Office Research Studies

ACG ABSTRACT 2017:
Risk of Addiction For IBS Patients Prescribed Anxiolytics: A Community-Based Study

Douglas Jay Sprung, MD. The Gastroenterology Group, Maitland, FL

Introduction: To evaluate if the prevailing perception over the past decades that anxiolytics lead to or have a significant risk for addiction, or in some other way are deleterious to patients (pts) in our com­munity setting, is a valid and worthy concern.

Methods: A retrospective study of adult Irritable bowel syndrome (IBS) pts seen between 6/2012-1/2017 was undertaken, from our community based gastroenterology practice in Orlando, Florida. We culled out those with IBS and general anxiety state (GAS), and those with IBS and non-cardiac chest pain (NCCP). A follow up period of >3 months was required. All insurances except Medicaid and certain HMO’s were accepted. Use of anxiolytics had to begin during the study period. A minimum of 3 follow up visits were required. All patients studied were on an anticholinergics (hyoscyamine, dicyclomine, donnatal), but a few were on lubiprostone or Linaclotide. Anxiolytics included: clonazepam, alprazolam, lorazepam and diazepam. Doses ranged from 0.125 mg bid to 0.5 mg tid and 2-5 mg bid for diazepam.

Results: Of 1148 unique pts identified with IBS, 182(15%) had concomitant GAS and/or NCCP, 141/182(77%) had GAS and IBS, 41/182 (23%) had NCCP and IBS. The mean follow up was 1.5 years. The mean age was 65 and the sex ratio was 3:1 female to male. 11 pts (6%) increased their initial anxiolytic dose during follow up, but then maintained that dose. 18(10%) decreased their dosage, due to lethargy. Many patients had to be convinced that anxiolytics were 1. not deleterious or addictive and 2. would help their primary GI ailment, and 3. that stress was an important element in their IBS and that they had stress in their lives. It often took many months of convincing before pts would commit to a treatment trial. No complications, falls, memory disorders or clinical indications of addiction were brought to our attention, other than lethargy and foggy headedness, that resolved with a lower dose.

Conclusion:
1. No clinical indication of addiction to anxiolytics was seen in our community based suburban cohort with IBS and GAS or NCCP.
2. Anxiety treatment yielded improvement in IBS and NCCP symptoms in all pts.
3. Improved quality of life on anxiolytics was observed by patient, family and physician.
4. Anxiolytics appear to be quite safe in this cohort when given in judicious doses. Perceptions of addiction need to be updated by physicians and society.

ACG ABSTRACT 2011:
Decreasing Incidence of Esophageal Adenocarcinoma in Patients with Barrett’s Esophagus in our Community Over the Past 20 Years

Douglas Sprung, MD, FACG

PURPOSE: The incidence of esophageal adenocarcinoma (EAC) in Barrett’s Esophagus (BE) has been reported to be increasing over the past decade, yet this has not been the observation in our community. We undertook to determine the incidence of EAC over the past 20 years in patients (pts) with BE, comparing the first 12 years from an earlier report to the last 8 years.

 METHODS: A retrospective review of all patients with pathologically documented non-dysplastic BE was undertaken over the past 20 years ( 1/1991-12/ 2010). Only pts followed for at least > 1 year from the index diagnostic endoscopy were included in this study. Prevalence cases of dysplasia or EAC were excluded. All pts were from a single private group practice in Altamonte Springs, Fl.

RESULTS: 373 pts were identified who met the criteria. 218 had > 3 cm of specialized intestinal metaplastic columnar epithelium, long segment Barrett’s (LSB); 155 had < 3 cm of BE, short segment Barrett’s (SSB). There was a mean follow up of 7.3 years. There were 7 cases of incidence EAC over 20 years, 6 in the first 12 years, but only 1 in the next 8 years. This yielded a 0.25% / year incidence of EAC over 20 years. We reported a 0.5% / year incidence of EAC in the initial 12 year report, with a decrease to 0.06% / year incidence of EAC over the last 8 years. The only recent case of EAC was in a patient with SSB. No new cases of high grade dysplasia without an associated mucosal abnormality were noted. 5% of LSB had low grade dysplasia, and all reverted to non-dysplastic biopsies in follow up.

CONCLUSIONS:

  1. There appears to be a decreasing incidence of EAC in non-dysplastic BE over the past 8 years (0.06% / year) compared to the 12 years prior to that ( 0.5% /year ). The overall 20 year incidence was 0.25 % / year.

  2. Early and continuous use of proton pump inhibitor drugs may be responsible for these changes in clinical outcomes.

  3. Since there was only 1 new case of EAC in the past 8 years, and that was in a SSB, perhaps the length of BE is not as potent a risk factor as previously thought.

AGA ABSTRACT 2011:
Do Anticholinergic Medications Really Pose a Higher Risk for Adverse Effects in Irritable Bowel Syndrome Patients Over Age 65? A Community Based Study

An updated version of the 2007 initial study. The pharmaceutical companies have focused on pharmacist review data that suggests that caution be given to using anticholinergic drugs in patients over age 65 due to the potential of increased side effects.  As a practitioner of clinical medicine for almost 30 years, it has been my long term observation that patients over 65, and up to the mid-nineties (90’s) benefit tremendously from these drugs and suffer few if any adverse effects, even at routine doses.  All of these drugs are generics at this point, and have been available for over 65 years.  I studied 192 patients over the age of 65 and found 83% to have very good results, 12% good results and only 5% didn’t benefit.  The most common side effect is a dry mouth (36%) that does not preclude its use, but is more of a nuisance.  Examples of these drugs are Levsin, Hyoscyamine, Bentyl, Dicyclomine, Librax and Donnatal/Belladona.  Unfortunately, proper usage and dosing is often not applied by many doctors, and therefore their results are suboptimal.  That, however, can be improved with proper education of the patients to the optimal manner of taking these medicines.

ACG ABSTRACT 2008:
Findings of Screening Colonoscopy in the Community: Flat Polyps Rule

Douglas Sprung, MD, FACG, Jane Rochester, RN, Mary Wagner, RN. Medicine, Florida Hospital, Maitland, FL.

Purpose: To report on the prevalence of adenomas and their characteristics in an average community population undergoing screening colonoscopy.

Methods: All patients (pts) seen for initial screening colonoscopy between 10/1/07- 4/30/08 at a community hospital (Florida Hospital Altamonte) and an ambulatory surgical center (Winter Park ASC) were evaluated. Criteria for entry required: asymptomatic pt, age 50 years or more, without blood per rectum, melena, chronic diarrhea, new change in bowel habits, abdominal pain, hemoccult positive stool or the history of a CT scan, ultrasound or MRI for GI symptoms (any of these over the past 6 months would exclude pts). We also required a negative family history of colon cancer or polyps. All pts were interviewed by an admitting nurse, who asked the above questions, and only those who met all the criteria were included.

Results: A total of 184 pts met screening criteria out of 2699 pts undergoing colonoscopy. Mean age = 56, 48% were female. 57/184 (31%) pts had polyps. Of screened pts 39/184 (21%) had adenomas, 10% hyperplastic polyps (HP). 58 adenomas were found in 39 pts, with 93% (54/58) being flat and 7% (4/58) pedunculated. 27 HP were found, 100% of which were flat. 25 (64%) pts had 1 tubular adenoma (TA), 11 (27%) pts had 2 TA, 1 (3%) pt had 3 TA and 2 (6%) had 4 TA. 17% (10/58) of TA were advanced adenomas (size 1 cm or more), and 16% (9/57) pts had advanced adenomas. No cancers or dysplasia was encountered.

Conclusion:
1. When a screening population as defined above was examined, 21% had TA and 10% HP.
2. 5% of pts screened had advanced adenomas.
3. 60% of pts with adenomas were male.
4. 93% of all TA were flat, likely the result of earlier discovery of polyps in an asymptomatic population.

ACG ABSTRACT 2007:
Antispasmodics are safe for treating irritable bowel syndrome patients age 65 and above

The pharmaceutical companies have focused on pharmacist review data that suggests that caution be given to using antispasmodic drugs in patients over age 65, due to the potential of increased side effects.  As a practitioner of clinical medicine for almost 30 years, it has been my long term observation that patients over 65, and up to the mid-nineties (90’s) benefit tremendously from these drugs and suffer few if any adverse effects, even at routine doses.  All of these drugs are generics at this point, and have been available for over 65 years.  I studied 100 patients over the age of 65 and found 85% to have very good results, 12% good results and only 3% didn’t benefit or had side effects.  The most common side effect is a dry mouth that does not preclude its use, but is more of a nuisance.  Examples of these drugs are Levsin, Hyoscyamine, Bentyl, Dicyclomine, Librax and Donnatal/Belladona.  Unfortunately, proper usage and dosing is often not applied by many doctors, and therefore their results are suboptimal.  That, however, can be improved with proper education of the patients to the optimal manner of taking these medicines.

