Effectiveness and safety of hominis placental pharmacopuncture for chronic temporomandibular disorder: a multicenter randomized controlled trial
Integrative Medicine Research(2024)
摘要
Background
Hominis placental (HPP) extract has been approved by the Ministry of Food and Drug Safety in Korea for treating chronic liver diseases and postmenopausal syndrome. However, its efficacy and safety for treating chronic temporomandibular disorder (TMD) remains unclear. We aimed to assess the effectiveness and safety of HPP for treating chronic TMD compared with physical therapy (PT).
Methods
This study is a 2-arm parallel, multi-centre, randomised controlled trial. We enrolled 82 chronic TMD patients from 2 Korean medicine hospitals between December 2019 and January 2021. We included patients with chronic TMD and randomly assigned them to undergo HPP or PT. The primary outcome was the difference in the scores for temporomandibular joint (TMJ) pain at baseline and week 6. The secondary outcomes were the scores for TMJ pain and bothersomeness, TMJ range of motion, the Korean version of Beck's depression index-Ⅱ, jaw functional limitation scale (JFLS) score, patient global impression of change (PGIC) scores, EuroQoL 5-dimension 5-level score, and short form-12 health survey (SF-12) scores.
Results
Compared with PT, HPP showed significantly superior effects on TMJ pain and bothersomeness, protrusive movement pain, JFLS (verbal, emotional, and global), SF-12, and PGIC scores at week 6 (P<0.05). Compared with the PT group, the HPP group showed a significantly higher recovery rate (≥50% reduction in the scores for TMJ pain at the 24-week follow-up).
Conclusion
HPP was more effective than PT managing pain and improving function and quality of life. Our findings demonstrate the effectiveness and safety of HPP for TMD treatment.
Trial registration/Protocol registration
clinicaTrials.gov (NCT04087005)/ Clinical Research Information Service (CRIS) (KCT0004437)/ Ministry of Food and Drug Safety (No. 31886)
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关键词
pharmacopuncture,hominis placental pharmacopuncture,hominis placenta,temporomandibular disorder,temporomandibular joint
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