Dang Gui Shao Yao San (DGSYS or DSS) is a traditional Chinese herbal medicine (CHM) that has been used historically for the treatment of health complications such as primary dysmenorrhea, one of the complications associated with menstruation-related disorders.

The Efficacy of Dang Gui Shao Yao San for the Treatment of Primary Dysmenorrhea

By
Kuei Ku Liu

A Capstone Project
Presented in partial fulfillment of the requirements for the
Doctor of Acupuncture and Oriental Medicine Degree

Yo San University
Los Angeles, California
January 2020

Approval Signatures

This Capstone Project has been reviewed and approved by:

Jiling Hu L.Ac. Capstone Project Advisor Date

Name, Degree/license, Specialty Chair Date

Robert Hoffman, DAOM, L.Ac., Dean, Doctoral Program Date


Abstract
Dang Gui Shao Yao San (DGSYS or DSS) is a traditional Chinese herbal medicine (CHM) that has been used historically for the treatment of health complications such as primary dysmenorrhea, one of the complications associated with menstruation-related disorders. To address the symptoms, DSS has both sedative as well as anti-inflammatory agents that make it effective and the number one treatment for pain-related problems. The purpose of the study is to determine the efficiency of Dang Gui Shao Yao San as a possible treatment approach for primary dysmenorrhea. The study involved a systematic review of 746 relevant studies and four randomized controlled trials (RCTs) that used DSS for the treatment of primary dysmenorrhea. Both qualitative and quantitative data methods were used to score the efficacy of DSS. The Meta-analysis and systematic review provided sufficient evidence suggesting the efficacy and success of DSS in the alleviation of dysmenorrhea symptoms. The conclusion of this research is that the Chinese herbal medicine, DSS, originally believed to ameliorate menstruation-related disorders, is capable of efficiently helping women recover from dysmenorrhea symptoms quicker than any other intervention. and has no side effects as observed in other CHMs used to treat the same symptoms.


Contents

Abstract 3
Contents 4
Chapter 1: Introduction 6
Background of the Study 6
Problem Statement 7
Purpose of the Study 8
Understanding Dysmenorrhea 9
The Menstruation Cycle 12
Beneficial Effects of DSS 13
The Action Points of DSS in the Treatment 16
Definition of Terms 18
Research Questions 18
Research Objective 19
Research Hypothesis 19
Chapter 2: Literature Review 20
Chapter 3: Methods and Analysis 24
The General Statement of the Methodology 24
Sample Procedures 24
Inclusion Criteria 26
Exclusion Criteria 27
Data Analysis 28
Ethical Considerations 29
Chapter 4: Results 31
Studies of Beneficial Effects of DSS 33
Results from studying Primary Dysmenorrhea 37
Results from the Action Efficiency of DSS in Treating Primary dysmenorrhea 37
Summary 40
Chapter 5: Discussion 42
Implications for Practice 44
Limitations to the Study 46
Recommendations to Study 48
Conclusion 48
References 50

Tables and Figures
Table 1: Composition of Dang Gui Shao Yao San 6
Table 2: Studies Reviewed……..………………………………………………………………36
Table 3: Comparing Efficiency of DSS over other TCMs 39
Figure 1: Graph showing usage of DSS over other TCMs 39


Chapter 1: Introduction
Background of the Study
Menstruation pain is a widespread gynecological problem among women, which indicate a cramp-like, dull, throbbing pain mainly emanating from the lower abdomen before, during, and/or after menstruation. In that regard, this problem in the clinical set-up is termed as primary dysmenorrhea and has several treatments, including analgesics or prescribed painkillers, which are most commonly used. However, the question of the effectiveness or efficacy of these treatments varies. Dang Gui Shao Yao San (DSS) is a widely used formula of traditional Chinese medicine (TCM) derived from “Jin Gui Yao Lue 金匱要略” a medical classic written by Zhongjing Zhang during the Eastern Han Dynasty. DSS has been used for gynecological disorders for thousands of years. It contains a mixture of medicinal herbs, with some intended for blood activating while the others are for stasis eliminating. DSS is commonly used clinically to treat dysmenorrhea, menstrual abnormalities, irregular menstrual cycles, lack of menstruation, vaginal discharge, and many other gynecological disorders. DSS is widely used in China to alleviate these types of symptoms.
No. Pinyin Gram
1. Dang Gui 6
2. Shao Yao 6
3. Shuan Xiong 6
4. Ze Xie 6
5. Bai Zhu 6
6. Fu Ling 6
Table 1: Composition of Dang Gui Shao Yao San
Most TCM seekers tend to be younger and have tried using a combination of DSS and Western or prescribed medicine. One study involved the use of participants including two groups, one of which with 41,558 (89.69%) TCM seekers and the other with 4,779 (10.31%) non-TCM seekers. About 95 percent of TCM seekers had their symptoms improving. More than half of TCM seekers (55.41%) had to combine treatment with both acupuncture and Chinese herbal remedies (Scheild et al. 2015). The popularity of the use of TCMs such as DSS is based on evidence seen in this study that it is more effective than all the other interventions. However, there is a need to conduct further clinical trials and pharmacological experiments to validate the efficiency and safety of these products (Lin et al, 2017). DSS is the primary herbal intervention for the treatment of primary dysmenorrhea that women in Taiwan consume. Findings from about 53 percent of participants drawn from Taiwanese women who had diagnosed with primary dysmenorrhea indicated over 90 percent of this experimental group preferred DSS to relieve pain related to menstruation. Furthermore, the researchers noted that traditional medical practitioners in Taiwan were more likely to prescribe the herbal formula to treat this condition because it was the most efficient. The study also found out that its high efficacy due to the “sedative and anti-inflammatory agents” it contains.

Problem Statement
The current treatments for primary dysmenorrhea that utilize acupuncture and other synthetic medications, such as analgesics and placebo, have not been effective and have raised doubts as to why the traditional medication solved these symptoms effectively. One widely used prescription of DSS in China is Shaofu Zhuyu decoction, a famous formula. Precisely, in a study conducted randomly in a Chinese clinic confirmed that the prescription prevents symptoms recurrence of several illnesses, increases conception rate, and accommodates fewer and lighter side effects (Zhu et al. 2018). Although DSS has been used for a long time to treat primary dysmenorrhea, its efficacy has not been ascertained, especially in comparison with the other interventions (Leem et al, 2019). Therefore, to address the issues of discomfort resulting from this menstrual cycle-related disorder comprehensively, there is a need to identify the most effective treatment. This paper uses a combination of systematic review and meta-analysis to analyze various studies that provide both empirical and secondary evidence on the efficacy of DSS.

Purpose of the Study
Approximately 30 to 60 percent of women in the United States have acknowledged experiencing the distressing pain associated with primary dysmenorrhea in the ensuing menstruation cycles after the first menses. Statistics have indicated that there is a loss of approximately 6 billion work hours through such gynecology related complications in the United States alone, which is detrimental to the workforce. Therefore, healthcare scholars have carried out several studies determining the most appropriate form of medicine to alleviate this distressing pains and cramps experienced by women during menstruation. The main goal of this study is to find out the efficiency of DSS in the treatment of primary dysmenorrhea over other treatment and medication options.
The need to close the gap between the use of other medications and that of DSS is, therefore, very critical in medical research for the provision of data that is statistical and inclusive of all the facts prescribed for treatment (Lee et al., 2016). In addition, healthcare systems are diversified with using local herbs and provide opportunities for DSS utilization, introducing the need to know its efficiency in treating primary dysmenorrhea among other pain-related symptoms mainly in women. Therefore, this topic is important as a detailed analysis of finding out the effectiveness and efficiency of using DSS can pave the way for research on other herbal medicines across China.
Understanding Dysmenorrhea
Primary dysmenorrhea is a painful menstruation that does not have identifiable pelvic pathology common in the years after menarche with severe forms of limited activity while secondary dysmenorrhea is the consequence of pelvic pathology presence, which is associated with painful sexual intercourse and menstrual cycle disturbance. The former peaks at 20-24 years of age and decreases thereafter while the latter affects patients at their thirties and forties. At adolescence, the first four to five years of the menstrual flow are accompanied by painful cramps in women and the pain reduces as the age grows. Causes of primary dysmenorrhea are not as widely known and are classified as a reproductive condition that is either present or not present in women. The chances of it affecting women in the teenage age bracket and above are high. The main cause of the pain is the muscular contractions of the uterine wall stimulated by the decrease of prostaglandins in blood flow leading to limited oxygen supply to the uterus (Solos, Rong, & Jia-Xu, 2012). Just like labor pains, the contractions result in extreme pain and discomfort in women that may extend to even diarrhea and nausea at some points.
Symptoms of primary dysmenorrhea include severe back pains in women and sometimes pain in the thighs as well. This pain occurs a few days just before the menstrual cycle begins and gradually reduces as the days go by. The severity of pain is usually intermittent and range from mild to disabling conditions in women that can invite dizziness, fatigue, headache, and sometimes flu-like feelings (Armour, Dahlen & Smith, 2016). Physical examinations of the abdominal and pelvic regions are the most common way to diagnose women experiencing primary dysmenorrhea (Chen et al. 2018). Another test that can be done to diagnose primary dysmenorrhea is the pelvic ultrasound test performed vaginally. Treatments of primary dysmenorrhea range from the injection of vitamin K into the spleen, which has shown positive results especially in the first two days of the menstrual flow, the most painful stages of primary dysmenorrhea (Shen et al. 2005). Even though this is not a standard treatment, women have reported an intense decrease in pain and this makes it one of the best treatment options for primary dysmenorrhea (Chen et al. 2018).
Medical experts argue that the liver qi is carried by liver blood thus the inability to sustain a surge in blood production will lead to hyperactivity of the liver and causing the blood to become stuck (Usuki et al, 2002). The affected liver invades the spleen and damages it causing the spleen’s transformation and transportation functions to breakdown. The efficacy of DSS has been traced to Zhang Zhong-Jing’s understanding of how the pattern develops based on this aspect of disharmony. The signs and symptoms are characterized by a hypertonic abdomen presenting with pain, fluid retention, particularly edema affecting the lower limbs, as well as, of course, persistent mild abdominal pain, the chief symptom.
As explained earlier, the deficient supply of liver blood is the root and fundamental cause of this disharmony that leads to the hyperactivity of the liver. The findings of a study conducted by Pu et al., (2005) determined the impact of DSS on the liver: when there is a sufficient supply of blood that is necessary for carrying liver qi, the rest of the pattern is not expected to develop. The second aspect of the disharmony arises from the failure of the spleen to transform fluid and transport it, which becomes the underlying pattern associated with several disorders that affect the reproductive system, pain disorders, as well as other disorders associated with hematologic and gastrointestinal disorders. Similarly, blood deficiency resulting in qi stagnation can easily be grasped since the concept behind is primarily liver overreaction on the spleen. Therefore, DSS is one of the effective formulas used in treating these calibers of disharmony (Scheild et al. 2015).
In order to understand why DSS is more effective compared to other Chinese products and analgesics for the treatment of primary dysmenorrhea, researchers have conducted investigations about the molecular mechanisms of DSS in action. In a study conducted by Wang et al. (2015), researchers used a systematic review of databases. Collection of DSS formulas were obtained from the PubMed database and primary dysmenorrhea targets were gathered from the Gene Card database. The researchers constructed the “formula-syndromes-disease” network and analyzed the data obtained using Cytoscape software. Furthermore, the team used a molecular docking approach to verify the ingredients’ estrogen-like effect.
Furthermore, Wang et al. (2015) in a study found that DSS is efficient in ameliorating the deterioration of cognition in female Senescence Accelerated Mouse-Prone 8 (SAMP8) mice hence concluding that the efficiency of DSS in treating cognitive accommodates a strong evidence especially to patients with neurodegenerative disorders. Precisely, resend studies show that DSS has an immense effect on radical-mediated neurological diseases since it exhibits anti-inflammatory activities. Besides, men significantly outperform the women on multiple cognitive domains since ladies explicit a reduction in estrogen but fortunately DSS has the capability to increase the same hence a relief to them. Therefore, obtaining evidence through current reviews can make it easy to determine the most efficient CHM treatment, such as concluding that DSS is the most efficient management regimen for addressing primary dysmenorrhea (Kikuchi et al., 2017).

The Menstruation Cycle (This part is not well written—Do you want to talk about the cause of primary dysmenorrhea in western medicine?, or explain hormone imbalance causing primary dysmenorrhea? )
Women experience menstrual flow every month from their adolescent age, usually from age twelve or thirteen?. The hormones responsible for the menstrual flow include estrogen, follicle-stimulating hormone, progesterone, and luteinizing hormone. They all act in different ways to ensure that the reproductive cycle is not interfered with and can complete its cycle. For instance, the follicle-stimulating hormone is responsible for the stimulation of egg development in the ovary (Wong, Ip, & Lam, 2016). There can be an imbalance in the hormonal expressions periodically, which can interfere with the reproductive cycle while at the same time influence the other areas of the body such as changing the mood and energy availability in people. However, this is dependent on the time and stage of the cycle. Different people have different manifestations during menstruation, where some experience deep pains and cramps while others do not.
During menstruation, women can experience pain related to primary dysmenorrhea, in which DSS has become popular treatment due to its ability to provide relief to this problem. Pan et al. (2014) in a study aimed at analyzing the utilization of DSS among women with primary dysmenorrhea symptoms in Taiwan using cross-sectional survey found that multiple participants overlooked painkillers prescriptions (aOR=34.73, 94% CI: 32. 21-37.49) because they preferred taking TCM to relieve menstruation-related pain and those administered to pain medication were more likely to seek TCM treatment (aOR=0.99). The study produced an understanding that women with primary dysmenorrhea preferred using Chinese herbal products such as DSS to alleviate menstrual-related pain-related symptoms than acupuncture. DSS, which contains both anti-inflammatory and sedative agents, is extensively prescribed CHM for primary dysmenorrhea treatment (Pan et al., 2014).
For a particular medicine to have a high efficacy in the treatment of primary dysmenorrhea, it should not affect hormonal levels resulting in no adverse effects. The findings of the studies discussed earlier prove that DSS does not cause any side effects on the participants’ hormonal levels as long as their menstrual cycles were normal. Although the findings indicated that DSS tended to have a regulating effect on the participants’ hormonal levels, it lacks the ability of “pushing” levels of estrogen or other hormones out of the normal range in proportion to one another.

Beneficial Effects of DSS ( Other Effects of DSS? Comparing DDS with other pain relieve formulas?)
DSS has a long history of usage and makes up most of the pain-relieving treatments in traditional China since anemia and ovary disorders have been ameliorated and treated with the prescription (Chen et al. 2014). Studies have even shown that DSS has extended applications as well, such as in the treatment of depression while, the aqueous extract of the herbal medicine has been used for the prescription of chronic cases of stress and sleep disorders (Armour, Dahlen & Smith, 2016). Other treatment areas that use DSS in Chinese traditional medication include diabetic nephropathy. Streptozotocin-induced animals, like rats, showed that oral administration of DSS for twelve weeks helped lower their diabetic pressure without any negative effects, which paved the way for the human applications for this diabetic treatment. Diabetic-dependent changes in urinary albumin and clearance of creatinine or kidney hypertrophy were also observed after the twelve weeks and showed that humans can be treated with such complications using DSS (Chen, Kwekkeboom & Ward, 2016).
The efficacy of DSS is superior to analgesics and more effective than Wenjing decoction, Xuefu Zhuyu decoction, and Xiaoyao San decoction in the pain relief in the lower abdomen due to menses (Gao et al, 2019). Although the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) is the most common treatment of primary dysmenorrhea, it only provides temporary relief. It also causes several negative side effects to the kidney, digestive system, and liver. A study conducted using DSS for pain relief identified it as a feasible option for an alternative medicine. The antagonistic properties of DSS, due to KCl-depolarization, had effects on both acetylcholine-induced uterine and prostaglandin F2-alpha contractions and were more effective than all the other treatments in the study. These may be the major mechanisms of the beneficial effects of this Chinese prescription in treating primary dysmenorrhea (Hsu, Yang & Yang, 2006).
Treatment of menstrual irregularities such as primary dysmenorrhea using DSS reduces the use of NSAIDs. A study conducted by Proctor and Farquhar (2006) compared the efficacy of DSS and NSAIDs. DSS was administered for at least six months to women diagnosed with dysmenorrhea. Most of the women’s pain came from a similar cause: menstruation. According to the findings, 100 percent of the women, mainly drawn from a Japanese community, experienced a significant reduction of pain as their symptoms were easily alleviated. The result was achieved when a dosage of 2.5g was administered three times a day for a period of 6 months (Proctor & Farquhar, 2007). The results indicated that NSAIDs are not the preferred treatment when it comes to helping the Japanese women to overcome the challenges they face during menstruation.
Although NSAIDs are conventionally considered the first line of treatment for primary dysmenorrhea, the level of their efficacy is wanting. There is low evidence regarding its spectrum of use, comprehensive benefits, and side effects due to the lack of systematic or proper reporting. Some of the adverse side effects of NSAIDs include indigestion, drowsiness, and headaches. Consequently, many women in West Asia resort to alternative therapies that they believe can be more helpful in managing their menstrual discomfort such as DSS. Similarly, according to the selected Cochrane review, DSS was considered the most promising CHM for the primary management of primary dysmenorrhea, although many researchers acknowledge that the quality of the studies about it is poor (Kikuchi et al. 2017). Therefore, the review recommends that there is a need to conduct fresh studies where each study will focus on each of the CHMs identified.
The efficacy of DSS may be evaluated based on other therapeutic roles it may play. According to the findings of Chen, Kwekkeboom & Ward (2016), the efficacy and use of DSS in the treatment of primary dysmenorrhea takes a two-phase pattern that happens to be surprisingly common, particularly in women, in addressing a wide range of clinical indications. It proves challenging to determine how most of these indications happen to have a similar root cause. Although the first formulation prepared by Zhang Zhong-Jing was aimed at treating abdominal pain caused by a disharmony between the spleen and the liver among pregnant women, users only need to do minimal or no modification to the herbal medicine yet it remains highly effective in the treatment of numerous indications including primary dysmenorrhea, as long as it matches the underlying pattern. The study also found out that deficiency in the flow of blood into the liver is the root cause of this disharmony. The symptoms in primary dysmenorrhea cases are similar to those caused by this disharmony hence the rationale of evaluating the efficacy of DSS in the herbal therapy perspective usage is recognized easily.
The use of DSS as an effective substance in the treatment of ovarian dysfunction helps shed more light on it as a very competitive herbal medicine that may be recommended for the treatment of primary dysmenorrhea. A study has shown that the effectiveness of DSS in the treatment of ovarian dysfunction is linked to the neuroendocrine effect of the formula on the hypothalamic-controlled ovarian and pituitary functions. The efficacy of DSS is also associated with its ability to stimulate the process of synthesizing and releasing neurotransmitters, including acetylcholine, norepinephrine, and dopamine. The stimulation of DSS occurs when it activates the enzymes responsible for stimulating this neurological response in one’s brain (Usuki et al, 2002).
The Action Points of DSS in the Treatment
The action of DSS is exhibited in the liver where it interacts to send signals to calm the brain. It balances the emotions and nourishes the blood while consolidating with Yin and the vital fluids to soothe the liver and relieve pain. A study by Smith (2018) shows that DSS relieves hypertensive headaches, sweats that happen even at night, as well as abdominal and chest pains or spasms from the muscular actions through creating cold conditions that consolidates the pain, detoxifying bitter and sour tastes, and eliminating the vital fluids that cause the pain to be severe. DSS has a nourishing effect on the skin and calms the nervous system preventing stress and premature aging since it opens the liver directing the qi downwards and calming the targeted areas of the Lower Jiao (Wang, Wang & Yeh, 2016). Emotional issues are solved as well as stress and hypertension. Precisely, the prescription balances internal sweating with the cold conditions produced by nature thus making it effective and able to regulate abdominal and other muscle pains.
The preference and widespread use of DSS as a popular traditional Chinese prescription to treat inflammatory diseases such as primary dysmenorrhea in China has, for a long time, been poorly understood (Liu et al, 2007). However, research by Hua et al. (2008) has shown the mechanism of action of the substance in dealing with the inflammatory disorder. The findings of the study showed that prostaglandin F2α (PGF2α), an important mediator of inflammation, is an important factor in the pathological mechanism that results in primary dysmenorrhea. This study shows that DSS acts to substantially suppress oxytocin-evoked PGF2α production in rat’s endometrial epithelial, which occurs through an intricate and concentration-dependent manner. Furthermore, DSS mediates the down regulation of cyclooxygenases-2, which messages RNA transcription, enzyme activity, and protein expression, leading to more inhibition of PGF2α production. The study provides a possible mechanism for the bioactivity of DSS for treating primary dysmenorrhea and other gynecological disorders.
The results from the study revealed the “formula-syndromes-disease” involving shared multiple targets that involve various important nodes, including PGF2α and IL, served to be part of the analgesic and anti-inflammatory effects. DSS could influence how hormones function, for example, the corticotrophin-releasing hormone, is induced to inhibit hyperactivity of the adrenal axis. Therefore, the study employs an effective strategy in studying DSS in the treatment of primary dysmenorrhea (Wang et al, 2015).
Understanding the composition of DSS is crucial in order to understand its action points in the treatment of gynecological health disorders such as primary dysmenorrhea. Liu et al. (2007) conducted a study aimed at observing the effects of DSS-A-N-30, an extract ingredient of DSS, on the rat uterine smooth muscle contractility in vitro. The researchers in the study analyzed the potential physiological mechanism of the DSS extract. The method of the study involved making isolated uterine strips and using K+-depolarization and oxytocin in a Ca2+-free solution to induce the effect of DSS extract on spontaneous uterine contraction, as well as inducing uterine contraction. Findings from the study indicated that DSS (141.5, 383, 566 mg·L-1) inhibited the uterine from spontaneous contraction followed by induction of an intense contraction by three agonists: 10 IU·L-1 oxytocin, 10 μmol·L-1 acetylcholine, and 1 mg·L-1 prostaglandin F2α. The K+ depolarization-induced contraction remained and hence not inhibited by the DSS complex, but the oxytocin in a Ca2+-free solution-induced contractile could be inhibited by the DSS complex. The study concluded that DSS-A-N-30 was effective indirectly inhibiting the uterine contraction by inhibiting the release of Ca2+, thus relaxing the smooth muscle of the uterus. Therefore, DSS-A-N-30 was confirmed to be among the active ingredients of DSS and has a great potential to be improved into an effective drug that can be used to treat primary dysmenorrhea (Liu et al, 2007).

Definition of Terms
Dang Gui Shao Yao San (Chen et al., 2014). Chinese traditional herbal medicine.
Primary dysmenorrhea (Chen, Draucker & Carpenter, 2018). Recurrent menstrual cramps unrelated to other diseases.
Traditional Chinese Herbal Medicine (TCM) (Pan et al., 2014) is the collective terminology for all traditional medicines in China.
Research Questions
1. How efficient is the use of DSS on primary dysmenorrhea?
2. Is traditional herbal medication more effective than the current synthetic pain relievers?

Research Objective
The main objective of this research is to find out the efficacy of DSS usage in treating primary dysmenorrhea among women by comparing its outcomes with other modern drugs administered such as painkillers. Primary dysmenorrhea causes immeasurable pain and discomfort among women that on many occasions denies them the opportunity to go to work, which causes an adverse effect on economic growth. Therefore, studying the efficacy of DSS is beneficial in treating women hence providing a guarantee to their daily lives of facilitating continuous workforce participation. Furthermore, this research upon completion sheds improved awareness of traditional herbal medicines thus diversifying the healthcare field.

Research Hypothesis
Null Hypothesis: The use of traditional herbs such as DSS has very little and limited effects on the treatment of primary dysmenorrhea.
Alternative Hypothesis: DSS has high efficiency in the treatment of primary dysmenorrhea.

Chapter 2: Literature Review
The review involved a systematic review of 746 relevant studies and four randomized controlled trials (RCTs) that used DSS for the treatment of primary dysmenorrhea. Both qualitative and quantitative data methods were used to score the efficacy of DSS. The researcher used several databases including EMBASE; AMED: PubMed; the Cochrane Library; five Korean databases (DBPIA, Korea MEd, OASIS, KISS, and RISS); one Japanese database (CiNii), and three Chinese databases (CNKI, VIP, and Wan Fang) to find relevant articles and journals. The use of Cochrane criteria to conduct an assessment on the risk of bias associated with individual studies and all RCTs of DSS provided found that the research can be relied on to determine the efficacy of DSS in alleviating primary dysmenorrhea symptoms. The data obtained from all articles were tested for validity and reliability as it was obtained by two reviewers working independently.
BMJ Clinical Evidence was used in search of primary dysmenorrhea management and treatment information. Several databases were reviewed and used to identify relevant studies and to mine data related to the use of DSS in the Asian countries. Some of the databases identified and reviewed include the Medline (1966-July 2006), Embase (1980-July 2006), and The Cochrane Library (Issue 2, 2006). Additional searches carried out on these websites include the Turning Research into Practice (TRIP), NHS, Clinical Excellence (NICE), Centre for Reviews and Dissemination (CRD) applicable all databases, and the National Institute for Health. To collect the required and only relevant information, two information specialists retrieved and systematically and independently assessed the abstracts of the researches. The specialists used predetermined criteria to sort relevant studies. The selected study design criteria, particularly for inclusion, for each review were RCTs and published systematic reviews in most of the common languages: English, Chinese, and Japanese. They were single-blinded and had at least more than twenty individuals of whom at least 80 percent were identified for follow up.
The reviews did not set any minimum length of patient follow up as a requirement to include studies. Exclusion criteria were applied and included all studies defined as “open-label”, “open”, or not blinded, except for the interventions that could not be “blinded”. Additionally, a regular surveillance protocol was used to detect harm alerts especially from organizations, for example, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA), which are consistently added to the ongoing review since it is a requirement. To ensure that only quality and reliable information is collected from the reviews, it was necessary to perform GRADE evaluation of all the peer-reviewed articles and databases, with the baseline being the quality of the required evidence with regards the interventions in the management and treatment of primary dysmenorrhea (Proctor & Farquhar, 2007).
In order to accept the validity of the result obtained in this study, several factors must be implemented in the study. First, an effective study method is fundamental and this study, a meta-analysis was used to evaluate several Chinese herbal products concerning their comparative efficacy for primary dysmenorrhea treatment. Secondly, the findings from a systematic review involving randomized controlled trials with the aim of evaluating the efficacy of herbal medicine for primary dysmenorrhea. Using meta-analysis to pool the target data enabled the identification of a total of 746 hypothetically relevant studies, as well as four RCTs that met the inclusion criteria of the study (Proctor & Farquhar, 2006).
This research aimed at confirming the efficiency of the use of DSS in treating primary dysmenorrhea. This chapter gives highlights of the research methods applied for all the clinical procedures to conclude the data to justify that DSS is efficient in the management of primary dysmenorrhea compared to other herbal and synthetic medications (Proctor & Farquhar, 2007). A combination of meta-analysis and systematic review was used to analyze data and findings from a wide range of studies involving a comparison of the efficacy of DSS and other interventions. Data and findings from a wide range of studies were systematically compared. Some of the main search terms used included Chinese herbal medicine, Dang Gui Shao Yao San, and primary dysmenorrhea treatment. The evidence was collected from studies that used randomized controlled trials with participants diagnosed with primary dysmenorrhea (Proctor & Farquhar, 2006).
In another study to determine the efficacy of the DSS, a group of researchers carried out a survey using 23,120 Taiwanese women with a history of primary dysmenorrhea. Deriving the data by the National Health Insurance Research Database, the investigators identified and documented 213,248 TCM office visits comprising of a significant number of DSS individuals who sought to be treated of primary dysmenorrhea. More than 99 percent of the group of participants was administered with DSS, being their top choice (Lin et al, 2017). For this reason, the researchers went ahead to formally recommended research on the efficacy of this type of Chinese medicine herbal medicine.
Some current studies focusing on measuring the medicinal efficacy of DSS also supported the claim that medicine is the most preferred among all the CHMs and prescribed painkillers. Results from a study conducted in 2005 disclosed that using DSS led to the formation of anti-superoxide and “free radical scavenging activity” in a manner indicating concentration-dependency. The medicinal substance was also found to inhibit phorbol 12-myristate 13-acetate (PMA), a tumor promoter, and boosted FMLP, an induced superoxide anion mainly released neutrophils in human beings. These findings indicate that these antioxidant actions have cytoprotective effects that act against inducing human platelet aggregation arachidonic acid (AA), lipid peroxidation especially in a rat liver, as well as mitomycin C-mediated hemolytic and homogenate adenosine diphosphate (ADP) in human erythrocytes. Therefore, to determine the efficacy of the drug component of DSS, inhibition of PMA using the anti-superoxide radicals’ pain reduction pressures was measured. The medicine is also expected to experience no adverse effects, which depends on how the patient adapted to the process by use of the herbal medicine when compared with other drugs that are either traditional or synthetic.
The greater efficacy of DSS may be associated with its ingredients that include Dang Gui, Chuan Xiong, Bai Shao Yao, Fu Ling, Ze Xie, and Bai Zhu. The TCM performs key functions in this formula including nourishing the liver blood, transforming dampness and harmonizing the spleen and liver. The findings classically indicated that the treatment was used for primary dysmenorrhea and threatened miscarriage. The formula is effective in the TCM system as an appropriate intervention in some cases in which the classical indications match the differential diagnostic patterns (Kennedy et al, 2006).


Chapter 3: Methods and Analysis
The General Statement of the Methodology
This study applied a qualitative analysis of the literature with a focus on the primary data sources to see how the previous results and test statistics compare the outcomes and make justifications. Qualitative data was important for this study because of the intensity to describe the different primary dysmenorrhea conditions and effects. In RCTs, patients showing primary dysmenorrhea symptoms were administered with the DSS while the others were administered CHMs, placebo or NSAIDs the control. The findings from the study showed that the participants administered with DSS responded faster compared to those in the controls (Gao et al, 2019).
Moreover, the data and findings from a wide range of studies involving comparison of DSS efficacy and other interventions were systematically explored. Some of the main search terms used included Chinese herbal medicine. The main points given were distributed to the effects of DSS in the urinary bladder. The administration of questionnaires among the Chinese and Japanese speaking participants made it easier to provide important feedback for the research since DSS is primarily culture oriented. This showed that more than half of the respondents knew about primary dysmenorrhea although they expressed it in their local languages introducing difficulties to understand and interpret at the initial stages of the research.

