Effectiveness and Safety of Electro-acupuncture for Mild-to-moderate Perimenopausal Depression

Main objective: to compare the effects of electro-acupuncture and escitalopram oxalate tablets on mild-to-moderate perimenopausal depression, and to evaluate the safety of electroacupuncture stimulation.

Study Overview

• Status: Unknown
• Conditions: Depression; Perimenopause
• Intervention / Treatment: Device: electro-acupuncture; Drug: escitalopram oxalate tablets

• Study Type: Interventional
• Enrollment (Anticipated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenbin Fu, MD; Email: fuwenbin@139.com
• Study Contact Backup: Name: Zhaofeng Li; Email: qdlzfcmd@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Contact: Wenbin Fu, MD; Email: fuwenbin@139.com
      • Contact: Zhaofeng Li; Email: qdlzfcmd@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Conforms to the diagnosis standard of STRAW-10 for perimenopause, conforms to the diagnosis standard of The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for depression, and conforms to the diagnosis standard of The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) F32.0(mild depression) or F32.1(moderate depression);
• Fisrt attack during perimenopausal period;
• HAMD-17 score >7 and <23;
• Age ≥45 to ≤55;
• No hormone replacement therapy (HRT) or no antidepressant 3 months before into the group;
• Sign the consent consent, volunteered for this study

Exclusion Criteria:

• Fail to rule out the possibility of suicide in depression factor of The Symptom Checklist (SCL-90);
• Application of estrogen, progesterone, selective serotonin reuptake inhibitors (SSRIs), soybean isoflavone, vitamin E or black cohosh in recent 4 weeks;
• Allergic to citalopram or escitalopram tablets;
• Taken the non selective, irreversible inhibitor of monoamine oxidase (MAOIs) in recent 2 weeks;
• Taken linezolid, pimozide, tryptophane,tramadol, triptans or other drugs that may cause drug adverse reactions in recent 2 weeks;
• Patient with prolongation of the QT interval or congenital long QT syndrome
• Taken herbs or products that contain isatin, pilose antler, hawthorn, fleeceflower root, common St.John's wort herb, hypericin;
• Ovarian dropsy or hysteromyoma with more than 4cm diameter, oophorectomy, or hysterectomy;
• Mandatory indications of hormonotherapy, such as surgery-induced menopause or osteoporosis;
• Patient with history of radiotherapy or chemotherapy, or undergoing radiotherapy or chemotherapy;
• Vaginal bleeding of undetermined origin;
• Patient with coagulation disorders, or taking anticoagulants such as Warfarin, or heparin;
• Patient with skin diseases, such as eczema,or psoriasis;
• Serious hepatic insufficiency or serious renal inadequacy;
• Uncontrolled hypertension, diabetes, or thyroid disease;
• Diabetic neuropathy, or malignant tumor;
• Pregnancy intention, in pregnancy or lactation;
• Regular use of sedative and anti anxiety drugs;
• The long-term smoking and/or drinking;
• Having Pacemaker or artificial joint；
• Electrolyte is disorder, serious heart disease or other potential life-threatening disease patients;
• Compliance may be poor or fear of acupuncture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture; Baihui, Yintang, Guanyuan(dual), Zigong(dual), Sanyinjiao(dual), Hegu(dual), Taichong(dual). Insert needles to the acupoints mentioned above after sterilized.Needle handles of Baihui and Yintang are connected with the electroacupuncture instrument wire. And needle handles of bilateral Zigong are conneted with the electroacupunture instrument wire. And needle handles of bilateral Tianshu are connected with the electroacupunture instrument wire. Density wave, frequency of 10/50Hz and current intensity is 0.5~1.0 mA for 30 minutes. 3 times per week. Each treatment interval of more than 24 hours, continuous treatment for 12 weeks.	Device: electro-acupuncture; 8 acupoint: Guanyuan, Zigong (bilateral), Tianshu(bilateral), Sanyinjiao(bilateral), Hegu(bilateral), Taichong(bilateral), Baihui, Yintang. Every patient is supposed to have 36 times acupuncture treatment. 30 minutes per time. Baihui, Yintang, Zigong (bilateral), Tianshu (bilateral) are applied with electro-acupuncture device with dilatational wave, current frequency: 10/50Hz, intensity: 0.5~1.0 mA
Active Comparator: escitalopram oxalate tablets; 0.5 hour after breakfast oral taking 10mg escitalopram oxalate tablets, continuous treatment for 12 weeks.	Drug: escitalopram oxalate tablets; escitalopram oxalate tablet, once a day, 0.5 hour after breakfast, oral taken, 10mg, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in scores of the 17-item Hamilton depression rating scale (HAMD-17)	0 week, 4th week, 8th week, 12th week, 16th week and 24th week

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in scores of the Menopause-Specific Quality of Life questionnaire (MENQOL)	0 week, 4th week, 8th week, 12th week, 16th week, 20th week and 24th week
Change from Baseline in level of estradiol (E2),	0 week, 12th week
Change from Baseline in level of follicle-stimulating hormone (FSH)	0 week, 12th week
Change from baseline in level of Luteinizing hormone (LH)	0 week, 12th week
Change from baseline in level of FSH/LH	0 week, 12th week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of electro-acupuncture as measured by safety and acceptability questionnaires	safety and acceptability	0 week, 4th week, 8th week, and 12th week
safety of escitalopram as measured by Asberg Rating Scale for Side Effect (SERS)	Asberg Rating Scale for Side Effect (SERS)	0 week, 4th week, 8th week, and 12the week
safety of escitalopram as measured by liver functure test	ALT, aspartate transminase (AST), and TBIL	0 week, 4th week, 8th week, and 12the week
safety of escitalopram as measured by kidney functure test	Cr, BUN	0 week, 4th week, 8th week, and 12the week
safety of both groups before treatment as measured by EKG	EKG	0 week
safety of both groups before treatment as meausred by blood regular test	Blood regular test	0 week
safety of both groups before treatment as measured by urine regular test	Urine regular test	0 week

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: Study Chair: Wenbin Fu, MD, Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Li S, Li ZF, Wu Q, Guo XC, Xu ZH, Li XB, Chen R, Zhou DY, Wang C, Duan Q, Sun J, Luo D, Li MY, Wang JL, Xie H, Xuan LH, Su SY, Huang DM, Liu ZS, Fu WB. A Multicenter, Randomized, Controlled Trial of Electroacupuncture for Perimenopause Women with Mild-Moderate Depression. Biomed Res Int. 2018 May 29;2018:5351210. doi: 10.1155/2018/5351210. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: April 11, 2015
• First Submitted That Met QC Criteria: April 19, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 19, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide
• Other Study ID Numbers: 2012BAI24B01 (Other Grant/Funding Number: the Ministry of Science and Technology of PRC)