Examination of the significant placebo effect in the treatment of interstitial
cystitis/bladder pain syndrome.
Author(s): Bosch PC.
Affiliation(s): Author information:
Department of Urology, Palomar Medical Center, Escondido, CA. Electronic address:
pboschmd@gmail.com.
Publication date & source: 2014, Urology. , 84(2):321-6
OBJECTIVE: To examine the significant "placebo effect" in a randomized,
double-blind, placebo-controlled interstitial cystitis/bladder pain syndrome
trial. Randomized clinical trials are the reference standard for therapeutic
impact assessment. However, proving efficacy of treatments for interstitial
cystitis/bladder pain syndrome with rigorous placebo-controlled trials is
difficult due to a significant effect of the placebo intervention.
METHODS: Interstitial cystitis/bladder pain syndrome patients were randomized to
receive subcutaneous adalimumab or subcutaneous placebo every 2 weeks for 12
weeks and outcome measures were assessed.
RESULTS: Of the 43 patients, 21 received adalimumab and 22 received placebo. Of
the patients who received placebo, there was a statistically significant
improvement demonstrated in the O'Leary-Sant Interstitial Cystitis Symptom and
Problem Indexes of -8.1 (95% confidence interval [CI], 3.0-13.2), Interstitial
Cystitis Symptom Index of -3.7 (95% CI, 0.9-6.5), Interstitial Cystitis Problem
Index of -4.4 (95% CI, 2.0-6.8), and Pelvic Pain, Urgency, Frequency scale of
-6.9 (95% CI, 2.8-11.0) at week 12 compared with baseline. Most of the
significantly improved placebo patients felt their improvement was because they
were more conscientious about following physician advice and feeling less stress
while in the study.
CONCLUSION: Patients with moderate to severe interstitial cystitis/bladder pain
syndrome had significant improvement after receiving only advice and support.
This intervention is risk free and inexpensive. Physicians should review standard
advice with all interstitial cystitis/bladder pain syndrome patients before
starting medical therapy.
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