Clinical Observation On The Clinical Efficacy Of Acupuncture And Moxibustion Combined With Drug Therapy in The Treatment Of Functional ED
Mar 28, 2025
Abstract
Objective: To evaluate the efficacy of traditional Chinese acupuncture therapy combined with tadalafil in the treatment of functional erectile dysfunction (ED), and further assess the effectiveness of integrated traditional Chinese and Western medicine in treating ED.
Methods: Patients diagnosed with ED at the Acupuncture Department and Urology Outpatient Clinic of Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine between January 1, 2017, and November 30, 2017 (confirmed by Western medical diagnosis) were included in the study. Patients meeting the diagnostic criteria for functional ED were selected as research subjects and randomly divided into three groups: the acupuncture-medication combined group (Group A), the acupuncture-only group (Group B), and the tadalafil-only group (Group C). Group A received acupuncture treatment combined with tadalafil, while Group B underwent traditional Chinese medical treatments, including acupuncture at primary points, syndrome-based adjustments, and moxibustion at Guanyuan acupoint. Group C received only tadalafil medication. After two treatment courses, the International Index of Erectile Function-5 (IIEF-5) and the Male Sexual Function-4 (MSF-4) scoring systems were used to evaluate the therapeutic efficacy and safety of each group.
Results:
IIEF-5 Score Comparison: Post-treatment IIEF-5 scores improved in all three groups, but Group A showed significantly greater improvements compared to Groups B and C, with statistically significant differences (P<0.01).
MSF-4 Score Comparison: MSF-4 scores increased in all three groups after treatment, with Group A showing the most significant improvement. The differences compared to Groups B and C were statistically significant (P<0.01).
Overall Efficacy Comparison: The effective cure rate was 67% in Group A, 35% in Group B, and 40% in Group C. Group A's cure rate was significantly higher, with statistically significant differences compared to Groups B and C (P<0.01).
Safety Evaluation: No significant adverse reactions were observed in any of the three groups during treatment.
Conclusion: Acupuncture combined with tadalafil is highly effective and safe in the treatment of functional ED. This approach shows great clinical efficacy and can be promoted as a new method for treating functional ED.
Keywords: Traditional Chinese Acupuncture; Functional ED; Tadalafil Tablets
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Introduction
Erectile dysfunction (ED) is a condition characterized primarily by the inability of the male penis to achieve or maintain an erection, often accompanied by symptoms such as reduced libido and premature ejaculation. ED is one of the most common sexual dysfunctions in modern men [1], significantly affecting their physical and mental health. Epidemiological data suggest that approximately 52% of men aged 40–70 experience varying degrees of ED, with the number of cases projected to reach 322 million globally by 2025 [2]. According to the European Urological Association (EUA) Guidelines on Erectile Dysfunction (2015), the prevalence and incidence of ED are high worldwide [3]. A survey conducted across 11 cities in China showed that the prevalence of ED among men over 40 years old was 40.2% [4]. Consequently, the prevention and treatment of ED have garnered increasing attention across all levels of society.
Based on its etiology, ED is categorized as functional (psychogenic), organic, or mixed [3]. Modern medicine offers diverse treatment options for functional ED, including oral phosphodiesterase type 5 inhibitors (PDE5-Is), α-receptor blockers, dopamine activators, and intracavernosal injection therapy. Among these, PDE5-Is remain the first-line treatment for ED [5]. Common PDE5-Is used in China include sildenafil, vardenafil, and tadalafil, with tadalafil having the longest half-life [6]. Regular daily administration of 5 mg tadalafil for ED has received significant attention in recent years [7]. Studies have shown that compared to traditional on-demand PDE5-Is use, continuous daily administration of 5 mg tadalafil effectively eliminates the association between sexual activity and medication, significantly improves International Index of Erectile Function-5 (IIEF-5) scores, and enhances the sexual quality of life for both partners. Additionally, it greatly improves the tolerability of ED patients [8-11], making it a promising new treatment strategy for ED [12].
