IBS TREATMENT WITH PSYLLIUM

MOLLY WINKELER
FSHN 420

EVIDENCE-BASED MEDICINE

Integration of the best available research evidence with clinical knowledge

Properly treat a patient according to his/her values and circumstances

Aims to improve patient outcomes

Provides clinicians with the highest grade evidence available

5 STEPS OF EBM

1. Ask
2. Acquire evidence

3. Appraise validity
4. Apply
5. Evaluate

EVIDENCE-BASED MEDICINE
PROS
Gold standard of clinical practice
Express clinical benefit of tests and treatments

Using mathematical methods

Evaluate the quality of clinical research

Critically assesses techniques reported by

researchers

Based on evidence, not just the belief of

practitioners, experts, or administrators

CONS
Quality of evidence

Irreproducible protocols

Unsupported claims

Outdated evidence

Restriction of clinical freedom and time

Evidence based suggestions may change practice

and techniques

Do not have enough time to review evidence

Timely

WHEN TO USE EBM

Valid, current research

Benefits outweigh the risks
Room for error
Time for research

IRRITABLE BOWEL SYNDROME

Common disorder the affects the large intestine (colon)

Chronic condition

NOT IBD (Ulcerative Colitis and Crohns Disease)

Does not cause changes in bowel tissue or increase risk of colorectal cancer

INCIDENCE

Most common functional gastrointestinal disorder

Worldwide prevalence about 9-23%

US prevalence about 10-15%

More frequent in women
Many do not report or seek help (~25% seek help)

SYMPTOMS
Reoccuring
Abdominal pain/cramping
Bloating
Gas/flatulence
Diarrhea or constipation

Can alter between both

Mucus in stool

Decrease quality of life

Decrease productivity

SYMPTOMS

To be diagnosed:

3 days per month for 3 months

6 months prior to diagnosis

TREATMENT
No cure

Focuses on relief of symptoms so patients live as normally as possible

Diet and lifestyle modifications

Psychological and medical therapies available
Manage stress
Avoid foods that trigger symptoms
Exercise, water, and sleep

No clear first line treatment

PSYLLIUM

Laxative with high levels of soluble fiber

Lower cholesterol

Obesity treatment

Colonoscopy preparation

Constipation

Studied with IBS for over 20 years

*fiber supplements are NOT regulated by FDA

EVIDENCE-BASED FINDINGS

Medication management of irritable bowel syndrome.

Digestion
Impact factor: 2.032

Soluble or insoluble fiber in irritable bowel syndrome in primary care? Randomized placebo
controlled trial.
British Medical Journal
Impact factor: 16.378

MEDICATION MANAGEMENT OF IRRITABLE BOWEL

SYNDROME.
Medline search conducted from 1973-2013

irritable bowel syndrome, therapeutics, antidiarrheal, bulking agents, peppermint oil, laxatives, dietary
fiber psyllium

43 studies meet criteria that assessed efficacy of medication for treatment of IBS

Trails assessed efficacy of symptoms (abdominal pain, bloating, stool consistency, frequency of bowel

movements, presence of mucus, bowel urgency, incomplete evacuation and flatulence)

Studies included global improvements (only in English)
Studies excluded if drugs were not available in US, drugs were of restricted access, and probiotics

Wide variety of bacteria present

Inconsistencies among products

MEDICATION MANAGEMENT OF IRRITABLE BOWEL

SYNDROME.

Shows studies that met

inclusion criteria and
respective outcomes
1B:
moderate-quality
benefits clearly outweigh
risks
inconsistent results, flaws in
methods, indirect/impersice

MEDICATION MANAGEMENT OF IRRITABLE BOWEL

SYNDROME.

Studies were evaluated for

Strength of evidence supporting efficacy of each medication

To determine optimal management of each medication

Assessment of for safe and effective dosing regimens

Onset of efficacy

Duration of effect

Adverse effects

FDA product labeling when applicable

MEDICATION MANAGEMENT OF IRRITABLE BOWEL

SYNDROME.
Fiber Supplements
Successful in relieving a number of IBS symptoms
Psyllium and bran

Psyllium:

3 g twice daily to 6.4 g three times daily to 30 g once daily

Onset of efficacy occurred within 4 weeks

Bran:

10 g twice daily

Onset of efficacy occurred delayed until 3 months

MEDICATION MANAGEMENT OF IRRITABLE BOWEL

SYNDROME.

