[Lactitol in chronic idiopathic constipation in children]. A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. A dietary fiber mixture versus lactulose in the treatment of childhood constipation: a double-blind randomized controlled trial. Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. Constipation in childhood: a controlled comparison between lactulose and standardized senna. [Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study]. A prospective randomized study with mineral oil and oral lavage solution for treatment of faecal impaction in children. A randomized, prospective, comparison study of polyethylene glycol 3350 without electrolytes and milk of magnesia for children with constipation and fecal incontinence. Comparison of the effectiveness of polyethylene glycol 4000 without electrolytes and magnesium hydroxide in the treatment of chronic functional constipation in children. Polyethylene glycol 3350 plus electrolytes for chronic constipation in children: a double blind, placebo controlled, crossover study. Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation. Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. PEG3350 in the treatment of childhood constipation: a multicenter, double-blinded, placebo-controlled trial. Rectal fecal impaction treatment in childhood constipation: enemas versus high doses oral PEG.
Fifty-one children affected by chronic idiopathic constipation (23 males, 28 females), ranging in age from 8 months to 16 years were enrolled in the study; 42 completed the trial. The patients were divided into two groups: Group A: 19 children treated with lactitol (250-400 mg/kg/day); Group B:23 patients treated with lactulose (500-750 mg/kg/day). Parents filled a questionnaire concerning clinical response to therapy for a period of 30 days. In 17 Group A children and in 17 Group B children orocecal transit time using H2 Breath Test with lactulose was performed. A statistically significant increase of week stool frequency was found after treatment both with lactitol or lactulose (p < 0.001). Nevertheless Group B patients complained abdominal pain (p < 0.005) and flatus (p < 0.001) more frequently. Other adverse reactions, such as vomiting and meteorism, were more frequent in Group B patients (n.s.). In addition patients treated with lactitol found that sugar as more palatable and had a better compliance to the therapy. Orocecal transit time did not show statistically significant differences after the therapy with both these sugars, indicating that the activity of lactulose and lactitol occurs in the colon and that small bowel functions are not affected by a previous therapy with these sugars. In conclusion, our study demonstrate that lactitol, because of the less number of side effects compared to lactulose, should be considered as an useful agent in the treatment of chronic idiopathic constipation in childhood. To determine and compare efficacy, safety and optimal dose of two laxatives, liquid paraffin and lactulose, in 40 children with chronic functional constipation.
                A total of 20 children were treated with liquid paraffin and 20 with lactulose for 8 weeks and at an initial dose of 1 mL/kg per day for both drugs. The dose was adjusted every 3 days as required and a diary was kept to monitor dose, side-effects, stool frequency and consistency, and other symptoms.
                During first 4 weeks, improvement in stool consistency and frequency was significantly higher in liquid the paraffin group (P < 0.01 and P < 0.05, respectively). Improvement in the number of stools per week was also significantly higher in the liquid paraffin group during the last 4 weeks of therapy (P < 0.05). Compliance rates averaged 95% in the liquid paraffin group and 90% in the lactulose group during the first 4 weeks of therapy and 90% in the liquid paraffin group and 60% in the lactulose group during the last 4 weeks of therapy (chi(2) = 4.8, SD = 1, P = 0.02). During the first 4 weeks of therapy and during the last 4 weeks of therapy, mostly side-effects and poor symptom control, respectively, influenced the compliance in the liquid paraffin group.
                Liquid paraffin is more effective in the treatment of children with constipation. Patients treated with liquid paraffin responded more rapidly than patients responding to lactulose and showed fewer side-effect. It is considered that late response and side-effects in conjunction with poor symptom control influence the patient compliance and the successful treatment of childhood constipation. Constipation is a common problem in children. As first-line treatment, increased dietary fiber is often advocated. To our knowledge, however, no large studies evaluating the effect of dietary fibers in childhood constipation have been published.
                A randomized, double-blind, prospective controlled study was performed. Patients received either a fiber mixture or lactulose in a yogurt drink. After a baseline period of 1 week, patients were treated for 8 weeks followed by 4 weeks of weaning. Polyethylene glycol 3350 was added if no clinical improvement was observed after 3 weeks. Using a standardized bowel diary, parents recorded defecation frequency during the treatment period. In addition, incontinence frequency, stool consistency, presence of abdominal pain and flatulence, necessity for step-up medication, and dry weight of feces were recorded, as were adverse effects.
                A total of 147 children were eligible; 12 children wished not to participate. Of the remaining children, 65 were randomized to treatment with fiber mixture and 70 to treatment with lactulose. In all, 97 children completed the study. No difference was found between the groups after the treatment period concerning defecation frequency (P = 0.481) and fecal incontinence frequency (P = 0.084). However, consistency of stools was softer in the lactulose group (P = 0.01). Abdominal pain and flatulence scores were comparable (P = 0.395 and P = 0.739, respectively). The necessity of step-up medication during the treatment period was comparable (P = 0.996), as were taste scores (P = 0.657). No serious adverse effects were registered.
                A fluid fiber mixture and lactulose give comparable results in the treatment of childhood constipation. To assess the safety of a polyethylene glycol (PEG) 4000 laxative without additional salts in pediatric patients.
                This was a 3-month multicenter, randomized, double-blind, double-dummy, lactulose-controlled, parallel study enrolling 96 ambulatory constipated children aged 6 months to 3 years, treated daily with 4-8 g PEG or 3.33 g-6.66 g lactulose. Total protein, albumin, iron, electrolytes, and vitamins B9 (folates), A and D (25OHD3) were measured in blood before and after treatment (day 84) in a central laboratory.
                The percentage of children with at least one value out of normal range at day 84 with respect to baseline status (with or without at least one value out of normal range), i.e. the primary endpoint, was 87% and 90% in the PEG and lactulose groups, respectively, without any difference between groups. The whole blood parameters showed no qualitative or quantitative treatment-related changes. Vitamin A values were above normal range in 56% and 41% of children at baseline versus 33% and 36% at day 84 in the PEG and lactulose groups, respectively. Iron values were similarly under normal range in 47% and 51% at baseline versus 42% and 51% at day 84. Clinical tolerance was similar for both treatments except for vomiting and flatulence, which were significantly higher with lactulose. Significantly higher improvements were evidenced with PEG regarding stool consistency, appetite, fecaloma and use of additional laxatives.
                This 3-month study in 96 constipated children aged 6 months to 3 years confirms the long-term tolerance of PEG 4000 in pediatrics and indicates a PEG efficacy similar to or greater than that of lactulose. Twenty-one children under 15-years' old with chronic constipation were treated in a crossover trial lasting 3 weeks. In the first week they received either lactulose or senna, in the next week no treatment, and in the third week the alternative treatment. Patient diaries were kept by parents on the number and character of stools passed, and of side-effects reported, during the 3 weeks. There was a significant difference, in favour of lactulose, in the number of days on which normal stools were passed during the treatment weeks. The number and frequency of the side-effects reported in the senna treatment week were very much higher (p less than 0.001) than in the lactulose week. Lactulose is recommended as an effective and very well tolerated treatment for the constipated child. To determine the therapeutic effectiveness and safety of polyethylene glycol 4000 (forlax) in the treatment of constipation in children over 8 years old.
                This study was designed as a randomized, positive medicine (lactulose) controlled multicenter trial. A total of 216 children with constipation from 8-18 years old from 7 hospitals across China who were matched with a uniform entry criteria were enrolled in this study. The 216 patients were randomized to receive either oral forlax (20 g/d, n=105) or lactulose (15 mL/d, n=111) for 2 weeks. The therapeutic effects, including bowel movement frequency, stool consistency, clinical complete remission rate of constipation and abdominal symptoms, and the safety of forlax and lactulose were evaluated at 1 and 2 weeks of treatment.
