# Effects of Modified Wenjing Decoction Combined with Online Publicity and Education on the Treatment of Primary Dysmenorrhea of Cold Coagulation and Blood Stasis

Authors: Na Li; Jie Li; Pengpeng Gai
Journal: Journal of Healthcare Engineering
 (2022)

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## Abstract

Objective. To explore the effects of modified Wenjing decoction combined with online publicity and education on the treatment of primary dysmenorrhea of cold coagulation and blood stasis. Methods. The materials of 111 patients with primary dysmenorrhea of cold coagulation and blood stasis in the outpatient department (January 2019–June 2021) were collected to conduct the retrospective study. The 111 patients were randomized into treatment group (n = 59) and control group (n = 52). The control group received online publicity and education and conventional treatment, and the treatment group received online publicity and education and modified Wenjing decoction. The patients in the two groups were continuously treated for three menstrual cycles. The treatment effects, the dosage of analgesics, the scores of associated symptoms before and after treatment, and other indexes were compared between the two groups. Results. The differences in the efficacy on abdominal pain were statistically significant between the two groups P<0.05. Compared with the control group, the treatment group had lower scores of associated symptoms after treatment p<0.5. After the treatment of three menstrual cycles, 54 patients in the treatment group stopped taking ibuprofen, and the average ibuprofen dosage of the other 5 patients was (0.24 ± 0.16)g. The 52 patients in the control group still needed to take ibuprofen, and the mean dosage was (0.51 ± 0.05)g. The differences in the ibuprofen dosage between the two groups had remarkable difference P<0.001. Conclusion. Modified Wenjing decoction combined with online publicity and education can obviously improve the clinical symptoms of the patients with primary dysmenorrhea of cold coagulation and blood stasis and reduce the dosage of analgesics. It is worth promoting and applying in practice.


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## Body

## 1. Introduction

Primary dysmenorrhea, as a common gynecological disease in clinic, features such symptoms as periodic abdominal pain, lumbosacral dragging pain, and even syncope due to megalgia during or around menstruation. Dysmenorrhea can be divided into primary dysmenorrhea and secondary dysmenorrhea. The former, also known as functional dysmenorrhea, has no organic lesion in pelvic cavity and often occurs within a few years after menarche. The latter is mainly caused by pelvic diseases such as endometriosis, so it is called secondary dysmenorrhea. Compared with secondary dysmenorrhea, primary dysmenorrhea is more common. It may happen to the women after 1-2 years of the menarche or after the age of 40, severely affecting their daily work and life. At present, the modern medicine has not clearly explained the pathogenesis of primary dysmenorrhea, which is commonly attributed to the contraction of uterine smooth muscle caused by the elevated prostaglandin in the endometrium. Hence, the main treatment for primary dysmenorrhea is taking prostaglandin inhibitors in the modern medicine [1]. According to clinical practice, although such drugs can alleviate the patients’ symptoms, they cannot prevent and eradicate the primary dysmenorrhea. After the treatment, the patients are at still a risk of recurrence.The traditional Chinese medicine (TCM) believes that primary dysmenorrhea is closely related to cold pathogen. During or around menstruation, the blood filling in Xuehai overflows and qi-blood suddenly becomes deficient from vigorous. As a result, the women are susceptible to pathogenic factors because of the relative insufficiency of healthy energy and the sharp changes of qi and blood in the uterus and Chong and Ren meridians [2]. If the women with good physique do not avoid raw or cold food or catch a cold due to inadequate care during menstruation, the cold pathogen will intrude the uterus and the blood will coagulate and stagnate in the uterus and Chong and Ren meridians. As a result, they suffer from the pain due to the blood stasis. If the women have yang asthenia or do not get proper care, they may have kidney deficiency cold syndrome, low temperature of meridians, blood stasis, and menstrual obstruction. As a result, they suffer from the pain due to the lack of nourishment of the uterus and Chong and Ren meridians. Besides, if the protective energy is weakened for the yang asthenia, the cold pathogen may intrude the uterus and lead to the blood stasis, which may also cause pain. Therefore, both the external invasion of cold pathogen and the yin cold in the interior can lead to the meridian obstruction and coagulation, and the treatment should aim at warming up and dredging the meridians, promoting blood circulation, removing blood stasis, nourishing blood and hemostasis, and replenishing healthy energy. Based on this, this paper adopted the self-made modified Wenjing decoction to treat the patients with primary dysmenorrhea of cold coagulation and blood stasis according to TCM theory and clinical treatment experience, with the results summarized as follows.


## 2. Clinical Materials

All the 111 patients were from the outpatient department (January 2019–June 2021) and met the diagnostic criteria for primary dysmenorrhea of cold coagulation and blood stasis. They were randomized into treatment group (n = 59) and control group (n = 52). In the treatment group, the mean age was (31.58 ± 8.08) years old and the mean duration of disease was (30.32 ± 5.97) months. In the control group, the mean age was (29.31 ± 7.53) years and the mean duration of disease was (30.30 ± 6.88) months. The differences in age, duration of disease, and the scores of associated symptoms before treatment between the two groups had no statistical significance P>0.05, and the two groups were comparable.


### 2.1. Diagnostic Criteria

The criteria were formulated according to the contents of dysmenorrhea inGynecology of Traditional Chinese Medicine [3] and Obstetrics and Gynecology [4].


#### 2.1.1. Diagnostic Criteria of Primary Dysmenorrhea in Western Medicine

During or around menstruation, the patients felt severe pain and fall-swell in lower abdomen, accompanied with waist soreness or other discomforts. The symptoms were severe and affected the quality of life and work of the patients. There was no organic lesion in the generative organ.


#### 2.1.2. Criteria of TCM Syndrome Differentiation for Cold Coagulation and Blood Stasis

The main symptoms were the lower abdominal pressing pain and chill (the pain reduced when the body got warm). The secondary symptoms were little menstrual volume, impeded discharge of menses, dark or clotting menstrual blood (the pain reduced when the blood clots were passed out of the body), pale complexion, fearing of cold, chilly extremity, cold sweat, nausea, vomiting, and diarrhea, which affected the work and study.


## 2.1. Diagnostic Criteria

The criteria were formulated according to the contents of dysmenorrhea inGynecology of Traditional Chinese Medicine [3] and Obstetrics and Gynecology [4].


### 2.1.1. Diagnostic Criteria of Primary Dysmenorrhea in Western Medicine

During or around menstruation, the patients felt severe pain and fall-swell in lower abdomen, accompanied with waist soreness or other discomforts. The symptoms were severe and affected the quality of life and work of the patients. There was no organic lesion in the generative organ.


### 2.1.2. Criteria of TCM Syndrome Differentiation for Cold Coagulation and Blood Stasis

The main symptoms were the lower abdominal pressing pain and chill (the pain reduced when the body got warm). The secondary symptoms were little menstrual volume, impeded discharge of menses, dark or clotting menstrual blood (the pain reduced when the blood clots were passed out of the body), pale complexion, fearing of cold, chilly extremity, cold sweat, nausea, vomiting, and diarrhea, which affected the work and study.


## 2.1.1. Diagnostic Criteria of Primary Dysmenorrhea in Western Medicine

During or around menstruation, the patients felt severe pain and fall-swell in lower abdomen, accompanied with waist soreness or other discomforts. The symptoms were severe and affected the quality of life and work of the patients. There was no organic lesion in the generative organ.


## 2.1.2. Criteria of TCM Syndrome Differentiation for Cold Coagulation and Blood Stasis

The main symptoms were the lower abdominal pressing pain and chill (the pain reduced when the body got warm). The secondary symptoms were little menstrual volume, impeded discharge of menses, dark or clotting menstrual blood (the pain reduced when the blood clots were passed out of the body), pale complexion, fearing of cold, chilly extremity, cold sweat, nausea, vomiting, and diarrhea, which affected the work and study.


## 3. Treatment Methods

### 3.1. Treatment Group

The patients were given modified Wenjing decoction. In the first course of treatment, they orally took ibuprofen when they felt obvious pain. In the second and third courses of treatment, the ibuprofen was discontinued and the improvement on pain was observed. When the patients felt obvious pain, they could orally take ibuprofen again. To ensure the stable quality of the Chinese medicine and avoid the impact of decocting process on the efficacy, the TCM formula granules (CR Sanjiu or Guangdong E-Fong) were selected for the treatment. The prescription ingredients were as follows: 9 g of medicinal evodia fruit, 9 g of Chinese Thorowax root, 9 g ofCinnamomum cassia, 20 g of Chinese angelica root, 20 g of root of herbaceous peony, 12 g of Chuanxiong Rhizome, 20 g of Corydalis, 15 g of motherwort, 9 g of safflower, 20 g of Pilose Asiabell root, 20 g of eucommia bark, 20 g of Himalayan teasel root, and 15 g of malaytea scurfpea fruit. The patients took one dose a day with boiled water in the morning and at night. The patients began to take the granules three days before the menstruation, took them for six consecutive days, and continuously received such a treatment for three menstrual cycles.


