The Comparison of Efficacy of Manual Acupuncture and Laser Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The autonomic nerve activity change.
研究概览
简要总结
Integrative medicine raises public's attention due to either mainstream or traditional medicine has its limitation. The topic "dysmenorrhea", with prevalence up to 50%, troubled many females with symptom as depression, reduced the quality of life; and even withdraw from daily activity.
Clinically, gynecologists apply analgesic such as Non-steroidal Anti-inflammatory Drugs, and oral contraceptive pills or progestin as conventional therapy. As NSAIDs cause gastrointestinal discomfort, while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety.
Furthermore, laser acupuncture has been practiced in recent years for it integrates the meridian theory and laser therapy; hence there are also some positive research in academic field.Whether laser or traditional acupuncture is more effective is still under debate.
Additionally, investigators had published that the theory of yin/yang (meridian) is compatible with autonomic nerve theory. As many women with dysmenorrhea suffered from insomnia, anxiety, convulsion of the uterine muscle, which are related to autonomic nerve dysfunction, investigators are intrigued to know whether the effect of acupuncture is related to adjusting autonomic nerve system.
Investigators intend to investigate the efficacy of laser and manual acupuncture in dysmenorrhea, and whether their mechanism is germane to hormone alternation or autonomic nervous system adjustment. The points in this proposal are 1.evaluate the efficacy of manual/laser acupuncture in dysmenorrhea in respects of symptoms and quality of life 2. compare whether these types acupuncture will alter the prostaglandin or hormone and the relationship between with the efficacy. 3. evaluate whether the mechanism of manual and laser acupuncture is relevant to alternating the autonomic nerve activity and if not correspond to Yin-Yang theory.
详细描述
1.1 The prevalence and mechanism of dysmenorrhea Dysmenorrhea is a troubling problem affect more than 50% reproductive-aged women and affect females' quality of life is not only physical but also psychologic aspects. It costs a lot of health, social and economic burden. The symptom is characterized by cramping pain in the lower abdomen, starting within the first eight to 72 hours of menstruation. According to research, the severity of dysmenorrhea ranged widely from mild, tolerable to incapability for 1 to 3 days each menstrual cycle, even incapable of work or daily activity. Some women even suffer from autonomic dysfunction symptoms such as dizziness, diarrhea, migraine, vomiting, unable to concentrate, negative mood and anxiety or depression. The mechanism of pain associated with dysmenorrhea can be addressed by two aspects: neuro-endocrine regulated and neuro-physiologic related. One is by the action of prostaglandins such as prostaglandin E2, prostaglandin F2α, or vasopressin-related from the endometrium at the onset of menstruation which stimulates pain neurons and induces excessive contraction of the uterus. Prostaglandin production is controlled by progesterone: when progesterone levels drop, immediately prior to menstruation, prostaglandin levels increase. The other aspect is that the increasing uterine muscle contractions and hormone secretion is regulated by the sympathetic nervous system. Therefore, some scholars stress the importance of reducing sympathetic tone or re-imbalance the autonomic nervous activity. Accordingly, investigators note that some research such as yoga, or aerobic exercise applied in dysmenorrhea are designed through this approach.
1.2 Current treatment of dysmenorrhea The conventional treatments adopt the use of non-steroidal anti-inflammatory drugs (NSAIDs) combined with oral contraceptives or progestins. Hormonal contraceptives are the first-line treatment for dysmenorrhea caused by endometriosis. Topical heat, exercise, and nutritional supplementation may be beneficial in patients who have dysmenorrhea. The NSAIDs may induce gastrointestinal disturbance while the hormone treatment may increase the risk of some cancer or other heart problems; therefore, around 25% of patients are refractory to conventional therapy. Some women choose alternative therapies such as yoga, acupuncture, or massage for relieving their pain albeit the evidence of these therapies is not enough.
1.3 The role of acupuncture in dysmenorrhea Acupuncture, which is non-invasive and with few side effects; has been proved with well anesthetic effect in pain control through varied mechanisms. On one hand, some study propose that the mechanism of acupuncture in dysmenorrhea is based on changes in neurophysiologic and neuro-hormonal activities such as endogenous opioid, serotonin, and acetylcholine which results in pain reduction; on the other hand, some study indicate that acupuncture has an effect in the reduction of inflammation, alterations in uterine blood flow and changes in prostaglandin levels. Previous research confirmed that acupuncture affects the autonomic status to some extent in diverting circumstances, yet the style of acupuncture varied from manual to warm to laser acupuncture etc. In addition to pain relieving, acupuncture has been reported with the efficacy in improving the quality of life and decreasing NSAID use after regular treatment for 3 to 6 months.
1.4 manual acupuncture VS Laser acupuncture Laser acupuncture raises the public's attention for its much less invasive than real acupuncture. In previous time, only TCM doctors or acupuncturists could practice the acupuncture; yet since laser acupuncture is not invasive, mainstream (western medicine) physicians could also practice laser therapy in the clinic, more and more research about laser acupuncture was published in the field of pain control, orthopedics, and internal medicine. Nevertheless, the research regarding laser acupuncture applied in dysmenorrhea is rare, only one trial is noted in the Pubmed, which intrigues us to further investigate the potential effect of laser acupuncture in dysmenorrhea now that investigators already have abundant manual acupuncture experience in this issue. Additionally, it is believed that acupuncture could attenuate pain or improve microcirculation by regulating the autonomic nervous system. However, whether the effect of manual and laser acupuncture on autonomic nerve activity is the same is still controversial. Some study indicates laser acupuncture could be an alternative stimulate therapy for it has the same effect as manual acupuncture on vagal activity whereas still, other studies note laser acupuncture has a different effect from manual acupuncture on autonomic activity. As a result, investigators aim to know more about these two types acupuncture's effect on HRV and compare their effectiveness.
1.5 Prospective of laser acupuncture in dysmenorrhea As many females troubled with the dysmenorrhea and hormone or analgesics therapy has a certain effect, acupuncture is promising for its less-invasiveness. Furthermore, if laser acupuncture is non-inferior to manual acupuncture or even much more effective; then it could be another alternative therapy in this issue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 49 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women within reproductive age (15 to 49 years);
- •Participants who complain about dysmenorrhea with at least grade II level.
- •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.
- •Some accompanied symptoms as dizziness and syncope, cramping, nausea, vomiting, diarrhea, headaches, and fatigue present compatible with the menses cycle were also included.
排除标准
- •Dysmenorrhea resulting from the use of an intra-uterine device (IUD);
- •Mild or infrequent dysmenorrhea.
- •Dysmenorrhea with possible underlying tumor or malignancy
结局指标
主要结局
The autonomic nerve activity change.
时间窗: baseline, before and after every month treatment for 3 months, after 1 month wash out, before and after every month treatment for 3 months.ts
Heart rate variance equipment
The serum prostaglandin E2 level change.
时间窗: baseline, after 3 months treatments, after 1 month wash out, after another 3 months treatments
serum test
次要结局
- The quality of life change.(baseline, after every month treatment for 3 months, after 1 month wash out, after every month treatment for 3 months.ts)
