Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Conditions
Keywords
Chronic prostatitis, chronic pelvic pain syndrome, acupuncture, randomized controlled trial
Brief summary
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It affects men of all ages without apparent racial predisposition, among which, 36-50 years old are the most commonly influenced. Yet, few effective therapies are available for treating CP/CPPS. Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture on CP/CPPS remain uncertain because of the small sample sizes or other methodological limitations. The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will provide a robust conclusion with a high level of evidence.
Interventions
DEVICEAcupuncture
For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol. Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
DEVICESham acupuncture
For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35. Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 1.History of pain perceived in the prostate region and absence of other lower urinary tract pathology for a minimum of three of the past 6 months. In addition, any associated lower urinary tract symptoms, sexual function, and psychological factors should be addressed. Physical examinations, urinary analyses, and urine cultures will be performed for all subjects; * 2\. Age 18 to 50 years. * 3\. NIH Chronic Prostatitis Symptom Index (NIH- CPSI) total score ≥ 15.
Exclusion criteria
* 1\. Prostate, bladder, or urethral cancer, seizure disorder in any medical history. * 2\. Inflammatory bowel disease, active urethral stricture, neurologic disease or disorder affecting the bladder, liver disease, neurologic impairment or psychiatric disorder preventing understanding of consent and self-report scale. * 3\. Urinary tract infection with a urine culture value of more than 100,000 CFU/mL, clinical evidence of urethritis, including urethral discharge or positive culture, diagnostic of sexually transmitted diseases (including gonorrhoea, chlamydia, mycoplasma or trichomonas, but not including HIV/AIDS), symptoms of acute or chronic epididymitis). * 4\. Residual urine volume≥100ML. * 5\. Qmax≤15ML/S. * 6\. Prior 4 weeks used androgen hormone inhibitors (finasteride), alpha-blockers (terazosin HCI, doxazosin mesylate, tamsulosin hydrochloride), antibiotics (ciprofloxacin hydrochloride), or any other prostatitis-specific medication (including herb and Chinese medicine).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Responders at the End of 8-week | week 8 | The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). |
| Proportion of Responders at the End of 32-week | week 32 | The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Change From Baseline in NIH-CPSI Total Score | weeks 1-8; week 20; week 32 | The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain (score range, 0-21), urinary function (0-10) and quality of life impact (0-12) in CP/CPPS, with a total score ranging from 0 to 43 and higher scores indicating worse conditions. |
| the Change From Baseline in NIH-CPSI Subscales | weeks 1-8; week 20; week 32 | The NIH-CPSI is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain, urinary function and quality of life impact in CP/CPPS. The score range of pain subscale is 0-21, with higher scores indicating worse conditions. The score range of urinary function subscale is 0-10, with higher scores indicating worse conditions. The score range of quality-of-life subscale is 0-12, with higher scores indicating worse quality of life. |
| the Change From Baseline in the International Prostate Symptom Score (IPSS) | week 4; week 8; week 20; week 32 | IPSS is a valid, reliable and sensitive measure for patients with lower urinary tract symptoms; it is widely used in clinical practice and research to determine the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5 (almost always). IPSS score ranges from 0 to 35, with higher score indicating more severe urinary symptoms. |
| the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) | week 8; week 20; week 32 | HADS is made up of 7 items for the assessment of depression and anxiety; the completion of this scale usually requires 2-5 minutes. HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression. |
| the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire | week 8; week 20; week 32 | The EQ-5D-5L is a well-established and suitable for evaluation of quality of life in participants with CP/CPPS. EQ-5D-5L overall index ranges from -0.39 to 1.00, with higher overall index indicating better generic health-status. |
| the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | week 4; week 8; week 20; week 32 | GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved. |
| the Change for Peak and Average Urinary Flow Rate From Baseline | weeks 8 and 32 | — |
| the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5) | week 8; week 20; week 32 | The IIEF-5 is a psychometrically valid and reliable instrument with high sensitivity and specificity for detecting treatment effects in patients with erection dysfunction of a broad spectrum of aetiology. Chinese version IIEF-5 score ranges from 0 to 25, with lower scores indicating greater severity of dysfunction and minimal clinical important difference over 5. |
| Proportion of Responders at Other Time Points | weeks 1-7; week 20 | The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Expectation Assessment | baseline | Expectation assessment will be assessed at baseline, which includes 2 brief questions to investigate whether patients are confident that acupuncture treatment will help their CP/CPPS: In general, is acupuncture effective for controlling the illness?, Do you think acupuncture will helpful to improve your CP/CPPS symptoms? For each question, participants could choose Yes, No or unclear as the answer. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.
