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.

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.

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.

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.

Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms

2019 ◽  
pp. 331-340
Author(s):  
Susan Churchill ◽  
◽  
Kayla Deru ◽  
Lindell K. Weaver ◽  
Steffanie H. Wilson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Hyperbaric Oxygen ◽  
Gas Flow ◽  
Randomized Trials ◽  
Symptom Improvement ◽  
Sham Control ◽  
Serious Adverse Events ◽  
Double Blind ◽  
To Receive

Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the BIMA study). Minor, non-limiting barotrauma was the most frequently reported. Rarely, some participants experienced headache with chamber sessions. No serious adverse events were associated with chamber sessions. An allocation questionnaire completed after intervention revealed that the sham control arm adequately protected the blind in both trials. Participants based allocation assumptions on symptom improvement or lack of symptom improvement and could not discern intervention arm by pressure, smell, taste, or gas flow.

scholarly journals Effectiveness and Prognosis: Drainage Skin-Bridge Sparing Surgery Combined with Fistulotomy versus Fistulotomy Only in the Treatment of Anal Fistula

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Xiao Wang ◽  
Chunliang Wang ◽  
Ruihua Qi
Keyword(s):  
Anal Fistula ◽  
Postoperative Bleeding ◽  
Length Of Hospital Stay ◽  
Control Group ◽  
Anal Function ◽  
Double Blind ◽  
Voiding Function ◽  
Vas Scores ◽  
The Difference ◽  
Better Than

Objective. This study intends to analyze the difference in the efficacy of drainage skin-bridge sparing surgery combined fistulotomy (DSCF) and fistulotomy alone. Methods. 125 patients with anal fistula were enrolled as study subjects and randomly divided into control group (CG) and observation group (OG) by double-blind lottery. The CG received drainage skin-bridge sparing surgery with fistulotomy and the OG received fistulotomy only. Results. The VAS scores of the trauma in the OG were lower than those in the CG on 1st day of surgery and 7 days after surgery ( P < 0.05 ). The length of hospital stay and time to wound healing were shorter in the OG than in the CG ( P < 0.05 ). The incidence of postoperative bleeding in the OG was 9.52%, which was lower than 22.58% in the CG ( P < 0.05 ). The rectal examination scores were lower in the OG than in the CG at 3 and 5 days postoperatively ( P < 0.05 ). The Wexner scores of solid incontinence (0 to 4), liquid incontinence (0 to 4), gas incontinence (0 to 4), pad wearing (0 to 4), and lifestyle alteration (0 to 4) in the OG were lower than those of the CG at 5 days postoperatively ( P < 0.05 ). Voiding function scores were lower in the OG than in the CG at 2 and 3 days postoperatively ( P < 0.05 ). Conclusions. The efficacy of drainage skin-bridge sparing surgery combined fistulotomy is better than that of fistulotomy alone, which can accelerate postoperative healing, enhance urinary function, reduce postoperative bleeding, and improve anal function.

scholarly journals Aspirin-Persantin Prophylaxis in Elective total hip Replacement

1977 ◽  
Author(s):  
A.J. Silvergleid ◽  
R. Bernstein ◽  
D.S. Burton ◽  
J.B. Tanner ◽  
J.F. Silverman ◽  
...  
Keyword(s):  
Total Hip Replacement ◽  
Hip Replacement ◽  
Treated Group ◽  
Control Group ◽  
Double Blind ◽  
Total Hip ◽  
Blind Area ◽  
Effective Prophylaxis ◽  
Clinically Significant ◽  
To Receive

A prospective, double-blind clinical study was performed to evaluate the combination of dipyridamole(Persantin)225 mg/day and acetyl salicyclic acid (ASA) 1 g/day prophylaxis of post-operative venous thromboembolism in elective total hip replacement. Patients were stratified according to age, and randomly assigned to receive drug or placebo. All patients were followed with 125I-labelledfibrinogen scanning for one week post-operatively, or until fully mobile. Venography was performed in 67/129 patients; in 27 patients the venogram was obtained to confirm a positive fibrinogen scan, in 40 patients an elective venogram was obtained on the 7th post-operative day to evaluate the operated thigh (a blind area for scanning). Thrombosis (by scan or venogram) was found in 16/66(24%) in the control group, and in 21/63(33%) in the treated group. Overall incidence was 37/129 (29%). Correlation of scan with venography was 90%. There were no clinically significant pulmonary emboli in either group. We conclude that the combination of ASA and dipridamole as given in this study is not effective prophylaxis in elective total hip replacement.

