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The Efficacy of Different Doses of Acupuncture in Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881319
Recruitment Status : Unknown
Verified July 2018 by Taipei City Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei City Hospital

Brief Summary:

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?


Condition or disease Intervention/treatment Phase
Premenstrual Syndrome Dysmenorrhea Drug: Conventional gynecologic treatment Device: Low dose acupuncture Device: High dose acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Efficacy and Effect of Different Dose Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: 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)




Primary Outcome Measures :
  1. Wang Qi Chinese Medicine Questionnaire [ Time Frame: 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) ]
    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).

  2. Heart rate variation (HRV) test [ Time Frame: 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) ]
    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.


Secondary Outcome Measures :
  1. Visual analogue scale(VAS) score [ Time Frame: 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) ]
    VAS is used to assess the extent of menstrual pain.

  2. Verbal multidimensional scoring system (VMSS) assessment [ Time Frame: 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) ]

    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.


  3. SF-12 Health Survey [ Time Frame: 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) ]
    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.

  4. Blood test [ Time Frame: 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) ]
    Contain:estrogen, progesterone and prostaglandin

  5. Menstrual Distress Questionnaire(MDQ) [ Time Frame: 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) ]
    Contain: Pain;Concentration;Behavioral Change;Autonomic Reactions;Water Retention;Negative Affect



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881319


Locations
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Taiwan
Taipei City H
Taipei, Taiwan
Sponsors and Collaborators
Taipei City Hospital
Investigators
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Principal Investigator: Tsai-Ju Chien, PhD degree Taipei City Hospital
Study Director: Yi-Shuo Huang, B.S. degree Taipei City Hospital
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Responsible Party: Taipei City Hospital
ClinicalTrials.gov Identifier: NCT03881319    
Other Study ID Numbers: TCHIRB-10701111
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study will have a continuous plan.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei City Hospital:
Acupuncture
Premenstrual Syndrome
Dysmenorrhea
Autonomic nervous activity
TCM syndrome
Meridian
Additional relevant MeSH terms:
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Syndrome
Dysmenorrhea
Premenstrual Syndrome
Disease
Pathologic Processes
Menstruation Disturbances
Pelvic Pain
Pain
Neurologic Manifestations
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female