Observation on the Effect of Umbilical Therapy of Herbal Medicine Combined with Self-Made Dysmenorrhea Paste on Primary Dysmenorrhea

Wen-Ming Cao, Xiu-Rong Wang＊

1Department of gynaecology, changle people’s hospital, Shandong 262400, China.

Abstract Objective: To investigate the clinical effect of self-made dysmenorrhea paste combined with umbilical therapy of herbal medicine on primary dysmenorrhea. Methods: 160 patients with primary dysmenorrhea were recruited from Changle People’s Hospital. Participants were randomly divided into control group and treatment group, with 80 cases in each group. The control group were administered the dysmenorrhea paste sold on the market for 5 days during three menstruation cycles, and the treatment group was given the umbilical therapy of herbal medicine combined with self-made dysmenorrhea paste. The outcome was the intensity of menstrual pain measured by using the visual analogue scale, TCM symptom score and dysmenorrhea symptom score of patients, responder rate. The clinical outcomes were measured on each menstrual cycle at baseline, treatment course (3 cycles), and follow-up period. Results: In this study, there was no significant difference in age and severity of disease between the two groups before treatment. After treatment, VAS score, TCM symptom score and dysmenorrhea symptom score of patients in both groups decreased. The total effective rate was 90.75% in the treatment group and 81.25%in the control group. Conclusion: The treatment of primary dysmenorrhea patients with self-made dysmenorrhea paste combined with application of drugs and moxibustion naval-button method has a significant clinical effect.This method can reduce the pain of patients, improve the quality of life of patients, and homemade dysmenorrhea paste has a good taste, long shelf life, easy to carry, and is worthy of promotion and application.

Keywords: Self-made dysmenorrhea paste； Dressing and moxibustion umbilicus； Primary dysmenorrhea；Therapeutic effect；

Introduction

Primary dysmenorrhea is a main gynecological disorder in the absence of significant pathological changes and is common in adolescents and young women [1]. The risk factors for primary dysmenorrhea are endocrine,mechanical, genetic, mental； Endocrine dyscrasia is believed to be the main cause. Nonsteroidal antiinflammatory drugs (NSAIDs) and oral hormonal contraceptives are suggested for reducing the symptoms of dysmenorrhea； but these drugs can only temporarily relieve pain and cannot completely cure dysmenorrhea [2]. Traditional Chinese medicine treatment for dysmenorrhea has great advantage； the alternative therapies, especially moxibustion, umbilical moxibustion, acupuncture, ear beans, acupuncture point embedded wire have been used as the important treatment methods [3]. However, most patients are afraid of acupuncture and Acupoint Catgut Embedding.The application of herbal medicine remedies to the umbilical region, along with hot ironing, play an important role in the treatment of various diseases.This paper observed the clinical effect of umbilical therapy of herbal medicine combined with self-made dysmenorrhea paste on primary dysmenorrhea.

Materials and methods

Clinical data

160 patients with primary dysmenorrhea who were admitted to the outpatient department of gynecology in Changle County People's Hospital of Shandong Province from November 2018 to November 2019 were recruited. They randomly divided into control group and observation group. There were 80 patients in each group. All participants joined in this trial voluntarily signed a written consent form, who have the right to participate or dropout at any time.

Inclusion criteria

(1) met the diagnostic criteria of primary dysmenorrhea,and received no other treatment in the menstrual cycle before receiving this therapy.

(2) aged 15-35.

(3) regular menstrual cycle (28±7 days).

(4) sign the informed consent.

(5) patients not participating in clinical trials of other drugs or therapies.

Exclusion criteria

(1) allergic to umbilical therapy drugs.

(2) nursing women.(3) patients with serious life-threatening primary diseases such as cardio-cerebrovascular diseases,liver, kidney and hematopoietic system, as well as mental diseases, are not suitable for patients with other diseases such as acupuncture.

Methods

Interventions. Patients in the control group received Yueziyun dysmenorrhea patch therapy (Shandong Shiji Tong Medicine Co, Lt, national medicine standard ID:lu xun registration permit 20152260687.specification:9cm*11cm*1 stick *4 bags *100 boxes/piece. ) on Shenque acupoint 5 days in a row starting at first day to the onset of menstruation. Dysmenorrhea patch were used for 3 menstrual cycles. Self-made dysmenorrhea paste combined with medications moxibustion on navel was applied in treatment group.