scholarly journals The role of oral mifepristone in pre-induction cervical ripening at term

2019 ◽  
Vol 8 (11) ◽  
pp. 4337
Author(s):  
Uma H. Chourasia ◽  
Mudita Kamlesh Jain ◽  
Juzar I. Fidvi
Keyword(s):  
Placebo Group ◽  
Labor Induction ◽  
Cervical Ripening ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Bishop Score ◽  
The Difference ◽  
Pg E2 ◽  
To Receive

Background: Planned induction of labor is an established part of modern obstetrics and is used as a definite form of treatment where continuation of pregnancy would be detrimental to the health of mother or fetus. The objective of this study was to evaluate the effect of mifepristone in pre-induction cervical ripening and labor induction.Methods: A total of 200 pregnant women at term with Bishop Score 4 or less were selected for this prospective randomized placebo-controlled study. The sample was equally divided into study group to receive 200 mg of mifepristone and control group to receive placebo orally for 2 days. Bishop score was assessed at every 24 hours interval till patient entered in spontaneous labor or 72 hours after 1st dose. Women who did not enter labor spontaneously, labor induction was planned with per vaginal insertion of prostaglandin (PG) E2 analogue, Dinoprostone gel 2.5 mg or PGE1 analogue Tab. Misoprostol 25 µg.Results: Ninety-six subjects in the study group and eighty-one in the control achieved successful ripening of cervix and the difference was statistically significant. Sixty-eight of study group and thirty-nine of placebo group entered in spontaneous active labor within 72 hours. Requirement of oxytocin as adjuvant treatment was significantly lower in the study group. Nineteen women of study group and fifteen of control group delivered within 24 hours, and eighty-one of study group and sixty-two of placebo delivered in 48 hours. The mean induction delivery interval was 35.53±13.67 hours in the study group, whereas it was significantly prolonged in the placebo group 50.49±20.92 hours. Eighty-two subjects of study group and seventy-eight of the control group delivered vaginally, the differences were statistically not significant.Conclusions: Mifepristone was found to be an effective agent for cervical priming prior to labor induction in women at term and significantly reduces the induction delivery interval compared with placebo.

Netupitant/palonosetron (NEPA) for prevention of delayed chemotherapy-induced nausea and vomiting (CINV) in multiple cycles of chemotherapy.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 211-211
Author(s):  
Lee Steven Schwartzberg ◽  
Richard J. Gralla ◽  
Kimia Kashef ◽  
Hope Rugo
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Complete Response ◽  
Control Group ◽  
Double Blind ◽  
Report Data ◽  
Multiple Cycles ◽  
To Receive ◽  
Delayed Phase ◽  
Significant Nausea

211 Background: Prevention of CINV in the delayed phase (24-120 h post-chemotherapy) and over multiple cycles of chemotherapy remains a challenge. NEPA, a fixed combination of the NK1 receptor antagonist (RA) netupitant (300 mg) and the 5-HT3 RA palonosetron (PALO; 0.5 mg), has demonstrated efficacy in multiple studies, in both acute and delayed phases, during the first cycle of moderately or highly emetogenic chemotherapy (MEC and HEC, respectively) regimens. Two clinical trials evaluated NEPA over multiple cycles of chemotherapy. We report data for the delayed phase for each cycle. Methods: Both studies were Phase 3, double-blind, active-controlled studies. In study 1 (MEC), patients were randomized 1:1 to receive a single oral dose of NEPA (n = 724) or PALO 0.5 mg (n = 725) on Day 1; following cycle 1, patients could participate in a multi-cycle extension phase. In study 2 (MEC or HEC), patients were randomized 3:1 to receive a single oral dose of NEPA on Day 1 (n = 309) or oral aprepitant (APR) 125 mg plus oral PALO 0.5 mg on Day 1, then APR 80 mg/d on days 2 and 3 of each cycle (n = 103). In both studies, all patients also received dexamethasone. Efficacy endpoints included complete response (CR; no emesis, no rescue medication) and no significant nausea. Results: In both studies, CR rates were consistently numerically higher with NEPA (Study 1 range: 77%-89%; Study 2 range: 83%-93%) than with PALO (Study 1; range: 69%-83%) or APR/PALO (Study 2; range: 78%-88%) in each cycle up to cycle 6 (Table). In both studies, rates of no significant nausea in the NEPA group were similar to or higher than in the control group. NEPA was well tolerated in both studies; treatment-related adverse events included constipation and headache. Conclusions: These studies demonstrate sustained efficacy of NEPA (administered as a single dose on Day 1) across multiple cycles of MEC or HEC for prevention of CINV in the delayed phase. Clinical trial information: 2009-016775-30; 2010-023297-39. [Table: see text]

