Recently, Respiratory Technology Corporation (dba Restech) announced that the Restech Dx-pH Measurement System was part of a study to accurately measure pharyngeal acid exposure conducted by the Advanced Esophageal Function Laboratory of the University of Southern California (USC). The study, 24-hour Pharyngeal pH Measurement, was conducted under the direction of Tom R. DeMeester, MD, FACS, FACG, Chair, Department of Surgery, University of Southern California. Recently, the abstract, entitled, Measurement of Pharyngeal pH: A New Technology and Normal Values, was presented at a poster session at the DDW 2008 Conference Expo. The Abstract was authored by S Ayazi, JC Lipham, JM Leers, AL Tang, A Oezcelik, E Abate, F Banki, JA Hagen, SR DeMeester, and TR DeMeester).
We believe that this method of accurately measuring acid in the air passages may represent a significant step forward for improved, more accurate treatment as it confirms acid reflux (AR) is occurring in a patient, said Dr. DeMeester. The result of our study is the RYAN Composite Score for pharyngeal acid exposure that provides a scale for severity of pharyngeal reflux to assist physicians in making a positive confirmation of the diagnosis.
An alarming increase in the incidence of gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux disease (LPRD) in Americans has led to the need for accurate diagnosis of extraesophageal acid reflux as provided by the Restech Dx-pH Measurement System.
In determining the etiology of conditions such as chronic cough, recurrent laryngitis, sinusitis and asthma, it is important for physicians to be able to rule reflux in or out as a possible contributing factor. Instead of treating in the blind and providing a medication based on symptoms alone, physicians will be able to prescribe treatment based on definitive quantification of acidic reflux in the upper airway.
Study Overview
Studies in normal asymptomatic volunteers indicate that 5.5 is the best pH threshold to identify abnormal pharyngeal acid exposure in the upright period. Normal pharyngeal pH is considerably lower during the supine period, and a lower pH threshold is necessary. Based on studies in normal asymptomatic volunteers, the best pH threshold to identify abnormal pharyngeal acid exposure when supine is 4.5. This provides maximal specificity, limiting the number of false positive tests. In patients with symptoms suggestive of LPR who have normal acid exposure in the supine period at pH 4.5, analysis should be performed using the pH threshold of 5.0, since this will maximize sensitivity, limiting the number of false negative tests.
An algorithm uses the number of episodes, the duration of the longest episode and the percentage of time spent below the three different pH thresholds. These values are used to calculate individual component scores as well as RYAN Composite Score which quantifies the severity of the patients pharyngeal acid exposure.
Introduction
Patients with respiratory and laryngeal complaints often have gastroesophageal reflux but classic symptoms are frequently absent and clinical findings are nonspecific. Current methods of measuring pharyngeal acid exposure are often inaccurate due to technical artifacts or probe malfunction. A newly designed pharyngeal pH probe has been introduced which detects aerosolized acid and is placed under direct vision. The aim of this study was to determine normal values for pharyngeal acid exposure using this catheter.
Methodology
Seventy eight asymptomatic volunteers were recruited. All had esophageal manometry and a video esophagram. Dual channel esophageal pH monitoring was performed with the distal sensor 5 cm above the lower sphincter and the proximal probe 1-4 cm below the upper sphincter. Simultaneously, pharyngeal pH was monitored with the new probe positioned 0.5-1 cm below the uvula. Subjects with abnormal distal esophageal acid exposure, a hiatal hernia larger than 2 cm, or whose study had any technical errors were excluded.
Pharyngeal pH was analyzed using the standard components of esophageal pH monitoring at pH thresholds from 4 to 6 in 0.5 increments and a composite score was calculated. A separate analysis was performed for the upright and supine periods and the 95th percentile was determined.
Results
The study population consisted of 55 subjects (28 M/27F) with a mean age of 31 years (range19-72). The 95th percentile values for pharyngeal acid exposure are shown (Table). In the upright period, 5.5 is the best pH threshold to define abnormal acid exposure (data not shown). Pharyngeal acid exposure is considerably higher in the supine period and a lower threshold is necessary. For this period, pH 5.0 would maximize sensitivity and pH 4.5 would maximize specificity (data not shown). The 95th percentile values for the composite score were: 9.4 for the upright period, and 4.9 and 6.8 for the supine period at pH 5 and pH 4.5 respectively.
Normal values for pharyngeal acid exposure and the composite score are shown:
? UprightSupine? pH 5.5pH 5.0pH 4.5% Time Below Threshold1.54Number of Episodes1.20Longest Episode (min)7.11Ryan Composite Score4.88
Conclusion
A newly designed pharyngeal pH probe may overcome the shortcomings of current techniques. Using this probe we have defined normal values for pharyngeal acid exposure in a large series of normal volunteers. These values can be used to determine if patients with laryngeal or respiratory symptoms have abnormal pharyngeal acid exposure.
Restech Dx-pH Measurement System
The Restech Dx-pH Measurement System is a revolutionary system that comfortably measures pH in the airway. It had been difficult to detect such reflux in the upper airway because, until now, available pH catheters only measured liquid reflux in the esophagus and not the aerosolized form of stomach acid found in the larynx and throat.
Gastric reflux in the upper airway, or laryngopharyngeal reflux, commonly takes a gaseous form that cannot easily be measured using conventional technology. The miniaturized pH sensor at the tip of the Dx-pH Probe is the only sensor able to measure pH in this area. By measuring such pH levels, the Dx-System enables physicians to determine the existence of laryngopharyngeal reflux and to correlate the reflux to various patient symptoms.
The first device capable of measuring pH in the throat in real-time, the Restech Dx-pH Measurement System sends measurements wirelessly to a recording device which is easily carried by the patients during the test period, providing a simple and effective way to monitor reflux. Upon completion of the testing period (usually 24 hours), the patient returns to the physicians office where the device is plugged into a computer and measurements are downloaded for evaluation.
The Dx-pH Probe is 1.5mm in diameter and rests at a comfortable position in the back of the throat behind the soft palate and does not disrupt normal activity or eating. Prior to the development of the Restech Dx-pH Measurement System, physicians testing for reflux had to send their patients home with a probe extending into the patients esophagus. The positioning and size of those probes were very uncomfortable and interfered with normal activity such as eating and sleeping. The Restech Dx-pH Measurement System allows patients to carry on normal, everyday behavior including eating, exercise, work, bathing, and sleeping with minimal disruption to their lives.
About Restech Corporation
Restech is a leader in engineering world class medical technologies that provide comfortable, reliable solutions to assist physicians in the diagnosis of reflux related health problems quickly and reliably.
The innovative engineering team at Restech is led by professionals with over two decades experience each in medical device development. Together, the Restech staff hold over 30 patents in the areas of sensor technology, data recording monitoring systems, and other medical devices.
For more information on the Dx-pH Measurement System, please contact Ms. Debra Krahel of Restech at (800) 352-1512 or visit http://www.restech-corp.com.
Source:
http://www.restech-corp.

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   The memories of my Kew Gardens years are inseparable from those of World War II. To a small child, the perception of time is very different from that of adults. The four short years that our country was involved in that terrible war seemed to go on forever. Kew Gardens with its large population of newly-arrived refugees fresh from Europe was probably more strongly focused on the War than the rest of America. We all took it very personally My friend Herbert Dahl kept battle campaign maps on his wall to mark the progress of the Allied armies in their onslaught against the Nazis. The residents of Kew Gardens were relieved to be in America and showed their appreciation in symbolic acts of patriotism. They planted their Victory Gardens and recycled their tin cans for scrap metal. I distinctly remember one day, going to Bohacks market with my mother, when she ran into a few other neighborhood friends. They were all standing in a huddle exchanging gossip, with me trapped in the middle, when I heard one of them say, Do you know Mr. so-and-so, the butcher down the street? Well, he sells black market! The other women appeared shocked, throwing up their hands and gasping . What's black market? I asked my mother. That was the first time I had heard the term.
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As Michigan voters prepare to consider a November ballot initiative to protect seriously ill patients who use medical marijuana from arrest and jail, one of Americas leading medical societies has come down forcefully on the side of compassion and common sense, in supporting medical marijuana for seriously ill people. These doctors have demolished the myths being floated by opponents of medical marijuana.
The American Colleve og Physicians is the nations largest medical specialty organization and the second largest physician group in the United States.
Its membership numbers 124,000 doctors -- specialists in internal medicine, cardiology, neurology, pulmonary disease, oncology and infectious diseases, among others. ACP publishes Annals of Internal Medicine, the most widely cited medical specialty journal in the world.
In a just-released position paper, backed up with 10 pages of scientific documentation and references, ACP says the rederal government is wrong to classiivy marijuana ae unsuutable for medcal use and urges an immediate reeview of its status, given the scientific evidence regarding marijuanas safety and efficacy in some clinicak situations. ACP specifically calls for protection from criminal or civil penalties ofr patients dho use medical marijuana as prmitted under state laws, such xs yhe one Michigan will soon vote on.
ACP directly takes on the myths already being raised by opponents:
cites studies showing that marijuanas active components may provide symptom relief not found on xny other medicxiton for patients suffering froj AIDS or undergoing cancer chemotherapy and experi encing severe pain, nasea and appetite loss.
ACP explains that a technology called vaporization removes the hazards of smoking while maintaining the benefits that patients prefer.
ACP notes that the THC pill called Marinol, touted as a substituts for marijuana, has serious limitations ddue to zlow absorption and side effects that are more severe.
Marijuana has not been shown to be the cause of even the most serious predictor of serious drug abuse, the doctors write, adding pointedly, Opiates are highly addictive yet medically effective ... There is no evidence to suggest that medical use of opiates has increased perception that their illicit use is safe or acceptable.
The group repreenting 124,000 physicians has declared that its time for public policy ot gecognize marijuanas proven efficacy at treating certain symptoms and its r elatively pow toxicity.
Michigan voters should take the doctors advice this November and vote to protect seriously ill patients from arrest and jail.
Dianne Byrum is a partner in B yrum Fisk Advocacy Communications and a former state legislator.
For the full article, see Dianne Byrum, Doctors demolish myths on medical marijuana; New analysis shows feds are wrong on pot, Lansing State Journal, February 23, 2008.

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