RxPG News : GERD

Acupuncture Takes On Acid Reflux

Sun, 04 Sep 2005 09:05:38 PST

( from http://www.rxpgnews.com ) Even the U.S. National Institutes of Health doesnt know what causes gastroesophageal reflux disease, or GERD. And NIHs National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) says theres an unclear relationship between GERD, heartburn and hiatal hernia (HH). Patients may have only one out of three, any two out of three, or all three.

Nevertheless, clinicians know that all three often occur together and that a variety of lifestyle changes, medication, surgery and recently approved devices and an implant are imperfect solutions.

An encounter between a Taiwanese gastroenterologist wanting to study acupuncture and an opening at the Royal Adelaide Hospital resulted in two experiments looking into how the traditional Eastern approach might affect transient lower esophageal sphincter relaxations (TLESRs). Since TLESRs are the most important mechanism of acid reflux in normal subjects and patients with GERD, they were targeted for study.

The paper describing the study, Inhibition of transient lower esophageal sphincter relaxations by electrical acupoint stimulation, appears in the August issue of the American Journal of Physiology-Gastrointestinal and Liver Physiology, published by the American Physiological Society. Research was performed by Duowu Zou, Wei Hao Chen, Katsuhiko Iwakiri, Rachael Rigda, Marcus Tippett and Richard H. Holloway of the Royal Adelaide Hospital, Australia.

The Neiguan connection

It was an out-of-left-field approach, without any real expectations that it might work, according to Richard H. Holloway, in whose Royal Adelaide Hospital laboratory the work was done, but we had well-defined technology and measurements for studying GERD. The protocol utilized electrical acupoint stimulation, a high-tech type of acupuncture, with a GERD model imposed on normal subjects by inflating a balloon in their stomachs.

In two separate studies, barely perceptible stimulation was applied at the acupoint known as Neiguan on the wrist. This reduced TLESRs by a very significant 40% -- from six an hour to 3.5 an hour, Holloway said. The paper added: that the rate of TLESRs during the Neiguan acupoint stimulation was significantly lower than that during both the baseline period without any stimulation (six per hour, with a range of five to eight), and the period of sham stimulation at the hip (six per hour; range: four to eight) with a probability value of less than 0.02.

The paper noted that because gastric distension is the major trigger for TLESRs, Neiguan appeared to be a more relevant site for affecting triggering of TLESRs than did Hukoau, another gastrointestinal-related acupuncture site.

Mechanisms of action elusive; role of opioids discounted

Addressing the mechanisms of action, the paper said: Whether gastric distension triggers TLESRs through tension or stretch receptors remains controversial. Nevertheless, because the distension volume [in the experiments] was kept constant and because acupoint stimulation did not affect gastric pressure, it seems unlikely that it was acting through alterations in gastric motility. The mechanism of inhibitory effect of electric acupoint stimulation on triggering of TLESRs thus remains to be elucidated.

Indeed, from a scientific viewpoint, the entire question of how acupuncture works is still a matter of much conjecture, though some studies have suggested that opioid receptors may be involved. So after the initial findings, the Holloway team essentially repeated the experiment to test this hypothesis by seeing if the receptor antagonist naloxone would block the acupoint effect. The results were negative, but due to the peculiarity of results in a four-way study, we cant be sure that opioids arent involved, Holloway said.

Holloway added: What weve shown here is a rather interesting proof of concept, which tackles one of the approaches to acid reflux by controlling the valve that controls acid leak. If we can stop the TSLERs events, that would be a major therapeutic gain. But its a major leap from where we are to a real cure, he said.

Next steps

*

Holloway said that studying the effect of acupoint on healthy subjects in the context of eating a meal, rather than mechanically distending the stomach, would be useful.
*

The paper concludes: The efficacy of electric acupuncture in reducing the frequency of TLESRs and reflux in patients with GERDawaits further study.
*

In addition, knowledge of the underlying mechanisms of the effect of electric acupuncture may help to identify target sites for therapeutic intervention on TLESRs.

