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Placebo
Kinds of Placebo Terms modified by Placebo Selected AbstractsAdding Gabapentin to a multimodal regimen does not reduce acute pain, opioid consumption or chronic pain after total hip arthroplastyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 8 2009H. CLARKE Background: Gabapentin (GPN) is effective in reducing post-operative pain and opioid consumption, but its effects with regional anesthesia for total hip arthroplasty (THA) are not known. We designed this study to determine whether (1) gabapentin administration reduces pain and opioid use after THA using a multimodal analgesic regimen including spinal anesthesia; (2) pre-operative administration of gabapentin is more effective than post-operative administration. Methods: After REB approval and informed consent, 126 patients were enrolled in a double-blinded, randomized-controlled study. Patients received acetaminophen 1 g per os (p.o.), celecoxib 400 mg p.o. and dexamethasone 8 mg intravenously, 1,2 h pre-operatively. Patients were randomly assigned to one of three treatment groups (G1: Placebo/Placebo; G2: GPN/Placebo; G3: Placebo/GPN). Patients received gabapentin 600 mg (G2) or placebo (G1 and G3) 2 h before surgery. All patients had spinal anesthesia [15 mg (3cc) of 0.5% hypobaric bupivacaine with 10 ,g of fentanyl]. In the post-anesthetic care unit, patients received gabapentin 600 mg (G3) or placebo (G1 and G2). On the ward, patients received acetaminophen 1000 mg p.o. q6h, celecoxib 200 mg p.o. q12h and a morphine PCA device. Patients were interviewed 6 months post-surgery to determine the incidence and severity of chronic post-surgical pain. Results: Mean±SD cumulative morphine (mg) consumption (G1=49.4±24.8, G2=47.2±30.1 and G3=56.1±38.2) at 48 h and pain scores at 12, 24, 36 and 48 h post-surgery were not significantly different among the groups [G1 (n=38), G2 (n=38) and G3 (n=38)]. Side effect profiles were similar across groups. Six months after surgery, the number of patients who reported chronic post-surgical pain (G1=10, G2=12 and G3=9) and the severity of the pain (G1=4.2±2.9, G2=4.1±2.2 and G3=4.9±2.2) did not differ significantly among the groups (P>0.05). Conclusions: A single 600 mg dose of gabapentin given pre-operatively or post-operatively does not reduce morphine consumption or pain scores in hospital or at 6 months after hip arthroplasty within the context of spinal anesthesia and a robust multimodal analgesia regimen. [source] Botulinum Toxin Type A Treatment of Multiple Upper Facial Sites: Patient-Reported OutcomesDERMATOLOGIC SURGERY, Issue 2007JEAN CARRUTHERS MD BACKGROUND Aesthetic treatment planning must address subjects' goals and include subject-reported outcomes. OBJECTIVE The objective was to compare the effect of botulinum neurotoxin type A (BoNTA) with placebo on subject-reported outcomes and to assess the utility of 64 U of BoNTA to treat the entire upper face. METHODS Forty female subjects were randomized to receive 64 U of BoNTA or identical placebo injections (double-masked) divided among 16 sites of the upper face and were followed for 12 weeks. Subjects unimproved at Week 4 were eligible for open-label BoNTA treatment and were followed through Week 16. Main outcome measures were scores on seven items of the Facial Line Outcomes Questionnaire (FLO-7) and results on the Self-Perception of Age (SPA) for assessing age of appearance relative to actual age. RESULTS BoNTA treatment resulted in significant improvements on the FLO-7 scores that were maintained throughout the study. BoNTA treatment also reduced age of appearance in a majority of subjects. Placebo had no effects on any measure. No serious adverse events occurred. CONCLUSION Sixty-four-unit BoNTA treatment of upper facial rhytids safely and significantly improves subject-reported outcomes, as measured by the FLO-7 and SPA, and results in a younger, more satisfying, relaxed appearance. [source] Nitric oxide synthase inhibition in Thoroughbred horses augments O2 extraction at rest and submaximal exercise, but not during short-term maximal exerciseEQUINE VETERINARY JOURNAL, Issue S36 2006M. MANOHAR Summary Reason for performing study: Work is required to establish the role of endogenous nitric oxide (NO) in metabolism of resting and exercising horses. Objectives: To examine the effects of NO synthase inhibition on O2 extraction and anaerobic metabolism at rest, and during submaximal and maximal exertion. Methods: Placebo and NO synthase inhibition (with N,-nitro-L-arginine methyl ester [l -NAME] administered at 20 mg/kg bwt i.v.) studies were performed in random order, 7 days apart on 7 healthy, exercise-trained Thoroughbred horses at rest and during incremental exercise leading to 120 sec of maximal exertion at 14 m/sec on a 3.5% uphill grade. Results: At rest, NO synthase inhibition significantly augmented the arterial to mixed-venous blood O2 content gradient and O2 extraction as mixed-venous blood O2 tension and saturation decreased significantly. While NO synthase inhibition did not affect arterial blood-gas tensions in exercising horses, the exercise-induced increment in haemoglobin concentration and arterial O2 content was attenuated. In the l -NAME study, during submaximal exercise, mixed-venous blood O2 tension and haemoglobin-O2 saturation decreased to a greater extent causing O2 extraction to increase significantly. During maximal exertion, arterial hypoxaemia, desaturation of haemoglobin and hypercapnia of a similar magnitude developed in both treatments. Also, the changes in mixed-venous blood O2 tension and haemoglobin-O2 saturation, arterial to mixed-venous blood O2 content gradient, O2 extraction and markers of anaerobic metabolism (lactate and ammonia production, and metabolic acidosis) were not different from those in the placebo study. Conclusion: Endogenous NO production augments O2 extraction at rest and during submaximal exertion, but not the during short-term maximal exercise. Also, NO synthase inhibition does not affect anaerobic metabolism at rest or during exertion. Potential relevance: It is unlikely that endogenous NO release modifies aerobic or anaerobic metabolism in horses performing short-term maximal exertion. [source] The Complicated Meaning of Placebo and Placebo EffectACADEMIC EMERGENCY MEDICINE, Issue 8 2000Terri Schmidt MD No abstract is available for this article. [source] Dissociation between objective psychomotor impairment and subjective sleepiness after diazepam administration in the aged peopleHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 6 2007Masaru Echizenya Abstract The aim of the present study was to clarify whether subjective sleepiness accurately reflects benzodiazepine-related decline in psychomotor function after taking benzodiazepines (BZPs) in aged people. Subjects were eight healthy, young (mean age, 19.8,years) and seven healthy, older (mean age, 60.9,years) men. Placebo and diazepam (DZP) were administered orally in a single-blind crossover manner to the young subjects (placebo, 5,mg DZP and 10,mg DZP) and to the older subjects (placebo and 5,mg DZP). Plasma drug concentration, choice reaction time (CRT) as an objective measure of psychomotor function, and the Stanford Sleepiness Scale (SSS) as a measure of subjective sleepiness were monitored every 20,min from 1000 until 1600,h, being the drug administered at 1200,h. Pharmacokinetic variables did not differ significantly between the two age groups. DZP at 10,mg in young subjects induced significant increases in both the CRT and SSS score. DZP at 5,mg induced no significant increase in SSS score in either age group but did induce a significant increase in CRT only in the older subjects that matched that in young subjects given 10,mg DZP. The older subjects suffered from dissociation between subjective sleepiness and objective psychomotor impairment under DZP treatment. Such individuals may underestimate the detrimental effects on brain function. Copyright © 2007 John Wiley & Sons, Ltd. [source] Hidden in Plain Sight: The Active Ingredients of Executive CoachingINDUSTRIAL AND ORGANIZATIONAL PSYCHOLOGY, Issue 3 2009D. DOUGLAS McKENNA We propose that I/O psychologists who coach executives have overlooked psychotherapy outcome research as a source of information and ideas that can be used to improve our executive coaching practices. This research, based on thousands of studies