Novel Treatments Relieve Constipation, IBS in Women

WASHINGTON, D.C. -- Three new therapy options, including two novel medications, showed promise in the treatment of irritable bowel syndrome (IBS), according to research presented at Digestive Disease Week® 2007 (DDW®). Participants in the studies who received one of the two investigational medications experienced significant relief in constipation, while a third study demonstrated the benefits of hypnotherapy in treating bowel and abdominal complications in children. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"With few successful treatment options currently available for IBS sufferers, these studies represent promising progress in the treatment of this and other bowel disorders," said María Abreu, MD, director, Inflammatory Bowel Disease Center, associate professor of medicine, Mount Sinai School of Medicine.

Lubiprostone Significantly Improves Symptom Relief Rates in Adults with Irritable Bowel Syndrome and Constipation (IBS-C): Data from Two, Twelve-week, Randomized, Placebo-Controlled, Double-blind Trials (Abstract #639f)
Lubiprostone is a novel therapy indicated for treatment of chronic idiopathic constipation in adults. Two twelve-week, independent studies showed patients who received lubiprostone were nearly twice as likely as those who did not receive the treatment to report moderate or significant relief of IBS symptoms. Endpoints included abdominal discomfort, stool consistency, straining and others. Lubiprostone was also well-tolerated, with only one percent of patients experiencing serious adverse events and only 22 percent of patients experiencing related adverse events, compared with 21 percent of patients on placebo.

The studies included more than 1,100 patients, most of whom were female (91.6 percent) and aged 18-65 years (91.7 percent). Participants were given either lubiprostone or placebo for 12 weeks and asked to rate their IBS symptoms. To be considered a monthly responder, patients had to report moderate relief four out of four weeks or significant relief two out of four weeks. Overall responders were defined as those who had been monthly responders two out of three months.

"The lubiprostone study demonstrates the continuing need for new and emerging therapies for IBS, especially for women," said Douglas A. Drossman, MD, co-director, University of North Carolina Center for Functional Gastrointestinal and Motility Disorders in Chapel Hill, N.C., and lead author of the study. "We believe more research needs to be done to better determine lubiprostone's benefits and tolerability, but this study suggests people suffering from IBS and constipation may soon have another option for relief."

Effects of Novel, First-in-Class Guanylate Cyclase-C Activator, Linaclotide Acetate (MD-1100), on Gastrointestinal and Colonic Transit and Bowel Habits in Patients with Constipation-Predominant Irritable Bowel Syndrome (C-IBS) (Abstract #532)
Researchers are continually looking for unique pathways to treat digestive diseases, such as constipation and irritable bowel syndrome. Linaclotide is a novel therapy that works on a transmembrane protein in the lining of the gut called guanylate cyclase-C (GC-C). Specific gut hormones utilize GC-C to regulate intestinal fluid secretion. Linaclotide is unique in that it exerts its effect locally in the intestine while having minimal systemic exposure.

Thirty-six women suffering from IBS with constipation (IBS-C) were examined in a double-blind, placebo-controlled study, which consisted of a five-day baseline and a five-day treatment period. The endpoints were gastrointestinal transit and bowel function. Patients who received linaclotide experienced a significant acceleration of ascending colon emptying and overall colonic transit as well as a significant improvement in stool consistency, stool frequency, ease of passage and time to first bowel movement. The degree to which stool was loosened was strongly dependent on the dosage of linaclotide administered.

"Among the study participants, linaclotide was able to improve a range of bowel functions, which are typically impaired in patients with IBS-C," said Viola Andresen, MD, of Mayo Clinic in Rochester, Minn., and lead author of this study. "Clearly, additional studies are warranted, but we remain optimistic that this treatment may hold promise for people with constipation-predominant IBS."

Hypnotherapy for Children with Functional Abdominal Pain or Irritable Bowel Syndrome: a Randomized Controlled Trial (Abstract #914)
As hypnotherapy has demonstrated effectiveness in adults with IBS, researchers sought to compare its effects in children to standard medical therapy commonly used for the condition as an alternative to drug therapy.

The study involved 53 patients between eight and 18 years old with FAP or IBS, who were administered six half-hour hypnotherapy sessions over a three-month period. Endpoints were pain intensity, pain frequency and other symptoms, such as nausea, headache and appetite, which were recorded at baseline, one, two, and three months after randomization and six and 12 months after therapy. Researchers defined "cure" as those who experienced greater than 80 percent improvement in pain.

The study revealed that hypnotherapy was superior to conventional therapy for children with longstanding functional abdominal pain (FAP) or IBS, curing 59 percent of the patients, versus just 12 percent of patients who received conventional therapy. After one year, the figures were 85 percent and 25 percent, respectively. Patients who received hypnotherapy also experienced less pain after treatment compared to the group that received conventional therapy.

"Our team was pleased to learn that the demonstrated benefits of hypnotherapy on IBS complications appear to be translatable to children," said Arine M. Vlieger, MD, PhD, of St. Antonius Hospital in Nieuwegein, Netherlands, and lead author of the study. "Hopefully, these findings will be confirmed with additional research so that more children can experience relief from the symptoms of IBS without adherence to a medication regimen."

Source: American Gastroenterological Association

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