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Study on Acupuncture Treatment of Perimenopausal Syndrome by Shu-Mu Point Pairing Method: A Randomized Controlled Trial

注册号：

Registration number：

ITMCTR2025000689

最近更新日期：

Date of Last Refreshed on：

2025-04-10

注册时间：

Date of Registration：

2025-04-10

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于俞募配穴法针刺治疗围绝经期综合征的随机对照研究

Public title：

Study on Acupuncture Treatment of Perimenopausal Syndrome by Shu-Mu Point Pairing Method: A Randomized Controlled Trial

注册题目简写：

俞募配穴法针刺治疗围绝经期综合征

English Acronym：

AcupunctureTreatment of Perimenopausal Syndrome with Shu-Mu Point Pairing Method

研究课题的正式科学名称：

基于俞募配穴法针刺治疗围绝经期综合征的随机对照研究

Scientific title：

Study on Acupuncture Treatment of Perimenopausal Syndrome by Shu-Mu Point Pairing Method: A Randomized Controlled Trial

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

刘路生

研究负责人：

马桂芝

Applicant：

Lusheng Liu

Study leader：

Guizhi Ma

申请注册联系人电话：

Applicant telephone：

15945014764

研究负责人电话：

Study leader's telephone：

18964746998

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

l15146387143@163.com

研究负责人电子邮件：

Study leader's E-mail：

Sandy@126.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

上海市虹口区保定路230号上海市中西医结合医院

研究负责人通讯地址：

上海市虹口区保定路230号上海市中西医结合医院

Applicant address：

230 Bao Ding Road Hongkou District Shanghai China. Shanghai TCM-Integrated Hospital Shanghai University of TCM

Study leader's address：

230 Bao Ding Road Hongkou District Shanghai China. Shanghai TCM-Integrated Hospital Shanghai University of TCM

申请注册联系人邮政编码：

Applicant postcode：

200082

研究负责人邮政编码：

Study leader's postcode：

200082

申请人所在单位：

上海市中西医结合医院

Applicant's institution：

Shanghai TCM-Integrated Hospital Shanghai University of TCM

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2024-047-2

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

上海中医药大学附属上海市中西医结合医院伦理委员会

Name of the ethic committee：

IRB of Shanghai TCM-Integrated Hospital Shanghai University of TCM

伦理委员会批准日期：

Date of approved by ethic committee：

2025/1/6 0:00:00

伦理委员会联系人：

张晶

Contact Name of the ethic committee：

Jing Zhang

伦理委员会联系地址：

上海市虹口区保定路230号 上海中医药大学附属上海市中西医结合医院

Contact Address of the ethic committee：

230 Bao Ding Road Hongkou District Shanghai China. Shanghai TCM-Integrated Hospital Shanghai University of TCM

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-65415910-5389

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zxyllb@126.com

研究实施负责（组长）单位：

上海市中医药大学附属上海市中西医结合医院

Primary sponsor：

Shanghai TCM-Integrated Hospital Shanghai University of TCM

研究实施负责（组长）单位地址：

上海市虹口区保定路230号 上海中医药大学附属上海市中西医结合医院

Primary sponsor's address：

230 Bao Ding Road Hongkou District Shanghai China. Shanghai TCM-Integrated Hospital Shanghai University of TCM

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

虹口区

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海市中医药大学附属上海市中西医结合医院

具体地址：

上海市虹口区保定路230号 上海中医药大学附属上海市中西医结合医院

Institution
hospital：

Shanghai TCM-Integrated Hospital Shanghai University of TCM

Address：

230 Bao Ding Road Hongkou District Shanghai China. Shanghai TCM-Integrated Hospital Shanghai University of TCM

经费或物资来源：

自筹

Source(s) of funding：

self - financed

研究疾病：

围绝经期综合征

研究疾病代码：

Target disease：

Perimenopause

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

采用随机对照试验方法，通过对比俞募配穴针刺法与口服芬吗通治疗前后，围绝经期综合征患者更年期评定量表（Menopausal Rating Scale ,MRS）、围绝经期生存质量量表(Menopause Specific Quality of Life, MENQOL)、焦虑自评量表（Self-rating Anxiety Scale, SAS）、抑郁自评量表(Self-rating Depression Scale ,SDS)、失眠严重指数量表(Insomnia Severity Index,ISI)、中医症候评分、及血清雌二醇(E2)、促卵泡激素(FSH)、促黄体生激素(LH)水平变化，评价俞募配穴法针刺治疗围绝经期综合征的临床疗效。

Objectives of Study：

A randomized controlled trial was conducted to evaluate the clinical efficacy of acupuncture at Shu-mu point in the treatment of perimenopausal syndrome by comparing the changes of Menopausal Scale (MRS) Menopause Specific Quality of Life (MENQOL) Self-rating Anxiety Scale (SAS) Self-rating Depression Scale (SDS) Insomnia Severity Index (ISI) TCM symptom score and E2 FSH and LH levels before and after treatment with acupuncture at Shu-mu point and oral fenmotone.

