Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study

Abstract

Background/Aims: Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. Methods: The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. Results: At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. Conclusion: This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted.

Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial

“…Sugimoto et al used the Chinese herbal medicine Qing-Dai to treat 20 patients with moderate ulcerative colitis. The rates of clinical response, clinical remission, and mucosal healing were 72%, 33%, and 61% at week 8, respectively [24]. Qing-Dai stimulates mucosal type 3 innate lymphoid cells to generate interleukin-22, which induces antimicrobial peptide and tight junction production, suggesting a therapeutic mechanism for mucosal healing [25].…”

Indigo Naturalis Ameliorates Oxazolone-Induced Dermatitis but Aggravates Colitis by Changing the Composition of Gut Microflora

“…Increased levels of IL-13 have been proven to exist in the intestines of UC patients [26,37]. Therefore, the amelioration of UC symptoms by IND reported by 2 clinical studies [1,13] may be by this mechanism. Furthermore, we have also confirmed that IND reduces free radicals (online suppl.…”

“…The bacterial DNA content was extracted using a PowerFecal™ DNA isolation kit (MO BIO; Carlsbad, CA, USA). For 2-step PCR amplification, the bacterial V4 variable region of the 16S rRNA gene was amplified with primers containing Illumina adapter overhang nucleotide sequences (Illumina; San Diego, CA, USA), followed by amplification with barcoded primers [13]. The DNA concentration of each sample was measured using Qubit® and a dsDNA HS assay kit (Invitrogen; Carlsbad, CA, USA).…”

“…Despite the lack of English-language reports demonstrating clinical efficacy, the official indication of IND for UC in China and its reputation have caught the attention of Japanese gastroenterologists. Consequently, 2 recent clinical papers from Japan have documented a promising efficacy of IND for the treatment of UC [1,13]. …”

Recent trends and future directions for the medical treatment of ulcerative colitis

“…Previously, the usefulness of Qing-Dai for UC was reported [63,64]; however, no prospective clinical trial had been conducted. Recently, we conducted a prospective study to confirm the safety and efficacy of Qing-Dai for UC [65]. Patients received QingDai twice a day (daily dose, 2 g) for 8 weeks.…”