As mentioned, between 12 and 19% of Americans have experienced chronic constipation and persons with chronic constipation generally have fewer than three bowel movements a week, and the bowel movements they have may be hard, lumpy and difficult to pass.
To be classified as chronic, these difficulties generally have to occur for at least three months, and most of the people enrolled in the trials had experienced chronic constipation for years. The goal of the study was three or more spontaneous bowel movements a week.
For the 145 microgram dose, the researchers found that 21.2% in the first trial and 16% of people in the second achieved the goal. For the higher 290 microgram dose, the results were 19.4% and 21.3% respectively. Only 3.3% and 6% of those on the placebo met the study's goal.
In addition to achieving the study goal, the drug helped reduce abdominal discomfort, bloating, and the severity of constipation, according to the researchers. Between 57 and 65% of the study's participants said they were "quite or very likely" to continue the treatment at the end of the study.
Dr. Anthony J. Lembo, an associate professor of medicine at Harvard Medical School and director of the GI Motility Center at Beth Israel Deaconess Medical Center in Boston stated:
"People who received the drug had improvement in symptoms, and the treatment was generally well-tolerated. Chronic constipation is a pretty heterogeneous disorder with different causes. Some cases are related to pelvic floor issues, where the rectal area doesn't relax properly, and I wouldn't expect this medication to be very effective for that type of disorder."
The most significant side effect experienced was diarrhea, according to Lembo. About 14 to 16% of people had diarrhea, but Lembo said that only around 4 percent dropped out due to that side effect.
Linaclotide's main mechanism of action is to stimulate intestinal secretions, which wouldn't have an effect on rectal muscles. Lembo said the researchers tried to exclude people with constipation related to pelvic floor issues, but that these issues haven't always been diagnosed.
Roshini Rajapaksa, a gastroenterologist at New York University Langone Medical Center in New York City adds:
"People who suffer from chronic constipation or irritable bowel syndrome with constipation do need more medication choices. Even though linaclotide was an improvement, only one in five people would have a result. This is probably something we would offer if other options had failed."
Before turning to meds, one might want to add more exercise, water and fiber in their diet. However, don't add fiber to your diet too quickly, because too much fiber too soon can cause gas and bloating, and may even worsen constipation.
Written by Sy Kraft