To evaluate the efficacy and safety of Honghua Xiaoyao tablets in the treatment of premenstrual syndrome, and the results were further analyzed and evaluated by target trial simulation (TTE) framework.
Age:18-40 years old (both ends included);
According to the 8th edition of "Obstetrics and Gynecology" (2014), patients diagnosed with premenstrual syndrome;
In accordance with the TCM syndrome differentiation standard of liver depression and qi stagnation.
those who were allergic to the ingredients and excipients of Honghua Xiaoyao tablet (exposure group);
In the non-exposed group, those receiving or planning to receive other targeted medications for PMS, such as serotonin reuptake inhibitors (SSRIs), hormones, etc.;
irregular menstrual cycle (menstrual cycle not within 28±7 days);
serious diseases of cardiovascular, cerebrovascular, hematopoietic system, liver and kidney, and malignant tumors;
The somatic symptoms included headache, abdominal distension, limb swelling, breast pain, and insufficient motor coordination. Mental symptoms included irritability, emotional instability, depression and anxiety, changes in sexual desire, physical fatigue, insomnia, and loss of appetite. Behavioral changes are characterized by inattention, accidents, criminality, and suicidal tendencies, and these symptoms disappear after menstruation. The diagnostic basis is that if the above physical, mental and behavioral changes occur repeatedly and periodically during the luteal phase and last for more than three menstrual cycles, premenstrual syndrome can be diagnosed.
Cohort
Prospective
Honghua Xiaoyao tablets
DrugThe non-exposed group (patients who did not receive Honghua Xiaoyao Tablets or other targeted drug treatments) only received routine clinical observation, and no drug intervention was applied after obtaining informed consent. If patients need to withdraw from the study due to their condition during the study period, on the premise that the patients have given full informed consent, doctors shall recommend other treatment regimens in accordance with clinical standards (when necessary, first-line drugs such as selective serotonin reuptake inhibitors (SSRIs) may be selected for intervention).
The change of premenstrual syndrome
The Daily Record of Symptom Severity (DRSP) is a tool for assessing symptoms of premenstrual syndrome. The scale contained 14 items, including depression, anxiety and tension, emotional instability, irritability, reduced interest, inattention, lethargy and fatigue, abnormal appetite, abnormal sleep, feeling out of control, body pain and swelling. Each item was scored from 1 to 6 points according to the severity of symptoms (1 = none, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe, 6 = extremely severe). The total score of premenstrual symptoms, physical/emotional/behavioral symptoms and individual index scores were calculated. In this study, participants were asked to fill in the form of the most severe feeling on the 5th day before the menstrual cycle and the previous menstrual cycle before the initiation of the medication at 20:00 to 22:00 every day on the 5th to 9th day of the menstrual cycle to evaluate the changes in symptoms before and after the treatment.
Change of single index of DRSP scale
In DRSP, the scores of premenstrual somatic symptoms, emotional symptoms, and behavioral symptoms, and the scores of individual indicators and their disappearance rates.
Change of TCM premenstrual syndrome
The TCM premenstrual syndrome score scale was designed according to the theory of TCM, which was used to evaluate the TCM syndromes of patients with premenstrual syndrome, including breast swelling and pain, small abdominal distension, irritability, dizziness, insomnia, headache, difficulty in menstruation and other TCM symptoms and signs such as tongue and pulse. The changes of symptom scores of premenstrual syndrome reflect the improvement or deterioration of the condition. The scale uses a semi-quantitative grading method to score the severity of different symptoms into 0, 2, 4, and 6 points (such as breast pain, etc.) or 0, 1, 2, and 3 points (such as dizziness, etc.). The lowest score was 0, and the highest specific score was determined according to the accumulation of each symptom score. The higher the score, the more severe the condition. The reduction rate of TCM syndrome and the disappearance rate of single symptom in the TCM syndrome score table were calculated.
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Lianxin Wang
Lead sponsor
China Academy of Chinese Medical Sciences
Sponsor institution
Chaoyangmen Community Health Service Center of Dongcheng District in Beijing
Collaborator
Hepingli Community Health Service Center,Dongcheng District,Beijing
Collaborator
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