Abstracts published in the 2006 American Journal of Gastroenterology:

Does the Timing of Laxatives make a Difference in Colonoscopy Prep Outcomes?
 

This study revealed that by starting the preparation late in the afternoon, as opposed to the morning, the patients had much cleaner colons and that means a better exam. They likely spent more time drinking fluids all day. That helped hydrate the colon. Also, patients did not have to miss much work. They only had to get home by 5pm the day prior to the procedure, helping them to avoid the costs of lost wages and the costs to their companies of an absent employee.

Declining Prevalence of New Cases of Ulcerative Colitis
 

Rapidly Rising Prevalence of Microscopic Colitis
 

This study, over the past 15 years, revealed a sharp rise in the number of cases of Microcopic colitis since 2004. It is still relatively rare, but it has now significantly exceeded the number of cases of Crohn's disease and Ulcerative colitis that we see. We are the first to report this observation, and will keep a vigilant eye for further developments. This is now the most common (of the unusual) causes of diarrhea, excluding bacterial and viral diseases.

Prevalence of Barrett's Esophagus among Symptomatic Patients in a Community GI Practice
 

This study revealed a much lower prevalence (or cases of Barrett's per year) than was previously thought. There is not much community data available in general and less in this country. We are the first community report on these figures. Fewer than 0.5% of patients had a long segment Barrett's, and 1% of patients had a short segment Barrett's Esophagus.

Celiac Disease in the Adult Community: Still a Rare Occurrence

The Risk of Colorectal Cancer in Ulcerative Colitis in a Population-Based Setting
This editorial in the journal Gastroenterology reviewed our findings of extremely low incidence of cancer, even in patients with long standing Ulcerative Colitis. This reflects our experience over the past 15 years. There is likewise a very low incidence of any type of dysplasia that has been found on surveillance biopsies. This may be due to changes in the disease process itself, or due in part to the better chronic medical treatment most patients receive. In either case this is excellent news for our patients.

Link to Abstract 

Link to Editorial 

Lack of Relationship of Ischemic Colitis with Irritable Bowel Syndrome
We reviewed our experience with patients who were diagnosed with ischemic colitis, finding only 32 patients over the past 10 years.  88% were female, 12% were males.  Only 2 required surgery, the rest healed with conservative treatment.

Ischemic Colitis is inflammation of the colon due to a lack of oxygen to the tissue for a period of time.  It is uncommon, occurring in 0.16% of colonoscopies we performed.  0.13% of IBS patients seen over the past decade developed ischemic colitis, showing no clear relationship between the 2 entities.  This data refutes some of the published studies over the past few years.

Low Prevalence of H. Pylori Associated Gastric Cancer in Our Community:
Over the past 15 years we saw 49 patients with gastric cancer.  Only 12% were H. Pylori positive.  The remainder (88%) did not have H. Pylori associated with the cancer.  The prevalence of Gastric Cancer seemed to decline in the last 5 years.  Interestingly, we did not find a stronger association with H. Pylori in patients born outside the United States.

Our conclusion was that H. Pylori does not appear to have a strong correlation with Gastric Cancer.

Link to full Gastric Cancer Abstract

For more information on H. Pylori, see the H. Pylori information page in the Patient Information section.

A separate article titled What is the Role Of Helicobacter Pylori in Peptic Ulcer and Gastric Cancer Outside the Big Cities was published by our practice.

Endoscopic Appearance of the Terminal Ileum in 100 Normal Patients:
Out of interest 100 patients were studied during Colonoscopy to evaluate the anatomic variants associated with normal individuals.  This has never been reported in the endoscopic literature.  We did not find any pathology, but found lymphoid nodules (Peyer’s patches) in 14% of patients and large visible villi in 12%.  This should help avoid unnecessary biopsies by the inexperienced endoscopist.

Link to full Endoscopic Appearance of the Terminal Ileum Abstract Poster

Time for Colonoscopic Withdrawal of the Endoscope during Colonoscopy:
We set up a prospective study, to see if the time spent in examining the colon when withdrawing it from the end of the colon was similar to national recommendations.  These recommendations were based on a very small study, so we wished to see how this related to the Orlando GI community.  Over a 6 month period, 14 endoscopists were clocked on their procedure times, and a total of 1337 colonoscopies were examined.  The average withdrawal time was 6.15 minutes without polyps and 8.75 minutes with polyps or biopsies.  This did fall into the lower range of what had been recommended, suggesting a high level of quality regarding colonoscopic evaluations in this community.

