the Effects of Different Therapy Regimens on Menopausal Sleep Disorders
Study Details
Study Description
Brief Summary
Sleeping disorders are one of the most common menopausal symptoms, which seriously affect health and life quality of perimenopausal women. Menopausal hormone therapy is an effective treatment for menopausal symptoms, meanwhile, traditional Chinese medicine is also effective to some extent. This prospective randomized controlled study plan to compare the effects of different therapy regimens, including Tibolone and Xiangshao granules, on menopausal sleep disorders.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tibolone take Tibolone 1.25mg/day orally for 8 weeks |
Drug: Tibolone
1.25mg po qd
|
| Experimental: Xiangshao granules take Xiangshao granules orally 3 times a day, 4g each time |
Drug: Xiangshao granules
4g po tid
|
| Experimental: Tibolone plus Xiangshao granules take Tibolone 1.25mg/day and Xiangshao granules 3 times a day, 4g each time orally for 8 weeks |
Drug: Tibolone plus Xiangshao granules
Tibolone 1.25mg po qd plus Xiangshao granules 4g po tid
|
Outcome Measures
Primary Outcome Measures
- Polysomnography [V0(screening period), V3(week 8)]
Extract PSG EEG data: record time, bed time, sleep time, awakening time, rapid eye movement sleep time (REM), non rapid eye movement sleep time (NREM), non rapid eye movement sleep phase 1 (N1), non rapid eye movement sleep phase 2 (N2), non rapid eye movement sleep phase 3 (N3), total sleep time (TST), sleep latency (SL), wake after sleep onset (WASO), sleep efficiency (SE).
- PSQI questionnaire [V0(screening period), V2(week 4), V3(week 8)]
The total score of PSQI questionnaire is 0-21 points. Normal sleep quality is defined as less than 11 points.
- Sleep diary [V0(screening period), V1（dsy 1）, V2(week 4), V3(week 8)]
Sleep diary is recorded by study participants daily.
Secondary Outcome Measures
- Improved Kupperman score [V0(screening period), V2(week 4), V3(week 8)]
The total score of improved K score is graded into four levels: nomal(<7), mild(7-14), moderate(15-29), severe(>30).
- Menopause-specific Quality of Life Scale [V0(screening period), V2(week 4), V3(week 8)]
Evaluate vasomotor symptoms, psychological and emotional symptoms, physical symptoms and sexual activity symptoms.
- Self-Rating Anxiety Scale [V0(screening period), V2(week 4), V3(week 8)]
Assess anxiety level over the past two weeks. The evaluation adopts a 1-4 scoring system, where the scores of 20 questions are added together to obtain the total score. The total score is multiplied by 1.25 and rounded to the nearest whole number to obtain the standard score.
- Center for Epidemiological Survey, Depression Scale [V0(screening period), V2(week 4), V3(week 8)]
The total score of CES-D is graded into three levels: asymptomatic(<15), possible depressive symptoms(16-19), exsisted depressive symptoms(≥20)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
women aged 40-60
-
natrual menopause for 1-10 years
-
PSQI score >=11 points
-
improved K-score>=14 points
-
able to independently sign informed consent forms
Exclusion Criteria:
-
Vaginal bleeding of unknown cause
-
Known or suspected breast cancer and other sex hormone dependent tumors
-
Active venous or arterial thromboembolic disease within past 6 months
-
Have used sex hormone or traditional Chinese medicine/botanical drugs that affect menopausal symptoms within the past month
-
Have used anti anxiety, depression drugs or sedative hypnotics within the past month
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Patients with anxiety or depression above moderate level
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Severe liver or kidney dysfunction, with transaminase or creatinine level exceeding twice of the normal value
-
BMI ≥ 28 kg/m2
-
Allergies to research drugs
-
Other situations that doctor deems unsuitable to participate in the study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Study Director: Rong Chen, Professor, Peking Union Medical College Hospital
Study Documents (Full-Text)
More Information
Additional Information:
- Guideline for the evaluation and treatment of insomnia in Chinese adults(2017)
- The 2023 Chinese menopause symptom management and menopausal hormone therapy guidelines
- Curative Effect Analysis on Xiang Shao Particle in the Treatment of Women Perimenopausal Syndrome
- Efficacy and safety of Jingqianping granule in treatment of 403 cases of the liver-qi invasion of premenstrual syndrome with multicentre, random,double-blind and double simulation and control method
Publications
- Chen R, Tang R, Zhang S, Wang Y, Wang R, Ouyang Y, Xie X, Liu H, Lv S, Shi H, Zhang Y, Xie M, Luo Y, Yu Q. Xiangshao granules can relieve emotional symptoms in menopausal women: a randomized controlled trial. Climacteric. 2021 Jun;24(3):246-252. doi: 10.1080/13697137.2020.1820476. Epub 2020 Oct 5.
- Gold EB, Sternfeld B, Kelsey JL, Brown C, Mouton C, Reame N, Salamone L, Stellato R. Relation of demographic and lifestyle factors to symptoms in a multi-racial/ethnic population of women 40-55 years of age. Am J Epidemiol. 2000 Sep 1;152(5):463-73. doi: 10.1093/aje/152.5.463.
- Jiang XR, Ren L, Li CR. [Effect of Electroacupuncture on Hypothalamus-Pituitary-Ovary (HPO) Axis in Rats with Peri-menopausal Depression]. Zhen Ci Yan Jiu. 2017 Feb 25;42(1):45-9. Chinese.
- Kaplan KA, Hardas PP, Redline S, Zeitzer JM; Sleep Heart Health Study Research Group. Correlates of sleep quality in midlife and beyond: a machine learning analysis. Sleep Med. 2017 Jun;34:162-167. doi: 10.1016/j.sleep.2017.03.004. Epub 2017 Mar 27.
- Kenemans P, Speroff L; International Tibolone Consensus Group. Tibolone: clinical recommendations and practical guidelines. A report of the International Tibolone Consensus Group. Maturitas. 2005 May 16;51(1):21-8. doi: 10.1016/j.maturitas.2005.02.011.
- Moline ML, Broch L, Zak R, Gross V. Sleep in women across the life cycle from adulthood through menopause. Sleep Med Rev. 2003 Apr;7(2):155-77. doi: 10.1053/smrv.2001.0228.
- Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
- menopausal sleep disorders