Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

March 4, 2020 updated by: Taipei City Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei City H

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wang Qi Chinese Medicine Questionnaire
Time Frame: 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
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
Time Frame: Change from Baseline VAS score at 4 cycles (each cycle is 30 days).
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
Time Frame: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Blood test progesterone
Time Frame: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Blood test prostaglandin
Time Frame: Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Menstrual Distress Questionnaire(MDQ)
Time Frame: 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
Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei City Hospital

Investigators

  • Principal Investigator: Tsai-Ju Chien, Taipei City Hospital
  • Study Director: Yi-Shuo Huang, Taipei City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

September 18, 2020

Study Completion (Anticipated)

September 18, 2020

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCHIRB-10712111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study will have a continuous plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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