Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine

Summary

This study is an open-label randomized controlled trial of the efficacy of the integration of Traditional Chinese medicine (TCM) and western medicine based on TCM syndrome differentiation. The hypothesis is (1) TCM model can identify the primary and secondary type burning mouth syndrome (BMS); (2) TCM model can identify BMS after treatment with western medicine; (3) There is a positive effect of TCM in treating BMS.

Timeline

Start

2020-06-20

Primary completion

2022-07

Completion

2022-12

Publications

• Background Grushka M, Epstein JB, Gorsky M. Burning mouth syndrome. Am Fam Physician. 2002 Feb 15;65(4):615-20.
• Background Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
• Background Jaaskelainen SK. Is burning mouth syndrome a neuropathic pain condition? Pain. 2018 Mar;159(3):610-613. doi: 10.1097/j.pain.0000000000001090.
• Background Liu YF, Kim Y, Yoo T, Han P, Inman JC. Burning mouth syndrome: a systematic review of treatments. Oral Dis. 2018 Apr;24(3):325-334. doi: 10.1111/odi.12660. Epub 2017 Mar 30.
• Background McMillan R, Forssell H, Buchanan JA, Glenny AM, Weldon JC, Zakrzewska JM. Interventions for treating burning mouth syndrome. Cochrane Database Syst Rev. 2016 Nov 18;11(11):CD002779. doi: 10.1002/14651858.CD002779.pub3.
• Background Minguez-Sanz MP, Salort-Llorca C, Silvestre-Donat FJ. Etiology of burning mouth syndrome: a review and update. Med Oral Patol Oral Cir Bucal. 2011 Mar 1;16(2):e144-8. doi: 10.4317/medoral.16.e144.
• Background Zakrzewska JM, Forssell H, Glenny AM. Interventions for the treatment of burning mouth syndrome. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD002779. doi: 10.1002/14651858.CD002779.pub2.
• Results Adamo D, Sardella A, Varoni E, Lajolo C, Biasotto M, Ottaviani G, Vescovi P, Simonazzi T, Pentenero M, Ardore M, Spadari F, Bombeccari G, Montebugnoli L, Gissi DB, Campisi G, Panzarella V, Carbone M, Valpreda L, Giuliani M, Aria M, Lo Muzio L, Mignogna MD. The association between burning mouth syndrome and sleep disturbance: A case-control multicentre study. Oral Dis. 2018 May;24(4):638-649. doi: 10.1111/odi.12807. Epub 2018 Mar 13.
• Results Cavalcanti DR, da Silveira FR. Alpha lipoic acid in burning mouth syndrome--a randomized double-blind placebo-controlled trial. J Oral Pathol Med. 2009 Mar;38(3):254-61. doi: 10.1111/j.1600-0714.2008.00735.x. Epub 2009 Jan 23.
• Results Chang CM, Wu PC, Chiang JH, Wei YH, Chen FP, Chen TJ, Pan TL, Yen HR, Chang HH. Integrative therapy decreases the risk of lupus nephritis in patients with systemic lupus erythematosus: A population-based retrospective cohort study. J Ethnopharmacol. 2017 Jan 20;196:201-212. doi: 10.1016/j.jep.2016.12.016. Epub 2016 Dec 12.
• Results Chang YY, Tsai YT, Lai JN, Yeh CH, Lin SK. The traditional Chinese medicine prescription patterns for migraine patients in Taiwan: a population-based study. J Ethnopharmacol. 2014 Feb 12;151(3):1209-1217. doi: 10.1016/j.jep.2013.12.040. Epub 2014 Jan 2.
• Results Chen HY, Lin YH, Wu JC, Chen YC, Yang SH, Chen JL, Chen TJ. Prescription patterns of Chinese herbal products for menopausal syndrome: analysis of a nationwide prescription database. J Ethnopharmacol. 2011 Oct 11;137(3):1261-6. doi: 10.1016/j.jep.2011.07.053. Epub 2011 Aug 2.
• Results Chen HY, Huang BS, Lin YH, Su IH, Yang SH, Chen JL, Huang JW, Chen YC. Identifying Chinese herbal medicine for premenstrual syndrome: implications from a nationwide database. BMC Complement Altern Med. 2014 Jun 27;14:206. doi: 10.1186/1472-6882-14-206.
• Results Chen LL, Lin JS, Lin JD, Chang CH, Kuo HW, Liang WM, Su YC. BCQ+: a body constitution questionnaire to assess Yang-Xu. Part II: Evaluation of reliability and validity. Forsch Komplementmed. 2009 Feb;16(1):20-7. doi: 10.1159/000197770. Epub 2009 Feb 17.
• Results Chen YL, Lee CY, Huang KH, Kuan YH, Chen M. Prescription patterns of Chinese herbal products for patients with sleep disorder and major depressive disorder in Taiwan. J Ethnopharmacol. 2015 Aug 2;171:307-16. doi: 10.1016/j.jep.2015.05.045. Epub 2015 Jun 9.