### 3.2. Control Group

The patients began to take ibuprofen tablets (0.2 g/tablet, Shandong Shinva) from the first day of the menstruation cycle, 0.2 g one time, 3-4 times a day. The patients with severe pain could increase the dosage. The course was generally 1–3 days.


### 3.3. Online Publicity and Education

The health publicity and education were performed through private WeChat and WeChat Official Account for the patients, and their relevant consultations were answered in time. The patients were guided to maintain a good mood, have a light diet, and avoid eating raw, cold, and irritating food during menstruation. Besides, proper exercises before and after menstruation, such as yoga and Pilates, were also recommended, which could enhance uterine blood circulation and improve uterine arterial blood flow. During nonmenstrual period, the patients could properly adopt the external treatment, such as moxa-wool moxibustion and local hot compress, which could ease the symptoms of dysmenorrhea to a certain extent.


## 3.1. Treatment Group

The patients were given modified Wenjing decoction. In the first course of treatment, they orally took ibuprofen when they felt obvious pain. In the second and third courses of treatment, the ibuprofen was discontinued and the improvement on pain was observed. When the patients felt obvious pain, they could orally take ibuprofen again. To ensure the stable quality of the Chinese medicine and avoid the impact of decocting process on the efficacy, the TCM formula granules (CR Sanjiu or Guangdong E-Fong) were selected for the treatment. The prescription ingredients were as follows: 9 g of medicinal evodia fruit, 9 g of Chinese Thorowax root, 9 g ofCinnamomum cassia, 20 g of Chinese angelica root, 20 g of root of herbaceous peony, 12 g of Chuanxiong Rhizome, 20 g of Corydalis, 15 g of motherwort, 9 g of safflower, 20 g of Pilose Asiabell root, 20 g of eucommia bark, 20 g of Himalayan teasel root, and 15 g of malaytea scurfpea fruit. The patients took one dose a day with boiled water in the morning and at night. The patients began to take the granules three days before the menstruation, took them for six consecutive days, and continuously received such a treatment for three menstrual cycles.


## 3.2. Control Group

The patients began to take ibuprofen tablets (0.2 g/tablet, Shandong Shinva) from the first day of the menstruation cycle, 0.2 g one time, 3-4 times a day. The patients with severe pain could increase the dosage. The course was generally 1–3 days.


## 3.3. Online Publicity and Education

The health publicity and education were performed through private WeChat and WeChat Official Account for the patients, and their relevant consultations were answered in time. The patients were guided to maintain a good mood, have a light diet, and avoid eating raw, cold, and irritating food during menstruation. Besides, proper exercises before and after menstruation, such as yoga and Pilates, were also recommended, which could enhance uterine blood circulation and improve uterine arterial blood flow. During nonmenstrual period, the patients could properly adopt the external treatment, such as moxa-wool moxibustion and local hot compress, which could ease the symptoms of dysmenorrhea to a certain extent.


## 4. Evaluation Criteria

### 4.1. General Efficacy

The criteria were formulated according toGuiding Principles for Clinical Study of New Chinese Medicines [5]. If the abdominal pain during menstruation disappeared after treatment, the patients were considered as being cured. If the abdominal pain during menstruation was obviously relieved and the pain duration remarkably shortened, the treatment was considered markedly effective. If the abdominal pain during menstruation was relieved and the pain duration shortened after treatment, the treatment was considered effective. If the abdominal pain during menstruation was not relieved, the treatment was regarded as ineffective.


### 4.2. Scores of Associated Symptoms

The scores were determined according toGuiding Principles for Clinical Study of New Chinese Medicines. The associated symptoms included pale complexion, cold sweat, chilly extremity, and waist soreness. The patients with pale complexion and waist soreness were scored 0.5 point, and the patients without were scored 0 point; the patients with cold sweat and chilly extremity were scored 1 point, and the patients without were scored 0 point. The scores of associated symptoms before and after treatment of the two groups were recorded.


