IBS. PLACEBO. So What?

James Flannery, MD
PGY-2
Today

IBS (in brief): definition, diagnosis, treatment

Placebo
The Study: Components of placebo effect:
randomised controlled trial in patients with
irritable bowel syndrome. BMJ. 2008 May
3;336(7651):999-1003. doi:
10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.
So what?
IBS - Definition
IBS - Definition

Abdominal discomfort or pain associated with

altered bowel habits for at least three days per
month in the previous three months, with the
absence of organic disease. 1
IBS - Impact

1 of the top 10 reasons to seek primary care.

1/3 of all GI consults.
In the G8 nations costing 41 billion dollars
annually.
In NA prevalence is 5 – 10%
Women > men (1.5 : 1)
Peak: 20 – 39 years. 1,2
IBS - Diagnosis

ROME criteria:
 Improved pain with defecation.
 Onset associated with change in frequency of stool.
 Onset associated with change in consistency of stool.
 Above criteria met for the previous 3 months with first
symptom onset at least 6 months prior.
Placebo - Definition
Placebo - Definition

 a beneficial effect, produced by a placebo drug or treatment, that cannot

be attributed to the properties of the placebo itself, and must therefore be
due to the patient's belief in that treatment
The Study - Objective

 To investigate whether placebo effects can

experimentally be separated into the response to three
components-assessment and observation, a therapeutic
ritual (placebo treatment), and a supportive patient-
practitioner relationship-and then progressively
combined to produce incremental clinical improvement
in patients with irritable bowel syndrome. To assess the
relative magnitude of these components.
The Study

2009
single academic center
single blinded
6 week study
3 Randomised groupings
262 participants
The Study - Who

262 participants – all of whom met

Rome criteria with no alarm features
76% female
Mean age 39yrs (SD 14)
Randomised into 3 groups
The Study - What

Randomised into 3 groups:

1> Wait list: Hawthorne Effect (observation)
2> Limited interaction: Placebo/sham
acupuncture + < 5min interaction
3> Augmented Interaction: Placebo/sham
acupuncture + augmented patient – practitioner
interaction of 45min.
The Study – Augmented Interaction

5 key factors:
1> Warm, friendly manner.
2> Active listening.
3> Empathy.
4> 20 seconds of thought silence.
5> Communication of confidence in the
treatment.
Study - What

 Participants received their intervention for 3 weeks and then were

randomised to continue the study for a further 3 weeks or not.
Study - Results
Study - results

 Statistically significant incremental improvements across

treatment groups.
Study - Limitations

No true control group.

The assumption that more is more: no
friendly practitioner group.
Others?
SO WHAT?
Cited:

1. Kaptchuk TJ1, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch
I, Schyner RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou
E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect:
randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008
May 3;336(7651):999-1003. doi: 10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.
2. Wilkins T1, Pepitone C, Alex B, Schade RR. Diagnosis and management of IBS
in adults. Am Fam Physician. 2012 Sep 1;86(5):419-26.