Randomized, Placebo-Controlled, Double-Blind, Phase II Study of Axitinib Plus Docetaxel Versus Docetaxel Plus Placebo in Patients With Metastatic Breast Cancer

2011 ◽  
Vol 29 (18) ◽  
pp. 2459-2465 ◽  
Author(s):  
Hope S. Rugo ◽  
Alison T. Stopeck ◽  
Anil A. Joy ◽  
Stephen Chan ◽  
Shailendra Verma ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Objective Response ◽  
Metastatic Breast ◽  
Double Blind ◽  
The Difference ◽  
To Receive

Purpose This multicenter, randomized, double-blind, phase II study assessed safety and efficacy of axitinib plus docetaxel in metastatic breast cancer (MBC). Patients and Methods Women with MBC were randomly assigned 2:1 to receive docetaxel 80 mg/m2 once every 3 weeks plus axitinib 5 mg twice per day (combination arm) or placebo (placebo arm), following a lead-in phase I trial. The primary end point was time to progression (TTP). Results In all, 168 patients were enrolled; 112 were randomly assigned to axitinib and 56 to placebo. Median TTP was numerically longer in the combination arm than in the placebo arm (8.1 v 7.1 months), but this difference was not statistically significant (hazard ratio, 1.24; 95% CI, 0.82 to 1.87; one-sided P = .156). The difference in median TTP was greatest among patients who had received prior adjuvant chemotherapy (9.2 v 7.0 months; P = .043, prespecified subgroup analysis). Objective response rate was higher in the combination arm (41.1% v 23.6%; P = .011). The most common grades 3 to 4 treatment-related adverse events (combination/placebo) included diarrhea (10.8%/0%), fatigue (10.8%/5.4%), stomatitis (12.6%/1.8%), mucositis (9.0%/0%), asthenia (7.2%/0%), and hypertension (4.5%/0%). Three patients in the combination arm experienced serious thromboembolic events (one death). Febrile neutropenia was more frequent in the combination arm (15.3% v 7.1%); rates of other hematologic toxicities were comparable. Increased toxicity with axitinib was generally managed by dose reduction and/or growth factor support. Conclusion The addition of axitinib to docetaxel did not improve TTP in first-line MBC treatment. Combination therapy may be more effective in patients previously exposed to adjuvant chemotherapy.

scholarly journals The Effect of Vitamin B6 on Reducing the Number and the Size of Breast Cysts and the Amount of Recurrence after Aspiration in Women

2019 ◽  
pp. 1-7
Author(s):  
Setareh Soltany ◽  
Hamid Reza Hemmati ◽  
Jafar Alavy Toussy ◽  
Parisa Alavi Toosi
Keyword(s):  
Vitamin B6 ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Breast Cyst ◽  
The Difference ◽  
Palpable Breast ◽  
Breast Lumps ◽  
And Control

Introduction: Palpable breast lumps are one of the most prevalent breast problems in women who visit a doctor. Most of these lumps are benign, and many of these benign lumps, have cystic nature. One of the suggested treatments for breast cyst is vitamin B6 intake. So, this study aimed to determine the effect of vitamin B6 on reducing the number and the size of breast cysts and reducing the amount of recurrence after aspiration. Materials and Methods: This study is a double-blind randomized clinical trial. Patients simply divided into two groups randomly, intervention group (receiving 150 mg vitamin B6 twice a day for two months) and control group (placebo). After data collection, the database produced, and information came in by SPSS-22 software. Descriptive results extracted in the form of tables and graphs. In all cases was used α=0.05. Results: At the end of the study, 65 patients (34 people in the intervention group, and 31 people in the control group) studied. At the end of the survey in the non-palpable cysts, was observed a significant decrease in the number and the size of breast cysts in each group receiving vitamin B6 or placebo. Still, the difference was not significant in comparing the two groups. 19 patients (2.29%) had palpable cysts that aspiration performed in all cases. After the study period, no recurrence of cysts observed in any of the intervention and control groups. Conclusion: The study showed that vitamin B6 had no effect on reducing the size and the number of non-palpable breast cysts and prevent recurrence of palpable cysts after aspiration.

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