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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