Clinical Efficacy of Acupuncture on the Liver Meridian in Men With Erectile Dysfunction Reserve

Erectile Dysfunction Clinical Trial

— GJZLBQGNZA  

Official title:

Clinical Study of Liver Meridian in the Treatment of Male Impotence and Female Premature Ovarian Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749354
• Other study ID #: 2019YFC1709104
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Erectile dysfunction (ED) is a kind of worldwide and common sexual dysfunction disease, which mainly affects men over forty years old. The clinical characteristics of ED is the inability to maintain sufficient erection to obtain satisfactory sexual intercourse. Age, education, diabetes, stroke, obesity, and hypertension are factors inducing ED. Recent years, the prevalence of ED is rising, and more men aged below forty years old are suffering ED. Published review indicated that the prevalence of ED was 40.56% in Chinese men aged over forty years old. A survey conducted in China suggested that 40.56% men aged over forty years old suffered from ED. Another international survey found that, 21.48% sexually active participants suffered from ED. Several researches demonstrated that, ED affects health and quality of life of patients and partner. Besides, ED induces patients' psychosocial problems, including depression and anxiety, and reduce work efficiency. According to American Urological Association guideline published in 2018, the clinical therapies for ED include phosphodiesterase type 5 inhibitor (PDE5i), vacuum erection device, and penile prosthesis implantation. PDE5i (such as sildenafil, vardenafil, and tadalafil) is a first-line drug for ED, recommended by doctors and patients. However, the most common side effects of PDE5i were headache, dyspepsia, flushing, and blurred vision. Furthermore, the ideal dose and type of PDE5i still need to be further studied. The use of PDE5i is restricted by those reasons. Acupuncture is an important role of Traditional Chinese Medicine (TCM), and acupuncture received more concerned recently. The correlation between meridians and viscera is the center of acupuncture scientific problem. Acupoints stimulation can regulate visceral sensation and mobility to treat diseases.

Description:

This is a three-arm, multi-center, randomized controlled trial. Participants will be recruited in this study, with participants in each group. This trial is reported on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines and complies with the principles of the Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Clinical Trial of Acupuncture (STRICTA).The study will be carried out from January 2023 to December 2023 at five hospitals in China. Those hospitals include the first hospital of Hunan university of Chinese Medicine, Chengdu university of traditional Chinese medicine, Jiangsu Province Hospital of Chinese Medicine, The Affiliated Hospital of Jiangxi University of TCM, and Guizhou university of TCM. This research will recruit participants with ED by outpatient and inpatient department and social media. The patients who meet the diagnostic criteria of American Urological Association will be included in this study. The eligible patients with ED will be allocated into three groups: the liver meridian group, the stomach meridian group, and the non-acupoint group in a 1:1:1 ratio. The total observation period is twenty weeks, including a one-week baseline, eight-week treatment period, and twelve-week follow-up period. Outcome evaluation will be implemented at the baseline, during the treatment period, and during the follow-up period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 159
• Est. completion date: December 31, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age between 22 and 50 years
• Having a sexual partner and having regular sex life at least twice a week
• Meeting the diagnostic criteria of ED
• The scores of IIEF-5 between 8 points to 21 points
• PDE5i or similar medication weren't taken one month before treatment
• Patients agree to participate in this study.

Exclusion Criteria:

• Congenital genital malformation and dysplasia
• Severe reproductive system infection
• ED induced by genitourinary surgery and lower abdominal surgery
• Severe cardiovascular disease, liver disease, kidney disease
• Severe hypertension, diabetes, and blood diseases have not been controlled
• Severe mental illness
• Contraindications of PDE5i.

Related Conditions & MeSH terms

• Acupuncture Therapy
• Erectile Dysfunction
• Median Nerve Disease
• Median Neuropathy
• Nervous System Diseases

Intervention

Other:
• electroacupuncture
Electroacupuncture (EA) is a method of treating diseases by inserting a needle (usually a filiform needle) into the skin or tissue of a patient at a certain Angle, and then passing through the needle (sensing) micro-current waves of human bioelectricity to stimulate specific parts of the human body (acupoints). Disposable sterile acupuncture filiform needle (0.16mm×13mm, 0.30mm×25mm, 0.30mm× 40mm), Guizhou Andi Medical Equipment Co, LTD, Guizhou Food and Drug Supervision and Equipment Production Xu 20170011. Electroacupuncture apparatus: SDZ-? electroacupuncture apparatus of Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Registration No. : 20172270675. For non-acupoint group,the internal wire of the electroacupuncture instrument will be interrupted, no current passed through.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Hunan University of Chinese Medicine	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (7)

