At present, the therapeutic choice for people with MS requires informed discussion on the equivalence of therapeutic agents. This study is important because it is the first report evaluating through a direct comparison whether two treatments, interferons-beta IFNs-beta and glatiramer acetate GAhave the same effect on the disease course.
Aetna considers the Stretta System Curon Medical, Sunnyvale, CA experimental and investigational for the management of members with gastro-esophageal reflux disease GERD and all other indications because there is insufficient published scientific evidence to support the effectiveness of these interventions, especially with respect to long-term outcomes.
Aetna considers the use of the Angelchik anti-reflux prosthesis experimental and investigational for the management of GERD and all other indications because it has not been shown to be as safe and effective as other options for the treatment of GERD or other indications.
Aetna considers the use of Enteryx experimental and investigational for the management of GERD and all other indications because it has not been established as an effective option for the treatment of GERD or other indications.
Aetna considers electrical stimulation of the lower esophageal sphincter e.
Background Gastroesophageal reflux disease GERDalso known as reflux esophagitis, is probably the most prevalent clinical condition that arises from the gastrointestinal GI tract.
Reflux occurs when the gradient between the LES pressure and the intra-gastric pressure is compromised as a result of a transient or sustained reduction in the former, or an elevation in the latter. However, some patients have normal LES pressures, but their sphincters relax inappropriately, thus resulting in refluxes.
The objectives are to eliminate symptoms, heal esophagitis, prevent recurrence of symptoms or progression of disease. The initial treatment of GERD is geared toward reducing esophageal refluxes. Antacids, H2-receptor antagonists, as well as dietary and lifestyle modifications have been used for such purposes.
For patients who fail initial treatment, proton pump inhibitors e.
When these standard medical therapies fail, surgery may be considered. These procedures are designed to raise the pressure within the LES by wrapping a portion or all of the cardia stomach around the esophagus.
The most commonly used surgical procedure, Nissen fundoplication open or laparoscopicis the mobilization of the lower end of the esophagus and plication of the fundus of the stomach around it. In general, patients are discharged from the hospital on the second post-operative day and can return to work in 7 to 10 days.
Other surgical options include Belsey partial fundoplication as well as Collis gastroplasty combined with Belsey partial fundoplication. However, anti-reflux surgery can be associated with complications. However, there is insufficient scientific data to support the effectiveness of these devices.
Well-designed studies are needed to show that these procedures reduce or eliminate the use of anti-GERD medications. Comparative studies with standard drug therapy and traditional surgical procedures may shed some light on the role these devices play in the treatment of GERD. Some of the issues that have to be addressed are: Randomized trials have compared medical versus surgical management, laparoscopic versus open surgery and partial versus total fundoplications.
However, the evidence base for endoscopic procedures is limited to some small sham-controlled studies, and uncontrolled cohort studies. Laparoscopic fundoplication has been shown to be an effective anti-reflux operation.
It facilitates quicker convalescence and is associated with fewer complications, but has a similar longer term outcome compared with open anti-reflux surgery. In most randomized trials, anti-reflux surgery achieves at least as good control of reflux as medical therapy, and these studies support a wider application of surgery for the treatment of moderate-to-severe reflux.
Laparoscopic partial fundoplication is an effective surgical procedure with fewer side effects, and it may achieve high rates of patient satisfaction at late follow-up.
Many of the early endoscopic anti-reflux procedures have failed to achieve effective reflux control, and they have been withdrawn from the market. Newer procedures have the potential to fashion a surgical fundoplication. However, at present there is insufficient evidence to establish the safety and efficacy of endoscopic procedures for the treatment of GERD, and no endoscopic procedure has achieved equivalent reflux control to that achieved by surgical fundoplication.
Esophageal hyper-sensitivity, persistent non-acid reflux and incomplete acid suppression all can play a role in the pathogenesis of persistent GERD symptoms. New prokinetics and inhibitors of transient lower esophageal sphincter relaxations TLESRs can potentially reduce both acid and non-acid reflux and drugs that reduce hyper-sensitivity are possibly helpful for the treatment of non-erosive reflux disease.
Whether these drugs will make it to the markets will mainly depend on their side effect profile and their ability to have an additional beneficial effect over the current gold standard therapy as it likely that a new anti-reflux drug will be used in combination with PPIs.
Over the last decade various endoscopic anti-reflux techniques have been introduced, most of them have been withdrawn soon after introduction due to lack of effect or after the occurrence of severe side-effects.
These procedures may provide an alternative treatment for selected patients with mild to moderate GORD who are dependent on medication and are reluctant or unable to undergo surgery.
However, a substantial placebo effect has been demonstrated in sham controlled trials, and endoscopic results were generally inferior when compared with laparoscopic fundoplication. Doubts about the durability of the therapeutic effect remain since the follow-up period in most studies was short.
The assessment found that data on comparative endoscopic treatments with continued or intensified use of PPIs are needed to better understand their efficacy compared to an established standard. The report also noted the need for more efficacy and safety data on new endoscopic approaches tested against a sham procedure with adequate follow-up.
Until then, widespread clinical use of endotherapy for GORD should probably be avoided. In a review on endoscopic anti-reflux procedures, Pace et al concluded that none of the proposed anti-reflux therapies has fulfilled the criteria of efficacy, safety, cost, durability and, possibly, of reversibility.
There is at present no definite indication for endoscopic therapy of GERD. EndoCinch Suturing System is suggested for endoscopic placement of sutures in the soft tissue of the esophagus and stomach and for approximation of tissue.
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