title: Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. Evaluation of the effect of a fiber-enriched formula on infant colic. Effectiveness of massage, sucrose solution, herbal tea or hydrolysed formula in the treatment of infantile colic. Lactobacillus reuteri (American Type Culture Collection Strain 55730) Versus Simethicone in the Treatment of Infantile Colic: A Prospective Randomized Study AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both How Quickly Do Systematic Reviews Go Out of Date? A Survival Analysis Infant massage compared with crib vibrator in the treatment of colicky infants. Efficacy of herbal tea preparation in infantile colic. Acupuncture for infantile colic: A blinding-validated, randomized controlled multicentre trial in general practice The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. Effectiveness of Mentha piperita in the Treatment of Infantile Colic: A Crossover Study [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]. Safety and Efficacy of Acupuncture in Children: A Review of the Evidence Effectiveness of Lactobacillus reuteri in infantile colic and colicky induced maternal depression: a prospective single blind randomized trial 454 Pyrosequencing Analysis on Faecal Samples from a Randomized DBPC Trial of Colicky Infants Treated with Lactobacillus reuteri DSM 17938 Dietary treatment of infant colic: a double-blind study. A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation Oral hypertonic glucose solution in the treatment of infantile colic. The effect of fennel (Foeniculum Vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study. Probiotic Lactobacillus rhamnosus GG therapy and microbiological programming in infantile colic: a randomized, controlled trial Use of sucrose as a treatment for infant colic Effect of minimal acupuncture for infantile colic: a multicentre, three-armed, single-blind, randomised controlled trial (ACU-COL) A randomized double-blind placebo-controlled trial of a standardized extract of Matricariae recutita, Foeniculum vulgare and Melissa officinalis (ColiMil) in the treatment of breastfed colicky infants. Synbiotic in the management of infantile colic: a randomised controlled trial. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial. Lactobacillus reuteri DSM 17938 in Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial
abstract: 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 Because infants with colic appear to have  abdominal pain  similar to that of adults with irritable bowel syndrome , who may benefit from the addition of fiber to their diet , we tested whether fiber added to infant formula would alleviate colic .  Twenty-seven normal , term infants ( aged 2 to 8 weeks ; 14 girls ) with colic , defined as crying plus fussing for more than 3 hours a day for at least 3 days of a 6-day baseline period , were enrolled . Infants were r and omly assigned in 9-day periods to a sequence of placebo ( Isomil formula ) followed by fiber-supplemented formula ( Isomil plus soy polysaccharide ) ( n = 12 ) or the reverse ( n = 15 ) . Daily diaries of crying , fussing , sleeping , formula , intake , and stooling were kept . Twenty-two infants completed three lactulose breath hydrogen tests at the end of the baseline period and after each study period . The crossover trial was followed by 30 to 35 days of use of the study formula chosen by the parents as most beneficial but unknown to the investigators . Growth was monitored throughout . Serum cholesterol , calcium , phosphate , albumin , iron , and zinc concentrations were measured at the conclusion . There were no significant differences in average daily time spent by the infants in fussing and crying during ingestion of the fiber-supplemented formula . However , parents of 18 of 27 infants chose fiber-supplemented formula as most beneficial in ameliorating symptoms of colic . While the infants were consuming fiber-supplemented formula , stool frequency increased , and breath hydrogen excretion increased significantly , in response to lactulose . Growth and serum biochemical measurements were normal in all infants . Supplementation of infant formula with the level of soy polysaccharide used in this study may have reduced crying and fussing in some infants but did not affect colicky behavior in the majority of infants , who continued to cry and fuss excessively 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 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 The number of published systematic review s of studies of healthcare interventions has increased rapidly and these are used extensively for clinical and policy decisions . Systematic review s are subject to a range of biases and increasingly include non-r and omised studies of interventions . It is important that users can distinguish high quality review s. Many instruments have been design ed to evaluate different aspects of review s , but there are few comprehensive critical appraisal instruments . AMSTAR was developed to evaluate systematic review s of r and omised trials . In this paper , we report on the updating of AMSTAR and its adaptation to enable more detailed assessment of systematic review s that include r and omised or non-r and omised studies of healthcare interventions , or both . With moves to base more decisions on real world observational evidence we believe that AMSTAR 2 will assist