Clinical Observation On The Clinical Efficacy Of Acupuncture And Moxibustion Combined With Drug Therapy in The Treatment Of Functional ED Ⅱ
Mar 28, 2025
2. Research Methods
2.1 Survey Methods
Based on knowledge from TCM and Western urology, and under the guidance of senior physicians, the research design was completed, and a standardized questionnaire was developed. Patients visiting the urology or acupuncture outpatient departments were selected as survey subjects. For patients preliminarily diagnosed with ED, a thorough investigation of basic data (general information, medical history, clinical symptoms, body mass index, and TCM syndrome scores) was conducted. After completing each section of the survey, no fewer than two physicians with intermediate or higher qualifications performed ED classification to select patients meeting the diagnostic criteria for functional ED. For patients included in the functional ED study, TCM syndrome differentiation and classification were conducted by at least one TCM physician with intermediate or higher qualifications, including at least one associate chief physician, who also guided acupuncture-based syndrome differentiation treatment. Data were then compiled and entered by two medical professionals to ensure the completeness and accuracy of the sample data.
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2.1.1 Survey Forms
Based on the survey content, 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 following forms were designed:
TCM Syndrome Survey for ED.
TCM Clinical Symptom Frequency Table.
Additionally, raw data collection was completed using content from the International Erectile Function Questionnaire-5 (Appendix 1) and the International Male Sexual Desire Scale-4 (Appendix 2).
2.1.2 Investigators
Two to three outpatient postgraduate trainees and one TCM physician with intermediate qualifications participated as investigators for this study. Before the survey began, relevant training was conducted to ensure consistency in applying inclusion criteria.
2.1.3 Survey Content
2.1.3.1 General Clinical Data of Patients
Data on age, weight, and height were collected, and BMI (kg/m²) was calculated using the formula:
BMI = Weight (kg) / Height² (m²) [29]. Height was measured to an accuracy of 0.01 m.
2.1.3.2 IIEF-5 Score [23]
Patients were provided with questionnaires and instructed on how to complete them. Patients filled in the IIEF-5 Questionnaire, which includes five questions covering confidence in achieving an erection, erection hardness, ability to maintain an erection, and sexual satisfaction.
2.1.3.3 International Male Sexual Desire Scale
Patients were provided with questionnaires and instructed on how to complete the International Male Sexual Desire Scale-4. This questionnaire includes four questions addressing subjective sexual desire, satisfaction with ejaculation, satisfaction after self-pleasure or intercourse, and satisfaction with erectile function.
2.1.3.4 TCM Clinical Symptom Investigation
Symptoms such as "inability to achieve erection" or "inability to maintain erection" were classified as the primary symptoms. Other symptoms were categorized according to the clinical manifestations of each syndrome and rated on a five-level scale:
Symptoms are obvious and voluntarily reported.
Symptoms are significant or persistent upon inquiry.
Symptoms appear intermittently or fluctuate.
Symptoms are mild or occur occasionally.
No symptoms.
Tongue Diagnosis: Includes tongue body, color, shape, and coating.
Pulse Diagnosis: Includes pulse length, position, strength, and rate.
Syndrome-Specific Symptoms:
Liver Qi Stagnation: Emotional depression, frequent sighing, irritability, hypochondriac distension, poor appetite; tongue is pale red with thin white coating; pulse is wiry.
Damp-Heat Downward Flow: Nausea, bitter taste, dizziness, heaviness, fatigue, hypochondriac or abdominal distension, yellow urine, post-urination dribbling or odor, burning urethra, damp or itchy scrotum with foul odor; tongue is red with yellow greasy coating; pulse is soft and rapid or slippery and rapid.
Heart and Spleen Deficiency: Palpitations, insomnia, pale yellow complexion, fatigue, forgetfulness, poor appetite, abdominal distension, loose stools; tongue is pale with thin white coating; pulse is thin and weak.
Stasis Obstructing Collaterals: Loss of libido, mental depression, coarse skin, lower abdominal pain, perineal distension, stabbing pain in the testes; tongue is dark purple or has petechiae; pulse is choppy.
Yin Deficiency with Hyperactive Fire: Dizziness, tinnitus, forgetfulness, dry throat, flushed cheeks, five-center heat sensation, weak lower back and knees, yellow urine, dry stools; tongue is red with little or thin yellow coating, with possible cracks or exfoliation; pulse is thin and rapid.