• Results Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
• Results Femiano F, Gombos F, Scully C, Busciolano M, De Luca P. Burning mouth syndrome (BMS): controlled open trial of the efficacy of alpha-lipoic acid (thioctic acid) on symptomatology. Oral Dis. 2000 Sep;6(5):274-7. doi: 10.1111/j.1601-0825.2000.tb00138.x.
• Results Grushka M, Epstein J, Mott A. An open-label, dose escalation pilot study of the effect of clonazepam in burning mouth syndrome. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Nov;86(5):557-61. doi: 10.1016/s1079-2104(98)90345-6.
• Results Heckmann SM, Kirchner E, Grushka M, Wichmann MG, Hummel T. A double-blind study on clonazepam in patients with burning mouth syndrome. Laryngoscope. 2012 Apr;122(4):813-6. doi: 10.1002/lary.22490. Epub 2012 Feb 16.
• Results Hens MJ, Alonso-Ferreira V, Villaverde-Hueso A, Abaitua I, Posada de la Paz M. Cost-effectiveness analysis of burning mouth syndrome therapy. Community Dent Oral Epidemiol. 2012 Apr;40(2):185-92. doi: 10.1111/j.1600-0528.2011.00645.x. Epub 2011 Nov 1.
• Results Hidaka T, Yonezawa R, Saito S. Kami-shoyo-san, Kampo (Japanese traditional medicine), is effective for climacteric syndrome, especially in hormone-replacement-therapy-resistant patients who strongly complain of psychological symptoms. J Obstet Gynaecol Res. 2013 Jan;39(1):223-8. doi: 10.1111/j.1447-0756.2012.01936.x. Epub 2012 Jul 6.
• Results Hsu PC, Tsai YT, Lai JN, Wu CT, Lin SK, Huang CY. Integrating traditional Chinese medicine healthcare into diabetes care by reducing the risk of developing kidney failure among type 2 diabetic patients: a population-based case control study. J Ethnopharmacol. 2014 Oct 28;156:358-64. doi: 10.1016/j.jep.2014.08.029. Epub 2014 Aug 29.
• Results Imura H, Shimada M, Yamazaki Y, Sugimoto K. Characteristic changes of saliva and taste in burning mouth syndrome patients. J Oral Pathol Med. 2016 Mar;45(3):231-6. doi: 10.1111/jop.12350. Epub 2015 Aug 21.
• Results Kuten-Shorrer M, Treister NS, Stock S, Kelley JM, Ji YD, Woo SB, Lerman MA, Palmason S, Sonis ST, Villa A. Safety and tolerability of topical clonazepam solution for management of oral dysesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Aug;124(2):146-151. doi: 10.1016/j.oooo.2017.05.470. Epub 2017 May 11.
• Results Lien AS, Jiang YD, Mou CH, Sun MF, Gau BS, Yen HR. Integrative traditional Chinese medicine therapy reduces the risk of diabetic ketoacidosis in patients with type 1 diabetes mellitus. J Ethnopharmacol. 2016 Sep 15;191:324-330. doi: 10.1016/j.jep.2016.06.051. Epub 2016 Jun 20.
• Results Lee AL, Chen BC, Mou CH, Sun MF, Yen HR. Association of Traditional Chinese Medicine Therapy and the Risk of Vascular Complications in Patients With Type II Diabetes Mellitus: A Nationwide, Retrospective, Taiwanese-Registry, Cohort Study. Medicine (Baltimore). 2016 Jan;95(3):e2536. doi: 10.1097/MD.0000000000002536.
• Results Lin JD, Chen LL, Lin JS, Chang CH, Huang YC, Su YC. BCQ-: a body constitution questionnaire to assess Yin-Xu. Part I: establishment of a provisional version through a Delphi process. Forsch Komplementmed. 2012;19(5):234-41. doi: 10.1159/000343580. Epub 2012 Oct 18.
• Results Lin SK, Tsai YT, Lai JN, Wu CT. Demographic and medication characteristics of traditional Chinese medicine users among dementia patients in Taiwan: a nationwide database study. J Ethnopharmacol. 2015 Feb 23;161:108-15. doi: 10.1016/j.jep.2014.12.015. Epub 2014 Dec 17.
• Results Lin YC, Chang TT, Chen HJ, Wang CH, Sun MF, Yen HR. Characteristics of traditional Chinese medicine usage in children with precocious puberty: A nationwide population-based study. J Ethnopharmacol. 2017 Jun 9;205:231-239. doi: 10.1016/j.jep.2017.05.006. Epub 2017 May 10.
• Results Lin YR, Wu MY, Chiang JH, Yen HR, Yang ST. The utilization of traditional Chinese medicine in patients with dysfunctional uterine bleeding in Taiwan: a nationwide population-based study. BMC Complement Altern Med. 2017 Aug 29;17(1):427. doi: 10.1186/s12906-017-1939-1.