decision makers in the identification of high quality systematic review s , including those based on non-r and omised studies of healthcare interventions Context Clinicians rely on systematic review s for current , evidence -based information . Contribution This survival analysis of 100 meta-analyses indexed in ACP Journal Club from 1995 to 2005 found that new evidence that substantively changed conclusions about the effectiveness or harms of therapies arose frequently and within relatively short time periods . The median survival time without substantive new evidence for the meta-analyses was 5.5 years . Significant new evidence was already available for 7 % of the review s at the time of publication and became available for 23 % within 2 years . Implication Clinical ly important evidence that alters conclusions about the effectiveness and harms of treatments can accumulate rapidly . The Editors Systematic review s have become increasingly common in recent years ( 1 ) and are recommended by many as the best sources of evidence to guide both clinical decisions ( 2 ) and health care policy ( 3 ) . For systematic review s to fulfill these roles , their findings must remain relatively stable for at least several years or effective mechanisms must exist for alerting end users to important changes in evidence . Yet , surprisingly little research has assessed the extent to which systematic review s become out of date or the rate at which this occurs ( 47 ) . Some organizations , such as the Cochrane Collaboration , recommend updating systematic review s every 2 years , but few empirical data guide this or other recommendations about updating . We sought to determine how quickly systematic review s meet explicitly defined criteria for changes in evidence of sufficient importance to warrant updating . We also sought to identify predictors of survival time , the time to such important changes in evidence . Survival time might vary depending on many factors , including the type of question posed by the original review ( for example , therapeutic or diagnostic ) , the types of studies included ( for example , r and omized trials or observational studies ) , and whether the systematic review provided quantitative synthesis . To limit such variation , we focused on systematic review s of r and omized , controlled trials that evaluated therapeutic benefit or harm by providing quantitative synthesis ( meta- analysis ) for at least 1 outcome . Methods Study Design and Sample We used a quasi-r and om process ( alphabetical sort order by author ) to select 100 systematic review s that were indexed in ACP Journal Club with an accompanying commentary between January 1995 and December 2005 ( with a search date no later than 31 December 2004 to ensure at least 1 full year for new evidence to appear ) . We chose this sampling frame because ACP Journal Club selects systematic review s that meet explicit quality st and ards and are deemed directly relevant to clinical practice ( 8) . We regarded the sample size of 100 as sufficiently large to achieve suitably narrow confidence intervals and to permit evaluation of up to 5 potential predictors of survival . Eligibility Criteria Eligible review s evaluated the benefit or harm of a specific drug , class of drug , device , or procedure ( invasive procedure or surgery ) and included r and omized or quasi-r and omized , controlled trials . We excluded evaluations of alternative and complementary medicines because the stability of review s of such therapies might differ substantially from review s of conventional therapies . We required that review s provide a point estimate and 95 % confidence interval for at least 1 outcome in the form of a relative risk , odds ratio , or absolute risk difference for binary outcomes and weighted mean differences for continuous outcomes . We excluded meta-analyses of individual-patient data , meta-regressions , and indirect meta-analyses because of the difficulty of determining whether new data would alter previous quantitative results . Two team members independently assessed eligibility , with disagreements resolved by consensus involving a third review er . When more than 1 review on the same topic was identified , only the earliest was included . Search ing For each review , search es for new trials included identifying new systematic review s on the same topic , su bmi tting relevant content terms to the Clinical Queries function in Ovid , applying the Related Articles function in PubMed to the 3 largest and the 3 most recent trials in the original review ( up to 6 trials in total ) , and using Scopus ( www . scopus .com/ scopus /home.url ) to identify new r and omized trials that cited the original review . When these search strategies yielded no eligible new trials , we conducted more comprehensive electronic search es and review ed relevant chapters in such sources as Clinical Evidence and UpTo Date to ensure that we had not missed new trials . Team members who had background s in both medicine and clinical research screened citations retrieved by the preceding methods to identify trials that would have met the inclusion criteria in the original review . Retrieved articles were screened in chronological order to ascertain quantitative or qualitative signals for the need for updating . The review protocol stopped when any criteria for