Placebo Injections (placebo + injection)

Distribution by Scientific Domains

Selected Abstracts

Comparing botulinum toxin A with casting for treatment of dynamic equinus in children with cerebral palsy

Jeffrey D Ackman MD
The purpose of this study was to compare the cumulative efficacy (three treatment sessions) of botulinum toxin A (BTX-A) alone, casting alone, and the combination of BTX-A and casting in the management of dynamic equinus in ambulatory children with spastic cerebral palsy (CP). Thirty-nine children with spastic CP (mean age 5y 10mo, range 3 to 9y) were enrolled in the study. A multicenter, randomized, double blind, placebo-controlled prospective study was used. Children were randomly assigned to one of three treatment groups: BTX-A only (B), placebo injection plus casting (C), or BTX-A plus casting (B+C). The dosage for the BTX-A injections was 4U/kg per extremity. Assessments were performed at baseline, 3,6,7.5, and 12 months with a total of three treatments administered after the evaluations at baseline, 3, and 6 months. Primary outcome measures were ankle kinematics, velocity, and stride length. Secondary outcome measures were ankle spasticity, strength, range of motion, and ankle kinetics. Group B made no significant change in any variable at any time. Groups C and B+C demonstrated significant improvements in ankle kinematics, spasticity, passive range of motion, and dorsiflexor strength. Results of this 1-year study indicate that BTX-A alone provided no improvement in the parameters measured in this study, while casting and BTX-A/casting were effective in the short- and long-term management of dynamic equinus in children with spastic CP. [source]

Is improved high speed performance following frusemide administration due to diuresis-induced weight loss or reduced severity of exercise-induced pulmonary haemorrhage?

Summary Reasons for performing study: Prerace administration of frusemide to horses has been linked with a significant improvement in racing performance, but the basis for this improvement is unclear. Objective: To test whether improved performance with prerace administration of frusemide is due to the drug's diuresis-induced weight loss rather than its apparent alleviation of exercise-induced pulmonary haemorrhage (EIPH). Methods: Eight thoroughbred horses underwent 3 trials in a random order, 2 or 3 weeks apart: control (C), frusemide/unburdened (FU), and frusemide/burdened (FB). None of the horses were known to have exhibited post-exercise epistaxis or endoscopic evidence of EIPH. Endoscope-guided bronchoalveolar lavages (BALs) were performed before and after each horse completed a standardised exercise test (SET) on an inclined treadmill to assess semi-quantitatively the volume of EIPH. For C, horses received an i.v. saline placebo injection (5 ml) and were unburdened while performing the SET. With FU, horses received frusemide (0.5 mg/kg) and were also unburdened. For FB, horses received frusemide and were burdened with weight equal to that lost during the 4 h post frusemide injection period. Erythrocyte number in BAL fluid, mass specific VO2max, time and distance for the entire SET as well as at maximum speed were recorded. A one-way repeated measures analysis of variance was conducted on all results. Results: Mass specific VO2max was significantly higher for the FU than for FB or C. Mass specific VO2max for FB and C were not different. More RBCs were found in BAL samples after C runs than after both FU and FB trial runs. Horses with the frusemide treatment (either burdened or unburdened) produced less EIPH than in the C trial, but their mass specific VO2max values were higher on the FU trial alone. For FU, horses ran longer at 115% VO2max than under C or FB conditions. Conclusion and potential relevance: Improvement of performance in the furosemide trials was due more to the weight-loss related effects of the drug than its apparent alleviation of EIPH. Further research is warranted with the same or similar project design, but with a larger sample size and with horses known to have more severe EIPH. [source]

