The efficacy and safety of thalidomide on the recurrence interval of continuous recurrent aphthous ulceration: A randomized controlled clinical trial

Abstract

Background: Recurrent aphthous ulceration (RAU) is the most common oral mucosal disease. Some patients have almost continuous oral ulcers which influence the quality of life. The aim of this study was to observe the efficacy and safety of thalidomide on the recurrence interval of continuous RAU. Methods:A randomized controlled clinical trial was designed, and 60 continuous RAU patients were randomly assigned to the experimental group (n = 32, taking thalidomide before bed at a dose of 100 mg/d for 10 days, then 50 mg/d for 10 days, and 25 mg/d for 10 days) and the control group (n = 28, taking 0.4 mg/kg/d prednisone every morning for 15 days and then 0.2 mg/kg/d for 15 days). The clinical outcomes consisted of the primary outcome (recurrence interval) and the secondary outcomes (pain level, number of ulcers, and days for ulcer healing), and they were measured at every visit. Adverse reactions were recorded. Results:A total of 54 and 51 patients presented at the first and second return visit, respectively. After 1 month, the increase in the recurrence interval was not shown to differ between the two groups (P = .12). However, the improvement in the recurrence interval was significantly greater in the experimental group (P < .001) at the second return visit. The improvement in the secondary outcomes was identical between two groups at each return visit (P > .05). The incidence of adverse reactions was similar between two groups (P = .50). Conclusions:Thalidomide had a long-term effect of extending the recurrence interval of continuous RAU. K E Y W O R D Sa randomized controlled clinical trial, continuous recurrent aphthous ulceration, recurrence interval, thalidomide

Efficacy and safety of thalidomide in preventing oral mucositis in patients with nasopharyngeal carcinoma undergoing concurrent chemoradiotherapy: A multicenter, open‐label, randomized controlled trial

“…An increasing number of studies using animal models have shown that THD can ameliorate OM induced by chemotherapy and/or radiotherapy 13,14 . THD has also been demonstrated to be beneficial in the treatment of oral ulcers in patients with recurrent aphthous ulceration, HIV infection, or Behçet syndrome 15‐17 . Furthermore, our previous clinical observational study also found that THD could decrease the occurrence and severity of OM in patients with NPC 18 .…”

Serum interleukin‐6, interleukin‐17A, and tumor necrosis factor‐alpha in patients with recurrent aphthous stomatitis

“…Thalidomide, however, is an immune‐modulatory drug that acts throughout the body through the circulatory system. Previous studies generally believe that thalidomide is by regulating TNF‐α levels to reduce the recurrence rate of RAS 28‐30 . Clinically, we have found that no significant changes in serum TNF‐α were observed after thalidomide was used; on the contrary, the IL‐6 level was significantly decreased.…”

A Randomized controlled clinical trial on dose optimization of thalidomide in maintenance treatment for recurrent aphthous stomatitis

“…For instance, short-term administration of prednisone (eg, for 2 weeks) should produce fewer side effects. 14,15 On the other hand, it is likely that the total doses of oral thalidomide cause adverse reactions. As such, low-dose thalidomide should be better tolerated in patients.…”

“…13,14 Thalidomide has been shown to be an effective systemic drug in the treatment of refractory oral ulceration, with growing evidence regarding its efficacy in the management of RAS. [14][15][16][17] The exact mechanism of thalidomide action on oral ulcers remains unknown. Its anti-inflammatory action is believed to derive from modulation of the inflammatory cascade and from interaction with various cytokines, including interleukin (IL)-6, IL-10, and tumor necrosis factorα (TNFα).…”

“…14 A recently well-designed study reported that thalidomide at a starting dose of 100 mg/d was superior to prednisone at a starting dose of 25 mg/d in extending the RI of RAS. 15 To further optimize the therapeutic strategy of systemic medication for RAS, we performed this clinical trial with a two-stage design. To begin with, all of the RAS patients received prednisone at a starting dose of 15 mg/d for one week as an initial therapeutic drug.…”