Acupuncture for infantile colic: A blinding-validated, randomized controlled multicentre trial in general practice Effectiveness of Mentha piperita in the Treatment of Infantile Colic: A Crossover Study Effectiveness of Lactobacillus reuteri in infantile colic and colicky induced maternal depression: a prospective single blind randomized trial Effect of minimal acupuncture for infantile colic: a multicentre, three-armed, single-blind, randomised controlled trial (ACU-COL) Cimetropium Bromide in the Treatment of Crisis in Infantile Colic Self-medication for infants with colic in Lagos, Nigeria Treatment of infantile colic with dicyclomine hydrochloride. Cow's milk whey protein elicits symptoms of infantile colic in colicky formula-fed infants: a double-blind crossover study. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. Effectiveness of massage, sucrose solution, herbal tea or hydrolysed formula in the treatment of infantile colic. Reduction of crying episodes owing to infantile colic: a randomized controlled study on the efficacy of a new infant formula Synbiotic in the management of infantile colic: a randomised controlled trial. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. Dicyclomine hydrochloride in infantile colic. Mothers’ postpartum psychological adjustment and infantile colic The effect of fennel (Foeniculum Vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study. Lactobacillus reuteri (American Type Culture Collection Strain 55730) Versus Simethicone in the Treatment of Infantile Colic: A Prospective Randomized Study Probiotic Lactobacillus rhamnosus GG therapy and microbiological programming in infantile colic: a randomized, controlled trial Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. [Infants with colic. A heterogenous group possible to cure? Treatment by pediatric consultation followed by a study of the effect of zone therapy on incurable colic]. Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial. Infant distress and development of functional gastrointestinal disorders in childhood: is there a connection? Evidence-based Complementary and Alternative Medicine. Cow's milk proteins cause infantile colic in breast-fed infants: a double-blind crossover study. A prospective 10-year study on children who had severe infantile colic. Lactobacillus reuteri DSM 17938 in Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial A Pilot Study of St36 Acupuncture for Infantile Colic Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial.
Abstract Objective . Infantile colic is a painful condition in the first months of infancy . Acupuncture is used in Sc and inavia as a treatment for infantile colic . A r and omized controlled trial was carried out with the aim of testing the hypothesis that acupuncture treatment has a clinical ly relevant effect for this condition . Design . A prospect i ve , blinding-vali date d , r and omized controlled multicentre trial in general practice . Research assistants and parents were blinded . Setting . 13 GPs ’ offices in Southern Norway . Intervention . Three days of bilateral needling of the acupuncture point ST36 , with no treatment as control . Subjects . 113 patients were recruited ; 23 patients were excluded , and 90 r and omized ; 79 diaries and 84 interviews were analysed . Main outcome measures . Difference in changes in crying time during the trial period between the intervention and control group . Results . The blinding validation questions showed a r and om distribution with p = 0.41 and 0.60 , indicating true blinding . We found no statistically significant difference in crying time reduction between acupuncture and control group at any of the measured intervals , nor in the main analysis of differences in changes over time ( p = 0.26 ) . There was a tendency in favour of the acupuncture group , with a non-significant total baseline-corrected mean of 13 minutes ( 95 % CI –24 to + 51 ) difference in crying time between the groups . This was not considered clinical ly relevant , according to protocol . Conclusion . This trial of acupuncture treatment for infantile colic showed no statistically significant or clinical ly relevant effect . With the current evidence , the authors suggest that acupuncture for infantile colic should be restricted to clinical trials Background . Infantile colic is a distressing and common condition for which there is no proven st and ard treatment . Objective . To compare the efficacy of Mentha piperita with simethicone in treatment for infantile colic . Methods . A double-blind crossover study was performed with 30 infants attending IMIP , Recife , Brazil . They were r and omized to use Mentha piperita or simethicone in the treatment of infantile colic during 7 days with each drug . Primary outcomes were mother_s opinion about responses to the treatment , number of daily episodes of colic , and time spent crying , measured by a chronometer . Mann-Whitney and chi-square tests were used to compare the results . This study was previously approved by the Ethical Committee in Research at IMIP . Results . At baseline daily episodes of infantile colic was 3.9 ( ±1.1 ) and the mean crying time per day was 192 minutes ( ±51.6 ) . At the end of the study daily episodes of colic fell to 1.6 ( ±0.6 ) and the crying duration decreased to 111 ( ±28 ) minutes . All mothers reported decrease of frequency and duration of the episodes of infantile colic and there were no differences between responses to Mentha piperita and simethicone . Conclusions . These findings suggest that Mentha piperita may be used to help control infantile