چکیده: (25 مشاهده)
Background: This study aimed to evaluate the effect of oral Anaheal (bromelain 500 mg) compared to diclofenac sodium (50 mg) on reducing pain and symptoms in patients with temporomandibular joint osteoarthritis (TMJ OA).
Methods: This randomized, double-blind, parallel-group clinical trial conducted from 2024 to 2025 at Mashhad dental school and Velayat Hospital, Mashhad, Iran. Forty patients with radiographically confirmed TMJ OA were randomly assigned to receive either Anaheal 500 mg (intervention group, n=20) or diclofenac sodium 50 mg (control group, n=20) orally twice daily for 7 d. Pain intensity was assessed using a visual analog scale (VAS, 0-10), and maximum mouth opening (MMO) was measured at baseline (T0), day 1 (T1), day 7 (T2), and day 14 (T3). Joint clicking was also evaluated at all-time points.
Results: Both groups demonstrated significant within-group improvements in pain and MMO over time (P<0.001). At T2, a decrease in pain and an increase in MMO were observed in both groups without significant between-group differences. At T3, Anaheal maintained a lower mean pain (7.5±1.3) compared to diclofenac (7.9±1.5), though this was not statistically significant (P=0.398). Notably, between-group comparison of pain change from T0 to T3 showed significant superiority for Anaheal (+0.5 ± 0.9 vs. −0.5 ± 0.9; P=0.004). Similar sustained functional benefit was observed in MMO change from T0 to T3 favoring Anaheal, but without statistical significance (P=0.308). Joint clicking persisted unchanged in all patients at all-time points.
Conclusion: Anaheal (bromelain 500 mg) and diclofenac sodium 50 mg provide comparable acute pain relief and functional improvement in TMJ osteoarthritis. However, Anaheal offers more stable pain control after treatment cessation. These findings support Anaheal as a safe and effective conservative therapy for TMJ osteoarthritis, though larger and longer-term studies are needed.
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