Sample Procedures
Many types of research have been done on primary dysmenorrhea giving many articles for search. Using keywords like primary dysmenorrhea in the search gave more than thirty articles. In addition, the search on DSS gave about 25 articles though almost all linked to Chinese researchers. The study applied more of the peer review article and journals to survey and connects to what the previous studies found on matters of primary dysmenorrhea and the action shape of DSS. Wiley Online Library and the Google Scholar search options provided access to the sources. The articles despite relating to the content in the search did not have similar contents since the research topics in them were also different but interconnected to share on both the DSS and primary dysmenorrhea (Proctor & Farquhar, 2007).
The survey utilized one-on-one meetings with women to discuss openly the experiences during menstruation that necessitated content sharing of the research articles and the real results from what women go through in their urge to stop this painful experience. The use of questionnaires and interview guides were used to obtain results and organize the information into the most active ages of the condition and whether it has similar effects or other symptoms in all women . Additionally, the Cochrane criteria to carry out an assessment on the risk of bias associated with individual studies and all RCTs of DSS provided finding that the studies can rely on to determine the efficacy of DSS in alleviating primary dysmenorrhea symptoms. The data obtained from all articles were tested for validity and reliability as it was obtained by two reviewers working independently. However, the use of BMJ Clinical Evidence in search of alternative or comparable methods of primary dysmenorrhea management and treatment information required authorization from the management to accesses the data in the databases. Other several databases were accessible, and this made reviewing them take a short time to identify relevant studies and to mine data related to the use of DSS in the Asian countries. The findings will then be used to draw conclusions on the classically indicated symptoms in the treatment of primary dysmenorrhea.

Inclusion Criteria
In order to limit the collection of data to a specific population that is relevant to the research, the research design limited the key inclusion criteria to include women within the age of age 18 to 45 years; those with menstrual cycles occur every 21– 42 days as well as those with primary dysmenorrhea and usually needed and accessed treatment from analgesia as well as had their day to day activities significantly impaired. The inclusion criteria also state that women with irregular menstrual cycles, they were required to be informed early enough that they were expecting menstruation. Additionally, the research admitted participants who were willing to desist from consuming any other forms of prescribed drugs, tranquilizers; and stimulants. They were also requested to maintain the diet they usually take, mealtimes, as well as smoking and drinking habits.
This study accepted only those responses and search articles with women’s reproductive challenges we picked. Other areas of concern in accepting sources include the studies that focused on the menstrual flow and the actions of hormones as well as how they coordinate to make the cycle complete. Such studies gave a clear results demonstration and were the best options for the topic. Survey tools such as questionnaires and interview guides were also used to make only the positive feedbacks accepted with little chances to the negative ones as they did not share much on the menstrual cycle on the primary dysmenorrhea situations. The understanding of Chinese medicine was a better score through research articles, and this made them the major sources used for this study.
In order to comprehensively address the discomfort ?resulting from this menstruation-related disorder, there is a need to identify the most effective intervention. The studies focused on identifying the problem would most likely find out the efficiency of DSS in the treatment of primary dysmenorrhea. For example, the identification of SS-A-N-30 as one of the components in DSS, which contributes to its efficiency, was effective indirectly inhibiting the uterine contraction by inhibiting intracellular stores from releasing the Ca2+ to relax the smooth muscle of the uterus.

Exclusion Criteria
Key exclusion criteria included participants identified as having diseases-related to primary dysmenorrhea. For example, adenomyosis and/or endometriosis; involving a concurrent utilization of a prior identified intrauterine contraceptive device, alternative therapy, or herbal remedy for primary dysmenorrhea. Concurrent use of other TCM, likely to use analgesics, or muscle relaxants, and sedatives, in the 48 hours before menstruation, use of mood-altering medication, and not willing to use reliable contraception if sexually active.
Studies done beyond five years from the time of the study did not meet the comparison and analysis criteria as they tend to give unreliable data and with change of tools and that more research done in the near past at least share the qualities of exposure in the current world and not too old situational understandings as given in the old articles. Studies that are non-peer reviewed were also rejected on conditions that they have little or slim solutions to research and that their contents are full of biases in the information they post online. Additionally, studies that did not touch any idea on primary dysmenorrhea and DSS were not accepted for they did not tie to the research questions or hypothesis in the test. Lack of demonstrative approaches to the studies also gave a ready lead to disown some articles.

Data Analysis
The interview guide and the questionnaires were used to compare and analyze the data. The study involved an analysis of the findings obtained within a period of six weeks to three months as was for analyzed from the research gives a good window to start seeing the pain reduction results following the administration of the DSS and its comparable analgesics or other herbal medicines that were administered against primary dysmenorrhea to women in the 13-25 age bracket . DSS, therefore, is capable of opening the liver directing the qi downwards and calming the targeted areas of the Lower Jiao. The researcher used the abstract to see that all points of critical importance were picked and analyzed to give a clear understanding of the research demands. DSS is a traditional herbal remedy used in China and has been used in many researches on its effects and efficiency on primary dysmenorrhea with results that the best ways the traditional world embraced natural medication then, should the modern world give inputs to the same in line with making killing an easy solution or approach to curbing the stress of such complications as primary dysmenorrhea at their early stages.
The inclusion and exclusion criteria gave clues to the best action points for the researcher to pick points and this included the specific action of pain associated with primary dysmenorrhea that is, usually being intermittent and ranging from mild conditions to disabling conditions in women (Armour, Dahlen & Smith, 2016). Other symptoms to be considered under primary dysmenorrhea are dizziness, fatigue, headache, and sometimes a flu-like feeling is experienced. The analysis will also consider the nature of the participants used in the research. Identifying the right participants is concordant in obtaining relevant results. One aspect in all the studies referred to here is that the participants are divided into two groups, with one group being the experimental group while the other is the control group. The findings from the study showed that the participants administered with DSS responded to the treatment with symptoms being alleviated while there is little or no significant change in the control group.

Ethical Considerations
This research obtained consent from all the subjects reached with the questionnaire and interview guides, thus giving ease of interaction once they read and saw the attached ethical note that allowed the study to reach out to them. This systematic review complies with all the requirements befitting the publishing of this research in a peer-reviewed journal. As a result, the paper qualifies for dissemination both electrically and in print (Leem et al, 2019). The review will benefit patients and practitioners in the fields of traditional and conventional medicine. Very little privacy risks were seen as most of the research sources operated around the articles with only a few linked to the original researchers.
The articles and other sources referred to in this research were obtained from databases created through a detailed protocol that had been reviewed, exempted, and approved by various relevant boards such as the Institutional Review Board of the Chang Gung Memorial Foundation (number 201700066B1) (Pan et al, 2014). The studies alluded to have not contravened the privacy and confidentiality policies of the participants used in the various studies used in the researches, therefore, the individual’s identity is well encrypted in the database, and the privacy information cannot be easily traced or recognized. Physical examination is another area that requires a patient’s consent before a diagnosis is required. The extent to which a medical practitioner is required to reach can sometimes lead to a legal filing due to a violation of privacy rights.
The assessment of the patient’s abdominal and pelvic conditions is the most common diagnostic procedure of women experiencing primary dysmenorrhea; therefore, the medical specialist must communicate with the patient clearly to ensure that there is an informed consent to conduct the procedure. The informed consent from the respondents and the special attention to have clear results of the abstracted information was also given keen interest (Chen, Shieh, Draucker & Carpenter, 2018).

Chapter 4: Results
This chapter gives details to the findings of the results as was conducted by the researcher in line with what is given in the literature review. The summary of the effectiveness of DSS on the treatment of primary dysmenorrhea was critical in the findings for it contained all the reasons for the study. What happens before the menstrual flow and what follows after then narrowing all down to what is experienced during the cycle gave the researched batter approach to the results?. All the data used in this study was primarily attained through a survey with the respondents giving their firsthand views and the use of peer-reviewed or journal articles. The inclusion and exclusion criteria also linked to positive guidelines for what is given in this chapter. The researchers in this study were also to carry out an analysis of the potential physiological mechanism of the DSS extract. The method of the study involved first making isolated uterine strips and using K+-depolarization and oxytocin in Ca2+-free solution to induce the effect of DSS extract on spontaneous uterine contraction, as well as introducing the uterine contraction. The reliability and validity of the results were justified on the quality of the questionnaire survey and the type of articles used by the researcher.
This data gives details of the research findings from several data collected from a wide range of studies and based on the specific research methods and the selection criteria used in each of them for all the clinical procedures to conclude the data to justify that DSS is efficient in the management of primary dysmenorrhea compared to other herbal and synthetic medications (Proctor & Farquhar, 2007). A combination of meta-analysis and systematic review was used to analyze data and findings from a wide range of studies involving a comparison of the efficacy of DSS and other interventions.
The efficiency of DSS in alleviating primary dysmenorrhea depends on its ability to alleviate the symptoms but leave estrogen balance intact. Although DSS has an Estrogen-like effect concerning the treatment of primary dysmenorrhea, it is stronger compared to Guizhi Fuling Wan and does not interfere with the normal functioning of the hormone or its levels (Chen et al. 2014). Basing their arguments on these findings, the researchers proposed that the regulatory response that DSS is identified with is opposed to the generated estrogenic levels following the stimulation of estradiol, which sometimes used as hormone replacement therapy.
The use of animals is fundamental in conducting researches although they might end up detrimental to human life. In this experiment, researchers treated animals with DSS for two months. From the graphs used to analyze the data, the latency of SAMP8 presented in the step-down test graph was shorter compared to that SAMR1 (Huang et al, 2014). The administration of DSS was observed to increase the latency, particularly when experimenting with female animals. The results in Morris water maze (MWM) test were not different from that of step-down test since the time SAMP8 spent was enough to acquire the platform leading to a decrease in time finding the platform of the mice administered DSS, but the effects of DSS on swim velocity was little when the mice were training. Precisely, there is a need to use interventions that have minimal side effects to ameliorate primary dysmenorrhea and significantly decrease menorrhagia symptoms. As shown in the findings in this paper based on data collection meta-analysis and systematic review, the data obtained is sufficient and significant to conclude that DSS is the best intervention for the disorders.

Studies of Beneficial Effects of DSS
Unfortunately, out of 25 articles researched encompassing 233 women, only five met our criteria for acceptance. Moreover, our questionnaire reached out to 43 women with only 31 giving feedback that complied with all questions in the survey . The decline from the survey was due to the lack of familiarity between my team and the respondents despite the obtained consent to share the experience. Some respondents picked the interview questions and interview guides to answer privately, which was accepted but never returned them while others did not complete the survey because of time constraints to finalize the data for analysis. More than half of the respondents reached have their feedback and this was positive considering the research was not limited to a particular social class, as even male doctors were able to respond from the results they get with women in such conditions.
From the data collected, the reliability gave a more percentage connection to DSS, a Chinese traditional herb to being connected and known in China only and no other parts of the world. However, all the study findings gave results that the use of DSS has many positive effects in relieving painful conditions with primary dysmenorrhea included. Here, a measure of the findings was given based on the pain reduction pressures and how the patient adapted to the process by use of the herbal medicine and no other drugs that are either traditional or synthetic. Many women gave similar feedback to those read in the articles that the primary times they experienced the pain was during the menstrual flow and this affected their daily activities, both domestic and commercial.
Data from the articles gave results that women are supportive of the use of DSS to treat primary dysmenorrhea and suggest that it will be effective even on other painful conditions from physical harm or the internal body pains. In China, the traditional herb is used as a painkiller and this lowers the rate of use of synthetic drugs in any form. From the articles, the researchers suggest that the combination in this herb must be used in other countries because only the naming of the plants is different going by culture diversity and the herb usage although its utilization in addressing menstrual-related pain would depend on the stage of the ovulation cycle when the pain starts (Leem et al. 2019).
Most of the studies that have focused on searching the beneficial effects of DSS have based their efforts on empirical data obtained from quantitative research and qualitative research methods. The findings from these studies have shown that the famous Chinese complex herbal prescription has been in existence for a very long period hence the beneficial effects are worth identifying to understand why DSS has been the first-line intervention for primary dysmenorrhea in China and other Asian countries. Recent study has shown that DSS possesses its therapeutic efficacy in the treatment of other ailments such as depression (Zhou et al. 2015). Focusing on the efficiency of DSS in alleviation of symptoms associated with stress, the research also sought to identify the effects of DSS aqueous extract and its therapeutic efficacy in the treatment of chronic restraint stress (CRS), an induced sleep disorder.
In the above study, the researchers treated three mice with DSS by administering them with doses of 0.626g/kg, 1.24g/kg and 2.6g/kg for a period of 10 days . They were then subjected to sleep latency and sleep time which was measured 24 hours after the completion of CRS procedures. The food intake and body weight of the mice were also determined. The findings from the study indicated that the DSS dose-dependent caused a prolonged latency but resulted in a decrease in the sleep time of the mice. The conclusion in the study is that there was an indication of the efficiency of DSS to exert measurable therapeutic improvement in CRS-induced hypersomnia (Zhou et al. 2015). Therefore, the study was successful in determining the beneficial effects of DSS.
Similarly, the therapeutic effect of DSS is recognized as being among the top ten most frequently prescribed formulas for the treatment of a wide range of disorders including primary dysmenorrhea (Zhou et al. 2015). This study acknowledged that DSS has features to regulate menstrual flow, nourish blood, and relieve psychological and emotional symptoms clinically. Findings from previous studies showed that DSS ameliorated depression that commonly affected menopausal women by acting on organs to increase serum TNF-α and also helped people with depression-like behaviors, based on the murine model, through causing a decrease in central arginine vasopressin (Lin et al, 2017). DSS is highly utilized probably because of the many cases of patients with psychological disorders. Furthermore, DSS is also efficient in exerting analgesic effect not only on primary dysmenorrhea but also on many other disorders caused by suppression of contractions of the uterine smooth muscle as well as corrected luteal phase insufficiency (Huang et al. 2014). The study, just like many other studies discussed earlier identifies DSS as an efficient formula meeting very common needs in the cultures frequently mentioned in this paper. For example, its findings are concordant with other studies that DSS is the most preferred remedy for the treatment of many menstrual disorders that result from blood stasis, and several studies have demonstrated how the formula exerts estrogen-like activities that bring about a relief of the climacteric disorders symptoms. The activities also cause decreased uterine contraction, therefore attenuating primary dysmenorrhea (Lin et al, 2017).

Name Date Number of Participants Methodology Findings
Chen et al. 2017 1.9 billion queries Text-mining There is a need for information for both men and women on menstruation hence the need for educational interventions.
Gao et al. 1998 – Meta-analysis Databases targeting primary and secondary outcomes in the use of CHM.
Kennedy et al. 2006 41 women Meta-analysis 53% of participants in the TCM group had reduced pain than usual against 26 percent in the placebo group.
Lee et al 2015 – Systematic review Three RCTs indicated favorable effects of the DSS with regards to response rate in comparison to conventional medicine.
Wang et al 2015 – Systematic analysis DSS provides an effective strategy in the treatment of primary dysmenorrhea.
Yen et al 2015 35,786 Meta-analysis Prescription patterns and characteristics identified in patients with uterine fibroid responded to the use of DSS.
Table 2: Studies Reviewed

Results from studying Primary Dysmenorrhea
The response from the women confirmed that four out of ten women had the knowledge of the experiences they were undergoing concerning primary dysmenorrhea though they have local ways of expressing it regarding the symptoms they gave. Some women in their local language majored on spleen, the gall bladder effect and that of the urinary bladder as well as that what Chinese call Shiqizhui. The main points given were distributed to the effects in the urinary bladder, thus showing more than half of the respondents know about primary dysmenorrhea and the only difficulty is to understand and interpret at the initial stages of the research since their expression ability is highly based on indigenous languages. Health practitioners reached also gave a detailed understanding of primary dysmenorrhea and the number of cases they receive from women in such conditions. Most respondents reached through survey shared that most primary dysmenorrhea cases were realized near the end of every month. Nonetheless, the health professionals confirmed that the menstrual cycle is guided by age, which is also determined by the date of birth, women come visiting every time in the month since they have varying dates of the periods.

