were control group students. The overall performance of both treatment and control students, however, points to the need for early and sustained support for students with learning and behavioral disabilities to attain academic and behavioral standards.

scholarly journals Effect of symbiotic supplementation on fecal calprotectin levels and lactic acid bacteria, Bifidobacteria, Escherichia coli and Salmonella DNA in patients with cervical cancer

2018 ◽  
Author(s):  
Genaro Gabriel Ortiz ◽  
Luis Humberto De Loera Rodríguez ◽  
Paloma Rivero Moragrega ◽  
Irma Ernestina Velázquez Brizuela ◽  
Juan Francisco Santoscoy Gutiérrez ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Adverse Effects ◽  
Pathogenic Bacteria ◽  
The United States ◽  
Fecal Calprotectin ◽  
Control Group ◽  
Double Blind ◽  
Faecal Calprotectin ◽  
Bacterial Dna ◽  
Polymerase Chain

Background: Patients with cervical cancer (CC) receiving chemotherapy and radiotherapy have several gastrointestinal adverse effects. Objective: To evaluate the effect of dietary symbiotic supplementation on fecal calprotectin, bacterial DNA levels, and gastrointestinal adverse effects in patients with CC. Methods: Clinical, controlled, randomized, double-blind trial. Patients consumed symbiotics or placebo three times a day for 7 weeks. Fecal calprotectin was assessed by Elisa method. DNA from probiotic and pathogenic bacteria were determined by quantitative real-time polymerase chain reaction. Diarrheal evacuations were evaluated with the Bristol scale and nausea and vomiting were measured using the scale of the National Institute of Cancerology of the United States. Results: Fecal calprotectin concentration was lower in the symbiotic group compared to the control group (p <0.001). The concentrations and total proportions of the probiotic and pathogenic bacteria were similar in both groups. Nausea cases significantly diminished in both groups (p <0.001) at the end of the trial. Furthermore, the symbiotic group had a statistically significant decrease in the frequency and intensity of vomiting when compared to the control group (p <0.001). Conclusions: The symbiotic treatment decreases significantly the fecal calprotectin levels and the frequency and intensity of vomiting in patients with CC. KEYWORDS: faecal calprotectin, cervical cancer, symbiotic, qPCR.

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