Acupuncture: For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.
Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks). | 220 |
| Sham Acupuncture The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation.
Sham acupuncture: For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.
Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks). | 220 |
| Total | 440 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Decline to participate | 5 | 4 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Without reason | 4 | 5 |
Baseline characteristics
| Characteristic | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Age, Continuous | 35.5 years STANDARD_DEVIATION 8 | 36.1 years STANDARD_DEVIATION 7.9 | 35.8 years STANDARD_DEVIATION 8 |
| National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score | 31.0 units on a scale STANDARD_DEVIATION 4.8 | 31.4 units on a scale STANDARD_DEVIATION 5.2 | 31.2 units on a scale STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized Han | 213 Participants | 214 Participants | 427 Participants |
| Race/Ethnicity, Customized Others | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment China | 220 participants | 220 participants | 440 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 220 Participants | 220 Participants | 440 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 220 | 0 / 220 |
| other Total, other adverse events | 20 / 220 | 14 / 220 |
| serious Total, serious adverse events | 0 / 220 | 0 / 220 |
Outcome results
Primary
Proportion of Responders at the End of 32-week
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
Time frame: week 32
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acupuncture | Proportion of Responders at the End of 32-week | 61.5 percentage of participants |
| Sham Acupuncture | Proportion of Responders at the End of 32-week | 38.3 percentage of participants |
Primary
Proportion of Responders at the End of 8-week
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
Time frame: week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acupuncture | Proportion of Responders at the End of 8-week | 60.6 percentage of participants |
| Sham Acupuncture | Proportion of Responders at the End of 8-week | 36.8 percentage of participants |
Secondary
Proportion of Responders at Other Time Points
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
Time frame: weeks 1-7; week 20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acupuncture | Proportion of Responders at Other Time Points | Week 2 | 15.2 percentage of participants |
| Acupuncture | Proportion of Responders at Other Time Points | Week 5 | 42.6 percentage of participants |
| Acupuncture | Proportion of Responders at Other Time Points | Week 1 | 9.1 percentage of participants |
| Acupuncture | Proportion of Responders at Other Time Points | Week 6 | 53.0 percentage of participants |
| Acupuncture | Proportion of Responders at Other Time Points | Week 7 | 61.0 percentage of participants |
| Acupuncture | Proportion of Responders at Other Time Points | Week 3 | 27.2 percentage of participants |
| Acupuncture | Proportion of Responders at Other Time Points | Week 20 | 64.1 percentage of participants |
| Acupuncture | Proportion of Responders at Other Time Points | Week 4 | 39.5 percentage of participants |
| Sham Acupuncture | Proportion of Responders at Other Time Points | Week 20 | 34.8 percentage of participants |
| Sham Acupuncture | Proportion of Responders at Other Time Points | Week 1 | 8.3 percentage of participants |
| Sham Acupuncture | Proportion of Responders at Other Time Points | Week 2 | 13.9 percentage of participants |
| Sham Acupuncture | Proportion of Responders at Other Time Points | Week 3 | 19.8 percentage of participants |
| Sham Acupuncture | Proportion of Responders at Other Time Points | Week 4 | 26.4 percentage of participants |
| Sham Acupuncture | Proportion of Responders at Other Time Points | Week 5 | 24.1 percentage of participants |
| Sham Acupuncture | Proportion of Responders at Other Time Points | Week 7 | 35.3 percentage of participants |
| Sham Acupuncture | Proportion of Responders at Other Time Points | Week 6 | 33.3 percentage of participants |
Secondary
the Change for Peak and Average Urinary Flow Rate From Baseline
Time frame: weeks 8 and 32
Population: Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up.~Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up.~Additionally, the data of peak and average urinary flow rate was not available for several participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | the Change for Peak and Average Urinary Flow Rate From Baseline | Changes in peak urinary flow rate at week 8 | 0.6 ml/s |
| Acupuncture | the Change for Peak and Average Urinary Flow Rate From Baseline | Changes in average urinary flow rate at week 8 | 0.6 ml/s |
| Acupuncture | the Change for Peak and Average Urinary Flow Rate From Baseline | Changes in average urinary flow rate at week 32 | 0.5 ml/s |
| Acupuncture | the Change for Peak and Average Urinary Flow Rate From Baseline | Changes in peak urinary flow rate at week 32 | 0.5 ml/s |
| Sham Acupuncture | the Change for Peak and Average Urinary Flow Rate From Baseline | Changes in average urinary flow rate at week 32 | -0.2 ml/s |
