To further complicate the GORD picture, Endoscopy-Negative Reflux Disease (ENRD), Non-Erosive   Reflux Disease (NERD), functional heartburn or reflux-like dyspepsia is often diagnosed, and most   patients with heartburn do not have mucosal breaks. Moreover, diagnostic approaches vary between   primary and secondary care.
In the absence of gold standard diagnostic testing for GORD, symptom assessment and    understanding how symptoms impact on a patient’s quality of life is critical to the successful    management of a patient. Recent research has suggested that the symptom complex experienced by  GORD patients is much wider than previously appreciated.
Besides heartburn, acid eructation, and pain on swallowing, a variety of other GORD-related    symptoms are experienced, including nausea, diarrhoea or constipation and sleep disturbance, as    well as other symptoms, such as respiratory complaints. GORD is a condition of diverse and variable    symptoms, many of which significantly impair quality of life.
SIMPLE QUESTIONNAIRE
One such approach is ReQuest™, a simple and effective questionnaire, which patients use to assess    themselves daily for a wide range of GORD symptoms. It was created following discussions with    patients and physicians to identify the spectrum of symptoms reported and establish how they were    described by GORD patients. The questionnaire was also based on an evaluation of relevant medical    literature and clinical trial data.
ReQuest is divided into seven dimensions covering acid complaints, upper abdominal/stomach    complaints, lower abdominal / digestive complaints, nausea, sleep disturbances, general well-being    and other complaints. A short version of the questionnaire, which can be completed in less than five    minutes, focuses solely on these seven dimensions, while the full version, which takes approximately    20 minutes, is more wide-ranging.
Both tests have undergone extensive clinical trial evaluation and statistical analysis, which has    confirmed their internal consistency, test-retest reliability, construct validity, and responsiveness to    changes during treatment.4,5,6
ReQuest fulfils the criteria set by the regulatory authorities for a validated symptom-based system for    use as the primary outcome measure in clinical trials of GORD therapy. It has now been validated in    26 languages and tested in 20 countries.
REQUEST / LA CLASSIFICATION
The ReQuest / LA classification system is the first to effectively integrate a highly sensitive patient    questionnaire (ReQuest) with an adaptation of the LA classification for esophagitis. The new index    allows the combined assessment of symptom relief and the healing of oesophageal lesions in    GORD.
The adapted LA classification (N = lesions not present, grade A–D) was paired with a grading of    patients’ symptom burdens from 0–4 (0 = no disease, 1 = minor, 2 = tolerable, 3 = troublesome, 4 =    intense), as assessed by the rescaled subscale of the established GORD symptom evaluation    instrument ReQuest.
By comparing both scales in a matrix, clinicians are able to quantify both aspects of GORD and assign    an index to each patient. An index of 0N indicates optimal treatment outcome, in other words complete    remission (relief from symptoms and the healing of oesophageal lesions).
VALUABLE INSIGHTS
A recent randomised, double-blind study of 581 patients using ReQuest has established that    pantoprazole is as effective as esomeprazole (both 40mg/day) over 12 weeks in achieving the    complete remission of erosive GORD. With respect to endoscopically confirmed healing, pantoprazole    was superior to esomeprazole.
A second randomised, double-blind ReQuest study, this time of four weeks’ duration (561 patients),    again comparing pantoprazole and esomeprazole (both 40mg/day), demonstrated parity between the    two PPIs in terms of symptom relief scores, but it also showed that the beneficial effects of    pantoprazole were sustained for longer, with significantly fewer symptomatic relapses in the    seven- day post- treatment phase.8
Professor K D Bardhan, consultant physician and gastroenterologist at the District General Hospital,    Rotherham, in the UK, who was instrumental in developing the ReQuest/ L A classification, says: ‘We    need a device that enables an accurate assessment of treatment success in GORD patients that    combines the main parameters of symptom relief and oesophageal healing. The new ReQuest / LA    classification enables a detailed clinical and treatment outcome assessment of GORD patients at any    stage of their disease using a single and reliable global measure. In my view, ReQuest / LA    classification represents a helpful step in the right direction and provides a means of standardising    the assessment and reporting of GORD clinical trials.’
An extensive ReQuest database, which provides information on patient demographics, symptom    profiles and treatment outcomes, now exists for over 8,000 patients with GORD. Use of the combined    endpoint ‘complete remission’, evaluated using the ReQuest™/LA classification, will permit even    greater insights by helping to analyse patient populations and shed light on the factors that dictate    whether a treatment works. Such a source of GORD treatment outcomes, during various stages of the    disease, could be of major benefit to patients, physicians and the organisations that fund healthcare    in the future.
REFERENCES
COMPANY PROFILE
ALTANA Pharma is the pharmaceutical division of ALTANA AG. The company concentrates on innovative pharmaceutical products in therapeutics, imaging (contrast media) and OTC medication. Therapeutics, the most important business area, is based on prescription drugs for gastrointestinal and respiratory diseases.
