Biofeedback for treatment of chronic idiopathic constipation in adults.

Woodward S, Norton C, Chiarelli P. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD008486. DOI: 10.1002/14651858.CD008486.pub2.

Laura Scheufele, PT, DPT, WCS

August 6, 2014

Purpose: Examine the effectiveness and side effects of biofeedback (BF) therapy used for the treatment of chronic constipation in adults who are unable to relax the muscles ,which control bowel movements.

Aim: Answer the question “Does biofeedback decrease physical or psychological morbidity and symptom distress and improve QoL in patients with a diagnosis of chronic constipation (functional constipation.)

Search

·         Inception to December 16, 2013

·         Criteria: all randomized trials evaluating biofeedback in adults with chronic idiopathic constipation

·         No language restriction

 

Primary outcome: global or clinical improvement as defined by the included studies

·         Only one study used validated symptom outcome score with sound psychometric properties (PAC-SYM)

·         11 studies included a patient reported outcome measure evaluating patient’s perception of change in, or relief of symptoms

o   Symptom diaries and questionnaires were used to assess presence of abdominal pain, straining at stool, feeling of incomplete evacuation, frequency of unassisted bowel motions and laxative use

§  FDA has identified complete spontaneous bowel movements (CSBM) as the preferred patient-reported outcome as primary end-point for registry trials of constipation

§  Lack of evidence as to which outcome measures are most appropriate

Secondary outcomes: included QoL, and adverse events as defined by the included criteria

When possible the risk ratios (RR) calculated and corresponding 95% Confidence Interval (CI) for dichotomous outcomes and the mean difference (MD)

Participants

·         Male or female at least 18 years of age

o   18 to 82 yo, women (764/931= 82%) and men

·         Diagnosed with chronic idiopathic constipation. Chronic constipation defined using Rome I, II or III criteria  or definition from American College of Gastroenterology Chronic Constipation Task Force (Brandt 2005)

o   Rome criteria two or more of the following symptoms for at least 3 months:1. straining during at least 25% defecations;
2. lumpy or hard stools in at least 25% defecations;
3. sensation of incomplete evacuation for at least 25% defecations; 4. sensation of anorectal obstruction or blockage in at least 25% defecations;
5. manual manoeuvres to facilitate at least 25% of defecations (e.g. digital evacuation, support of the pelvic floor);
6. fewer than 3 defecations per week;
7. loose stools are rarely present without the use of laxatives; and 8. insufficient criteria for a diagnosis of irritable bowel syndrome (IBS).

o   Task force broadened definition “unsatisfactory defecation characterized by infrequent stools, difficult stool passage or both. Difficult stool passage includes straining, a sense of difficulty passing stool, incomplete evacuation, hard/lumpy stools, prolonged time to stool, or need for manual maneuvers to pass stool.”

·         Rome criteria is thought to not adequately differentiate between idiopathic constipation and IBS (Wong 2010)

Exclusion criteria

·         Constipation secondary to use of constipating medication

·         Conditions such as diabetes, long-term neurological conditions, hypothyroidism, tumor, anal fissure, acute constipation 

Types of interventions

·         All types of visual or auditory biofeedback considered

o   No two studies included used the same protocol for BF

o   EMG X11 studies (surface electrodes and probe), Manometry X2, balloon sensory training X3

§  Number of sessions, frequency, and duration of treatment sessions varied greatly

·         Number od sessions ranged from 5 to 14, frequency from daily to every 2 weeks, and duration from 2 weeks to 3 months

·         F/U varied from end of study to up to 24 months

o   Education

§  3 studies described education regarding normal bowel function, dietary manipulation, and lifestyle advice while 4 studies considered this standard of care

·         Needed to be carried out by qualified healthcare practitioner

·         Could be in primary, secondary, or tertiary setting

Assessment of studies

·         Methodological quality- Cochrane risk of bias tool

·         Overall quality of the evidence- GRADE criteria

 

Main results:

·         17 eligible studies with total of 931 participants (sample sizes 21-109)

·         16/17 high risk of bias for blinding

·         Meta analysis not possible –

·         Effect size ranged from 40-100%of patients who received

·         EMG biofeedback most commonly used

o   Lack of evidence that any one type is superior

EMG Biofeedback vs oral diazepam, sham biofeedback and laxatives. (Heyman 2007)

·         Low or very low quality

·         70% (21/30) BF patients improved constipation vs 23% (7/30) Diazepam at 3 months

·         GRADE score very low

 

Manometry BF vs sham vs standard (Rao 2007)

·         BF group significantly increased in number of CSBM per week  (4.6 vs 2.8 vs. 1.9)

·         Statistically significant improvement in global bowel satisfaction

·         Dyssynergic patter corrected in 79% BF and 4% sham and 8.3% standard tx

·         GRADE rating low

EMG BF vs Conventional treatment (laxatives, dietary and lifestyle advice) (Chiarioni 2006)

·         80%  (43/54) BF improved constipation vs 22% (12/55) conventional at 6 and 12 months

·         GRADE rating low

 

BF vs Surgery

·         EMG BF vs STARR Surgery (partial division of puborectalis and stapled transanal rectal resection) (Lehur 2008)

o   Success defined as decrease in the obstructed score of ≥ 50% at one year

o   EMG success 33% (3/39) vs 82% (44/54) STARR

o   High risk of adverse events in surgical group (wound infection, FI, pain, bleeding)

o   GRADE rating low

·         Balloon Sensory BF vs Surgery (partial division of puborectalis

o   1 year mean constipation score 16.1 balloon sensory gp vs 10.5 in surgery

o   GRADE=very low

·         BF vs Surgery (posterior myomectomy of internal anal sphincter and puborectalis) (You 2001)

o   No significant difference

 

Balloon sensory BF vs Botox (Botulinum toxin-A)  (Farid 2009)

§  Conclude BF may have short term benefits

·         Relative to effects of treatment uncertain at 1 year

·         GRADE score very low

 

BF versus no treatment

·         No studies found

 

Comparison of one BF to another

·         No studies directly compares

·         Authors note some poor quality studies included in review suggest EMG BF superior to balloon sensory or manometry BF, but not statistically significant

Conclusion

·         Currently insufficient evidence to allow any firm conclusions regarding efficacy and safety of BF

o   Notes that methodological quality and quality of reporting of RCT have improved over time, and now there is “some evidence that BF treatment is specific and more than just a placebo response”

·         Low to very low quality evidence from single studies to support effectiveness

o   Specifically superior to oral diazepam, sham BF, and laxatives

o   High risk of bias

·         Some surgical procedure reported superior response than BF

o   Surgery high risk of adverse events

·         Conflicting results comparing BF and Botox

o   Botox with short term benefit but doesn’t lasst

·         Majority of trials poor methodological quality and subject bias

·         Further well designed RCT with adequate sample size, validated outcome measures (especially patient reported outcome measures) and long-term follow-up

·         No adverse effects

Questions

What type of outcome measures do you use with your constipation patients?

Should the PT community follow the recommendation made from FDA for outcome measure of CSBM?

What would you like to see in the literature?

Do you see any parallels between structure of Constipation literature and UI?

How much do you rely on BF in your treatment and which type do you use?

 

Additional resources

Frank L, Kleinman L, Farup C, Taylor L, Miner Jr P. Psychometric validation of a constipation symptom assessment questionnaire.Scand J Gastroenterol 1999;34(9):870–7.