colic . However , these results must be repeated by others studies Infant colic , excessive crying of unknown cause , is a major burden to families and effects about 10–30 % of infants . Despite decades of research , the exact cause and treatment of infant colic has remained elusive . The use of Lactobacillus reuteri ( DSM 17938 ) in infant colic is somewhat controversial and hence , we design ed this study to evaluate its efficacy in infantile colic . We recruited predominantly or exclusively breastfed infants , aged less than 4 months in a placebo controlled observational r and omized study . Participants ’ were assigned to receive L. reuteri at a dose 108 colony forming units ( n = 21 ) and placebo ( n = 21 ) . Placebo was an identical formulation without live micro-organisms . Treatment was given to subjects for 21 days and they were followed for 4 weeks . Treatment success ( primary outcome ) , daily reduction in crying time , parent satisfaction and reduction in maternal depression ( secondary outcomes ) were assessed at the end of study period . Treatment success was observed in all infants ( 100 % ) of the probiotic group while it was seen in 15.7 % of the placebo group . Mean daily crying time was more significantly reduced to 32.1 ± 8.3 min/day ( P < 0.01 ) from 200.9 ± 6.3 min/day in the probiotic group as compared to the placebo group ( 120.6 ± 20.0 min/day ) . Moreover , throughout the study period , parent ’s satisfaction and improvement in maternal depression ( Edinburgh postnatal depression scale ) was also significantly higher in the probiotic group . In our study population , reduction in crying time was significant ( P < 0.01 ) even during first week of initiation of therapy . We conclude that L. reuteri ( DSM 17938 ) reduces daily crying time and maternal depression during infantile colic . We suggest L. reuteri may be a safe and efficacious option for reducing infant colic Background Evidence for treating infantile colic with acupuncture is contradictory . Aim To evaluate and compare the effect of two types of acupuncture versus no acupuncture in infants with colic in public child health centres ( CHCs ) . Methods A multicentre , r and omised controlled , single-blind , three-armed trial ( ACU-COL ) comparing two styles of acupuncture with no acupuncture , as an adjunct to st and ard care , was conducted . Among 426 infants whose parents sought help for colic and registered their child 's fussing/crying in a diary , 157 fulfilled the criteria for colic and 147 started the intervention . All infants received usual care plus four extra visits to CHCs with advice/support ( twice a week for 2 weeks ) , comprising gold st and ard care . The infants were r and omly allocated to three groups : ( A ) st and ardised minimal acupuncture at LI4 ; ( B ) semi-st and ardised individual acupuncture inspired by Traditional Chinese Medicine ; and ( C ) no acupuncture . The CHC nurses and parents were blinded . Acupuncture was given by nurses with extensive experience of acupuncture . Results The effect of the two types of acupuncture was similar and both were superior to gold st and ard care alone . Relative to baseline , there was a greater relative reduction in time spent crying and colicky crying by the second intervention week ( p=0.050 ) and follow-up period ( p=0.031 ) , respectively , in infants receiving either type of acupuncture . More infants receiving acupuncture  cried <3 hours/day , and thereby no longer fulfilled criteria for colic , in the first ( p=0.040 ) and second ( p=0.006 ) intervention weeks . No serious adverse events were reported . Conclusions Acupuncture appears to reduce crying in infants with colic safely . Trial registration number NCT01761331 ; Results Background Treatment of infantile colic remains an open issue . In Italy , cimetropium bromide is used extensively to treat infantile colic . The aim of this r and omized , double-blind , placebo-controlled clinical trial was to investigate the effectiveness and side effects of cimetropium bromide in the treatment of infants with colic crisis . Methods Ninety-seven infants with colic were enrolled . The diagnosis of infantile colic in healthy infants with regular growth , aged 15 to 60 days was made according to the criteria of Wessel . The infants were divided into two groups , one treated with cimetropium bromide ( 1.2 mg/kg ) and the other treated with placebo at onset of each crisis for 3 days . Duration of crying and side effects were recorded daily in a structured diary for the 3 days of therapy . Statistical analysis was performed using the chi-square and t tests . Results Eighty-six infants completed the trial .  The average duration of crying for each crisis was 17.3 ± 12.6 minutes in the cimetropium bromide group and 47.5 ± 28.5 minutes in the placebo group ( P < 0.005 ) . Response to cimetropium bromide was 74 % . Response to placebo was 33 % ( P < 0.05 ) . Side effects did not differ significantly between the two groups , except sleepiness , which increased in the infants treated with cimetropium bromide . Conclusion Cimetropium bromide was more effective than placebo in reducing the duration of crying in children with infantile colic . The use of the anticholinergic drugs , aside from the dicyclomine because of its dangerous side effects , should be revaluated for treating infantile colic Background Infantile colic is a self-limiting condition that is distributed worldwide . It is often misdiagnosed as an organic disease for which an infant is admitted to the hospital . Many studies have described the aetiopathogenesis , pharmacologic and non-pharmacologic management of colic but none has evaluated self-medication for infants with colic . The aim of this study was therefore to determine the knowledge of Nigerian mothers about colic , their home-based management , extent of self-medication for the infants with colic and the types of medicines involved . Methods It is a prospect i ve study conducted at the  vaccination clinics of 20 primary health care centres , each from different Local Government Areas in Lagos , Nigeria . Eight hundred mothers that brought their infants for vaccination between April and September , 2006 were interviewed with open- and close-ended question naire . Results Six hundred and eighty three ( 85.4 % ) mothers cl aim ed they had a good knowledge of colic . Incessant and excessive cry was the main clinical feature of colic identified by 430(62.9 % ) mothers . Three hundred and seventy eight ( 67.7 % ) infants were treated by self-medication , 157 ( 28.1 % ) sought medical intervention and 17 ( 3.1 % ) were treated at a traditional birth attendant home . Herbal medicines constituted 51.8 % of the self-medicated medicines , of which 48 ( 26.2 % ) were " Ororo Ogiri " . Nospamin ® ( 49.5 % ) and Gripe water ® ( 43.0 % ) were the two frequently prescribed and self-medicated medicines for infants with colic . Conclusion Nigerian mothers are deficient in their knowledge of colic . Self-medication was the most frequently used home-based intervention . Health education would appear necessary to improve parental management of this self-limiting condition We performed a prospect i ve , r and omized , double-blind , placebo-controlled clinical trial of dicyclomine hydrochloride using specific diagnostic criteria for infantile colic : spells of unexplained irritability , agitation , fussiness or crying lasting greater than or equal to 3 hours/day , occurring greater than or equal to 3 days/week , and continuing for greater than or equal to 3 weeks .  Dicyclomine eliminated colic in 15 of 24 ( 63 % ) infants , whereas placebo was effective in six of 24 ( 25 % ) ( corrected X2 = 5.42 , P = 0.02 ) . The study also addressed the hypothesis that parental distress caused by infantile colic affects subsequent temperament and sleep patterns . The data fail to document easier temperaments or longer sleep duration s at 4 months in infants whose colic ceased during treatment There are several causes of infantile colic . The aim of this study was to evaluate , under controlled conditions , whether bovine whey proteins can elicit symptoms of infantile colic in colicky formula-fed infants . The mean age for entering the study was 6.4 weeks and the mean age for colic debut was 3.7 weeks . In 24 of 27 infants with severe colic , the symptoms disappeared when they were given a cow 's milk-free diet ( Nutramigen ) .  These 24 infants were entered into a double-blind crossover study . The infants ( receiving cow 's milk-free diet ) were given the contents of identical capsules with each meal during day 6 . The same procedure was repeated on day 10 . The capsules contained either whey protein powder ( with Nutramigen added ) or human albumin powder ( with Nutramigen added ) . Eighteen infants receiving the whey protein-containing capsules reacted with colic , two infants receiving placebo reacted with colic ( P less than .001 ) , and four infants did not react at all . Crying hours per day for the 24 infants were 5.6 hours for formula-fed infants and 0.7 hour for cow 's milk-free diet-fed infants ( P less than .001 ) . Crying hours per day were 3.2 hours for the infants receiving whey protein capsules and 1.0 hour for those receiving placebo ( P less than .001 ) . In conclusion , bovine whey protein can elicit symptoms of infantile colic in colicky formula-fed infants OBJECTIVE To determine whether there is a short-term effect of spinal manipulation in the treatment of infantile colic . DESIGN A r and omized controlled trial . SETTING A private chiropractic practice and the National Health Service 's health visitor nurses in the suburb Ballerup ( Copenhagen , Denmark ) . SUBJECTS Infants seen by the health visitor nurses , who fulfilled the diagnostic criteria for infantile colic . INTERVENTION One group received spinal manipulation for 2 weeks , the other was treated with the drug dimethicone for 2 weeks . OUTCOME MEASURE Changes in daily hours of crying as registered in a colic diary . RESULTS By trial days 4 to 7 , hours of crying were reduced by 1 hour in the dimethicone group compared with 2.4 hours in the manipulation group ( P = .04 ) . On days 8 through 11 , crying was reduced by 1 hour for the dimethicone group , whereas crying in the manipulation group was reduced by 2.7 hours ( P = .004 ) . From trial day 5 onward the manipulation group did significantly better that the dimethicone group . CONCLUSION Spinal manipulation is effective in relieving infantile colic AIM AND OBJECTIVE The aim of the study was to evaluate the effectiveness of massage , sucrose solution , herbal tea or hydrolysed formula , each used individually in the treatment of infantile colic . BACKGROUND The term colic describes a group of symptoms that occur frequently in infants , consisting of paroxysmal abdominal pain and severe crying . Infant colic is of importance for both parents and the community health services that provide families with care , and is therefore an important clinical problem that is amenable to nursing interventions . DESIGN This prospect i ve and r and omised-controlled study involved 175 infants in Turkey . METHODS Data were gathered by using Wessel criteria ; parents wrote a daily structured diary , recording the onset and duration of crying . Patients were assigned r and omly into four different intervention groups ( massage , sucrose solution , herbal tea and hydrolysed formula ) and control group .  