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Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA… Janssen, Patricia A; Demorest, Louise C; Kelly, Anne; Thiessen, Paul; Abrahams, Ron Dec 23, 2012

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RESEARCH Open AccessAuricular acupuncture for chemically dependentpregnant women: a randomized controlled trialof the NADA protocolPatricia A Janssen1*, Louise C Demorest1, Anne Kelly2, Paul Thiessen3 and Ron Abrahams4AbstractBackground: The prevalence of maternal drug use during pregnancy in North America has been estimated to beas high as 6-10%. The consequences for the newborn include increased risk for perinatal mortality and ongoingphysical, neurobehavioral, and psychosocial problems. Methadone is frequently used to wean women off streetdrugs but is implicated as a cause of adverse fetal/neonatal outcomes itself. The purpose of our study was to testthe ability of maternal acupuncture treatment among mothers who use illicit drugs to reduce the frequency andseverity of withdrawal symptoms among their newborns.Methods: We randomly assigned chemically dependent pregnant women at BC Women’s Hospital in Vancouver,British Columbia to daily acupuncture treatments versus usual care. By necessity, neither our participants noracupuncturists were blinded as to treatment allocation. Our primary outcome was days of neonatal morphinetreatment for symptoms of neonatal withdrawal. Secondary neonatal outcomes included admission to a neonatalICU and transfer to foster care.Results: We randomized 50 women to acupuncture and 39 to standard care. When analyzed by randomizedgroups, we did not find benefit of acupuncture; the average length of treatment with morphine for newborns inthe acupuncture group was 2.7 (6.3) compared to 2.8 (7.0) in the control group. Among newborns of women whowere compliant with the acupuncture regime, we observed a reduction of 2.1 and 1.5 days in length of treatmentfor neonatal abstinence syndrome compared to the non-compliant and control groups, respectively. Thesedifferences were not statistically significant.Conclusions: Acupuncture may be a safe and feasible treatment to assist mothers to reduce their dosage ofmethadone. Our results should encourage ongoing studies to test the ability of acupuncture to mitigate theseverity of neonatal abstinence syndrome among their newborns.Clinical Trial Registration: http://www.clinicaltrials.gov registry: W05-0041Keywords: Acupuncture, Addiction, Pregnancy, Substance abuse, Neonatal abstinence syndromeBackgroundThe prevalence of maternal drug use during pregnancyin Canada [1] and the US [2] has been estimated to beas high as 6-10%. The consequences for the newborn aresevere, and include increased risk for perinatal mortalityand morbidity, as well as ongoing physical, neurobeha-vioral, and psychosocial problems [3-7]. Between 60-90%of infants exposed to illicit drugs in utero will exhibitclinical symptoms of withdrawal, particularly if opiatesare among the drugs used [8-10].Methadone treatment is currently the recommendedapproach to opiate addiction during pregnancy [11]. Thepurpose of this treatment is to alleviate the symptoms ofdrug withdrawal in order to prevent use of street drugs.It is widely believed that intrauterine death or fetal com-promise is due to the “bingeing” or drastic fluctuationsin serum levels of opiates or cocaine associated with“street” use [12]. Methadone substantially minimizes the* Correspondence: patti.janssen@ubc.ca1School of Population and Public Health, Child and Family Research Institute,University of British Columbia, 2206 East Mall, Vancouver, BC, CanadaV6T-1Z3Full list of author information is available at the end of the article© 2012 Janssen et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.Janssen et al. Substance Abuse Treatment, Prevention, and Policy 2012, 7:48http://www.substanceabusepolicy.com/content/7/1/48peak and trough in maternal serum opioid levels thattypically occur with repeat use of short-acting opioidssuch as heroin, thereby reducing the harm that the fetusencounters as a result of repeated intoxication and with-drawal [13]. Methadone use during pregnancy has beenassociated with improved prenatal care, [14] longer ges-tation, [15] higher birthweight, [16] and increased ratesof infants discharged home in the care of their mothers[17]. In hospital, the dosage of methadone is tailored tothe mother’s tolerance of symptoms and is titrated over a24-hour period to avoid fluctuations in levels of metha-done in the fetal circulation. Unfortunately, if symptomsare not well controlled with methadone use, or perhapseven if they are, women