| van Dijk et al. Behavioral therapy for childhood constipation: a randomized, controlled trial. 2008. Pediatrics 121[5], e1334-e1341 | Study Type:
Parallel-RCT
Evidence level:
1+
Study aim:
To evaluate the clinical effectiveness of behavioural therapy with laxatives compared with conventional treatment in treating functional constipation in childhood | 134 children
Inclusion criteria:
Children with functional constipation aged 4 to 18 years referred to the gastrointestinal outpatient clinic at the Emma Children's Hospital between 11/ 2002 and August 2004
Exclusion criteria:
Having received a comprehensive BT in the previous 12 months, use of drugs influencing gastrointestinal function other than laxatives, organic causes for defecation disorders, e.g. Hirschsprung's disease, spina bifida occulta, hypothyroidism, or other metabolic or renal abnormalities | 134 children
76 boys
age range: 4 to 18 years
- -
mean age: CT group: 6.5 (2.1) BT group: 6.9 (2.5)
Country:
The Netherlands | General:
- -
Disimpaction: daily Klyx enemas (sodium-dioctylsulfosuccinate and sorbitol; 60 mL/day for children ≤ 6 years of age; 120 mL/day for children > 6 years of age) for 3 consecutive days was prescribed by paediatric gastroenterologists before starting treatment - -
Maintenance: polyethylene glycol 3350, 1 sachet (10 g) per day, and if treatment considered to have insufficient effect dose increased by 1 sachet. If spontaneous defecation delayed for >3 days, parents advised to give an enema or bisacodyl suppository of 5 mg. In BT preferred to give oral bisacodyl tablets of 5 mg instead of rectal laxatives. During BT, paediatric psychologists adjusted laxative dose and consulted paediatric gastroenterologist when necessary. In both treatment groups, patients kept a bowel diary
Intervention:
Protocolised behavioural therapy (BT)
- -
developed by paediatric psychologists of the psychosocial department of our hospital. Basic assumption that phobic reactions related to defecation can be reduced and that adequate toileting behaviour and appropriate defecation straining can be (re)acquired by teaching parents behavioural procedures and by behavioural play therapy with the child in presence of his or her parents. The protocol consists of 2 age-related modules:a module for children aged 4 to 8 years and a module for children aged ≥8 years. Learning process for child and parents: 5 sequential steps (know, dare can, will, and do). This approach is derived from a multidisciplinary BT to treat children with defecation disorders. For all involved psychologists, a detailed manual for both age-related modules available to ensure a standard delivery of therapy. Visits lasted ~45 minutes
Comparison:
Conventional treatment (CT)
- -
conducted by paediatric gastroenterologists, visits lasted ~20 to 30 minutes, laxative treatment and bowel diary discussed. Patients and their parents received education to explain that symptoms are not harmful and are common in children with functional constipation and that a positive, non-accusatory approach is essential. Children instructed not to withhold stool when they feel urge to defecate. Motivation enhanced by praise and small gifts from the paediatric gastroenterologists
| Intervention period:
For both CT and BT 12 visits during 22 weeks with similar intervals between treatment sessions
Assessment point (s) & follow-up period:
At the last visit (post-treatment time point) and 6 months after the 22-week treatment ended (follow-up).
Time between baseline assessment and follow-up: ~1 year
Outcome Measures:
- -
Primary outcomes defecation frequency per week faecal incontinence frequency per week successful treatment
- -
Secondary outcomes: stool withholding behaviour
| IRR: incidence rate ratio
RR: relative risk
CT (n=67)
BT (n=67)
Defecation frequency per week, mean (95% CI)
- -
Post-treatment CT: 7.2 (6.1 to 8.5) BT: 5.4 (4.3 to 6.7) - -
Follow-up CT: 6.6 (5.0 to 8.8) BT: 5.3 (4.4–6.3)
Group (main effect of BT):
IRR=0.75 (0.59 to 0.96) p=0.021
Group × time (interaction effect of BT with measurement at follow up):
IRR= 1.06 (0.75 to 1.50) p=0.758
Faecal incontinence per week, mean (95% CI)
- -
Post-treatment CT: 2.1 (0.8 to 5.8) BT: 5.0 (2.1 to 12.0) - -
Follow-up CT: 6.4 (3.5 to 11.7) BT: 8.6 (4.0 to 18.3)
Group (main effect of BT):
IRR=2.36 (0.77 to 7.31) p=0.135
Group × time (interaction effect of BT with measurement at follow up):
IRR= 0.57 (0.12 to 2.61) p=0.467
Success, % (95% CI)
- -
Post-treatment CT: 62.3 (51.1 to 76.1) BT: 51.5 (39.7 to 66.9)
RR= 0.83 (0.60 to 1.14) p=0.249
- -
Follow-up CT: 57.3 (46.6 to 70.4) BT: 42.3 (31.8 to 56.4)
RR= 0.74 (0.52 to 1.05) p=0.095
Stool withholding behaviour at follow-up (% children with behaviour)
CT: 13.8
BT: 10.6
NS | Additional information from study:
At entry, patients had to meet at least 2 of 4 criteria: defecation frequency< 3 times per week, faecal incontinence ≥ 2 times per week, passage of large amounts of stool at least once every 7 to 30 days (large
enough to clog the toilet), or a palpable abdominal or rectal faecal mass
After baseline measurement and if written informed consent was given, a research assistant performed a telephone call to a randomization centre and revealed the allocation to parents immediately. A computer-based system used to generate a sequence of random group assignment for consecutive patients. Random assignment stratified by age (4 to 8 years or ≥8 years) and gender. Within 2 weeks after random assignment, patients received their 1rst treatment session
Sample size calculated to allow detection of a 25% difference in the proportion of success between BT and CT. It was estimated that CT reached success in 35% of the children at follow-up. Under the additional assumption of a significance level of .05, a power of .80, and 2-sided hypothesis testing, a minimal sample size of 124 with 62 children in each group was determined
During treatment 2 (3.1%) of 64 in the CT group and 9 (13.8%) of 65 in the BT group discontinued intervention
(P=0.054). At follow-up, 4 patients dropped out in CT. There was 1 loss of contact, and 3 children were referred for BT directly after CT, making them unsuitable for follow-up measurements. Questionnaires were not returned by 3 patients in both intervention arms at posttreatment and by 9 patients (CT: 6; BT: 3) at follow-up
Except for painful defecation (65.0% CT vs. 43.1% BT, P=0 .014), no significant differences between the 2 groups in baseline sociodemographic factors or for clinical characteristics
Intent-to-treat analyses conducted. Because of withdrawal before treatment start, dropouts during the study, failure to fill out questionnaires, or research procedure violations, missing data occurred. Imputation of missing values used to make intent-to-treat analyses feasible
Treatment considered successful if patients achieved a defecation frequency of ≥3
times per week and a faecal incontinence frequency of ≤1 times per 2 weeks, irrespective of laxative use
Reviewer comments:
Insufficient details on how outcomes were measured
Results controlled for confounders
Source of funding: funded in part by the Dutch Digestive Disease Foundation (SWO 02-16) |
