|Date: 05-31-2017||HC# 111635-569|
Pellegrini L, Milano E, Franceschi F, et al. Managing ulcerative colitis in remission phase: usefulness of Casperome®, an innovative lecithin-based delivery system of Boswellia serrata extract. Eur Rev Med Pharmacol Sci. 2016;20(12):2695-2700.
Ulcerative colitis (UC), an inflammatory bowel disease, is characterized by various symptoms depending on the severity of inflammation and its location. Therapies range from topical therapy with 5-aminosalicylic acid (5-ASA) to treat active proctitis to topical and oral aminosalicylates for mild-to-moderate left-sided colitis and hospitalization and systemic therapy for severe left-sided colitis. The goal of treatment is to induce and maintain a remission phase and prevent disease- and treatment-related complications. For remission maintenance, the first-line therapy is 5-ASA administered orally or rectally. For mild cases of the disease, the benefits of long-term maintenance treatment are less certain. Herbal remedies could help manage mild UC during remission. Oleo-gum-resins from frankincense (Boswellia serrata, Burseraceae) have been used traditionally in India and Africa to treat various inflammatory diseases. The goal of this open-label, observational, registry study was to evaluate the efficacy of Casperome® (Indena SpA; Milan, Italy), a standardized frankincense extract, in patients with minimally symptomatic UC in remission phase.
Casperome is a lecithin-based delivery form of a highly purified standardized extract from the gum resin of frankincense and soy (Glycine max, Fabaceae) lecithin in a 1:1 ratio formulated with Phytosome® (Indena SpA; Milan, Italy) technology, which enhances absorption. It is standardized to contain ≥ 25% of triterpenoid acids.
The study, conducted in Italy, included 43 patients with clinically evaluated and confirmed UC who had been in remission for at least 1 year. Their symptoms were minimal, and they were not using any medications. The patients chose to receive the oral daily Casperome supplementation (n=22) or no supplementation (control group, n=21). The patients in the treatment group consumed one 250-mg Casperome tablet daily for 4 weeks.
At baseline and after 4 weeks, the following parameters were assessed: intestinal pain (ranging from no pain at 1 to continuous, severe pain at 5); bloody diarrhea, as number of episodes weekly; evacuation with blood and mucus, as episodes weekly; bowel movements, as episodes daily; intestinal cramps; suspected rectal involvement; watery stools; malaise; anemia; body weight; white blood cell count; need for specific drugs; and need of medical attention or hospitalization. A fecal immunochemical test was used to detect occult blood in stool samples, which were collected on alternate days. Bowel inflammation was assessed by determining the fecal concentration of calprotectin, an antimicrobial protein released in the intestinal lumen when inflammatory processes are present.
At baseline, all patients were similar in demographics and clinical characteristics. No safety or tolerability issues were observed during the study. Patients who left the study, 5 in the control group and 3 in the treatment group, did not do so for medical problems.
All tested parameters improved significantly after treatment with Casperome. Mild, diffuse intestinal pain and cramps decreased in intensity and frequency in the treatment group compared with the control group and compared with baseline (P<0.05). During the 4 weeks, the episodes of diarrhea, evacuations with blood/mucus, and number of bowel movements decreased in the treatment group compared with baseline and compared with the control group (P<0.05). The number of patients with suspected rectal involvement remained the same in the control group (13 patients) and decreased from 12 to 4 patients in the treatment group during the 4-week study (P<0.05). Anemia improved significantly in the treatment group from baseline to week 4 and compared with the control group (P<0.05).
In the treatment group, occult blood in the stool decreased during the 4 weeks. The number of patients with calprotectin levels in the stool > 100 μg/g totaled 19 (86.4%) in the treatment group and 18 (85.7%) in the control group at baseline. After 4 weeks, that number decreased significantly to 11 (50%) patients in the treatment group compared with 16 (76.2%) patients in the control group (P<0.05). Significant between-group differences were observed for the need for specific drugs (4 patients in the treatment group and 16 patients in the control group) and for the need for medical attention (9 in the control group and 4 in the treatment group) (P<0.05 for both measures).
Long-term treatment with 5-ASA drugs could have potential adverse effects and is costly. The authors conclude, "Despite all the limitations implicit in any observational analysis, our study demonstrated the Casperome®supplementation efficacy in controlling minor symptoms of UC in remission, and in reducing the use of drugs and medical consultation." Larger studies are needed to further evaluate these findings.
Three of the authors (E. Milano, F. Franceschi, and S. Togni) are employees of Indena SpA.—Shari Henson