updating were met . Each systematic review was discussed in detail , with the final statussignal for updating was or was not detectedadjudicated by consensus ( Figure 1 ) . Figure 1 . Overall process for determining updating status . ACP Journal Club Signals for the Need to Up date Systematic Review s In design ing criteria for comparing new findings with those in a previous review , we adapted methods used by other investigators to address similar problems with comparing 2 sets of results relating to the same question ( 913 ) , such as r and omized and nonr and omized studies of the same intervention . These investigators identified conflicting findings among different publications using a combination of quantitative thresholds for differences in effect magnitude and qualitative judgments about the language used to describe the results . We have similarly conceptualized quantitative and qualitative signals of potential changes in evidence that are sufficiently important to warrant updating previous systematic review s. Quantitative Signals Quantitative signals consisted of a change in statistical significance or relative change in effect magnitude of at least 50 % . We restricted these changes to those involving 1 of the primary outcomes of the original review or any mortality outcome . We also ignored trivial changes in statistical significance when the original and up date d meta-analytic results both had P values between 0.04 and 0.06so that quantitative signals of changes in evidence would represent robust indicators of the need to up date previous review s. Quantitative signals were detected by combining data from eligible new trials with the previous results using a fixed-effects approach . Use of fixed-effect models allowed pooling of the new trials with the previous meta-analytic result , as opposed to having to obtain original data from all of the included trials in each of 100 systematic review s. Although r and om-effects models are usually preferred to avoid spurious precision in the face of heterogeneity , our goal was to detect potential changes in evidence that would warrant a formal up date , not produce exact estimates of the up date d results . Qualitative Signals Qualitative signals included new information about harm sufficient to affect clinical decision making , important caveats to the original results , emergence of a superior alternate therapy , and important changes in certainty or direction of effect . Qualitative signals were detected by using explicit criteria for comparing the language in the original review with descriptions of findings in new systematic review s that addressed the same topic , pivotal trials , clinical practice guidelines , or recent editions of major textbooks ( for example , UpTo Date ) . Pivotal trials were defined as trials that had a sample size at least 3 times larger than that of the previous largest trial or were published in 1 of the 5 highest-impact general medical journals ( The New Engl and Journal of Medicine , Lancet , Journal of the American Medical Association , Annals of Internal Medicine , and the British Medical Journal ) . We defined 2 levels of importance for qualitative signals : potentially invalidating changes in evidence , which would make one no longer want clinicians or policymakers to base decisions on the original findings ( such as a pivotal trial that characterized treatment effectiveness in terms opposite of those in the original systematic review ) , and major changes in evidence , which would affect clinical decision making in important ways without invalidating the previous results ( such as the identification of patient population s for whom treatment is more or less beneficial ) . Major changes also included differing characterizations of effectiveness that were less extreme than those for potentially invalidating signals but that would still affect clinical decision making ( for example , a change from possibly beneficial to definitely beneficial ) . Of importance , such characterizations as possibly effective , probably effective , and promising , were all categorized as possibly effective . Thus , qualitative signals for changes in evidence captured substantive differences in the characterization of treatment effects , not merely semantic differences . Full definitions for each of the specific signals can be found at www.ohri.ca/UpdatingSystRevs . Data Collection For each review , we characterized the clinical content area , eligibility criteria for included trials , definitions of reported outcomes , number of included trials and participants , meta-analytic result for each outcome , identification of statistical heterogeneity , and excerpted quotations of the authors ' characterizations of the main results . We also abstract ed whether a given outcome was explicitly identified as 1 of the primary or main outcomes . We discounted identification of more than 3 such outcomes as inconsistent with the OBJECTIVE To evaluate the effectiveness of infant massage compared with that of a crib vibrator in the treatment of infantile colic . METHODS Infants < 7 weeks of age and perceived as colicky by their parents were r and omly assigned to an infant massage group ( n = 28 ) or a crib vibrator group ( n = 30 ) . Three daily intervention periods were recommended in both groups . Parents recorded infant crying and given