The effectiveness of olibanum orally disintegrating tablet in the treatment of oral aphthous ulcers: A randomized, double-blind, placebo-controlled clinical trial

Abstract

Background: Boswellia serrata oleo-gum-resin (frankincense; olibanum) has anti-inflammatory, analgesic, and antimicrobial effects. This study aimed to evaluate the clinical effectiveness of frankincense extract in the treatment of oral aphthous ulcers.

Materials and methods: In a randomized, double-blind, placebo-controlled clinical trial, patients with aphthous ulcers were randomly assigned to either experimental (Frankincense extract) or placebo groups to use orally disintegrating tablets (ODT) of frankincense and placebo, respectively, four times a day for 3 days. The size of aphthous ulcers and the pain severity by visual analogue scale were recorded at days 0, 2, and 4 and compared between the groups.

Results: Twenty-five patients in each group completed the study. Olibanum extract ODT significantly reduced the ulcer size on the second (P < 0.001) and fourth (P < 0.001) days as well as the pain score on the second (P = 0.002) and fourth (P < 0.001) days of the intervention compared to placebo. Furthermore, at the end of the intervention, the number of patients with complete ulcer healing and pain relief in the experimental group was significantly more than the placebo group (5 vs. 0, P = 0.02; and 11 vs. 0, P < 0.001, respectively).

Conclusion: Taking olibanum extract ODTs reduces the ulcer size and pain severity and accelerates the healing process in the oral aphthous lesions.

Keywords: Boswellia serrata; Frankincense; clinical trial; olibanum; oral aphthous ulcer.

Figure 1

Gas chromatography-mass spectrum of frankincense orally disintegration tablet. The sample is silylated prior to injection. For silylation N, O-bis (Trimethylsilyl) acetamide, and TMCS (chlorotrimethylsilane) each 0.5 mL were added for 1 h at 40°C. The gas chromatograph equipped with an HP-5 gas chromatography column, 30 m × 0.25 mm (film thickness of 0.25 μm). Helium was used as carrier gas (flow = 2 mL/min), and the oven temperature was started from 50°C for 2 min, raised by 8°C/min up to 250 °C, and by 3°C/min up to 330°C. The total analysis time was 58 min

Figure 2

CONSORT flowchart of the study