Herbal combo regimen shows promise for ulcerative colitis

A combination regimen comprising two herbal extracts – curcumin and Qing Dai (QD) – have shown potential in the treatment of active* ulcerative colitis (UC), according to two trials from Israel presented at Crohn’s & Colitis Congress (CCC) 2023.

Fifty-nine patients were enrolled in a two-part trial. Part 1 was an open-label study evaluating the effect of curcumin-QD for 4 weeks. In part 2, 42 participants were randomized 2:1 to either curcumin-QD 3 g daily or placebo for 8 weeks. Treatment responders continued either curcumin alone or placebo for 8 more weeks as maintenance treatment. [CCC 2023, abstract P032]

Of the seven participants who exhibited a treatment response in part 1, three achieved clinical remission (SCCAI** ≤2).

In part 2, nearly half of participants (43 percent) on curcumin-QD achieved the coprimary endpoints of clinical response (≥3-point improvement in SCCAI) and an objective evidence*** of response at week 8. This was more than fivefold higher than placebo recipients who achieved this outcome (8 percent). A comparison between arms yielded a p value of 0.033.

Curcumin-QD also trumped placebo in terms of the fractions of participants achieving clinical response (86 percent vs 31 percent; p<0.001), 50-percent reduction in calprotectin (46 percent vs 15 percent; p=0.08), and endoscopic improvement (75 percent vs 20 percent; p=0.03).

Among responders who were treated for 8 more weeks, 93, 80, and 40 percent maintained clinical response, clinical remission, and clinic-biomarker response, respectively, at week 16.

The overall incidence of adverse events (AEs) was comparable between arms.

This study showed that curcumin-QD was effective for inducing clinical response and remission in active UC patients, according to the investigators led by Professor Shomron Ben-Horin from Sheba Medical Centre, Tel Aviv, Israel.

Of note was the AhR^# pathway activation in curcumin-QD recipients, owing to the upregulated expression of CYP1A1 in the rectal mucosa. “[This] was not observed in patients receiving placebo nor was it observed in patients responding to 5ASA^## or biologic drugs,” the investigators noted. “Induction of AhR may merit further study as potential treatment target in active UC.”

In another study, 82 patients with active UC (median age 32 years, 57 percent female) were retrospectively evaluated. Most patients had pancolitis (44 percent) while 36 percent had left-sided colitis. The rest were reported to have proctitis. Ninety-five percent of participants were initiated on curcumin-QD. [CCC 2023, abstract P045]

At treatment onset, 42 percent of participants were on corticosteroids while a third were being treated with a biologic or small molecule. About 15 percent failed treatment with ≥3 biologics or small molecules.

At end of induction, 78 percent responded to treatment. Of these, 64 percent achieved clinical remission.

End of induction also saw improvements in baseline median SCCAI (from 6 to 2; p<0.001) and median endoscopic Mayo score (from 2 to 1; p=0.03). Other parameters that improved between baseline and end of induction were median C-reactive protein (from 5 to 2 mg/L; p=0.003) and faecal calprotectin levels (from 698 to 75 mg/g; p<0.001).

The only AEs reported were headaches (n=2) and mild liver function elevations (n=5), which resolved either spontaneously or after QD withdrawal.

“[Our findings show that] QD treatment (predominantly as a combination with curcumin) was effective for induction of clinical response and remission in active UC patients, including biologic-experienced patients,” said the researchers led by Professor Uri Kopylov, also from Sheba Medical Center.

Taking the results of both studies into context, these findings underline the potential of the curcumin-QD combination as a plant-based alternative for the treatment of active UC.