interventions in a structured cry diary that was kept for 1 week before ( baseline ) and for 3 weeks during the intervention . Parents were interviewed after the first and third weeks of intervention to obtain their evaluation of the effectiveness of the given massage or crib vibration . RESULTS At baseline , the mean amount of total crying was 3.6 ( st and ard deviation : 1.4 ) hours/day in the massage group infants and 4.2 ( 2.0 ) hours/day in the vibrator group infants . The mean amount of colicky crying was 2.1 ( st and ard deviation : 1.1 ) hours/day and 2.9 ( 1.5 ) hours/day , respectively . The mean number of daily intervention periods was 2.2 in both groups . Over the 4-week study , the amount of total and colicky crying decreased significantly in both intervention groups . The reduction in crying was similar in the study groups : total crying decreased by a mean 48 % in the massage group and by 47 % in the vibrator group , and colicky crying decreased by 64 % and 52 % , respectively . The amount of other crying ( total crying minus colicky crying ) remained stable in both groups over the intervention . Ninety-three percent of the parents in both groups reported that colic symptoms decreased over the 3-week intervention , and 61 % of the parents in the massage group and 63 % of the parents in the crib vibrator group perceived the 3-week intervention as colic reducing . CONCLUSIONS Infant massage was comparable to the use of a crib vibrator in reducing crying in colicky infants . We suggest that the decrease of total and colicky crying in the present study reflects more the natural course of early infant crying and colic than a specific effect of the interventions We evaluated the effect of an herbal tea preparation on  infantile colic  in a prospect i ve double-blind study . The use of tea eliminated the colic in 19 ( 57 % ) of 33 infants , whereas placebo was helpful in only 9 ( 26 % ) of 35 ( p < 0.01 ) . The mean colic score was significantly improved in tea-treated infants . No significant differences were noted between groups regarding number of night wakings 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 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 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 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 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 Acupuncture has been used therapeutically in China for thous and s of years and is growing in prominence in Europe and the United States . In a recent review of complementary and alternative medicine use in the US population , an estimated 2.1 million people or 1.1 % of the population sought acupuncture care during the past 12 months . Four percent of the US population used acupuncture at any time in their lives . We review ed 31 different published journal articles , including 23 r and omized controlled clinical trials and 8 meta- analysis / systematic review s. We found evidence of some efficacy and low risk associated with acupuncture in pediatrics . From all the conditions we review ed , the most extensive research has looked into acupuncture 's role in managing postoperative and chemotherapy-induced nausea/vomiting . Postoperatively , there is far more evidence of acupuncture 's efficacy for pediatrics than for children treated with chemotherapy . Acupuncture seems to be most effective in preventing postoperative induced nausea in children . For adults , research shows that acupuncture can inhibit chemotherapy-related acute vomiting , but conclusions about its effects in pediatrics can not be made on the basis of the available published clinical trials data to date . Besides nausea and vomiting , research conducted in pain has yielded the most convincing results on acupuncture efficacy . Musculoskeletal and cancer-related pain commonly affects children and adults , but unfortunately , mostly adult studies have been conducted thus far . Because the manifestations of pain can be different in children than in adults , data can not be extrapolated from adult research . Systematic review s have shown that existing data often lack adequate control groups and sample sizes . Vas et al , Alimi et al , and Mehling et al demonstrated some relief for adults treated with acupuncture but we could not find any well-conducted r and omized controlled studies that looked at pediatrics and acupuncture exclusively . Pain is often unresolved from drug therapy , thus there is a need for more studies in this setting . For seasonal allergic rhinitis , we review ed studies conducted by Ng et al and Xue et al in children and adults , respectively . Both population s showed some relief of symptoms through acupuncture , but questions remain about treatment logistics . Additionally , there are limited indications that acupuncture may help cure children afflicted with nocturnal enuresis . Systematic review s show that current published trials have suffered from low trial quality , including small sample sizes . Other areas of pediatric afflictions we review ed that suffer from lack of research include asthma , other neurologic conditions , gastrointestinal disorders , and addiction . Acupuncture has become a dominant complementary and alternative modality in clinical practice today , but its associated risk has been question ed . The National Institutes of Health Consensus Statement states “ one of