and many meta-analyses, has converged on the conclusion that four "active ingredients" account for most of the variance in psychotherapy outcomes. We describe how this literature has identified four primary "active ingredients" that account for most of the variance in psychotherapy outcomes: 1) Client/extratherapeutic factors (40%), 2) The relationship or alliance (30%), 3) Placebo or hope (15%), and 4) Theory and technique (15%). Working on the assumption that psychotherapy and executive coaching are sufficiently similar to justify generalization from one domain to the other, we describe these four active ingredients at length and explore how they may be at work in the executive coaching process. We also suggest that I/O psychologists have training and experience that allows us to leverage some of these active ingredients in our executive coaching (e.g., understanding of client individual differences related to coaching outcomes). But we also have areas of weakness (e.g., building a strong working relationship with an individual client) that may need to be bolstered with additional training and development experiences. [source] Microencapsulation of doxycycline into poly(lactide- co -glycolide) by spray drying technique: Effect of polymer molecular weight on process parametersJOURNAL OF APPLIED POLYMER SCIENCE, Issue 6 2008Pradip Patel Abstract Poly(lactide- co -glycolide) (PLGA) polymers with three different molecular weights were prepared, and microparticles were produced by spray drying and water-in-oil-water (w/o/w) double emulsion techniques to encapsulate 86% of doxycycline (DXY), an antibiotic drug, for the use of periodontitis. Placebo and drug-loaded microspheres and pristine DXY were analyzed by Fourier transform infrared spectroscopy, which indicated no chemical interactions between DXY and PLGA. X-ray diffraction of drug-loaded microspheres confirmed the molecular level dispersion of DXY in PLGA. Scanning electron microscopy confirmed spherical nature and smooth surfaces of the microspheres. Mean particle size as measured by laser light scattering technique ranged between 10 and 25 ,m. In vitro release of DXY performed in 7.4 pH media continued up to 72 h and depended on molecular weight of PLGA and extent of DXY loading. Antimicrobial studies performed on one formulation and placebo microspheres suggested that drug concentrations during in vitro release are above the minimum inhibitory concentration (MIC) for Staphylococcus aureus growth. Overall, the release studies depended on the molecular weight of PLGA, extent of drug loading, and the method used to prepare microspheres. Statistical analyses of release data performed using the analysis of variance (ANOVA) method agreed well with experimental observations. © 2008 Wiley Periodicals, Inc. J Appl Polym Sci, 2008 [source] Amoxicillin plus metronidazole in the treatment of adult periodontitis patientsJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 4 2001A double-blind placebo-controlled study Abstract Background, aims: The aim of this double-blind, parallel study was to evaluate the adjunctive effects of systemically administered amoxicillin and metronidazole in a group of adult periodontitis patients who also received supra- and subgingival debridement. Methods: 49 patients with a diagnosis of generalised severe periodontitis participated in the study. Random assignment resulted in 26 patients in the placebo (P) group with a mean age of 40 years and 23 patients in the test (T) group which had a mean age of 45 years. Clinical measurements and microbiological assessments were taken at baseline and 3 months after completion of initial periodontal therapy with additional placebo or antibiotic treatment. Patients received coded study medication of either 375 mg amoxicillin in combination with 250 mg metronidazole or identical placebo tablets, every 8 hours for the following 7 days. Results: At baseline, no statistically significant differences between groups were found for any of the clinical parameters. Except for the plaque, there was a significantly larger change in the bleeding, probing pocket depth (PPD) and clinical attachment level (CAL) in the T-group as compared to the P-group after therapy. The greatest reduction in PPD was found at sites with initial PPD of 7 mm, 2.5 mm in the P-group and 3.2 mm in the T-group. The improvement in CAL was most pronounced in the PPD category 7 mm and amounted to 1.5 mm and 2.0 mm in the P- and T-groups, respectively. No significant decrease was found in the number of patients positive for any of the test species in the P-group. The number of patients positive for Porphyromonas gingivalis, Bacteroides forsythus and Prevotella intermedia in the T-group showed a significant decrease. After therapy there was a significant difference between the P- and the T- group in the remaining number of patients positive for P. gingivalis, B. forsythus and Peptostreptococcus micros. 4 subgroups were created on the basis of the initial microbiological status for P. gingivalis positive (Pg-pos) and negative patients (Pg-neg) in the P- and the T-groups. The difference in reduction of PPD between Pg-pos and Pg-neg patients was particularly evident with respect to the changes in % of sites with a probing pocket depth 5 mm. This % decreased from 45% at baseline to 23% after treatment in the Pg-pos placebo subgroup and decreased from 46% to 11% in the Pg-pos test subgroup (p0.005). In contrast, the changes in the proportions of sites with a probing pocket depth 5 mm in the Pg-neg placebo and Pg-neg test subgroup were similar, from 43% at baseline to 18% after treatment versus 40% to 12%, respectively. Conclusions: This study has shown that systemic usage of metronidazole and amoxicillin, when used in conjunction with initial periodontal treatment in adult periodontitis patients, achieves significantly better clinical and microbiological results than initial periodontal treatment alone. Moreover, this research suggests that especially patients diagnosed with P. gingivalis benefit from antibiotic treatment. Zusammenfassung Zielsetzung: Das Ziel dieser placebokontrollierten Doppelblindstudie mit parallelen Gruppen war es, die zusätzlichen Effekte der systemischen Gabe von Amoxicillin und Metronidazol bei Patienten mit Erwachsenenparodontitis zu untersuchen, bei denen auch eine supra- und subgingivale Instrumentierung durchgeführt worden war. Material und Methoden: 49 Patienten mit einer generalisierten schweren Erwachsenenparodontitis nahmen an der Studie teil. Zufällige Zuweisung der Therapien führte zu 26 Patienten in der Placebo-Gruppe (P) mit einem mittleren Alter von 40 und 23 Patienten in der Test-Gruppe (T) mit einem mittleren Alter von 45 Jahren. Klinische Messungen und mikrobiologische Untersuchungen wurden zu Beginn der Therapie sowie 3 Monate nach parodontaler Initialbehandlung mit zusätzlicher Placebo- bzw. Antibiotikagabe durchgeführt. Nachdem alle Zähne mit pathologisch vertieften Taschen subgingival instrumentiert worden waren, erhielten die Patienten eine kodierte Studienmedikation, die entweder aus 375 mg Amoxicillin und 250 mg Metronidazol oder identisch aussehenden Placebotabletten bestand, die die Patienten für 7 Tage alle 8 Stunden einnehmen sollten. Ergebnisse: Zu Beginn der Studie bestand kein statistisch signifikanter Unterschied zwischen den Versuchsgruppen hinsichtlich klinischer Parameter. Nicht für den Plaque Index, aber für Sondierungsblutung, Sondierungstiefen (ST) und klinische Attachmentlevel (PAL) kam es in der T-Gruppe zu signifikant stärkeren Veränderungen im Vergleich zur P-Gruppe. Die stärkste ST-Reduktion bzw. die größten Attachmentgewinne wurden bei Stellen gefunden, die initial ST 7 mm aufgewiesen hatten: P-Gruppe: ST=2.5 mm, PAL=1.5 mm; T-Gruppe: ST=3.2 mm, PAL=2.0 mm. Für keines der untersuchten Parodontalpathogene wurde eine signifikante Reduktion in der P-Gruppe beobachtet, während sich in der T-Gruppe eine signifikante Reduktion für Porphyromonas gingivalis, Bacteroides forsythus und Prevotella intermedia ergab. Nach Therapie ergab sich ein statistisch signifikanter Unterschied zwischen T- und P-Gruppe hinsichtlich Persistenz von P. gingivalis, B. forsythus und Peptostreptococcus micros. Entsprechend dem initialen mikrobiologischen Status für P. gingivalis wurden 4 Untergruppen gebildet: P. gingivalis positive (Pg+) oder (Pg,) Patienten in der T-bzw. P-Gruppe. Der Unterschied zwischen Pg+ und Pg, Patienten war besonders groß hinsichtlich der Veränderung des %-Anteils der Stellen mit ST5 mm. Dieser verringerte sich in der Pg+ P-Untergruppe von 45% auf 23% und in der Pg+ T-Untergruppe von 46% auf 11% (p0.005). Im Unterschied dazu war die Reduktion des Anteils der ST 5 mm in der Pg, P- und T-Untergruppen gleich: P-Gruppe: 43% auf 18%; T-Gruppe von 40% auf 12%. Schlußfolgerungen: Die systemische Gabe von Amoxicillin und Metronidazol zusätzlich zu subgingivaler Instrumentierung bei Patienten mit Erwachsenenparodontitis führt zu signifikant günstigeren klinischen und mikrobiologischen Ergebnissen als die konventionelle Therapie allein. Insbesondere Patienten mit P. gingivalis scheinen von dieser unterstützenden antibiotischen Therapie zu profitieren. Résumé Le but de cette étude parallèle en double aveugle était d'évaluer les effets supplémentaires apportés par l'administration d'amoxicilline et de metronidazole dans un groupe de patients atteints de parodontite de l'adulte qui ont reçu également un débridement supra et sous gingival. 