chronic prostatitis/chronic pelvic pain syndrome: acupuncture helps

 

A Chinese randomized trial found that acupuncture helped men with Chronic Prostatitis /Chronic Pelvic Pain Syndrome (CP/CPPS): see acupuncture helps chr prostatitis/chronic pelvic pain in men AIM2021 in dropbox, or doi:10.7326/M21-1814 

 

Details:

-- 440 men from 10 tertiary hospitals in cities across China were randomized to real acupuncture versus sham acupuncture

    -- acupuncture was applied in the standard manner with needles inserted to a depth of 25 to 30 mm at the designated acupuncture sites, accompanied with gentle and even manipulations once every 10 minutes, 30 seconds at a time

    -- sham acupuncture involved using minimally invasive needles inserted 2 to 3 mm at non-acupoints, without manipulation

    -- patients were given 20 sessions over 8 weeks, with follow up 24 weeks after treatment ended

--all patients were 18 to 50 years old, and scored at least 15 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)

    -- the NIH-CPSI is a universally accepted, reliable, and valid instrument recommended in consensus guidelines, which measures pain (score 0-21), urinary function (0-10), and the effect on quality of life (score 0-12), with a total score ranging from 0 to 43, higher scores being worse

    -- a 6-point decrease in the total score is considered a clinically important improvement

    -- this instrument was used at weeks 8 and 32 (24 weeks after finishing treatment)

-- mean age 36, BMI 24, median sexual frequency once per week, current smoker 37%, current drinker 53%, sedentary life 70%, median CP/CPPS symptom duration was 2 years 

-- mean peak urinary flow rate 22 mL/s; mean average urinary flow rate 12.5 mL/s; median total PSA 0.6 ng /mL; median residual urinary volume 4ml 

-- prior therapies: herbal medicine 35%, local treatments 11%, antibiotics 8%, alpha blockers 5%, physical therapy 3%, 5-alpha reductase inhibitors 2% 

-- NIH-CPSI mean was 31, with subscales:

    -- pain subscale: 17 (range 0-21)

    -- urinary subscale: 5 (range 0-10)

    -- quality-of-life subscale: 9 (range 0-12)

-- 78% of patients believed that acupuncture “is effective for treating diseases in general”  and 71% thought “it will be helpful to improve your CP/CPPS symptoms”

 

-- primary outcome: proportion of participants who achieved a clinically important reduction of at least 6points from baseline in the NIH-CPSI at weeks 8 and 32

-- secondary outcomes: evaluation for quality of life (EuroQol 5 Dimension 5 Level, minimally clinically important difference between 0.03-0.05), the Hospital Anxiety and Depression Scale (HADS, minimally important difference 1.7 points), the International Prostate Symptom Score (IPSS, minimally important difference was 5.2), and urologic measures of peak and mean urinary flow rates

 

Results:

-- response at week 8 (at end of acupuncture sessions), with response defined as a reduction at least 6 in NIH-CPSI:

    -- acupuncture: 60.6% (53.7%-67.1%)

    -- sham acupuncture: 36.8% (30.4%-47.3%)

    -- adjusted difference 21.6 percentage points (12.8-30.4 percentage points), adjusted OR 2.6 (1.8-4.0), p<0.001 (adjusted scores were for the baseline NIH-CPSI total score)

-- response at week 32:

    -- acupuncture: 61.5% (54.5%-68.1%)

    -- sham acupuncture: 38.3% (31.7%-45.4%)

    -- adjusted difference: 21.1 percentage points (12.2 - 30.1 percentage points), adjusted odds ratio 2.6 (1.7-3.9), p<0.001

 

--marked or moderate improvement, acupuncture vs sham acupuncture:

    --week 4: 39.9% vs 22.1%

    --week 8: 67.0% vs 36.5%

    --week 20: 48.5% vs 24.5%

    --week 32: 47.1% vs 25.0% 

--marked improvement 

    -- week 4: 15.9% vs 7.5% 

    -- week 8: 30.6% vs 8.7%  

    -- week 20: 24.3% vs 6.7% 

    -- week 32:  22.3% vs 8.2% 

 

Mean change in NIH-CPSI total score from baseline (top=sham acupuncture; bottom-=real acupuncture); treatment ended at week 8

 

other outcomes:

-- NIH-CPSI subscales at week 32, adjusted difference of acupuncture vs sham acupuncture:

    -- pain: acupuncture: -2.0 (-2.3 to -1.8) vs sham -1.3 (-1.5 to -1.0), adjusted difference -0.8 (-1.1 to -0.4)

    --urinary: -2.1 (-2.4 to -1.9) vs sham -1.5 (-1.8 to -1.2), adjusted difference -0.6 (-1.0 to -0.3)

    --quality of life: -3.1 (-3.5 to -2.8) vs sham -2.1 (-2.4 to -1.8),  adjusted difference -1.1 (0-1.5 to -0.6)

-- adjusted mean change in average urinary flow rate at week 32: 0.5 mL/s for acupuncture and -0.24 mL/s for sham acupuncture

-- adjusted mean change in peak urinary flow rate: at week 32: 0.5 mL/s for acupuncture and -0.64 mL/s for sham acupuncture