Araujo AB, Allen KR, Ni X, Rosen RC. Minimal clinically important differences in the vaginal insertion and successful intercourse items of the sexual encounter profile. J Sex Med. 2012 Jan;9(1):169-79. doi: 10.1111/j.1743-6109.2011.02506.x. Epub 2011 Oct 7. — View Citation

Gjerris A, Bech P, Bojholm S, Bolwig TG, Kramp P, Clemmesen L, Andersen J, Jensen E, Rafaelsen OJ. The Hamilton Anxiety Scale. Evaluation of homogeneity and inter-observer reliability in patients with depressive disorders. J Affect Disord. 1983 May;5(2):163-70. doi: 10.1016/0165-0327(83)90009-5. — View Citation

Kubin M, Trudeau E, Gondek K, Seignobos E, Fugl-Meyer AR. Early conceptual and linguistic development of a patient and partner treatment satisfaction scale (TSS) for erectile dysfunction. Eur Urol. 2004 Dec;46(6):768-74; discussion 774-5. doi: 10.1016/j.eururo.2004.08.001. — View Citation

Maier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988 Jan-Feb;14(1):61-8. doi: 10.1016/0165-0327(88)90072-9. — View Citation

Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K. Validation of the erection hardness score. J Sex Med. 2007 Nov;4(6):1626-34. doi: 10.1111/j.1743-6109.2007.00600.x. Epub 2007 Sep 21. — View Citation

Rong P, Zhu B, Li Y, Gao X, Ben H, Li Y, Li L, He W, Liu R, Yu L. Mechanism of acupuncture regulating visceral sensation and mobility. Front Med. 2011 Jun;5(2):151-6. doi: 10.1007/s11684-011-0129-7. Epub 2011 Jun 22. — View Citation

Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-item version of the International Index of Erectile Function (IIEF-5)	In this trial, the 5-item version of IIEF will be applied as primary outcome. The IIEF-5 contains 5 questions and measures the erectile function and intercourse satisfaction. Responses are rated on 5-point Likert scales for every item. The total scores of all 5 items are the overall IIEF-5 score.	Baseline period,enrollment 2 weeks, enrollment 4 weeks, enrollment 6 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up)
Secondary	Sexual Encounter Profile (SEP) diaries	In this trial, the development of sexual activity will be assessed using the Sexual Encounter Profile (SEP) diaries (SEP-Questions 2 and 3). After each sexual intercourse, the participants will be asked to record the following two yes/no questions of the test: SEP Question 2: " Were you able to insert your penis into your partner's vagina?" SEP3 Question 3: " Did your erection last long enough for you to have successful intercourse? ".	Baseline period,enrollment 2 weeks, enrollment 4 weeks, enrollment 6 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up)
Secondary	Erectile hardness grading scale (EHS)	To investigate the erectile hardness, the erectile hardness grading scale (EHS) was used in this trial. According to the EHS, the erectile hardness is divided into four grades. Grade one of EHS is that penis enlarged but not hard. Grade two of EHS is that the penis is slightly erect, but not enough for penetration. Grade three of EHS is that penis erection hard for penetration but not hard completely. Grade four of EHS is that penis is completely hard and fully rigid.	Baseline period,enrollment 2 weeks, enrollment 4 weeks, enrollment 6 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up)
Secondary	Treatment satisfaction scale (TSS)	The treatment effectiveness for both patients and partners will be measured using The Treatment Satisfaction Scale (TSS) . The TSS questionnaire consist of four parts, including unmedicated patient, medicated patient, unmedicated partner, and medicated partner modules. The content of TSS include the satisfaction with sexual spontaneity, quality of erection, quality of ejaculation, sexual pleasure, orgasm, confidence, reliability of treatment, side effects, convenience, overall satisfaction, conformity to treatment expectations and intent to continue treatment.	Baseline period,enrollment 2 weeks, enrollment 4 weeks, enrollment 6 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up)
Secondary	The Hamilton Anxiety Scale (HAMA)	The symptoms of anxiety induced by ED will be evaluated by The Hamilton Anxiety Scale (HAMA) separately. The higher the score, the heavier anxiety.	Baseline period, enrollment 4 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up)
Secondary	The Hamilton Depression Scale (HAMD)	The symptoms of depression induced by ED will be evaluated by The Hamilton Depression Scale (HAMD) separately. The higher the score, the heavier the depression.	Baseline period, enrollment 4 weeks, enrollment 8 weeks, enrollment 12 weeks, enrollment 16 weeks, enrollment 20 weeks(changes from Baseline at 8 weeks of treatment and 12 weeks of follow-up)