Traditional Chinese medicine (TCM) offers a variety of effective methods for treating ED, with acupuncture being widely recognized for its efficacy in addressing functional ED [13]. In 2016, the Andrology Committee of the Chinese Society of Integrated Traditional Chinese and Western Medicine included acupuncture in the "Guidelines for Integrated Diagnosis and Treatment of Erectile Dysfunction (Trial)" [7]. According to the Delphi grading of evidence-based TCM, acupuncture for ED is recommended at Grade C [14]. Research has shown that acupuncture is particularly effective in treating ED with concurrent low libido [15]. Moxibustion therapy, a TCM practice with a history spanning thousands of years, has been shown in modern studies to activate acupoints, promote circulation of qi and blood, and provide warming and tonifying effects. It is widely used to regulate reproductive functions [16] and enhance the efficacy of ED treatment. Among moxibustion therapies, the treatment of ED by moxibustion at the Guanyuan acupoint is the most frequently employed [17], especially for reproductive system disorders [18]. A systematic review by Xing Xuelian [19] of 752 clinical studies revealed that the Guanyuan acupoint is the most commonly used for treating reproductive system disorders, with a usage rate of 67.6%. Liu Xiaoyan et al. [20] demonstrated that reverse moxibustion at the Guanyuan acupoint significantly improves reproductive axis function and prevents reproductive disorders. Chen Zhongjie [21] found that moxibustion at the Guanyuan acupoint alleviates symptoms such as poor appetite, fatigue, weak lumbar and knee pain, and cold intolerance, and has a statistically significant effect on improving TCM symptoms of erectile dysfunction.
Both TCM acupuncture therapy and regular administration of 5 mg tadalafil are effective treatments for ED. Could combining these two methods in clinical practice produce a synergistic and enhanced effect? This study aims to observe the efficacy of TCM acupuncture combined with medication in the treatment of functional ED and further evaluate its safety, in an effort to explore a new integrated TCM and Western medicine approach for treating ED.
1. Clinical Data
1.1 Source of Cases
The study subjects were selected from individuals who sought treatment at the Acupuncture Department and Urology Outpatient Clinic of Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine between January and November 2017. Patients were preliminarily diagnosed with ED based on Western medical diagnostic criteria. Disease classification was performed by physicians with qualifications of intermediate professional titles or above, and patients meeting the diagnostic criteria for functional ED were included. Final TCM syndrome differentiation and classification were conducted by TCM physicians with intermediate professional titles or higher.
1.2 Diagnostic Criteria
1.2.1 Western Medical Diagnostic Criteria
According to the National Institutes of Health (NIH) definition of ED [22]: the inability to achieve or maintain an erection of the penis sufficient for satisfactory sexual performance during intercourse, with symptoms lasting for more than 3 months. Additionally, patients with an International Index of Erectile Function-5 (IIEF-5) score [23] of less than 21 are diagnosed with ED [24].
1.2.2 Traditional Chinese Medicine Diagnostic Criteria and Classification
Based on the "15th Five-Year Plan" national textbook Internal Medicine of Traditional Chinese Medicine [25], ED is defined as the inability of the male penis to effectively achieve an erection, insufficient penile hardness to penetrate the vagina, or a short duration of erection that cannot sustain effective sexual intercourse in more than 75% of cases. These conditions must persist for 3 months or longer to diagnose the condition as impotence.
According to the Diagnostic and Efficacy Criteria of TCM Diseases and Syndromes issued by the State Administration of Traditional Chinese Medicine [26], and the "13th Five-Year Plan" national textbook Andrology of Traditional Chinese Medicine [27], the TCM classification of ED syndromes is as follows:
1.2.2.1 Liver Qi Stagnation
Main Symptoms:
(1) Inability to achieve erection.
(2) Inability to maintain erection.
Secondary Symptoms:
(1) Emotional depression or frequent sighing.
(2) Loss of motivation, suspicion.
(3) Fullness in the chest and hypochondrium.
(4) Irritability and anger.
(5) Epigastric distension and poor appetite.
Tongue and Pulse:
Tongue is pale red or has red edges, with a thin white coating. Pulse is wiry and thin.
Diagnostic Criteria:
A diagnosis of liver qi stagnation type ED can be made if the patient exhibits symptom (1) from the main symptoms, along with either another main symptom or two secondary symptoms.
1.2.2.2 Damp-Heat Downward Flow
Main Symptoms:
(1) Inability to achieve erection.
(2) Inability to maintain erection.
Secondary Symptoms:
(1) Dizziness and a sense of heaviness.
(2) Fatigue or abdominal fullness with hypochondriac distension.
(3) Dampness or itching in the scrotum, with a foul odor.
(4) Yellowish urine with post-urination dribbling or a foul smell.
(5) Burning pain in the urethra.
(6) Nausea and bitterness in the mouth.
Tongue and Pulse:
Tongue is red with a yellow greasy coating. Pulse is soft and rapid, or slippery and rapid.
Diagnostic Criteria:
A diagnosis of damp-heat downward flow type ED can be made if the patient exhibits symptom (1) from the main symptoms, along with either another main symptom or two secondary symptoms.
1.2.2.3 Heart and Spleen Damage
Main Symptoms:
(1) Inability to achieve erection.