                The median weekly frequency of bowel movement in the forlax group increased by 4 and 5 times respectively after 1 and 2 weeks of treatment, and increased by 3 and 4 times in the lactulose group (P < 0.05). The stool consistency of the two groups was both improved significantly after treatment. The Bristol score of stool consistency of the forlax and lactulose groups were 3.41+/-1.11 and 3.64+/-1.33 respectively (P < 0.05) after 1 week of treatment, and were 4.26+/-0.89 and 3.63+/-1.33 respectively (P < 0.05) after 2 weeks of treatment. The clinical complete remission rate of constipation in the forlax and lactulose groups was 70% and 40% respectively (P < 0.05) by week 1 of treatment, and that was 72% and 41% respectively (P < 0.05) by week 2 of treatment. Abdominal pain disappeared in 75% of patients in the forlax group but in only 57% in the lactulose group by week 2 of treatment (P < 0.05). No serious adverse events happened and no abnormalities were found in laboratory tests and physical examinations in the two groups after medication.
                Forlax is safe and effective in the treatment of constipation in children over 8 years old. Faecal impaction with or without encopresis is a very common problem. We performed a randomized, open-label, prospective study to compare the efficacy and acceptability of the treatment of faecal impaction using either mineral oil or pineapple-flavoured isotonic intestinal lavage solution containing polyethylene glycol-3350 (Colyte). Thirty-six patients over 2 years of age were randomized to receive either mineral oil or flavoured lavage solution. The dose of mineral oil was 2 to 8 tablespoons twice a day for two days (17 patients--Group I) and of lavage solution was 20 ml/kg/h for 4 hours on two consecutive days (19 patients--Group II). The patients were assessed for the presence of abdominal faecal masses, presence and consistency of rectal mass, perineal soiling before and two days after either of the randomly assigned treatment. The patients and parents were asked regarding the compliance with treatment, side-effects, number of bowel movements after treatment and willingness to try similar treatment if faecal impaction recurred. Patients in the lavage group had more frequent bowel movements, and showed more effective clearance of abdominal and rectal lumps (P < 0.01) at the time of repeat examination at two days. However, they had some vomiting and were less compliant (P < 0.01) when compared to mineral oil patients. We conclude that balanced lavage solution effectively relieves faecal impaction, however, compliance with its use is poorer than that with mineral oil. Our aim was to compare 2 laxatives, namely, polyethylene glycol 3350 without electrolytes and milk of magnesia, evaluating the efficacy, safety, acceptance, and 1-year outcomes.
                Seventy-nine children with chronic constipation and fecal incontinence were assigned randomly to receive polyethylene glycol or milk of magnesia and were treated for 12 months in tertiary care pediatric clinics. Children were counted as improved or recovered depending on resolution of constipation, fecal incontinence, and abdominal pain after 1, 3, 6, and 12 months. An intent-to-treat analysis was used. Safety was assessed with evaluation of clinical adverse effects and blood tests.
                Thirty-nine children were assigned randomly to receive polyethylene glycol and 40 to receive milk of magnesia. At each follow-up visit, significant improvement was seen in both groups, with significant increases in the frequency of bowel movements, decreases in the frequency of incontinence episodes, and resolution of abdominal pain. Compliance rates were 95% for polyethylene glycol and 65% for milk of magnesia. After 12 months, 62% of polyethylene glycol-treated children and 43% of milk of magnesia-treated children exhibited improvement, and 33% of polyethylene glycol-treated children and 23% of milk of magnesia-treated children had recovered. Polyethylene glycol and milk of magnesia did not cause clinically significant side effects or blood abnormalities, except that 1 child was allergic to polyethylene glycol.
                In this randomized study, polyethylene glycol and milk of magnesia were equally effective in the long-term treatment of children with constipation and fecal incontinence. Polyethylene glycol was safe for the long-term treatment of these children and was better accepted by the children than milk of magnesia. To compare the effectiveness of two drugs, polyethylene glycol 4000 without electrolytes and magnesium hydroxide, in the treatment of chronic functional constipation in children.
                Thirty-eight children were randomly assigned to either of two groups, polyethylene glycol 4000 without electrolytes or magnesium hydroxide. The children were followed through periodic appointments until they reached 6 months of treatment. In each medical appointment the following aspects were evaluated: stool consistency, frequency of bowel movements, fecal incontinence, abdominal pain, straining and acceptance of the drugs.
                Seventeen children made use of polyethylene glycol and twenty-one received magnesium hydroxide. All variables analyzed improved for both groups, with no statistically significant differences. All children accepted polyethylene glycol, while 42.9% refused magnesium hydroxide.
