TABLE 1

Characteristics of Included Studies

AuthorStudy populationExperimental group age, medianControl group age, medianIntervention(s)Control condition(s)Measurement(s)Outcome measure(s)Results
Gastroenteritis
Diarrhea
Akşit et al30Patients with acute diarrhea, N = 80; age: 4–48 mo15 ± 13 mo18 ± 14 moWHO-ORS and CBJ 20 mL/kg body weight and breast milk or cows’ milk-yoghurt-mixWHO-ORS 20 mL/kg body weight and breast milk or cows’ milk-yoghurt-mixInitial visit, then regularly until diarrhea stoppedPrimary outcomeSignificant group differences after therapy
 1. Duration of diarrhea (d)Primary outcome
 2. Stool output (g/kg body weight) 1. Duration of diarrhea (d)
Secondary outcomes 2. Stool output (g/kg body weight)
 1. WHO-ORS intake (mL/kg body weight)Secondary outcomes
 2. Weight gain in percent 1. WHO-ORS intake (mL/kg body weight)
 3. Serum sodium (mmol/L) 2. Serum sodium (mmol/L)
 4. Serum potassium (mmol/L) 3. Serum potassium (mmol/L
Subbotina et al31Patients with rotavirus diarrhea, N = 40; age: 3 mo–7 y23.5 mo22.5 moWHO-ORS 20 mL/kg body weight; 3 drops P erecta elixir (1 part of dried root with 10 parts of 40% ethyl alcohol) per year of life, 3 times daily until discontinuation of diarrhea or maximum of 5 dWHO-ORS 20 mL/kg body weight; 3 drops placebo elixir per year of life, 3 times daily until discontinuation of diarrhea or maximum of 5 dInitial visit, then daily until diarrhea ceased, or stool output was <10 mL/kg/d, stool consistency was normalized, and symptoms of dehydration were correctedPrimary outcomeSignificant group differences after therapy
 1. Duration of diarrhea (d)Primary outcome
Secondary outcomes 1. Duration of diarrhea (d)
 1. Duration of abnormal stool (d)Secondary outcomes
 2. Duration of hospitalization (d) 1. Duration of abnormal stool (d)
 3. Stool output (mL/kg/d) 2. Duration of hospitalization (d)
 4. Oral rehydration volume (mL/kg/d) 3. Stool output (mL/kg/d)
Becker et al32Patients with acute diarrhea, N = 225; age: 6 mo–6 y33.76 ± 22.99 mo33.02 ± 22.77 moOralpädon and Diarrhoesan (apple pectin, M chamomilla) dosage: Diarrhoesan up to 40–80 mL/d depending on age; Oralpädon within the first 24 h: 1 sachet after each stool over 5 dOralpädon and placebo in same dosageInitial visit, and at day 3 and day 5 of interventionPrimary outcomeSignificant group differences after therapy
 1. Duration of diarrhea (h)Primary outcome
 2. Stool frequency 1. Duration of diarrhea (h)
 3. Consistency of stool 2. Stool frequency
Secondary outcomes
 1. Therapeutic response
 2. General condition
 3. Existence of abdominal cramps
 4. Efficacy
De la Motte et al33Patients with acute diarrhea, N = 79; age: 6 mo–5.5 yDiarrhoesan 5 mL per dose bag, maximum dose 12 bags a day depending on agePlacebo in same dosageDiary assessed by parents: Initial, then 2 times/d until diarrhea ceasedPrimary outcomeSignificant group differences after therapy
 1. Duration of diarrhea (h)Primary outcome
Secondary outcomes 1. Duration of diarrhea (h)
 1. Consistency of stool
 2. Well-being
Dehydration
Freedman et al34Patients with mild gastroenteritis, N = 647; age: 6–60 mo28 ± 15.4 mo29 ± 16.5 moHalf-strength apple juice, 5 mL aliquots every 2–5 min up to 2 L, and preferred other liquids (juices or milk)Apple-flavored, sucralose-sweetened pediatric electrolyte solution, in same dosageInitial visit, then daily telephone assessment by parents for 7 d of interventionPrimary outcomeSignificant group differences after therapy
 1. Treatment failure, defined as a composite score of intravenous rehydration or hospitalization, subsequent unscheduled physician encounter, protracted symptoms or significant weight loss occurring within 7 d of enrollmentPrimary outcome
 1. Treatment failure
Secondary outcomesSecondary outcomes
 1. Intravenous rehydration 1. Intravenous rehydration
 2.Hospitalization
 3. Frequency of diarrhea and vomiting
 4. Percentage of weight change
Functional gastrointestinal disorders
Infantile colic
Alexandrovich et al35Patients with infantile colic, N = 125; age: 2–12 wk29.7 ± 8.2 d30.5 ± 6.9 dEmulsion of 0.1% of fennel seed oil (F vulgare) and 0.4% polysorbate-80 in water, a minimum of 5 mL and a max of 20 mL up to 4 times a dayEmulsion of 0.4% polysorbate-80 in water in same dosageDiary assessed by parents. Diaries were entered for 21 d (7 d before the trial, during the 7-d trial, 7 d after the trial). Visits before, during, and after interventionPrimary outcomeSignificant group differences after therapy
 1. Relief of colic symptoms (defined as <9 h cumulative crying h/wk)Primary outcome
Secondary outcomes 1. Relief of colic symptoms (defined as <9 h cumulative crying h/wk)
 1. Cumulative crying at the end of treatment (h/wk)Secondary outcomes
 2. Consumed emulsion/placebo (mL/d) 1. Cumulative crying at the end of treatment (h/wk)
 3. No. doses per day 2. Consumed emulsion/placebo (mL/d)
 3. No. doses/d