Results from the Action Efficiency of DSS in Treating Primary dysmenorrhea
Studies distributed over the last five years from this research give guidelines into how the Chinese republic has the adoption of more herbal medications( Medicine) than modern synthetic drugs. They define the compounds in the herbal medicines as natural with immediate actions and results on the patients. However, at the health centers surveyed, the practitioners said that no drug lacks the natural extracts and that only the form changes, yet the chemical combination remains untouched even in research and development of drugs DSS is a traditional herbal used in China and has been used in many researches on its effects and efficiency on primary dysmenorrhea with results that the best ways the traditional world embraced natural medication then, should the modern world give inputs to the same in line with making killing an easy solution or approach to curbing the stress of such complications as primary dysmenorrhea at their early stages (Chen et al. 2014). Women replied to one question on DSS and primary dysmenorrhea with some suggesting deeper research be done in understanding the compound mix in DSS so that it be produced and used globally. Any findings from the articles also showed that doctors reached on the knowledge of DSS thought that the herb is effective and that no negative cases have been reported on its use.
The efficiency (efficacy) of herbal medicine was understood by considering a review of articles addressed the use of DSS as the most preferred form of treatment, especially in China. For this reason, it becomes more effective in comparison with other Chinese products and analgesics for the treatment of primary dysmenorrhea, researchers have conducted investigations about the molecular mechanisms of DSS action. Importantly, there are four stages of the cycle that a woman experiences that include the proliferative and secretory phases, which result in the growth of the endometrium in the uterus, follicular and the luteal phase where the follicles develop within the ovary whereby the latter two demands utmost care (Usuki et al, 2002). Therefore, a confirmatory value on the worth and efficiency of DSS acting against primary dysmenorrhea in women aged 13-25 years-old should be handled with care on constant research to see that such cases are reduced and remained handled locally once women are educated on how they can manage the condition.

Name Aim Results Conclusion
Pan et al. 2014 To analyze the utilization of TCM by women in Taiwan 92.2% of 53.4% who utilized TCM sought TCM. DSS was the most frequently TCM prescribed.
Yen et al 2015 To determine the population that preferred to use DSS over other TCMs. 61.8% of 87.1 % who visited TCM clinics used herbal medicines such as DSS. Most people with 45 years and less reported a greater tendency of using TCM formulas such as DSS.
Table 3: Comparing the Efficiency of DSS over other TCMs

Figure 1: Graph showing usage of DSS over other TCMs

Summary (Poor writing and hard to understand) I don’t see the key points but still list the referents here
The results collected give a guide that first women are aware of what they are going through in their monthly periods. Second to that is that more than half of the women reached in the study and previous studies have built ideas on what they should do when they are going through the menstrual pains. They know what primary dysmenorrhea is and what should be done to lower the pain and reduce health complications during menstruation. More results are also concentrated on the urinary balder having the highest number of pain distribution. ? Spleen and the gall bladder also have painful feelings in the action (Lee et al. 2016). The action of DSS on the treatment (of what?) gave a likely outcome that women need just some little training to understand this local herb and to further do accurate timing of their periods since its application has reduced immensely those painful occurrences across women presently.
The research paper provides sufficient information on the origin of DSS and the need to investigate its efficacy. From the studies above, findings show that the use of DSS is believed to have been associated with the work of Zhang Zhong-Jing’s understanding of how the pattern develops based on this aspect of disharmony, although this has not been verified. It is claimed that the scientist provided basics and early trials that proved the efficiency of DSS in its use in treating primary dysmenorrhea symptoms. The research has also revealed that DSS has several ingredients, mainly including a mixture of olive oil and other Chinese herbal medications (Chen, Kwekkeboom, & Ward, 2016). The research understanding the signs and symptoms associated with the original pattern identified by Zhang Zhong-Jing provides the basis of understanding how the brain and hormones contribute to the occurrence of menstrual-related disorders and how amelioration involves both of them as well. The findings indicate that the brain is the core factor in the nervous system that actively plays the role of coordinating all nervous information in the body, especially organs linked to reproduction and even some in the reproductive system such as the ovaries and the uterus.
A period of six weeks to three months was analyzed in the research producing a good window to start seeing the pain reduction results when DSS is used against primary dysmenorrhea to women aged between 13-25 years. Therefore, DSS has the capability of opening the liver directing the Qi downwards and calming the targeted areas of the Lower Jiao (Wang, Wang & Yeh, 2016). In that regard, DSS is an efficient remedy for intervention against primary dysmenorrhea due to its command in stimulating the nervous system without causing any side effects.

Chapter 5: Discussion
With the wide results sourced from women on the effects and efficiency ( Efficacy )of DSS on the treatment of primary dysmenorrhea, women have the future hope to adopt the use of DSS to reduce and even stop the painful stress during their menstruations, which affects their social and even economic lives nearly every month. The use of the medication( You mean herbal medicine?) from licensed practitioners has also been realized to be more efficient as people would tend to question the legality of medical operations of an individual and especially the use of local herbs. Finally, positive results of the usage of DSS, regardless of the time of menstruation, provided comfort for all women with the use of this local herb from Chinese databases.
Additionally, DSS is comprehensively assessed to determine its efficacy as a Chinese herbal medicine to bring about improvement of cramping pain associated with DSS. The use of the network meta-analysis data collection method is of paramount importance when comparing the efficacy of the herbal medicines and prescribed painkillers. Since there is a wide range of CHM being used in the normal practice in Chinese meta-analysis, choosing the medicine that is most effective would not only relieve the symptoms of primary dysmenorrhea pain more quickly, but it is also economic. Using various studies alluded to in this study determined how the inclusion and exclusion criteria are involved in the use of both the primary and secondary primary dysmenorrhea targets as obtained from the Gene Card database.
The data collection processes used a combination of meta-analysis and systematic review provides the most reliable method of collecting and analyzing data. The method made it easy to analyze data and findings from a wide range of studies involving a comparison of the efficacy of DSS and other interventions. Data and findings from a wide range of studies were systematically compared. The conclusion of the experiment was a significant advantage in patients administered with DSS compared with other interventions. Similar conclusions were obtained in a study conducted by Lin et al. (2017), which used 3475 women with primary dysmenorrhea related symptoms in a systematic review conducted with an aim of assessing the safety and efficacy of traditional Chinese products such as DSS to alleviate primary dysmenorrhea.
The quality of the method of the study used in this research determines the reliability of the information and data obtained. Some of the methods used are complicated, for example, using isolated of strips using K+-depolarization and oxytocin in a Ca2+-free solution helps to understand the mechanism of action of DSS, since it demonstrates the inducing the effect of DSS extract on spontaneous uterine contraction. Similarly, there is a need to use interventions that have minimal side effects while ameliorating primary dysmenorrhea and menorrhagia symptoms. Considering the findings obtained in this research through the meta-analysis and systematic review, the data obtained is sufficient and significant to conclude that DSS is the best intervention for the disorders.
To findings in this study are based on what researchers in various sources were able to discover based on the resources at their disposal. To the best of their knowledge, the specialists in various medical practices have provided vital research procedures and aims focused on identifying the efficiency of DSS. Some have provided original evidence derived from properly conducted research procedures, including those involving RCTs, an efficient tool in the evaluation of several samples at the same time. In this paper, RCTs have been used in the determination of the efficacy of at least three TCM ingredients that are most common in the treatment of primary dysmenorrhea in China: Sinensis, Lactiflora, and Yanhusuo. However, these substances may be combined with a large number of other ingredients to form more efficient complexes in the therapy for the disorder. The criteria for choosing these herbs is based on their dosages, as well as depended on several other factors.
The medical practitioners and those authorized to handle herbal medicines in China contribute to determine the efficiency of particular medicines, such as DSS. Similarly, the effectiveness of the intervention has been reported in Chinese literature; it is based other factors such as the inclusion of the personal experience of author of TCM and the tendency of a TCM to have side effects, therefore, patients are required or should be careful not to use a TCM with obvious and known toxicity or adverse effects. The root of each herbal medicine’s Sinensis, which refers to the specific source of herbal medicine, for example, Dang Gui, Dang Quai, Dong Quai, Ferulic acid, Danggui, and Ligustilide are regarded as the important active DSS- containing compounds.
The research revealed that numerous pharmacological effects have been claimed during the following a search for the most efficient intervention. Some of these pharmacological effects include anti-inflammatory, antispasmodic, sedative, analgesic, and sedative actions. Medical specialists recommend that a TCM unless the disease is dermal or presents its symptoms physically, be administered orally in a dosage ranging from an equivalent to 4.5 g to 9.0 g of root daily. For instance, P. lactiflora’s root is the source of one TCM product usually referred to as Chi Shao, Baishao, Chishao, Shaoyao, Shao Yao and Bai Shao, while albiflorin and Paeoniflorin are identified as the key active compounds (Zhou, 2015).

