Effects of Minimal Acupuncture in Children with Infantile Colic – a Prospective, Quasi-Randomised Single Blind Controlled Trial On pins and needles? Pediatric pain patients' experience with acupuncture. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials Safety and Efficacy of Acupuncture in Children: A Review of the Evidence Feeding, stooling and sleeping patterns in infants with colic - a randomized controlled trial of minimal acupuncture A Pilot Study of St36 Acupuncture for Infantile Colic Electric acupuncture treatment of peripheral nerve injury. Reasons for referrals of children and adolescents to alternative medicine in southern Israel. Quantitative Synthesis in Systematic Reviews [Treatment of simple obesity in children with photo-acupuncture]. Acupuncture in preterm babies during minor painful procedures. Acupuncture therapy for infants: a preliminary report on reasons for consultation, feasibility, and tolerability.
Background Colic causes crying in 10–30 % of infants and is one of the primary reasons parents seek health care . Treatments are generally not totally effective and some cause side effects . In this study we aim ed to test the effect of light needling ( minimal acupuncture ) on crying . Methods Forty children ( median six weeks of age ) with excessive crying unresponsive to conventional therapies , were recruited from 21 Child Welfare Clinics within an area of western Sweden , and quasi-r and omised to control or light needling treatment . Parents were unaware of which group their child was assigned to . Children were given light needling acupuncture on one point ( LI4 ) on both h and s for approximately 20 seconds on four occasions , or received the same care except needling .  Parental assessment question naires were used pre- and post-treatment to assess crying intensity , frequency , duration of crying and pain related behaviour throughout the day in six hour periods . Results Light needling result ed in a significant reduction in the rated crying intensity ( assessed by a numeric rating scale , 0 to 10 ) . For example , during the morning time period 0600–1200 hours , the median ( range ) rated crying intensity changed from 6 ( 1 to 9 ) pre-treatment to 2 ( 0 to 5 ) post-treatment ( P=0.002 ) , in the light needling group . The corresponding ratings for the children in the control group was 6 ( 0 to 10 ) and 5 ( 0 to 10 ) respectively . The difference between the groups was significant ( P=0.016 ) . There were also significant differences between the groups for the afternoon ( 1200–1800 hours ) , and evening ( 1800–midnight ) time periods . Pain related behaviour like facial expression , was also significantly less pronounced in the light needling group as compared to the control group post-treatment , ( P=0.027 ) . The parents rated the light needling as more effective in improving symptoms than the control group ( P<0.001 ) . Conclusion Four treatments with light needling on one point in the h and may alleviate crying and pain related behaviour without any noted side effects INTRODUCTION Despite its increasing use as a complementary therapy to treat pain , acupuncture is rarely considered by pediatricians , in part due to perceptions that it will not be acceptable to pediatric patients . We wished to describe pediatric pain patients ' experience with acupuncture treatment for chronic pain . DESIGN Retrospective case series . METHODS Subjects were pediatric pain patients referred by the Pain Treatment Service at Children 's Hospital in Boston , who went to a pediatric acupuncturist .  A research assistant not involved in the patient 's care conducted the survey by telephone . Data were analyzed qualitatively and descriptively . RESULTS Of 50 eligible patients , 47 families were reached by telephone ; all agreed to be interviewed . Patients had a median age of 16 years at the time of referral , 79 % were female , and 96 % were white . The most common three diagnoses were migraine headache ( n = 7 ) , endometriosis ( n = 6 ) , and reflex sympathetic dystrophy ( n = 5 ) . Patients had a median of 8 treatments ( range : 0 - 60 ) within 3 months ( range : 0 - 48 months ) ; 85 % of families paid out-of-pocket . Acupuncture therapies included needle insertion ( 98 % ) , heat/moxa ( 85 % ) , magnets ( 26 % ) , and cupping ( 26 % ) . Most patients and parents rated the therapy as pleasant ( 67 % children/60 % parents ) , and most ( 70 % children/59 % parents ) felt the treatment had helped their symptoms ; only 1 said that treatment made symptoms worse . CONCLUSION Pediatric patients with chronic , severe pain found  acupuncture treatment pleasant and helpful . Additional , prospect i ve studies are needed to quantify the costs and effectiveness of acupuncture treatment for pediatric pain Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more 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 Background The aim was to describe the feeding- and stooling patterns of infants with colic and evaluate the influence of minimal acupuncture . Methods A prospect i ve , r and omized , controlled , blind clinical study was conducted at a private acupuncture clinic in Sweden . 