Efficacy of Danzhixiaoyao tablets combined with methylcobalamin tablets in the treatment of burning mouth syndrome: an open-label, randomized controlled trial.
Anxiety
Chinese patent medicine
Chinese traditional treatment
Danzhixiaoyao pills
Depression
Syndrome
Traditional Chinese medicine(TCM)
VAS
burning mouth syndrome
Journal
BMC oral health
ISSN: 1472-6831
Titre abrégé: BMC Oral Health
Pays: England
ID NLM: 101088684
Informations de publication
Date de publication:
24 May 2024
24 May 2024
Historique:
received:
31
10
2023
accepted:
02
05
2024
medline:
25
5
2024
pubmed:
25
5
2024
entrez:
24
5
2024
Statut:
epublish
Résumé
This randomized controlled trial compared the efficacy and tolerability of danzhixiaoyao pills in the accurate treatment of patients with burning mouth syndrome (BMS). Collect a total of 78 patients (75 female patients and 3 male patients) from the oral mucosa department who were considered eligible fromOctober 2020 to October 2022.The patients were randomized and divided into trial group and control group.The trail group received danzhixiaoyao pills and mecobalamine tablets while the control group was given mecobalamine tablets.The Visual Analogue Scale (VAS), Beck Anxiety Inventory(BAI), Beck Depression Inventory (BDI), Oral Health Impact Profile (OHIP-14), Traditional Chinese medicine(TCM) syndrome integral and adverse reactions were performed at baseline and after 2, 4, and 6 weeks of treatment. Descriptive statistics, including the Wilcoxon rank-sum test and the Chi-square test for median comparisons between different times, were used. 1.After treatment, the VAS, BDI,OHIP-14, and TCM syndrome integral in the trial group had a significant decrease than the control group(P< 0.05).However, there was no statistical difference in the BAI scores between the two groups (P> 0.05). 2.According to the efficacy determination criteria , the total effective rate of the test group was 73.68% , the control group was 52.94% and the recurrence rate was 0. There was a significant difference between the two groups (Z=-2.688, P < 0.05). The results showed that the curative effect of test group was better than that of control group.3. No adverse effects occurred in patients in either group. Danzhixiaoyao pills has demonstrated to have a positive effect in relieving BMS symptoms and in improving a patient's overall quality of life with no AEs compared with the control group. The efficacy evaluation systems that can be verified and complementary in this study provide a perfect, effective and referential evaluation system for the use of Chinese patent medicine in the treatment of oral mucosal diseases. Registry name: Chinese Clinical trail Registry Registration number: ChiCTR2000038189 Date of Registration: 2020-09-13 Please visit ( https://www.chictr.org.cn/showproj.html?proj=61462 ) to the protocol.
Identifiants
pubmed: 38789997
doi: 10.1186/s12903-024-04318-2
pii: 10.1186/s12903-024-04318-2
doi:
Substances chimiques
Vitamin B 12
P6YC3EG204
mecobalamin
BR1SN1JS2W
Drugs, Chinese Herbal
0
Tablets
0
danzhi xiaoyao
0
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
603Subventions
Organisme : National Key Research and Development Program of China
ID : 81170968
Organisme : Traditional Chinese Medicine Scientific Research Project of Shanghai Municipal Health Commission in 2020-2021
ID : 2020LP023
Informations de copyright
© 2024. The Author(s).
Références
Daniela Adamo, Antonio Celentano, Elvira Ruoppo, et al. The Relationship Between Sociodemographic Characteristics and Clinical Features in Burning Mouth Syndrome. Pain Med. 2015;16:2171–9.
doi: 10.1111/pme.12808
Xiaojie Liu, Caichun Liu, Junsheng Tian, et al. Plasma metabolomics of depressed patients and treatment with Xiaoyaosan based on mass spectrometry technique [J]. J Ethnopharmacol. 2020;246:112219.
doi: 10.1016/j.jep.2019.112219
Hui Liao. Banbury Linda K, Leach David N, Elucidation of danzhixiaoyao wan and its constituent herbs on antioxidant activity and inhibition of nitric oxide production. Evid Based Complement Alternat Med. 2007;4:425–30.
doi: 10.1093/ecam/nel091
Goncalves Sandra,Carey Barbara,Farag Arwa M et al. WWOM VII: Effectiveness of topical interventions in the management of burning mouth syndrome: A systematic review.[J] .Oral Dis. 2022. https://doi.org/10.1111/odi.14297
Jacek Zborowski, Tomasz Konopka. Comparison of Clonazepam and Tongue Protector in the Treatment of Burning Mouth Syndrome [J]. Int J Environ Res Public Health. 2022;19:8999. https://doi.org/10.3390/ijerph19158999 .
doi: 10.3390/ijerph19158999
Miziara I, Chagury A, Vargas C, et al. Therapeutic options in idiopathic burning mouth syndrome: literature review. Int Arch Otorhinolaryngol. 2015;19(1):86–89.
Heckmann SM, Kirchner E, Grushka M, et al. A double-blind study on clonazepam in patients with burning mouth syndrome. Laryngoscope. 2012;122(4):813–6.
Ori F, Layla K, Rakefet C, et al. Photobiomodulation relieves immediate pain in patients with burning mouth syndrome. Oral Dis. 2024.
