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Sunday, October 12, 2014

Examination of the Significant Placebo Effect in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome. Bosch P. UROLOGY 84:321-326, 2014.

Michelle Spicka, DPT
October 8th
Pelvic Physical Therapy Distance Journal Club

Objective: To examine the significant “placebo effect” in a randomized, double-blind, placebo-controlled interstitial cystitis (IC)/bladder pain syndrome (BPS) trial.  Randomized clinical trials are the reference standard for therapeutic impact assessment however, proving efficacy of treatments for IC/BPS with rigorous placebo-controlled trials is difficult due to a significant effect of the placebo intervention.
In past studies, a significant effect has been repeatedly observed in patients who only received placebo interventions in IC/BPS trials and the placebo global response assessment overall response ranged from 12% to 20%.
Another study by this same author in 2014 showed 50% of the placebo patients had an over 50% overall improvement in the global response assessment. 
The significant improvement with only advice and support is higher than many commonly used medications for the treatment of IC/BPS.

Methods: Men and women aged 18-65 diagnosed with moderate to severe IC/BPS and had symptoms of: urinary urgency, frequency or pain for more than 6 months; urinating at least 7 times/day; had a total score of (greater than or equal to) 15 on the Pelvic Pain and Urgency/Frequency Symptom Scale; and a total score of (greater than or equal to) 18 on the OSPI (O’leary-Sant IC Symptom Index and Problem Index).
Participants were radmonized in a blinded fashion to receive 1:1 subcutaneous adalimumab (Humira) 80mg followed by 40 mg every 2 weeks OR a subcutaneous placebo for 12 weeks.  43 patients were included in the study with 21 receiving the medication and 22 receiving placebo.
Standard IC/BPS advice was reviewed with all patients at the beginning of the study.
Placebo patients who significantly improved were questioned after the study as to why they felt they improved.

Data analysis: The primary efficacy outcome measure was the change from baseline to week 2, 6 and 12 in the OSPI score.
Results: Of the 22 patients who received placebo, there was a statistically significant improvement demonstrated in OSPI comparing baseline with week 12.    Patients who received placebo and statistically improved were surprised that they had not received the study drug.
Statistical improvement in 50% of the placebo patients was confirmed with ICSI outcome data.

Discussion: Studies have shown improvement in treatment-naïve patients randomized to placebo who received an education and behavior medication program.  The greater “placebo effect” may represent benefits of advice, support, education and behavior modification programs.

The significant benefit of advice and support was a surprising and unexpected result of the previous study performed by this investigator which promoted this follow up study.  What they found was that patients were not given or did not follow important behavior modifications that could improve their symptoms.

Most of the significantly improved placebo patients felt their improvement was due to following the physician advice and feeling less stress while in the study (and not due to spontaneous remission). 

This individual advice was risk free and inexpensive but did require more of the physician’s time.  The greatest improvement was seen in patients who were stricter about their diet and used stress reduction techniques while in the study.
1)      The IC/BPS Standard Advice Checklist should be used to insure all health-care topics are discussed with the patient:

a.       Validate to the patient that they have IC/BPS
                                                               i.      Patients are reassured to know that they are not alone with these symptoms and they are part of a well-described syndrome which is not life threatening.

b.      Explain IC/BPS is a chronic disease requiring a long-term health-care plan

c.       Encourage water hydration
                                                               i.      Adequate fluid intake flushes the bladder, may help prevent UTIs and dilutes irritants and toxins in the urine. 

d.      Recommend a bowel program
                                                               i.      Constipation can exacerbate or mimic symptoms of IC/BPS.

e.      Explain dietary restrictions
                                                               i.      Elimination diets can help determine which foods or fluids affect each individual patient; avoid common bladder irritants

f.        Discuss sexual therapy
                                                               i.      88% of women with IC/BPS with a current partner have sexual dysfunction symptoms

g.       Explain stress reduction
                                                               i.      Stress is the most significant flare factor for IC/BPS and higher level so stress were related to greater urgency and pain.

h.      Discuss support resources
                                                               i.      Social support results in better mental health, less discomfort and an overall better quality of life for patients with IC/BPS.  Support includes spouses, family, friends, social media, support groups and other health care professionals.

The researcher concludes that successful treatment for IC is possible when there is communication, compassion and proper care.  Patients need to be aware that no single treatment may be effective and multiple therapeutic trials may be necessary for acceptable symptom control.

Additional Resources/Information:
1)      The American Urologic Association in 2011 recommended that first-line treatments should be performed on all patients and include patient education, self-care practices, behavior modifications, stress management and coping techniques.

2)      Bryan et al in Physical Therapy October 2014 (94:1443-1454) found that a systematic approach to training and accrediting physical therapists to deliver a standardized pain coping skills program can result in high and sustained levels of adherence to the program.  This is a promising indicator of greater potential for psychologically informed practice to be a feature of effective health care.

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