Duration of crying following each intervention was recorded in the diary by parents for a one week period . RESULTS There was a significant reduction in crying hours per day in all intervention groups . The difference between mean duration of total crying ( hours/day ) before and after the intervention infants in hydrolysed formula group was found higher than massage , sucrose and herbal tea group . The difference between mean duration of total crying(hours/day ) before and after the intervention infants in massage group was found lower than other intervention groups and all groups . CONCLUSION Our findings demonstrated that varied interventions such as administration of massage , sucrose solution , herbal tea and hydrolysed formula are effective in the treatment of colic . The difference between mean duration of total crying ( hours/day ) before and after the intervention in hydrolysed formula group was found higher than other intervention groups . Hydrolysed formula was the most effective in reducing the duration of crying ( hours/day ) when compared with the other intervention groups . Massage intervention yielded the least symptomatic improvement among all the interventions . RELEVANCE TO CLINICAL PRACTICE Colic treatment models used in this study can be used by nurses in neonatal and primary healthcare setting s as an aid to families for the treatment of infantile colic Objectives : The aim of this study was to evaluate the efficacy on crying episodes owing to infantile colic of a new infant formula containing partially hydrolysed whey proteins , prebiotic oligosaccharides ( OS ) , with a high β-palmitic acid content . Design : Prospect i ve r and omized controlled study . Setting : Italy . Subjects : Two hundred and sixty-seven formula-fed infants , aged less than 4 months , with infantile colic , were r and omized to receive either the new infant formula ( study treatment ( ST ) ) or a st and ard formula and simethicone ( 6 mg/kg twice a day ) ( control treatment ( CT ) ) . A question naire was given to parents to evaluate for 14 days the daily number of colic episodes and crying time . Results : Out of the 199 infants who completed the study , 96 were treated with the new formula and 103 were not treated . Infants receiving the new formula had a significant decrease in colic episodes after 1 week ( 2.47±1.94 at day 7 vs 5.99±1.84 at the study entry ) compared to infants receiving the CT ( 3.72±1.98 at day 7 vs 5.41±1.88 at the study entry ) ( P<0.0001 ) . Also at day 14 , the crying episodes were significantly different between the two groups of infants ( 1.76±1.60 in ST vs 3.32±2.06 in CT ) ( P<0.0001 ) . Conclusions : The use of a partially hydrolysed formula supplemented with fructo- and galacto-OS induces a reduction of crying episodes in infants with colic after 7 and 14 days when compared with a st and ard formula and simethicone . Sponsorship : The study was supported by funds from Numico , Italy AIM Infant colic is a frequent problem affecting up to 10 - 30 % of infants in first 3 months of life . Results from previous trials have shown that manipulation of gut microbiota can lead to symptomatic improvements . In a r and omised clinical trial , we aim ed to determine efficacy of synbiotic in reducing average infant crying time at day 7 and day 30 after starting intervention . METHODS Fifty breastfed infants aged 15 - 120 days with infantile colic r and omly assigned to receive either the synbiotic sachet containing 1 billion CFU of : Lactobacillus casei , L. rhamnosus , Streptococcus thermophilus , Bifidobacterium breve , L. acidophilus , B. infantis , L. bulgaricus and fructooligosacharide ( Protexin Healthcare , Somerset , UK ) , or placebo daily for 30 days . Parents were asked to record details of crying times in a symptoms diary . The primary outcome measure was the treatment success ( reduction in the daily crying time > 50 % ) and the secondary outcome measure was symptom resolution ( reduction in the daily crying time > 90 % ) . RESULTS The treatment success was significantly higher in synbiotic group ( 82.6 % ) compared with placebo ( 35.7 % ) at day 7 ( P < 0.005 ) . At day30 , treatment success was 87 % and 46 % in synbiotic and placebo group , respectively ( P < 0.01 ) . Symptom resolution was also higher in synbiotic group ( 39 % ) compared with placebo ( 7 % ) at day 7 ( P < 0.03 ) but not at day 30 ( 56 % vs.36 % , P = 0.24 ) . We encountered no complication related to synbiotic use . CONCLUSION This synbiotic ( a mixture of seven probiotic strains plus FOS ) significantly improved colic symptoms in comparison with placebo AIMS To investigate the efficacy of chiropractic spinal manipulation in the management of infantile colic . METHODS One hundred infants with typical colicky pain were recruited to a r and omised , blinded , placebo controlled clinical trial . RESULTS Nine infants were excluded because inclusion criteria were not met , and five dropped out , leaving 86 who completed the study . There was no significant effect of chiropractic spinal manipulation . Thirty two of 46 infants in the treatment group ( 69.9 % ) , and 24 of 40 in the control group ( 60.0 % ) , showed some degree of improvement . CONCLUSION Chiropractic spinal manipulation is no more effective than placebo in the treatment of infantile