Table 3 Study characteristics
Study, methodological quality scoreSettingParticipantsDiagnosisInterventionsFollow-up (FU) duration (n (%) loss to FU)
Banaszkiewicz et al 200514 QS 10Paediatric gastroenterology departmentAge 2–16 years. Exclusion: enteric neuromuscular, anatomic, or metabolic diseases (established by medical history, abnormal thyroid hormone level, prior anorectal manometry, barium, or ionogram examination)Constipation: <3 BM/week for at least 12 weeksGeneral: 1 ml/kg/day of 70% lactulose (in 2 doses). I: 109 colony-forming units of Lactobacillus GG twice daily orally for 12 weeks. n = 43; mean (SD) age: 79 (47) mo.; M/F? C: placebo. n = 41; mean (SD) age: 65 (36) mo.; M/F?24 weeks. Loss to FU: I: 5 (11.6). C: 3 (7.3)
Bellomo-Brandao et al 200315 QS 5General paediatric practiceAge not stated. Exclusion: previous/current disease affecting GI motility; history of GI subocclusive episodes; mechanical obstruction (barium enema); outlet obstruction (defecography)Constipation: <3 BM/week; diurnal/nocturnal soiling; faecal impaction on palpation/RT; rectal anal inhibitory reflex (manometry)General: lactulose (667 mg/ml) or magnesium hydroxide (80 mg/ml), daily dose 2 ml/kg, max. 60 ml. When no spontaneous BM after 72 h: saline glycerol enema. I: erythromycin estolate 20 g/kg/day in 4 oral doses every 6 h before meals, max. 1000 mg. n = see notes. C: placebo. n = see notes. Notes: crossover study: Group I (E-P): n = 6; mean (SD) age 9.7 (3.0) yrs.; M/F: 5/1 Group II (P-E): n = 8; mean (SD) age 9.6 (3.3) yrs; M/F: 6/28 weeks. Loss to FU: 7/14 (50)
Berg et al 198316 QS 1General paediatric practiceAge not stated. Children referred to one of the authors with soiling as main complaint. Exclusion: not statedUncomplicated functional faecal incontinence indicated by initial assessment and physical examinationGeneral: behavioural treatment. I: Senokot tablets, starting with 1 tablet. If no improvement on the next visit, then increase of dosage to 2 tablets. If still no improvement on the next visit, the dosage was increased to 3 tablets. Tablets were stopped when defecation was regular and there was no soiling. n = 14; age:?; M/F:? C1: placebo tablets, see intervention. n = 11; age:?; M/F:? C2: no medication. n = 15; age:?; M/F:? Notes: mean (SD) total age: 7.9 (2.3) yrsVariable; up to 12 months. Loss to FU at 12 months.: I: 5 (36). C: 2 (18). C2: 6 (40)
Bongers et al 200717 QS 8Paediatric gastroenterology departmentAge 3–20 weeks. Healthy, receiving at least 2 bottles of milk-based formula a day. Exclusion: Hirschsprung’s disease, spinal or anal anomalies, previous colonic surgery, metabolic, cerebral and renal abnormalities, laxative treatment at enrolmentConstipation: at least one of the following: <3 BM/week, painful defecation (crying), or an abdominal or rectal palpable massI: new formula with high concentration of sn-2 palmitic acid, a mixture of prebiotic oligosaccharides and partially hydrolysed whey protein (Nutrilon Omneo). n = 18; median age 1.8 (1.1–5.0) mo.; M/F 11/7. C: standard formula (Nutrilon 1). n = 20; median age 1.7 (0.7–3.7) mo.; M/F 8/12. Notes: originally designed as crossover study, but because of large loss to FU, only the first treatment period was analysed3 weeks. Loss to FU: 3/38 (7.9). Loss to FU after 6 weeks (original crossover concept, see notes): 24/38 (37)
Bu et al 200719 QS 8General paediatric practiceAge 0–10 years. Exclusion: children with organic causes of constipation such as Hirschsprung’s disease, spina bifida (occulta), hypothyroidism or other metabolic or renal abnormalities, mental retardation, use of drugs influencing GI function other than laxativesConstipation: <3 BM/week for >2 months and one of the following: anal fissures with bleeding, faecal soiling, passage of large and hard stoolsGeneral: lactulose use (1 ml/kg/day in case of no stool passage for 3 days); glycerin enema was used in case of no stool passage for >5 days or abdominal pain due to fecal impaction. I: lactobacillus casei rhamnosus (Lcr35) 8×108 colony-forming units/day (Antibiophilus 250 mg, 2 capsules, Laboratoires Lyocentre, France). n = 18; mean (SD) age: 36.7 (14.5) mo.; M/F 10/8. C1: magnesium oxide 50 mg/kg/day. n = 18; mean (SD) age; 32.4 (13.9) mo.; M/F 9/9. C2: matching placebo (starch in content). n = 9; mean (SD) age: 35 (14.7) mo.; M/F 4/54 weeks. Loss to FU: 4/45 (8.8)
Candy et al 200620 QS 6Paediatric gastroenterology departmentAge 2–11 yrs. Children with intractable constipation that had failed to respond to conventional treatment who were admitted and successfully treated for faecal impaction. Exclusion: contraindication for the use of PEG+E or lactuloseFaecal impaction: definition not statedGeneral: additional treatment with senna if the response to study treatment was judged inadequate by the investigator. I: PEG+E: starting with half the dosage required for disimpaction per day (13.8 g powder per sachet, dissolved in 125 ml water). n = 28; mean (SD) age 5.8 (2.5) yrs; M/F 17/11. C: lactulose: starting with half the dosage required for disimpaction per day (10 g per sachet, dissolved in 125 ml water). n = 30; mean (SD) age 5.6 (2.8) yrs; M/F 22/812 weeks. Loss to FU: I: 1/28 (3). C: 4/30 (13)
Castillejo et al 200621 QS 8Paediatric gastroenterology departmentAge 3–10 yrs. Referred for chronic constipation between January 2004 and April 2005. Exclusion: faecal impaction that required enemas in the week before the study, treatment with fibre, laxatives or bulk-forming agents in the 2 weeks prior to the study, organic cause of constipation, renal insufficiency, hypocalcaemia, hyperkalaemia, or metabolic disease at start of the study, long-term use of drugs that affect GI motility, inability to adhere to the study’s medication or proceduresChronic constipation: Rome II criteriaGeneral: standardised toilet training (toilet sitting after each meal, positive motivational reinforcement). I: a cocoa husk supplement (sachet of 5.2 g soluble powder with 4 g cocoa husk and 1 g betafructosans: 3–6 yrs; one sachet before lunch and one before dinner; 7–10 yrs: 2 before lunch and dinner dissolved in 200 ml whole milk). n = 28; mean (SD) age 6.6 (2.3) yrs; M/F 11/17. C: placebo: sachet of 5.2 g soluble powder with glucose, cocoa flavouring and excipients. n = 28; mean (SD) age 6.0 (2.1) yrs; M/F 11/174 weeks. Loss to FU: I: 4/28 (14). C: 4/28 (14)
Chao et al 200722 QS 1Paediatric gastroenterology departmentAge 2–6 months. Exclusion: not statedConstipation: definition not statedI: magnesium-enriched infant formula (Novalac-IT). n = 47; mean (SD) age 3.9 (1.6) mo.; M/F 24/23. C: 20% strengthened infant formula. n = 46; mean (SD) age 3.8 (1.5) mo.; M/F 23/238 weeks. Loss to FU: 0
Dupont et al 200523 QS 4Not statedAge 6 mo. to 3 yrs ambulatory. Exclusion: history of intractable faecaloma or organic GI disease or other neurological, endocrine, metabolic disorders, allergic diseases or allergiesConstipation: <1 BM/day for >1 mo. (age 6–12 mo.); or <3 BM/week for >3 mo. (age 13 mo. to 3 yrs)General: in case of unsuccessful maximum dose (8 g/day for PEG; 6.66 g/day for lactulose) 1 micro-enema (glycerol) per day was given (max. 3 consecutive days). In case of no defecation, 2 enemas were given in a 48 h interval (max. 2 during the study). I: PEG 4000 4 g/sachet. Starting dose: 1 pair of sachets (1 with PEG 4000 and 1 with placebo). In children 13 mo.−3 years the dose could be doubled if ineffective. If liquid stools are produced for more than 1 day, or more than 2–3 stools/day, the dose could be decreased by 1 pair of sachets/day to a min. of 1 pair every other day and possibly to transitory interruption. n = 51; median age 28 mo.; M/F: 22/29. C: Lactulose 3.33 g/sachet. See above. n = 45; median age 25.8 mo.; M/F: 29/2584 days. Loss to FU: I: 11 (21.6). C: 9 (20.0)
