Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

Not Applicable

• Conditions: Premenstrual Syndrome
• Interventions: Drug: NSAIDs or oral contraceptives treatment; Device: Low dose acupuncture; Device: High dose acupuncture

• Registration Number: NCT04296422
• Lead Sponsor: Taipei City Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-02
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-04
• Last Update Submitted: 2020-03-04
• Study First Posted: 2020-03-05
• Last Update Posted: 2020-03-05
• Primary Completion: 2020-09-18
• Study Completion: 2020-09-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Gynecologic Treatment group	NSAIDs or oral contraceptives treatment	Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
Low dose acupuncture group	Low dose acupuncture	Acupuncture has fewer acupuncture points.
High dose acupuncture group	High dose acupuncture	Acupuncture has more acupuncture points.

Primary Outcome Measures

Name	Time	Method
Wang Qi Chinese Medicine Questionnaire	Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days).	This questionnaire is used to survey TCM constitutions. Evaluate body constitution of

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei City H; 🇨🇳 Taipei, Taiwan