Comparison of <i>Xilei-san</i>, a Chinese Herbal Medicine, and Dexamethasone in Mild/Moderate Ulcerative Proctitis: A Double-Blind Randomized Clinical Trial

Zhang, Fangbin; Li, Ya; Xu, Feng; Chu, Yanqi; Zhao, Wugan

doi:10.1089/acm.2012.0296

Cited by 28 publications

(19 citation statements)

References 10 publications

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“…After 6 months, the rate of recurrence was lower in the group of Xilei-San (Xilei-San 18.2% vs. placebo 83.3%, p < 0.001) [25] . In another randomized, double-blinded study that compared Xilei-San with dexamethasone enemas, a similarly significant clinical, histological and endoscopic response compared with the baseline in the 2 groups was achieved [26] . Importantly, no significant adverse side effects were observed in either study [25,26] .…”

Section: Discussionmentioning

confidence: 84%

“…In another randomized, double-blinded study that compared Xilei-San with dexamethasone enemas, a similarly significant clinical, histological and endoscopic response compared with the baseline in the 2 groups was achieved [26] . Importantly, no significant adverse side effects were observed in either study [25,26] . In the dextran sulfate sodium-induced colitis rat model, topical treatment with Xilei-San attenuates colitis by degrading proinflammatory mediators and promoting mucosal repair [29] .…”

Section: Discussionmentioning

confidence: 84%

“…In Japan, Suzuki et al [20] have reported that Qing-Dai is clinically efficacious and safe in treating UC patients, although the data collected were retrospective in nature. Additional reports have been published on the Chinese herbal medicine Xilei-San [24][25][26] , Kui Jie Qing enema [27] and Fufangkushen colon-coated capsules [28] . These treatments are multiple herbal formulas that partly contain Qing-Dai.…”

Section: Discussionmentioning

confidence: 99%

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

Sugimoto¹,

Naganuma²,

Kiyohara³

et al. 2016

Digestion

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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.

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Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 99%

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

Sugimoto¹,

Naganuma²,

Kiyohara³

et al. 2016

Digestion

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“…Some examples are discussed here. In double-blind, randomised studies, Xilei-san (a traditional Chinese herbal medicine) suppositories were shown to be superior to placebo [41] and comparable to dexamethasone enemas [42] in proctitis. Curcumin is the active ingredient of turmeric and has been shown to have anti-inflammatory properties in experimental models of colitis.…”

Section: Proctitismentioning

confidence: 99%

Managing Intractable Proctitis and the Problematic Pouch

Kent

Keshav²

2014

Dig Dis

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Proctitis accounts for a significant proportion of cases of ulcerative colitis (UC), and some patients subsequently develop more extensive disease. However, most patients continue to have limited inflammation, although the changes in the distal colon and rectum can occasionally be severe, and symptoms of increased frequency, rectal bleeding and urgency can be as disabling as they are for patients with more extensive colitis. Furthermore, although symptoms are typically well controlled with standard medications, medically refractory proctitis poses particular problems. Patients generally are not systemically unwell, and there is no added fear of cancer. Therefore, the prospect of colectomy for such limited disease is resisted by patients, physicians and surgeons alike. Unusual therapies, often delivered locally by enema or suppository, have been tested in small case series without definitive outcomes. The pathogenesis of such limited, yet intractable inflammation remains unclear, and the differential diagnosis should be carefully reviewed to ensure that local disease, whether it is infectious, vascular, or a result of injury or degeneration, is not overlooked. Ileo-anal pouch formation is the surgery of choice for about 20% of patients with UC who undergo colectomy. In the majority of cases, this surgery results in an acceptable quality of life and freedom from a stoma. However, in a sizeable minority of cases, pouch dysfunction can cause intractable problems. The causes of pouch dysfunction are varied and must all be considered carefully, particularly in refractory cases. Pouchitis is a common issue and is usually transient and easily treated. However, refractory and chronic pouchitis can be challenging. Ischaemia, injury, infection and Crohn's disease can all cause refractory pouch dysfunction. In a minority of cases, there appears to be no apparent organic pathology, and the presumptive diagnosis is that of a functional pouch disorder. Although it is much rarer, neoplastic changes in the pouch must also be considered, and the risk managed appropriately. The management of both intractable proctitis and the problematic pouch is made more challenging by the wide differential diagnosis that must be considered and by the paucity of high-quality clinical trials to support any one therapy. Key strategies to overcoming these limitations include methodical and systematic investigation and review, and a willingness to tailor therapy to the individual patient. Clinical trials of new treatments should be supported, and data from the experience with small cohorts of patients should be meticulously collected, critically analysed and widely disseminated.

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“…In China, XLS is traditionally used in disorders that feature erosion or ulceration of mucosa or skin, including oral ulcer, esophagitis, erosive gastritis, peptic ulcer, chronic cervicitis, and UC [6–12]. Although a few studies have investigated the mechanism of action of XLS in an animal model [11], the exact pharmacological steps of XLS in UC have never been fully elucidated.…”

Section: Introductionmentioning

confidence: 99%

Xilei San Ameliorates Experimental Colitis in Rats by Selectively Degrading Proinflammatory Mediators and Promoting Mucosal Repair

Hao

Nagase

Hori

et al. 2014

Evidence-Based Complementary and Alternative Medicine

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Xilei san (XLS), a herbal preparation widely used in China for erosive and ulcerative diseases, has been shown to be effective in ulcerative colitis (UC). The present experiments were conducted to assess its efficacy and determine its mechanism of action in a rat model that resembles human UC. The model was induced by adding 4% dextran sulfate sodium (DSS) to the rats' drinking water for 7 days. XLS was administered daily by retention enema from day 2 to day 7; the rats were sacrificed on day 8. The colon tissues were obtained for further experiments. A histological damage score and the activity of tissue myeloperoxidase were used to evaluate the severity of the colitis. The colonic cytokine levels were detected in a suspension array, and epithelial proliferation was assessed using Ki-67 immunohistochemistry. Intrarectal administration of XLS attenuated the DSS-induced colitis, as evidenced by a reduction in both the histological damage score and myeloperoxidase activity. It also decreased the levels of proinflammatory cytokines, but increased the mucosal repair-related cytokines. In addition, the epithelial Ki-67 expression was upregulated by XLS. These results suggest that XLS attenuates DSS-induced colitis by degrading proinflammatory mediators and promoting mucosal repair. XLS could be a potential topical treatment for human UC.

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Comparison of Xilei-san, a Chinese Herbal Medicine, and Dexamethasone in Mild/Moderate Ulcerative Proctitis: A Double-Blind Randomized Clinical Trial

Abstract: Xilei-san enemas are comparable to dexamethasone enemas in this study. This medicine is safe, well accepted, and may be an alternative drug in the treatment of mild-to-moderate active UP.

Cited by 28 publications

References 10 publications

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

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

Managing Intractable Proctitis and the Problematic Pouch

Xilei San Ameliorates Experimental Colitis in Rats by Selectively Degrading Proinflammatory Mediators and Promoting Mucosal Repair

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