Decline of Mingmen Fire: Cold body and limbs, dizziness, pale complexion, weak lower back and knees, cold penis, thin semen, frequent urination, prolonged nocturia; tongue is pale and swollen with thin white coating; pulse is deep and weak, especially in the right chi position.
2.2 Grouping Method
A total of 100 ED patients were surveyed (IIEF-5 score <21) [24]. After final classification of ED syndromes, 61 patients meeting the diagnostic criteria for functional ED were selected as study subjects and randomly divided into three groups:
Acupuncture-Medication Combined Group (Group A): 21 patients.
Acupuncture Treatment Group (Group B): 20 patients.
Tadalafil Medication Group (Group C): 20 patients (treated with 5 mg tadalafil daily).
2.3 Treatment Methods
2.3.1 Preparation of Needles and Medications
Filiform Needles:
Brand: Huanqiu.
Manufacturer: Suzhou Acupuncture Supplies Co., Ltd.
Specifications: 0.25mm × 25-50mm filiform needles (1.0-1.5 cun), compliant with GB2024-87 Acupuncture Needle standards and GB1220-75 Stainless Acid-Resistant Steel Technical Conditions.
Moxa Sticks:
National Drug Approval Number: Z32021062.
Manufacturer: Suzhou Dongfang Moxa Factory.
Characteristics: Cylindrical, 20-21 cm in length, 1.9-2.1 cm in diameter.
Specifications: 25g per stick, packaged 10 sticks per bag/box.
Moxibustion Device:
Patent Number: ZL200920079158.7.
Brand: Xin Ai Xing, small size.
Tadalafil (Cialis):
Specifications: 5 mg * 14 tablets.
Manufacturer: Lilly del Caribe Inc.
Registration Number: H20170022.
2.3.2 Specific Implementation
Group A: Acupuncture Combined with Regular Administration of 5 mg Tadalafil
Acupuncture Prescription:
Main points: Ren meridian and acupoints of the three yin meridians of the foot, including Guanyuan (CV4), Sanyinjiao (SP6), Baihuanshu (BL30), Huiyang (BL35), Ciliao (BL32), and Zusanli (ST36). Points were adjusted based on syndromes:
For decline of Mingmen fire, add Mingmen (GV4), Shenshu (BL23), and Qihai (CV6) to warm the kidneys and strengthen yang.
For damp-heat downward flow, add Yinlingquan (SP9), Yanglingquan (GB34), and Qugu (CV2) to clear and drain damp-heat [30].
Acupuncture alternated between abdominal and back points. Standard disinfection was performed.
Deep needling was applied at Huiyang and Baihuanshu (using 0.35mm × 100mm needles), with radiating needle sensations towards the perineum being ideal.
Other points were needled conventionally with standard disinfection. After achieving "deqi" (arrival of qi), balanced reinforcing and reducing techniques were applied.
Treatment was administered daily, with needles retained for 30 minutes per session and manipulated twice during retention. Five consecutive treatments constituted one course (with a 2-day break between courses). A total of three courses were conducted.
Moxibustion at Guanyuan (CV4):
Moxa sticks were cut to approximately 3 cm (1 stick per session) and fixed in the moxibustion device.
After the acupuncture session, the device was placed over the Guanyuan acupoint for moxibustion.
Initially, moxibustion was performed daily for three sessions, then every other day. Each session used one moxa stick, lasting approximately 25-30 minutes.
The skin was observed for redness without discomfort or burning. Five treatments constituted one course, with a 2-day break before the next course. A total of three courses were conducted [31].
This moxibustion method was applied across all TCM syndromes of functional ED.
Tadalafil Administration:
Dosage: 5 mg once daily (Qn), orally.
Six consecutive doses constituted one course, with a 2-day break before the next course. A total of two courses were conducted.
Patients were instructed to avoid smoking, alcohol, spicy, fried, and other irritating foods, as well as limit intake of fish, shrimp, and seafood to prevent adverse reactions.
Group B: Acupuncture Plus Moxibustion at Guanyuan
The acupuncture and moxibustion methods were the same as those used in Group A.
Group C: Daily Regular Oral Administration of Tadalafil
The dosage and administration of tadalafil were the same as in Group A.
3. Observation Indicators
3.1 IIEF-5 Score Index [23]
The questionnaire consists of five questions, each scored on a scale of 0-5, with a total score of 25. A score of ≤21 indicates erectile dysfunction (ED). The severity of ED is categorized as follows:
Severe ED: IIEF-5 score <7.