colic . This study emphasises the need for placebo controlled and blinded studies when investigating alternative methods to treat unpredictable conditions such as infantile colic OBJECTIVE To determine whether administration of Lactobacillus reuteri ( L reuteri ) DSM 17938 is beneficial in breastfed infants with infantile colic . STUDY DESIGN Eighty infants aged < 5 months with infantile colic ( defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 7 days prior to enrollment ) , who were exclusively or predominantly ( > 50 % ) breastfed were r and omly assigned to receive L reuteri DSM 17938 ( 10(8 ) colony-forming units ) ( n = 40 ) or an identically appearing and tasting placebo ( n = 40 ) , both orally , in 5 drops , 1 time daily , for 21 days . The primary outcome measures were the treatment success , defined as the percentage of children achieving a reduction in the daily average crying time ≥ 50 % , and the duration of crying ( minutes per day ) at 7 , 14 , 21 , and 28 days after r and omization . RESULTS The rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 ( P = .026 ) , at day 14 ( relative risk ( RR ) 4.3 , 95 % CI 2.3 - 8.7 ) , at day 21 ( RR 2.7 , 95 % CI 1.85 - 4.1 ) , and at day 28 ( RR 2.5 , 95 % CI 1.8 - 3.75 ) . In addition , throughout the study period , the median crying time was significantly reduced in the probiotic group compared with the control group . CONCLUSION Exclusively or predominantly breastfed infants with infantile colic benefit from the administration of L reuteri DSM 17938 compared with placebo Dicyclomine hydrochloride is often used to treat infantile colic in Sweden , although in the United Kingdom it is now regarded as being contraindicated in infants aged six months and under . Results from three previous studies suggested its effectiveness.53 In these studies , however , the placebo did not taste like dicyclomine ( in the most recent study , for instance , cherry syrup was used as the placebo3 ) , and thus whether these studies were blind is not clear , as parents often taste their children 's drugs . One aim of the present study was to investigate the effects of dicyclomine compared with a placebo with identical smell , taste , colour , and texture . Another goal was to identify factors , such as  age and rhythm and amount of crying  , that would predict whether treatment would be successful Background : Infantile colic is a common problem of early infancy . There is limited data on the relation between postpartum maternal psychological problems and colic . Aim : : To investigate whether infantile colic is associated with postpartum mood disorders or insecure adult attachment style of the mother . Methods : Seventy eight mothers and newborns were enrolled in this prospect i ve , longitudinal study . Maternal depressive symptoms were screened with Edinburgh Postpartum Depression Score ( EPDS ) and maternal anxiety was assessed with State-Trait Anxiety Inventory ( STAI ) . The  Adult Attachment Scale  was used to determine the attachment style of the mother . Infantile colic was defined according to Wessel criteria . Results : Infantile colic was present in 17 infants ( 21.7 % ) ; 12.9 % of the mothers had an EPDS ⩾13 . The mean EPDS of the mothers whose infants had infantile colic ( 10.2±6.0 ) was significantly higher than that of the mothers of infants without colic ( 6.3±4.0 ) . Among infants with infantile colic , 62.5 % had mothers who had insecure attachment style , whereas only 31.1 % of mothers had insecure attachment when the infant did not have infantile colic . Conclusion : Postpartum maternal depressive symptoms and insecure attachment style are associated with infantile colic . Screening and early intervention of postpartum depression might promote the health of both the mother and infant CONTEXT Despite its benign , natural course , colic is a significant problem in infants and imparts a psychological , emotional , and physical burden to parents . Dicyclomine hydrochloride is the only pharmacological treatment for infantile colic that has been consistently effective . Unfortunately , 5 % of infants treated with dicyclomine hydrochloride develop serious side effects , including death .  Fennel seed oil has been shown to reduce intestinal spasms and increase motility of the small intestine . However , there have not been any clinical studies of its effectiveness . OBJECTIVES To determine the effectiveness of fennel seed oil emulsion in infantile colic . DESIGN R and omized placebo-controlled trial . SETTING S Two large multi-specialty clinics . SUBJECTS 125 infants , 2 to 12 weeks of age , who met definition of colic . INTERVENTION Fennel seed oil emulsion compared with placebo . OUTCOME MEASURE Relief of colic symptoms , which was defined as decrease of cumulative crying to less than 9 hours per week . RESULTS The use of fennel oil emulsion eliminated colic , according to the Wessel criteria , in 65 % ( 40/62 ) of infants in the treatment group , which was significantly better than 23.7 % ( 14/59 ) of infants in the control group ( P < 0.01 ) . There was a significant improvement of colic in the treatment group compared with the control group [ Absolute Risk Reduction ( ARR ) = 41 % ( 95 % CI 25 to 57 ) , Number Needed to Treat ( NNT ) = 2 ( 95 % CI 2 to 4 ) ] . Side effects were not reported for infants in either group during the trial . CONCLUSION Our study suggests that fennel seed oil emulsion is superior to placebo in decreasing intensity of infantile colic OBJECTIVE . The goal was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospect i ve r and omized study would improve symptoms of infantile colic .  