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

NCT ID: NCT05749354

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2023-12-31

Brief 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.

Detailed 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.

Conditions

Erectile Dysfunction; Acupuncture Therapy; Median Nerve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

liver meridian group

Four acupoints; LR3 Taichong, LR5 Ligou, LR8 Ququan, and LR12 Jiman. Based on the national standard of the People's Republic of China in 2006 (GB/T 12346-2006). The patient will be in a supine position. Taichong will be punctured at a 25-mm depth using a 0.35×25-mm filiform needle, Ligou will be punctured at a 15-20-mm depth with a 0.35×25-mm filiform needle, Ququan at a 20-25-mm depth with a 0.30×40-mm filiform needle, and an acute pulse of 15-20 mm. Each acupoint will be subject to a small amount of uniform lifting and twisting to the degree of local acid distension. An auxiliary needle (0.16×13 mm) will be inserted approximately 5 mm into the needle, 2 mm proximal to the heart of each acupoint along the meridian. The negative electrode will be connected to the main point, and the positive electrode will be connected to the auxiliary needle, and connect the electroacupuncture instrument. The needles will be retained for 30 min respectively, once every other day, 24 treatments.

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: OTHER

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).

1. 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.

2. Electroacupuncture apparatus: SDZ-Ⅱ 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.

stomach meridian group

Four acupoints have been selected for the gastric meridian group, including ST42 Chongyang, ST40 Fenglong, ST36 Zusanli, and ST31 Biguan. The acupoint locations are based on the national standard of the People's Republic of China in 2006 (GB/T 12346-2006). The patient will be supine during the procedure, and the needles will be routinely sterilized. Straight needling will be performed in the hip region using a 0.30×50-mm-filiform needle, a 0.30×50-mm filiform needle in Zusanli, and a 0.30×40-mm filiform needle in Fenglong. A 0.35×25-mm filiform needle will be used to stimulate Chongyang for 10-15 mm, and each acupoint will be gently and evenly lifted, inserted, and twisted to local acid distension. Electroacupuncture will be applied in the same manner as for the liver meridian group. The needles will be retained for 30 min respectively, once every other day, then thrice weekly for a total of 24 treatments in the three groups.

Group Type: ACTIVE_COMPARATOR

electroacupuncture

Intervention Type: OTHER

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).

1. 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.

2. Electroacupuncture apparatus: SDZ-Ⅱ 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.

non-acupoint group

Four points: (1) On the lateral thigh, between the vastus lateralis and biceps femoris, the midpoint of the popliteal stria, and the highest point of the greater trochanter. (2) On the lateral side of the calf, beside the level of Zusanli, and at the lateral edge of the tibia. (3) On the fibular side of the calf, the midpoint of the stomach meridian, and the bile meridian, 3 cm above the tip of the lateral malleolus and in front of the hanging bell. (4) On the lateral side of the calcaneus, and the servant enters the midpoint of the line connecting the posterior edge of the calcaneus at the same level. The 0.30×25-mm filiform needles are inserted straight for 3-5 mm at the points, the needles can stand without Deqi. The auxiliary needle will be inserted and electroacupuncture will be connected (same as in the other group). The internal wire of the electroacupuncture instrument will be interrupted, no current passed through. The treatment time is the same as the other two groups.

Group Type: PLACEBO_COMPARATOR

electroacupuncture

Intervention Type: OTHER

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).

1. 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.

2. Electroacupuncture apparatus: SDZ-Ⅱ 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.

Interventions

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).

1. 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.

2. Electroacupuncture apparatus: SDZ-Ⅱ 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.

Intervention Type: OTHER

Other Intervention Names

acupuncture

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wei Ms Zhang, Doctor

Role: primary

507395550@qq.com

86-13548639198 ext. 0731

Feng Mr Zhong, Doctor

Role: backup

ahtcmzhong@qq.com

86-18711009633 ext. 0731

References

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.

Reference Type: BACKGROUND

PMID: 21695619 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10637462 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21981744 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17888069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15548446 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2963053 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6222096 (View on PubMed)

Other Identifiers

2019YFC1709104

Identifier Type: -

Identifier Source: org_study_id