Moderate ED: IIEF-5 score 8-11.
Mild ED: IIEF-5 score 12-21.
No ED: IIEF-5 score ≥22 [32-33].
3.2 International Male Sexual Desire Scale Score
The scale includes four questions, each scored on a scale of 0-4, for a total score of 16. The questions assess subjective sexual desire, satisfaction with ejaculation, satisfaction with orgasm after masturbation or intercourse, and satisfaction with erectile function.
3.3 TCM Clinical Symptom Scores
Based on the Internal Medicine of Traditional Chinese Medicine [25] from the "15th Five-Year Plan" national textbook and combining locally common clinical symptoms, five basic syndromes were included in the questionnaire: damp-heat downward flow, decline of Mingmen fire, liver qi stagnation, kidney damage due to fright, and heart-spleen deficiency. Each symptom was scored using a five-level system:
4 points: Symptoms are obvious and voluntarily reported.
3 points: Symptoms are significant or persistent upon inquiry.
2 points: Symptoms occur intermittently or fluctuate.
1 point: Symptoms are mild or occur occasionally.
0 points: No symptoms.
For composite syndromes (mixed syndromes), the two syndromes with the highest scores among the basic syndromes were used for classification. If the scores of secondary syndromes were the same, tongue and pulse diagnoses were used to determine the combination of basic syndromes.
4. Efficacy Evaluation
4.1 Observation of IIEF-5 Score Index [23]
Ineffective: No change in clinical symptoms; IIEF-5 total score remains the same before and after treatment.
Effective: Improvement in clinical symptoms; IIEF-5 total score is 15-18 or increases by more than 10 points compared to the baseline score.
Significantly Effective: Significant improvement in clinical symptoms; IIEF-5 total score is 19-21.
Cured: Complete disappearance of clinical symptoms; IIEF-5 total score >22.
4.2 Observation of MSF-4 Score Changes
Changes in the scores from the International Male Sexual Desire Scale-4 were observed.
4.3 Observation of TCM Clinical Symptom Score Changes
Ineffective: Symptom scores decrease by less than 30% after treatment.
Effective: Symptom scores decrease by 30% after treatment.
Significantly Effective: Symptom scores decrease by 60% after treatment.
Cured: Symptoms completely disappear after treatment.
5. Safety Evaluation
Abnormal events such as needle fainting, burns, or infections were recorded in detail, including subsequent handling, impact on the trial, and analysis of causes. It was determined whether the trial could continue or needed to be terminated. During medication administration, patients were advised to avoid spicy, cold, or greasy foods, as well as smoking and alcohol. If allergic reactions occurred, the medication was discontinued, and desensitization treatment was performed. Adverse reactions, their duration, main symptoms, and physical signs were carefully recorded. Liver and kidney function levels were monitored before and after treatment to assess safety.
Safety Grading:
Grade 1: No adverse reactions; treatment is safe.
Grade 2: Minor adverse events occur but do not require special treatment and do not affect further treatment; relatively safe.
Grade 3: More obvious adverse events occur, requiring special treatment before continuing; indicates a certain safety concern.
Grade 4: Severe adverse events occur, making it impossible to continue treatment; observation is terminated, indicating significant safety issues.
6. Statistical Methods
Data from the trial were analyzed using SPSS 19.0 statistical software.
For measurement data:
If comparing two groups and data follow a normal distribution with homogeneous variance, a t-test was used.
If variance was not homogeneous, a rank-sum test was used.
If comparing three groups, variance analysis was used if conditions for overall comparison were met.
For categorical data, a chi-square test (χ²) was used, with a significance level of α=0.05.
Analysis Components:
Frequency analysis of clinical symptoms based on questionnaire data to understand the distribution characteristics of TCM symptoms in functional ED patients.
Comparison of categorical data using chi-square tests or composition ratios to understand differences in general patient data and proportions of different TCM syndromes in functional ED patients, providing a preliminary assessment of local incidence trends.
Sample Size Calculation:
The sample size for multi-group rate comparison was calculated using the formula:
n = 2λ / [2sin⁻¹(√Pmax) - 2sin⁻¹(√Pmin)]
Parameters:
α = 0.05, β = 0.10, K = number of groups (K=3 in this study).
The minimum sample size was calculated to be no less than 60 cases, with at least 20 cases per group.