• Results Lo LC, Chen YF, Chen WJ, Cheng TL, Chiang JY. The Study on the Agreement between Automatic Tongue Diagnosis System and Traditional Chinese Medicine Practitioners. Evid Based Complement Alternat Med. 2012;2012:505063. doi: 10.1155/2012/505063. Epub 2012 Aug 8.
• Results Lo LC, Cheng TL, Chiang JY, Damdinsuren N. Breast cancer index: a perspective on tongue diagnosis in traditional chinese medicine. J Tradit Complement Med. 2013 Jul;3(3):194-203. doi: 10.4103/2225-4110.114901.
• Results Lo LC, Cheng TL, Chen YJ, Natsagdorj S, Chiang JY. TCM tongue diagnosis index of early-stage breast cancer. Complement Ther Med. 2015 Oct;23(5):705-13. doi: 10.1016/j.ctim.2015.07.001. Epub 2015 Jul 10.
• Results Ma YC, Lin CC, Li CI, Chiang JH, Li TC, Lin JG. Traditional Chinese medicine therapy improves the survival of systemic lupus erythematosus patients. Semin Arthritis Rheum. 2016 Apr;45(5):596-603. doi: 10.1016/j.semarthrit.2015.09.006.
• Results Park DM, Kim SH, Park YC, Kang WC, Lee SR, Jung IC. The comparative clinical study of efficacy of Gamisoyo-San (Jiaweixiaoyaosan) on generalized anxiety disorder according to differently manufactured preparations: multicenter, randomized, double blind, placebo controlled trial. J Ethnopharmacol. 2014 Dec 2;158 Pt A:11-7. doi: 10.1016/j.jep.2014.10.024. Epub 2014 Oct 23.
• Results Pinder RM, Brogden RN, Speight TM, Avery GS. Clonazepam: a review of its pharmacological properties and therapeutic efficacy in epilepsy. Drugs. 1976 Nov;12(5):321-61. doi: 10.2165/00003495-197612050-00001.
• Results Puhakka A, Forssell H, Soinila S, Virtanen A, Roytta M, Laine M, Tenovuo O, Teerijoki-Oksa T, Jaaskelainen SK. Peripheral nervous system involvement in primary burning mouth syndrome--results of a pilot study. Oral Dis. 2016 May;22(4):338-44. doi: 10.1111/odi.12454. Epub 2016 Feb 26.
• Results Qu Y, Gan HQ, Mei QB, Liu L. Study on the effect of Jia-Wei-Xiao-Yao-San decoction on patients with functional dyspepsia. Phytother Res. 2010 Feb;24(2):245-8. doi: 10.1002/ptr.2920.
• Results Sun A, Lin HP, Wang YP, Chen HM, Cheng SJ, Chiang CP. Significant reduction of serum homocysteine level and oral symptoms after different vitamin-supplement treatments in patients with burning mouth syndrome. J Oral Pathol Med. 2013 Jul;42(6):474-9. doi: 10.1111/jop.12043. Epub 2013 Jan 9.
• Results Sikora M, Verzak Z, Matijevic M, Vcev A, Siber S, Music L, Carek A. Anxiety and Depression Scores in Patients with Burning Mouth Syndrome. Psychiatr Danub. 2018 Dec;30(4):466-470. doi: 10.24869/psyd.2018.466.
• Results Su YC, Chen LL, Lin JD, Lin JS, Huang YC, Lai JS. BCQ+: a body constitution questionnaire to assess Yang-Xu. Part I: establishment of a first final version through a Delphi process. Forsch Komplementmed. 2008 Dec;15(6):327-34. doi: 10.1159/000175938. Epub 2008 Dec 5.
• Results Terauchi M, Hiramitsu S, Akiyoshi M, Owa Y, Kato K, Obayashi S, Matsushima E, Kubota T. Effects of three Kampo formulae: Tokishakuyakusan (TJ-23), Kamishoyosan (TJ-24), and Keishibukuryogan (TJ-25) on Japanese peri- and postmenopausal women with sleep disturbances. Arch Gynecol Obstet. 2011 Oct;284(4):913-21. doi: 10.1007/s00404-010-1779-4. Epub 2010 Dec 1.
• Results Tsai DS, Chang YS, Li TC, Peng WH. Prescription pattern of Chinese herbal products for hypertension in Taiwan: a population-based study. J Ethnopharmacol. 2014 Sep 29;155(3):1534-40. doi: 10.1016/j.jep.2014.07.047. Epub 2014 Aug 1.
• Results Yang YH, Chen PC, Wang JD, Lee CH, Lai JN. Prescription pattern of traditional Chinese medicine for climacteric women in Taiwan. Climacteric. 2009 Dec;12(6):541-7. doi: 10.3109/13697130903060081.
• Results Yu MC, Lin SK, Lai JN, Wei JC, Cheng CY. The traditional Chinese medicine prescription patterns of Sjogren׳s patients in Taiwan: a population-based study. J Ethnopharmacol. 2014 Aug 8;155(1):435-42. doi: 10.1016/j.jep.2014.05.049. Epub 2014 Jun 4.

Drugs

Indications