Liu YF, Kim Y, Yoo T, et al. Burning mouth syndrome: a systematic review of treatments. Oral Dis. 2017;24(3):325–34.
Fenelon M, Quinque E, Arrive E, et al. Pain-relieving effects of clonazepam and amitriptyline in burning mouth syndrome: a retrospective study. Int J Oral Maxillofac Surg. 2017;46(11):1505–11.
Al-Maweri SA, Javed F, Kalakonda B, et al. Efficacy of low level laser therapy in the treatment of burning mouth syndrome: a systematic review. Photodiagnosis Photodyn Ther. 2017;(17):188–93.
Palmer A, Hamann T, Liese J, et al. Efficacy of cranial electrotherapy stimulation in patients with burning mouth syndrome: a randomized, controlled, double-blind pilot study.Front Neurol. 2024;15:1343093.
Mario Carbone, Monica Pentenero, Marco Carrozzo, et al. Lack of efficacy of alpha-lipoic acid in burning mouth syndrome: a double-blind, randomized, placebo-controlled study. Eur J Pain. 2009;13:492–6. https://doi.org/10.1016/j.ejpain.2008.06.004 .
doi: 10.1016/j.ejpain.2008.06.004
Manian Nanmathi,Schmidt Elizabeth,Bornstein Marc H et al. Factor structure and clinical utility of BDI-II factor scores in postpartum women. J Affect Disord. 2013;149: 259-68. https://doi.org/10.1016/j.jad.2013.01.039 .
Eskelinen Matti,Ollonen Paula,Beck Depression Inventory (BDI) in patients with breast disease and breast cancer: a prospective case-control study.[J] .In Vivo, 2011;25: 111-6.
Özgül Karaaslan, Yunus Kantekin, Yunus Hacımusalar, et al. Anxiety sensitivities, anxiety and depression levels, and personality traits of patients with chronic subjective tinnitus: a case-control study. Int J Psychiatry Clin Pract. 2020;24:264–9. https://doi.org/10.1080/13651501.2020.1757117 .
doi: 10.1080/13651501.2020.1757117
Dong Baozhen Lu, Cuitian Niu Yanan. Analysis of the curative effect of adding flavor to Xiaoyao powder in the treatment of menopause syndrome. The Journal of Traditional Chinese Medicine. 2013;28(3):428.
Xiuzhong Li. Danzhi Xiaoyao powder treated 105 cases of menopausal syndrome. Henan traditional Chinese medicine. 2004;24(12):62.
Baozhen Dong. Danzhi Xiaoyao loose plus and minus treatment of mammary gland hyperplasia. Prescription medicine application of Chinese folk therapy. 2015;23(10):45–6.
Shichun Wen. Progress of modern clinical application of flavored Xiaoyao powder. Summary of Chinese folk therapy. 2019;27(18):108–9.
Hua’en Cui. Clinical application of wei Xiaoyao pill. Journal of Clinical Laboratory. 2018;7(2):358–9.
Qunying Gu, Jiankai Wang, Guangliang Niu. Danzhi Xiaoyao powder experience in the treatment of oral mucosal diseases. The Journal of Traditional Chinese Medicine. 2013;12(28):1928–9.
Rustand Kristin,Aass Anne Merete,Sen Abhijit et al. Oral health-related quality of life following peri-implantitis surgery: A prospective study. Clin Oral Implants Res. 2022, 33: 858-867. https://doi.org/10.1111/clr.13967 .
Yiping Yin, Yang Guanghui Gu, Qiuxia. 45 cases of female burning mouth syndrome. Chinese Journal of Traditional Chinese Medicine Information. 2005;12(10):66.
Chun Hu. Summary of 48 cases of burning mouth syndrome treated with combined traditional Chinese and Western medicine. Hunan Traditional Chinese Medicine Guide. 2004;10(6):58–9.
Mila Wang, Chenglin Qiu. Clinical observation of 32 cases of burning mouth syndrome treated with integrated Traditional Chinese and Western medicine. Chinese Journal of Integrated Chinese and Western Medicine Otolaryngology. 2012;20(1):61.
Beneng K, Yilmaz Z, Yiangou Y, et al. Sensory purinergic receptor P2X3is elevated in burning mouth syndrome. Int J Oral Maxillofac Surg. 2010;39(8):815–9.
doi: 10.1016/j.ijom.2010.03.013
pubmed: 20418063
Liu YF, Kim Y, Yoo T, et al. Burning mouth syndrome: a systematic review of treatments. Oral Dis. 2017;24(3):325–34.
doi: 10.1111/odi.12660
pubmed: 28247977
Galli F, Lodi G, Sardella A, et al. Role of psychological factors in burning mouth syndrome: A systematic review and meta-analysis. Cephalgia. 2017;37:265–77.
Dugan C, Popescu BO, Țovaru S, et al. Neuropsychological assessment of Romanian burning mouth syndrome patients: stress, depression, sleep disturbance, and verbal fluency impairments. Front Psychol. 2023;14:1176147.
Zhao Y, Li Y. Analysis on the experience of burning mouth syndrome. J Pract Oral Med. 2020;36(2):378–80.
Kisely S, Forbes M, Sawyer E, et al. A systematic review of randomized trials for the treatment of burning mouth syndrome. J Psychosom Res. 2016;86:39–46.