Controlled Trials Available (controlled + trials_available)

Distribution by Scientific Domains


Selected Abstracts


Efficacy of enamel matrix derivatives (Emdogain®) in treatment of replanted teeth , a systematic review based on animal studies

DENTAL TRAUMATOLOGY, Issue 5 2008
Annette Wiegand
A review of the published literature [search term: (Emdogain OR enamel matrix derivative OR enamel matrix protein] AND [avulsion OR replantation OR autotransplantation)] was conducted by two independent investigators according to defined selection criteria. For data extraction of the identified animal studies, the following histomorphometric findings were considered: (i) healed PDL, (ii) surface resorption, (iii) inflammatory resorption and (iv) replacement resorption. The heterogenity of data collection and the small amount of identified publications did not allow for statistical analysis. Four controlled trials (CT) conducted in animals, but no randomized controlled trials (RCT) or clinical controlled trials (CCT) could be received from the systematic search. From the selected studies, two CT gave evidence of EMD treatment to be effective in inducing healing of replanted teeth, while one CT found no differences between EMD treated teeth and controls. Finally, one CT compared EMD and sodium fluoride application, but revealed no differences between the treatments. The data of controlled trials available are limited and conflicting. No firm conclusion regarding the efficacy of EMD application on healing of replanted or autotransplanted permanent teeth can be drawn because of lack of RCT and CCT. [source]


Levels of evidence available for techniques in antireflux surgery

DISEASES OF THE ESOPHAGUS, Issue 2 2007
M. Neufeld
SUMMARY., The objective of this study was to determine the levels of evidence and grades of recommendations available for techniques in antireflux surgery. Areas of technical controversy in antireflux surgery were identified and developed into eight answerable questions. The external evidence was surveyed using the databases Medline and EMBASE. Abstracts and appropriate articles were identified from January 1966 to December 2005. A set of search strategies was systematically employed to determine the levels of evidence available for each clinical question. Primary outcome measures included the determination of levels of evidence and grade of recommendation based on The Oxford Center for Evidence-Based Medicine. Secondary outcome measures included for randomized controlled trials were Jadad scores, noting the presence of a sample size calculation, and the determination of an effect estimate and the reporting of a confidence interval. Higher quality randomized controlled trials (mostly level 2b, occasional level 1b) existed to answer three questions: whether to complete a 360° or partial wrap; whether or not to divide the short gastric vessels; and whether to perform laparoscopic or open surgery. Lower quality randomized controlled trials were available to determine whether the use of mesh was helpful, whether or not to use a bougie catheter for calibration of the wrap, and whether an anterior or posterior wrap results in a superior outcome. This was deemed to be of inferior grade of recommendation due to the lack (< 2) of trials available and the sole presence of level 2b evidence. The final two questions: whether to complete fundoplication using a thoracic or abdominal approach and whether to use intraoperative manometry relied exclusively upon level 4 evidence and thus received a lower grade of recommendation. A higher Jadad score seemed to be associated with studies having a higher level of evidence available to answer the question. Sample size calculations were given to answer three questions. Effect estimate was difficult to interpret given inconsistent findings, composite outcomes and lack of reported confidence intervals. In conclusion, antireflux surgery has many randomized controlled trials available upon which to base clinical practice. Unfortunately, these are generally of poor quality. We recommend that esophageal surgeons determine consistent outcome measures and endeavor to improve the quality of randomized controlled trials they perform. [source]


Randomized controlled trial of intrasphincteric botulinum toxin A injection versus balloon dilatation in treatment of achalasia cardia

