AUA: Acupuncture, Electrical Stimulation Show Promise for Chronic Prostatitis

By Charles Bankhead
ORLANDO, 08 june 2008-- Novel strategies to treat chronic prostatitis and pelvic pain produced mixed results in clinical trials reported here.
Acupuncture and transrectal electrical stimulation of the pelvic floor significantly improved symptoms, but the alpha-blocker alfuzosin (Uroxatral) proved no better than placebo, investigators told attendees at the American Urological Association meeting.
Acupuncture is an attractive option for chronic pelvic pain because of its demonstrated efficacy in other pain syndromes and low risk of adverse events, said Shaun W. Lee, of the University of Science in Penang, Malaysia. In addition, observational evidence has suggested acupuncture efficacy in chronic prostatitis.
Lee reported findings from a multinational trial involving 89 men who had a two-year history of chronic prostatitis and pelvic pain. They were randomized to acupuncture or sham needle insertion.
Acupuncture involved insertion of six needles at four trigger points previously associated with chronic prostatitis and pelvic pain. Needles were inserted to a depth of 1.5 to 2.5 inches. Patients had two 30-minute treatment sessions a week for 10 weeks.
Sham procedures involved insertion of needles to a depth of no more than one-half inch at sites that were a half-inch away from the acupuncture trigger points.
The primary endpoint was the proportion of patients who had at least a six-point decrease in the NIH-Chronic Prostatitis Symptom Index, a threshold response that would permit detection of subtle changes in symptoms, said Lee.
The secondary endpoint was the percentage of patients in each group who had at least 50% improvement in the subjective global assessment.
The median baseline NIH-CPSI score was 25 in both groups. At the end of the treatment period, 32 of 44 (73%) of the acupuncture patients and 21 of 45 (47%) of the sham-treated patients met response criteria (P=0.02).
The symptom index declined by an average of 10.3 points in the acupuncture group compared with 6.0 points in the sham group.
Acupuncture's symptom relief was significantly more durable compared with the sham procedure. One month after the study, 18 acupuncture patients remained symptom-free compared with only one patient in the sham group (P=0.03). Three months after the study ended, 14 acupuncture patients remained symptom-free compared with six in the sham group (P=0.04).
Adverse events in the acupuncture group consisted of hematoma in four patients and pain at the needle insertion site in two. Adverse events in the sham group consisted of one hematoma, three cases of needle-site pain, and one case of acute urinary retention.
"Acupuncture was 50% more effective than the sham procedure," Lee said. "Acupuncture and sham were both safe, as all adverse events were minor and resolved quickly."
Several lines of evidence suggest that pelvic floor dysfunction plays a role in chronic prostatitis and pelvic pain, providing a rationale for evaluating transrectal electrical stimulation of the pelvic floor, said Jordan D. Dimitrakov, M.D., of Harvard.
So he and his colleagues compared electrical stimulation against a sham procedure in a randomized trial involving 77 patients with chronic prostatitis and pelvic pain.
Active treatment consisted of daily transrectal electrical stimulation procedures for one month, followed by twice-weekly sessions for five months. Patients who completed the six months of treatment had the option to continue twice-weekly treatment for an additional six months. Dr. Dimitrakov said the treatment could be self-administered at home.
Patients randomized to sham treatment followed the same treatment schedule as the patients who received active therapy.
The primary endpoint was patient-reported improvement in pain, as reflected in the NIH-CPSI. The secondary endpoint was patient global assessment of pain, disease activity, and response to therapy.
At one month, active therapy was associated with a 3.7-point reduction in the pain score versus 1.6 points in the sham group (P<0.001). After six months, the electrostimulation group had a mean reduction in pain score of 2.9 points compared with 1.1 in the sham group (P<0.001).
Electrostimulation also led to significantly greater improvement in all components of the secondary endpoint compared with sham treatment (P<0.001).
"Future studies should evaluate the optimal duration of this treatment approach," Dr. Dimitrakov concluded.
Observational studies had provided evidence of efficacy for several alpha-blockers in early-stage chronic prostatitis and pelvic pain, said J. Curtis Nickel, M.D., of Queen's University in Kingston, Ontario.
He and his colleagues sought to extend those findings in a randomized clinical trial involving 272 patients whose baseline NIH-CPSI score averaged 24 to 25.
The trial examined the efficacy of alfuzosin when given for more than six weeks to patients with early-stage chronic prostatitis and pelvic pain and no history of treatment with an alpha-blocker.
Patients were randomized to placebo or alfuzosin and followed for 12 weeks. The primary endpoint was the proportion of patients who responded to therapy, defined as a decrease of four points or more in the NIH-CPSI score at 12 weeks.
The secondary endpoint was the percentage of patients who reported moderate or marked improvement in the subjective global assessment.
At the end of the study, the two patient groups had identical response rates of 49%.
Global assessment responses demonstrated 34% to 35% improvement in each group. The treatment arms also did not differ with respect to pain, quality of life, depression, or erectile function.
"This was a great hypothesis ruined by good science," Dr. Nickel said.
Lee and Dr. Dimitrakov had no disclosures. Dr. Nickel reported relationships with multiple pharmaceutical companies, including sanofi-aventis, which provided the active drug for the NIH-sponsored study.
Primary source: American Urological Association meetingSource reference:Lee SW, et al "Randomized, double blind comparison of acupuncture versus sham acupuncture for chronic prostatitis/chronic pelvic pain syndrome" AUA Meeting 2008; Abstract 88. Additional source: American Urological Association meetingSource reference: Dimitrakov JD et al. "Pelvic floor electrical stimulation in the treatment of chronic pelvic pain syndrome: a randomized controlled trial" AUA Meeting 2008; Abstract 91. Additional source: American Urological Association meetingSource reference: Nickel JC, et al "A randomized multicenter double-blind clinical trial to evaluate the efficacy and safety of alfuzosin in the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in recently diagnosed and/or newly symptomatic alpha-blocker naïve patients" AUA Meeting 2008; Abstract 87.