Table 3.
Clinical studies reporting the use of the Kampo formulae for the treatment of stomatitis.
| No. | First Author, Year [Reference No.] | Kampo Formula | Study Design | Target Patient | Principal Result |
|---|---|---|---|---|---|
| 1 | Ogino, 1992 [11] | Shosaikoto (SSK) | case series study | cryptogenic stomatitis (n = 10) | Efficacy rate was 80%. (very effective = 2, effective = 4, slightly effective = 2, no change = 2) |
| 2 | Oka, 2007 [12] | Orento (ORT) | RCT | acute aphthous stomatitis (n = 39) > non-treated (n = 6), steroid ointment-treated (n = 6) and ORT-treated (n = 27) groups | The administration of Orento reduced the number of days until the disappearance of pain and the complete cure compared to other groups. |
| 3 | Yuki, 2003 [13] | Orengedokuto (OGT) | case-control (retrospective) study | chemotherapy-induced stomatitis in patients with acute leukemia (n = 40) > ORG-treated (n = 15) and gargling (n = 25) groups | Incidence of stomatitis was 27.9% in the ORG-treated group, which was significantly lower compared with 71.6% in those who received a gargle consisting of allopurinol, sodium gualenate, and povidone-iodine (p < 0.0001). |
| 4 | Kono, 2010 [14] | Hangeshashinto (HST) | case series study | chemotherapy-induced oral mucositis during mFOLFOX6 or FOLFIRI treatment for metastasis of advanced colorectal cancer (n = 14) | Thirteen patients (92.8%) showed improvements in oral mucositis, with significantly decreased mean CTCAE grades (p = 0.0012). |
| 5 | Aoyama, 2014 [18] | RCT | gastric cancer chemotherapy-induced oral mucositis (COM) (n = 91) > HST-treated (n = 45) and placebo (n = 46) groups | Although HST treatment did not reduce the incidence of ≥grade 2 COM, a trend was observed in which HST reduced the risk of COM in the patients who developed grade 1 COM. |
|
| 6 | Matsuda, 2015 [15] | RCT | infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis (n = 93) > HST-treated (n = 46) and placebo (n = 47) groups | Although the incidence of grade ≥2 mucositis was lower for patients treated with HST compared to those treated with placebo, there was no significant difference (48.8 vs. 57.4%; p = 0.41). The median duration of grade ≥2 mucositis was 5.5 versus 10.5 days (p = 0.018). | |
| 7 | Yoshida, 2017 [16] | case series study | cancer chemotherapy-induced oral mucositis (grade ≥ 2) (n = 50) | Thirty-seven patients (74%) showed improvements in oral mucositis, with significantly decreased mean NRS and CTC-grade (p < 0.001). | |
| 8 | Nishikawa, 2018 [17] | RCT | chemotherapy-induced oral mucositis (COM) in patients with gastric cancer and colorectal cancer (n = 181) > HST-treated (n = 88) and placebo (n = 93) groups | The incidence of grade ≥2 COM in the HST group was 55.7%, while that in the placebo group was 53.8% (p = 0.796). The median time to remission of grade ≥ 2 COM to grade < 1 was 8 days in the HST group and 15 days in the placebo group (p = 0.072). | |
| 9 | Ohoka, 2018 [19] | RCT | sunitinib-induced oral mucositis (OM) in patients with metastatic renal cancer (n = 22) > HST-gargling (n = 12) and non-gargling (n = 10) groups | The gargling with HST significantly improved OM grade and eating status (Global self assessment) (p = 0.002). | |
| 10 | Wada, 2004 [20] | Juzentaihoto (JTT) | RCT | radiation (40 Gy >)-induced stomatitis in patients with oral cancer (n = 15) > JTT-treated (n = 8) and non-treated (n = 7) groups | The mean period that patients could not ingest orally was 17.9 ± 7.1 days in the JTT-treated group, while that in the non-treated group was 26.0 ± 11.6 day (p = 0.121). |
RCT: randomized controlled trial.