Microplasmin improves surgical outcome in a rabbit model for trabeculectomy

Purpose This study was designed to study the efficacy and safety of Microplasmin as an anti-scarring agent after trabeculectomy in a rabbit model. Methods The effect of Microplasmin was investigated in vivo in a rabbit model for glaucoma surgery. Clinical outcome measures were intra-ocular pressure, bleb area and survival, side effects on slit lamp examination. Moreover, (immuno-) histochemical analysis of the eyes was performed, with quantification of inflammation (CD 45) and collagen deposition (Trichrome and Sirius Red). In the first experiment (n=10), Microplasmin anterior chamber injection was compared to placebo injection. In the second experiment (n=3), topical Microplasmin drops were compared to placebo drops. In the third experiment (n=5) the combination of Microplasmin anterior chamber injection and topical drops was compared to placebo injection and drops. All experiments were conducted in a masked observator way. Results Microplasmin significantly augmented the bleb area and survival in a rabbit model of trabeculectomy after a single anterior chamber injection or combination therapy (injection combined with drops) compared to control. Collagen deposition was borderline reduced after Microplasmin administration compared to control. No significant changes in inflammation were noticed in the anterior chamber or in the conjunctiva. Conclusion Microplasmin single injection or combination with postoperative drops improved the outcome after trabeculectomy. In a rabbit model, larger blebs were produced for a longer period compared to control, and collagen deposition tended to decrease in this small series. [source]

Botulinum Toxin Type A Treatment of Multiple Upper Facial Sites: Patient-Reported Outcomes

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]

Role of botulinum toxin in migraine therapy

Wilhelm J. Schulte-Mattler
Abstract Botulinum toxin effectively blocks the release of acetylcholine from motor nerve terminals. Thus, botulinum toxin injections are well established in the treatment of disorders in which patients are impaired by involuntary muscle contractions. A remarkable pain reduction was frequently observed in these patients, and in vitro studies showed that botulinum toxin reduces not only the release of acetylcholine, but also the release of neuropeptides involved in pain perception. It was therefore hypothesized that botulinum toxin may help patients with pain not caused by muscular contractions, such as migraine or chronic daily headache, which includes chronic migraine. So far, the results of randomized, double-blind, placebo controlled trials on botulinum toxin in a total of 2,612 patients with migraine or with chronic daily headache were published. A superiority of botulinum toxin compared with placebo injections could not clearly be confirmed in any of the studies. One hypothesis derived from these results was that subgroups of patients with migraine can be defined in whom botulinum toxin may be efficacious. This hypothesis awaits confirmation. Interestingly, the efficacy of both botulinum toxin and placebo injections was found to be significant and similar to the efficacy of established oral migraine treatment. This finding may help explain the enthusiasm that followed the first open-label use of botulinum in patients with migraine. Drug Dev Res 68:397,402, 2007. © 2008 Wiley-Liss, Inc. [source]

Growth Hormone Administration and Exercise Effects on Muscle Fiber Type and Diameter in Moderately Frail Older People

James V. Hennessey MD
OBJECTIVE: Reduced muscle mass and strength are characteristic findings of growth hormone deficiency (GHD) and aging. We evaluated measures of muscle strength, muscle fiber type, and cross sectional area in response to treatment with recombinant human growth hormone (rhGH) with or without a structured resistance exercise program in frail older subjects. DESIGN: Placebo-controlled, randomized, double blind trial. SETTING: Outpatient clinical research center at an urban university-affiliated teaching hospital. PARTICIPANTS: Thirty-one consenting older subjects (mean age 71.3 ± 4.5 years) recruited as a subset of a larger project evaluating rhGH and exercise in older people, who underwent 62 quadricep-muscle biopsies. INTERVENTION: Random assignment to a 6-month course of one of four protocols: rhGH administered subcutaneously daily at bedtime, rhGH and a structured resistance exercise program, structured resistance exercise with placebo injections, or placebo injections only. MEASUREMENTS: Muscle biopsy specimens were obtained from the vastus lateralis muscle. Isokinetic dynamometry strength tests were used to monitor individual progress and to adjust the weights used in the exercise program. Serum insulin-like growth factor-I (IGF-I) was measured and body composition was measured using a Hologic QDR 1000W dual X-ray densitometer. RESULTS: The administration of rhGH resulted in significant increase in circulating IGF-I levels in the individuals receiving rhGH treatment. Muscle strength increased significantly in both the rhGH/exercise (+55.6%, P = .0004) as well as the exercise alone (+47.8%, P = .0005) groups. There was a significant increase in the proportion of type 2 fibers between baseline and six months in the combined rhGH treated subjects versus those not receiving rhGH (P = .027). CONCLUSIONS: Our results are encouraging in that they suggest an effect of growth hormone on a specific aging-correlated deficit. IGF-I was increased by administrating rhGH and muscle strength was increased by exercise. The administration of rhGH to frail older individuals in this study resulted in significant changes in the proportions of fiber types. Whether changes in fiber cross-sectional area or absolute number occur with long-term growth hormone administration requires further study. [source]

