Researchers at Tel Aviv University note that constipation is the most common digestive health disorder, affecting up to 42 million Americans annually. Symptoms of chronic constipation including pain, bloating, infrequent bowel movements and painful and/or hard stools. Typical treatments include both pharmaceutical and non-prescription laxative agents, and in severe cases, enemas — all of which cause some side-effects to a greater or lesser degree.
However, a new constipation treatment demonstrated in a pilot study by researchers led by Dr. Yishai Ron, MD, director of neurogastroenterology and motility at Tel Aviv Sourasky Medical Center of the Department of Gastroenterology and Hepatology at Tel Aviv University-affiliated Tel Aviv Sourasky Medical Center, utilizes a vibrating pill-size capsule that shows promise for alleviating chronic constipation. The Sourasky Medical Center research team presented their findings last month at the Digestive Disease Week convention in Chicago.
The presentation, entitled “Vibrating Capsule for the Treatment of Chronic Idiopathic Constipation (CIC) and Constipation Predominant Irritable Bowel Syndrome (c-IBS) – Safety and Efficacy Sa2023″ was coauthored by Dr. Ron and Zamir Halpern of The Tel-Aviv Sourasky Medical Center, Rifaat Safadi of the Gastroenterology and Hepatology of the The Holy Family Hospital, at Nazareth, Israel, and Ram Dickman of the The Rabin Medical Center, Petach-Tikva, Israel.
The coauthors note that pharmacologic treatment is the mainstay of treatment for constipation; yet, nearly 50 percent of patients are unsatisfied with the treatment — eighty percent because of inefficacy and 20 percent because of side effects and long term use safety concerns.
Surgery is reserved for extreme refractory cases, and sacral neuro-modulation is still an investigational tool. The Israeli researchers used a recently developed new capsule that is similar in appearance and the way it`s swallowed to the routine well known video capsule (PillCam, Given Imaging), but in this instance its main feature is the ability to vibrate in the colon, with the objective being to explore a new concept of non-pharmacologic treatment of constipation in terms of safety and efficacy. The capsule houses a small engine that is programmed to begin vibrating six to eight hours after ingestion. The mechanical stimulation caused by the pill produces contractions in the intestines, facilitating the movement of stool through the digestive tract. The hope is that this innovative non-drug therapy may offer a solution for anyone who suffers from chronic constipation but who finds laxatives, fiber drinks, enemas and other standard treatments unhelpful or uncomfortable.
Consecutive constipated patients aged 18-70 years, all fulfilling the Rome III criteria for CIC or C-IBS were enrolled in the study. All patients over age 50 underwent colonoscopy in the past 5 years and had normal blood tests at entry. All were pharmacologic treatment failures.
In this open pilot trial, all patients underwent a 2 week run-in period during which they were instructed to stop all laxatives. The capsule was then activated and started vibrating 6 hours after administration in a special mode developed by Vibrant Ltd.
Each patient received 2 capsules per week and filled a daily bowel movement and laxative use questionnaire. On each follow-up visit, expelled capsules were collected and side effects were recorded.
Of the twenty-two patients were originally recruited, two withdrew citing the inconvenience of capsule collection. Twenty patients completed the study and are the research study group (18 women, mean age 48 years, 10 CIC patients).
The researchers report the vibrating capsule was found to nearly double the frequency of weekly spontaneous bowel movements of patients suffering from chronic idiopathic constipation (CIC) and constipation predominant irritable bowel syndrome (C-IBS) from 2.21 to 3.99 per week (p<0.001). The total number of constipation parameters was reduced from 5.25 to 3.2 (p=0.0009). The number of patients requiring “rescue” laxatives more than once was identical during the run-in period and during the study period — numbering three patients. During the treatment period, two patients had minor complaints of abdominal pain, which resolved spontaneously during the study, two patients complained about diarrhea, one about flatulence and one of sensation abdominal wall twitches. No other related side effects were reported.
The coauthors conclude that this study, showed for the first time, that swallowed capsule which vibrates in the colon is safe and it can affect bowel movements in patients with CIC and C-IBS. The next step for Dr. Ron and his team will be to initiate a controlled, double-blind study to expand on these findings and further explore the capsule’s potential.
However, in a report by Gastroenterology & Endoscopy News’s Caroline Helwick, another expert in the field Nicholas J. Talley, MD, PhD, currently Pro Vice-Chancellor, Dean of Health, and Professor of Medicine at the University of Newcastle. Australia, said its not clear why the capsule might help relieve constipation and urges caution without more data.
“How this would work, I don’t know, and I’m not sure the investigators know either. That’s part of the problem,” Dr. Talley told Ms. Helwick. “They say it is mimicking peristalsis, but to be honest, we have no idea.”
Dr. Talley also holds adjunct Professorial appointments at the Mayo Clinic, University of North Carolina and the Karolinska Institute, and was formerly a Professor of Medicine and Professor of Epidemiology in the Mayo Clinic College of Medicine, Rochester, Minnesota and Jacksonville, Florida, as well as formally Chair of the Department of Internal Medicine at Mayo Clinic Florida. His research is primarily focused on functional gastrointestinal disorders, dyspepsia, Helicobacter pylori, gastroesophageal reflux disease, and eosinophilic disorders of the gut.
Dr. Talley and research colleagues recently described a new disease entity in adults, eosinophilic duodenitis, linked to functional dyspepsia, and his group has documented a genetic component in upper and lower functional bowel diseases. He has published over 700 original and review articles in the peer-reviewed literature, and he is considered one of the world’s leading authorities in clinical research on the stomach. He currently has research support as a Chief Investigator from the National Health and Medical Research Council, and has been funded as a Principal Investigator (RO1) by the National Institutes of Health in the USA.
Ms. Helwick says Dr. Ron acknowledges that while the clinical results are favorable, they must be confirmed, and that the U.K. firm Vibrant Medical, which makes the device and supported the study, is planning a multinational, randomized and placebo-controlled trial that will aim to enroll approximately 80 patients.
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Tel Aviv University Sourasky Medical Center
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