| Ritterband et al. An Internet intervention as adjunctive therapy for pediatric encopresis. 2003. Journal of Consulting and Clinical Psychology 71[5], 910-917 | Study Type:
Parallel-RCT (multicentre)
Evidence level:
1+
Study aim:
To examine the utility and effectiveness of an Internet-based version of enhanced toilet training | 24 children
Inclusion /exclusion criteria:
Children aged between 6 and 12 years, soling at least once a week and have no medical diagnosis other than constipation that could explain their faecal incontinence | 24 children
19 boys
mean age: 8.46
years (SD1.81)
- -
Web group: 12 children (10 boys) - -
No-Web group: 12 children (9 boys)
Country:
USA | Intervention:
Laxatives + Web intervention
Comparison:
Laxatives only
Laxatives: all children instructed to start with a basic regime of one square of Ex-Lax (senna), twice a day
- -
The Web site: Web-based program for the treatment of paediatric encopresis (U-CAN-POOP-TOO
Child-focused programme, targets primarily 5 to 10 years old children but was designed to be used by child and parent (s) together
3 core modules take 60 to 90 minutes to complete, all users instructed to review them during the first week:
The body (anatomy, physiology and pathophysiology of digestion) How to poop (behavioural techniques for treatment of encopresis) Medication (clean-out and laxative treatment)
New modules assigned each week based on a follow-up assessment the user completes about their child's status. Not all modules necessarily used by all users, only those modules identified as relevant are assigned and reviewed. However all modules can be viewed by all users. Follow-up comprised of 17 to 20 questions, depending on the week. System contains a total o 22 modules, each takes 5 to 10 minutes to review | Duration of intervention:
3 weeks
Assessment point (s):
3 weeks after initial home visit
Follow-up period:
None
Outcome Measures:
- -
number of faecal accidents per week - -
number of bowel movements (BM) passed in the toilet per week - -
bathroom use without prompts - -
bathroom use with prompts - -
internet use (most/least useful aspect of the programme; preference questions regarding individual cores an modules)
| Percentage change from pre- to post-assessment
Number of faecal accidents per week (mean, SD)
- -
Web group: 0.50 (.85) - -
No-Web group: 8.27 (13.83)
Number of bowel movements (BM) passed in the toilet per week
- -
Web group: +152% - -
No-Web group: -16% p=0.001
Bathroom use without prompts
- -
Web group: +109% - -
No-Web group: - 37%p=0.021
Bathroom use with prompts
- -
Web group: +47% - -
No-Web group: -45% NS
Internet use (Web group only)
Most useful aspect of the programme: - -
the step by step program to get the child regulated - -
understanding why his body does what it needs to do every day-and what happens when he doesn't have a BM and health consequences…information was tremendously useful - -
developing a feeling that he can control his own body - -
realising that he's not the only child with this problem…that was reassuring
Least useful aspect of the programme - -
difficulty with connections - -
modules regarding fear of toilet and “monsters” - -
art work of the body did not print out - -
Miralax should have been included (as a choice of laxative) - -
nutrition portion was too limited
Internet experience: parents' views / satisfaction - -
found material understandable (mean 5.00, SD 0.00, N = 20) - -
found it easy to use (mean 4.62, SD 0.74, N = 21) - -
believed their child liked the program (mean 4.05, SD 1.28, N = 21) - -
believed their child found it understandable (mean 4.32, SD 0.89, N = 19) - -
believed their child found it easy to use (mean 4.47, SD 0.77, N = 19) Preference regarding cores modules (CM) (mean, SD) (score 0 to 4) How useful: CM1: 3.84 (0.38) CM2: 3.94 (0.24) CM3: 4.00 (0.00) How well did you understand the material CM1: 3.89 (0.32) CM2: 3.89 (0.32) CM3: 3.92 (0.28) how well did your child understand the material CM1: 3.53 (0.61) CM2: 3.28 (1.07) CM3: 3.54 (1.13) How much did you enjoy using the module CM1: 3.68 (0.48) CM2: 3.67 (0.49) CM3: 3.69 (0.48) How much did your child enjoy using the module CM1: 3.63 (0.76) CM2: 3.61 (0.98) CM3: 3.46 (1.13)
| Additional information from study:
Computer and internet access provided to all families who contacted the research centre and met the inclusion criteria
Participants received a $25 gift certificate to a local toy store for completing the pre-treatment assessment and another $25 gift certificate for completing the post-treatment assessment
Information regarding BM assessed by parent report on the Child Information Form. Question regarding child's bowel habits included such as number of BMs in toilet and use of toilet with / without parental prompts. Questions regarding use of internet programme also included in post-treatment form for the intervention group. The Virginia Encopresis/Constipation Apperception Test (VECAT) also administered. It assesses bowel specific problems related to the process of encopresis, such as avoidance of the toilet, non responsiveness to rectal distension cues and fear of defecation pain. A generic subscale included as a comparison measure, addresses problem behaviours not related to bowel issues. The VECAT consists of 18 pairs of drawings (9 pairs bowel-specific and 9 parallel generic events) and child selects the picture in each pair that best describes him/herself
No significant differences in baseline characteristics between the 2 groups (age, gender, race, stage of bowel movement training, length of current laxative regime or any of the outcomes measured)
CM1: anatomy and pathophisiology
CM2: medication (enemas/laxatives)
CM3: behavioural intervention
Reviewer comments:
No definition of constipation / soling given
Small sample size, no sample size calculation
Randomisation and allocation concealment method not described
No dropouts/lost to follow up reported
Results not controlled for potential confounders
Source of funding: National Institutes of Health Grant RO1 HD28160 |
| Borowitz et al. Treatment of childhood encopresis: A randomized trial comparing three treatment protocols. 2002. Journal of Pediatric Gastroenterology and Nutrition 34[4], 378-384United States. | Study Type:
Parallel-RCT
Evidence level:
1+
Study aim:
To compare short- and long-term effectiveness of three additive treatment protocols in children experiencing chronic encopresis | 87 children
Inclusion criteria:
Children aged between 5 and 15 years of age who had experienced encopresis for a minimum of 6 months, defined as at least weekly episodes of faecal soiling for at least 6 months
Exclusion criteria:
any chronic underlying medical conditions or developmental disabilities | 87 children
72 boys
Mean age at time of enrolment: 8.6 ± 2.0 years (range, 5 to 13 years)
Country:
USA | Intervention:
Intensive medical therapy (IMT)
1 of 2 paediatric gastroenterologists directed treatment: colonic disimpaction with a series of enemas followed by sufficient laxative therapy to produce at least 1 soft stool each day without associated pain.
