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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
159
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.
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
RECRUITING5-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.
Time frame: 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）
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? ".
Time frame: 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）
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.
Time frame: 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）
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.
Time frame: 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）
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.
Time frame: 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）
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.
Time frame: 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）
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