| Sham Acupuncture | the Change for Peak and Average Urinary Flow Rate From Baseline | Changes in peak urinary flow rate at week 8 | 0.7 ml/s |
| Sham Acupuncture | the Change for Peak and Average Urinary Flow Rate From Baseline | Changes in peak urinary flow rate at week 32 | -0.6 ml/s |
| Sham Acupuncture | the Change for Peak and Average Urinary Flow Rate From Baseline | Changes in average urinary flow rate at week 8 | 0.4 ml/s |
Secondary
the Change From Baseline in NIH-CPSI Subscales
The NIH-CPSI is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain, urinary function and quality of life impact in CP/CPPS. The score range of pain subscale is 0-21, with higher scores indicating worse conditions. The score range of urinary function subscale is 0-10, with higher scores indicating worse conditions. The score range of quality-of-life subscale is 0-12, with higher scores indicating worse quality of life.
Time frame: weeks 1-8; week 20; week 32
Population: Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy.~Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 6 | -1.7 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 20 | -2.0 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 7 | -1.9 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 2 | -0.8 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 8 | -2.1 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 32 | -2.0 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 20 | -2.1 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 6 | -1.8 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 32 | -2.1 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 1 | -0.5 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 1 | -0.8 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 4 | -1.6 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 2 | -1.2 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 2 | -0.8 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 3 | -1.7 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 7 | -2.0 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 4 | -1.9 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 3 | -1.0 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 5 | -2.2 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 3 | -1.1 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 6 | -2.4 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 4 | -1.3 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 7 | -2.8 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 8 | -2.1 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 8 | -3.1 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 5 | -1.6 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 20 | -3.2 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 5 | -1.5 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 32 | -3.1 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 1 | -0.6 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 32 | -2.1 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 1 | -0.5 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 2 | -0.8 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 3 | -0.8 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 4 | -1.1 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 5 | -1.1 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 6 | -1.1 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 7 | -1.3 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 8 | -1.3 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 20 | -1.0 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI pain subscale at week 32 | -1.3 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 1 | -0.4 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 2 | -0.6 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 3 | -0.9 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 4 | -1.0 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 5 | -1.1 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 6 | -1.2 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 7 | -1.3 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 8 | -1.4 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 20 | -1.5 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI urinary subscale at week 32 | -1.5 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 1 | -0.5 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 2 | -0.9 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 3 | -1.2 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 4 | -1.5 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 5 | -1.5 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 6 | -1.7 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 7 | -1.9 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 8 | -2.2 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Subscales | Change in NIH-CPSI quality of life subscale at week 20 | -2.0 score on a scale |
Secondary
the Change From Baseline in NIH-CPSI Total Score
The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain (score range, 0-21), urinary function (0-10) and quality of life impact (0-12) in CP/CPPS, with a total score ranging from 0 to 43 and higher scores indicating worse conditions.