Laxatives prescribed: Milk of Magnesia and/or senna (Senokot, Ex-Lax, or Fletcher Castoria).
Laxative dosages adjusted regularly to produce 1 to 3 soft bowel movements daily.
An enema or suppository administered if child had not produced a bowel movement during a 48-hour period. No specific dietary recommendations or manipulations undertaken.
Families received specific instructions and written brochure detailing treatment protocol and need for children to attend the toilet at least twice dally, preferably after breakfast and supper
Comparison 1:
Intensive medical therapy + enhanced toilet training (ETT)
Similar enema and laxative therapy, with 1 clinical psychologist adjusting laxative dose. Only difference from previous therapy was that laxative therapy was decreased gradually when children demonstrated stable bowel frequency with no soiling episodes. As long as child had daily bowel movements of normal size for a week, laxative dose was decrease by one quarter. This process was continued until laxative therapy was discontinued. If child did not pass daily bowel movements of normal size, laxative dose was increased. Parents and child instructed on the psychophysiology of constipation and encopresis, and how responding to early rectal distention cues along with regular toileting was critical to avoid reimpaction and to establish regular bowel habits. Various incentive programs established, depending on the developmental age and the motivation of the child. Target behaviours: spontaneous trips to the toilet and clean pants. Toilet training was “enhanced” because instructions were given on the role of paradoxic constriction of the external anal sphincter, and because appropriate defecation straining was modeled. The therapist sat on a portable toilet and demonstrated how to relax the legs and feet, how to take in a deep breath and hold it while sitting up straight, and how to push down with the held breath and pull in from the lower abdomen (rectus abdominous muscle) to propel out a stool. The child then replicated this while sitting on a portable toilet. The child received “hand feedback” by placing one hand on the abdomen just below the navel to feel the abdomen move out when the breath was pushed down, and placing the second hand just below the first to feel inward movement with contraction of the rectus abdominous. Parents instructed to prompt these behaviours at home.
Additionally, 8 to 12 minutes of “toilet time” was scheduled daily, beginning 15 to 30 minutes after the same two meals. During these times, children were instructed to practice tensing and relaxing the external anal sphincter for the first 4 minutes, with the objective of localizing control of and fatiguing the external anal sphincter, and to mechanically stimulate the rectum. To desensitize children to toilet sitting, the second 4 minutes were spent “having fun” while being read to or playing games. During the final 4 minutes, the child was to strain and attempt to have a bowel movement while relaxing his or her legs and feet. This routine toilet sitting was discontinued 2 weeks after the last scheduled treatment session
Comparison 2:
Intensive medical therapy + enhanced toilet training + anal sphincter biofeedback (BF)
Same instructions that previous 2 groups and simultaneously received surface electromyographic biofeedback training. Same 2 psychologists who worked with the ETT group also worked with the BF group | Duration of treatment
Unclear
Assessment point (s) and follow-up period
When subjects had been enrolled in the study, data concerning toileting habits were collected for 14 consecutive days before and after the initial outpatient visit, and again at 3 months, 6 months, and 12 months after initiation of therapy
Outcome Measures:
- -
soling frequency - -
improvement rate - -
cure rate - -
number of bowel movements passed in the toilet each day - -
self-initiated toileting each day - -
laxative use
| Soling frequency(mean, SD)
- -
at 3 months: IMT: 0.54 (0.68) ETT: 0.22 (0.21) BF: 0.34 (0.51)
- -
at 6 months: IMT:0.44 (0.52) ETT: 0.38 (0.45) BF:0.20 (0.26)
- -
at 12 months: IMT:0.33 (0.48) ETT: 0.36 (0.53; 95% confidence interval, 0.05 to 0.47) BF:0.27 (0.37) NS among the 3 groups at any time Improvement rate (% children)
- -
at 2 weeks: IMT: 41 ETT: 48 BF: 62 NS between 3 groups
- -
at 3 months: - -
at 6 months: - -
at 12 months:
At 3 months, 6 months, and 12 months, the number of children who responded in the ETT group was significantly greater than in either the IMT or the BF group (P < 0.05), and these results were very stable over time (P < 0.001). With all 3 regimens, response to treatment during the first 2 weeks of therapy strongly correlated with response to treatment at 3, 6, and 12 months (r > 0.90, P < 0.0001 in all cases). Of those children who had significant improvement after 2 weeks of therapy, 86 continued to improve at 3 months, 83 at 6 months, and 81 at 12 months
Cure rate (number of children cured)
- -
at 12 months: IMT: 10/29 (34.5%) ETT: 12/27 (44.4%) BF: 11/31 (35.5%) chisquare=0.9488 p=0.7005
Number of bowel movements passed in the toilet each day (mean, SD)
- -
at 3 months: IMT:1.44 (0.57) ETT: 1.21 (0.49) BF: 1.25 (0.64)
- -
at 6 months: IMT:1.36 (0.61) ETT:1.31 (0.63) BF:1.12 (0.60)
- -
at 12 months:
Self-initiated toileting each day (times/day, mean, SD)
- -
at 3 months: IMT: 1.53 (0.77) ETT: 1.62 (0.82) BF:1.40 (0.71)
- -
at 6 months: IMT:1.49 (0.60) ETT:1.67 (0.95) BF:1.34 (0.72)
- -
at 12 months:
Laxative use (number of children using)
- -
at 12 months:
| Additional information from study:
Using a random number generator, blocks of six consecutive children were randomly assigned to one of 3 treatment groups
All data were collected using the Automated Patient Symptom Monitor system, a computerized voice-mail system that telephones the families each day. With each telephone call, the computer asked parents the same 8 prerecorded questions relating to bowel habits during the previous 24 hours. After parents had answered all questions, the computer checked responses to ensure all items were answered and that responses were within acceptable ranges. If the computer detected an error, the questionnaire was repeated
No significant differences in baseline clinical or demographics characteristics between the 3 groups
Treatment considered successful if the child experienced no episodes of faecal soiling during the 2-week assessment 12 months after initiation of therapy
Reviewer comments:
No definition of constipation given
No sample size calculation performed
Method of allocation concealment not reported
No drop outs/lost to follow up children reported
Source of funding: supported by National Institutes of Health grant RO1 HD 28160 |
Loening-Baucke. Modulation of abnormal defecation dynamics by biofeedback treatment in chronically constipated children with encopresis. 1990. Journal of Pediatrics
116[2], 214-222 | Study Type:
Parallel-RCT
Evidence level:
1 +
Study aim:
To determine whether outcome in chronically constipated and encopretic children with abnormal defecation dynamics could be improved with biofeedback training | 43 children
Inclusion criteria:
Children 5 to 16 years with chronic constipation and encopresis and abnormal defecation dynamics
Exclusion
criteria:
Hirschsprung's disease, hypothyroidis m, mental deficiency, chronic debilitating diseases, neurologic abnormalities, previous surgery of the colon | 43 children
33 boys
Mean age: 8.9 years (range 5 to 16)
Country:
USA | Intervention:
Conventional treatment alone (CT)
CT: use of laxatives, increase of dietary fibre and scheduled toileting
Disimpaction with enemas (type and dose not reported)
Maintenance: milk of magnesia ~2ml/kg body weight daily to induce at least 1 bowel movement daily and prevent faecal retention. Doses decrease gradually to maintain daily bowel movement and prevent faecal retention and soiling
Patients instructed to discontinue laxative therapy at 6 ± 0.5 months after initiation of therapy
Comparison:
Conventional treatment (CT) + biofeedback (BF)
Up to 6 sessions of biofeedback therapy 7 +/- 2 days apart. 1 session included approximately 30 to 35 defecation trials and lasted approximately 45 minutes
Patients instructed to discontinue laxative therapy at 6 ± 0.5 months after initiation of therapy | Duration of treatment
6-month protocol.
Assessment point (s) and follow-up period:
7 & 12 months
Outcome Measures:
Recovery rate | Recovery rate (number recovered, %)
- -
at 7 months: CT(n=19): 1(5) BF (n=22): 12 (55) P<0.001
Recovery rates did not differ between boys and girls in general and within the biofeedback group in particular. Prior unsuccessful treatment no related to treatment outcome in either group
Patients with an initial abdominal faecal mass (severe constipation) significantly more likely to recover with BF training than with CT alone (46% vs. 0%, p<0.02)
- -
at 12 months: CT (n=19): 3 (16) BF (n=22): 11 (50) P<0.05
A 14-yeor old boy in the BF group had a relapse. He had severe faecal impaction with enormous abdominal distension initially. Faecal impaction recurred 4 months after successful discontinuation of milk of magnesia. at time study was written he had no soiling but required intermittent treatment for constipation | Additional information from study:
Constipation and encopresis defined as having ≥ 2 soiling episodes/week and evidence of a huge amount of faecal material in the rectal ampulla at rectal examination. In many patients stool evacuation was incomplete as evidenced by periodic passage of very large amounts of stools (every 7 to 30 days), often clogging the toilet
Abnormal defecation dynamics defined as abnormal contraction of the external anal sphincter and pelvic floor during defecation attempts, as determined by anorectal manometry
Sample size and calculation: 2 pairs of subjects would be needed per group to allow a power of approximately 0.9 to detect a difference of 0.7 vs. 0.2 in achieving normal bowel habits (recovery from constipation and encopresis)
Sealed envelopes with cards indicating either conventional therapy alone or conventional therapy with biofeedback training used for randomisation
1 boy in the conventional treatment group was lost to follow-up 1 month after treatment began. At that visit he was taking milk of magnesia and his soiling had resolved. 1 boy was lost to follow-up in the biofeedback group after the first biofeedback session
Baseline characteristics not significantly different between both groups apart from gender: more girl in the BF group than in the CT group (41% vs. 5%, p<0.02). During initial evaluation the following significantly more frequent in girls than in boys: severe constipation (an abdominal faecal mass present) (90% vs. 48%, p<0.03), daytime urinary incontinence (70% vs. 23%, p<0.02) and a history of previous urinary tract infection (60% vs. 6%, p<0.001)
Patients considered to have recovered if they had ≥3 bowel movements/week and soiling ≤ 2 episodes/month while not receiving laxatives for 4 weeks. Patients considered not to have recovered if they had <3 bowel movements/week or were soiling >2 times/month or had been started on a regime of laxatives again
Re-evaluation of patients included review of last month's stool, soiling and medication dairy. Follow-up interview by questionnaire at 12 months
Reviewer comments:
Not completely clear who measured outcomes and how, and whether questionnaires were piloted
ITT analysis not performed
Source of funding: Supported by grant No. M01-RR-00059 from the General Clinical Research Centre Program,, Division of Research Resources, National Institute of Health; the Children's Miracle Network Telethon and the Spelman-Rockefeller Child and Parenting Seed Grant |
| Sunic-Omejc et al. Efficiency of biofeedback therapy for chronic constipation in children. 2002. Collegium Antropologicum 26 Suppl, 93-101 | Study Type:
Parallel-RCT
Evidence level:
1+
Study aim:
To assess the success of biofeedback method vs. conventional method in the treatment of chronic constipation in childhood over a 12-week period and to follow-up the effect of biofeedback treatment on defecation dynamics and other anorectal manometric parameters | 49 children
Inclusion criteria:
Children aged >5 years who met at least 2 of the following criteria from chronic constipation: defecation frequency < 3 times/week, ≥ 2 episodes of soiling and/or encopresis /week, periodic evacuation of large volume stools at least once every 7 to 30 days and palpable abdominal or faecal mass
Exclusion criteria:
Hirschsprung' s disease, spina bifida, hypothyroidis m, metabolic or renal disorders, mental retardation, taking drugs for | 49 children
27 male
Mean age
(CON):
94 ± 33 months
Mean age
(BFB):
92 ± 35 months
Country:
Croatia | Intervention:
Conventional treatment (CON)
Per oral administration of Portalak (lactulosis, 240 mg/day or 10 mL syrup) with dose titration for the patient to have at least 3 stools/week. When spontaneous defecation failed to occur for > 3 days in spite of appropriate therapy an enema was used. In addition a fibre-rich diet and attempting defecation after meal were advised
Comparison:
Conventional treatment (CON, as previous) + Biofeedback (BFB)
Pressure technique. Child and parents instructed on how to perform Kegel exercises at home. Exercises include alternating 10-second contraction and relaxation of sphincter and pubo-rectal muscle, performed 5 times a day in 20 cycles | Duration of treatment
12 weeks
Assessment point (s):
At 12 weeks
Follow-up period:
None
Outcome Measures:
Therapeutic success | Therapeutic success (number of children cured)
- -
CON: 15/24 (62.5%) - -
BFB: 21/25 (84%)
P<0.05 | Additional information from study:
Treatment considered successful if a frequency of ≥ 3 stools /week and < 2 episodes of soling or encopresis per month were achieved without laxatives
Therapeutic success evaluated by use of questionnaires distributed on weekly visits
No significant differences in baseline characteristics between 2 groups
All children completed treatment
Reviewer comments:
Small sample size, no sample size calculation
Randomisation and allocation concealment methods not described
Insufficient details on who measured outcomes and how
Results not controlled for potential confounders
Source of funding: Not stated |
van der Plas et al. Biofeedback training in treatment of childhood constipation: a randomised controlled study. 1996. Lancet
348[9030], 776-780 | Study Type:
Parallel-RCT
Evidence level:
1+
Study aim:
To evaluate the effect of biofeedback training and conventional treatment on defaecation dynamics and outcome in chronically constipated children | 192 children
Inclusion criteria:
Patients with paediatric constipation who fulfilled at least 2 of these 4 criteria: stool frequency <3 per week, ≥2 soiling and/or encopresis episodes per week, periodic passage of very large amounts of stool at least once every 7–30 days, or a palpable abdominal or rectal mass. Children needed to be at least 5 years old to understand the manometric procedures and instructions and had to have had treatment with laxatives for a minimum of 1 month before randomisation
Exclusion criteria:
Hirschsprung' s disease, spina bifida occulta, hypothyroidism or other metabolic or renal abnormalities, mental retardation, and children using drugs influencing gastrointestinal function other than laxatives | 192 children
126 boys
- -
age range (total population): 5 to 16 years - -
median age for both groups: 8 years
Country:
The Netherlands | Intervention:
Conventional laxative treatment (CT)
5 outpatient visits lasting approximately 30 min during which laxative treatment and information from a diary containing defaecation frequency and encopresis and/or soiling episodes were discussed
High-fibre diet advised but additional fibre supplements not prescribed
Patients instructed to try to defecate on the toilet for 5 min immediately after each meal
During the first 3 days patients were to use daily enemas (120 mL sodiumdioctylsulfo succinate, 1 mg sorbitol, 250 mg per mL, Klyx) at home. If, on day 3, enemas still resulted in large amounts of stool, enemas were continued for a maximum of 7 days. After the initial 3-day enema treatment, patients started oral laxatives with Importal (lactitol betagalactoside sorbitol, 1 sachet of 5 g/10 kg body weight per day divided in 2 doses). Enemas given whenever spontaneous defaecation was delayed for more than three days. Motivation enhanced by praise and small gifts
Comparison:
5 outpatient visits, including the same conventional treatment as described above, in combination with 5 biofeedback training sessions. As far as possible, both groups received equal attention. | Duration of intervention
6 weeks
Assessment point (s) and follow-up period:
after the last visit of the intervention period at 6 weeks, then at 6 months, 1 year, and 1 ½ years
Outcome Measures:
Treatment success | Treatment success (number of children cured, %)
- -
at 6 weeks - -
at 6 months - -
at 1 year at 1 ½ year
| Additional information from study:
A faecal mass defined as a large hard or soft stool in the rectum which completely filled the rectal vault. Soiling defined as loss of loose stools in underwear. Encopresis defined as voluntary or involuntary passage of a quantitatively normal bowel movement in underwear in children over the age of 4, occurring on a regular basis without any organic cause. A large amount of stool was estimated to be twice the standard shown in a clay model
High percentage of non compliance reported by parents if the child was asked to attempt toilet training 15–30 min after the meal to profit from the gastro—colic reflex
Treatment was considered successful if the patients achieved ≥3 bowel movements per week and < 2 soiling or encopresis episodes per month while not receiving laxatives for 4 weeks
It was estimated that a sample of 180 patients would be adequate to show a difference of at least 70% success at 6 months for CT+BF compared to 45% success using CT with a two-tailed alfa 2 of 0·05 with a power of 90%
At baseline patients were comparable for gender, age, and frequency of gastrointestinal complaints, and urinary problems
At 6 months, 5 patients were lost (4 patients in the CT+BF and 1 patient in the CT group), and at 1 year 8 patients were lost to follow up (another 2 in the CT+BF and 1 in the CT group). Patients lost to follow up were withdrawn from further analysis
During the intervention period, 3 patients in the CT group refused manometry at the end of the treatment period: 1 patient was successfully treated and the parents refused permission for manometry; 1 patient was unsuccessfully treated and refused manometry; and 1 patient was lost to follow-up after two visits. 2 patients of the CT+BF group discontinued treatment: one 5-year-old patient did not cooperate and another patient discontinued treatment because his parents could not afford the cost of transport.
At the beginning and end of the 6-week treatment period, each patient had a detailed medical history, abdominal and rectal examination, and anorectal manometry. The child and parents were asked about bowel function, frequency of defaecation soiling and/or encopresis, consistency and size of stool, pain during defaecation, and associated symptoms such as abdominal pain, appetite, and enuresis. Follow up done either during a clinical visit using a standard questionnaire or by telephone
Because other studies have selected patients for evaluation according to the presence of abnormal defaecation dynamics at the start of the study, authors compared defaecation dynamics at randomisation and after treatment, and found no correlation between achievement of normal defaecation dynamics and success. Analysis of all patients showed no relationship between post-treatment defaecation dynamics and success. Log-linear modelling showed significant relationships between pre-treatment and post-treatment defaecation dynamics (x2= 13·91, p<0·001) and between treatment and post-treatment defaecation dynamics (x2=28·38, p<0·001). There was no association between post-treatment defaecation dynamics and treatment success after 6 weeks (x2=2·41, p=0·12). The results at 6 months and 1 year were similar
Reviewer comments:
Randomisation and allocation concealment methods not reported
Not completely clear who measured outcomes and how
ITT analysis not performed
Source of funding: Not stated |
Nolan et al. Randomised controlled trial of biofeedback training in persistent encopresis with anismus. 1998. Archives of Disease in Childhood
79[2], 131-135United Kingdom. | Study Type:
Parallel-RCT
Evidence level:
1+
Study aim:
To determine whether surface electromyographic (EMG) biofeedback training produces sustained faecal continence in medical treatment resistant and/or treatment dependent children with anismus | 29 children
Inclusion criteria:
Children aged ≥4 years, judged to be of adequate maturity to cooperate with biofeedback treatment and had received 3 months or more of conventional multimodal therapy; had continuing soiling with or without laxative treatment (more than once a month) or had achieved remission from soiling but could not sustain continence without continued laxative treatment; and had anismus on EMG during anorectal manometry
Exclusion criteria:
known structural congenital or postoperative anatomical defect (such as spina bifida or anorectal malformation) , or Hirschsprung' s disease (excluded by rectal biopsy only if clinically indicated) | 29 children
24 boys
age range: 4.8 to 14.9 years
- -
mean age (years) (SD): BFT+CT: 9.2 (2.7) CT: 8.4 (2.3)
Country:
Australia | Intervention:
EMG biofeedback training and conventional medical treatment (BFT+CT)
Up to 4 sessions at weekly intervals conducted for each patient, each session consisting of ~ 30–35 defecation attempts. Aim was to achieve 10 relaxations of the external anal sphincter without visual feedback in 2 successive sessions. If this occurred in less than 4 sessions then biofeedback was discontinued. At completion of training, subjects followed at monthly intervals by a single paediatrician, who gave verbal reinforcement of the skills learned during training
Comparison:
Conventional medical treatment alone (CT)
- -
Laxative therapy in 2 phases: Initial disimpaction phase: 3-day cycles of 5 mL ‘Microlax’ enemas (sodium citrate) on day 1, one 5 mg bisacodyl tablet after school and 1 in evening of day 2. Up to 4 cycles (12 days) undertaken. Further cycles prescribed if later evidence of stool reaccumulation Maintenance phase: liquid paraffin 5 to 30 ml once or twice a day, senna granules and or bisacodyl tablets. Medication use decreased to a level consistent with maintenance of continence as monitored by bowel diary - -
Standard paediatric behaviour modification: clarification during joint parent-child interview of the postulates underlying physiological basis for encopresis. Bowel training programme used positive reinforcement for successful defection in toilet and additional reinforcement for each 24h without soiling. Reinforcement consisted of parental praise and use of start-chart diary (fitness training card) to indicate soiling-free days. Regular sitting programme of 5 to 10 minutes toilet-time within 30 minutes of each meal was basis of the programme. - -
Dietary advice, general counselling and support provided by paediatrician. Psychiatric assessment or treatment initiated when indicated clinically
| Duration of treatment
CT: Unclear
BFT: up to 4 weeks
Assessment point (s):
6 months
Follow-up period:
None
Outcome Measures:
Treatment success | Treatment outcome
- -
Full remission: - -
Improved: - -
No improvement: BFT+CT (n=14): 10 (71%) CT (n=15): 9 (60%)
3/14 patients in the BFT group completed the training in 3 sessions, and the remainder underwent 4 sessions. Only 1 patient was unable to demonstrate relaxation of the external anal sphincter with attempted defecation. Only 1 patient (same one) was unable to defecate the biofeedback balloon by the time of their final session. All complied well with instructions and procedures involved in the training. 2 complained of transient discomfort when the biofeedback apparatus was inserted. No other adverse effects seen or reported | Additional information from study:
Originally, it was planned to recruit 25 subjects into each group, which would mean that, at the alfa = 0.05 level (one tailed), there would be 80% power to detect at least a 38% point advantage of biofeedback (32% against 70% or better) in the comparison group. An interim analysis conducted when it became clear that successful and sustained biofeedback outcomes were not occurring. A revised sample size calculation was based on argument that if no successful outcomes were to be achieved in 15 subjects randomised to biofeedback, there would be a 95% confidence that the true rate of successful outcome could not be greater than 18%. The precision of the final result was expressed in the confidence interval (CI) around the difference in remission rates
Procedure to determine whether anismus was present involved the use of a balloon filled with 50 ml warm water. After a tuition period to explain what was required to achieve correct straining and squeezing, patient asked to make 5 alternating attempts each to squeeze and strain. Normal strain response defined as a persistent decrease in external anal sphincter activity (measured by a decrease in amplitude of the electromyographic recording and an increase in rectal pressure of at least 50 mm Hg) in at least 3 of 5 attempts. A persistent increase in external anal sphincter activity with a corresponding increase in rectal pressure in at least four of five attempts were deemed as indicating anismus
Randomisation carried out using a stratified, blocked schedule, with subjects stratified on the basis of whether they were soiling or were in laxative dependent remission. Each treatment allocation was recorded on a card in an opaque numbered and sealed envelope and stored sequentially. An individual not connected with the clinic or the study carried out the randomisation plan
Full remission defined as no medication and no soiling for at least 4 weeks; full remission on medication was defined as on medication and no soiling for at least 4 weeks; partial remission defined as soiling no more than once a week, regardless of medication used. The use of medication was attempted by all those not in full remission, not only those who were worse or not improved. The remainder were those who were soiling more than once a week, regardless of medication use. Improvement defined as progression by at least one level from baseline status, but without achieving full remission
Presence or absence of continued soiling ascertained on the basis of parental report, assisted by daily diary record. Patient data recorded prospectively in a relational database was also used for appointment scheduling and data quality control
At baseline there were slightly more subjects with primary encopresis in the biofeedback group than in the control group
Reviewer comments:
No definition of constipation given
Small sample size
Unclear how the use of medication was measured
No dropouts/lost to follow up reported
Results not controlled for potential confounders
Source of funding: grants from the National Health and Medical Research Council (grant 910621) and the Royal Children's Hospital Research Foundation |
| Loening-Baucke. Biofeedback treatment for chronic constipation and encopresis in childhood: long-term outcome. 1995. Pediatrics 96[1 Pt 1], 105-110 | Study Type:
Retrospective cohort
Evidence level:
2+
Study aim:
To evaluate if patients who received biofeedback treatment (BF) continued with improved outcome compared with patients who received conventional treatment alone (CT) | 129 children
Inclusion
criteria:
Children 5 to 18 years with chronic constipation and encopresis (≥1 soiling episode per week)
Exclusion criteria:
Hirschsprung's disease, hypothyroidis m, mental deficiency, chronic debilitating diseases, neurologic abnormalities, previous surgery of the colon | 129 children
97 boys
Mean age
(years):
- -
CT group Initial: 9.1 ± 3.3
Follow-up:
13.4 ± 3.3
- -
BF group Initial: 10.4 ± 3.2
Follow-up:
14.5 ± 3.3
Country:
USA | Intervention:
Conventional treatment (CT) + biofeedback (BF)
At least 2 and up to 6 weekly training sessions given. 1 session included approximately 30 to 35 defecation trials and lasted approximately 45 to 60 minutes. Number of training sessions given depended on how soon child learned to relax external sphincter. Sessions stopped after 10 relaxations of the external sphincter without visual feedback could be accomplished in each of 2 successive training sessions
Comparison:
Conventional treatment alone (CT)
CT: use of laxatives, increase of dietary fibre and scheduled toileting (child instructed to defecate for 5 minutes after each meal and after returning from school for the initial months, and try to defecate at least daily once they could recognise the urge to defecate
Disimpaction with enemas (type and dose not reported)
Maintenance: milk of magnesia ~ 2ml/kg body weight daily to induce at least 1 bowel movement daily and prevent faecal retention. Doses decreased gradually to maintain daily bowel movement and prevent faecal retention and soiling. Occasionally mineral oil or senna used instead of milk of magnesia | Duration of treatment
BF: between 2 and 6 weeks
CT: unclear
Follow-up period:
- -
CT group: 4.2 ± 2.5 years - -
BF group: 4.1 ± 2.4 years
Outcome Measures:
- -
stool frequency - -
presence of soiling - -
soiling frequency - -
recovery rate - -
laxative use
| Stool frequency/week (mean ± SD)
BF (n=63): 5 ± 3
CT (n=66): 6 ± 3
N.S
% of children soiling
BF (n=63): 35
CT (n=66): 24
N.S
Soiling
frequency/week (mean ± SD)
BF (n=63):1 ± 2
CT (n=66):1 ± 2
N.S
Recovery rate (number of children, %)
BF (n=63): 28 (44)
CT (n=66): 41 (62) N.S
Laxative use (% children using laxatives)
BF (n=63): 25
CT (n=66): 18
N.S | Additional information from study:
Parents and children instructed to keep diary of bowel movements, faecal soiling and medication used
Of 64 patients who originally received biofeedback 1 patient did not return after the first unsuccessful biofeedback session and was lost to follow-up. The 63 patients included in the biofeedback group were combined from 2 studies (clinical characteristics of both groups were similar): 21 patients from an RCT (included already in this review, see Loening-Baucke, 1990) and 42 patients who had not recovered after at least 6 months of conventional treatment.
Patients were charged for this service. Because of cost, inability to return for weekly biofeedback training or parent's and children's satisfaction with the marked improvement of constipation and encopresis with conventional treatment these patients chose to continue with conventional treatment. 23 patients have been originally included in the RCT but 1 boy was lost to follow-up after the first biofeedback session and a second patient received a central nervous system shunt during the follow-up period and was exclude from analysis
In May 1993 parents requested by email to fill out with the help of their children a structured questionnaire eliciting information on the presence of soiling and frequency and amount of soiling per week, the frequency and size of bowel movements per week and the use of laxatives. In December 1993 questionnaires again were mailed to non responders and to those families evaluated between January and May 1993. non responders were contacted by telephone
Patients considered to have recovered if they had ≥3 bowel movements/week and soiling ≤ 2 episodes/month while off laxatives for at least 1 month. Patients considered not to have recovered if they had <3 bowel movements/week or were soiling >2 times/month or had been started on a regime of laxatives again
Baseline characteristics were comparable between both groups except for the presence of an abdominal faecal mass (number of children, BF: 60 vs. CT: 41; p<0.05)
Age and follow-up age were not related to outcome in either group. The length of follow-up was significantly related to recovery for the biofeedback group (p<0.02) and for all patients (p<0.01) but showed no relationship for the conventionally treated group
Reviewer comments:
No clear definition of constipation given
Source of funding: Supported by grant No. M01-RR-00059 from the General Clinical Research Centre Program,, Division of Research Resources, National Institute of Health; the Children's Miracle Network Telethon and the Spelman-Rockefeller Child and Parenting Seed Grant |
| Silver et al. Family therapy and soiling: An audit of externalizing and other approaches. 1998. Journal of Family Therapy 20[4], 413-422 | Study Type:
Retrospective
audit
Evidence level:
3
Study aim:
To assess the effectiveness of Externalizing Treatment EXT) as compared to traditional treatments in children with soiling problems | 108 children and their families
Inclusion criteria:
Children treated for soiling problems. Referrals included ‘faecal soiling’, ‘encopresis’, ‘psychological soiling’, ‘failed toileting’, ‘constipation with overflow’ and ‘deliberate soiling’.
Exclusion criteria:
Families who failed to attend or cancelled their first appointment, the problem had been resolved, the children were put into care or sent to boarding school very early in treatment or the soiling had a medical cause (Hirschsprung 's disease). Children who had full control, but would insist on a nappy for a bowel movement. 3 more families where a therapist who usually used externalizing switched to a behavioural approach in a systems context in the belief that externalizing would not work. Within the remaining families in the audit there was no known selection for a particular therapy | 108 children
3 to 5 years: 45 >6 years: 63
mean age (years):
- -
EXT: 6.98 - -
OTH: 6.68
Country:
UK | Intervention:
Externalizing Treatment (EXT)
Families were only included if the approach included:
Externalizing the poo from the first interview with the child and family (based on White, 1984 and White and Epston, 1990) Developing a narrative with the child and family where they could see themselves as capable, skilful and determined to teach the poo a lesson, outwit the poo or defeat the poo Not using rewards, interpretation, confrontation or paradoxical interventions as therapeutic manoeuvres. Attempting to see the whole family at least once.
Comparison:
Other Treatments (OTH)
Mixed group of traditional treatments with predominantly (but not only) a behavioural approach in a family systems context. There were no elements of externalizing in any OTH sessions | Duration of treatment (mean, months)
- -
EXT: 7.8 - -
OTH: 6.6
Assessment point (s) & follow-up period
At a minimum of 6 months (mean 28 months) after treatment ended
Outcome Measures:
- -
Parent assessment of usefulness of treatment - -
Soiling presence /frequency (parents' assessment /GP assessment /paediatric notes - -
Number of appointments
| EXT (n=54)
OTH (n=54)
Not all children assessed for all outcomes
Parent assessment of treatment (number of parents)
- -
EXT: - -
OTH: Helpful: 10 Unhelpful: 20 p = 0.0001
End of treatment outcome (from notes)
- -
EXT: No soiling/improved: 42 Soiling: 5
- -
OTH: No soiling/improved: 30 Soiling: 13 p = 0.02
GP follow-up
- -
EXT: - -
OTH: No soiling: 24 Soiling: 18 p = 0.045
Parent follow-up
- -
EXT: No soiling/stains: 24 Soiling: 14
- -
OTH: No soiling/stains: 13 Soiling: 22 p = 0.026
Number of appointments (mean)
- -
EXT: 8.2 - -
OTH: 10
NS Externalizing proved to
be superior for boys, for children aged ≥ 6 years, for those with frequent soiling at the outset, for those with over 2 years' continuous soiling and those diagnosed as constipated on referral | Additional information from study:
162 sets of notes of all referrals for soiling over a four-year period were audited
Some children clearly diagnosed in the referral letter as ‘constipated’ or ‘not constipated’, but in some referral letters it was not stated whether the referring doctor had checked for constipation
The treatment given depended only on the current approach of the therapist who received the referral. All the families had received either ‘externalizing’ or ‘other treatments’
No significant differences between the groups on baseline variables
At a minimum of 6 months' follow-up (mean 23 months), all parents (including those who dropped out) sent a questionnaire with a letter from the secretary, explaining that we could learn a great deal from their responses, whether negative or positive, with no names being recorded. Parents asked whether there had been any further soiling incidents since they were last seen and frequency of these incidents in the past month. Parents asked whether they had found their treatment helpful or unhelpful and what was helpful or unhelpful and to offer other comments. Where children had returned for paediatric consultation, frequency of soiling stated in paediatric notes was recorded even if parents did not reply to the audit. GPs asked whether they were aware of any further soiling after treatment had ended
Reviewer comments:
No definition of constipation given
Unclear exactly how many children dropped out/ were lost to follow up
Source of funding: Not stated |
Taitz et al. Factors associated with outcome in management of defecation disorders. 1986. Archives of Disease in Childhood
61[5], 472-477 | Study Type:
Quasi-RCT
Evidence level:
1+
Study aim:
To report our experience with children who presented with faecal soiling, with or without constipation, who were treated by incentive based behavioural modification, plus or minus psychotherapy, and consider factors that might predict the outcome for a non-intensive approach and in particular, to draw attention to social background as a prognostic indicator | 47 children
Inclusion criteria:
children who presented with faecal soiling, with or without constipation
Exclusion criteria:
identified organic bowel disease or neurological handicaps | 47 children
26 boys
age not reported
Country:
UK | General
In cases where constipation was severe with large faecal masses children initially admitted to the ward for defecation was made impossible by severe impaction. They were then continued on whatever laxative they had been on before referral. Where no laxative had previously been used the child was offered a twice daily dose of lactulose. If no accumulation of faeces no laxatives prescribed. No other laxatives used in this study, and in general their use was minimised, with the parents encouraged to stop the treatment with laxatives as soon as a regular bowel habit established. In none of the children were suppositories used at any time. All the children were encouraged to take a high residue diet and in particular were asked to take bran with their breakfast cereal
Intervention:
Behaviour modification (BhM)
Carried out by paediatrician. All children placed on a star chart regimen. Children offered varying coloured stars for ‘sitting on the toilet’ and ‘remaining unsoiled for a full day’. In some cases stars awarded to encourage children who were reluctant to take bran in their diet. Contract negotiated between child and parent (usually father) for an award to be made at the discretion of the paediatrician. Child was to understand that the giving of the award would depend on response to treatment. ‘Demystification’, alleviation of guilt, and use of explanatory diagrams generally followed the lines recommended by Levine and Bakow. Children seen at 6 weekly intervals by paediatrician for between 3 months and 1 year and subjected to shows of affection and interest, which included careful and serious inspection of the charts. Failure to keep a star chart on 2 successive visits resulted in firm statement of displeasure. 2 further failures at 6 week intervals led to the stopping of treatment and discharge with the option of psychiatric referral. Discharge of cured patients was at discretion of the parents
Comparison:
Behaviour modification (as previous) + psychotherapy (BhM +Psy)
-Psychotherapy:
children seen by the child psychiatrist at roughly monthly intervals for periods between two and 12 months. Treatment was organised along the following lines:
(1) At each appointment mother (and also father in 4 cases) seen for 15-30 minutes to explore her feelings in respect of the child's bowel problem and its effect on the family and her own relationship with the child. Whenever possible mother's own history explored and other emotional problems discussed where relevant e.g. expressions of grief, anger, depression, etc.
(2) Child seen for between 15-30 minutes for play, including picture drawing, games, and sharing of their own toys and belongings. Their feelings concerning their problem also explored. Behavioural star chart also often brought, and reviewed and child praised and encouraged according to progress
(3) Mother and child seen together sometimes early in treatment, sometimes later, depending on their relationship and success with management of the problems to assess to overall progress. | Duration of treatment
- -
BhM: 6 weekly intervals for between 3 months and 1 year
Assessment point (s):
1 year after initiating treatment
Follow-up period:
None
Outcome Measures:
Treatment success | Treatment success did not differed between both groups.
It is not possible to report the figures here, as they were only analysed by the authors according to compliance with treatment and with children social class, but not according to treatment groups | Additional information from study:
One year after the beginning of treatment parents sent a postal questionnaire, which sought to elicit the response to treatment. This survey included all patients who ‘dropped out’ of this study at any stage. They were asked whether they considered the child cured, improved, or unchanged and asked how often the child defecated; whether and how often soiling occurred; and whether and how often laxatives were needed. These answers were made as objective as possible by requesting parents to place ticks in appropriate boxes. This response was then graded into three categories-cured, improved, and no response, on the basis of the parents' answers to the questionnaire, compared with the clinical assessment before allocation to treatment groups. Assessment of results were thus made by the parents at home and not by the professionals involved
Criteria for the classification of the results of treatment:
Cured. At least 5 normal stools each week without soiling. Only occasional use of laxatives (less than once a week) Improved. At least three stools each week and soiling less than once a week Non-responders. Less than three stools each week or soiling more than once a week. These children were considered as failing to improve, despite the fact that in most cases there was less soiling than at the beginning of treatment 4 children dropped out from the study and 13 failed to keep adequate ‘star charts’. The ‘drop outs’ occurred at 1, 2, 3, and 4 months. 2 children were subsequently found to be cured
Reviewer comments:
No definition of constipation given Small sample size, no sample size calculation
Baseline characteristics not compared
Randomisation and allocation concealment methods not reported
ITT analysis not performed
Source of funding: Grants from the Hawley Trust, National Health Service Locally Organised Research Grant (Trent RHA) and CHRIS Fund, Children's Hospital |
