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Saline Placebo (saline + placebo)
Selected AbstractsPericranial injection of botulinum toxin type A (Dysport®) for tension-type headache , A multicentre, double-blind, randomized, placebo-controlled studyEUROPEAN JOURNAL OF NEUROLOGY, Issue 3 2008A. Straube Increasingly, botulinum type A toxin is used to influence pathologically increased muscle activity in conditions such as dystonia and spasticity. Studies have also assessed its efficacy in tension-type headache, where muscle tenderness may be increased. We undertook a prospective, multicentre, randomized, double-blind, placebo-controlled trial. Patients received injections of Dysport® (total dose of 420 or 210 units) or saline placebo in 18 sites on the head and neck. Of 125 patients treated, 118 were included in the intention-to-treat dataset. No significant differences between each verum group and placebo were seen for the primary efficacy parameter , change in the number of headache-free days at 4,8 weeks after injection compared with 4 weeks before injection. The groups receiving 420 or 210 units of Dysport experienced 2.60 and 2.87 more headache-free days respectively, compared with 1.93 more headache-free days for the placebo group (P = 0.66 versus 420 units; P = 0.52 versus 210 units). Treatment with 420 units of Dysport was associated with significant improvements compared with placebo for two secondary efficacy parameters: mean change in headache duration from baseline to weeks 8,12 (P < 0.05) and improved global physician and patient assessment scores (P < 0.05). Further studies should address the possible value of multiple injections with extended observation periods, dose optimization, and whether duration of headache history and number of previous treatments are predictors of patient response. [source] Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubationACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 8 2005G. Guler Background:, The alpha agonist dexmedetomidine, a sedative and analgesic, reduces heart rate and blood pressure dose-dependently. We investigated whether it also has the ability to attenuate airway and circulatory reflexes during emergence from anaesthesia. Methods:, Sixty ASA I,III patients received a standard anaesthetic. Five minutes before the end of surgery, they were randomly allocated to receive either dexmedetomidine 0.5 µg/kg (Group D) (n = 30) or saline placebo (Group P) (n = 30) intravenously (i.v.) over 60 s in a double-blind design. The blinded anaesthetist awoke all the patients, and the number of coughs per patient was continuously monitored for 15 min after extubation; coughing was evaluated on a 4-point scale. Any laryngospasm, bronchospasm or desaturation was recorded. Heart rate (HR) and systolic and diastolic blood pressure (SAP, DAP) were measured before, during and after tracheal extubation. The time from tracheal extubation and emergence from anaesthesia were recorded. Results:, Median coughing scores were 1 (1,3) in Group D and 2 (1,4) in Group P (P < 0.05), but there were no differences between the groups in the incidence of breath holding or desaturation. HR, SAP and DAP increased at extubation in both groups (P < 0.05), but the increase was less significant with dexmedetomidine. The time from tracheal extubation and emergence from anaesthesia were similar in both groups. Conclusion:, These findings suggest that a single-dose bolus injection of dexmedetomidine before tracheal extubation attenuates airway-circulatory reflexes during extubation. [source] Zoledronic acid for the treatment of osteopenia in pediatric Crohn's diseasePEDIATRICS INTERNATIONAL, Issue 5 2010Anne Marie Sbrocchi Abstract Background:, Pediatric patients with Crohn's disease often have low bone mass (osteopenia) for age. No randomized, placebo-controlled trials using zoledronic acid have ever been performed in this population. The objective of this study was to assess the efficacy of zoledronic acid in children with Crohn's disease and osteopenia. Methods:, A double-blind, randomized, placebo-controlled design was used. Thirteen adolescents received either a single intravenous dose of zoledronic acid (0.066 mg/kg, max 4 mg, n= 7) or saline placebo (n= 6). The primary outcome was change in lumbar spine bone mineral density (LSBMD) z-score at 6 months. Secondary outcomes included bone markers and adverse events. Results:, At 6 months, the change in LSBMD z-score was significantly higher in the zoledronic acid group compared to placebo (0.7 vs 0.1, P < 0.001). Volumetrically adjusted LSBMD z-score also significantly increased in the treated group. This significant difference persisted until 12 months. With zoledronic acid, urinary C-telopeptide excretion decreased by 50% at 6 months and remained suppressed at 12 months (P= 0.02), but no changes were observed with placebo. Both groups had similar adverse events which included transient fever, arthralgias, and nausea (3/7 treated, 2/6 placebo, P= NS). Conclusions:, In this study, zoledronic acid demonstrated a significant increase in LSBMD at 6 and 12 months following a well-tolerated infusion. [source] Predictors of Cardiovascular Response to Methamphetamine Administration in Methamphetamine-Dependent IndividualsTHE AMERICAN JOURNAL ON ADDICTIONS, Issue 2 2008Gilles Fleury MD The goal of the present investigation was to determine predictors of cardiovascular response to methamphetamine administrated in the laboratory. Heart rate (HR) and blood pressure (BP) were measured at baseline and at several time points following the administration of methamphetamine or saline placebo. One-way ANOVA was used to determine the differences