Discussion
allergic reaction, ulcer size reduction, pain, RAU, pseudomembranous ulcer, ulcer
ULCER, ALLERGIC REACTION, HEALING ULCERS
In recent years, complementary and alternative medicine (CAM) has been increasingly used worldwide. CAM is defined as a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine [The present study evaluated the use of 0.1% CBD as a topical treatment for RAU. None of the subjects experienced an allergic reaction to 0.1% CBD either on their skin or oral mucosa. Applying CBD to normal oral mucosa for 7 days did not affect the subjects’ vital signs, glucose, hematocrit, electrolyte levels, or liver and kidney function. These results indicate that topical 0.1% CBD is safe for human skin and oral mucosa application.In this study, phase 3 was conducted as a randomized controlled trial (RCT) in which ulcer size, erythematous border size, pain level, satisfaction, and OHIP-14 score were evaluated. These are the standard variables or factors that are often assessed when evaluating the pharmacological efficacy for RAU management. The findings from the present randomized, double-blind controlled clinical trial study indicate that CBD treatment reduced pseudomembranous ulcer and erythematous border size and alleviated pain during the 7-day application. The pseudomembranous ulcer size was significantly reduced due to CBD’s wound healing promotion and anti-inflammatory effects [The pain scores of the three intervention groups decreased over time [A study revealed that RAUs affect patient QoL due to pain (during talking, eating, and swallowing), discomfort (impaired food and liquid intake), interpersonal relationship problems, and self-confidence [A previous study [This study has some limitations that must be carefully considered. One limitation was the two-dimensional measurement of the ulcer. Because ulcer size reduction and pain relief are not the only signs of improvement in healing ulcers, decreases in ulcer depth should also be measured. If the ulcer depth variable is incorporated into the ulcer healing outcomes, the findings may be more comprehensive. However, USS was used at baseline and some parts of the USS overlapped with other measurements, i.e., ulcer size and pain score, that were recorded at each monitoring visit; and the ulcer numbers and sites were collected at baseline. A comprehensive score that includes QoL outcomes for assessing improvement rates during RAU treatment interventions would be relevant to use in further clinical investigations. Furthermore, topical CBD dosages above 0.1% have not been investigated in early trials and should be considered in future RCTs for RAU management to improve the clinical efficacy while comparing CBD side by side with TA.To our knowledge, this is the first randomized clinical trial investigating the clinical effects of 0.1% CBD for RAU topical treatment. The efficacy of CBD was clinically meaningful, specifically on reducing the pseudomembranous ulcer and erythematous border size and on pain relief.