Gremse et al 200225 QS 2Paediatric gastroenterology departmentAge 2–16 yrs. Referred for subspecialty evaluation of constipation. Exclusion: organic diseases of the large and small intestine; known allergy to PEG or lactulose; previous GI surgery; renal or heart failure; bowel obstruction; ileus; pregnancy; lactation; galactosaemia; diabetes mellitusConstipation: definition not statedI: PEG 3350 (Miralax, Braintree Laboratories, Inc, Braintree, Massachusetts) 10 g/m2/d orally for 2 weeks followed by the other agent for 2 weeks. n = see notes. C: lactulose 1.3 g/kg/day orally for 2 weeks followed by the other agent for 2 weeks. n = see notes. Notes: crossover study. Characteristics of analysed children: n = 37; mean (SD) age 7.8 (3.7) yrs; M/F: 23/144 weeks. Loss to FU: 7/44 (15.9)
Halabi et al 199926 QS 5Paediatric gastroenterology departmentAge 4–18 yrs. Children with constipation, adequate documentation, and good patient compliance. Exclusion: small or large bowel organic diseaseConstipation: pain, difficulty in defecation, or ⩽3 BM/week for >3 monthsGeneral: clearance of accumulated impacted stool by using lactulose alone or in combination with enema cleansing. I: cisapride syrup 0.3 mg/kg four times a day (Janssen UK) for 8 weeks. Analysed: n = 32; mean (SD) age 8.45 (2.42) yrs; M/F: 18/14. C: placebo (a matching syrup) for 8 weeks. Analysed: n = 32; mean (SD) age 8.26 (2.43) yrs; M/F: 19/1310 weeks. Loss to FU: 9/79 (11)
Hejl et al 199027 QS 5General paediatric practiceAge not stated. Relatively compact faeces and difficulties at defaecation. Exclusion: not statedDefinition not statedI: Milk formula “Blue Allomin” with 4% lactulose (5.2 g/l milk) (no other food). n = 109; age: 7.1 wks (1–23); M/F ? C: 2% lactulose (2.6 g/l milk) in the Blue Allomin formula (no other food). n = 111; age: 6.8 (1–26) weeks; M/F? Notes: “dose finding”2 weeks. Loss to FU: 48/220 (21.8)
Loening-Baucke 200229 QS 3General paediatric practiceAge ⩾4 yrs. Referred to and newly evaluated by the author for functional constipation and encopresis. Exclusion: children who refused the toilet for stooling but who had no constipation, children with Hirschsprung’s disease, chronic intestinal pseudo-obstruction, or previous surgery of colon or anusConstipation: delay or difficulty in defecation, and encopresis (⩾1/week) for >1 yearI: Miralax (PEG) beverage 17 g dissolved in 240 ml. Initial dose was 0.5 g/kg/day for children with full rectums but no abdominal masses and no history of long intervals between huge BMs. Initial dose was 1 g/kg/day for those with palpable abdominal faecal masses or history of infrequent huge BMs. Large doses were divided in 2 daily doses. Adjustment by 30 ml every 3 days to a dosage that results in 1–2 soft BMs/day and prevents soiling and abdominal pain. n = 28; mean (SD) age 8.7 (3.6) yrs. M/F: 20/8. C: milk of magnesia. Initial dose was 1 ml/kg for children with rectal faecal masses only at initial evaluation or no history of infrequent large BMs. 2.5 ml/kg was given to those who had palpable abdominal faecal masses or history of infrequent huge BMs. Large doses were divided in 2 daily doses. To be adjusted by 7.5 ml every 3 days to a dosage that results in 1–2 soft BMs/day and prevents soiling and abdominal pain. n = 21; mean (SD) age: 7.3 (3.0) yrs; M/F: 17/4. Notes: comparative clinical trial12 months. Loss to FU: ?
Loening-Baucke et al 200430 QS 5General paediatric practiceAge >4 yrs. Chronic functional constipation for ⩾6 mo. with or without encopresis. Exclusion: children with Hirschsprung’s disease, hypothyroidism, mental deficiency, chronic debilitating disease or neurological abnormalities or children who had previous surgery of the colon or anusConstipation: a delay or difficulty in defecation for >2 weeks, sufficient to cause significant distress to the child, not attributable to organic and anatomic causes or intake of medicationI: Glucomannan (Dicofarm, Rome, Italy), equal to 450 mg of alimentary fibre (4 wks). Given as 100 mg/kg/day (max. 5 g/day), rounded to the nearest 500 mg. Each capsule was either sprinkled on food given with 50 ml of fluid per capsule, or given as a solution (mixed with 50 ml of fluid), or swallowed as a capsule with 50 ml of fluid. n = see notes. C: placebo (maltodextrins) (Dicofarm, Rome, Italy). Administration: see above. n = see notes. Notes: crossover study: Group I (P–G): n = 19; age?; M/F?. Group II (G–P): n = 27; age?; M/F?8 weeks. Loss to FU: 15/46 (32)
Loening-Baucke et al 200631 QS 4General paediatric practiceAge ⩾4 yrs. Referred for treatment of functional constipation with faecal incontinence. Exclusion: stool toiletting refusal, faecal incontinence without constipation, previous refusal of one of the study medications, children who came from far away for a second opinion, and children with Hirschsprung’s disease, chronic intestinal pseudo-obstruction, or previous surgeryFunctional constipation: ⩾2 of the following for at least 8 wks: <3 BM/wk, >1 faecal incontinence/wk, large stools in rectum, passing of large stools obstructing the toilet, retentive posturingGeneral: at first visit disimpaction with 1 or 2 phosphate enemas if necessary. Dosage of study medication was adjusted to reach 1 or 2 stools of milkshake consistency/day. I: 0.7 g/kg body weight PEG daily in 1 or 2 doses. Mixed with a beverage in a solution of 2 g/30 ml. n = 39; mean (SD) age 8.0 (2.8) yrs; M/F 31/8. C: 2 ml/kg body weight milk of magnesia daily. n = 40; mean (SD) age 8.2 (3.1) yrs; M/F 34/612 months loss to FU: I: 5/39 (12.8). C: 19/40 (47.5)
Ni et al 200134 QS 3General paediatric practiceAge 1–7 yrs. Exclusion: underlying diseases such as hypothyroidism, hyperparathyroidism, spinal and anal anomalies or mental retardation and those taking medications which might affect the efficacy. Concomitant use of macrolide antibiotics, azole antifungants, HIV protease inhibitors of nefazodone. Patients failing to complete the 4-wk treatmentConstipation: <2 BM/week for at least 1 mo.I: MgO (125 mg 3 times/day for patients weighing <20 kg, or 250 mg 3 times/day for those >20 kg) plus cisapride syrup (0.2 mg/kg) three times a day. Analysed children: n = 44; mean (SD) age 3.31 (1.68) yrs; M/F: 24/20. C: MgO (125 mg 3 times/day for patients weighing <20 kg, or 250 mg 3 times/day for those >20 kg). Analysed children: n = 40; mean (SD) age 3.46 (1.47) yrs; M/F: 27/134 weeks. Loss to FU: 40/128 (31)
Nolan et al 199135 QS 4General paediatric practiceAge 4–16 yrs. Encopresis, evidence of stool on plain abdominal radiograph, attendance at normal school. Exclusion: severe or prolonged constipation necessitating previous hospital admissions for enemas and other treatments; neuromuscular disorders (spina bifida, cerebral palsy, muscular dystrophy); Hirschsprung’s disease; use of purgatives for at least 2 wks before baseline assessmentEncopresis: definition not statedI: laxative therapy: disimpaction: 3-day cycles of 5 ml microlax enemas on day 1, one 5 mg bisacodyl supp after school and one in the evening on day 2, and a 5 mg bisacodyl tablet after school and one in the evening on day 3, up to four cycles; maintenance phase: agarol 5–30 ml once or twice a day, senna granules, and/or bisacodyl tablets (doses were adjusted to maintain at least daily stools); standard paediatric behaviour modification intervention (see below) n = 83; age?; M/F: 55/28. C: standard paediatric behaviour modification intervention: clarification of the postulated underlying physiological basis for encopresis; bowel training programme with possible reinforcement for successful defecation in the toilet and additional reinforcement for every 24 h without soiling; regular sitting programme (5–10 min after each meal); dietary advice, general counseling and support by paediatrician; psychiatric assessment when necessary. n = 86; age?; M/F: 69/1712 months. Loss to FU: I: 4/83 (4.8). C: 3/86 (3.4)
Nurko et al 200036 QS 6Paediatric gastroenterology departmentAge 2–16 yrs. History of chronic constipation referred for evaluation, and <3 BMs/week. Exclusion: Hirschsprung’s disease, congenital abnormalities of the GI tract, pelvic floor dyssynergiaConstipation: <3 BMs/weekGeneral: disimpaction: hypertonic phosphate enemas, senna. I: Cisapride: orally (suspension of 1 mg/ml (Janssen Pharmaceutics, Mexico City)) at 0.2 mg/kg/dose 3 times a day. The dose was increased after 8 wks if there was no clinical response. Max. dose was 10 mg 3 times a day. Analysed: n = 17; mean (SD) age 63 (7.4) mo.; M/F 12/5. C: placebo (see above). Analysed: n = 19; mean (SD) age 75 (9.7) mo.; M/F 12/712 weeks Loss to FU: I: 3/20 (15%). C: 1/20 (5%)
Perkin 197737 QS 3General practiceAge 0–15 yrs. Attending surgery with a history of constipation treated at home for 3 mo. or more; understanding and agreeing to the completion of the patient diary card. Exclusion: requirement of surgical or medical correction (other than laxative)Constipation: definition not statedI: lactulose 10–15 ml daily. n = see notes. C: senna syrup 10–20 ml daily. n = see notes. Notes: crossover study: Group I (L–S): n = 11; age?; M/F:? Group II (S–L): n = 9; age:?; M/F:?3 weeks. Loss to FU: 1/21 (4.7)
Sondheimer et al 198140 QS 3Paediatric gastroenterology department/constipation clinicAge 3–13 yrs. Referred to a clinic for chronic functional constipation. Exclusion: neurological impairment or faecal soiling in absence of stool retentionChronic functional constipation: diagnosis based on historical features and a physical exam (dilated rectum, excessive retained stool directly within the anal verge, evidence of perianal soiling)General: initial catharsis: 5-day course of oral bisacodyl, some combined with a daily enema for 3–5 days. I: mineral oil orally twice daily in doses sufficient to induce loose stools and leakage of oil per rectum. After week 1 the dose was reduced until oil leakage ceased. This dose was maintained for a min. of 3 mo. If symptom control was satisfactory at 3 mo., the daily volume of oil was gradually reduced. n = 19; mean (SD) age 6.3 (2.5) yrs; M/F: 13/6. C: Senokot (tablet or syrup) in doses sufficient to induce at least 1 BM/day during the first 2 wks. After 3 mo. tapering was done by changing from daily to every other day and then every third day. n = 18; mean (SD) age 8.1 (2.6) yrs; M/F: 13/56 months. Loss to FU: I: 1/19 (5.2). C: 0%
Thomson et al 200742 QS 7General paediatric practiceAge 2–11 years. Exclusion: current or previous faecal impaction, previous intestinal perforation or obstruction, paralytic ileus, toxic megacolon, Hirschsprung’s disease, severe inflammatory conditions, severe gastrooesophagal reflux, diabetes, or use of high doses of stimulant laxatives with no effectConstipation for ⩾3 months: <3 BM/week, pain at defecation for ⩾25% of the days, and ⩾25% of the BMs with straining and hard or lumpy stoolsGeneral: 1 week run in-period, in which previously used laxative treatment was continued. I: PEG+E 6.9 g powder per sachet, dissolved in 62.5 ml tap water (age-specific dose) for 2 weeks. C: matching placebo. Notes: crossover study: Group I (PEG-placebo): n = 27; mean (SD) age 5.3 (2.4) yrs; M/F: 13/14 Group II (placebo-PEG): n = 24; mean (SD) age 5.5 (2.9) yrs; M/F: 9/157 weeks (including run-in and washout periods). Loss to FU: 2/51 (4)
Tolia et al 43 1993 QS 4Paediatric gastroenterology departmentAge >2 yrs. Normal growth and development. Exclusion: Hirschsprung’s disease, history of recurrent vomiting and/or aspiration, central nervous system problems or known history of liver, kidney and heart diseaseConstipation: infrequent, large, firm to hard stools, rectal pain or bleeding, small amounts of stool daily, incomplete stool evacuation, periodic passage of large amounts of stool, faecal impactionI: pineapple-flavoured, balanced oral lavage solution containing PEG 3350 (sweetened with Nutra-sweet) in the dose of 20 ml/kg/h for 4 h once daily on 2 consecutive days (max. amount/h: 1 l), and a single oral dose of metoclopramide (0.1 mg/kg) to prevent nausea and vomiting. n = 19; mean (SD) age 6.44 (2.36) yrs; M/F 12/7. C: 2–8 tablespoons of mineral oil in two divided doses for 2 days (≅30 ml/10 kg bodyweight), blended with 120–180 ml of orange juice. n = 17; mean (SD) age 6.88 (3.26) yrs; M/F 11/62 days. Loss to FU: I: 6/23 (26). C: 6/25 (24)
Urganci et al 200544 QS 3Paediatric gastroenterology departmentAge 2–12 yrs. Referred for chronic constipation with evidence of faecal impaction. Exclusion: Hirschsprung’s disease, hypothyroidism, mental deficiency, chronic debilitating diseases, neurological abnormalities, previous surgery of colonConstipation: ⩾2 of the following for ⩾3 mo.: hard stools, painful defecation, rectal bleeding, encopresis, <3 BM/weekGeneral: increase of fibre intake: “age+10” in grams. I: lactulose orally (suspension of 1 ml/kg), twice daily. Dose is adapted by 25% every 3 days as is required to yield two firm loose stools per day. Max. dose is 3 ml/kg/day. n = 20; mean (SD) age 43.7 (31.3) mo.; M/F 10/10. C: liquid paraffin orally (suspension of 1 ml/kg) twice daily. Adaptation of dose/max. dose: see above. n = 20; mean (SD) age 46.1 (36.4) yrs; M/F 12/88 weeks. Loss to FU: 0
