LAUSR

75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 Bshows a chronic relapsing and remitting course with medical intractability in a substantial proportion of patients, various types of alternative medicines have been tried for treating IBD. Herbal medicine or phytotherapy is one form of alternative medicine that has been practiced for centuries, particularly in traditional Chinese medicine. Complementary and alternative medicine have been reported to be used by 30% to 50% of patients with IBD. To date, there have been several placebo-controlled trials that have evaluated the efficacy of alternative medicinal agents such as marijuana, curcumin, aloe vera, extracts of Andrographis paniculata, and wheat grass juice (Triticum aestivum) for patients with IBD. Positive results have been observed in oral curcumin, paniculata extracts, and wheat grass juice treatments for patients with active ulcerative colitis (UC; Table 1). However, most studies have small to modest sample sizes and the use of alternative strategies are still limited owing to uncertain dosing and safety issues. Indigo naturalis (also referred to as Qing-Dai) is an herbal preparation extracted from leaves and stems of Baphicacanthus cusia (Nees) Bremek that has been used as a blue dye since ancient times. Indigo naturalis has also been used as an antipyretic, an antiphlogistic, and as a hemostatic remedy for centuries in traditional Chinese medicine. For specific diseases, it was reported to be efficacious for psoriasis and chronic hemorrhagic radiation proctitis in studies from China and Taiwan. For the treatment of IBD, a previous retrospective case series of 9 patients and an open-label, prospective pilot study of 20 patients suggested the efficacy of oral indigo naturalis for inducing remission in active UC. Based on those encouraging results, in this issue of Gastroenterology, Naganuma et al reported results from the first randomized, controlled trial to investigate the safety and efficacy of indigo naturalis in patients with moderate to severe UC. In this study, a total of 86 subjects were randomly assigned to groups given a daily dose of 0.5, 1.0, or 2.0 g indigo naturalis or placebo (1:1:1:1 ratio) for 8 weeks. The primary endpoint was clinical response at week 8 and secondary endpoints included clinical remission, endoscopic remission, and levels of quantitative fecal blood test and fecal calprotectin at week 8. However, the trial was early terminated owing to an external reason: the report of a possible adverse event of pulmonary arterial hypertension (PAH) in a patient with UC