Dec 08 2009
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a somewhat nebulous diagnosis with unknown etiology and no effective treatment. To make the diagnosis, bacterial infection must be excluded and the symptoms must last at least 3 months. Symptoms include pain in various locations (between rectum and testicle, in the testicles, at the tip of the penis, in the lower back, in the abdomen over the pubic or bladder area), pain or burning with urination, frequent urination, pain or discomfort during or after sexual climax. There are also systemic features like decreased libido, myalgias, and fatigue, and there is a higher incidence of chronic fatigue syndrome in these patients. The connection to the prostate is uncertain; in one study, women with chronic pelvic pain reported more of these symptoms than men did. Diagnosis is based on self-reported symptoms; there are no objective diagnostic markers. Somewhere between 2 and 10% of the male population are reported to suffer from this syndrome.
Since there is no effective mainstream treatment for this disorder, why not try acupuncture? Two randomized, placebo-controlled studies have reported positive results from acupuncture treatment. Is this enough evidence for us to recommend it to patients?
The Malaysian Study
This well-designed study was done in Malaysia, in a hospital with traditionally trained acupuncturists on its staff, in conjunction with the University of Washington Department of Urological Surgery. It was funded by the NIH and published in the American Journal of Medicine. There were 90 subjects randomized into two groups. They compared acupuncture at traditional points to sham acupuncture with more superficial needling 15 mm to the left of traditional points. They used no adjunctive treatments. They minimized interaction between participants and acupuncturists. They looked for a primary endpoint of a 6 point decrease from baseline to week 10 in a validated scale of symptoms, the NIH Chronic Prostatitis Symptom Index (NIH-CPSI), and for secondary outcomes including complete resolution and decreased scores at other intervals. They treated twice weekly for 30 minutes for 10 weeks, then followed the patients for an additional 24 weeks. They tested blinding by asking participants which therapy they thought they had received: 95% of those receiving acupuncture and 82% of those receiving the sham treatment thought they had received acupuncture. They found that acupuncture was twice as effective as sham acupuncture for the primary endpoint (73% vs. 48%, p=0.02) at 10 weeks, that more acupuncture patients had complete resolution of symptoms (18 vs. 10, p=0.07), and that acupuncture recipients had a greater long-term response 20 weeks after completing therapy (32% vs. 13%, p=0.04).
The Korean Study
The other study was done in Korea and was published in the journal Urology. It was a three-arm study comparing advice and exercise (A & E) alone to A&E plus electroacupuncture (where the acupuncture needles were electrically stimulated) to A&E plus sham acupuncture. There were only 13 men in each group. The sham acupuncture involved (1) more superficial needling, (2) placement 15 mm to the left of acupuncture points, and (3) the sound of the pulse generator without actual electrical stimulation. In the acupuncture group they found a significant reduction in the NIH-CPSI scores for pain, but no reduction in the scores for urinary symptoms or quality of life. On another scale, the International Prostate Symptoms Score, there were no significant differences. There is no mention of an exit poll to see if patients could guess which treatment they had received.
This study had one other intriguing wrinkle. There had been some hints of a correlation between prostatitis symptoms and prostaglandin E and beta endorphin levels, so they measured these in post-massage urine samples. They found a significant decrease in prostaglandin level in the electroacupuncture group (p=0.023) and a non-significant increase in the other two groups. They present a bar graph that makes it look like the increase in the sham group was more significant than the decrease in the electroacupuncture group, but they don’t provide the raw data or even report calculated p values, so we can only guess what the bars mean.
There was no significant change in endorphins for any group. It’s intriguing that they were able to measure something objective, but at this point, without replication, it’s impossible to say what the data mean, if anything.
A PubMed search for “clinical trials, chronic prostatitis and acupuncture” brought up these two studies and only 5 others that were a mish-mash of different kinds of prostatitis and different treatments: warm needle moxibustion, suspended moxibustion (where a burning stick is held above the acupuncture point with no skin contact), abdominal cluster needling, sometimes in association with herbal enemas and other treatments. A meta-analysis of case-control studies out of China found a significantly higher cure rate with acupuncture than with controls, but they were looking at studies of a different diagnosis: chronic prostatitis, not chronic prostatitis/chronic pelvic pain syndrome. And none of the studies were randomized controlled trials.
Additionally, the Korean study referenced another study that did not come up on my PubMed search for some reason. This study of CP/CPPS involved three sets of acupuncture points totaling 30 points (8 points were electrically stimulated) given alternatively twice weekly for 6 weeks. It showed an even more impressive effect: 83% of subjects reported marked improvement, but it was an uncontrolled pilot study with only 12 subjects.
So we don’t have a lot of evidence, but the evidence we do have consistently supports acupuncture for CP/CPPS. Acupuncturists can say their treatments are evidence-based.
As you may have guessed, I have some reservations. In the first place, what do they mean by acupuncture? The Malaysian study used 4 acupuncture points: CV1, CV4, SP6 and SP9. The Korean study used acupuncture points BL 32, Bl33, GB30 bilaterally, for a total of 6 entirely different points. The Malaysian study used only needle insertion; the Korean study used electrical stimulation. The pilot study used 30 points with electrical stimulation of 8 of them. If you were going to do acupuncture based on these studies, which points would you choose?
Studies can’t really support each other if they’re not testing the same treatment, can they? In addition, even the Malaysian study was not a test of acupuncture per se. The “true” acupuncture arm did not even attempt to elicit the “de qi” sensation that many acupuncturists consider essential to the acupuncture effect. They followed a rigid protocol rather than offering the kind of individual treatment adjustments acupuncturists typically use in practice. And they did not twirl or stimulate the needles in any way after insertion. If their results had been negative, they might well have argued that their study didn’t discredit acupuncture because it didn’t represent the practice of acupuncture at all.
More importantly, we need to look at these studies in the context of everything else we know. Good studies with better controls (retracting needles) have shown no difference between acupuncture points and non-points. Other studies with toothpicks and with simple electrical transcutaneous stimulation have shown that it doesn’t matter whether the skin is penetrated. So many studies have shown sham acupuncture to be equal to “true” acupuncture that in several recent studies acupuncturists themselves have chosen not to use a sham acupuncture control on the theory that it is not a placebo control because any skin stimulation is effective. (But then what is acupuncture??!!) And even the best studies are not double blind: double blind studies would be extremely difficult to design, since the acupuncturist is aware of what he is doing.
Another concern is that studies from Asian countries are prone to the “file drawer effect” where negative studies are filed away rather than submitted for publication. This is a bigger problem in Asia than elsewhere: 98% of published acupuncture trials from Asia are positive, versus 30% of acupuncture trials from Canada, Australia and New Zealand. What if most of the evidence is really negative? What if 4 studies were done, 3 with negative results and one with positive results, and only the one with positive results was submitted for publication? Replication in a country with a better track record would make the results more credible.
We know there are many things that can go wrong with experiments, and that most published research findings are false. When initial findings are mixed for a treatment that really works, there is a gradual accumulation of more convincing data that tips the balance over time. Acupuncture studies have never shown any such progress.
I will admit to being prejudiced by the fact that acupuncture is based on pre-scientific thinking and on points, meridians and vitalistic forces whose existence can’t be demonstrated. But we wouldn’t have to know “how” it worked if it clearly “did” work. The evidence is inconsistent and not robust enough to convince rigorous scientists that acupuncture is more effective than placebo for any medical condition.
A Question Rather Than a Conclusion
Since medical science has little to offer for CP/CPPS, is recommending acupuncture ethically justified; and if so, should patients be told it is evidence-based?
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