Voskuijl et al 200446 QS 7Paediatric gastroenterology departmentAge 6 mo.–5 yrs. Exclusion: organic causes for defecation disorders, including Hirschsprung’s disease, spina bifida occulta, or hypothyroidismConstipation: ⩾2 of the following symptoms for the last 3 mo.: <3 BM/week; encopresis >1/week; large amounts of stool every 7–30 days; palpable abdominal or rectal mass on physical examinationGeneral: one enema daily for 3 days to clear any rectal faecal remains (⩾6 yrs 60 ml Klyx; >6 yrs 120 ml Klyx). Toilet training after each meal. I: PEG 3350 (6 mo–6 yrs: 1 sachet/day = 2.95 g) (>6 yrs: 2 sachets/day = 5.9 g). After 1 week the dose was doubled in case of insufficient effect; or halved in case of diarrhoea. n = 50; mean (SD) age 6.5 (3.2) yrs; M/F 27/23. C: lactulose (6 mo–6 yrs: 1 sachet/day = 6 g) (>6 yrs: 2 sachets/day = 12 g). After 1 week the dose was doubled in case of insufficient effect; or halved in case of diarrhoea. n = 50; mean (SD) age 6.5 (3.4) yrs; M/F 28/228 weeks of treatment; 26 weeks of FU. Loss to FU: I: 4/50 (8). C: 5/50 (10)
Wald et al 198747 QS 3General paediatric practiceAge not stated. Encopresis for at least 6 mo. Description of participants in a previous study (Wald 1986). Exclusion: not statedEncopresis: definition not statedI: biofeedback: children with an abnormal expulsion pattern were taught a technique to normalise their patterns and they and children with normal expulsion pattern were told to use the technique whenever they attempted to defecate. n = 24; age 8.3 (6–15) yrs; M/F 20/4. C: mineral oil in graded amounts (1–4 tablespoons a day). n = 26; age 8.4 (6–13) yrs; M/F 20/612 months. Loss to FU: 10/50 (20)
Wang et al 200748 QS 7General paediatric practiceAge 8–18 years. Children with Bristol stool score I, II or III, informed consent. Exclusion: children with digestive organic diseases or systemic diseases, treatment 1 week previous to inclusionConstipation: decrease of bowel movement frequency, dry stools, difficult and painful bowel movements, usually with crying and refusal of defecation, affecting appetite and quality of lifeI: PEG (Forlax), 20 g/day orally. n = 105; mean (SD) age 11.3 (2.8) yrs; M/F 43/26. C: lactulose 15 g/day in the first 3 days, then 10 ml/day, orally. n = 111; mean (SD) age 11.2 (2.75) yrs; M/F 47/642 weeks. Loss to FU: 25/216 (11.6)
Youssef et al 200249 QS 7Paediatric gastroenterology departmentAge 3–18 yrs. Evidence of faecal impaction. Exclusion: previous gastrointestinal surgery; allergy/sensitivity to PEG solution or phosphates; signs or symptoms suggestive of obstructionFaecal impaction: palpable mass in the left lower abdomen and/or a dilated rectum filled with a large amount of hard stool on rectal examI1: PEG 3350 in 0.25 g/kg/day. n = 10; mean (SD) age 7.9 (2.5) yrs; M/F 7/3 I2: PEG 3350 in 0.5 g/kg/day. n = 10; mean (SD) age 5.7 (1.7) yrs; M/F 7/3 I3: PEG 3350 in 1.0 g/kg/day. n = 10; mean (SD) age 7.8 (2.9) yrs; M/F 8/2 I4: PEG 3350 in 1.5 g/kg/day. n = 10; mean (SD) age 8.6 (2.9) yrs; M/F 7/3 max. dose: 100 g daily. Notes: “dose finding”5 days. Loss to FU: 1/41 (2.4)
Zoppi et al 199850 QS 3Not statedAge not stated. Exclusion: evidence of anatomical disorders; encopresis/soiling; laxative use; pharmacological treatment for 2 mo. prior to entry; presence of infectious diseasesFunctional chronic constipation: stool frequency <1/48 h and hard stool consistencyGeneral: balanced diet supplying an amount of energy of 80 kCal kg/day in accordance with age. I: calcium polycarbophil orally (dosage 0.62/g 3 times/day). n = 14, age?; M/F? C: matching placebo. n = 14; age?; M/F? Notes: mean (SD) total age 9.5 (3.0) yrs; total M/F: 16/121 month. Loss to FU: 0%
  • BM, bowel movement; C, control intervention; GI, gastrointestinal; I, intervention under study; loss to FU, loss to follow-up; M/F, male/female; PEG, polyethylene glycol; QS, quality score; RT, rectal toucher, rectal digital exam.