METHODS . Ninety breastfed colicky infants were assigned r and omly to receive either the probiotic L reuteri ( 108 live bacteria per day ) or simethicone ( 60 mg/day ) each day for 28 days . The mothers avoided cow 's milk in their diet . Parents monitored daily crying times and adverse effects by using a question naire . RESULTS . Eighty-three infants completed the trial : 41 in the probiotic group and 42 in the simethicone group . The infants were similar regarding gestational age , birth weight , gender , and crying time at baseline . Daily median crying times in the probiotic and simethicone groups were 159 minutes/day and 177 minutes/day , respectively , on the seventh day and 51 minutes/day and 145 minutes/day on the 28th day . On day 28 , 39 patients ( 95 % ) were responders in the probiotic group and 3 patients ( 7 % ) were responders in the simethicone group . No adverse effects were reported . CONCLUSIONS . In our cohort , L reuteri improved colicky symptoms in breastfed infants within 1 week of treatment , compared with simethicone , which suggests that probiotics may have a role in the treatment of infantile colic Background : Probiotic Lactobacillus reuteri and reduced allergen load may lessen the daily crying of colic infants , but the role of Lactobacillus rhamnosus GG ( LGG ) has remained obscure . Methods : Infants with colic ( n = 30 ) were enrolled during the first 6 wk of life . All families received behavioral support and allergen avoidance diet :  breastfeeding mothers followed cow ’s milk elimination diet and formula-fed infants received extensively hydrolyzed casein formula . The r and omized , double-blind intervention employed of LGG 4.5 × 109 cfu/d or placebo for a 4-wk study period . Daily crying was recorded by diaries and parental interviews . Fecal calprotectin and gut microbiota composition by quantitative PCR were evaluated before and after the intervention . Results : Daily crying time was comparable between the probiotic ( 173 min ) and the placebo group ( 174 min ; P = 0.99 ) at the end of the intervention according to the parental diary . However , parents reported a decrease of 68 % ( 95 % confidence interval ( CI ) : 58–78 ) in daily crying in the probiotic and 49 % ( 95 % CI : 32–66 ) in the placebo group ( P = 0.05 ) . Conclusion : LGG in infants treated in t and em with behavioral support and a cow ’s milk elimination diet did not provide additional treatment effect for diary-verified colic crying although parental report of crying suggested the probiotic intervention effective OBJECTIVE To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants , compared with placebo . STUDY DESIGN A r and omized , double-blind , placebo-controlled trial was conducted involving 52 infants with colic , according to modified Wessel criteria , who were assigned at r and om to receive L reuteri DSM 17938 ( 10(8 ) colony-forming units ) ( n = 24 ) or placebo ( n = 28 ) for 21 days . Daily crying and fussing times were recorded in a structured diary , and maternal question naires were completed to monitor changes in infant colic symptoms and adverse events . RESULTS Total average crying and fussing times throughout the study ( from baseline to day 21 ) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group ( 1719 ± 750 minutes [ 29 ± 13 hours ] vs 2195 ± 764 minutes [ 37 ± 13 hours ] ; P = .028 ) ( relative risk , 0.78 ; 95 % CI , 0.58 - 0.98 ) . Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo ( median , 60 minutes/day [ IQR , 64 minutes/day ] vs 102 minutes/day [ IQR , 87 minutes/day ] ; P = .045 ) . On day 21 , a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a ≥50 % crying time reduction compared with infants given placebo ( 17 vs 6 , P = .035 ; relative risk , 3.3 ; 95 % CI , 1.55 - 7.03 ) . CONCLUSION Administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic INTRODUCTION The aim of the study was to investigate and treat infants with colic by conventional medicine followed by an investigation of the effect of reflexological treatment . MATERIAL AND METHODS The investigation was prospect i ve , followed by a r and omised , single-blind , double-controlled , prospect i ve study of reflexological treatment with an interview and diary . Sixty-three infants aged 1 - 3 months referred by general practitioners with crying for > 90 minutes a day were given a paediatric examination and intervention . The cause of crying was discovered in 33 infants : Vitamin D ( 5 ) , elimination of cow 's milk protein ( 3 ) , and anal stenosis ( 3 ) ; counselling on feeding , sleep , reduction of stimulation , and avoidance of passive smoking ( 22 ) . Thirty infants without the benefit of paediatric consultation were r and omised to three groups for a duration of two weeks : A : Presumed non-effective reflexological treatment vs B : Presumed effective reflexological treatment vs C : No treatment -- only observation . The most important parameter was the number of crying hours over 24 hours . Cure was defined as crying for less than or equal to 30 minutes . RESULTS Examination by the paediatrician : Thirty-three of 63 infants benefited with a reduction in crying of less than 90 minutes and 13 of these infants were cured . The r and omised study : In group C ( control ) , none of the patients was cured . In groups A and B ( presumed non-effective reflexological treatment and presumed effective treatment ) , half the patients were cured , which was significantly better than in group C. There was no significant difference between groups A and B , but B seemed better than group A. B was significantly better than C. DISCUSSION Infantile colic had a significant cure rate at paediatric consultation and the children who did not benefit from this intervention had a significantly better outcome after reflexological treatment than had the observation group . Further investigations in reflexological treatment in infants are recommended OBJECTIVE To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherl and s. STUDY DESIGN R and omized , double-blind , parallel trial with a 1-week qualification period and a 1-week intervention period . Participants . Forty-three healthy , thriving , formula-fed infants , < 6 months old , crying > 3 hours per day on at least 3 days per week . Infants were r and omized to whey hydrolysate formula ( n = 23 ) or st and ard formula ( n = 20 ) . MAIN OUTCOME MEASURE Difference in duration of crying ( minutes per day ) between qualification week and intervention week . RESULTS Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [ 95 % confidence interval : 1 - 127 minutes per day ] in favor of the whey hydrolysate formula .  Five infants did not complete the trial . The scope of the study was not sufficient to expect significant differences in the subgroup analyses . CONCLUSIONS An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting Infant Distress and Development of Functional Gastrointestinal Disorders in Childhood : Is There a Connection ? One infant in 4 manifests with abundant crying , fussing , or colic cry  and is brought for medical evaluation during the first months of life.1 Concomitantly , excessive antigen uptake and bacterial translocation ensue across the immature gut barrier.2 Not surprisingly , infant crying has been related to food allergy3 and aberrant gut microbiota composition4 and these have , in turn , been linked to functional gastrointestinal disorders (FGIDs).5 We hypothesized that colic crying is associated with FGIDs later in childhood We introduce the current research on complementary and alternative medicine ( CAM ) in the West , which we refer to as Evidence -based CAM ( EBCAM ) , and discuss its characteristics , problems , and perspectives . Compared with the common attitude of CAM research ers in Japan , that of EBCAM research ers is more objective and often self-critical . EBCAM research is still developing because r and omized controlled trials on CAM have many method ological flaws . Caution should be employed in interpreting provisional conclusions of relevant systematic review s. CAM research ers in Japan should view the case report method from a perspective other than efficacy . Also , they will have to prepare evidence in response to dem and s from CAM consumers . Priority of research subjects from various kinds of CAM should be decided according to their popularity . Therefore , a large-scale survey on CAM use in Japan is essential Sixty-six mothers of 66 breast-fed infants with infantile colic were put on a diet free from cow 's milk . The colic disappeared in 35 infants ; it reappeared on at least two challenges ( cow 's milk to mother ) in 23 infants ( 35 % ) . A double-blind crossover trial with cow 's milk whey protein was performed in 16 of these 23 mothers and infants . Six infants had to be taken out of the study for various reasons ; of the remaining ten infants , nine reacted with colic after their mothers ' intake of whey protein-containing capsules . Sequential analysis showed a high correlation between infantile colic in breast-fed infants and their mothers ' consumption of cow 's milk protein . A diet free of cow 's milk is suggested for the mothers as a first trial of treatment of infantile colic in breast-fed infants AIM To evaluate the association between infantile colic and gastrointestinal , allergic and psychological disorders in childhood . METHODS A prospect i ve study was conducted on 103 infants aged 31 - 87 d. After 10 y , between 2001 and 2003 , the children were recalled and a paediatrician evaluated the selected disorders by anamnesis , medical examination , laboratory tests and parent interviews . RESULTS Of the 103 infants enrolled , 96 completed the study . There was an association between infantile colic and recurrent abdominal pain ( p=0.001 ) and allergic disorders : allergic rhinitis , conjunctivitis , asthmatic bronchitis , pollenosis , atopic eczema and food allergy ( p<0.05 ) . Sleep disorders , fussiness , aggressiveness and feelings of supremacy are more frequent in children who suffered from colic during early infancy ( p<0.05 ) . A family history of gastrointestinal diseases and atopic diseases was significantly higher in infants with colic than in controls ( p<0.05 ) . CONCLUSION Susceptibility to recurrent abdominal pain , allergic and psychological disorders in childhood may be increased by infantile colic . Our findings confirm that severe infantile colic might be the early expression of some of the most common disorders in childhood OBJECTIVE : To test the efficacy of Lactobacillus reuteri on infantile colic and to evaluate its relationship to the gut microbiota . STUDY DESIGN : Fifty exclusively breastfed colicky infants , diagnosed according to modified Wessel 's criteria , were r and omly assigned to receive either L reuteri DSM 17 938 ( 108 colony-forming units ) or placebo daily for 21 days . Parental question naires monitored daily crying time and adverse effects . Stool sample s were collected for microbiologic analysis . RESULTS : Forty-six infants ( L reuteri group : 25 ; placebo group : 21 ) completed the trial . Daily crying