the advantages of acupuncture is that the incidence of adverse effects is substantially lower than that of many drugs or other accepted procedures for the same conditions . ” A review of serious adverse events by White et al found the risk of a major complication occurring to have an incidence between 1:10,000 and 1:100,000 , which is considered “ very low . ” Another study found that the risk of a serious adverse event occurring from acupuncture therapy is the same as taking penicillin . The safety of acupuncture is a serious concern , particularly in pediatrics . Because acupuncture 's mechanism is not known , the use of needles in children becomes question able . For example , acupoints on the vertex of infants should not be needled when the fontanel is not closed . It is also advisable to apply few needles or delay treatment to the children who have overeaten , are overfatigued , or are very weak . Through our review of pediatric adverse events , we found a 1.55 risk of adverse events occurring in 100 treatments of acupuncture that coincides with the low risk detailed in the studies mentioned previously . The actual risk to an individual patient is hard to determine because certain patients , such as an immunosuppressed patient , can be predisposed to an increased risk , acupuncturist 's qualifications differ , and practice s vary in certain parts of the world . Nevertheless , it seems acupuncture is a safe complementary/alternative medicine modality for pediatric patients on the basis of the data we review ed 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 Objective To analyze the global microbial composition , using large-scale DNA sequencing of 16 S rRNA genes , in faecal sample s from colicky infants given L. reuteri DSM 17938 or placebo . Methods Twenty-nine colicky infants ( age 10–60 days ) were enrolled and r and omly assigned to receive either Lactobacillus reuteri ( 108 cfu ) or a placebo once daily for 21 days . Responders were defined as subjects with a decrease of 50 % in daily crying time at day 21 compared with the starting point . The microbiota of faecal sample s from day 1 and 21 were analyzed using 454 pyrosequencing . The primers : Bakt_341F and Bakt_805R , complemented with 454 adapters and sample specific barcodes were used for PCR amplification of the 16 S rRNA genes . The structure of the data was explored by using permutational multivariate analysis of variance and effects of different variables were visualized with ordination analysis . Results The infants ’ faecal microbiota were composed of Proteobacteria , Firmicutes , Actinobacteria and Bacteroidetes as the four main phyla . The composition of the microbiota in infants with colic had very high inter-individual variability with Firmicutes/Bacteroidetes ratios varying from 4000 to 0.025 . On an individual basis , the microbiota was , however , relatively stable over time . Treatment with L. reuteri DSM 17938 did not change the global composition of the microbiota , but when comparing responders with non-responders the group responders had an increased relative abundance of the phyla Bacteroidetes and genus Bacteroides at day 21 compared with day 0 . Furthermore , the phyla composition of the infants at day 21 could be divided into three enterotype groups , dominated by Firmicutes , Bacteroidetes , and Actinobacteria , respectively . Conclusion L. reuteri DSM 17938 did not affect the global composition of the microbiota . However , the increase of Bacteroidetes in the responder infants indicated that a decrease in colicky symptoms was linked to changes of the microbiota . Trial Registration Clinical Trials.gov The possible role of cows milk intolerance in the aetiology of infant colic was evaluated in 19 babies presenting to their health visitor or general practitioner in one town . Over a three week period a st and ard modified cows milk formula was compared with a soya milk formula on a double blind basis . The duration of colic symptoms was significantly reduced during the week on soya milk ( P less than 0.01 ) , with 11 out of 19 babies fulfilling the diagnostic criteria for cows milk intolerance . Four babies whose symptoms failed to improve either spontaneously or with soya milk were given a hydrolysed protein milk with a positive response in two , confirmed by challenge testing . Thus in 13 out of 19 babies ( 68 % ) the symptoms of infant colic resolved almost completely with dietary change In this open , controlled , prospect i ve study , 28 infants with colic were r and omized to either  cranial osteopathic manipulation or no treatment ;  all were seen once weekly for 4 weeks . Treatment was according to individual findings , and administered by the same practitioner . Parents recorded time spent crying , sleeping and being held/rocked on a 24-hour diary . A progressive , highly significant reduction between weeks 1 and 4 in crying ( hours/24h ) was detected ( P<0.001 ) in treated infants ; similarly , there was a significant improvement in time spent sleeping ( P<0.002 ) . By contrast , no significant differences were detected in these variables for the control group . Overall decline in crying was 63 % and 23 % , respectively , for treated and controls ; improvement in sleeping was 11 % and 2 % . Treated infants also required less parental attention than the untreated group . In conclusion , this preliminary