90 otherwise healthy 2 - 8 weeks old infants , born after gestational week 36 , fulfilling the criteria for infantile colic and not medicated with dicyclomine , were included . 81 infants went through a structured program consisting of six visits to the clinic , twice weekly . Infants r and omized to receive acupuncture  were given minimal , st and ardized acupuncture for two seconds in LI4 . Frequency and size of stooling , as well as duration of , and intervals between , feeding sessions were reported by parents in a diary . Parental assessment of sleep and comments on stooling and side effects were collected in a question naire . Results At baseline when the mean age was five weeks , infants in both groups were fed a median of eight times/day , 148 min/day , with considerable variations . No differences were found between groups in the frequency and duration of feeding during the intervention weeks . Furthermore there were no significant differences between the groups regarding the frequency of stooling , neither at baseline , at which point the infants of both groups had bowel movements 4.2 times/day , nor during the intervention weeks . There was an expected decrease in frequency of stooling in both groups , reaching 2.1 ( p = 0,001 ) in the acupuncture group and 3.1 ( p < 0,001 ) in the control group . The groups differed regarding large bowel movements which decreased linearly in the control group ( p = 0,011 ) but not in the acupuncture group ( p = 0,787 ) . More parents in the acupuncture group than in the control group ( 28 % and 15 % respectively , p = 0.006 ) experienced the infant 's sleep to be " better " or " much better . " No other significant differences were found . However , parents described a normalized stooling and experienced an improvement in colic in their infants more frequently in the acupuncture group than in the control group . Conclusions Infants with colic in the present study had a higher frequency of stooling than reported internationally in healthy infants .  Minimal acupuncture had no major effect on feeding , stooling and sleep , although a minor effect of minimal acupuncture on stooling and sleep can not be ruled out . Trial registration Clinical Trials.govID 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 54 cases of peripheral nerve injury were treated by electric acupuncture and compared with 54 control cases treated with supportive medication . The changes after treatment were observed chiefly by electromyography while sensory and motor improvement were also recorded as auxiliary indicators . The therapeutic results in the acupuncture group were 5 cases cured , 26 markedly effective , 19 improved , and 4 cases failed , a total effective rate of 92.6 % in contrast to the 55.6 % for the controls . Analysis of the therapeutic results showed that 1 ) those in the acupuncture group were significantly better than in the control group ; 2 ) nerve injuries should be treated as early as possible ; 3 ) the radial nerve and the common peroneal nerve recovered faster than others ; 4 ) cases not surgically explored recovered faster than those that were , and 5 ) patients with prompt propagation of the needling sensation recovered significantly faster than those with slow propagation OBJECTIVES The use of complementary and alternative medicine ( CAM ) has increased over recent years . Little is known about the use of CAM by children and adolescents . The study objectives were to characterize reasons for referrals and types of therapy for children and adolescents who turned to a CAM clinic . DESIGN An observational study with prospect i ve collection of data through interviews with the parents conducted by the clinic triage physician using question naires . SUBJECTS Parents of children and adolescents who came for treatment to a CAM clinic . INTERVENTION None . OUTCOME MEASURES The medical reasons for using CAM .  