### 4.3. Ibuprofen Dosage

The ibuprofen dosages after the treatment of three menstrual cycles of the two groups were recorded.


### 4.4. Statistical Treatment

This study adopted SPSS 20.0 as the data processing software. The study included count data and measurement data and usedX2 test and t test. When P<0.05, the differences were considered statistically significant.


## 4.1. General Efficacy

The criteria were formulated according toGuiding Principles for Clinical Study of New Chinese Medicines [5]. If the abdominal pain during menstruation disappeared after treatment, the patients were considered as being cured. If the abdominal pain during menstruation was obviously relieved and the pain duration remarkably shortened, the treatment was considered markedly effective. If the abdominal pain during menstruation was relieved and the pain duration shortened after treatment, the treatment was considered effective. If the abdominal pain during menstruation was not relieved, the treatment was regarded as ineffective.


## 4.2. Scores of Associated Symptoms

The scores were determined according toGuiding Principles for Clinical Study of New Chinese Medicines. The associated symptoms included pale complexion, cold sweat, chilly extremity, and waist soreness. The patients with pale complexion and waist soreness were scored 0.5 point, and the patients without were scored 0 point; the patients with cold sweat and chilly extremity were scored 1 point, and the patients without were scored 0 point. The scores of associated symptoms before and after treatment of the two groups were recorded.


## 4.3. Ibuprofen Dosage

The ibuprofen dosages after the treatment of three menstrual cycles of the two groups were recorded.


## 4.4. Statistical Treatment

This study adopted SPSS 20.0 as the data processing software. The study included count data and measurement data and usedX2 test and t test. When P<0.05, the differences were considered statistically significant.


## 5. Results

### 5.1. Efficacy on Abdominal Pain

The differences in the efficacy on abdominal pain between the two groups had statistical significance (P<0.05; Table 1).Table 1
Comparison of the efficacy on abdominal pain (n (%)).
GroupnCuredMarkedly effectiveEffectiveIneffectiveEffective in totalTreatment group5912 (20.3)36 (61.0)6 (10.2)5 (8.5)54 (91.5)Control group525 (9.6)15 (28.8)15 (28.8)17 (32.7)35 (67.3)X22.45111.5186.28510.20110.201P0.1170.0010.0120.0010.001


### 5.2. Scores of Associated Symptoms

The differences in the scores of associated symptoms after treatment between the two groups had statistical significance (P<0.05; Table 2).Table 2
Comparison of the scores of associated symptoms after treatment (x¯ ± s, points).
GroupPale complexionWaist sorenessCold sweatChilly extremityBefore treatmentAfter treatmentBefore treatmentAfter treatmentBefore treatmentAfter treatmentBefore treatmentAfter treatmentTreatment group0.41 ± 0.190.11 ± 0.210.41 ± 0.190.15 ± 0.230.81 ± 0.390.25 ± 0.440.83 ± 0.380.22 ± 0.41Control group0.41 ± 0.190.28 ± 0.250.41 ± 0.190.29 ± 0.250.79 ± 0.410.46 ± 0.500.79 ± 0.410.42 ± 0.50t0.0003.8930.0003.0720.2633.3540.5332.314P1.000<0.051.0000.0030.7930.0200.5950.023


### 5.3. Ibuprofen Dosage

In the treatment group, 54 patients stopped taking ibuprofen after the treatment of three menstrual cycles, and the average ibuprofen dosage of the other 5 patients was (0.24 ± 0.16)g. After the treatment of three menstrual cycles, the 52 patients in the control group still needed to take ibuprofen, and the mean dosage was (0.51 ± 0.05)g. The differences in the ibuprofen dosage between the two groups had statistical significanceP<0.001.