DISEASES OF THE ESOPHAGUS, Issue 3-4 2001
U. C. Ghoshal
As the few randomized controlled trials available in the literature comparing botulinum toxin (BT) injection with established endoscopic treatment of achalasia cardia, i.e. pneumatic dilatation, showed conflicting results, we conducted a prospective randomized trial. Seventeen consecutive patients with achalasia cardia diagnosed during a period between December 1997 and February 2000 were randomized into two treatment groups [pneumatic dilatation by Rigiflex dilator (n=10), BT injection by sclerotherapy needle into four quadrants of lower esophageal sphincter (LES) (n=7) 80 units in five cases, 60 units in two cases] after dysphagia grading, endoscopy, barium esophagogram, and manometry, all of which were repeated 1 week after treatment. Patients were followed up clinically for 35.2 ± 14 weeks. Chi-squares, Wilcoxon rank-sum test, Kaplan,Meier method and log-rank tests were used for statistical analysis. After 1 week, 6/7 (86%) BT-treated vs. 8/10 (80%) dilatation-treated patients improved (P=NS). There was no difference in LES pressure and maximum esophageal diameter in the barium esophagogram in the two groups before therapy. Both therapies resulted in significant reduction in LES pressure. The cumulative dysphagia-free state using the Kaplan,Meier method decreased progressively in BT-treated compared with dilatation-treated patients (P=0.027). Two patients with tortuous megaesophagus, one of whom had failed dilatation complicated by perforation previously, improved after BT. One other patient in whom pneumatic dilatation had previously failed improved in a similar manner. BT is as good as pneumatic dilatation in achieving an initial improvement in dysphagia of achalasia cardia. It is also effective in patients with tortuous megaesophagus and previous failed pneumatic dilatation. However, dysphagia often recurs during 1-year follow up. [source]


Current techniques of liver transection

HPB, Issue 3 2007
RONNIE T.P. POON
The operative mortality rate of liver resection has decreased from 10% to 20% before the 1980s to <5% in most specialized hepatobiliary centers nowadays. The most important factor for better outcome is reduced blood loss due to improvement in surgical techniques. Liver transection is the most challenging part of liver resection, associated with a risk of massive hemorrhage. Understanding the segmental anatomy of the liver and delineation of the proper transection plane using intraoperative ultrasound are prerequisites to safe liver transection. Clamp crushing and ultrasonic dissection are the two most widely used transection techniques. In recent years, new instruments using different types of energy for coagulation or sealing of vessels have been developed for liver transection. These include radiofrequency devices, Harmonic Scalpel, Ligasure and TissueLink dissecting sealer. Whether these new instruments, used alone or in combination with clamp crushing or ultrasonic dissection, improve the safety of liver transection has not been clearly demonstrated. The use of the vascular stapler for transection of major intrahepatic vascular trunks is also gaining popularity. These new instruments are particularly useful in liver transection during laparoscopic liver resection. Adjunctive measures such as intermittent Pringle maneuver and low central venous pressure anesthesia are also useful measures to reduce the risk of hemorrhage. This article reviews the safety and efficacy of different techniques of liver transection, with particular attention to evidence from randomized controlled trials available in the literature. [source]


Melatonin and sleep disorders associated with intellectual disability: a clinical review

JOURNAL OF INTELLECTUAL DISABILITY RESEARCH, Issue 1 2007
S. G. Sajith
Abstract Background Melatonin is used to treat sleep disorders in both children and adults with intellectual disability (ID), although it has no product license for such use. The evidence for its efficacy, potential adverse effects and drug interactions are reviewed in the context of prescribing to people with ID. Methods A literature search was performed using multiple electronic databases. More literature was obtained from the reference lists of papers gathered through the searches. Results Most of the studies were uncontrolled and the few controlled trials available were of small size. Melatonin appears effective in reducing sleep onset latency and is probably effective in improving total sleep time in children and adolescents with ID. It appears to be ineffective in improving night-time awakenings. Melatonin is relatively safe for short-term use. Its safety for long-term use is not established. Potential drug interactions, possible effects on puberty and concerns regarding the use of melatonin in epilepsy, asthma and depressive disorders are discussed. Conclusions Melatonin appears to be an effective sleep-initiator for children and adolescents with ID and probably has a similar effect for adults. There may be heterogeneity of response depending on the nature of the sleep problem and cause of the ID or associated disabilities. Further studies are necessary before firm conclusions can be drawn and guidelines for the use of melatonin for people with ID formulated. [source]