药物成份或治疗方案详述：

观察组 采用俞募配穴针刺治疗 取穴：肾俞（BL23）、肝俞（BL18）、心俞(BL15)、脾俞(BL20)、京门（GB25）、巨阙(RN14)、章门(LR13) 期门(LR14)。以上诸穴均取双侧。 操作：患者均先取仰卧位针刺，后取俯卧位，针刺京门、期门、章门、巨阙、百会、四神聪、太冲、膻中、足三里、三阴交、复溜、合谷等取仰卧位；针刺心俞、肝俞、脾俞、肾俞、安眠取俯卧位。佩戴眼罩，所有穴位常规消毒，采用针管进针。选用直径0.30mm、长40mm“华佗牌”一次性无菌针灸针（苏州医疗用品厂有限公司生产），穴位针刺均采用针管敲击进针，心俞、肝俞、脾俞向脊柱方向斜刺0.5～0.8寸；肾俞直刺0.5～1寸；京门、期门、章门斜刺0.5～0.8寸，巨阙穴直刺0.5～0.6寸；百会、四神聪平刺0.5～0.8寸；安眠：直刺0.8～1.2寸；太冲直刺0.5～0.8寸；膻中：平刺0.3～0.5寸；足三里、三阴交：直刺1～1.5寸。复溜直刺0.8～1寸；合谷：直刺0.5～1寸。进针后用平补平泻手法，以上腧穴针刺得气后，留针30min，每隔10min行针1次。第1个月每周3次，隔日1次，治疗4周，第2个月起每周治疗2次，连续治疗8周，结束后4周（第16周）为随访期。 对照组 予以口服芬吗通治疗 方法：芬吗通（荷兰 Abbott Biologicals B.V.，注册证号 H20150346），给予常规剂量芬吗通进行治疗，第 1-14 片每片含2mg17-β雌二醇，15~28片每片含 2 mg 17-β雌二醇 及10 mg地屈孕酮；均1片/d，按顺序连续服用28 d，28 d为1个疗程。1个疗程结束后，不停药开始服用下一疗程药物，连续治疗3个疗程。（若仍有月经来潮患者，于月经来潮第一天开始服用；若绝经患者，于就诊当天开始服用）。若用药期间月经来潮，无需停药。 所有穴位定位均根据中华人民共和国国家标准GB/T 12346-2021《经穴名称与定位》进行定位。

Description for medicine or protocol of treatment in detail：

The observation group was treated with acupuncture at Shu-mu points: Shenshu (BL23) Ganshu (BL18) Xinshu (BL15) Pishu (BL20) Jingmen (GB25) Juque (RN14) and Zhangmen (LR13) stage gate (LR14).All the above points were taken bilaterally.Operation: First take supine acupuncture then take prone position acupuncture Jingmen Jimen Zhangmen Juque Baihui Sishencong Taichong Yuzhong Zusanli Sanyinjiao Fuglu Hegu etc. take supine position; acupuncture Xinshu Ganshu Pishu Shenshu hypnosis take prone position.Eye shields were worn all acupoints were routinely disinfected and needle insertion was performed using a needle tube.Select 0.30 mm diameter 40 mm length "Huatuo brand" disposable sterile acupuncture needle (produced by Suzhou Medical Products Factory Co. Ltd.) acupoint acupuncture using needle tube knocking needle insertion Xinshu Ganshu Pishu obliquely puncture 0.5 ~ 0.8 inches in the direction of the spine; Shenshu direct puncture 0.5 ~ 1 inches; Jingmen Jimen Zhangmen obliquely puncture 0.5 ~ 0.8 inches Juque point direct puncture 0.5 ~ 0.6 inches; Baihui Sishen Congping puncture 0.5 ~ 0.8 inches; hypnosis: direct puncture 0.8 ~ 1.2 inches; Taichong direct puncture 0.5 ~ 0.8 inches; Yuzhong: flat puncture 0.3 ~ 0.5 inches; Zusanli Sanyinjiao: direct puncture 1 ~ 1.5 inches.Compound direct puncture 0.8 ~ 1 inch; Hegu: direct puncture 0.5 ~ 1 inch.After inserting the needle the flat supplement and flat purging maneuver was used. After acupuncture at the above acupoints to deqi the needle was retained for 30 minutes and the needle was performed every 10 minutes.The first month was treated three times a week every other day for 4 weeks the second month was treated twice a week for 8 weeks and 4 weeks after the end (week 16) was the follow-up period. The control group was treated with oral fenmotone: fenmotone (Abbott Biologicals B.V. Netherlands registration certificate number H20150346) and was treated with conventional doses of fenmotone containing 2 mg 17-β estradiol per tablet from tablets to 14 2 mg 17-β estradiol and 10 mg dydrogesterone per tablet from 15 to 28 tablets; all 1 tablet/d continuously for 28 days in sequence and 28 days as a course of treatment. After one course of treatment the drug was stopped and the next course of treatment was started for three consecutive courses. (If there are still patients with menstruation start taking it on the first day of menstruation; if postmenopausal patients start taking it on the day of presentation). If menstruation occurs during medication no discontinuation is required. All acupoints were located according to the National Standard of the People 's Republic of China GB/T 12346-2021 "Name and Localization of Meridian Points".