Time frame: weeks 1-8; week 20; week 32
Population: Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy.~Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 1 | -1.9 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 2 | -2.9 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 3 | -3.9 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 4 | -4.8 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 5 | -5.2 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 6 | -5.9 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 7 | -6.7 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 8 | -7.4 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 20 | -7.2 score on a scale |
| Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 32 | -7.4 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 8 | -4.9 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 1 | -1.3 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 6 | -4.0 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 2 | -2.4 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 32 | -4.9 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 3 | -3.0 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 7 | -4.6 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 4 | -3.7 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 20 | -4.5 score on a scale |
| Sham Acupuncture | the Change From Baseline in NIH-CPSI Total Score | Week 5 | -3.7 score on a scale |
Secondary
the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire
The EQ-5D-5L is a well-established and suitable for evaluation of quality of life in participants with CP/CPPS. EQ-5D-5L overall index ranges from -0.39 to 1.00, with higher overall index indicating better generic health-status.
Time frame: week 8; week 20; week 32
Population: Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy.~Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire | Week 8 | 0.06 units on a scale |
| Acupuncture | the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire | Week 20 | 0.06 units on a scale |
| Acupuncture | the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire | Week 32 | 0.06 units on a scale |
| Sham Acupuncture | the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire | Week 8 | 0.03 units on a scale |
| Sham Acupuncture | the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire | Week 20 | 0.03 units on a scale |
| Sham Acupuncture | the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire | Week 32 | 0.03 units on a scale |
Secondary
the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)
HADS is made up of 7 items for the assessment of depression and anxiety; the completion of this scale usually requires 2-5 minutes. HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Time frame: week 8; week 20; week 32
Population: Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy.~Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) | Week 8 | -1.9 score on a scale |
| Acupuncture | the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) | Week 20 | -2.4 score on a scale |
| Acupuncture | the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) | Week 32 | -2.8 score on a scale |
| Sham Acupuncture | the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) | Week 8 | -0.8 score on a scale |
| Sham Acupuncture | the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) | Week 20 | -0.6 score on a scale |
| Sham Acupuncture | the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) | Week 32 | -0.5 score on a scale |
Secondary
the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)
The IIEF-5 is a psychometrically valid and reliable instrument with high sensitivity and specificity for detecting treatment effects in patients with erection dysfunction of a broad spectrum of aetiology. Chinese version IIEF-5 score ranges from 0 to 25, with lower scores indicating greater severity of dysfunction and minimal clinical important difference over 5.
Time frame: week 8; week 20; week 32
Population: Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up. Additionally, the data of IIEF-5 was not available for two participants at week 32.~Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up. Additionally, the data of IIEF-5 was not available for one participant at weeks 8, 20 and 32.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5) | Week 8 | 0.8 score on a scale |
| Acupuncture | the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5) | Week 20 | 0.7 score on a scale |
| Acupuncture | the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5) | Week 32 | 1.0 score on a scale |
| Sham Acupuncture | the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5) | Week 8 | 0.3 score on a scale |
| Sham Acupuncture | the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5) | Week 20 | 0.2 score on a scale |
| Sham Acupuncture | the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5) | Week 32 | 0.4 score on a scale |
Secondary
the Change From Baseline in the International Prostate Symptom Score (IPSS)
IPSS is a valid, reliable and sensitive measure for patients with lower urinary tract symptoms; it is widely used in clinical practice and research to determine the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5 (almost always). IPSS score ranges from 0 to 35, with higher score indicating more severe urinary symptoms.
Time frame: week 4; week 8; week 20; week 32
Population: Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up. Additionally, the data of IPSS was not available for one participant at week 32 in the acupuncture group.~Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | the Change From Baseline in the International Prostate Symptom Score (IPSS) | Week 4 | -2.7 score on a scale |
| Acupuncture | the Change From Baseline in the International Prostate Symptom Score (IPSS) | Week 20 | -4.7 score on a scale |
| Acupuncture | the Change From Baseline in the International Prostate Symptom Score (IPSS) | Week 8 | -4.4 score on a scale |
| Acupuncture | the Change From Baseline in the International Prostate Symptom Score (IPSS) | Week 32 | -4.7 score on a scale |
| Sham Acupuncture | the Change From Baseline in the International Prostate Symptom Score (IPSS) | Week 32 | -3.1 score on a scale |
| Sham Acupuncture | the Change From Baseline in the International Prostate Symptom Score (IPSS) | Week 4 | -1.7 score on a scale |
| Sham Acupuncture | the Change From Baseline in the International Prostate Symptom Score (IPSS) | Week 8 | -2.7 score on a scale |
| Sham Acupuncture | the Change From Baseline in the International Prostate Symptom Score (IPSS) | Week 20 | -3.0 score on a scale |
Secondary
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved.
Time frame: week 4; week 8; week 20; week 32
Population: Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy.~Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Slightly worsened | 0.5 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Moderately worsened | 0 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Markedly worsened | 0 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Markedly improved | 22.3 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Moderately improved | 24.8 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Slightly improved | 27.2 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : No change | 20.9 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Slightly worsened | 4.4 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Moderately worsened | 0.5 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Markedly worsened | 0 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Markedly improved | 15.9 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Moderately improved | 24.0 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Slightly improved | 46.6 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : No change | 13.0 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Slightly worsened | 0.5 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Moderately worsened | 0 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Markedly worsened | 0 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Markedly improved | 30.6 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Moderately improved | 36.4 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Slightly improved | 27.2 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : No change | 5.3 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Moderately worsened | 0 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Markedly worsened | 0 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Markedly improved | 24.3 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Moderately improved | 24.3 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Slightly improved | 27.7 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : No change | 19.4 percentage of participants |
| Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Slightly worsened | 4.4 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Slightly worsened | 1.9 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Slightly improved | 31.7 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Moderately worsened | 1.4 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Moderately worsened | 0 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Markedly worsened | 0 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Moderately worsened | 0 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Markedly improved | 8.2 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Markedly worsened | 0 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Moderately improved | 16.8 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Moderately improved | 17.8 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Slightly improved | 29.3 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Markedly improved | 8.7 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : No change | 32.7 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Markedly worsened | 0 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Slightly worsened | 8.7 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Moderately improved | 27.9 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Moderately worsened | 3.9 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : No change | 30.3 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 32 : Markedly worsened | 0.5 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Slightly improved | 40.9 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Markedly improved | 7.5 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Markedly improved | 6.7 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Moderately improved | 14.6 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : No change | 19.2 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : Slightly improved | 50.7 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 20 : Slightly worsened | 12.0 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 4 : No change | 25.4 percentage of participants |
| Sham Acupuncture | the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) | Week 8 : Slightly worsened | 3.4 percentage of participants |
Other Pre-specified
Expectation Assessment
Expectation assessment will be assessed at baseline, which includes 2 brief questions to investigate whether patients are confident that acupuncture treatment will help their CP/CPPS: In general, is acupuncture effective for controlling the illness?, Do you think acupuncture will helpful to improve your CP/CPPS symptoms? For each question, participants could choose Yes, No or unclear as the answer.
Time frame: baseline
Population: 5 participants in the acupuncture group declined to participate the trial and did not receive treatment. Additionally, the data of expectation assessment was not available for 2 participants in the acupuncture group.~4 participants declined to participate the trial and 1 withdrew without reason in the sham acupuncture group. All those 5 participants did not receive treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Acupuncture | Expectation Assessment | Do you believe acupuncture is effective for treating diseases in general? | Yes | 167 Participants |
| Acupuncture | Expectation Assessment | Do you believe acupuncture is effective for treating diseases in general? | No | 0 Participants |
| Acupuncture | Expectation Assessment | Do you believe acupuncture is effective for treating diseases in general? | Unclear | 46 Participants |
| Acupuncture | Expectation Assessment | Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? | Yes | 156 Participants |
| Acupuncture | Expectation Assessment | Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? | No | 0 Participants |
| Acupuncture | Expectation Assessment | Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? | Unclear | 57 Participants |
| Sham Acupuncture | Expectation Assessment | Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? | No | 1 Participants |
| Sham Acupuncture | Expectation Assessment | Do you believe acupuncture is effective for treating diseases in general? | Yes | 165 Participants |
| Sham Acupuncture | Expectation Assessment | Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? | Yes | 150 Participants |
| Sham Acupuncture | Expectation Assessment | Do you believe acupuncture is effective for treating diseases in general? | No | 1 Participants |
| Sham Acupuncture | Expectation Assessment | Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? | Unclear | 64 Participants |
| Sham Acupuncture | Expectation Assessment | Do you believe acupuncture is effective for treating diseases in general? | Unclear | 49 Participants |