A daily enema containing cannabidiol (CBD) and sodium propionate was associated with significant reductions in disease activity, pain and other symptoms among patients with treatment-resistant ulcerative proctitis, according to a newly published pilot study (PDF).
The research, published in Inflammatory Intestinal Diseases, examined IcBD-01, an experimental formulation designed to provide localized anti-inflammatory effects while limiting systemic exposure.
Researchers from Meir Medical Center, Tel Aviv University and CannaMore in Israel enrolled 14 adults with mild to moderate ulcerative proctitis who had failed to adequately respond to at least three months of mesalamine treatment. Participants self-administered the enema once daily for 12 weeks. Each 50-milliliter dose contained 60 milligrams of synthetic CBD and 70 milligrams of sodium propionate.
Nine participants completed the full 12-week study, while 10 received treatment for at least 10 weeks.
Among all 14 participants, 50% achieved the study’s primary endpoint, defined as at least a three-point reduction in the Mayo score, a measure commonly used to assess ulcerative colitis activity. Among the nine participants who completed the entire study, 77% reached that endpoint.
The average full Mayo score among study completers fell from 6.8 at baseline to 3.0 after treatment, a statistically significant improvement. Five of the nine participants, or 55.6%, had a Mayo score below two at the end of treatment, which researchers classified as clinical remission.
Researchers also reported significant improvements in stool frequency, rectal bleeding and endoscopic appearance. Average pain scores fell from 3.8 at screening to 1.2 by the end of the study.
Endoscopic examinations found that the average length of ulcerated colon declined from 16.4 centimeters to 11.7 centimeters among the nine participants evaluated both before and after treatment. Three showed either complete mucosal healing or only minimal residual inflammation.
The treatment was generally well tolerated. Researchers reported 18 adverse events, with two considered possibly treatment-related. No treatment-related serious adverse events were reported.
However, researchers found no statistically significant improvement in the Nancy histological index or fecal calprotectin, a marker of intestinal inflammation.
The authors cautioned that the study was small, open-label and lacked a placebo or comparison group, meaning the results cannot establish that the CBD formulation caused the improvements. They said larger randomized, placebo-controlled trials are needed.
The study was funded by CannaMore Biotechs, and one of the authors is an employee of the company. The researchers said data collection and analysis were conducted independently.