## 5.1. Efficacy on Abdominal Pain

The differences in the efficacy on abdominal pain between the two groups had statistical significance (P<0.05; Table 1).Table 1
Comparison of the efficacy on abdominal pain (n (%)).
GroupnCuredMarkedly effectiveEffectiveIneffectiveEffective in totalTreatment group5912 (20.3)36 (61.0)6 (10.2)5 (8.5)54 (91.5)Control group525 (9.6)15 (28.8)15 (28.8)17 (32.7)35 (67.3)X22.45111.5186.28510.20110.201P0.1170.0010.0120.0010.001


## 5.2. Scores of Associated Symptoms

The differences in the scores of associated symptoms after treatment between the two groups had statistical significance (P<0.05; Table 2).Table 2
Comparison of the scores of associated symptoms after treatment (x¯ ± s, points).
GroupPale complexionWaist sorenessCold sweatChilly extremityBefore treatmentAfter treatmentBefore treatmentAfter treatmentBefore treatmentAfter treatmentBefore treatmentAfter treatmentTreatment group0.41 ± 0.190.11 ± 0.210.41 ± 0.190.15 ± 0.230.81 ± 0.390.25 ± 0.440.83 ± 0.380.22 ± 0.41Control group0.41 ± 0.190.28 ± 0.250.41 ± 0.190.29 ± 0.250.79 ± 0.410.46 ± 0.500.79 ± 0.410.42 ± 0.50t0.0003.8930.0003.0720.2633.3540.5332.314P1.000<0.051.0000.0030.7930.0200.5950.023


## 5.3. Ibuprofen Dosage

In the treatment group, 54 patients stopped taking ibuprofen after the treatment of three menstrual cycles, and the average ibuprofen dosage of the other 5 patients was (0.24 ± 0.16)g. After the treatment of three menstrual cycles, the 52 patients in the control group still needed to take ibuprofen, and the mean dosage was (0.51 ± 0.05)g. The differences in the ibuprofen dosage between the two groups had statistical significanceP<0.001.


