Head Yuanshi Dian Therapy in Burning Mouth Syndrome
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
Burning mouth syndrome is one of the most common oral mucosal diseases in clinic. It is a
chronic pain syndrome with extensive burning pain of oral mucosa as its main symptoms. There
are no pathological changes in oral mucosa and no characteristic histopathological changes.
Patients often have accompanying symptoms such as depression and xerostomia. Although the
patient does not have obvious oral lesions, the pain symptoms are more serious and the mental
pressure is greater.
BMS, as a complex clinical syndrome associated with multiple factors, mainly occurs in people
aged 27-87, with an average age of 61. BMS is rare among people under 30 years old. BMS is
predominant in women, the ratio of male to female is 1:5 to 1:7, the incidence is 0.7%-15%,
and increases with age. Up to 90% of female patients are in perimenopausal period. Symptoms
occur from 3 years before menopause to 12 years after menopause.
The causes of BMS are complex, and the treatment is difficult, easy to relapse and
protracted. Studies have confirmed that the occurrence and development of BMS are directly
related to mental factors. Therefore, psychosocial factors are the most important pathogenic
factors of BMS. If we intervene in these factors, it is hopeful to improve the curative
effect of BMS.
Traditional psychotherapy methods include drug treatment, psychotherapy, surgical treatment,
traditional Chinese medicine treatment, etc. Drug treatment is mainly based on different
types of mental and psychological diseases, choose different pharmacological effects of
drugs, so as to effectively control the disease. However, these drugs are prone to adverse
reactions such as sleepiness, weight gain, headache, physical weakness, etc. The basic
principle of psychotherapy is to let patients fully expose symptoms, listen to their
complaints patiently, carry out explanatory psychotherapy according to their medical history
or take other psychological training, so as to relieve patients' mental stress and alleviate
symptoms. But this method has a long course of treatment and needs the cooperation of the
patients' family members; the basic principle of surgical treatment is to resect the
corresponding areas of the brain or adopt endoscopy and micro-current to treat them, but the
risks and injuries caused by the operation are greater, and the adverse reactions after the
operation are larger; the treatment of traditional Chinese medicine needs a long course of
treatment, and the treatment of some patients. The effect is not stable enough.
The causes of BMS are complex, there is no objective disease in clinic, and the patients
suffer from abnormal pain, but the treatment methods are not uniform, and the curative effect
is not good, which makes the patients unable to get effective treatment in the early stage of
the disease, and easy to relapse, resulting in the aggravation and development of BMS into
intractable sensory abnormalities, and protracted! Literature reports confirm that the
tri-drug of oryzanol-riboflavin-vitamin E (oryzanol-riboflavin-vitamin E) is a classic
treatment for BMS and has been included in the classic book in China, Pharmacotherapy for
oral mucosal disease . However, its long-term clinical application has found that its
efficacy is unstable, and clinical symptoms after drug withdrawal. The symptoms are prone to
recurrence or even aggravation. Therefore, it is necessary to use the classical program on
the basis of a combination of interventions to promote the efficacy of stable and safe.
Over the past two years, the investigators has treated nearly 100 cases of BMS with head
yuanshi dian therapy, and achieved satisfactory results. It can obviously relieve burning
pain of BMS oral mucosa, promote saliva secretion, improve dry mouth and bitter mouth, and
improve sleep to a certain extent. However, due to the limited number of cases treated, the
classification of BMS is not meticulous enough, and there are still vague areas in the
classification of BMS, which affects the rigorous evaluation of the therapeutic effect of
BMS.
Therefore, the investigators propose a hypothesis: can the head yuanshi dian therapy be used
as the main adjuvant therapy for BMS? By consulting Pubmed, OVID, CNKI, Wanfang and other
major databases at home and abroad, the investigators found that there is no relevant report
at home and abroad. In view of this, the investigators intend to design this randomized
positive controlled clinical trial, using conventional valley-nucleus-E triple drug therapy
as the positive control group, to observe the efficacy and safety of head yuanshi dian
therapy for BMS, in order to find a safe and effective green non-invasive therapy,
effectively alleviate or eliminate oral mucosal pain, dry mouth, etc.
Phase:
Early Phase 1
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators:
Guiyang Hospital of Stomatology Stomatological Hospital of Guiyang Zhejiang Provincial Hospital of TCM