Assay Sensitivity and Study Features in Neuropathic Pain Trials: An ACTTION Meta-Analysis.

Assay sensitivity and study features in neuropathic pain trials: An ACTTION meta-analysis.

Neurology. 2013 May 22;
Dworkin RH, Turk DC, Peirce-Sandner S, He H, McDermott MP, Farrar JT, Katz NP, Lin AH, Rappaport BA, Rowbotham MC

OBJECTIVE: Our objective was to identify patient, study, and site factors associated with assay sensitivity in placebo-controlled neuropathic pain trials. METHODS: We examined the associations between study characteristics and standardized effect size (SES) in a database of 200 publicly available randomized clinical trials of pharmacologic treatments for neuropathic pain. RESULTS: There was considerable heterogeneity in the SESs among the examined trials. Univariate meta-regression analyses indicated that larger SESs were significantly associated with trials that had 1) greater minimum baseline pain inclusion criteria, 2) greater mean subject age, 3) a larger percentage of Caucasian subjects, and 4) a smaller total number of subjects. In a multiple meta-regression analysis, the associations between SES and minimum baseline pain inclusion criterion and age remained significant. CONCLUSIONS: Our analyses have examined potentially modifiable correlates of study SES and shown that a minimum pain inclusion criterion of 40 or above on a 0 to 100 scale is associated with a larger SES. These data provide a foundation for investigating strategies to improve assay sensitivity and thereby decrease the likelihood of falsely negative outcomes in clinical trials of efficacious treatments for neuropathic pain. HubMed – addiction


Ethics and Smoking Cessation: Should the Medical Treatment Be a “Freewill” Choice or a Mandatory Issue for Hospitalized COPD Patients?

Chest. 2012 Oct 1; 142(4_MeetingAbstracts): 1089A
Tilea L, Postolache P, Lica F, Ciobanu M

SESSION TYPE: Tobacco Cessation and Prevention PostersPRESENTED ON: Wednesday, October 24, 2012 at 01:30 PM – 02:30 PMPURPOSE: To identify the results of respecting the free-choice of COPD-related hospitalized patients regarding the method for smoking cessationMETHODS: All smokers hospitalized for COPD exacerbation in a Pneumology hospital received the same intensive counseling, consisting in motivational and behavioral counseling, specific education regarding smoking-related influences on COPD, the role of medication for cessation. It was emphasized the opportunity to start medication during hospitalization and to continue after discharge, free-of-charge. After one day, the patients were asked if they wish to follow the medical treatment for smoking cessation with varenicline or if they want to quit “cold turkey”. The treatment was initiated after all the possible drug interactions were evaluated. The smoker status was determined by CO measurement. A final evaluation was made at discharge. Evaluations at 3, 6 and 12 months will follow.RESULTS: In the first 2 months of our study, 56 smokers with COPD-related exacerbations were admitted. 35 out of 56 patients (62,5%) considered sufficient the specific counseling for smoking cessation, while 21 patients (37,5%) expressed their wish to start medical treatment. From the 21 patients receiving medication, only one discontinued medication due to complications of COPD, meaning that 95.2% were non-smokers at discharge. From the 35 patients receiving only specific counseling, 19 (representing 54.3%) were non-smokers at discharge. This means that almost a third (30.3%) of all COPD patients were still smokers at discharge.CONCLUSIONS: Despite their precarious physical and psychological status, intensive psychological counseling and free-of-charge, efficient treatment, almost one third of patients hospitalized for COPD exacerbation are reluctant to choose the evidence-based recommendation for quitting smoking and continue to smoke.CLINICAL IMPLICATIONS: Taking into account the evidences about the effects of smoking on the evolution and prognosis of COPD, the efficacy of the medication for smoking cessation, these preliminary results could contribute to give an answer to the ethical issue: should we or should we not introduce the treatment for tobacco addiction in the regular treatment of COPD exacerbation, regardless the opinion of the patient.DISCLOSURE: The following authors have nothing to disclose: Lavinia Tilea, Florentina Lica, Magdalena CiobanuNo Product/Research Disclosure InformationNational Institute of Pneumology “Marius Nasta”, Bucharest, Romania. HubMed – addiction


Frequent Use and Addiction to Smoking Among School-Aged Adolescents (Salvador, Bahia, Brazil).

Chest. 2012 Oct 1; 142(4_MeetingAbstracts): 1086A
Machado Neto AD, Machado G, Machado AP

SESSION TYPE: Tobacco Cessation and Prevention PostersPRESENTED ON: Wednesday, October 24, 2012 at 01:30 PM – 02:30 PMPURPOSE: A significant proportion of teenagers consume tobacco almost daily. In Brazil the frequency of this substance dependence is 2.9% among adolescents (12 to 17 years old).METHODS: To estimate the prevalence of tobacco use and dependence among school-aged adolescents (11-19 years old). Design: cross sectional study with a representative sample. Population: adolescent students (elementary and high-school) from public and private schools in Salvador, Brazil. An anonymous questionnaire was applied to the pupils in the period of april 07th to June 13th, 2008. The selection of schools, classes and students was obtained by a multiple-stage sampling. Of the 6,500 questionnaires, 5,347 were considered valid for the study. Were selected 254 participants (current tobacco use). The variables were tobacco dependence (Fagerstrom-FC) and frequency use of this substance. Statistics analysis: descriptive measures, 95%CI (precision of estimates).RESULTS: The prevalence of smoking experimentation was 16.1% (95%CI:15.1-17.2), 30.9% (95%CI:27.6-34.4) of these, consumed it in the last month. The adolescents consumed it 1 to 9 days (66.1%; 95%CI=58.5-72.8), however 16.4% consumed it for more than 20 days in the last month, and 9.2% use 20 cigarettes or more in the same period. The estimation of tobacco dependence by FC, 24 adolescents fulfilled the six FC. Most of them presented lightweight dependency, however, 25% (IC95%=12-44.9) presented high scores, greater than five (moderate to severe). Whereas FC, the number of cigarettes consumed per day (27.9 % use 10 cigarettes or more) and the difficulty of not smoking in “no smoking” places (19,5%;95%CI=14.7-25.5) were the most frequent. Most did not present any withdrawal symptoms, however the presence of abstinence syndrome (at least one symptom) (21.2% ;IC95%=16.2-27.2). The anxiety was the most frequent symptom (15.2%;95%CI=10.5-21.4). Teenagers tried to stop smoking by 1 to 2 times (68.8%;95%CI=58,8-73.3), 23.7% of them tried by more than 4 times. Those who have tried the smoking cessation, 47.3% succeeded and achieved with ease or little difficulty, 10.7% tried and failed, and 25.4% even thought in quitting smoking. Half of then managed to stay 12 months or more without smoking and was 34.5% without consuming this substance is less than 15 to 30 days.CONCLUSIONS: It can be concluded that nicotine is addictive property among adolescents, can produce withdrawal symptoms and has difficulty in cessation.CLINICAL IMPLICATIONS: Tobacco dependency can be early and led to future diseases.DISCLOSURE: The following authors have nothing to disclose: Adelmo de Souza Machado Neto, Gisele Machado, Ana Paula MachadoNo Product/Research Disclosure InformationEscola Bahiana de Medicina e Saúde Pública (FBDC), Salvador, Brazil. HubMed – addiction