                The two laxatives showed no difference in effectiveness for the treatment of constipation. However, due to its better acceptance, because it is odorless and tasteless, polyethylene glycol proved to be a better option for treating chronic functional constipation. To assess the efficacy and safety of polyethylene glycol 3350 plus electrolytes (PEG+E) for the treatment of chronic constipation in children.
                Randomised, double blind, placebo controlled crossover trial, with two 2-week treatment periods separated by a 2-week placebo washout.
                Six UK paediatric departments.
                51 children (29 girls, 22 boys) aged 24 months to 11 years with chronic constipation (lasting > or =3 months), defined as < or =2 complete bowel movements per week and one of the following: pain on defaecation on 25% of days; > or =25% of bowel movements with straining; > or =25% of bowel movements with hard/lumpy stools. 47 children completed the double blind treatment.
                Number of complete defaecations per week (primary efficacy variable), total number of complete and incomplete defaecations per week, pain on defaecation, straining on defaecation, faecal incontinence, stool consistency, global assessment of treatment, adverse events and physical examination.
                The mean number of complete defaecations per week was significantly higher for children on PEG+E than on placebo (3.12 (SD 2.05) v 1.45 (SD 1.20), respectively; p<0.001). Further significant differences in favour of PEG+E were observed for total number of defaecations per week (p = 0.003), pain on defaecation (p = 0.041), straining on defaecation (p<0.001), stool consistency (p<0.001) and percentage of hard stools (p = 0.001). Treatment related adverse events (all mild or moderate) occurred in similar numbers of children on PEG+E (41%) and placebo during treatment (45%).
                PEG+E is significantly more effective than placebo, and appears to be safe and well tolerated in the treatment of chronic constipation in children. BACKGROUND AND THE PURPOSE OF THE STUDY: Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008-2009.
                Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2-12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0-1.5 g/kg/day PEG 3350 or 1.0-1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups.
                Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events. To assess the efficacy of polyethylene glycol 3350 plus electrolytes (PEG + E; Movicol) as oral monotherapy in the treatment of faecal impaction in children, and to compare PEG + E with lactulose as maintenance therapy in a randomised trial.
                An initial open-label study of PEG + E in the inpatient treatment of faecal impaction (phase 1), followed by a randomised, double-blind comparison between PEG + E and lactulose for maintenance treatment of constipation over a 3-month period (phase 2) in children aged 2 to 11 years with a clinical diagnosis of faecal impaction.
                Disimpaction on PEG + E was achieved in 58 (92%) of 63 of children (89% of 2-4 year olds and 94% of 5-11 year olds) without additional interventions. A maximum dose of 4 sachets (for 2-4 year olds) or 6 sachets (for 5-11 year olds) was required; median time to disimpaction was 6 days (range, 3-7 days). Seven children (23%) reimpacted whilst taking lactulose, whereas no children reimpacted while taking PEG + E (P = 0.011). The total incidence rate of adverse events seen was higher in the lactulose group (83%) than in the PEG + E group (64%).
                PEG + E is safe and highly effective in the management of childhood constipation. It allows a single orally administered laxative to be used for disimpaction without recourse to invasive interventions. It is significantly more effective than lactulose as maintenance therapy, both in efficacy in treating constipation and efficacy in preventing the recurrence of faecal impaction. Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative.
                To compare PEG 3350 (Transipeg: polyethylene glycol with electrolytes) with lactulose in paediatric constipation and evaluate clinical efficacy/side effects.
                One hundred patients (aged 6 months-15 years) with paediatric constipation were included in an eight week double blinded, randomised, controlled trial.
                After faecal disimpaction, patients <6 years of age received PEG 3350 (2.95 g/sachet) or lactulose (6 g/sachet) while children > or =6 years started with 2 sachets/day. Primary outcome measures were: defecation and encopresis frequency/week and successful treatment after eight weeks. Success was defined as a defecation frequency > or =3/week and encopresis < or =1 every two weeks. Secondary outcome measures were side effects after eight weeks of treatment.
