Insomnia Due to Liver Qi Stagnation Syndrome After Breast Cancer Surgery
Conditions
Interventions
Treatment group:Shugan Anmian formula + Zopiclone tablet
Control Group:Shugan Anmian formula placebo + Zopiclone Tablet
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Women aged 18–75; Karnofsky Performance Status score =70 at enrollment; complete healing of the breast surgery incision; 2) Patients diagnosed with primary malignant breast tumors, clinical stage I–III, with no evidence of postoperative recurrence or distant metastasis; 3) Completed chemotherapy, radiotherapy, or endocrine therapy before enrollment, with the last treatment occurring =1 month and =5 years before enrollment; for those on endocrine therapy, the standard dose must have been maintained for =2 weeks, and the dose must not have been adjusted in the past month; 4) Postoperative insomnia symptoms meeting the diagnostic criteria for insomnia disorder in the International Classification of Sleep Disorders, 3rd edition (ICSD-3), as well as traditional Chinese medicine (TCM) diagnostic criteria for insomnia; Epworth Sleepiness Scale (ESS) score 7; 7) Has not received cognitive behavioral therapy for insomnia (CBT-I) or other interventions such as acupuncture or Chinese herbal medicine for insomnia in the past month; 8) If taking sleep medications before enrollment, the dose must have been stable for =2 weeks, and no increase, decrease, or change of medication is allowed during the study without the researchers' consent; 9) Voluntarily participates in this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals with cognitive or behavioral abnormalities, those who have used psychiatric medications in the past 3 months, or those who have engaged in heavy drinking in the past year; individuals diagnosed with severe mental disorders such as schizophrenia or bipolar disorder according to DSM-5, or those with major mood disorders; 2) Individuals with other malignant tumors, or those with breast cancer who have already developed distant metastases; 3) Individuals with serious diseases of major organs; 4) Individuals with other types of sleep disorders, such as sleep apnea or restless legs syndrome; 5) Individuals with a clear history of allergy to any of the Chinese herbal components in the Shugan Anmian formula; 6) Pregnant or breastfeeding women; 7) Individuals with poor compliance, unable to complete the expected treatment and follow-up, or those with incomplete information that may affect efficacy and safety assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Scoring;Insomnia Severity Index;Morningness-Eveningness Questionnaire Scoring;Epworth Sleepiness Scale Scoring;Hamilton Anxiety Scale Scoring;Hamilton Depression Scale Scoring;Sleep Log Status;Liver and kidney function;Blood Routine;electrocardiogram;Electrolyte; | — |
Countries
China
Contacts
Public ContactWeikang Zhu
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed