This monumental study is the first to use an abdominal score assessment in irritable bowel syndrome with predominantly constipation. Those with IBS-C have been found to have more severe abdominal pain than IBS alone, along with more bloating and general discomfort. The goal of this study was to assess abdominal scores before, during, and after using FDA approved Linaclotide (Linzess) versus placebo. Using an 11-point scale, patients’ change from baseline was -1.9 for those using linaclotide, whereas the placebos group was -1.2.
For many patients with IBS-C there is a gap in communication in symptoms and severity. They may be telling their doctor that they are suffering from constipation, but leave out details like bloating, pain, and discomfort. This can often slow the diagnosis process as the doctor may just treat constipation without realizing the patient is suffering from IBS-C. It may be uncomfortable, but the more specific information you can give, the better and more correct your treatment can be. This is another reason this study is so important. By assessing IBS-C on an abdominal pain scale, patients were able to quantitate their symptoms and see improvement or reassess. Â
At 12 weeks participants’ using Linaclotide had scores change from baseline at -2.35, where the placebo group was at -1.48. 40.5% of the Linaclotide group were also able to achieve a 2-point decrease on the scale for at least 6 of the 12 weeks. The placebo group on the other hand was at only 23.4%. No participants showed any worsening of symptoms after the trial, but 31% of the Linaclotide group did report the adverse event of diarrhea. Those in the placebo reported the same adverse effect, but at a slightly lower rate of 26.6%. Lin Chang, MD, of the University of California Los Angeles, and colleagues noted “Linaclotide was associated with significant reductions in individual abdominal bloating, discomfort, and pain symptoms vs placebo in the first week, followed by progressive reductions through 12 weeks of the treatment period and sustained in the linaclotide-treated patients who continued on linaclotide through week 16.”Â
Linaclotide works by increasing luminal secretion which results in improved bowel movement as well as stool formation. It was approved by the FDA in 2012 for chronic idiopathic constipation which is a subtype of IBS. This particular subtype is characterized by constipation and abdominal pain. Researchers added that this drug was approved on endpoint improvements in pain and spontaneous bowel movements. Furthermore, baseline abdominal scores averaged 6 out of 11, with stool scores at 2 out of 7, and constipation severity at 3.5 out of 5. The endpoint of combined abdominal scores for pain and constipation was better in the Linaclotide group at 29.4% and 16.9% for the placebo.Â
Researchers hope that the findings of this study will prompt more in-depth conversations between patients with IBS-C and their doctors, as well as potential ways to manage them including Linaclotide as a treatment option. The way in which a quantitative scale was used to assess symptoms in IBS-C is monumental, as it had not been done before. Studies on IBD frequently use a similar scale, but this is a new way to assess symptoms for those with IBS. The authors of this particular study are hopeful that other IBS studies will follow in their footsteps, and scaling of symptoms will become the norm for those suffering from any type of IBS. With these promising results it may become just that.
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