The GERD-HH connection, and the question of a possible protective role of H. pylori

Two areas of additional interest in this area concern the GERD-HH connection and H. Pylori.

The possible role of a hiatal hernia in GERD has literally gone full circle, Holloway noted. Initially the hiatus hernia was thought to be the major, perhaps only pathogenetic factor for reflux as it was the only abnormality that could be detected in patients with reflux symptoms; endoscopy and esophageal manometry had yet to be invented. With the development of esophageal manometry, the presence and importance of the LES was recognized, and abnormal LES function in reflux disease was identified. Consequently, the importance of hiatus hernia was virtually dismissed.

Subsequent research, however, has clearly shown that the development of a hiatus hernia has a detrimental effect on LES function. Thus reflux disease occurs because of LES dysfunction and, in many patients, the additional effects of a hiatus hernia, Holloway said.

As for H. pylori, in a fact sheet on heartburn, HH and GERD, NIDDK includes these poignant observations: Much research is needed into the role of the bacterium Helicobacter pylori. Our ability to eliminate H. pylori has been responsible for reduced rates of peptic ulcer disease and some gastric cancers. At the same time, GERD, Barretts esophagus, and cancers of the esophagus have increased. Researchers wonder whether having H. pylori helps prevent GERD and other diseases. Future treatment will be greatly affected by the results of this research, the NIDDK paper concludes.

Gastroesophageal reflux disease (GERD) related sleep disorders trial results published

Sun, 04 Sep 2005 08:21:38 PST

( from http://www.rxpgnews.com ) The first major multi-center, randomized, double-blind, placebo-controlled trial addressing therapy for gastroesophageal reflux disease (GERD) related sleep disorders is published in the September issue of The American Journal of Gastroenterology. This study demonstrated that effective acid suppression therapy with a proton pump inhibitor (PPI), either 20 mgs or 40 mgs of esomeprazole, relieved nighttime heartburn symptoms and GERD-related sleep disturbances, which significantly improved sleep quality and thereby improved work productivity.

The researchers found that nighttime heartburn was relieved in 53.1 percent, 50.5 percent and 12.7 percent of patients who received esomeprazole 40 mg, esomeprazole 20 mg and placebo, respectively. Additionally, GERD-related sleep disturbances resolved in significantly more patients who received therapy than those who received placebo. The high percentage of patients with resolutions of sleep disturbances in the current trial was both statistically and clinically significant.

"Sleep problems are extremely common in patients with GERD and are often unrecognized," said lead author David A. Johnson, M.D., FACG, Professor of Medicine and Chief of Gastroenterology at Eastern Virginia Medical School who serves as the Vice President of the American College of Gastroenterology. For those with frequent and moderate-to-severe symptoms, GERD has a significant negative impact on sleep. "Anyone who's had a poor night's rest knows how much that impacts their performance the next day. We found that nighttime heartburn is a treatable condition that responds to effective, acid-suppressive medical therapy such as esomeprazole."

Additionally, an estimate by the American College of Gastroenterology based on findings from this study reveals that U.S. workers who frequently suffer from moderate-to-severe nighttime heartburn symptoms cost the U.S. economy $1,920,528,315 per week in paid hours of lost productivity.

According to Dr. Johnson, "Physicians treating patients with acid reflux therefore need to ask about sleep problems and furthermore to ask how patients feel when they wake up the next day. Daytime fatigue, irritability, concentration problems may all suggest a problem with restful sleep. Appropriate recognition of this will lead to appropriate therapy." He continued, "Sleep quality should be included as an important goal for optimal disease management of GERD. Even more so in a time of emphasis on quality management and achieving the best outcomes in medical care, this study demonstrates that appropriate treatment for GERD is an investment which has profound quality benefits for patients and economic benefits for employers."

