Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Effect of Different Acupuncture Dose on Premenstrual Syndrome and the Relationship Between Premenstrual Syndrome and TCM Syndrome Complex

Conditions
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Premenstrual Syndrome

Intervention / Treatment
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* Drug: NSAIDs or oral contraceptives treatment
* Device: Low dose acupuncture
* Device: High dose acupuncture


Participation Criteria
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Eligibility Criteria
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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: irregular menstrual cycles intrauterine contraceptive device (IUCD/IUD) uncontrolled neurological diseases lactation， pregnant women，or those with plans to get pregnant in the coming half year

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Gynecologic Treatment group<br>Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin. | Drug: NSAIDs or oral contraceptives treatment<br>* Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.<br>* Other names: Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.;|
| Experimental: Low dose acupuncture group<br>Acupuncture has fewer acupuncture points. | Device: Low dose acupuncture<br>* Six acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Inner Pass(PC6)<br>|
| Experimental: High dose acupuncture group<br>Acupuncture has more acupuncture points. | Device: High dose acupuncture<br>* Twelve acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Middle Extremity(RN3)、Inner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wang Qi Chinese Medicine Questionnaire | This questionnaire is used to survey TCM constitutions. Evaluate body constitution of | Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale(VAS) score | VAS is used to assess the extent of menstrual pain. | Change from Baseline VAS score at 4 cycles (each cycle is 30 days). | 
| Blood test estrogen |  | Change from Baseline blood test at 4 cycles (each cycle is 30 days). | 
| Blood test progesterone |  | Change from Baseline blood test at 4 cycles (each cycle is 30 days). | 
| Blood test prostaglandin |  | Change from Baseline blood test at 4 cycles (each cycle is 30 days). | 
| Menstrual Distress Questionnaire(MDQ) | Contain: Pain；Concentration；Behavioral Change；Autonomic Reactions；Water Retention；Negative Affect | Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Premenstrual Syndrome, TCM syndrome