Non-Cochrane · intervention · PM42423860
Hangeshashinto for the prevention of oral mucositis in patients receiving chemotherapy: a systematic review and meta-analysis.
Ishizuka Mitsuru, Shibuya Norisuke, Hachiya Hiroyuki, et al. · Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026 · PubMed · doi:10.1007/s00520-026-10975-6
Findings
Population Patients with cancer receiving chemotherapy (gastric, colorectal, esophageal, head and neck; Japan)
3 findings
| Hangeshashinto (TJ-14) during chemotherapy | No hangeshashinto or placebo | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) Overall (all 6 studies) | RR 0.86 [0.73, 1.00] 78/152 (51.3%) vs 65/141 (46.1%) Moderate 6 studies · 293 participants |
| Hangeshashinto (TJ-14) during chemotherapy | No hangeshashinto or placebo | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) Sensitivity analysis excluding the 2 radiotherapy studies | RR 0.90 [0.67, 1.21] GRADE not reported 4 studies |
| Hangeshashinto (TJ-14) during chemotherapy | No hangeshashinto or placebo | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) Other meta-analysis of the 2 placebo-controlled gastric and colorectal RCTs (Aoyama 2014, Matsuda 2015) Unresolved: the two extractors disagree on this row. | RR 0.81 [0.56, 1.17] GRADE not reported 2 studies |
Included primary studies 10
Open in Studies| Study | Year | Also included by | Outcomes it informs here | Trial data |
|---|---|---|---|---|
| Aoyama 2014 Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis DOI:10.1007/s00280-014-2440-x | 2014 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
| Aoyama 2014 Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral… PMID:24652604 | 2014 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
| Kato 2023 Efficacy of Cryotherapy and Hangeshashinto for Radiation-induced Oral Stomatitis: Preliminary Study DOI:10.21873/invivo.13149 | 2023 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
| Kato 2023 Efficacy of Cryotherapy and Hangeshashinto for Radiation-induced Oral Stomatitis: Preliminary Study. PMID:36881064 | 2023 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
| Matsuda 2015 Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based… DOI:10.1007/s00280-015-2767-y | 2015 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
| Matsuda 2015 Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based… PMID:25983022 | 2015 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
| Moriyama 2018 Impact of the use of Kampo medicine in patients with esophageal cancer during chemotherapy:a clinical trial for oral hygiene and oral… DOI:10.2152/jmi.65.184 | 2018 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
| Moriyama 2018 Impact of the use of Kampo medicine in patients with esophageal cancer during chemotherapy:a clinical trial for oral hygiene and oral… PMID:30282858 | 2018 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
| Taira 2020 The effect of Hangeshashinto on Oral Mucositis Caused by Induction Chemotherapy in Patients with Head and Neck Cancer. PMID:32884437 | 2020 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
| Takahashi 2018 Prevention of the Chemotherapy-Induced Oral Mucositis in Esophageal Cancer by Use of Hangeshashinto (TJ-14) DOI:10.9738/intsurg-d-17-00114.1 | 2018 | this review only | Chemotherapy-induced oral mucositis (grade 2 or higher by CTCAE v5.0, described as more than grade 1) | not extracted yet |
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Patients receiving chemotherapy | Patients with gastric, colorectal, esophageal, or head and neck cancer receiving chemotherapy in Japan (n=293) |
| Intervention | Hangeshashinto | Hangeshashinto 2.5 g x 3/day (one study 0.625 g x 3/day) as oral rinse and swallow, sorbet or frozen; 2 to 8 weeks (n=141) |
| Comparison | Without hangeshashinto or placebo | Placebo (3 studies) or no hangeshashinto (3 studies) (n=152) |
| Outcomes | Incidence of oral mucositis (grade 2 or higher) | Oral mucositis incidence (CTCAE grade 2 or higher) |
| Study designs | Randomized or case-matched studies; English | 5 RCTs and 1 case-matched study |
| Timing | Not specified | Studies published 2014 to 2023 |
AMSTAR 2 items
Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | Yes | yes |
| 2Protocol established before the reviewcritical | No | No | yes |
| 3Choice of study designs explained | Yes | Yes | yes |
| 4Comprehensive literature searchcritical | No | No | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | No | No | yes |
| 8Included studies described in detail | Partial Yes | Partial Yes | yes |
| 9Risk of bias assessed satisfactorilycritical | RCT: Yes · NRSI: Yes | NRSI: Yes · RCT: Yes | no |
| 10Funding of included studies reported | No | No | yes |
| 11Appropriate meta-analysis methodscritical | RCT: Yes · NRSI: No | NRSI: No · RCT: Yes | no |
| 12Impact of risk of bias on the pooled results | No | No | yes |
| 13Risk of bias accounted for in interpretationcritical | Yes | Yes | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | Yes | Yes | yes |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Critically Low | Critically Low | yes |