Clinical trial NCT05749354: Clinical Efficacy of Acupuncture on the Liver Meridian in Men With Erectile Dysfunction Reserve
Official title: Clinical Study of Liver Meridian in the Treatment of Male Impotence and Female Premature Ovarian Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Acupuncture Therapy
Median Nerve Disease
Lead sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 159
Sex: MALE
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 5-item version of the International Index of Erectile Function (IIEF-5)
timeFrame: 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 outcomes:
measure: Sexual Encounter Profile (SEP) diaries
timeFrame: 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）
measure: Erectile hardness grading scale (EHS)
timeFrame: 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）
measure: Treatment satisfaction scale (TSS)
timeFrame: 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）
measure: The Hamilton Anxiety Scale (HAMA)
timeFrame: 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）
measure: The Hamilton Depression Scale (HAMD)
timeFrame: 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）
Other outcomes:
Locations:
city: Changsha
country: China
facility: The First Affiliated Hospital of Hunan University of Chinese Medicine
state: Hunan
Study officials:
References:
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.
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.
citation: 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.
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.
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.
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.
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.