纳入标准：

①　年龄符合围绝经期阶段（40-55周岁）的女性； ②　符合上述中西医诊断标准； ③　无器质性疾病，子宫及双侧卵巢完整； ④　能够理解并配合完成治疗、评估及随访者； ⑤　同意并自愿参加本研究并当面签署知情同意书。

Inclusion criteria

1. Age in line with perimenopausal period (40-55 years old) women; 2. Meet the above diagnostic criteria of Chinese and Western medicine; 3. No organic disease uterus and bilateral ovaries intact; 4. Able to understand and cooperate with the completion of treatment evaluation and follow-up; 5. Agree and voluntarily participate in this study and sign informed consent in person.

排除标准：

①　不符合上述纳入标准者； ②　已知或怀疑妊娠； ③　原因不明的阴道流血：阴道流血病因包括肿瘤性、炎症、医源性、创伤性和卵巢功能失调等 ④　已知或可疑患有乳腺癌。 ⑤　已知或可疑患性激素依赖性恶性肿瘤。 ⑥　最近 6 个月内患有活动性静脉或动脉血栓栓塞性疾病。 ⑦　严重肝肾功能不全。若重复测定肝肾功能高于正常值的 2~3 倍，建议先行内科诊疗。 ⑧　有心血管、肺、肝、肾和造血系统及生殖系统等严重原发性疾病者； ⑨　近1个月内应用激素类药物、精神类药物及抗凝药物者； ⑩　受试者正在进行其他药物临床试验者。

Exclusion criteria：

1. do not meet the above inclusion criteria; 2. known or suspected pregnancy; 3. unexplained vaginal bleeding: vaginal bleeding causes including neoplastic inflammatory iatrogenic traumatic and ovarian dysfunction; 4. known or suspected breast cancer. 5 Known or suspected sex hormone-dependent malignancy. 6 Active venous or arterial thromboembolic disease within the last 6 months. 7 Severe liver and kidney dysfunction. If repeated measurements of liver and kidney function are 2 to 3 times higher than normal values medical diagnosis and treatment are recommended first. (8) Patients with serious primary diseases such as cardiovascular lung liver kidney hematopoietic system and reproductive system; (9) Patients who have used hormone drugs psychotropic drugs and anticoagulant drugs in the past 1 month; (10) Patients who are conducting other drug clinical trials.

研究实施时间：

Study execute time：

从From 2025-02-01

至To      2025-11-15

征募观察对象时间：

Recruiting time：

从From 2025-03-01

至To      2025-10-01

干预措施：

Interventions：

组别：

对照组

样本量：

42

Group：

Fenmotone group

Sample size：

干预措施：

予以口服芬吗通治疗

干预措施代码：

Intervention：

Treated with oral fenmotone

Intervention code：

组别：

试验组

样本量：

42

Group：

Acupuncture group

Sample size：

干预措施：

采用俞募配穴针刺治疗取穴：肾俞（BL23）、肝俞（BL18）、心俞(BL15)、脾俞(BL20)、京门（GB25）、巨阙(RN14)、章门(LR13) 期门(LR14)。以上诸穴均取双侧。

干预措施代码：

Intervention：

Shu-mu acupuncture was used to treat the acupoints: Shenshu (BL23) Ganshu (BL18) Xinshu (BL15) Pishu (BL20) Jingmen (GB25) Juque (RN14) and Zhangmen (LR13) stage gate (LR14). All the above points were taken bilaterally.