between female and male subjects in their cardiovascular response. In male subjects, linear regression and one-way ANOVA were used to determine the influence of potential predictors on cardiovascular response, including age, weight, drug use indicators, concurrent use of other substances, route of administration, and race. Methamphetamine administration provoked significant increases in HR and BP, as compared to placebo. Female gender was associated with larger peak change in diastolic BP following administration. Baseline HR and BP were found to be strong predictors of cardiovascular response to methamphetamine administration in male subjects. Lifetime use and recent use of methamphetamine and nicotine did not predict cardiovascular response to methamphetamine. Recent alcohol use was associated with increased peak change in diastolic BP. Also, current use of cannabis was negatively correlated with peak HR change. Male cannabis users show lower peak change in HR as compared to non-cannabis users. As compared to methamphetamine smokers, intravenous users demonstrated higher peak change in diastolic BP following drug administration. Race did not have a significant effect on cardiovascular response. Taken together, these findings may help in the prevention and treatment of cardiovascular events in a population at high risk of premature morbidity and mortality. [source] Botulinum Toxin Type A,A Novel Treatment for Provoked Vestibulodynia?THE JOURNAL OF SEXUAL MEDICINE, Issue 9 2009Double Blinded Study, Placebo Controlled, Results from a Randomized ABSTRACT Introduction., Vestibulodynia is an increasingly recognized problem among women and is often difficult to treat. Aim., This randomized, double blinded, placebo-controlled study aimed to evaluate the efficacy of Botox in the treatment of vestibulodynia. Methods., Sixty-four women were randomized to receive Botox (N = 32) or saline placebo (N = 32). Botulinum toxin A (20 I.E.) diluted in 0.5 mL saline or 0.5 mL saline was injected in the musculus bulbospongiosus at baseline. Main Outcome Measures., Pain was measured monthly on a visual analog scale (VAS) Likert scale. Sexual function was measured using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale at baseline and at 3 and 6 months follow up. Quality of life was measured using the 36-item short-form (SF-36). Results., Sixty women (94%) completed the 6 months follow up. Both Botox and placebo produced significantly pain reduction (P < 0.001). There was no significant difference in the median VAS score between the groups at 6 months follow up (P = 0.984). An improvement on the FSFI full score from baseline until 6 months was not significantly different between the groups (P = 0.635). In the placebo group a statistical significant larger reduction in sexual distress was observed from baseline until 6 months follow up compared to the Botox group (P = 0.044). No statistical significant differences were observed between the B- and P-groups in regard to the SF-36 scores. Conclusion., Injection of 20 I.E. Botox in the vestibule of women diagnosed with vestibulodynia does not reduce pain, improve sexual functioning, or impact the quality of life compared to placebo and evaluated at 3 and 6 moths follow up. Both the Botox group and the placebo groups experienced a reduction in pain on the VAS Likert scale at 6 months follow up. Women with vestibulodynia have difficulty with sexual function and present with sexual distress, which has to be addressed in conjunction with pain to eliminate the disorder. Petersen CD, Giraldi A, Lundvall L, and Kristensen E. Botulinum toxin Type A,A novel treatment for provoked vestibulodynia? Results from a randomized, placebo controlled, double blinded study. J Sex Med 2009;6:2523,2537. [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] Oral nifepidine versus subcutaneous terbutaline tocolysis for external cephalic version: a double-blind randomised trialBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 1 2009R Collaris Objective, To evaluate oral nifedipine versus subcutaneous terbutaline tocolysis for external cephalic version (ECV). Design, A double-blind randomised trial. Setting, A university hospital in Malaysia. Population, Non-labouring women with a term singleton fetus in breech presentation or transverse lie suitable for elective ECV. Methods, Participants were randomised to either 10 mg oral nifedipine tablet and subcutaneous saline placebo or oral placebo tablet and 250 microgram bolus terbutaline subcutaneously. Participants and providers were blinded. Ultrasound assessment and cardiotocogram were performed prior to ECV. ECV was commenced 20,30 minutes after treatment. A maximum of two ECV attempts were permitted. Elective caesarean delivery or a repeat ECV attempt at a later date was offered to participants following failed ECV. After successful ECV, management was expectant. Main outcome measures, Primary outcomes were successful ECV (cephalic presentation immediately after ECV) and caesarean delivery. Results, Ninety women were randomised: 44 to nifedipine and 46 to terbutaline. Initial ECV success rate was 15/44 (34.1%) versus 24/46 (52.2%) (relative risk [RR] 0.7, 95% CI 0.4,1.1; P= 0.094), and caesarean delivery rate was 34/44 (77.3%) versus 26/46 (56.5%) (RR 1.4, 95% CI 1.01,1.85; numbers needed to treat to benefit 5, 95% CI 2.5,55; P= 0.046) for nifedipine and terbutaline groups, respectively. Neonatal outcome was not different. Conclusions, Bolus subcutaneous terbutaline tocolysis for ECV compared with oral nifedipine resulted in less caesarean deliveries. ECV success rate was not significantly higher. Larger studies are indicated. [source] | ||||||||||