49 patients présentant un diagnostic de parodontite généralisée sévère participèrent à l'étude. La composition des groupes sélectionnés au hasard, était de 26 patients dans le groupe placebo (P) avec un âge moyen de 40 ans et 23 patients dans le groupe test (T) avec une moyenne d'âge de 45 ans. Des mesures cliniques et des prélèvements microbiologiques étaient réalisés initialement et 3 mois après la fin de la thérapeutique parodontale initiale complétée par un placebo ou un traitement antibiotique. Les patients recevaient des médicaments codés pour l'étude de 375 mg amoxicilline combiné avec 250 mg de metronidazol ou des comprimés placebo identiques, toutes les 8 heures pendant les 7 jours suivants. Initalement, aucune différence statistiquement significative entre les groupes n'était observée, pour aucun des paramètres cliniques. En dehors de la plaque, il y avait une modification plus élevée significative pour le saignement, la profondeur de poche au sondage (PPD) et le niveau clinique d'attache (CAL) dans le groupe T, par rapport au groupe P, après traitement. La plus grande réduction pour PPD était observée pour les sites ayant une profondeur de poche au sondage intiale>ou égale à 7 mm, 2.5 mm dans le groupe P et 3.2 mm dans le groupe T. L'amélioration du CAL était plus prononcée pour la catégorie >ou égale à 7 mm et allait jusqu'à 1.5 et 2.0 mm dans les groupes P et T, respectivement. Aucune diminution significative n'était trouvée pour le nombre de patients positifs pour n'importe quelle espèce test dans le groupe P. Le nomber de patients positifs pour Porphyromonas gingivalis, Bacteroides forsythus et Prevotella intermedia dans le groupe T présentait une diminution significative. Après thérapeutique, il y avait une différence significative entre les groupe P et T, en ce qui concerne le nombre de patients positifs pour P. gingivalis, B. forsythus et Peptostreptococcus micros. 4-sous groupes furent créés sur la base de l'état microbiologique pour les patients positifs àP. gingivalis (Pg-pos), et négatifs (Pg-neg), dans les groupes P et T. La différence de réduction de PPD entre les patients Pg-pos et Pg-neg était particulièrement évidente en ce qui concernait les changements en % de sites présentant une profondeur de poche au sondage >ou égale à 5 mm. Ce % diminuait de 45% initialement à 23% après traitement dans le sous-groupe Pg-pos placebo et de 46% à 11% dans le sous-groupe Pg-pos test (p<0.005). A l'inverse, les changements observés dans les proportions de sites avec une profondeur de poche au sondage >5 mm dans les sous-groupes Pg-neg placebo et Pg-neg test étaient similaires, de 43% initialement à 18% après traitement contre 40% à 12% respectivement. En conclusion, cette étude a montré que l'utilisation systèmique de metronidazole et d'amoxicilline, lorsqu'elle est utilisée en complément du traitement parodontal initial chez des patients atteints de parodontite de l'adulte, donne, de façon significative, de meilleurs résultats cliniques et microbiologiques qu'un traitement parodontal initial seul. De plus, cette recherche suggère que les patients porteurs du P. gingivalis bénéficient particulièrement d'un traitement antibiotique. [source] Effects of SCN,/H2O2 combinations in dentifrices on plaque and gingivitisJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 3 2001Michael Rosin Abstract Objectives: A 10-week, double-blind, placebo-controlled clinical study on 140 male subjects was conducted to determine the effect on plaque and gingivitis of 5 dentifrices containing various thiocyanate (SCN,)/hydrogen peroxide (H2O2) combinations. Materials and Methods: The dentifrices consisted of a gel base without any detergents or abrasives (placebo, group A) to which SCN, and/or H2O2 were added as follows: 0.1% SCN, (group B), 0.5% SCN, (group C), 0.1% SCN,/ 0.1% H2O2 (group D), 0.5% SCN,/0.1% H2O2 (group E) and 0.1% H2O2 (group F). A baseline examination was performed in which the Silness and Löe Plaque Index (PI), the Mühlemann and Son Sulcus Bleeding Index (SBI), and the amount of gingival crevicular fluid (GCF) were recorded using the Periotron 6000 on teeth 16, 12, 24, 36, 32, and 44. The subjects were randomly assigned to either the placebo group (n=40) or one of the test groups (n=20) and used their respective dentifrices over a period of 8 weeks. Finally, each group used the placebo for another 2 weeks (wash-out). Re-examinations were performed after 1, 4, and 8 weeks and the 2-week wash-out period employing the clinical parameters used at baseline. Intragroup changes were analyzed with the Wilcoxon signed-ranks test, using the baseline and wash-out points as references. The Mann-Whitney U test was used for comparisons between the treatment groups and the placebo group. Results: At the 8-week examination, the plaque index in group E (p=0.017) and group F (p=0.032) was lower than in the placebo group. The Sulcus Bleeding Index in group F after 1 week was increased (p=0.023) and the SBI in group E after 8 weeks was reduced (p=0.047) as compared to the placebo group. Conclusion: The results demonstrated that a dentifrice containing 0.5% SCN, and 0.1% H2O2 but no detergents or abrasives inhibited plaque and decreased gingivitis. Zusammenfassung Zielsetzung: Eine 10 Wochen dauernde placebokontrollierte Doppelblindstudie wurde bei 140 männlichen Probanden durchgeführt, um die Auswirkungen von 5 Zahnpasten, die verschiedene Kombinationen von Thiozyanat (SCN,) und Wasserstoffperoxide (H2O2) enthielten, auf Plaque und Gingivitis zu untersuchen. Material und Methoden: Die Zahnpasten bestanden aus einer Gelbasis ohne jegliche Detergentien oder Putzkörper (Placebo, Gruppe A), der SCN, und/oder H2O2 wie folgt beigemengt waren: 0.1% SCN, (Gruppe B), 0.5% SCN, (Gruppe C), 0.1% SCN,/0.1% H2O2 (Gruppe D), 0.5% SCN,/0.1% H2O2 (Gruppe E) und 0.1% H2O2 (Gruppe F). Zu Beginn der Studie wurden der Plaque Index (PI), der Sulkus-Blutungs-Index (SBI) und die Sulkusflüssigkeitsfließrate (SFFR) mit dem Periotron 6000 an den Zähnen 16, 12, 24, 36, 32 und 44 bestimmt. Die Probanden wurden zufällig der Placebogruppe (n=40) oder einer der 5 Testgruppen (n=20) zugewiesen und benutzten die entsprechende Zahnpasta über einen Zeitraum von 8 Wochen. Schließlich benutzte jeder Proband die Placebopasta für weitere 2 Wochen ("wash-out"). Nachuntersuchungen fanden nach 1, 4 und 8 Wochen sowie nach der "wash-out"-Periode statt. Ergebnisse: Zur 8-Wochen-Nachuntersuchung war der PI in den Gruppen E (p=0.017) und F (p=0.032) niedriger als in der Placebogruppe. Der SBI in Gruppe F war im Vergleich zur Placebogruppe nach einer Woche erhöht (p=0.023) und in Gruppe E nach 8 Wochen reduziert (p=0.047). Schlußfolgerungen: Die Ergebnisse zeigen, daß eine Zahnpasta, die 0.5% SCN, und 0.1% H2O2 aber keinerlei Detergentien oder Putzkörper enthält Plaque hemmen und Gingivitis reduzieren kann. Résumé Une étude clinique en double aveugle, controlée par un placebo, sur 10 semaines a été réalisée sur 140 sujets masculins pour déterminer les effets sur la plaque et la gingivite de 5 dentifrices contenant des combinaisons variées de thiocyanate (SCN,)/peroxyde d'hydrogene (H2O2). Les dentifrices étaient constitués d'une base de gel sans détergents ni abrasifs (placebo, groupe A) à laquelle étaient ajoutés SCN, et/ou H2O2 comme suit: 0.1% SCN, (groupe B), 0.5% SCN, (groupe C), 0.1% SCN,/0.1% H2O2 (groupe D), 0.5% SCN,/1% H2O2 (groupe E), et 0.1% H2O2 (groupe F). Un examen initial était réalise au cours duquel, l'indice de plaque de Silness et Löe (PI), l'indice de saignement sulculaire de Mühlemann et Son (SBI), et la quantité de fluide gingival (GCF) étaient enregistrés en utilisant le Periotron 6000 sur les dents 16, 12, 24, 36, 32 et 44. Les sujets étaient assignés au hasard soit dans le groupe placebo (n=20), soit dans un groupe test (n=20) et utilisaient leur dentifrices respectifs pendant une période de 8 semaines. Finalement, chaque groupe utilisait le placebo pendant 2 semaines supplémentaires (lessivage). Une réexamination était réalisée après 1, 4, 8 semaines et après la période de lessivage final de 2 semaines avec les mênes indices qu'à l'examen initial. Les modifications intragroupe étaient analysées par le test de Wilcoxon signed ranks, en utilisant les indices initiaux et ceux relevés lors de la période de lessivage. Le test de Mann-Whitney U fut utilisé pour comparer les groupes test et le groupe placebo. A l'examen de la huitième semaine, les indices de plaque du groupe E (p=0.017) et du groupe F (p=0.032) étaient plus bas que dans le groupe placebo. L'indice de saignement sulculaire du groupe F après une semaine était augmenté (p=0.023) et le SBI du groupe E après 8 semaines était diminué (p=0.047), comparé au groupe placebo. Les résultats montrent qu'un dentifrice contenant 0.5% SCN, et 0.1% H2O2, mais ni détergents, ni abrasifs, inhibe la plaque et réduit la gingivite. [source] Public Inquiry: Panacea or Placebo?JOURNAL OF CONTINGENCIES AND CRISIS MANAGEMENT, Issue 1 2002Dominic Elliott This article reviews and examines the role of the public inquiry as a mechanism for investigating disasters within the United Kingdom. A number of authors have considered the growing penetration of technology into our lives, as well as economic liberalisation, societal fragmentation and the globalisation of business, as factors that have contributed to a post modern view of the world. Within this context, this article considers the efficacy of the public inquiry as a tool for learning from disaster. Is an instrument born of the late nineteenth century suited to the demands of the early twenty-first century? Data are drawn from the football and rail industries, both of which have witnessed a sequence of large-scale accidents investigated through the public inquiry mechanism. Drawing upon literature from the fields of socio-legal studies and crisis management, three broad areas are critiqued: the process, underlying aims, and impartiality of the public inquiry process. [source] Placebo: A pleasing effectJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 1-2 2010Professor David Isaacs Editor-in-Chief No abstract is available for this article. [source] Antiglutamatergic Strategies for Ethanol Detoxification: Comparison With Placebo and DiazepamALCOHOLISM, Issue 4 2007Evgeny M. Krupitsky Background: Benzodiazepines are the standard pharmacotherapies for ethanol detoxification, but concerns about their abuse potential and negative effects upon the transition to alcohol abstinence drive the search for new treatments. Glutamatergic activation and glutamate receptor up-regulation contribute to ethanol dependence and withdrawal. This study compared 3 antiglutamatergic strategies for ethanol detoxification with placebo and to the benzodiazepine, diazepam: the glutamate release inhibitor, lamotrigine; the N -methyl- d -aspartate glutamate receptor antagonist, memantine; and the AMPA/kainite receptor inhibitor, topiramate. Methods: This placebo-controlled randomized single-blinded psychopharmacology trial studied male alcohol-dependent inpatients (n=127) with clinically significant alcohol withdrawal symptoms. Subjects were assigned to 1 of 5 treatments for 7 days: placebo, diazepam 10 mg TID, lamotrigine 25 mg QID, memantine 10 mg TID, or topiramate 25 mg QID. Additional diazepam was administered when the assigned medication failed to suppress withdrawal symptoms adequately. Results: All active medications significantly reduced observer-rated and self-rated withdrawal severity, dysphoric mood, and supplementary diazepam administration compared with placebo. The active medications did not differ from diazepam. Conclusions: This study provides the first systematic clinical evidence supporting the efficacy of a number of antiglutamatergic approaches for treating alcohol withdrawal symptoms. These data support the hypothesis that glutamatergic activation contributes to human alcohol withdrawal. Definitive studies of each of these medications are now needed to further evaluate their effectiveness in treating alcohol withdrawal. [source] Sodium Valproate in the Management of Painful Neuropathy in Type 2 Diabetes , a Randomized Placebo Controlled StudyJOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, Issue 2 2003DK Kochar OBJECTIVE: To study the effectiveness and safety aspects of sodium valproate in the management of painful neuropathy in patients of type 2 diabetes mellitus. MATERIAL AND METHODS: A randomized double-blind placebo controlled trial of sodium valproate was done in type 2 diabetic patients to assess its efficacy and safety in the management of painful neuropathy. We screened 60 patients but eight patients could not complete the study; hence, the present study was done on 52 patients. Each patient was assessed by clinical examination, pain score by short form of the McGill pain questionnaire (SF-MPQ) and electrophysiological examination, which included motor and sensory nerve conduction velocity, amplitude and H-reflex initially and at the end of 1 month of treatment. RESULTS: Significant improvement was noticed in the pain score of patients receiving sodium valproate in comparison to patients receiving placebo at the end of 1 month (P < 0.05). The changes in electrophysiological data were not significant. The drug was well tolerated by all patients except one who developed a raised aspartate transaminase (AST)/alanine transaminase (ALT) level after 15 days of treatment. CONCLUSION: Sodium valproate is a well-tolerated drug and provides significant subjective improvement in painful diabetic neuropathy. These data provide a basis for future trials of longer duration in a larger group of patients. [source] Clinical trial: the effects of a trans-galactooligosaccharide prebiotic on faecal microbiota and symptoms in irritable bowel syndromeALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2009D. B. A. SILK Summary Background, Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). Aim, To investigate the efficacy of a novel prebiotic trans-galactooligosaccharide in changing the colonic microflora and improve the symptoms in IBS sufferers. Methods, In all, 44 patients with Rome II positive IBS completed a 12-week single centre parallel crossover controlled clinical trial. Patients were randomized to receive either 3.5 g/d prebiotic, 7 g/d prebiotic or 7 g/d placebo. IBS symptoms were monitored weekly and scored according to a 7-point Likert scale. Changes in faecal microflora, stool frequency and form (Bristol stool scale) subjective global assessment (SGA), anxiety and depression and QOL scores were also monitored. Results, The prebiotic significantly enhanced faecal bifidobacteria (3.5 g/d P < 0.005; 7 g/d P < 0.001). Placebo was without effect on the clinical parameters monitored, while the prebiotic at 3.5 g/d significantly changed stool consistency (P < 0.05), improved flatulence (P < 0.05) bloating (P < 0.05), composite score of symptoms (P < 0.05) and SGA (P < 0.05). The prebiotic at 7 g/d significantly improved SGA (P < 0.05) and anxiety scores (P < 0.05). Conclusion, The galactooligosaccharide acted as a prebiotic in specifically stimulating gut bifidobacteria in IBS patients and is effective in alleviating symptoms. These findings suggest that the prebiotic has potential as a therapeutic agent in IBS. [source] Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation , a 12-week, randomized, double-blind, placebo-controlled studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2009E. M. M. QUIGLEY Summary Background, Chronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL). Aim, A randomized, double-blind, placebo-controlled, phase III trial to evaluate the efficacy and safety of a selective, high-affinity 5-HT4 receptor agonist, prucalopride, in patients with