Clinical trial NCT04296422: Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis
Official title: Evaluation of the Effect of Different Acupuncture Dose on Premenstrual Syndrome and the Relationship Between Premenstrual Syndrome and TCM Syndrome Complex
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Acupuncture
Premenstrual Syndrome
TCM syndrome
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2020-03-05
Enrollment: 105
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The design of the study includes 3 groups for women with premenstrual syndrome, 1low dose acupuncture in the low-dose group, 2 high dose acupuncture in the high-dose group, and 3 the drug group (contraceptives) . Serum marker change of PGE2, CA125, E2, and progesterone in enrolled patients will be measured before and after treatment, along with VAS and MDQ questionnaires. The treatment efficacy of different groups and the relationship between PMS and patients TCM syndrome pattern will also be recorded and estimated.

Detailed description: Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Women who have such symptoms have been estimated as high as 75%; of which 3% to 8% are severe symptoms, called premenstrual dysphoric disorder (premenstrualdysphoric syndrome, PMDD). The two groups are very similar. PMS is mostly for physical discomfort, while PMDD is for emotional problems, affecting women's sleep seriously.

Regarding the treatment of premenstrual syndrome (PMS), western medicine adopt oral contraceptive pills (OCP) as the first-line medication. However, the common side effects of OCP, such as headache, dizziness, nausea, vomiting, depression, breast pain and so on are also troublesome, In recent years, some women also use acupuncture as an adjunctive replacement therapy because of its safety and fewer side effects. Nevertheless, the factors affecting treatment effect of acupuncture and moxibustion. such as the selection of acupoint s ( of which meridians) or number(dose) of acupuncture ,etc., maight affect the efficacy, yet the relevant research on this issue is not enough. In traditional Chinese medicine theory, acupuncture and moxibustion regulate the energy of the meridians and adjust blood and qi, which in turn help the balance of yin and yang. Female menstrual cycle is a process of conversion between yin and yang in TCM theory. While in western medicine, it is regulated by the endocrine system.

Eligibility criteria: Inclusion Criteria:

1.15 to 49 years 2.with a history of regular menstrual cycles (28days±7 days) 3.Symptoms：breast pain、dizziness、bloating、cramps、nausea、vomiting、 diarrhea、headache、 fatigue，etc

Exclusion Criteria:

1. irregular menstrual cycles
2. intrauterine contraceptive device (IUCD/IUD)
3. uncontrolled neurological diseases
4. lactation， pregnant women，or those with plans to get pregnant in the coming half year

Primary outcomes:
measure: Wang Qi Chinese Medicine Questionnaire
timeFrame: Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days).
Secondary outcomes:
measure: Visual analogue scale(VAS) score
timeFrame: Change from Baseline VAS score at 4 cycles (each cycle is 30 days).
measure: Blood test estrogen
timeFrame: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
measure: Blood test progesterone
timeFrame: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
measure: Blood test prostaglandin
timeFrame: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
measure: Menstrual Distress Questionnaire(MDQ)
timeFrame: Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days).
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City H
Study officials:
affiliation: Taipei City Hospital
name: Tsai-Ju Chien
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei City Hospital
name: Yi-Shuo Huang
role: STUDY_DIRECTOR
References: