Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

Taipei City Hospital

Status: Unknown

Conditions: Premenstrual Syndrome

Treatments: Device: High dose acupuncture; Device: Low dose acupuncture; Drug: NSAIDs or oral contraceptives treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04296422

TCHIRB-10712111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: Female

Ages: 19 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Conventional Gynecologic Treatment group

Active Comparator group

Description:

Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.

Treatment:

Drug: NSAIDs or oral contraceptives treatment

Low dose acupuncture group

Experimental group

Description:

Acupuncture has fewer acupuncture points.

Treatment:

Device: Low dose acupuncture

High dose acupuncture group

Experimental group

Description:

Acupuncture has more acupuncture points.

Treatment:

Device: High dose acupuncture