                A total of 91 patients (49 male) completed the study. A significant increase in defecation frequency (PEG 3350: 3 pre v 7 post treatment/week; lactulose: 3 pre v 6 post/week) and a significant decrease in encopresis frequency (PEG 3350: 10 pre v 3 post/week; lactulose: 8 pre v 3 post/week) was found in both groups (NS). However, success was significantly higher in the PEG group (56%) compared with the lactulose group (29%). PEG 3350 patients reported less abdominal pain, straining, and pain at defecation than children using lactulose. However, bad taste was reported significantly more often in the PEG group.
                PEG 3350 (0.26 (0.11) g/kg), compared with lactulose (0.66 (0.32) g/kg), provided a higher success rate with fewer side effects. PEG 3350 should be the laxative of first choice in childhood constipation. Polyethylene glycol (PEG) 3350 and lactulose were compared in an unblinded, randomized, crossover design for treatment of constipation in 37 children aged 2 to 16 years. Subjects received lactulose (1.3 g/kg/d divided twice daily up to 20 g) or PEG 3350 (10 g/m2/day) for 2 weeks. PEG 3350 significantly decreased the total colonic transit time compared to lactulose (47.6+/-2.7 vs 55.3+/-2.4 hours, mean +/- SE, PEG 3350 vs lactulose, respectively, p = 0.038). The stool frequency, form, and the ease of passage were similar for each laxative. Polyethylene glycol 3350 is an effective laxative for the treatment of chronic constipation in children. To establish the efficacy and best starting dose of polyethylene glycol (PEG)3350 in the short-term treatment of children with functional constipation.
                Prospective, randomized, multicenter, double-blinded, placebo-controlled, dose-ranging study of PEG3350 in children with functional constipation. Patients were randomly assigned to either placebo or 0.2 g/kg per day, 0.4 g/kg per day, or 0.8 g/kg per day of PEG3350 after a 1 week run-in period, followed by 2 weeks of treatment. All received behavior modification. The primary outcome was the proportion of patients with a successful treatment response: >or=3 bowel movements (BM) in the second week.
                103 children (mean, 8.5 +/- 3.1 years) were enrolled. 77%, 74%, and 73% of the 0.2, 0.4, and 0.8 g/kg groups were successfully treated, as compared with 42% receiving placebo (P < .04). There was a significant increase in BM (P < .001) and straining improvement (P < .05) with the different PEG3350 doses. Stool consistency improved significantly for doses 0.4 g/kg or higher (P < .001). There was more abdominal pain and fecal incontinence in patients receiving 0.8 g/kg. PEG3350 was well tolerated.
                This placebo-controlled study confirms the efficacy and safety of PEG3350 for the short-term treatment of children with functional constipation. We recommend a starting dose of 0.4 g/kg per day. We hypothesized that enemas and polyethylene glycol (PEG) would be equally effective in treating rectal fecal impaction (RFI) but enemas would be less well tolerated and colonic transit time (CTT) would improve during disimpaction.
                Children (4-16 years) with functional constipation and RFI participated. One week before disimpaction, a rectal examination was performed, symptoms of constipation were recorded, and the first CTT measurement was started. If RFI was determined, then patients were assigned randomly to receive enemas once daily or PEG (1.5 g/kg per day) for 6 consecutive days. During this period, the second CTT measurement was started and a child's behavior questionnaire was administered. Successful rectal disimpaction, defecation and fecal incontinence frequencies, occurrence of abdominal pain and watery stools, CTTs (before and after disimpaction), and behavior scores were assessed.
                Ninety-five patients were eligible, of whom 90 participated (male, n = 60; mean age: 7.5 +/- 2.8 years). Forty-six patients received enemas and 44 PEG, with 5 dropouts in each group. Successful disimpaction was achieved with enemas (80%) and PEG (68%; P = .28). Fecal incontinence and watery stools were reported more frequently with PEG (P < .01), but defecation frequency (P = .64), abdominal pain (P = .33), and behavior scores were comparable between groups. CTT normalized equally (P = .85) in the 2 groups.
                Enemas and PEG were equally effective in treating RFI in children. Compared with enemas, PEG caused more fecal incontinence, with comparable behavior scores. The treatments should be considered equally as first-line therapy for RFI.