Long-Term Patient-Reported Symptom Control with an Ibuprofen Gargle in Oral Lichen Planus: An Exploratory Analysis of a Randomized Crossover Trial and Extension.

Oral lichen planus (OLP) causes chronic pain and functional limitations. In a randomized, placebo-controlled crossover trial of ibuprofen gargle, short-term analgesia on the visual analog scale (VAS) was not statistically significant, although patient-perceived functional gains were suggested. This study aimed to characterize the long-term patient-centered response patterns to ibuprofen gargling using predefined responder definitions. We performed a secondary exploratory analysis of a single-center trial and its long-term extensions (jRCTs051220009 and jRCTs051220010). Twenty-four participants were followed up on day 176. Endpoints combined within-day analgesia on VAS at 0, 5, and 15 min (VAS0, VAS5, VAS15) with multidimensional symptoms from the 10-item Patient-Reported Oral Mucositis Symptom (PROMS) scale. Time-to-first achievement (TFA) was summarized, and responses were evaluated descriptively and visually. Overall PROMS response (Definition C) occurred in 21/24 participants (median TFA, 5 d). Domain-level responders were frequent (e.g., pain domain D 20/24, eating domain F 18/24; both median 5 d). In contrast, fewer participants met VAS-based endpoints: A 16/24 (between-day VAS) and B 17/24 (within-day VAS) over the observation period. Visual summaries suggested that improvements tended to emerge early and were sustained or recurrent across subsequent weeks in some participants. Although immediate analgesia was modest, this exploratory analysis indicated that regular use of ibuprofen gargling may be associated with early and durable improvements in patient-reported symptoms and function in OLP. These exploratory findings suggest that patient-centered endpoints may be useful for evaluating topical NSAIDs, and should be examined in future studies with larger sample sizes.