RESULTS The parents of 86 ( 55 % ) of the children who came for CAM in the study period , November 2005 to June 2006 , participated in the study ( 54 males , 62.8 % ) . The mean patient age was 6.75 years ( median , 4.79 ) . The most common reasons for CAM were immunological and allergy problems ( 30 % ) , infectious diseases ( 21.4 % ) , and attention deficit and concentration disorders ( 14.6 % ) . The most common treatment modalities for children and adolescents were  homeopathy  ( 33.7 % ) , reflexology ( 29.7 % ) , and acupuncture ( 18.8 % ) . Most of the immunological problems ( 58.1 % ) and the infectious diseases ( 66.7 % ) were referred for homeopathy , and most of the attention deficit and concentration disorders ( 66.7 % ) were treated by reflexology . Nonmedical reasons for CAM included disappointment with the results of conventional treatment ; the desire for effective , innocuous , supplemental therapy ; and previous experience among parents , friends , and family members . CONCLUSIONS Dem and for CAM therapy for children is driven by universal factors . CAM can be an adjuvant therapy for children with common chronic pediatric problems A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis OBJECTIVE To study the treatment of simple obesity in children and observe its effect . METHODS Two hundred and two patients were treated with self-produced photo-acupuncture apparatus ( 101 cases ) or ear-pressing ( 101 cases ) , and their effects were observed and compared . RESULTS Effects of both methods were satisfactory . The photo-acupuncture showed a better result than that of the ear-pressing . After treatment , the obesity indexes lowered significantly and levels of blood lipids , glucose , cortisol and triiodothyronine were all improved markedly . CONCLUSIONS Photo-acupuncture is a safe , painless , nontraumatic and effective method for treatment of simple obesity , and it is easy to be accepted by children OBJECTIVE To evaluate analgesic effects of acupuncture in preterm neonates during minor painful procedures . METHODS Ten preterm neonates requiring heel prick for blood gas analysis were enrolled in the study , which had a crossover design . Oxygen saturation , systolic and diastolic blood pressure , respiratory rate , heart rate , and crying duration were recorded before and after heel prick . Babies were given expressed breast milk before each procedure . Patients were r and omly assigned to receive acupuncture or not , and the groups were crossed over on the following day , so that patients who had received acupuncture received only breast milk , and the previous breast milk only group received both acupuncture and breast milk . The neonatal infant pain scale ( NIPS ) was used for pain evaluation . RESULTS Crying duration and NIPS pain scores during heel prick were lower in the neonates who had received acupuncture . CONCLUSION Acupuncture is an effective method for the treatment of pain in neonates OBJECTIVES / AIMS The aim of this retrospective review was to determine the feasibility , safety , and potential therapeutic effects of acupuncture in an inpatient infant population and to obtain data that would support the design of a r and omized , controlled trial of acupuncture in infants . BACKGROUND Hospitalized infants are often exposed to sedative and analgesic medications to facilitate intensive and invasive medical care . With increasing concern about the potential neurotoxic effects of common analgesic and sedative medications , minimizing an infant 's exposure to such agents is desirable . Acupuncture can be therapeutic in adults and children , but data in infants are lacking . METHODS / MATERIAL S We performed a retrospective chart review of infants who received acupuncture during hospitalizations between 2008 and 2010 . Demographic data , diagnoses , reason for acupuncture consult , ventilator setting s , sedative/analgesic medication regimens , details of acupuncture therapy , and adverse effects were among data collected . RESULTS Ten infants were identified in this review , seven of whom had agitation issues , two of whom had feeding difficulties , and one had both symptoms . Six of the eight infants with agitation had a decrease in the use of sedative and analgesic medications over the acupuncture therapy period , and four of five initially requiring mechanical ventilation were successfully weaned . One of the three infants with oral aversion transitioned rapidly to oral intake .  Acupuncture therapy was well tolerated , and there were no complications observed . CONCLUSIONS In this small group of hospitalized infants , acupuncture was found to be safe , well tolerated , and therapeutic . More studies are warranted to define the role of acupuncture in this population
The aim of the paper was to review the literature about safety and efficiency of acupuncture therapy in term and preterm infants .