times in minutes/day ( median [ interquartile range ] ) were 370 ( 120 ) vs 300 ( 150 ) ( P = .127 ) on day 0 and 35.0 ( 85 ) vs 90.0 ( 148 ) ( P = .022 ) on day 21 , in the L reuteri and placebo groups , respectively . Responders ( 50 % reduction in crying time from baseline ) were significantly higher in the L reuteri group versus placebo group on days 7 ( 20 vs 8 ; P = .006 ) , 14 ( 24 vs 13 ; P = .007 ) , and 21 ( 24 vs 15 ; P = .036 ) . During the study , there was a significant increase in fecal lactobacilli ( P = .002 ) and a reduction in fecal Escherichia coli and ammonia in the L reuteri group only ( P = .001 ) . There were no differences in weight gain , stooling frequency , or incidence of constipation or regurgitation between groups , and no adverse events related to the supplementation were observed . CONCLUSION : L. reuteri DSM 17 938 at a dose of 108 colony-forming units per day in early breastfed infants improved symptoms of infantile colic and was well tolerated and safe . Gut microbiota changes induced by the probiotic could be involved in the observed clinical improvement Objective To conduct a pilot study to assess the feasibility of a proposed design of an acupuncture trial to relieve symptoms of  infantile colic .  Method An open r and omised single-blinded controlled trial , using st and ardised bilateral treatment of the acupuncture point ST36 . Infants fulfilling Wessel 's definition of infantile colic were included . Patients were r and omised to active treatment or to no-treatment control .  General practitioners ( GPs ) educated in Western medical acupuncture did the interventions . Parents and GPs ’ assistants were blinded . Active treatment was the bilateral insertion of 0.20 × 15 mm Seirin needles to 12 mm depth at ST36 . The intervention consisted of daily treatments of 30 s duration for three consecutive workdays . Blinding was done with a red point mark on the skin and circular adhesive dressing covering . The parents were asked two blinding validation questions in the course of the study period . The primary end point was the effect of the intervention assessed as change in crying time per 24 h measured with a crying registration form . Results The authors improved the st and ardisation and changed the blinding procedure as a result of the pilot study . Blinding validation questions were considered necessary . The changes made in the main study protocol are discussed . Conclusion The pilot study led to important changes that were implemented into the final trial protocol . Blinding validation is essential in no-treatment controlled trials of acupuncture on infants , where the parents are blinded assessors of symptom reduction . The authors suggest that blinding validation questions , and the answers to these questions , should be reported . Clinical Trial Registry Identifier : NCT00907621 IMPORTANCE Infantile colic , gastroesophageal reflux , and constipation are the most common functional gastrointestinal disorders that lead to referral to a pediatrician during the first 6 months of life and are often responsible for hospitalization , feeding changes , use of drugs , parental anxiety , and loss of parental working days with relevant social consequences . OBJECTIVE To investigate whether oral supplementation with Lactobacillus reuteri DSM 17938 during the first 3 months of life can reduce the onset of colic , gastroesophageal reflux , and constipation in term newborns and thereby reduce the socioeconomic impact of these conditions . DESIGN A prospect i ve , multicenter , double-masked , placebo-controlled r and omized clinical trial was performed on term newborns ( age < 1 week ) born at 9 different neonatal units in Italy between September 1 , 2010 , and October 30 , 2012 . SETTING Parents were asked to record in a structured diary the number of episodes of regurgitation , duration of inconsolable crying ( minutes per day ) , number of evacuations per day , number of visits to pediatricians , feeding changes , hospitalizations , visits to a pediatric emergency department for a perceived health emergency , pharmacologic interventions , and loss of parental working days . PARTICIPANTS In total , 589 infants were r and omly allocated to receive L reuteri DSM 17938 or placebo daily for 90 days . INTERVENTIONS Prophylactic use of probiotic . MAIN OUTCOMES AND MEASURES Reduction of daily crying time , regurgitation , and constipation during the first 3 months of life . Cost-benefit analysis of the probiotic supplementation . RESULTS At 3 months of age , the mean duration of crying time ( 38 vs 71 minutes ; P < .01 ) , the mean number of regurgitations per day ( 2.9 vs 4.6 ; P < .01 ) , and the mean number of evacuations per day ( 4.2 vs 3.6 ; P < .01 ) for the L reuteri DSM 17938 and placebo groups , respectively , were significantly different . The use of L reuteri DSM 17938 result ed in an estimated mean savings per patient of € 88 ( US $ 118.71 ) for the family and an additional € 104 ( US $ 140.30 ) for the community . CONCLUSIONS AND RELEVANCE Prophylactic use of L reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01235884
Probiotics , fennel extract  and  spinal manipulation  show promise to alleviate symptoms of colic , although some concerns remain .
Background Infantile colic is a distressing condition characterised by excessive crying in the first few months of life .
The aim of this research was to up date the synthesis of evidence of complementary and alternative medicine ( CAM ) research literature on infantile colic and establish what evidence is currently available .