(2) Inability to maintain erection.
Secondary Symptoms:
(1) Palpitations or insomnia with frequent dreams.
(2) Anxiety and forgetfulness.
(3) Pale yellow complexion.
(4) Fatigue and lack of energy.
(5) Poor appetite and abdominal distension.
(6) Loose stools or unsatisfactory bowel movements.
Tongue and Pulse:
Tongue is pale with a thin white coating. Pulse is thin and weak.
Diagnostic Criteria:
A diagnosis of heart and spleen damage type ED can be made if the patient exhibits symptom (1) from the main symptoms, along with either another main symptom or two secondary symptoms.
1.2.2.4 Stasis Obstructing Collaterals
Main Symptoms:
Inability to achieve erection.
Inability to maintain erection, or even complete loss of erection.
Secondary Symptoms:
Mental depression.
Loss of libido.
Coarse and dry skin.
A feeling of fullness or throbbing pain in the perineum.
Stabbing pain in the testes.
Tongue and Pulse:
Purple or dark tongue, possibly with petechiae. Pulse is choppy.
Diagnostic Criteria:
A diagnosis of stasis obstructing collaterals type ED can be made if the patient exhibits symptom (1) from the main symptoms, along with either another main symptom or two secondary symptoms.
1.2.2.5 Yin Deficiency with Hyperactive Fire
Main Symptoms:
Libido is present.
Inadequate erection or premature ejaculation upon arousal.
Secondary Symptoms:
Dizziness and forgetfulness.
Tinnitus.
Weakness and soreness in the lower back and knees.
Five-center heat sensation (palms, soles, and chest).
Dry throat and flushed cheekbones.
Yellow urine and dry stools.
Tongue and Pulse:
Red tongue with little or thin yellow coating, or with exfoliated coating and cracks. Pulse is thin and rapid.
Diagnostic Criteria:
A diagnosis of yin deficiency with hyperactive fire type ED can be made if the patient exhibits symptom (1) from the main symptoms, along with either another main symptom or two secondary symptoms.
1.2.2.6 Decline of Mingmen Fire
Main Symptoms:
Inability to achieve erection.
Inability to maintain erection.
Secondary Symptoms:
Cold limbs and body.
Pale complexion.
Dizziness and tinnitus.
Weakness and soreness in the lower back and knees.
Coldness in the penis or thin, clear semen.
Frequent and prolonged urination at night.
Tongue and Pulse:
Pale and swollen tongue with a thin white coating. Pulse is deep, thin, and weak, particularly noticeable in the right chi position.
Diagnostic Criteria:
A diagnosis of decline of Mingmen fire type ED can be made if the patient exhibits symptom (1) from the main symptoms, along with either another main symptom or two secondary symptoms.
1.2.3 Diagnostic Criteria for Functional ED [28]
According to the second revised edition of the Chinese Classification of Mental Disorders (CCMD-II-R):
Functional ED is defined in males aged 20–65 as the presence of libido but an inability to achieve or maintain an erection during intercourse, or an erection that is too brief or insufficiently firm to allow vaginal penetration. The condition must persist for at least 3 months and exclude causes such as medications, organic damage, alcohol, drugs, or toxins.
1.3 Inclusion Criteria
Meets the diagnostic criteria for functional ED.
Aged 20–65 years.
Married, cohabiting, and living in good conditions.
Spouse cooperates with treatment.
Tolerates acupuncture and medication treatment.
Excludes those with psychiatric, neurological, cardiovascular, or other severe organic diseases.
Patients must provide informed consent.
1.4 Exclusion Criteria
Does not meet the diagnostic criteria above.
ED caused by severe organic, pharmacological, or traumatic factors, or combined with other significant organic diseases.
Spouse has a severe medical condition.
Patients with primary disorders such as dyslipidemia, hyperglycemia, hypertension, impaired liver or kidney function, hematopoietic system diseases, psychiatric disorders, endocrine disorders, or psychological abnormalities.
Other cases that do not meet the inclusion criteria.
1.5 Criteria for Exclusion and Dropout Cases
Patients already included in the study but found to meet the exclusion criteria or not meet the inclusion criteria after further evaluation.
Cases with incomplete patient data, making accurate statistical analysis or evaluation impossible.
Cases where the treatment course is not completed due to patients discontinuing treatment, loss of contact, or other special circumstances.
Cases where severe adverse events or complications occur during treatment, making it impossible to continue.
Those who are unwilling to cooperate, cannot guarantee compliance, and cannot accurately evaluate the results.
Those who actively request to withdraw because the patient or family members do not want further treatment.
