Table 2.
Clinical trials of various treatments in RIOM.
| No. | Reference | Sample size | Treatment method | Evaluation criteria | Design | Result |
|---|---|---|---|---|---|---|
| 1 | Sahebjamee et al. (67) | 26 | Aloe vera mouthwash vs. benzydamine mouthwash | ≥Grade I RIOM development time | RCT, observational | Similar RIOM severity. |
| 2 | Sayed et al. (68) | 60 | Pentoxifylline and vitamin E | ≥Grade III RIOM incidence | Prospective, observational | Decreased the duration of RIOM. |
| 3 | Bonfili et al. (69) | 80 | Platelet gel supernatant | ≥Grade III RIOM incidence | RCT, observational | Decreased the incidence of WHO grade 3/4 RIOM: 13% |
| 4 | Soares et al. (70) | 42 | LLLT (660 and 808-nm wavelengths vs. only 660-nm wavelength) | ≥Grade I RIOM incidence | Parallel, single-blind, two-arm controlled, observational | Group 1 reduced RIOM grade in comparison to Group 2. |
| 5 | Huang et al. (71) | 71 | Oral glutamine vs. placebo | RIOM incidence and severity | Randomized double-blind; Phase III trial | Glutamine had no effect on the severity of RIOM. (P = 0.169) |
| 6 | Ueno et al. (72) | 97 | Placebo vs. rebamipide 2% vs. rebamipide 4% | ≥Grade III RIOM incidence | Multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase II trial | The incidences of severe RIOM: 39 vs. 29 vs. 25%. |
| 7 | Santos Filho et al. (73) | 20 | FITOPROT (curcuminoids plus Bidens pilosa Linn) | Adverse reactions development | Phase I trail | FITOPROT was safe and tolerable for RIOM patients. |
| 8 | Kawashita et al. (74) | 124 | Pilocarpine hydrochloride, topical dexamethasone ointment | ≥Grade III RIOM incidence | Multicenter, phase II, randomized controlled | Decreased incidence of severe RIOM (P = 0.046). |
| 9 | Ribeiro da Silva et al. (75) | 29 | PDT vs. LLLT | The number of clinical cures of RIOM | Open, controlled, and blind, randomized; observational | Satisfactory results in reducing pain. |
| 10 | Hadjieva et al. (76) | 38 | CAM2028-benzydamine | Pain intensity | Observational, Crossover; double-blind; controlled; single-dose; randomized | Relieve pain effectively. |
| 11 | Giralt et al. (77) | 183 | Clonidine vs. placebo | ≥Grade III RIOM development time | Phase II, randomized | RIOM developed in 45 vs. 60% (P = 0.06) |
| 12 | Anderson et al. (78) | 223 | GC4419 (a superoxide dismutase mimetic) | ≥Grade III RIOM development duration | Phase IIb, Randomized, Double-Blind | 90 mg produced a reduction of RIOM duration, incidence, and severity. |
| 13 | Legouté et al. (79) | 97 | LLLT | ≥Grade III RIOM incidence and time | Phase III | 95% of patients exhibited a very good tolerance of LLLT. |
| 14 | Sio et al. (80) | 275 | diphenhydramine-lidocaine-antacid mouthwash | RIOM pain reduction during the 4 h | Phase III, randomized | Deduced pain during the first 4 h after administration. |
| 15 | Hua et al. (81) | 56 | CRO | Total dose of CRO | Observational, prospective | Early introduction of CRO may reduce the total dose of CRO. |
| 16 | Jiang et al. (82) | 99 | Probiotic combination | ≥Grade III RIOM incidence | Randomized, double-blind, placebo-controlled | The incidences of grade 3 RIOM was 15.52%. |
| 17 | Wu et al. (83) | 156 | Actovegin | Grade III RIOM incidence and onset time | Multi-center prospective, randomized, multi-center | A low progression rate from grade 2 to 3 (39.2%). |
| 18 | Marín-Conde et al. (84) | 26 | LLLT | RIOM incidence and severity | Prospective randomized controlled | 72.7% of the LLLT group showed normal mucosa. |
| 19 | Onseng et al. (85) | 39 | Melatonin vs. placebo | Incidence and time to grade III | Randomized, double-blind, double dummy, placebo-controlled | Incidence of grade 3 RIOM: 42%. |
| 20 | Gautam et al. (2) | 46 | LLLT (λ = 632.8 nm) | RIOM incidence and duration | Double blinded, randomized, lacebo controlled | Reduce the incidence and duration of severe RIOM. |
RIOM, radiation-induced oral mucositis; LLLT, low-level laser therapy; PDT, photodynamic therapy; CRO, controlled-release oxycodone.