## 6. Discussion

Dysmenorrhea, as a common gynecological disease, is an important and urgent problem to be tackled in clinic. According to Western medicine, primary dysmenorrhea is closely related to endocrine disorders. Estrogen can stimulate the neurohypophysis to release pituitrin. The abnormal elevation of the estrogen in the late luteal phase of the patients with primary dysmenorrhea leads to abnormally high pituitrin, causing excessive uterine contraction and dysmenorrhea. Progesterone can promote the synthesis of prostaglandin in the endometrium and stimulate smooth muscle contraction through paracrine, causing and aggravating the dysmenorrhea. During or around menstruation, the prostaglandin synthesized and released by the uterus increases, and it is a tissue hormone produced by the arachidonic acid (a kind of essential fatty acid) under the action of cyclooxygenase. The active prostaglandin leads to dysmenorrhea [6–8]. At present, the modern medicine has not fully elucidated the pathogenesis of primary dysmenorrhea, so its treatment purpose for the primary dysmenorrhea is only to relieve pain and associated symptoms. Nonsteroidal anti-inflammatory drugs, as the most commonly used first-line drugs, can reduce the synthesis of prostaglandin by inhibiting the activity of cyclooxygenase and thus alleviate spasmodic contraction of the uterus caused by prostaglandin and ease pain. However, according to clinical practice, the conventional Western medicine is easy to cause gastrointestinal reactions, the patients are at a high risk of recurrence after drug withdrawal, and their dysmenorrhea is not completely improved after the treatment.According to TCM theory, the main cause of primary dysmenorrhea is cold pathogen, which can be divided into excess cold and deficient cold. If yang energy is deficient in the body, the cold will be generated from the inside and the women will suffer from it. If the healthy energy is deficient, the cold pathogen will intrude into the body and the blood will coagulate. As a result, the patients suffer from pain caused by the obstruction of the uterus and meridians. Besides, the pain may also result from the stagnation of qi and blood stasis, or qi-blood deficiency and the lack of nourishment of the uterus and meridians [9, 10]. For the treatment of secondary dysmenorrhea, TCM has longer course of treatment and is difficult to have quick effects, but TCM therapy with syndrome differentiation over a long period can effectively relieve pain. If primary dysmenorrhea is treated promptly and comprehensively, the patients can often get satisfactory results. This study adopted the self-made modified Wenjing decoction to treat the patients with primary dysmenorrhea of cold coagulation and blood stasis according to TCM theory and clinical treatment experience. The drugs in modified Wenjing decoction can be divided into four types. The first type is the warm-hot natured drugs, including medicinal evodia fruit and Cinnamomum cassia; the second type is the drugs promoting blood circulation to restore menstrual flow, including motherwort and safflower; the third type is the drugs promoting blood circulation to arrest pain, including Chuanxiong Rhizome and Corydalis; the forth type is the tonic drugs which tonify qi, yang, and blood, including Pilose Asiabell root, eucommia bark, Himalayan teasel root, malaytea scurfpea fruit, Chinese angelica root, and the root of herbaceous peony. The four types of drugs produce effects in accordance with the pathogenesis of primary dysmenorrhea of cold coagulation and blood stasis. The blood coagulates due to the cold and flows with the heat. The modified Wenjing decoction proposes adopting the warm-hot natured drugs to warm up and dredge the uterus and Ren and Chong meridians. On the one hand, these drugs can dispel cold to enhance the blood circulation; on the other hand, these drugs, companied with tonic drugs, can warmly nourish yang qi. For the patients with dysmenorrhea caused by kidney deficiency cold syndrome and endogenous cold, the temperature of their uterus and meridians is low and they suffer from blood stasis and menstrual obstruction. The warm-hot natured drugs companied with tonic drugs is suitable for these patients in particular. The drugs promoting blood circulation to restore menstrual flow have the effects of removing blood stasis and alleviating pain caused by cold pathogen. The drugs promoting blood circulation to arrest pain, on the one hand, can be combined with the warm-hot natured drugs to warmly dredge meridians. On the other hand, the combination of these drugs and the third type of drugs can replenish qi, activate blood circulation, remove blood stasis, and alleviate pain. Tang Yifeng pointed out in his paper that the analgesic potency of the total alkaloids in Corydalis was 40% of morphine. Among the total alkaloids, tetrahydropalmatine has the strongest analgesic effect. Its analgesic effect is weaker than morphine, but better than aspirin, and its analgesic effect on dull pain is better than that on acute pain. It has less side effects and no addition, so it is safe [11]. The carithamine (safflower extract) can inhibit the production of NO and prostaglandin E2 in the inflammatory response, as well as the protein levels of i NOS and cyclooxygenase-2 (COX-2) protein [12]. The tonic drugs have the effects of invigorating kidney, strengthening yang, warming up meridians, dispelling cold, and supplementing qi and blood. TCM theory believes that the kidney stores essence, and it closely relates to the uterus and Ren and Chong meridians. Therefore, primary dysmenorrhea is closely related to the kidney. Lumbus is the house of kidney, so the patients with dysmenorrhea often feel lumbago. The drugs of nourishing kidney and warming yang, such as eucommia bark, Himalayan teasel root, and malaytea scurfpea fruit, can significantly relieve lumbago. Combined with the drugs of warming meridians, dispelling cold, supplementing qi, and activating blood, they can relieve the symptoms of pale face, cold sweat, and chilly extremity. According to TCM theory, the kidney not only has the functions of kidney anatomically but also closely relates to the endocrine system. The modern pharmacological studies have confirmed that the Chinese medicine for tonifying kidney has the effect of parahormone and can regulate human endocrine. Eucommia bark decoction can significantly inhibit the spontaneous activity of isolated rat uterus, reduce its frequency and contraction intensity, and significantly antagonize the intensive contraction of uterine smooth muscle caused by the pituitrin [13]. Asperosaponin VI, the active ingredient in Himalayan teasel root, can promote the expression of progesterone receptor and has obvious analgesic effect [14]. Malaytea scurfpea fruit decoction has estrogen-like effect on ovariectomized rats, and the estrogen-like effect of psoralen and isopsoralen is achieved by affecting estrogen receptors [15]. The combination of the above four types of drugs has the effects of warming up meridians, dispelling cold, removing blood stasis, nourishing blood, supplementing qi, and relieving pain and can effectively improve the patients’ clinical symptoms. Therefore, the pale face, cold sweat, and other symptoms in the treatment group were obviously alleviated. After the treatment of three menstrual cycles, the patients’ abdominal pain was significantly reduced in the treatment group, and most of them could stop taking ibuprofen, while the patients in the control group still needed to take ibuprofen.In conclusion, modified Wenjing decoction combined with online publicity and education can obviously improve the clinical symptoms of the patients with primary dysmenorrhea of cold coagulation and blood stasis, can reduce their dependence on analgesics, and is conducive to radically cure the primary dysmenorrhea, so it is worth promoting and applying in practice.



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