Both well tolerated at these dosages

Suggested that titration is not necessary

Poor tolerance without titration

Is necessary!

Adverse effects were similar in placebo trials

Patients at risk for symptoms of non-IBS patients

Abdominal pain, constipation, nausea, flatulence, and diarrhea

MEDICATION MANAGEMENT OF IRRITABLE BOWEL

SYNDROME.

Advantages of fiber supplementation

Low cost
Long-term experience with use
Easily accessible
Mild adverse effects
level of evidence supporting fiber supplementation has been greater than many other medication and

fiber appears to be beneficial for all types of IBS

MEDICATION MANAGEMENT OF IRRITABLE BOWEL

SYNDROME.

Overall efficacy of
each medication

MEDICATION MANAGEMENT OF IRRITABLE BOWEL

SYNDROME.

Conclusion
Choice of medical therapy is specific to each patients symptoms
Listed among others as most robust evidence supporting IBS treatment
A

SOLUBLE OR INSOLUBLE FIBER IN IRRITABLE BOWEL

SYNDROME IN PRIMARY CARE? RANDOMIZED PLACEBO
CONTROLLED TRIAL.

Randomized placebo controlled trial in primary care patients with IBS to asses effective of treatment

with psyllium and bran on symptoms and quality of life

275 patients tested were 18-65 having IBS for at least two years

Using Rome 11 criteria, definite and probably patients were eligible for inclusion in study (2.5 years)

Patients were randomly allocated to a 12 week trail with 10g psyllium, 10g bran, or placebo (rice four)

twice a day

85 to psyllium, 97 to bran, 93 to placebo

111 patients lost to follow-up during treatment period

SOLUBLE OR INSOLUBLE FIBER IN IRRITABLE BOWEL

SYNDROME IN PRIMARY CARE? RANDOMIZED PLACEBO
CONTROLLED TRIAL.

Primary outcome
Did you have adequate relief of IBS related abdominal pain or discomfort in the past week
Patients were assessed after moths 1, 2 and 3 of treatment

Secondary outcome
Severity of symptoms

IBS symptom severity score

SOLUBLE OR INSOLUBLE FIBER IN IRRITABLE BOWEL

SYNDROME IN PRIMARY CARE? RANDOMIZED PLACEBO
CONTROLLED TRIAL.
Primary outcome
Rate of response (more than two weeks of adequate relief per month) significantly higher with psyllium

than placebo during first month

Similar positive effect during month two
No statistical significant difference in month 3

Only month that bran was more effective than placebo

Secondary outcome
Reduction of severity was significantly higher in psyllium than placebo
Change in severity was about the same for bran and placebo
No significant differences between groups with respect to changes in severity of abdominal pain or

quality of life

SOLUBLE OR INSOLUBLE FIBER IN IRRITABLE BOWEL

SYNDROME IN PRIMARY CARE? RANDOMIZED PLACEBO
CONTROLLED TRIAL.

SOLUBLE OR INSOLUBLE FIBER IN IRRITABLE BOWEL

SYNDROME IN PRIMARY CARE? RANDOMIZED PLACEBO
CONTROLLED TRIAL.

Conclusion
Support addition of soluble fiber as first treatment approach in the clinical management of patients with

IBS

Limitations
Randomizing process had flaws
Drop-out rate

QUESTIONS?

REFERENCES

Bijkerk, C. J., de Wit, N. J., Muris, J. W. M., Whorwell, P. J., Knottnerus, J. A., & Hoes, A. W. (2009).
Soluble or insoluble fibre in irritable bowel syndrome in primary care? randomised placebo controlled
trial. BMJ.British Medical Journal, 339, b3154. doi:10.1136/bmj.b3154
Trinkley, K., & Nahata, M. (2014). Medication management of irritable bowel syndrome. Digestion, 89(4),
253-67. doi:10.1159/000362405