The Efficacy of Different Doses of Acupuncture in Dysmenorrhea

The Study of Efficacy and Effect of Different Dose Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea

Subjects in this study included premenstrual syndrome and dysmenorrhea.

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. Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus.

In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few.

Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea?

Study Overview

• Status: Unknown
• Conditions: Dysmenorrhea; Premenstrual Syndrome
• Intervention / Treatment: Drug: Conventional gynecologic treatment; Device: Low dose acupuncture; Device: High dose acupuncture

Detailed Description

Subjects in this study included premenstrual syndrome and dysmenorrhea.

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 (premenstrual dysphoric syndrome, PMDD). The two groups are very similar. Premenstrual syndrome is mostly for physical discomfort, while premenstrual dysphoric syndrome is for emotional problems, affecting women's sleep seriously.

Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus. Many females afflicted with dysmenorrhea to different extents; some suffered from depression, reduced the quality of life; others even need to withdraw from work or school for incapable of daily activity. Thus, dysmenorrhea causes a lot of health burden and worth our attention. The prevalence of dysmenorrhea is up to 50 %. Generally speaking, primary dysmenorrhea is a menstrual pain in the absence of pelvic pathology while secondary dysmenorrhea is caused by organic dysfunction such as endometriosis, uterus malformation, cervix structure, pelvic inflammation, etc.

In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few. According to the theory of Traditional Chinese Medicine, acupuncture regulates meridians' energy and coordinates yin/yang while the western medicine reveals that the mechanism of pain-control of acupuncture is relevant to the theory of neurophysiology and some neuropeptide releasing, such as endorphin. Additionally, in our previous study, we noted that the theory of yin/yang (meridian) is compatible with autonomic nerve theory. Since many symptoms women with Premenstrual Syndrome and dysmenorrhea suffered, such as poor sleep, anxiety, convulsion of the uterine muscle, are related to autonomic nerve dysfunction, we are intrigued to know whether or not the effect of acupuncture relates to adjusting autonomic nerve system. Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea? We expect through this multidisciplinary study; we can coordinate not only the different viewpoints of both Chinese and western medicine but also verify the compatibility of the theory of yin/yang and autonomic nerve (parasympathetic/sympathetic). We look forward the study can not only be a reference for further evidence-based research but also by reconciling different perspectives of Chinese and western medicine, we can, in turn, promote the cross-talk of Chinese and Western medicine in practical and academic aspects.

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei City H

Participation Criteria

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. Women within reproductive age (15 to 49 years)
2. VAS≧4
3. Women with a history of regular menstrual cycles (28days±7 days)
4. Self-reported lower abdominal and pelvic, medial anterior thigh pain or low back pain associated with the onset of menses and lasting in 72 hours.

4.Symptoms: dysmenorrhagia, breast pain, dizziness, bloating, cramps, nausea, vomiting, diarrhea, headache, fatigue, etc.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

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: Conventional gynecologic treatment; Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.; Other Names: NSAIDs or oral contraceptives treatment
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 Pass(PC6) 、Supreme Rush(LR3) 、Joining Valley(LI4) 、Supreme Stream(KI3) 、Uterus(EX-CA1) 、Leg Three Miles(ST36)

What is the study measuring?

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 each individual by score(Balanced Constitution, Qi-deficient Constitution, Yang-deficient Constitution, Yin-deficient Constitution, Phlegm-dampness Constitution, Damp-heat Constitution, Stagnant Blood Constitution, Stagnant Qi Constitution, and Inherited Special Constitution).	We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Heart rate variation (HRV) test	HRV test include time domain analysis and frequency domain analysis.Time domain analysis includes SDNN, R-MSSD and pNN50. Frequency domain analysis includes LF, HF, LF/HF and total power.	We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline HRV parameter at 4 cycles (each cycle is 30 days). Time Frame: baseline and 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.	We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline VAS score at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Verbal multidimensional scoring system (VMSS) assessment	VMSS is used to assess the severity of dysmenorrhea. The VMSS assessment ranges from zero, one, two and three grade for evaluating the working ability, the systemic symptoms and whether analgesia is required or not. Grade 0 indicates that menstruation is not painful and daily activity is unaffected. Grade 1 indicates that menstruation is painful but seldom inhibits normal activity; analgesics are seldom required; mild pain. Grade 2 indicates that daily activity is affected; analgesics required and give sufficient relief so that absence from school is unusual; moderate pain. Grade 3 indicates that activity clearly inhibited; poor effect of analgesics; vegetative symptoms (headache, fatigue, vomiting, and diarrhea); severe pain.	We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline VMSS assessment at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
SF-12 Health Survey	SF-12 health survey is a questionnaire used to assess the quality of life of individuals. It contains a total of 12 questions and can be aggregated into physiological facets and psychological facets to assess the physiological and mental health status of the subjects.	We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline SF-12 Health Survey at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Blood test	Contain:estrogen, progesterone and prostaglandin	We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline blood test at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Menstrual Distress Questionnaire(MDQ)	Contain: Pain；Concentration；Behavioral Change；Autonomic Reactions；Water Retention；Negative Affect	We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Investigators: Principal Investigator: Tsai-Ju Chien, PhD degree, Taipei City Hospital; Study Director: Yi-Shuo Huang, B.S. degree, Taipei City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Acupuncture; Dysmenorrhea; Premenstrual Syndrome; Autonomic nervous activity; TCM syndrome; Meridian
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease; Menstruation Disturbances; Pelvic Pain; Syndrome; Dysmenorrhea; Premenstrual Syndrome; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral
• Other Study ID Numbers: TCHIRB-10701111

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