Prospective feasibility study of indigo naturalis ointment for chemotherapy-induced oral mucositis
| العنوان: | Prospective feasibility study of indigo naturalis ointment for chemotherapy-induced oral mucositis |
|---|---|
| المؤلفون: | Yuka Yamada, Yasuo Hamamoto, Sara Horie, Hiroshi Muramatsu, Takanori Kanai, Yasutaka Sukawa, Kazuyuki Tsunoda, Kenro Hirata, Makoto Naganuma, Taneaki Nakagawa |
| المصدر: | BMJ Supportive & Palliative Care. :bmjspcare-2021 |
| بيانات النشر: | BMJ, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, Chemotherapy, Oncology (nursing), business.industry, Secondary infection, medicine.medical_treatment, Medicine (miscellaneous), General Medicine, medicine.disease, Placebo, Ulcerative colitis, Medical–Surgical Nursing, Internal medicine, Mucositis, medicine, Clinical endpoint, Antimicrobial peptide production, Adverse effect, business |
| الوصف: | ObjectivesIndigo naturalis, a herbal medicine effective against ulcerative colitis, exhibits anti-inflammatory effects and induces interleukin-22-mediated antimicrobial peptide production. Anti-inflammatory activity and the prevention of secondary infection are essential for the management of chemotherapy-induced oral mucositis (CIOM); therefore, we developed an indigo naturalis ointment to be administered topically for CIOM and evaluated its feasibility.MethodsWe performed a single-centre, open-label, prospective feasibility study from March 2017 to December 2018. The key eligibility criteria for the subjects were as follows: (1) receiving chemotherapy for a malignant tumour; (2) grade 1 or 2 CIOM and (3) receiving continuous oral care. The treatment protocol comprised topical indigo naturalis ointment application three times a day for 7 days. The primary endpoint assessed was feasibility. The secondary endpoints assessed were the changes in oral findings, oral cavity pain and safety.ResultsNineteen patients with CIOM were enrolled. The average feasibility (the proportion of prescribed applications that were carried out) observed in this study was 94.7%±8.9% (95% CI 90.5% to 99.0%), which was higher than the expected feasibility. The revised oral assessment guide scores of the mucous membrane domain and total scores were significantly improved. All patients reported a reduction in oral cavity pain, with a median pain resolution duration of 6 days. No serious adverse events were observed.ConclusionsThe indigo naturalis ointment was feasible, and showed the potential for efficacy and safety. Larger randomised controlled trials are needed to further assess the efficacy and safety of indigo naturalis compared with a placebo.Trial registration numberUMIN000024271. |
| تدمد: | 2045-4368 2045-435X |
| DOI: | 10.1136/bmjspcare-2021-003199 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ef3f9e8b5962cdef064f9e081c08e5ed https://doi.org/10.1136/bmjspcare-2021-003199 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....ef3f9e8b5962cdef064f9e081c08e5ed |
| قاعدة البيانات: | OpenAIRE |
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