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冈田净化疗法联合度洛西汀与单用度洛西汀治疗颞下颌关节紊乱病和纤维肌痛患者的随机临床研究

Okada Purifying Therapy in combination with duloxetine vs. duloxetine alone in patients with TMD and fibromyalgia: a randomized clinical study.

作者信息

Bruti Gianluca, Atencio Manuela Ramos, D'Urso Anna, Di Giacomo Paola, Di Paolo Carlo

机构信息

"Sapienza" University of Rome and Eurekacademy ETS, Rome (RM), Italy.

Mokichi Okada Association (MOA), Rome (RM), Italy.

出版信息

J Complement Integr Med. 2020 Dec 31;18(2):371-377. doi: 10.1515/jcim-2020-0116.

DOI:10.1515/jcim-2020-0116
PMID:33583165
Abstract

OBJECTIVES

This randomized study was aimed at evaluating the additional analgesic effect of Okada Purifying Therapy (OPT) when administered in combination with duloxetine in patients with Temporomandibular Disorders (TMDs) and Fibromyalgia (FM).

METHODS

Patients with TMDs visited at Department of Oral and Maxillofacial Sciences, Sapienza University of Rome who were diagnosed with FM were selected for the study. The final sample was composed of 31 patients: 15 patients were treated only with duloxetine (Group I) and 16 patients underwent also OPT treatment (Group II), for eight weeks. Craniomandibular index, total tenderness score, Brief Pain Inventory Modified Short Form, Fibromyalgia Impact Questionnaire, Beck Depression Inventory and State and Trait Anxiety Inventory-1 were assessed at the beginning (T0), during the course (T1) and after therapy (T2). Descriptive and inferential statistics were performed.

RESULTS

In all the data analyzed, both groups showed an improvement in particular between T0 and T1. No statistically significant differences were observed between the two groups during the trial, except for the interaction between treatment and time as to the ability of walking at the BPI-I (F=7.57, p=0.002). No side effects due to the duloxetine were recorded in group II compared to group I.

CONCLUSION

The additional complementary treatment (OPT) did not appear to give the patients with TMDs and FM any further benefit but it might improve pharmacological tolerability of the traditional medication.

摘要

目的

本随机研究旨在评估冈田净化疗法(OPT)与度洛西汀联合应用于颞下颌关节紊乱病(TMD)和纤维肌痛(FM)患者时的额外镇痛效果。

方法

选择罗马第一大学口腔颌面科学系诊断为FM的TMD患者进行研究。最终样本由31名患者组成:15名患者仅接受度洛西汀治疗(第一组),16名患者还接受了OPT治疗(第二组),为期8周。在开始时(T0)、疗程中(T1)和治疗后(T2)评估颅下颌指数、总压痛评分、简明疼痛清单修订简表、纤维肌痛影响问卷、贝克抑郁量表以及状态和特质焦虑量表-1。进行描述性和推断性统计分析。

结果

在所有分析的数据中,两组在T0和T1之间均有改善。在试验期间,两组之间未观察到统计学上的显著差异,但在BPI-I中关于行走能力的治疗与时间交互作用除外(F=7.57,p=0.002)。与第一组相比,第二组未记录到度洛西汀引起的副作用。

结论

额外的补充治疗(OPT)似乎并未给TMD和FM患者带来进一步益处,但可能改善传统药物的药理学耐受性。

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