chronic constipation [,2 spontaneous complete bowel movements (SCBMs)/week]. Methods, Placebo, 2 or 4 mg prucalopride was administered orally once daily, for 12 weeks. The primary efficacy endpoint was the proportion of patients with ,3 SCBMs/week, averaged over 12 weeks. Other assessments included BM frequency, constipation-related QoL and symptoms and tolerability. Results, Among 641 patients, significantly more patients taking prucalopride 2 or 4 mg (24%) than placebo (12%), achieved the primary efficacy endpoint (,3 SCBMs/week) or an increase of ,1 SCBMs/week; 43% and 47% vs. 28% respectively. Prucalopride-treated patients also achieved significantly greater satisfaction with treatment and bowel function, and improved perception of constipation severity and constipation-related QoL, compared with placebo. Most frequent treatment-related adverse events were headache, abdominal pain, nausea and diarrhoea (mainly during day 1). There were no differences in comparison to placebo in the incidence of serious adverse effects or cardiovascular events. Conclusion, Over 12 weeks, prucalopride was effective and well tolerated in chronic constipation. [source] Acupuncture for Chronic Pain: Is Acupuncture More than an Effective Placebo?PAIN PRACTICE, Issue 2 2010A Systematic Review of Pooled Data from Meta-analyses Abstract Objectives: There is controversy as to whether or not acupuncture is more effective than placebo. To help clarify this debate, we synthesized the evidence gathered from systematic reviews on the pooled data of high-quality randomized controlled trials comparing acupuncture to sham acupuncture for chronic pain. Method: Systematic reviews of acupuncture for the most commonly occurring forms of chronic pain (back, knee, and head) published between 2003 and 2008 were sourced from Ovid databases: Medline, Allied and Complementary Medicine database, Cochrane Library and Web of Science during December 2008. Eight systematic reviews with meta-analyses of pooled data were eligible for inclusion. Data were extracted for short- and longer-term outcomes for the most commonly occurring forms of pain. Two independent reviewers assessed methodological quality. Results: For short-term outcomes, acupuncture showed significant superiority over sham for back pain, knee pain, and headache. For longer-term outcomes (6 to12 months), acupuncture was significantly more effective for knee pain and tension-type headache but inconsistent for back pain (one positive and one inconclusive). In general, effect sizes (standardized mean differences) were found to be relatively small. Discussion: The accumulating evidence from recent reviews suggests that acupuncture is more than a placebo for commonly occurring chronic pain conditions. If this conclusion is correct, then we ask the question: is it now time to shift research priorities away from asking placebo-related questions and shift toward asking more practical questions about whether the overall benefit is clinically meaningful and cost-effective? [source] H1 -antihistaminic activity of cetirizine and fexofenadine in allergic childrenPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 3 2003F. Estelle R. Simons The clinical pharmacology of H1 -antihistamines has not yet been optimally studied in children and other special groups of patients. Our objective was to determine the onset, extent, and duration of H1 -antihistaminic activity of cetirizine and fexofenadine in the pediatric population. We performed a prospective, randomized, placebo-controlled, double-blind, crossover, single-dose study of these H1 -antihistamines in 15 allergic children, mean±SEM age 8.8±0.5 years. We used suppression of the histamine-induced wheal and flare as the primary outcome. Compared with pre-dose baseline, cetirizine 10 mg suppressed the wheals significantly (p,0.05) from 2 to 24 h and the flares significantly from 1 to 24 h, achieving 77±SEM 10% to 86±9% suppression of the wheal from 2 to 7 h and 85±6% to 88±6% suppression of the flare from 2 to 24 h, inclusive. Compared with baseline, fexofenadine 30 mg did not suppress the wheals or flares significantly at any time, achieving 40±9% to 54±9% wheal suppression from 2 to 7 h and 45±11% to 68±9% flare suppression from 2 to 7 h, inclusive. Compared with placebo, cetirizine suppressed the wheals and flares significantly from 2 to 24 h. Compared with placebo, fexofenadine suppressed the wheals significantly at 4 and 6 h, and the flares from 4 to 7 h. Cetirizine suppressed the wheals and flares significantly more than fexofenadine at 2 h (wheals), and at 3 and 24 h (flares). Placebo did not suppress the wheals and flares significantly at any time. In children age 6,11 years, cetirizine 10 mg has a rapid onset of H1 -antihistaminic activity, a 24-h duration of action, and greater H1 -activity than fexofenadine 30 mg. Higher doses of fexofenadine should be tested in children. [source] Clinical pharmacology of the H1 -receptor antagonists cetirizine and loratadine in childrenPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 2 2000F. Estelle R. Simons H1 -receptor antagonists are widely used in children but are not as well-studied in children as they are in adults. Our objective was to determine the onset and duration of action and the relative potency of the H1 -receptor antagonists cetirizine and loratadine in children. We performed a prospective, randomized, placebo-controlled, double-blind, crossover, single-dose study of cetirizine and loratadine using suppression of the histamine-induced wheal and flare as the primary outcome. In 15 allergic children, mean age 9 years, compared with baseline, cetirizine (10 mg) suppressed the wheals and flares significantly from 0.25 to 24 h, achieving nearly 100% of flare suppression from 2 to 24 h, inclusive, and loratadine (10 mg) suppressed the wheals and flares significantly from 0.75 to 24 h, inclusive. Cetirizine suppressed the wheals and flares significantly more than loratadine from 0.25 to 1 h, inclusive, and at 0.5, 1, 2, 3, 5, 6, 7, and 24 h, respectively. Placebo also suppressed the wheal and flare significantly at some assessment times. Cetirizine and loratadine both have excellent antihistaminic activity in children, with a rapid onset of action and a 24-h duration of action in this population. [source] Antioxidants reverse depression of the hypoxic ventilatory response by acetazolamide in manTHE JOURNAL OF PHYSIOLOGY, Issue 3 2006Luc J. Teppema The carbonic anhydrase inhibitor acetazolamide may have both inhibitory and stimulatory effects on breathing. In this placebo-controlled double-blind study we measured the effect of an intravenous dose (4 mg kg,1) of this agent on the acute isocapnic hypoxic ventilatory response in 16 healthy volunteers (haemoglobin oxygen saturation 83,85%) and examined whether its inhibitory effects on this response could be reversed by antioxidants (1 g ascorbic acid i.v. and 200 mg ,-tocopherol p.o.). The subjects were randomly divided into an antioxidant (Aox) and placebo group. In the Aox group, acetazolamide reduced the mean normocapnic and hypercapnic hypoxic responses by 37% (P < 0.01) and 55% (P < 0.01), respectively, and abolished the O2,CO2 interaction, i.e. the increase in O2 sensitivity with rising PCO2. Antioxidants completely reversed this inhibiting effect on the normocapnic hypoxic response, while in hypercapnia the reversal was partial. In the placebo group, acetazolamide reduced the normo- and hypercapnic hypoxic responses by 33 and 47%, respectively (P < 0.01 versus control in both cases), and also abolished the O2,CO2 interaction. Placebo failed to reverse these inhibitory effects of acetazolamide in this group. We hypothesize that either an isoform of carbonic anhydrase may be involved in the regulation of the redox state in the carotid bodies or that acetazolamide and antioxidants exert independent effects on oxygen-sensing cells, in which both carbonic anhydrase and potassium channels may be involved. The novel findings of this study may have clinical implications, for example with regard to a combined use of acetazolamide and antioxidants at high altitude. [source] Randomized Double-blind Placebo Controlled Crossover Study of Acetaminophen, Ibuprofen, Acetaminophen/Hydrocodone, and Placebo for the Relief of Pain From a Standard Painful StimulusACADEMIC EMERGENCY MEDICINE, Issue 9 2009James R. Miner MD Abstract Objectives:, The objective was to compare subjects' change in perceived acute pain from an identical painful stimulus after receiving three separate, commonly used pain medications and placebo. Methods:, This was an institutional review board,approved, randomized, double-blind crossover study of healthy human volunteers. Subjects received 1000 mg of acetaminophen, 800 mg of ibuprofen, the combination of 650 mg of acetaminophen with 10 mg of hydrocodone, or placebo (800 mg of lactose) in a randomized order over four separate occasions each 1 week apart. Prior to receiving the drug on each study day, subjects placed their nondominant hand in a bath of 0°C water for 45 seconds. The bath was divided into two sections; the larger was the reservoir of cooled water monitored at 0°C, and the other half was filled from constant overflow. Water drained from the overflow section into the cooling unit and was then pumped up into the base of the reservoir through a diffusion grid. Subjects completed a 100-mm visual analog scale (VAS) representing perceived pain during the exposure. The cold water exposure and VAS were repeated 1 hour after receiving the study drug, and then subjects were observed for side effects for 4 hours. Data were compared using descriptive statistics, 95% confidence intervals (CIs), and repeated-measures analysis of variance (ANOVA). Results:, Twenty-five subjects were enrolled. The mean VAS preexposure was 56.9 mm (±15.1 mm; range = 5 to 92 mm). The mean decrease in VAS after receiving the study drug for acetaminophen was 10.2% (95% CI = ,1.4 to 20.4), for ibuprofen was ,6.6% (95% CI = ,16.5 to 3.20), for acetaminophen/hydrocodone was 9.5% (95% CI = 1.4 to 20.4), and for placebo was ,6.9% (95% CI = ,15.2 to 1.4). The range in change in pain scores for all agents was ,91.3% to 57.6%. Mild side effects (nausea, dizziness, or somnolence) were reported in 11 subjects (44%) after receiving acetaminophen/hydrocodone; no other side effects were reported. Conclusions:, There was a wide range of changes in pain scores from this identical painful stimulus after receiving the study medications. Acetaminophen and acetaminophen/hydrocodone resulted in a similar decrease in pain (10.2 and 9.5%), while ibuprofen and placebo had a similar lack of effect (,6.6 and ,6.9%). Forty-four percent of subjects receiving acetaminophen/hydrocodone reported mild side effects; no other side effects were seen. In this noninflammatory pain model, the VAS is not able to distinguish differences in pain relief between acetaminophen and acetaminophen/hydrocodone or ibuprofen and placebo. [source] A Randomized, Double-blind Controlled Study of Jet Lidocaine Compared to Jet Placebo for Pain Relief in Children Undergoing Needle Insertion in the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 5 2009Marc Auerbach MD Abstract Objectives:, The objectives were to determine whether pretreatment with needleless jet-delivered lidocaine decreases self-reported pain in children undergoing needle insertion in the emergency department (ED) and to explore whether pretreatment with a jet device decreases self-reported pain in children undergoing needle insertion in the ED. Methods:, This study examined needle insertion pain in children 5,18 years of age. In the first phase of this study, children received either pretreatment with jet-delivered lidocaine (0.2 mL of buffered 1% lidocaine; n = 75) or pretreatment with jet-delivered placebo (0.2 mL of preservative-free normal saline; n = 75) 60 seconds before undergoing needle insertion. This phase of the study had a randomized, double-blind, placebo-controlled design. In the second phase, an unblinded, nonconcurrent, nonintervention control group (n = 47) was examined to describe any effect of using the jet device. Patients reported pain upon administration of the jet device and at needle insertion using a 100-mm color analog scale (CAS). Patients also reported their satisfaction with this device. The physicians and nurses performing needle insertions were asked to rate their ability to visualize the vein and their satisfaction with the device. Results:, The mean (±standard deviation [SD]) needle insertion pain score for jet lidocaine, 28 (±7) mm, was similar to the mean needle insertion pain score for jet placebo, 34 (±7) mm. The mean needle insertion pain score for both the jet lidocaine and the jet placebo groups were lower than the needle insertion pain scores for the no device group, 52 (±8) mm. The majority of patients receiving the jet device reported that they would request this device for future needle insertions. Providers' ratings of their ability to visualize veins and the patient cooperation were similar in all three groups. Conclusions:, Jet-delivered lidocaine is no more effective than jet-delivered placebo in providing local anesthesia for needle insertion. Jet lidocaine and jet placebo may provide superior analgesia compared to no local anesthetic pretreatment. [source] Magnesium Sulfate versus Placebo for Paroxysmal Atrial Fibrillation: A Randomized Clinical TrialACADEMIC EMERGENCY MEDICINE, Issue 4 2009Kevin Chu MBBS Abstract Objectives:, The objective was to investigate the efficacy of magnesium sulfate (MgSO4) in decreasing the ventricular rate in emergency department (ED) patients presenting with new-onset, rapid atrial fibrillation (AF). Methods:, A double-blinded, placebo-controlled randomized clinical trial was conducted in an adult university hospital. Patients aged ,18 years with AF onset of less than 48 hours and a sustained ventricular rate of >100 beats/min were randomized to either intravenous (IV) MgSO4 10 mmol or normal saline (NSal). Rhythm and instantaneous heart rate as measured by the monitor were recorded at baseline and every 15 minutes for 2 hours after starting the trial drug. Heart rate and rhythm were compared at 2 hours. A multilevel modeling analysis was performed to adjust for differences in baseline heart rate and any additional treatment and to examine changes in heart rate over time. Results:, Twenty-four patients were randomized to MgSO4 and 24 to NSal. Baseline heart rate was lower in the MgSO4 group (mean ± standard deviation [±SD] = 125 ± 24 vs. 140 ± 21 beats/min]. One and 3 patients in the MgSO4 and NSal groups, respectively, were given another antiarrhythmic or were electrically cardioverted within 2 hours after starting the trial drug. Heart rate (mean ± SD) at 2 hours in both MgSO4 (116 ± 30 beats/min) and NSal groups (114 ± 31 beats/min) decreased below their respective baseline levels. However, the rate of heart rate decrease across time did not differ between groups (p = 0.124). The proportion of patients who converted to sinus rhythm 2 hours post,trial drug did not differ (MgSO4 8.7% vs. NSal 25.0%, p = 0.25). Conclusions:, This study was unable to demonstrate a difference between IV MgSO4 10 mmol and saline placebo for reducing heart rate or conversion to sinus rhythm at 2 hours posttreatment in ED patients with AF of less than 48 hours duration. [source] Updated meta-analysis of clinical trials of Serenoa repens extract in the treatment of symptomatic benign prostatic hyperplasiaBJU INTERNATIONAL, Issue 6 2004P. Boyle OBJECTIVES To determine, by analysing all available clinical trial data, the clinical efficacy against placebo of an extract from the fruit of the American dwarf palm tree, Serenoa repens (Permixon®, Pierre Fabre Médicament, Castres, France), as there is controversy about the use of phytotherapeutic agents in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). METHODS All clinical trial data published on Permixon, comprising 14 randomized clinical trials and three open-label trials, involving 4280 patients, were analysed. These trials were of different size (22,1100 patients) and duration (21,720 days). The peak urinary flow rate and nocturia were the two common endpoints. The statistical analysis was based on a random-effects meta-analysis. RESULTS Permixon was associated with a mean (sem) reduction in the International Prostate Symptom Score (IPSS) of 4.78 (0.41). The mean placebo effect on peak urinary flow rate was an increase of 1.20 (0.49) mL/s. The estimated effect of Permixon was a further increase of 1.02 (0.50) mL/s (P = 0.042). Placebo was associated with a reduction in the mean number of nocturnal voids of 0.63 (0.14); there was a further reduction attributable to Permixon of 0.38 (0.07) (P < 0.001). There was some heterogeneity among the studies for nocturia; one over 2 years involving 396 patients and showing no difference between placebo and Permixon had a large effect on the results. CONCLUSIONS This meta-analysis of all available published trials of Permixon for treating men with BPH showed a significant improvement in peak flow rate and reduction in nocturia above placebo, and a 5-point reduction in the IPSS. [source] Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy for fatigue in patients with advanced cancerCANCER, Issue 3 2010Maxine de la Cruz MD Abstract BACKGROUND: A significant response to placebo in randomized controlled trials of treatments for cancer-related fatigue (CRF) had been reported. A retrospective study was conducted to determine the frequency and predictors of response to placebo effect and nocebo effects in patients with CRF treated in those trials. METHODS: The records of 105 patients who received placebo in 2 previous randomized clinical trials conducted by this group were reviewed. The proportion of patients who demonstrated clinical response to fatigue, defined as an increase in Functional Assessment of Chronic Illness Therapy-Fatigue score of ,7 from baseline to Day 8, and the proportion of patients with a nocebo effect, defined as those reporting >2 side effects, were determined. Baseline patient characteristics and symptoms recorded using the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. RESULTS: Fifty-nine (56%) patients had a placebo response. Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate) were significantly associated with placebo response. Commonly reported side effects were insomnia (79%), anorexia (53%), nausea (38%), and restlessness (34%). Multivariate analysis indicated that worse baseline (ESAS) sleep, appetite, and nausea were associated with increased reporting of the corresponding side effects. CONCLUSIONS: Greater than half of advanced cancer patients enrolled in CRF trials had a placebo response. Worse baseline physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in the design of future CRF trials. Cancer 2010. © 2009 American Cancer Society. [source] Effects of desmopressin on the sleep of children suffering from enuresisACTA PAEDIATRICA, Issue 7 2010C Rahm Abstract Aim:, To evaluate the effect of 1-desamino-8-D-Arginine Vasopressin (DDAVP) on sleep architecture and arousal reactions in children with primary monosymptomatic nocturnal enuresis (PME). Methods:, A prospective, placebo-controlled, randomized, double-blind, cross-over study was performed on children suffering from bed-wetting. Placebo and DDAVP were given for 7 days each after which an unattended home polysomnography (PSG) was recorded. After lifting the blinding, the PSGs were compared. Results:, A total of 20 children with PME, aged 6,15 years, were enrolled in the study. The number of wet nights decreased significantly with DDAVP treatment. Delta power, distribution of sleep stages, number of arousals, arousal index and the effect of arousals on sleep stages did not differ significantly. Bed-wetting occurred within each sleep stage and did not follow any particular pattern. In most cases, it was preceded by an arousal reaction, but no awakening occurred. Conclusion:, DDAVP has no effect on the sleep architecture of children with PME when analysed by classical PSG, which is determined by collecting the electric activity of cortical neurons. Taking recent research findings into account, this supports the thesis that the disturbances causing PME occur at brain stem level and do not reach consciousness. [source] The impact of nicotine on bone healing and osseointegrationCLINICAL ORAL IMPLANTS RESEARCH, Issue 3 2005An experimental study in rabbits Abstract Objectives: To examine the short-term effect of nicotine on bone healing and osseointegration. Material and methods: Sixteen female rabbits were divided into two groups. The test group was exposed to nicotine tartrate for 8 weeks and the control group was exposed to placebo. Nicotine or placebo was administered via a miniosmotic pump and plasma cotinine levels were measured weekly. The pump delivered 15 mg of nicotine/day for the animals in the test group. All rabbits had three tibial bone preparations. In the proximal and distal bone bed, implants were placed after 4 weeks (right tibia) and after 6 weeks (left tibia). Thus, 2- and 4-week healing groups were created. Removal torque test (RMT) was performed at the distal implants. Ground sections were made from the proximal and the central bone beds. The fraction of mineralized bone in contact to the implant (BIC) and the bone density within the implant threads (BD-i) were determined for the bone,implant specimens. For the central bone beds without implants the bone density (BD-c) in the bone defects was determined. Results: No significant difference in RMT values was found between the test and the control group. Histomorphometric measurements of the BIC and the peri-implant BD-i showed no significant differences between the test and the control group after 2 or 4 weeks. Significant differences were, however, found between the 2- and 4-week samples. In the central bone beds, there was no significant difference in BD-c between the test and the control group. Conclusion: Nicotine exposure in a short period of time did not have a significant impact on bone healing or implant osseointegration in rabbits. Résumé Le but de l'étude a été d'examiner l'effet à court terme de la nicotine sur la guérison osseuse et l'ostéoïntégration. Seize lapines ont été réparties en deux groupes. Le groupe test était exposé au tartrate de nicotine durant huit semaines et le groupe contrôle était exposé au placebo. La nicotine et le placebo étaient administrés par une pompe miniosmotique et les teneurs de cotinine plasmatique étaient mesurées chaque semaine. La pompe distillait 15 mg de nicotine par jour pour les animaux du groupe test. Toutes les lapines avaient trois préparations osseuses. Dans le lit osseux proximal et distal, les implants étaient placés après quatre semaines (tibia droit) et six semaines (tibia gauche) Des groupes de guérison de deux et de quatre semaines ont ainsi été créés. Des tests de torsion à l'enlèvement ont été effectués au niveau des implants distaux. Des coupes ont été effectuées pour les lits osseux centraux et proximaux. La fraction d'os minéralisé en contact avec l'implant et la densité osseuse à l'intérieur des filetages ont été déterminées pour les spécimens os/implants. Pour les lits osseux centraux sans implant la quantité osseuse dans les lésions osseuses a été déterminée. Aucune différence significative dans les valeurs de torsion à l'enlèvement n'a été trouvée entre les deux groupes. Les mesures histomorphométriques du contact os/implant et la densité osseuse à l'intérieur des filetages paroïmplantaires ne montraient aucune différence entre les deux groupes ni après deux ni après quatre semaines. Cependant des différences significatives ont été trouvées entre les échantillons à deux et quatre semaines. Dans les lits osseux centraux il n'y avait pas de différence significative de densité osseuse entre le groupe test et le contrôle. L'exposition à la nicotine durant une brève période n'avait pas d'impact significatif sur la guérison osseuse ni sur l'ostéoïntégration d'implants chez les lapines. Zusammenfassung Ziele: Den frühen Einfluss von Nikotin auf die Knochenheilung und Osseointegration zu untersuchen. Material und Methoden: 16 weibliche Kaninchen wurden in zwei Gruppe eingeteilt. Der Testgruppe wurde während 8 Wochen Nikotintartrat gegeben und die Kontrollgruppe bekam ein Placebo. Das Nikotin oder das Placebo wurde mittels einer miniosmotischen Pumpe verabreicht und man bestimmte wöchentlich die Kotininspiegel im Plasma. Bei den Tieren der Testgruppe lieferte die Pumpe 15 mg Nikotin pro Tag. Bei allen Tieren wurden 3 Stellen des Tibiaknochens bearbeitet. In das proximale und distale Knochenbett wurden nach 4 Wochen (rechte Tibia) und nach 6 Wochen (linke Tibia) Implantate eingesetzt. So wurden Gruppen mit einer Heilungszeit von 2 und 4 Wochen kreiert. Bei den distalen Implantaten wurden Ausdrehmoment-Tests (RMT) durchgeführt. Von den zentralen und proximalen Knochenbetten wurden Schliffpräparate angefertigt. Bei den Präparaten mit Implantaten und Knochen bestimmte man den Anteil an mineralisiertem Knochen in Kontakt mit dem Implantat (BIC) und die Knochendichte