顎関節症における耳介鍼治療-偽薬対照無作為化臨床試験

Auricular acupuncture in TMD - A sham-controlled, randomized, clinical trial.

抄録

本研究では、耳介鍼治療（AA）が顎関節症患者の身体的側面（PA）と感情的側面（EA）に及ぼす影響を評価し、AAの効果をShamおよび咬合スプリント（OS）の効果と比較検討した。CONSORTガイドラインに従い、顎関節症患者をRDC-TMDのI軸とII軸で評価した。患者は3群に振り分けられた。患者はOS、Sham、AAの3群に分けられ、8週間追跡された。量的変数のグループ内およびグループ間評価は、ANOVA、one-way、Tukey testの順で分析された。質的変数は、Kruskal-Wallis検定とDunn検定（グループ間評価）で分析し、グループ内分析にはFriedman検定とWilcoxon検定を適用した。実験終了時には、カイ二乗検定を適用し、スコアが向上した変数の数に関して、3つのグループを比較した。すべての検定で採用した有意水準はα=5%であった。グループ内分析の結果、Shamグループでは、EAではいずれのパフォーマンスも改善されず、PAでは5つの変数と9つの変数で有意な改善がみられた。本試験終了時のOS群では、EAとPAでそれぞれ8変数と8変数で有意な改善が観察された。使用した治療法の分析では、治療後に有意な改善を示した変数の数は、AA群とOS群で同程度であったが、偽薬群では他の2群と比較すると統計的に有意な差が見られた。結論として、本研究は、特定の顎関節の耳点にAAを適用することで、顎関節症患者に改善をもたらし、OSで治療した患者と同様の結果を得ることができることを実証した。CLINICAL TRIAL REGISTRATION: RBR-69ynnw (Brazilian Registry of Clinical Trials)．

This study evaluated the effect of auricular acupuncture (AA) on physical (PA) and emotional (EA) aspects of patients with temporomandibular disorders (TMDs) and compared the effect of AA with those of Sham and occlusal splints (OS). In accordance with the CONSORT guidelines, patients with TMDs were evaluated by axes I and II of the RDC-TMD. The patients were allocated among three groups: OS, Sham and AA; and followed for 8 weeks. Both intragroup and intergroup evaluation for quantitative variables were analyzed with ANOVA, one-way, followed by the Tukey test. Qualitative variables were analyzed with the Kruskal-Wallis, and Dunn tests (intergroup evaluation) and for intragroup analyses, the Friedman and Wilcoxon tests were applied. At the end of the experiment, the chi-squared test was applied to compare the three groups with respect to the number of variables that had shown improved scores. The adopted level of significance for all tests was α = 5%. Intragroup analysis showed that, in the Sham group, no improvement in performance was seen in either EA and significant was improvements in 5 variables for 9 for PA, while in the AA group, significant improvements were observed in 2 variables for EA and in 9 for PA. In the OS group at the end of this study, significant improvements were observed in 8 and 8 variables for EA and PA, respectively. The analysis of therapies used revealed that the number of variables exhibiting significantly improved outcomes after treatment was similar between the AA and OS groups, whereas the sham group showed statistically significant differences when compared with the other two groups. In conclusion, this study demonstrated that AA applied at a specific TMJ ear point was able to bring about improvements in patients with TMDs, with outcomes similar to those in patients treated with an OS. CLINICAL TRIAL REGISTRATION: RBR-69ynnw (Brazilian Registry of Clinical Trials).