Preparation of Dysmenorrhea paste. The production of dysmenorrhea ointment includes four processes:soaking, boiling, concentration, collection and storage.The dysmenorrhea ointment comprises Yuanhu 30g,myrrh 30g, Puhuang 30g, wulingzhi 30g, Danshen 30g,red peony 30g, Evodia 30g, chuanxiong 30g and fennel 30g. First, this specific Chinese herbal were soaked in water for 12 hours, and the water is 10cm higher than these herbal medicines； Boil over high heat for 1 hour,low heat for 3 hours, 3 times in total. Boil and condense the medicine. The donkey hide gelatin (10g) after being soaked in yellow rice wine was heated and stewed,adding 50ml honey and concentrated medicine juice to mix well to make dysmenorrhea cream. One bottle of dysmenorrhea cream can be taken for 5 days, twice a day, once in the morning and once in the evening, and three bottles are a course of treatment.

Applying medicine and moxibustion on navel.Cinnamon, cannon ginger, angelica, Ligusticum chuanxiong, red peony, stir fried peach kernel, Xiangfu,wulingzhi, Puhuang, Yuanhu and amber respectively 3g are ground, then mix them with special transdermal liquida to form smooth paste, which was applied to the patient’s umbilical region for and then moxibustion for 1h. once a day. The umbilical region should be thoroughly cleaned with an iodophor solution before treatment. Start from the first day of period, use continuously 5 days, 3 months is 1 course of treatment.Then apply the medicine in the navel (shenque point),take it off after 6 hours.

Observation indicators

Visual analogue dysmenorrhea score scale. The primary outcome was intensity of menstrual pain measured by using the Visual Analogue Scale (VAS).The pain VAS is a continuous scale, 10 centimeters in length. The patient is asked to mark her pain level on the line between the two endpoints. A higher score indicates greater pain intensity.

Dysmenorrhea symptom scoring scale and grading criteria. The Criteria for dysmenorrhea symptom score recommended by Guiding principles for clinical research of new Chinese Medicine was used to assess symptoms of dysmenorrhea.

TCM symptom scoring scale and criteria. TCM symptoms and signs of dysmenorrhea patients recommended by Guiding principles for clinical research of new Chinese Medicine were recorded TCM symptom score (unit: points)

Statistical analysis

Statistical analysis was completed using SPSS 18.0(IBM Corporation, Chicago, the U.S.). For continuous data, the independent sample t-test was used under the assumption of normal distribution. Nonparametric tests such as the chi-square test would be used. A twosided p value ＜ 0.05 indicates a statistically significant difference.

Table 1 Dysmenorrhea symptom scoring scale and grading criteria

Table 2 TCM symptom scoring scale and criteria

Results

Clinical Characteristics of included participants before treatment

In this study, a total of 160 students (80 per group)were included. The mean ages of the patients in the control and treatment groups were 32.16±4.12 and 34.88±3.77 years, respectively. There was no significant difference between the two groups in the degree of disease. The mean scores of TCM symptom in the control and treatment groups were 19.39±6.74 and 20.26±7.30 respectively before treatment. The mean scores of VAS in the control and treatment groups were 7.38±1.35 and 7.25±1.82 respectively before treatment. The mean scores of dysmenorrhea symptom in the control and treatment groups were 10.63±2.74 and 10.61±2.28 respectively before treatment. There was no significant difference between the two groups in baseline characteristics before treatment (Table 3 and Table 4).

Comparison of VAS scores between the two groups after treatment

Table 5 presents pain scores after treatment after the intervention in the control and treatment groups.There was no significant significance in VAS scores between the two groups in first (cycle 0-cycle 1) and the second (cycle 0-cycle 2) cycles ( All P ＞ 0.05).The means of the VAS scores in the control group were 3.60 ± 1.62 and 2.95 ± 1.28 in third menstrual cycle and after a month of withdrawal after the intervention,respectively, whereas the means of the VAS scores in the treatment group were 1.78 ± 1.29 and 1.49 ± 1.12 in third menstrual cycle and after a month of withdrawal after the intervention, respectively. A significant change was found in the mean pain scores during the third menstrual cycle (P ＜ 0.001) and after a month of withdrawal (P ＜ 0.001) after using TJT compared with control group.

Comparison of TCM symptom scores between the two groups after treatment for three menstrual cycles

There was no significant change of symptom severity between the two groups in first (cycle 0-cycle 1) and the second (cycle 0-cycle 2) cycles ( All P ＞ 0.05) after treatment. At third menstrual cycle and after a month of withdrawal, the symptom severity of menstrual pain in the treatment group was significantly lower than that in the control group (P ＜ 0.05) (Table 6).

Comparison of dysmenorrhea symptom scores between the two groups after three menstrual cycles of treatment

There was no significant change of dysmenorrhea symptom scores between the two groups in first (cycle 0-cycle 1) and the second (cycle 0-cycle 2) cycles (All P＞0.05) after treatment. At third menstrual cycle and after a month of withdrawal, the dysmenorrhea symptom scores in the treatment group was significantly lower than that in the control group (P ＜0.05) (Table 7).