innerhalb der Gewindegänge (BD-i). Bei den zentralen Knochenbetten ohne Implantate bestimmte man die Knochendichte (BD-c) innerhalb der Knochendefekte. Resutate: Bei den RMT-Werten konnten zwischen der Test- und Kontrollgruppe keine signifikanten Unterschiede gefunden werden. Die histomorphometrischen Messungen des BIC und der periimplantären BD-i zeigten nach 2 oder 4 Wochen keine signifikanten Unterschiede zwischen der Test- und Kontrollgruppe. Jedoch konnten signifikante Unterschiede zwischen den Präparaten nach 2 und 4 Wochen gefunden werden. Bei den zentralen Knochenbetten bestand kein signifikanter Unterschied im BD-c zwischen der Test- und Kontrollgruppe. Schlussfolgerung: Die Verabreichung von Nikotin über einen kurzen Zeitraum hatte keinen signifikanten Einfluss auf die Knochenheilung und Osseointegration bei Kaninchen. Resumen Objetivos: Examinar los efectos a corto plazo de la nicotina en la cicatrización ósea y la osteointegración. Material y Métodos: Se dividieron 16 conejos hembras en dos grupos. El grupo de prueba fue expuesto a tartrato de nicotina durante 8 semanas y el grupo de control fue expuesto a un placebo. La nicotina o el placebo se administraron por medio de una bomba miniosmótica y se midieron e los niveles de nicotina semanalmente. La bomba suministró 15 mg de nicotina/día a los animales del grupo de prueba. Todos los conejos se sometieron a 3 preparaciones tibiales. En los lechos óseos proximales y distales, se colocaron implantes tras 4 semanas (tibia derecha) y 6 semanas (tibia izquierda). Creándose por lo tanto, dos grupos de cicatrización de 2 y 4 semanas. Se llevó a cabo un test de torque de remoción (RMT) en los implantes distales. Se realizaron cortes histológicos de los lechos óseos proximales y centrales. Se determinó la fracción de hueso mineralizado en contacto con el implante (BIC) y la densidad ósea entre las roscas (BD-i) para los especímenes de hueso-implante. Se determinó la densidad ósea (BD-c) en los defectos para los lechos óseos centrales sin implantes. Resultados: No se encontraron diferencias significativas en los valores RMT entre los grupos de prueba y de control. Las mediciones histomorfométricas del BIC y del BD-i periimplantario no mostraron diferencias significativas entre los grupos de prueba y de control tras 2 o tras 4 semanas. De todos modos se encontraron diferencias significativas entre las muestras de 2 y 4 semanas. En los lechos óseos centrales no hubo diferencias significativas en BD-c entre los grupos de prueba y de control. Conclusión: La exposición a la nicotina durante un corto periodo de tiempo no tuvo un impacto significativo en la cicatrización ósea o en la osteointegración implantaria en los conejos. [source] Adding Gabapentin to a multimodal regimen does not reduce acute pain, opioid consumption or chronic pain after total hip arthroplastyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 8 2009H. CLARKE Background: Gabapentin (GPN) is effective in reducing post-operative pain and opioid consumption, but its effects with regional anesthesia for total hip arthroplasty (THA) are not known. We designed this study to determine whether (1) gabapentin administration reduces pain and opioid use after THA using a multimodal analgesic regimen including spinal anesthesia; (2) pre-operative administration of gabapentin is more effective than post-operative administration. Methods: After REB approval and informed consent, 126 patients were enrolled in a double-blinded, randomized-controlled study. Patients received acetaminophen 1 g per os (p.o.), celecoxib 400 mg p.o. and dexamethasone 8 mg intravenously, 1,2 h pre-operatively. Patients were randomly assigned to one of three treatment groups (G1: Placebo/Placebo; G2: GPN/Placebo; G3: Placebo/GPN). Patients received gabapentin 600 mg (G2) or placebo (G1 and G3) 2 h before surgery. All patients had spinal anesthesia [15 mg (3cc) of 0.5% hypobaric bupivacaine with 10 ,g of fentanyl]. In the post-anesthetic care unit, patients received gabapentin 600 mg (G3) or placebo (G1 and G2). On the ward, patients received acetaminophen 1000 mg p.o. q6h, celecoxib 200 mg p.o. q12h and a morphine PCA device. Patients were interviewed 6 months post-surgery to determine the incidence and severity of chronic post-surgical pain. Results: Mean±SD cumulative morphine (mg) consumption (G1=49.4±24.8, G2=47.2±30.1 and G3=56.1±38.2) at 48 h and pain scores at 12, 24, 36 and 48 h post-surgery were not significantly different among the groups [G1 (n=38), G2 (n=38) and G3 (n=38)]. Side effect profiles were similar across groups. Six months after surgery, the number of patients who reported chronic post-surgical pain (G1=10, G2=12 and G3=9) and the severity of the pain (G1=4.2±2.9, G2=4.1±2.2 and G3=4.9±2.2) did not differ significantly among the groups (P>0.05). Conclusions: A single 600 mg dose of gabapentin given pre-operatively or post-operatively does not reduce morphine consumption or pain scores in hospital or at 6 months after hip arthroplasty within the context of spinal anesthesia and a robust multimodal analgesia regimen. [source] Would the elderly be better off if they were given more placebos?GERIATRICS & GERONTOLOGY INTERNATIONAL, Issue 2 2010E Paul Cherniack Placebos are useful in the medical care of the elderly, although the exact definition of a "placebo" or "placebo effect" is difficult to define precisely. They have an important role as control treatments in research trials, but a non-specific "placebo effect" may also be beneficial part of many physician,patient interactions. Physicians also give them deliberately according to several studies worldwide to satisfy patient demands or because they believe in a "placebo effect" among other reasons. A significant placebo effect has been observed among older patients in clinical trials of antidepressants (12,15%), and in treatments of Parkinson's disease (16%). Placebos activate serotonergic pathways in the brain used by antidepressants. In Parkinson's disease, the administration of a placebo stimulates dopamine release in the dorsal (resulting in motor effects) and ventral striatum (which influences expectation of reward). Much of our understanding of the placebo effect comes from studies of placebo analgesia which is influenced by conditioning, expectation, meaning and context of the treatment for the patient, and patient,physician interaction. It is anatomically medicated by brain opioid pathways. Response to "sham" acupuncture in osteoarthritis may be an example of its use in the elderly. Placebos have often been considered a deception and thus unethical. On the other hand, some physicians and ethicists have suggested conditions for appropriate uses for placebos. A placebo might offer the theoretical advantage of an inexpensive treatment that would not cause adverse drug reactions or interactions with other medications, potentially avoiding complications of polypharmacy. [source] The Meaning Response: Thinking about PlacebosPAIN PRACTICE, Issue 4 2006Daniel E. Moerman PhD First page of article [source] Analyses of mortality risk in patients with dementia treated with galantamineACTA NEUROLOGICA SCANDINAVICA, Issue 1 2009H. H. Feldman Objective,,, To analyze mortality data from patients with Alzheimer's disease (AD), Alzheimer's plus cerebrovascular disease (AD + CVD) or vascular dementia (VaD). Methods,,, (1) Meta-analysis of mortality data from double-blind, placebo-controlled, randomized trials; and (2) recontact study to collect additional longer term mortality data from previous galantamine trial participants. Results (meta-analysis),,, Across 12 trials (,6 months duration), there was no increased risk of mortality associated with the use of galantamine (n = 4116) compared with that of placebo (n = 2386) (OR galantamine/placebo: 0.67, 95% CI 0.41,1.10). Results (recontact study),,, Median survival was 79 months for patients with AD (n = 478) and 59 months for patients with AD + CVD (n = 180) or VaD (n = 145). Prolonged galantamine treatment (> vs ,6 months) was not associated with decreased survival time (75 vs 61 months respectively; P = 0.02). Cox regression analyses were consistent with the Kaplan,Meier analyses. Conclusions,,, We found no short-term or longer term evidence of increased risk of mortality associated with the use of galantamine in patients with AD, AD + CVD or VaD. [source] | ||||||||||||||||||||||||||||||||||||||||||||||