Intervention code：

样本总量 Total sample size ： 84

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

虹口区

Country：

China

Province：

Shanghai

City：

Hongkou

单位(医院)：

上海市中医药大学附属上海市中西医结合医院

单位级别：

三甲

Institution/hospital：

Shanghai TCM-Integrated Hospital Shanghai University of TCM

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

抑郁自评量表

指标类型：

主要指标

Outcome：

Self-rating Depression Scale

Type：

Primary indicator

测量时间点：

治疗前和第12周

测量方法：

问卷调查

Measure time point of outcome：

Before treatment and at Week 12

Measure method：

Questionnaire Survey

指标中文名：

更年期评定量表

指标类型：

主要指标

Outcome：

Menopause Rating Scale

Type：

Primary indicator

测量时间点：

治疗前、第4周、第8周、第12周及治疗结束后1月

测量方法：

问卷调查

Measure time point of outcome：

Before treatment Week 4 Week 8 Week 12 and 1 month after the completion of treatment

Measure method：

Questionnaire Survey

指标中文名：

更年期生活质量问卷

指标类型：

次要指标

Outcome：

Menopause-specific Quality of Life

Type：

Secondary indicator

测量时间点：

治疗前和第12周

测量方法：

问卷调查

Measure time point of outcome：

Before treatment and at Week 12

Measure method：

Questionnaire Survey

指标中文名：

焦虑自评量表

指标类型：

次要指标

Outcome：

Self-rating Anxiety Scale

Type：

Secondary indicator

测量时间点：

治疗前和第12周

测量方法：

问卷调查

Measure time point of outcome：

Before treatment and at Week 12

Measure method：

Questionnaire Survey

指标中文名：

血清性激素

指标类型：

次要指标

Outcome：

Serum Sex Hormones

Type：

Secondary indicator

测量时间点：

治疗前和第12周

测量方法：

免疫发光法

Measure time point of outcome：

Before treatment and at Week 12

Measure method：

Immunochemiluminescence Assay

指标中文名：

失眠严重指数量表

指标类型：

次要指标

Outcome：

Insomnia Severity Index

Type：

Secondary indicator

测量时间点：

治疗前和第12周

测量方法：

问卷调查

Measure time point of outcome：

Before treatment and at Week 12

Measure method：

Questionnaire Survey

指标中文名：

中医证候评分量表

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Syndrome Scoring Scale

Type：

Secondary indicator

测量时间点：

治疗前和第12周

测量方法：

问卷调查

Measure time point of outcome：

Before treatment and at Week 12

Measure method：

Questionnaire Survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 40 岁
Min age years
最大 55 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

本研究在随机方法上，采用简单随机法，运用SPSS26.0软件生成随机数字，由上海中西医结合医院针灸科何靖保管，根据患者就诊先后顺序获取随机数字进行入组治疗，试验严格按照随机化设计序列纳入患者。

Randomization Procedure (please state who generates the random number sequence and by what method)：

In this study simple randomization method was used to generate random numbers using SPSS 26.0 software which were kept by He Jing Department of Acupuncture and Moxibustion Shanghai Hospital of Integrated Traditional Chinese and Western Medicine and random numbers were obtained according to the order of patient visits for enrollment and treatment and the trial included patients in strict accordance with the randomized design sequence.

盲法：

盲法采用盲病人的方式，研究中心采用单个隔离方式进行治疗，尽可能避免患者之间的交流。此外，采用盲法疗效评价和统计分析，由不知分组的第三方完成，实行研究者和统计者分离。

Blinding：

Blinded patients were treated in a blinded manner and sites were treated in a single isolation to avoid communication between patients as much as possible. In addition blinded efficacy evaluation and statistical analysis were performed by a third party who did not know the group assignment and separation between the investigator and the statistician was performed.

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

临床试验公共管理平台

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Clinical Trial Public Management Platform

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

研究者填写CRF表。病历的电子采集及管理使用ResMan系统。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The researcher filled out the CRF form. Electronic records collection and management using the ResMan system.

数据管理委员会：

Data Managemen Committee：

无

No

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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