60 million individuals in the US with Gastrointestinal Disorders 

 

It is commonly accepted that 15 to 20% of the US population have some form of gastrointestinal (GI) disorder. One need only visit a supermarket and see the amount of shelf space given to products that are gluten free, lactose free, soy-based or soy-free, have active culture probiotics or names like “Goodbelly” to understand that this is an issue that affects much of society. Longstreth [4] reports “Up to 20% of the U.S. population reports symptoms consistent with IBS (Irritable Bowel Syndrome)”, which amounts to approximately 60M people. Other estimates [1] of the affected population are considerably higher. According to this study, only slightly over one-third of people with GI issues see a doctor. Peery [6] reports approximately 40M office visits in 2010 for complaints related to the lower GI tract, i.e. the stomach, small intestine and colon.

Patients who do see a doctor for their symptoms, including constipation, diarrhea, bloating and chronic abdominal pain, begin a process of diagnosis by exclusion. To rule out cancer, IBD (Inflammatory Bowel Disease), benign tumors, and various other anatomic problems they undergo a series of tests such as CT scan, colonoscopy, endoscopy, MRI, upper and lower GI Series X-rays, and so forth. These tests are variously invasive, physically unpleasant, expensive, and stressful. Most of the time they return negative results. Physicians are able to tell patients what they do not have, but not what they do have that is causing them pain and discomfort, and making them miss work or school, avoid vacations or even going to public places. A large proportion of those going to gastroenterologists have functional problems such as IBS and functional abdominal pain syndrome (FAPS).

Camilleri [2] writes “one could almost assume that patients presenting with abdominal pain are most likely to suffer a variant of functional gastrointestinal disorders, such as chronic functional abdominal pain or irritable bowel syndrome.” IBS and FAPS are catch-all terms that cover a range of symptoms and do not point to a particular treatment. Without a specific positive diagnosis physicians can only treat symptoms. This approach has not been successful, as symptoms like constipation or pain have numerous possible causes, and be centered in any of the organs 

Gastroenterologists have described patients with functional disorders as their most vexing. Without a specific positive diagnosis patients are left wondering if their problems are real or imagined, perhaps knowing they are real but still harboring doubts, and often not receiving the external support one would have if there was a diagnosis to point to. 

Unique to the digestive system, the stress of this exacerbates the symptoms. “Patients with IBS commonly express concerns or fears about their disease, believe that their symptoms represent something dangerous or life threatening, and feel as though their physicians are not answering their questions or providing appropriate support." [3] It is all too common for patients to “doctor shop” in hopes of finding a physician who can identify what is wrong and help them. They repeat tests they’ve been through with previous doctors, and even take tests that have little chance of being useful simply because the physician has run out of options. Web sites such as IBSGroup.org and ibs.about.com provide a glimpse into the suffering patients endure. While not life threatening, and often not discussed openly by patients, the impact on individuals and society is great.

 ~ 43 Million office and ER visits, 2010 

There were $40B in health care costs for GI diseases with over $10B spent on GI medications [5]. In a study at a US HMO Longstreth et al [4] found that IBS patients accounted for 51% greater spending than non-IBS patients. The limitations of anatomic testing (colonoscopy, CT scan, MRI, etc.) in regard to functional disorders has already been discussed. There are several functionally oriented tests that have been developed in an attempt to address the huge gap in testing capability. These functional tests provide useful but limited information. They focus on a single organ, or a brief period of time, or both. Many are invasive, involve radiation, and are expensive. Some can only be carried out by skilled practitioners with special equipment. Yet they are regularly used because there is nothing better and physicians are desperate for diagnostic help. 

 

G-Tech's system will provide motility information on all three major organs simultaneously, over several full days, non-invasively and inexpensively, without radiation or discomfort, without special meals or ingestibles. The comprehensiveness and statistical thoroughness of the information will potentially revolutionize the diagnosis of functional digestive disorders. In summary, the need for a way to help diagnose functional GI disorders is great, and the market is in the tens of millions, in a clinical arena where repeat customers will be common.

References:

  1. New Survey Reveals More Than Half Of Americans Are Living With Gastrointestinal Symptoms And Not Seeking Care From A Doctor, released 11-6-2013 by AbbVie Corp. www.abbvie.com
  2. Camilleri, M., Management of patients with chronic abdominal pain in clinical practice, Neurogastroenterol Motil (2006) 18, 499–506
  3.  A 42-Year-Old Woman Presents for Second Opinion: Nonconstipation IBS -- A Case Study Approach, Medscape Education Gastroenterology, Brian E. Lacy, MD, PhD
  4. Longstreth, Health care use and costs, US perspective, 2003, The American Journal Of Gastroenterology Vol. 98, No. 3, 2003
  5. Shaheen N et al. The burden of gastrointestinal and liver diseases, 2006. Am J Gastroenterol 2006;101:2128-2138.
  6. Peery, Anne F., et al. "Burden of gastrointestinal, liver, and pancreatic diseases in the united states." Gastroenterology 149.7 (2015): 1731-1741.

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