Table 4.

Summary of randomized controlled trials of biofeedback therapy for children with constipation

	Loening Baucke (48)	Van der Plas et al (49)	Wald et al ref (53)	Davila et al (54)	Nolan et al (55)	Borowitz et al (56)	Sunic-Omejc et al (57)
Trial Design	Conventional treatment (use of laxatives, increase of dietary fiber and scheduled toileting) vs Conventional treatment + biofeedback	Conventional treatment (toilet training, dietary advice, use of laxatives) vs conventional treatment + biofeedback	Conventional treatment (toilet training, use of mineral oil as laxative) vs. conventional treatment + biofeedback	Conventional treatment (enemas for three days + dietary advice + use of laxatives + toilet training) vs conventional treatment + biofeedback	Conventional treatment (laxatives + behavioral modification) vs EMG biofeedback training	Intensive medical care including laxatives (IMC) vs IMC + enhanced toilet training (EHT) vs IMC + ETT + EMG biofeedback	Conventional treatment (toilet training, dietary advice, use of laxatives) vs conventional treatment plus biofeedback
Subjects and Randomizat on and Intervention( s)	41 (31 boys, 5–16 yrs) 19 conventional treatment 22 biofeedback Sealed envelopes	192 (126 boys, 5–16 yrs) 94 patients conventional treatment 98 biofeedback Allocation Concealment unclear	50 (40 boys, 6–15 yrs) 26 Conventional treatment 24 biofeedback Allocation concealment unclear	21 (14 boys, average age 9 yrs) 10 patients conventional 11 patients biofeedback block randomisation, allocation concealment unclear	29 (24 boys, 4–14 yrs) 14 – conventional treatment 15 biofeedback Stratified blocked schedule by a person not connected with the study. Opaque numbered sealed envelopes stored sequentially	87 (72 boys, 5–13 years) 26 conventional treatment 24 biofeedback Block randomisation, Outcome data collected by means of a computerize d voice mail data collection system	49 (27 boys, 5–15 years) 24 conventional treatment 25 biofeedback Allocation concealment unclear
Duration & Number of biofeedback sessions	up to six sessions of therapy 7 +/− 2 days apart. performed by physician investigator	up to six sessions of therapy 7 +/− 2 days apart. 30 minutes training sessions performed by physician investigator	4 sessions at week 0,2,4 and 8 weeks 30 minute training sessions performed by physician investigator	8 sessions during a 4 week period performed by physician investigator	Up to four sessions of biofeedback training were conducted at weekly intervals	Number of biofeedback sessions unclear 30 minute training sessions performed by psychologist investigator	Duration of the study was 12 weeks. Both study groups were followed weekly at the outpatient clinic. Number of biofeedback sessions is unclear. Duration of the session is not mentioned neither the person who gave the instructions
Primary outcomes	Patients were considered to have recovered from chronic constipation and FI if they met the following criteria: > 3 bowel movements per week and ≤2 FI episodes per month while not receiving laxatives for 4 weeks	Patients were considered to have recovered from chronic constipation and FI if they met the following criteria: > 3 bowel movements per week and ≤2 FI episodes per month while not receiving laxatives for 4 weeks	Number of children cured or improved, number of bowel movements, FI episodes, anorectal manometric assessment	Patients were considered to have recovered from chronic constipation and FI if they met the following criteria: > 3 bowel movements per week and ≤2 FI episodes per month	Full remission was defined as no medication and no soiling for at least four weeks	No episodes of fecal incontinence during the 2- week assessment, 12 months after initiation of therapy.	Patients were considered to have recovered from chronic constipation and FI if they met the following criteria: > 3 bowel movements per week and ≤2 FI episodes per month without the use of a laxative
Success	Dyssynergia corrected at 7 months in 77% with biofeedback vs 13% in conventional group. At 7 and 12 months 5% and 16% in the conventional treatment recovered and 55% and 50% in the biofeedback- treated patients (p< 0.01 and p<0.05).	Dyssynergia corrected at 6 weeks increased in the conventional group from 41% to 52% (not significant) and in the biofeedback group from 38% to 86% (p = 0.001). At 1 year, 59% in the conventional group recovered and 50% in biofeedback group (p = 0.24).	55% success rates were reported in both groups at 3 months. No significant differences were found between the groups at 6 and 12 months; 62% vs 50% and 60% vs 50% respectively.	Dyssynergia corrected at 4 weeks increased from 79.6 ± 10 to 97.9% ± 6 (p<0.001) in the biofeedback group vs 84 ± 7 to 93% ± 6 (ns) in the conventional group. At 4 weeks 90.8% recovered in the biofeedback. While it is unclear how many in the conventional group recovered.	Dyssynergia corrected in all but one child. At six months’ follow up, laxative free remission was sustained in 2/14 patients in the biofeedback group and in 2/15 controls (95% confidence interval (CI) difference, −24% to 26%).	At 12 months, the cure rates for each group were: IMC-36%, ETT −48%, and BF – 39%, respectively (ns).	Correction of dyssynergia at 6 weeks increased in the conventional group from 50% to 58% (ns) and in the biofeedback group from 56% to 92% (p < 0.001). At 12 weeks, 63% in the conventional group and 84% in biofeedback group recovered (p< 0.05).
Conclusions	Biofeedback treatment is complementary to a good conventional therapeutic regimen in patients with constipation and abnormal defecation dynamics.	Additional biofeedback training compared to conventional therapy did not result in higher success rates in chronically constipated children. Furthermore, achievement of normal defecation dynamics was not associated with success.	Biofeedback was not superior to conventional treatment	Biofeedback seems useful in the treatment of the child with constipation and FI	No evidence of a lasting benefit in clinical outcome for biofeedback training in children who had treatment resistant or treatment dependent FI associated with abnormal defecation dynamics.	Enhanced toilet training is more effective in treating childhood FI than either intensive medical therapy or anal sphincter biofeedback therapy.	No clear evidence for long-term benefit of biofeedback therapy, despite recovery of abnormal anorectal dynamics and manometric parameters.