Implications for Practice
To find various data sources, the research tool used a word that has been used many times with the health PR actioners and of prescriptions, which are available in academic books available in Chinese database EMBASE and PubMed. The guidelines are beneficial and should be a central focus to guide the practitioners on the safe use of the medications. The treatment of primary dysmenorrhea needs more attention and with the use of DSS, women should be prepared at any risk to ensure it is done effectively. A key guide here is the timing of the menstrual cycle to know the specific times for the application of the medicine. However, no clear solution has been reached to the best time of application of the DSS dosage. Regardless, DSS has been studied to have effective aids and pain release for primary dysmenorrhea regardless of the time of the menstrual cycle (Wang, Wang & Yeh, 2016). Therefore, the medical practitioners have been guided to apply their treatment of primary dysmenorrhea using DSS any time the patients experience symptoms.
The efficacy of any medicine is determined by how fast it able to alleviate the signs and symptoms associated with diseases or disorders. The findings from the data and information collected indicate that DSS has proven to be quite efficient in helping women to recover from primary dysmenorrhea symptoms quicker than any other intervention and without any side effects. Some of the symptoms include hypertonic abdomen with pain, fluid retention, particularly edema affecting the lower limbs, and persistent mild abdominal pain, the chief symptom. As mentioned before, the lack of liver blood is the root cause of these symptoms as it leads to the hyperactivity of the liver.
The research provides a basis for placing DSS on a scale to determine how efficient it is in remedying primary dysmenorrhea. Having been used for a very long time in the history of China, DSS is one of the many herbal medicines that have now been proved the most efficient in the treatment of several menstruation-related disorders. It also serves as a challenge for future researchers to determine how the formula can be useful to other populations in the world. From the findings reported in the studies referred to in this research, the efficacy of DSS is approximately more than 97 percent. However, not all the studies that were accessible in this research paper may have met the general Western standards, especially if they do not provide detailed data and are difficult to access. This makes it difficult to achieve the required data to evaluate the efficacy of the formula.

Limitations to the Study
The study, despite the use of varied resources, still had some limitations that should, by all means, be avoided if similar studies are to be held. One main fact is that herbal medicine in the study, DSS, is a local herb to China and is difficult to use in a wide range of data analysis and approach. The language of the medication( You mean herbal medicine?) has many new words that the researcher avoided and tried all possible for the effectiveness of the study outcomes to use common terms know to everyone who might access the research for findings and analysis. In addition, some respondents reached for one on one interviews and questionings had biased opinions on why they support or not support the effectiveness and efficiency of DSS compared to other medications applied to cases of primary dysmenorrhea. The fact that DSS is herbal and has few practitioner licenses were also found to limit the study findings as many people still do not understand the diversity of the use of DSS and whether they can trust it with their health. Many gaps still exist in the government allowance for the use of traditional medications and people are also absorbed into letting not any practice related to health go against the government policy statements on medical access.
In a study by Lovett et al. (2019), the control was the urinary bladder despite the effects of primary dysmenorrhea being distributed throughout the body during the menstruation cycle. Other muscle pains have been isolated and they play active roles in easing the pains during contraction relaxations of the uterine walls. The research saw this as an alleviating point restricts the study to specified factors while blocking others. Otherwise, the study would be more effective when the control was selected among the symptoms such as nasal congestion and not the treatment. Using gallbladder in the treatment analysis for primary dysmenorrhea was also a wrong turn as used by Wong, Ip, & Lam (2016) since gall bladder has no effective point of control measurable to the treatment of primary dysmenorrhea. Most studies also did not give a link to the use of midwifery in ensuring this herbal medication becomes more efficient.
The researcher guides that further studies be more focused on the connection between societies and their medication awareness especially on the use of medical insurance benefits and licensing to the midwives who understand and are the central points for guiding the use of DSS in treating primary dysmenorrhea. The U.S government should also do more budgetary allocation to see that herbal medications are given more understanding and even sourced from the outside of China (Yen et al., 2015). The limitation needs to be overcome by increasing funding for current research-based on empirically collected from the populations where DSS is commonly used.
The use of DSS is not possible outside of Japan, China and other counties in the region. Although DSS has been proved efficient, it poses a difficulty regarding its availability in most other parts of the world, basically in its original form. The research is limited to find out if the ingredients of DSS are available in any other part of the world.

Recommendations to Study
The study has some points to share as recommendations to the class of health practice. First, the government needs to do more research on why women of this generation are constantly on leave and sick offs from work for ( From?)the pain of primary dysmenorrhea. To this effect, treatment should also be diversified and made more open to accepting that midwives have a critical role in the language of herbal medicines thus they should be given licenses to aid the health practitioners in working out this problem. Readiness to speak one language through all research accreditation should also be implemented so that all the data searched and researched be consistent with equal facts on similar issues. Precisely, research on medical practice requires more tools and resources to make the sector lively. Finally, the efficiency of DSS depends on how the target users understand it hence; this will make it even easier to provide people with the facts behind this herbal medication and whether it can be a permanent solution regarding primary dysmenorrhea treatment.
There is a need to increase RCTs in Western literature of TCM remedies such as DSS. Although DSS is heavily depended on in Japan and China as an herbal remedy, it lacks RCTs in the larger population to make it more accessible in the world where it can be used to treat primary dysmenorrhea. The result from various studies proves confidently that it should be used to treat the menstrual-related problem. Therefore, other research organizations should seek funding through writing proposals to carry out RCTs for DSS.

Conclusion
The move to use and research more herbal medications( medicine) is linked to making the country affordable on matters of healthcare. DSS is one of the traditional herbal medicines sourced from China used to address menstruation-related disorders, ( add especially for the abdominal pain associated to menstruation). The findings from the systematic review and meta-analysis conducted provided a significant number of reports of empirical and secondary evidence showing how DSS is effective in alleviating pain caused by dysmenorrhea. The Chinese herbal therapy’s six ingredients make DSS a complex medicine ( herbal formula )to comprehensively address the disorder and to bring about other beneficial effects to the liver and kidney. Doing more research to understand the combination and how it works in eliminating the stressful pains women undergo during their menstrual cycles will give more useful data for further findings of many more traditional herbs that can be used as painkillers or relievers, especially to women.
Furthermore, this paper gives both qualitative and quantitative scores to the understanding of the efficiency of DSS in the treatment of primary dysmenorrhea in women. The findings have it that the use of DSS has proven not only to be efficient in the treatment of primary dysmenorrhea but also effective in relieving pains and other bodily stress that create a lot of discomfort for women. This, therefore, confirms that as much as Affordable Care Act is in place for all the US citizens, a gap to find more medical solutions is still pending with a possible solution to absorb and make traditional medication a practice and provide licenses to all midwives and practitioners to clear them off the fear that they will not be accepted in the society for lack of credibility. Finally, the DSS is also expected to experience no adverse effects following the use of the Chinese formula when compared with other drugs that are either traditional or synthetic. 
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