Link to full Colonic Withdrawal Abstract Presentation Poster

Microscopic Colitis:
Microscopic Colitis is a relatively new type of colitis, recognized since the 1980’s as a form of microscopic inflammation, which causes chronic diarrhea. All stool studies, labs and x-rays are usually normal. Even the Colonoscopy appears normal, and only if biopsies are taken and examined under the microscope can the diagnosis be made. There are 2 types that we find: (1) Lymphatic colitis (equal in men and women) and (2) Collagenous colitis (5:1, female: male ratio). Sometimes a single individual has both types.

Patients usually have non-bloody diarrhea with stools ranging from less than or equal to 3/day (33%), to 4-9/day (52%) and more than 10/day (15%). In our study 47% of cases began suddenly and 53% insidiously. 66% of patients had only one episode of colitis, whereas 34% had either recurrent bouts or chronic symptoms. This is in contrast to other studies that showed few single episodes, and mostly chronic intermittent problems. 10% of our patients had concomitant celiac disease.

Treatments can include antibiotics such as Azulfidine & Flagyl, Lomotil/Immodium, and steroids, which were the most effective (Prednisone, Entocort).

As opposed to other studies we found only about 22% had abdominal pain or weight loss.

In summary, microscopic colitis, primarily a disease of middle aged women, can begin suddenly or insidiously, with the majority improving within 2 months. Some will have chronic or recurrent diarrhea and require ongoing therapy, the most successful being low dose Prednisone. The overall number of cases is still small and it appears to still lag far behind the frequency of ulcerative colitis.

In our study, we had a total of 39 patients with microscopic colitis over the past 10 years. 78% female and 22% male.  There were equal numbers of males and females with Lymphocytic colitis, but 5 times as many females had Collagenous colitis.

Colon polyps, colon cancer, and colonoscopy in the community:
We studied patients in our practice and found that men and women equally produced polyps and cancer. Most cancers are in the left colon. 35% of patients made polyps. There was a higher chanced of polyps if there was a family history of colon cancer. 22% of colon cancers were in patients under age 50. And 18% were between 50-55 years old. 5% of patients developed colon cancer within 3 years. 10% of patients who have colon cancer can get a recurrence within four years of their surgery. We advocate screening colonoscopy at age 50. If there is a family history of colon cancer, you should begin by age 40-45.

Link to full Colonoscopy Abstract

Link to full Colon Cancer Abstract

Barrett’s Esophagus In Our Community Over the Past 12 Years:
We found a very low incidence of cancer associated with long standing Barrett’s Esophagus with only 0.5% incidence per year. Low grade dysplasia returned to benign tissue 93% of the time. 70% of patients were men, 30% women. Most all of the patients who did develop cancer had the new onset of symptoms of difficulty swallowing, heartburn or chest pain while on appropriate medication. Current recommendations are for endoscopy every 3 years.

Link to the full Abstract

View the Abstract presentation

GI News

Current Ongoing Studies:
1. The Prevalence of Barrett’s Esophagus in the Community.  We feel that the prevalence in texts are overstated, and will try to establish the number of people we can expect to find in a community population with this condition.
2. A study to see if there is any association between ischemic bowel disease and irritable bowel syndrome (IBS), as has been suggested by some doctors.
3. A study on the value of endoscopic procedures in diagnosing the cause of microcytic anemia and normocytic anemia.
4. Continuing to collect data on Microscopic Colitis in a prospective fashion.
5. Prevalence of Celiac disease in the Orlando Community.
6. Endoscopic ultrasound findings in clinical community practice.
7. Comparative incidence rates of Microscopic Colitis vs. Ulcerative Colitis. 
8. Annual prevalence of Barrett's Esophagus in the Orlando Community.
9. Small bowel endoscopic findings in the Community: Does it alter medical therapy?
10. The diagnostic yield of small bowel x-rays in the community setting.
11. The value of small bowel series in the work up of hemoccult positive stools and anemia.

"Rapidly Rising Prevalence of Microscopic Colitis"
This study, over the past 15 years, revealed a sharp rise in the number of cases of Microcopic colitis since 2004. It is still relatively rare, but it has now significantly exceeded the number of cases of Crohn's disease and Ulcerative colitis that we see. We are the first to report this observation, and will keep a vigilant eye for further developments. This is now the most common (of the unusual) causes of diarrhea, excluding bacterial and viral diseases.