study suggests that cranial osteopathic treatment can benefit infants with colic ; a larger , double-blind study is warranted 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 BACKGROUND Safe and effective treatment of infantile colic ( IC ) has not yet been determined . In this study , the authors aim ed to investigate the efficiency of 30 % glucose solution in the treatment of IC . METHODS A total of 25 infants diagnosed as typical IC were given 1 mL of 30 % glucose solution or sterile water for 4 days consecutively , in a r and omized , double blind crossover trial . The effect was measured by parents ' scoring . RESULTS Parents reported varying degrees of improvement in 16 infants ( 64 % ) given glucose solution , and in 12 infants ( 48 % ) given placebo . Comparison of treatment modalities were statistically significant ( P = 0.031 ) . There was no side-effect during treatments . CONCLUSION The present study revealed that 30 % glucose was effective in the treatment of IC . Since oral glucose solution is natural , safe , cheap and easily achievable , it might be considered as an alternative therapy 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 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 AIMS To examine if sucrose has an analgesic effect on infant colic . METHODS Nineteen infants with typical infant colic were given 2 ml of 12 % sucrose or distilled water when crying , in a double blind double crossover study . The effect was measured by parents ’ score . RESULTS Twelve improved specifically on sucrose and one on placebo ( p < 0.01 ) . Five showed a non-specific improvement . CONCLUSIONS Sucrose has a significant ameliorating effect on 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 OBJECTIVE The aim of this r and omized , double-blind , placebo-controlled trial was to investigate the effectiveness and side effects of a phytotherapeutic agent with Matricariae recutita , Foeniculum vulgare and Melissa officinalis in the treatment of infantile colic . METHODS 93 breastfed colicky infants were enrolled , the diagnosis was made according to Wessel 's criteria . After a 3 day observation period , the infants were r and omly divided into two groups , one treated with phytotherapeutic agent ( PA ) and the other with placebo twice a day for 1 week . Crying time and side effects were recorded . RESULTS 88 infants completed the trial : 41 in the PA group and 47 in the control . The daily average crying time for the PA was 201.2 min/day ( SD 18.3 ) at the baseline and 76.9 min/day ( SD 23.5 ) at the end of the study ; for the placebo it was 198.7 min/day ( SD 16.9 ) and 169.9 min/day ( SD 23.1 ) ( p < 0.005 ) . Crying time reduction was observed in 85.4 % subjects for the PA and in 48.9 % subjects for the placebo ( p < 0.005 ) . No side effects were reported . CONCLUSION The present study shows that colic in breastfed infant improves within 1 week of treatment with an extract based on Matricariae recutita , Foeniculum vulgare and Melissa officinalis 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 The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials OBJECTIVE The purpose of this study was to determine the efficacy of chiropractic manual therapy for infants with unexplained crying behavior  and if there was any effect of parental reporting bias . METHODS Infants with unexplained persistent crying ( infant colic ) were recruited between October 2007 and November 2009 at a chiropractic teaching clinic in the United Kingdom . Infants younger than 8 weeks were r and omized to 1 of 3 groups : ( i ) infant treated , parent aware ; ( ii ) infant treated , parent unaware ; and ( iii ) infant not treated , parent unaware . The primary outcome was a daily crying diary completed by parents over a period of 10 days . Treatments were pragmatic , individualized to examination findings , and consisted of chiropractic manual therapy of the spine . Analysis of covariance was used to investigate differences between groups . RESULTS One hundred four patients were r and omized . In parents blinded to treatment allocation , using 2 or less hours of crying per day to determine a clinical ly significant improvement in crying time , the increased odds of improvement in treated infants compared with those not receiving treatment were statistically significant at day 8 ( adjusted odds ratio [ OR ] , 8.1 ; 95 % confidence interval [ CI ] , 1.4 - 45.0 ) and at day 10 ( adjusted OR , 11.8 ; 95 % CI , 2.1 - 68.3 ) . The number needed to treat was 3 . In contrast , the odds of improvement in treated infants were not significantly different in blinded compared with nonblinded parents ( adjusted ORs , 0.7 [ 95 % CI , 0.2 - 2.0 ] and 0.5 [ 95 % CI , 0.1 - 1.6 ] at days 8 and 10 , respectively ) . CONCLUSIONS In this study , chiropractic manual therapy improved crying behavior in infants with colic . The findings showed that knowledge of treatment by the parent did not appear to contribute to the observed treatment effects in this study . Thus , it is unlikely that observed treatment effect is due to bias on the part of the reporting parent 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
target: Probiotics , fennel extract  and  spinal manipulation  show promise to alleviate symptoms of colic , although some concerns remain .
background: 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 .