Comparison of efficacy of TCM syndromes between the two groups after three menstrual cycles

The total effective rate of TCM syndromes in the control and treatment groups were 81.25%, 90.75%respectively. There was statistical significance (Z =-2.534, P = 0.011) (Table 8).

Adverse reactions

No gastrointestinal reactions such as nausea and vomiting were observed in the treatment group and the control group. In the treatment group, 2 patients

were allergic to the application of calamine. In the control group, 3 patients showed hypersensitivity to dysmenorrhea patch, which improved after application of calamine.

Table 3 Clinical characteristics and demographics of included participants before treatment(±S)

Table 3 Clinical characteristics and demographics of included participants before treatment(±S)

Group Treatment group Control group P age 34.88 ± 3.77 32.16 ± 4.12 0.746 TCM symptom scores 20.26 ± 7.30 19.39 ± 6.74 0.797 VAS scores 7.25 ± 1.82 7.38 ± 1.35 0.886 dysmenorrhea symptom scores 10.61 ± 2.28 10.63 ± 2.74 0.989

Table 4 Comparison of severity between the two groups of patients before treatment

Table 5 comparison of VAS scores between the two groups after treatment (±S)

Table 5 comparison of VAS scores between the two groups after treatment (±S)

Observation Treatment group Control group t/Z P First menstrual cycle 4.92±1.35 5.53±1.36 -1.953 0.053 The second month cycle 3.82±1.26 4.92±1.37 -1.816 0.079 Third menstrual cycle 1.78±1.29 3.60±1.62 -3.834 0.000 After a month of withdrawal 1.49±1.12 2.95±1.28 -4.190 0.000

Table 6 Comparison of TCM symptom scores between the two groups after treatment (±S)

Table 6 Comparison of TCM symptom scores between the two groups after treatment (±S)

Observation Treatment group Control group Z P First menstrual cycle 17.63 ± 2.45 17.40 ± 2.68 -1.297 0.196 The second month cycle 12.30 ± 2.27 13.30 ± 2.35 -1.736 0.085 Third menstrual cycle 6.67 ± 4.22 8.60 ± 8.45 -2.103 0.035 After a month of withdrawal 6.01 ± 3.87 8.21 ±2 .82 -2.135 0.019

Table 7 Comparison of dysmenorrhea symptom scores between the two groups after treatment (±S)

Table 7 Comparison of dysmenorrhea symptom scores between the two groups after treatment (±S)

Observation Treatment group Control group t/Z P First menstrual cycle 9.12 ± 2.76 9.81 ± 2.65 -1.177 0.245 The second month cycle 7.95 ± 2.38 8.60 ± 2.53 -0.985 0.373 Third menstrual cycle 4.50 ± 3.35 6.70 ± 2.99 -2.220 0.030 After a month of withdrawal 4.23 ± 3.01 6.25 ± 2.75 -2.270 0.025

Table 8 Comparison of clinical efficacy of the two groups (%)

Discussion

Primary dysmenorrhea refers to dysmenorrhea without organic lesions in female reproductive organs, which is clinically manifested as periodic lower abdominal pain,falling and distension before and after menstruation or during menstruation, accompanied by nausea and vomiting, hand and foot syncope, and even severe pain and fainting [5]. Primary dysmenorrhea is the most common gynecological disease, which seriously affects the physical and mental health of patients and reduces their quality of life. In recent years, the treatment of primary dysmenorrhea has been widely concerned. In this study, there was no significant difference in age and severity of disease between the two groups before treatment. After treatment, VAS score, dysmenorrhea symptom score and TCM symptom score of patients in both groups decreased. The total effective rate was 90.75% in the treatment group and 81.25%in the control group. The results showed that the treatment group had an excellent effect on the relief of dysmenorrhea symptoms.

Dysmenorrhea is caused by the abnormality of qi and blood. The medicinal materials used in dysmenorrhea paste have the functions of promoting blood circulation and dispersing stasis, warming kidney and dispersing cold, relieving pain and regulating qi. The taste of dysmenorrhea paste is different from that of traditional Chinese medicine decoction. It tastes very good and is easy to be stored and carried for a long time.

In this study, traditional moxibustion and syndrome differentiation were applied to Shenque point, and the effects of acupuncture, medicine and moxibustion were brought into play. Moxibustion umbilicus method plays the role of medicine and hot temperature, heat was transfered to the pelvic viscera through the meridian of the points and nerve transmission to inhibit uterine smooth muscle and vasoconstriction, improve local microcirculation, to reduce pain. But the mechanism is not clear.

Conclusion

The combination of self-made dysmenorrhea paste and medicine moxibustion with hilus for the treatment of primary dysmenorrhea patients has a remarkable effect,which can reduce the pain of patients and improve their quality of life. Moreover, the self-made dysmenorrhea paste has a good taste and is easy to carry, which is worthy of popularization and application.