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积雪草对缓解颞下颌疼痛及改善功能的疗效:一项随机、双盲、试点临床试验。

Efficacy of Centella asiatica on mitigating temporomandibular pain and improving functionality: a randomized, double blind, pilot clinical trial.

作者信息

Potewiratnanond Prangtip, Surarit Rudee, Tantisira Mayuree H, Samaranayake Lakshman, Rotpenpian Nattapon, Wanasuntronwong Aree

机构信息

Department of Occlusion, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.

Department of Oral Biology, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.

出版信息

Head Face Med. 2025 Apr 19;21(1):28. doi: 10.1186/s13005-025-00503-y.

Abstract

OBJECTIVE

To determine the efficacy of Centella asiatica extract, ECa233, on alleviating pain symptoms and functional improvement of acute temporomandibular disorders (TMD).

MATERIALS AND METHODS

A randomized, double-blind, placebo-controlled, pilot clinical trial was performed using 23 adults with acute TMD. They were randomly assigned into four treatment groups, an ibuprofen (positive control) group, two test groups of ECa233 each of 250 mg, and 500 mg extracts, and a placebo (negative control) group. All subjects were requested to self-administer the test/control capsules, twice a day for 14 days. The pain intensity score, range of mandibular motion and tenderness of the masticatory muscles and temporomandibular joint (TMJ) were recorded at baseline, 7- and 14-days post-treatment.

RESULTS

One week after intervention, the pain intensity score significantly decreased in participants receiving 500 mg of ECa233 (P = 0.016), as well as the placebo group (P = 0.030) but not in the other groups. Additionally, those receiving 500 mg of ECa233 displayed the highest percentage reduction in self-reported pain intensity and pain on TMJ palpation compared with the other groups (P > 0.050). On day 14, there were no significant differences observed among the evaluated parameters in the four groups.

CONCLUSIONS

The orally administered ECa233 has the potential to induce rapid, short term, dose-dependent analgesia in individuals with TMD pain. However, longer-term RCT with a larger cohort is necessary to confirm these findings.

CLINICAL RELEVANCE

ECa 233 at 500 mg has the potential to induce a more rapid analgesic response in individuals with acute TMD after a 7-day period.

TRIAL REGISTRATION

This trial was registered on the ClinicalTrials.gov, the number is NCT06231212, date of registration: 30/01/2024.

摘要

目的

确定积雪草提取物ECa233对缓解急性颞下颌关节紊乱症(TMD)疼痛症状及功能改善的疗效。

材料与方法

采用随机、双盲、安慰剂对照的临床试验,纳入23名急性TMD成年患者。将他们随机分为四组,分别为布洛芬(阳性对照)组、两个ECa233测试组(每组分别服用250毫克和500毫克提取物)以及安慰剂(阴性对照)组。所有受试者均被要求每日自行服用测试/对照胶囊两次,持续14天。在基线期、治疗后7天和14天记录疼痛强度评分、下颌运动范围以及咀嚼肌和颞下颌关节(TMJ)的压痛情况。

结果

干预一周后,服用500毫克ECa233的参与者疼痛强度评分显著降低(P = 0.016),安慰剂组也显著降低(P = 0.030),但其他组未出现这种情况。此外,与其他组相比,服用500毫克ECa233的参与者自我报告的疼痛强度和TMJ触诊疼痛的降低百分比最高(P > 0.050)。在第14天,四组评估参数之间未观察到显著差异。

结论

口服ECa233有可能在TMD疼痛患者中诱导快速、短期、剂量依赖性镇痛作用。然而,需要更大样本量的长期随机对照试验来证实这些发现。

临床意义

500毫克的ECa233有可能在7天后对急性TMD患者诱导更快的镇痛反应。

试验注册

本试验已在ClinicalTrials.gov上注册,注册号为NCT06231212,注册日期:2024年1月30日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5242/12008970/9e8e8e0b8ca8/13005_2025_503_Fig1_HTML.jpg

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