Alves et al36Patients with infantile colic, N = 30; age: 8–56 d (m = 33 ± 11.1 d)Peppermint oil drops (1 drop/kg body weight).Simethicone drops (2.5 mg/kg body weight)Initial visit, and at day 7 and day 17 of interventionPrimary outcomeSignificant group differences after therapy
 1. Responses to treatmentNo significant group differences for responses to treatment. No other results reported
 2. Daily episodes of colic
 3. Crying time (h)
Secondary outcomes
 1. Milk regurgitation
 2. Vomiting
 3. Diarrhea
 4. Constipation
 5. Drowsiness
Arikan et al37Patients with infantile colic, N = 175; age: 4–12 wk2.24 ± 0.69 mocontr grp 1: 2.29 ± 0.75 moFennel tea (F vulgare) 3 times a day 35 mL up to 150 mLGrp. 1: massage 2 times 25 min/d; grp. 2: 12% sucrose solution 2 times a day 2 mL; grp. 3: hydrolyzed formula; grp. 4: treatment as usualDiary assessed by parents, 7 d during the interventionPrimary outcomeSignificant group differences after therapy
contr grp 2: 1.97 ± 0.75 mo 1. Crying time (h)Primary outcome
contr grp 3: 1.97 ± 0.71 moSecondary outcomes 1. Crying time (h) when compared with treatment as usual. No comparison of fennel tea to the other interventions was performed
contr grp 4: m = 2.28 ± 0.61 mo No secondary outcomes
Savino et al38Patients with infantile colic, N = 93; age: 21–60 d4.2 ± 1.4 wk4.4 ± 1.6 wkColiMil (F vulgare, M chamomilla, M officinalis) 2 mL/kg (body weight)Placebo in same dosageInitial visit, and after intervention period (7 d). Diary assessed by parents, 7 d during the intervention and 14 d after interventionPrimary outcomeSignificant group differences after therapy
 1. Crying time (mean min/d)Primary outcome
Secondary outcomes 1. Crying time (mean min/d)
 1. Treatment respondingSecondary outcomes
 1. Treatment responding
Weizmann et al39Patients with infantile colic, N = 68; age: 2–8 wk21.1 ± 9.3 d24.6 ± 7.6 dHerbal tea preparation (M chamomilla, V officinalis, G glabra, F vulgare, M officinalis); every episode of colic, up to 150 mL/dose, not more than 3 times a dayPlacebo tea preparation: instant powder of glucose and natural flavors in same doseDiaries assessed by parents: 7 d with no therapy, and 7 d of treatment. Initial examination by pediatrician, and at day 7, and day 141. No. of night wakings requiring parental responseSignificant group differences after therapy
2. Elimination of colic 1. Elimination of colic
3. Colic improvement 2. Colic improvement
No primary outcome defined
Irritable bowel syndrome
Kline et al40Patients with irritable bowel syndrome, N = 42; age: (8–17 y) Total: m = 12 yColpermin capsules (pH-dependent peppermint oil 187 mg), 3 times/d 1–2 capsules depending on weightPlacebo capsules with peanut oil in same dosageInitial visit, and at day 14 of interventionPrimary outcomeSignificant group differences after therapy
 1. Gastrointestinal symptom ratingNo significant group differences
Shulman et al41Patients with irritable bowel syndrome N = 103; age: 7–18 y13.1 ± 0.4 y13.5 ± 0.4 yPsyllium fiber powder, 6–12 g depending on age per dayMaltodextrin powder in same dosage2 wk baseline measurement, 6 wk treatment period, final assessment within the last 2 wk of treatment periodPrimary outcomeSignificant group differences after therapy
 1. Number abdominal pain episodesPrimary outcome
 2. Severity of abdominal pain episodes 1. Number abdominal pain episodes
 3. Percentage of normal stools
Secondary outcomes
 1. Changes in breath hydrogen/methane production
 2. Gut permeability
Functional abdominal pain
Asgarshirazi et al42Patients with functional abdominal pain, N = 120; age: 4–13 y7.06 ± 2.38 ycontr grp 1: 7.42 ± 2.49 yColpermin capsules (pH-dependent peppermint oil 187 mg), 3 times/d 1–2 capsules depending on weightGrp 1: Folic acid tablet 1 mg, daily 30 min before breakfast or lunch; grp 2: Lactol tablets (150 million spores of Bacillus coagulans + Fructooligosaccharide), 3 times/d after mealsQuestionnaire before, and after 4 wk intervention. Periodic visits during intervention period1. Duration of pain (min/d)Significant group differences after therapy
contr grp 2: 7.44 ± 2.44 y2. Frequency of pain, per weekCompared with Placebo
3. Severity of pain 1. Duration of pain (min/d)
No primary outcome defined 2. Frequency of pain, per week
 3. Severity of pain
Compared with Lactol
 1. Duration of pain (min/d)
 2. Severity of pain
Constipation
Quitadamo et al43Patients with chronic functional constipation, N = 100; age: 4–10 y6.5 ± 2.6 y6.7 ± 2.8 yMixture of Acacia fiber, Psyllium, and fructose powder 16.8 g/d + 0.5 g/kg body weightPolyethylene glycol 3350 with electrolytes 16.8 g/d + 0.5 g/kg body weightInitial visit, daily stool diary assessed by parents, and follow-up-visits 1, 2, 4 and 8 wk after enrollmentPrimary outcomeSignificant group differences after therapy
 1. Improvement of constipationNo significant differences between both groups
Secondary outcomes
 1. Improvement of other associated gastrointestinal symptoms
  • Cbj, carob bean juice; contr: control; grp, group; m, median; max, maximum; WHO-ORS, World Health Organization-oral rehydration solution; —, not applicable.