Clinical trial NCT03881319: The Efficacy of Different Doses of Acupuncture in Dysmenorrhea
Official title: The Study of Efficacy and Effect of Different Dose Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premenstrual Syndrome
Dysmenorrhea
Keywords: Acupuncture
Premenstrual Syndrome
Dysmenorrhea
Autonomic nervous activity
TCM syndrome
Meridian
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2019-03-19
Enrollment: 105
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility 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

Primary outcomes:
measure: Wang Qi Chinese Medicine Questionnaire
timeFrame: 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)
measure: Heart rate variation (HRV) test
timeFrame: 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 outcomes:
measure: Visual analogue scale(VAS) score
timeFrame: 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)
measure: Verbal multidimensional scoring system (VMSS) assessment
timeFrame: 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)
measure: SF-12 Health Survey
timeFrame: 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)
measure: Blood test
timeFrame: 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)
measure: Menstrual Distress Questionnaire(MDQ)
timeFrame: 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)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City H
Study officials:
affiliation: Taipei City Hospital
name: Tsai-Ju Chien, PhD degree
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei City Hospital
name: Yi-Shuo Huang, B.S. degree
role: STUDY_DIRECTOR
References: