NCT03213938

Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Completed NA Results posted Last updated 9 August 2022

What this trial tests

NA trial testing Acupuncture in Chronic Prostatitis With Chronic Pelvic Pain Syndrome in 440 participants. Completed in 10 December 2019.

Timeline

9 October 2017

Primary endpoint
10 December 2019

10 December 2019

Quick facts

Lead sponsor	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	440
Start date	9 October 2017
Primary completion	10 December 2019
Estimated completion	10 December 2019
Sites	1 location across China

Drugs / interventions tested

• Acupuncture — full drug profile →
• Sham acupuncture

Conditions studied

• Chronic Prostatitis With Chronic Pelvic Pain Syndrome — all drugs for Chronic Prostatitis With Chronic Pelvic Pain Syndrome →

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Who can join

Adults 18 to 50, male only, with Chronic Prostatitis With Chronic Pelvic Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Responders at the End of 8-week Primary · 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).

Group	Value	95% CI
Acupuncture	60.6
Sham Acupuncture	36.8

Proportion of Responders at the End of 32-week Primary · 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.

Group	Value	95% CI
Acupuncture	61.5
Sham Acupuncture	38.3

Proportion of Responders at Other Time Points Secondary · 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.

Week 1

Group	Value	95% CI
Acupuncture	9.1
Sham Acupuncture	8.3

Week 2

Group	Value	95% CI
Acupuncture	15.2
Sham Acupuncture	13.9

Week 3

Group	Value	95% CI
Acupuncture	27.2
Sham Acupuncture	19.8

Week 4

Group	Value	95% CI
Acupuncture	39.5
Sham Acupuncture	26.4

Week 5

Group	Value	95% CI
Acupuncture	42.6
Sham Acupuncture	24.1

Week 6

Group	Value	95% CI
Acupuncture	53.0
Sham Acupuncture	33.3

Week 7

Group	Value	95% CI
Acupuncture	61.0
Sham Acupuncture	35.3

Week 20

Group	Value	95% CI
Acupuncture	64.1
Sham Acupuncture	34.8

the Change From Baseline in NIH-CPSI Total Score Secondary · 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.

Week 1

Group	Value	95% CI
Acupuncture	-1.9	-2.4 – -1.5
Sham Acupuncture	-1.3	-1.8 – -0.9

Week 2

Group	Value	95% CI
Acupuncture	-2.9	-3.4 – -2.4
Sham Acupuncture	-2.4	-2.9 – -1.9

Week 3

Group	Value	95% CI
Acupuncture	-3.9	-4.4 – -3.4
Sham Acupuncture	-3.0	-3.5 – -2.5

Week 4

Group	Value	95% CI
Acupuncture	-4.8	-5.4 – -4.3
Sham Acupuncture	-3.7	-4.2 – -3.1

Week 5

Group	Value	95% CI
Acupuncture	-5.2	-5.8 – -4.6
Sham Acupuncture	-3.7	-4.3 – -3.2

Week 6

Group	Value	95% CI
Acupuncture	-5.9	-6.5 – -5.3
Sham Acupuncture	-4.0	-4.6 – -3.5

Week 7

Group	Value	95% CI
Acupuncture	-6.7	-7.3 – -6.1
Sham Acupuncture	-4.6	-5.2 – -4.0

Week 8

Group	Value	95% CI
Acupuncture	-7.4	-8.0 – -6.8
Sham Acupuncture	-4.9	-5.5 – -4.3

the Change From Baseline in NIH-CPSI Subscales Secondary · 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.

Change in NIH-CPSI pain subscale at week 1

Group	Value	95% CI
Acupuncture	-0.6	-0.9 – -0.4
Sham Acupuncture	-0.5	-0.7 – -0.2

Change in NIH-CPSI pain subscale at week 2

Group	Value	95% CI
Acupuncture	-0.8	-1.1 – -0.6
Sham Acupuncture	-0.8	-1.0 – -0.5

Change in NIH-CPSI pain subscale at week 3

Group	Value	95% CI
Acupuncture	-1.1	-1.4 – -0.9
Sham Acupuncture	-0.8	-1.1 – -0.6

Change in NIH-CPSI pain subscale at week 4

Group	Value	95% CI
Acupuncture	-1.6	-1.8 – -1.3
Sham Acupuncture	-1.1	-1.3 – -0.9

Change in NIH-CPSI pain subscale at week 5

Group	Value	95% CI
Acupuncture	-1.5	-1.7 – -1.2
Sham Acupuncture	-1.1	-1.3 – -0.9

Change in NIH-CPSI pain subscale at week 6

Group	Value	95% CI
Acupuncture	-1.8	-2.0 – -1.5
Sham Acupuncture	-1.1	-1.4 – -0.9

Change in NIH-CPSI pain subscale at week 7

Group	Value	95% CI
Acupuncture	-2.0	-2.3 – -1.8
Sham Acupuncture	-1.3	-1.5 – -1.1

Change in NIH-CPSI pain subscale at week 8

Group	Value	95% CI
Acupuncture	-2.1	-2.4 – -1.9
Sham Acupuncture	-1.3	-1.5 – -1.1

the Change From Baseline in the International Prostate Symptom Score (IPSS) Secondary · 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.

Week 4

Group	Value	95% CI
Acupuncture	-2.7	-3.2 – -2.3
Sham Acupuncture	-1.7	-2.1 – -1.2

Week 8

Group	Value	95% CI
Acupuncture	-4.4	-4.9 – -3.9
Sham Acupuncture	-2.7	-3.2 – -2.2

Week 20

Group	Value	95% CI
Acupuncture	-4.7	-5.3 – -4.2
Sham Acupuncture	-3.0	-3.6 – -2.4

Week 32

Group	Value	95% CI
Acupuncture	-4.7	-5.4 – -4.1
Sham Acupuncture	-3.1	-3.8 – -2.5

the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Secondary · 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.

Week 8

Group	Value	95% CI
Acupuncture	-1.9	-2.5 – -1.4
Sham Acupuncture	-0.8	-1.3 – -0.3

Week 20

Group	Value	95% CI
Acupuncture	-2.4	-3.0 – -1.8
Sham Acupuncture	-0.6	-1.3 – 0.0

Week 32

Group	Value	95% CI
Acupuncture	-2.8	-3.5 – -2.2
Sham Acupuncture	-0.5	-1.2 – 0.1

the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5) Secondary · 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.

Week 8

Group	Value	95% CI
Acupuncture	0.8	0.2 – 1.3
Sham Acupuncture	0.3	-0.3 – 0.8

Week 20

Group	Value	95% CI
Acupuncture	0.7	0.2 – 1.3
Sham Acupuncture	0.2	-0.3 – 0.7

Week 32

Group	Value	95% CI
Acupuncture	1.0	0.4 – 1.6
Sham Acupuncture	0.4	-0.1 – 1.0

the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire Secondary · 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.

Week 8

Group	Value	95% CI
Acupuncture	0.06	0.05 – 0.07
Sham Acupuncture	0.03	0.02 – 0.04

Week 20

Group	Value	95% CI
Acupuncture	0.06	0.05 – 0.07
Sham Acupuncture	0.03	0.02 – 0.04

Week 32

Group	Value	95% CI
Acupuncture	0.06	0.05 – 0.08
Sham Acupuncture	0.03	0.02 – 0.04

the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) Secondary · 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.

Week 4 : Markedly improved

Group	Value	95% CI
Acupuncture	15.9
Sham Acupuncture	7.5

Week 4 : Moderately improved

Group	Value	95% CI
Acupuncture	24.0
Sham Acupuncture	14.6

Week 4 : Slightly improved

Group	Value	95% CI
Acupuncture	46.6
Sham Acupuncture	50.7

Week 4 : No change

Group	Value	95% CI
Acupuncture	13.0
Sham Acupuncture	25.4

Week 4 : Slightly worsened

Group	Value	95% CI
Acupuncture	0.5
Sham Acupuncture	1.9

Week 4 : Moderately worsened

Group	Value	95% CI
Acupuncture	0
Sham Acupuncture	0

Week 4 : Markedly worsened

Group	Value	95% CI
Acupuncture	0
Sham Acupuncture	0

Week 8 : Markedly improved

Group	Value	95% CI
Acupuncture	30.6
Sham Acupuncture	8.7

the Change for Peak and Average Urinary Flow Rate From Baseline Secondary · weeks 8 and 32

Changes in peak urinary flow rate at week 8

Group	Value	95% CI
Acupuncture	0.6	-0.3 – 1.6
Sham Acupuncture	0.7	-0.2 – 1.6

Changes in peak urinary flow rate at week 32

Group	Value	95% CI
Acupuncture	0.5	-0.4 – 1.3
Sham Acupuncture	-0.6	-1.4 – 0.2

Changes in average urinary flow rate at week 8

Group	Value	95% CI
Acupuncture	0.6	0.1 – 1.1
Sham Acupuncture	0.4	-0.1 – 0.9

Changes in average urinary flow rate at week 32

Group	Value	95% CI
Acupuncture	0.5	0.1 – 1.0
Sham Acupuncture	-0.2	-0.6 – 0.3

Expectation Assessment Secondary · 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.

Do you believe acupuncture is effective for treating diseases in general?

Group	Value	95% CI
Acupuncture	167
Sham Acupuncture	165
Acupuncture	0
Sham Acupuncture	1
Acupuncture	46
Sham Acupuncture	49

Do you think acupuncture will be helpful to improve your CP/CPPS symptoms?

Group	Value	95% CI
Acupuncture	156
Sham Acupuncture	150
Acupuncture	0
Sham Acupuncture	1
Acupuncture	57
Sham Acupuncture	64

Adverse events — posted to ClinicalTrials.gov

Time frame: 34 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Acupuncture

Serious: 0/220 (0%)

Deaths: 0/220

Sham Acupuncture

Serious: 0/220 (0%)

Deaths: 0/220

Other adverse events (9 terms — click to expand)

Reaction	System	Acupuncture	Sham Acupuncture
Subcutaneous hematoma	Skin and subcutaneous tissue disorders	—	—
Cold	General disorders	—	—
Localized infection	Infections and infestations	—	—
Nausea	Gastrointestinal disorders	—	—
Fever	General disorders	—	—
Tonsillitis	Respiratory, thoracic and mediastinal disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Acute gastritis	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03213938 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial.
   Sun Y, Liu Y, Liu B, Zhou K, et al · · 2021 · cited 73× · PMID 34399062 · DOI 10.7326/m21-1814
2. Non-pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome.
   Franco JV, Turk T, Jung JH, Xiao YT, et al · · 2018 · cited 46× · PMID 29757454 · DOI 10.1002/14651858.cd012551.pub3
3. Non-pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome.
   Franco JV, Turk T, Jung JH, Xiao YT, et al · · 2018 · cited 19× · PMID 29372565 · DOI 10.1002/14651858.cd012551.pub2
4. Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial.
   Qin Z, Liu Y, Zhou K, Wu J, et al · · 2017 · cited 7× · PMID 29273095 · DOI 10.1186/s13063-017-2383-8
5. Differential placebo effect of sham acupuncture for chronic pain: a network meta-analysis of randomized controlled trials.
   Wan R, Zheng Q, Zeng X, Luo Y, et al · · 2025 · cited 2× · PMID 40890765 · DOI 10.1186/s12906-025-05055-x
6. Estimating minimal, moderate, and marked clinically important differences for patient reported outcome measure in randomised controlled trial.
   Wu J, Yao L, Liao K, Yorke J, et al · · 2026 · PMID 41914019 · DOI 10.1097/cm9.0000000000004084
7. Efficacy of acupuncture on drinkers with chronic prostatitis / chronic pelvic pain syndrome: secondary analysis of a randomized clinical trial.
   Zhu L, Sun Y, Yan S, Liu X, et al · · 2024 · PMID 39219163 · DOI 10.1177/09645284241274158
8. Impact of ejaculation upon effect of acupuncture on chronic prostatitis/chronic pelvic pain syndrome: Secondary analysis of a randomized controlled trial.
   Zhu L, Fang J, Sun Y, Yang M, et al · · 2023 · PMID 37122487 · DOI 10.1016/j.imr.2023.100943