Clinical trial: the glucagon-like peptide-1 analogue ROSE-010 for management of acute pain in patients with irritable bowel syndrome: a randomized, placebo-controlled, double-blind study

Summary Background, There is currently no treatment available to manage acute pain attacks in IBS patients regardless of subtype. Aims, To evaluate efficacy and safety of the GLP-1 analogue ROSE-010 in patients with irritable bowel syndrome (IBS) through a randomized, double-blind, placebo-controlled study. Methods, Eligible patients (n = 166) meeting Rome II criteria were randomly assigned to receive single subcutaneous injections of ROSE-010 100 ,g, 300 ,g and placebo in a cross-over design. Safety was assessed from spontaneously reported adverse events and measurement of vital signs. Patient-rated pain relief and intensity were measured on a 100-mm visual analogue scale. The primary efficacy variable was proportion of patients with >50% maximum total pain relief response from 10 to 60 min after treatment. Secondary endpoints included the maximum summed pain intensity difference, time to meaningful pain relief and patient ratings of satisfaction with treatment. Results, Twice as many patients were responders in the primary efficacy endpoint after both ROSE-010 injections compared to placebo (24%P = 0.011, 23%P = 0.005, and 12% after 300 ,g, 100 ,g and placebo injections, respectively). Similar results were obtained for the proportion of patients with total pain intensity response. Times to meaningful and total pain relief were shorter for both doses of ROSE-010 compared with placebo. Compared with placebo, more patients (P < 0.05) were satisfied with ROSE-010 and considered ROSE-010 better than previous IBS medications used. Conclusion, ROSE-010 was well tolerated and provided fast and effective relief of acute pain attacks on demand in IBS patients. [source]

Low-dose lenograstim is as effective as standard dose in shortening neutrophil engraftment time following myeloablative chemotherapy and peripheral blood progenitor cell rescue

L. Nolan
Summary Granulocyte colony-stimulating factor (G-CSF) is widely used following myeloablative chemotherapy (high-dose therapy; HDT) and peripheral blood progenitor cell rescue (PBPCR) to reduce neutrophil engraftment time. The dose and duration required to gain maximum clinical and economic benefit has not been fully investigated. This double blind placebo-controlled randomised trial was performed to determine whether short course low-dose or standard-dose Lenograstim (L) would influence recovery of haematopoiesis following HDT and PBPCR. Sixty-one patients were randomised between May 1999 and November 2004, to receive standard-dose lenograstim (263 ,g/d), low-dose lenograstim (105 ,g/d) or placebo injections. These commenced on day +5 following PBPCR and continued until neutrophil engraftment [absolute neutrophil count (ANC)] , 0·5 × 109/l. Patients received standard supportive care until haemopoietic recovery. Both standard- and low-dose lenograstim resulted in a significantly shorter median time to neutrophil recovery (ANC , 0·1 × 109/l:10·0 vs. 11·0 d, P = 0·025; ANC , 0·5 × 109/l:11·0 vs. 14·0 d, P = 0·0002) compared with placebo. There was no significant difference in blood product support, antibiotic usage, documented infection, overall survival or relapse-free survival between the groups. Short course low-dose lenograstim is as effective as standard-dose in reducing neutrophil engraftment time following HDT and PBPCR. [source]