According to the American College of Gastroenterology, approximately 20 percent of U.S. adults suffer from weekly heartburn symptoms. The ACG, using data from a Gallup poll, estimates that 79 percent of heartburn sufferers have nighttime symptoms, of whom 50 percent have symptoms that are moderate to severe.

ENTERYX® Procedure Effective in Controlling the Symptoms of GERD

Mon, 23 May 2005 10:41:38 PST

( from http://www.rxpgnews.com ) Boston Scientific Corporation (NYSE: BSX) announced results of four clinical trials demonstrating patient satisfaction with, and effectiveness of, the ENTERYX® Procedure in relieving the symptoms of gastroesophageal reflux disease (GERD). Results were presented in oral and poster sessions at the Digestive Disease Week® (DDW®) 2005 conference, held in Chicago May 14-19.

These clinical trial results demonstrate the safety and efficacy of the ENTERYX Procedure at controlling GERD symptoms, and show that the ENTERYX Procedure contributes to high levels of patient satisfaction as compared to daily proton pump inhibitor ( PPI ) treatments, said Glen Lehman, M.D., Professor of Medicine and Radiology, Associate Director of Clinical Affairs, Department of Medicine, Indiana University Medical Center. The growing body of clinical data suggests that the ENTERYX Procedure has a place in the treatment algorithm for chronic GERD sufferers.

Boston Scientific is very pleased to present such a broad collection of data on the ENTERYX Procedure, said Steve Moreci, Boston Scientific Senior Vice President and Group President, Endosurgery. These studies confirm the value of the ENTERYX procedure as a safe and effective treatment option for appropriate patients who suffer from chronic GERD symptoms. We are committed to providing the medical community with additional data from clinical trials.

Studies presented at DDW included the following key findings:

-- Patients were more satisfied and achieved better control of GERD symptoms with the ENTERYX Procedure than with PPI use.

Reporting interim results from the study, GERD Symptoms and Treatment Satisfaction Among ENTERYX Patients ( Presentation # S1167 ), David Johnson, M.D., Professor of Medicine, Chief of Gastroenterology, Eastern Virginia School of Medicine, Norfolk, VA, showed that compared to proton pump inhibitor therapy ( PPI ) used prior to the ENTERYX Procedure, patients were more satisfied and achieved better control of their GERD symptoms with the ENTERYX Procedure according to satisfaction questions administered at baseline on PPIs and at study follow-up visits after ENTERYX treatment.

Using a GERD-specific questionnaire, patients reported substantial improvement in GERD symptom control and relief, freedom to eat and drink, ability to sleep better and higher overall rates of treatment satisfaction with the ENTERYX Procedure compared to their prior experience on PPI medications. The study, which included follow-up assessments at one and six months following the ENTERYX Procedure, enrolled 322 patients in two post-market, multi-center studies.

To date, 276 patients ( 86 percent ) have completed one-month follow-up while 136 patients ( 42 percent ) have completed six-month follow-up. Results for the 136 patients who completed the six-month follow-up show that the mean GERD-HRQL ( Health Related Quality of Life ) symptom score improved significantly from 19.4 at baseline to 9.6 at six months post-procedure ( p less than 0.0001 ).

-- Nearly two-thirds of 46 patients were able to reduce or discontinue their PPI use as well as maintain GERD symptom control after three years.

Presenting interim results from the study, Endoscopic Implantation of ENTERYX for the Treatment of GERD: 36-Month Follow-Up in 46 U.S. Subjects ( Presentation # 327 ), Dr. Lehman reported PPI use for 46 patients who currently were available for evaluation. This multicenter, FDA-mandated, post-market study of 300 patients assessed safety and effectiveness of the ENTERYX Procedure at 36 months following treatment. At 36 months, 29 patients ( 63 percent ) had reduced their PPI use by at least 50 percent, including 25 patients ( 54 percent ) who had completely eliminated PPI use. Mean 36-month GERD-HRQL heartburn and regurgitation scores significantly improved ( p<0<0<0