"Does the Timing of Laxatives Make a Difference in Colonoscopy Prep Outcomes?"
This study revealed that by starting the preparation late in the afternoon, as opposed to the morning, the patients had much cleaner colons and that means a better exam. They likely spent more time drinking fluids all day. That helped hydrate the colon. Also, patients did not have to miss much work. They only had to get home by 5pm the day prior to the procedure, helping them to avoid the costs of lost wages and the costs to their companies of an absent employee.

"Prevalence of Barrett's Esophagus among Symptomatic Patients in a Community GI Practice"
This study revealed a much lower prevalence (or cases of Barrett's per year) than was previously thought. There is not much community data available in general and less in this country. We are the first community report on these figures. Fewer than 0.5% of patients had a long segment Barrett's, and 1% of patients had a short segment Barrett's Esophagus.

"The Risk of Colorectal Cancer in Ulcerative Colitis in a Population-Based Setting"
This editorial in the journal Gastroenterology reviewed our findings of extremely low incidence of cancer, even in patients with long standing Ulcerative Colitis. This reflects our experience over the past 15 years. There is likewise a very low incidence of any type of dysplasia that has been found on surveillance biopsies. This may be due to changes in the disease process itself, or due in part to the better chronic medical treatment most patients receive. In either case this is excellent news for our patients.

Gastro Group Studies The Time for Colonoscopy Evaluation in Community
“Observed Colonoscopic Withdrawal Time From the Cecum to the Anus in a Community Setting,” accepted for poster presentation at the 70th Annual Scientific Meeting 10/05 in Honolulu, Hawaii.

Gastro Group Studies the Terminal Ileum
”Endoscopic Appearance of the Terminal Ileum in 100 Normal Patients” accepted for poster presentation at the 70th Annual Scientific Meeting 10/05 in Honolulu, Hawaii.

Virtual Colonoscopy
The examination of the colon via a specific type of CT Scan is known as Virtual Colonoscopy.  It has been studied for the past 8-9 years, and only recently have we received some exciting study reports that have shown it to have promise as a screening test for colon polyps.

This test requires the patient to take a full colonoscopy  preparation (laxatives), then take a CT Scan (radiation) and have air pushed into the colon through the rectum during the x-ray.  This is done without sedation and the air may cause abdominal cramping.  If polyps are suspected, the patient is referred for colonoscopy, and polyp removal. 

The current problems with Virtual Colonoscopy are that:  1) It may miss polyps smaller than 1cm, but they are rarely ever malignant);  2) It may think a polyp is present, when in fact there are none;  3) There are very few radiologists who currently have any training in this procedure; 4) It is not covered by insurance companies;  5) It takes the radiologist too long to read the study at the present time.

In the future, Virtual (or CT) Colography will likely be one option for those who pursue screening colonoscopy.  That would include all those over 50 years of age without any rectal, colonic or gastrointestinal problems.  If symptoms of bleeding, diarrhea, constipation or abdominal pain were present, colonoscopy would be the choice test.  Hopefully, the kinks will be worked out soon, and Virtual Colonoscopy will be in general use before the year 2008.

Gastro Group Studies Microscopic Colitis
Microscopic Colitis is a cause for diarrhea in adults and is becoming more common over the past decade. Little is known about this, and less about what causes it. We studied our patient population and only found 28 patients, (78% women) who had this disease. 10% of these patients also had Celiac Sprue.

Gastro Group Studies Gastric Cancer
Gastric Cancer is said to be caused by H. Pylori bacteria in many parts of the world. A study by our group showed that only 12% of our patients with cancer had H. Pylori on biopsy of the stomach. This suggests that H. Pylori may not be a carcinogen as suspected by some.

Gastro Group completes study on Colon Cancer in the Community
We presented our abstract on Colon Cancer in the Community – Occurrence, Recurrence and Characteristics in a One Year Review, at the American College of Gastroenterology National Meeting on October 31, 2004, at the Gaylord Palms Convention Center in Orlando, Florida.

Gastro Group completes study on Barrett's Esophagus
Barrett’s Esophagus- A 12-year study of the incidence of adenocarcinoma and dysplasia in our patient population here in Orlando. We found only a 0.5% incidence of adenocarcinoma in patients who have Barrett’s Esophagus, which is consistent with the most recent national studies. We presented this data at the American College of Gastroenterology in Baltimore on November 3, 2003.

Gastro Group completes study on Colonoscopy in the Community
We have just completed a study on Colonoscopy in the Community—a review of findings of colon polyps, colon cancer, and the relationship of family history to these conditions. We found that 10% of patients who had colon cancer had a recurrence within four years of their surgery. We therefore recommend annual colonoscopy for the first five years after colon cancer is diagnosed.