-- mean change in IPSS score at 32 weeks: -4.7 versus -3.1

-- mean change in HADS score at week 32: -2.8 versus -0.5 (higher scores indicate more anxiety and depression)

-- mean change in EQ-5D-5L score at week 32: 0.06 for acupuncture, 0.03 for sham agriculture (higher score reflecting better generic health status)

 

-- No serious adverse events reported

  

Commentary:

-- CP/CPPS can be a disabling condition involving urogenital pain, lower urinary tract symptoms, psychological issues, and sexual dysfunction 

-- studies suggest that 2 to 16% of the male population of high-income countries and 11% in lower- and middle-income countries have this disorder 

-- studies have also shown that the negative effects on quality of life from CP/CPPS are on the order of those from angina, MI, heart failure, diabetes, and Crohn’s disease 

-- the purported mechanism of CP/CPPS is some combination of inflammation in the prostate, anxiety, stress, and dyssynergic voiding 

-- treatment with antibiotics (mostly for those with positive urine cultures and symptoms consistent with cystitis), alpha blockers, and anti-inflammatories are used in clinical practice but do not have much benefit over placebo (and much less than the acupuncture ones above), and any effect fades after the medication is discontinued 

-- prior studies on acupuncture have not been of high quality, though a 2018 Cochrane review of nonpharmacological interventions in treating CP/CPPS (doi:10.1002/14651858.CD012551.pub3) did note that only acupuncture and extracorporeal shock wave therapy were likely to result in symptom relief with a good safety profile

 

-- this study found that acupuncture did have significant and durable effects for 24 weeks after the end of treatment, in a group of men who had had these symptoms for a median of two years, scored pretty high on the NIH-CPSI scale, and many had tried different prior therapies

    -- it was impressive that there was no falloff in improvement in either acupuncture group from 8 weeks to 32 weeks

    -- all of the NIH-CPSI subscales showed improvement (other than sexual dysfunction)

    -- and, all of the scores around anxiety, depression, quality-of-life were better with acupuncture, though some did not reach clinically meaningful significance

-- one question is why did sham acupuncture work so well. Part of the issue may be that these patients were predisposed to feeling that it would help (71% thought acupuncture would help their symptoms) leading to an augmented placebo effect for both real and sham acupuncture. In addition, it is possible that sham acupuncture itself might have a clinical benefit:

    -- this study did find that although the net change from baseline was more than 7 points in the acupuncture group, the sham group was pretty close at about 5 points at weeks 8 and 32; ie, the acupuncture group did reach a clinically meaningful difference, though the difference between the achieved benefit in both groups was less than three points (which is less than the 6-point clinically meaningful difference).

    -- The reason for the closeness of these two results could be a few things: the placebo effect of the sham acupuncture or perhaps there was an actual benefit from sham acupuncture, as noted, or perhaps that this average response did not reflect a significant skew in benefit. For example, perhaps actual acupuncture led to dramatic benefit in a significant subpopulation of patients (for unknown reasons), yet there were many who did not respond, leading to a less impressive average for the group.

    -- Also, there may be significant differences in the approach and biases related to the acupuncturists for each group, who clearly knew which patient was in which group. Acupuncture does involve an intimate interaction between the clinician and patient, which might lead to a different placebo effect in the 2 acupuncture groups. and, as we know in primary care, the relationship itself is often clinically therapeutic. And this may be why the acupuncture results were better than our typical medication approach.

-- acupuncture does have some pretty clear physiologic effects: release of central opioid peptides (enkephalins, endorphins, dynorphins), with their attendant analgesic and euphoric effects; anti-inflammatory effects (inhibiting cyclooxygenase synthesis and peripheral and central nociceptive sites, eg see https://www.nature.com/articles/s41586-021-04001-4 ); and inhibiting prostaglandin E2 release, which is highly expressed in patients with CP/CPPS, (see acupuncture dec prostaglandin E2 in chronic prostatitis urol2009 in dropbox, or doi:10.1016/j.urology.2008.10.047)

 

Limitations:

-- the methodology of acupuncture versus sham acupuncture seems to me to be quite different, with the true acupuncture needles being inserted much more deeply and with manipulations, versus the sham acupuncture with only superficial insertion without manipulation. Not sure if this would clue people to knowing which group they were assigned to (though those in the sham group did quite well...)

-- and, as alluded to above, the attitude and sense of intimacy with patients may be different when an acupuncturist was convinced that they were doing real acupuncture (which the acupuncturist might have felt strongly would be beneficial) versus those doing very superficial needling of patients, where the acupuncturist might then have less of an intimate relationship and might create less of a feeling of hope for the patients (though, again, the sham group did quite well, but ??might have done better??)

-- this is a group of patients who were very attuned to acupuncture, and had a very positive outlook on its potential. This may not be generalizable to other populations

 

so, pretty impressive. acupuncture might really have a place in the treatment of this difficult and not-so-uncommon problem, especially given the apparent inadequacies of many of our current approaches. one concern, or course, is the acceptability and anticipation about acupuncture effectiveness in Western societies. My limited and skewed practice (largely immigrants from central america and cape verde) has found great acceptance and benefit from acupuncture when it was available at our health center. Maybe if presented in a strongly positive way, it would be generally acceptable (more like: "do i have a great option for you...")

 

geoff

 

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