frequently continue to use otherdrugs [18]. Methadone itself is highly addictive and isimplicated as a cause of adverse fetal/neonatal sequelae[19,20]. Methadone-exposed babies have demonstratedreduced birth weight and head circumference, prematurity,[21] and rates of neonatal withdrawal syndrome rangingfrom 46% [22] to 97% [12,23]. A dose–response relation-ship between methadone and neonatal abstinence syn-drome (NAS) has been reported in a large series of 618women [24] but a meta-analysis by the same author [23]and others [25] did not confirm these findings. A recentprospective study by this group concluded that neonatesexposed to methadone doses ≥ 80 mg required higher cu-mulative doses of morphine treatment for NAS but attrib-uted this to concomitant use of other drugs [26]. Increasedrates of congenital anomalies have been reported in non-randomized studies, [12,24,27] but these have not yet beenevaluated in randomized designs [28] capable of control-ling for concomitant consumption of other substances.While the physiological mechanisms underlying acu-puncture have yet to be unambiguously identified, thebalance of evidence favours quantitative differences inelectrodermal properties between acupuncture points andsurrounding skin [29,30]. There is also emerging evidenceof correlations between connective tissue anatomy, micro-circulatory blood flow, and acupuncture needling points[31]. Acupuncture in the context of addiction is still rela-tively new [32-35]. Acupuncture points are cutaneousareas containing relatively large concentrations of freenerve endings [36]. The acupuncture stimulus is transmit-ted to the spinal cord by afferent peripheral nerves [34].Acupuncture is believed to stimulate the release of endor-phins [37] from the pituitary gland and the hypothalamus.Endorphins are neurotransmitters involved in pain inhib-ition. They are 10–100 times more potent than morphineand may circulate for several hours. Levels of endorphinshave been shown to increase after acupuncture in animalmodels [38,39]. Alcohol and opioids may preferentiallybind to endorphin receptors and thereby displace en-dogenous endorphins [40,41]. Over time the productionand action of the natural endorphins is inhibited. Cravingduring withdrawal from illicit opioids may result from adeficiency in endogenous opioids as well as from otherneurochemical defects associated with drug abuse [40].The role of acupuncture in the treatment of addictionwas discovered serendipitously [42] and subsequently re-fined at the Lincoln Recovery Center in Bronx, New Yorkwhere the National Acupuncture Detoxification Associ-ation (NADA) protocol was developed [43]. A randomizedcontrolled trial of NADA auricular acupuncture utilizinganalysis of urine screens showed that acupuncture signifi-cantly reduced cocaine use compared with each of twocontrol conditions [32].There have been no studies to date specifically addres-sing the use of acupuncture for treatment of substanceabuse in pregnancy. The purpose of this study is to de-termine the efficacy of daily maternal acupuncture treat-ments in reducing the frequency and severity of (NAS)among infants born to substance-using women.MethodsWe conducted a randomized controlled trial of metha-done maintenance (standard treatment) to chemicallydependent hospitalized pregnant women vs. methadonecombined with the offer of daily acupuncture treat-ments. Our primary outcome was the number of daysthat neonates were treated with morphine for neonatalwithdrawal syndrome. We received ethical approvalfrom the University of British Columbia Clinical EthicsResearch Board and the BC Women’s Hospital ResearchReview Committee.SettingWe conducted our study at BC Women’s Hospital inVancouver, British Columbia between July 15, 2005-April30, 2008. Chemically dependent women living in Vancouverand surrounding suburbs are referred to the BC Women’sChemical Dependency Unit by their primary caregiver assoon as they present for prenatal care, usually in the secondtrimester. They are admitted to the chemical dependencyunit on a voluntary basis. They are offered a methadonemaintenance program or support to withdraw from metha-done and other illicit drugs. After an initial stay of approxi-mately two months, they are discharged then readmittedapproximately two weeks prior to their due date. After thebirth, mothers and their newborns are discharged togetherwhen the baby is stable, gaining weight, and does not re-quire treatment for symptoms of NAS. The unit is built onan empowerment model in which women have access to avariety of “healing” activities such as yoga, gardening, thera-peutic touch, peer support groups, arts and crafts, groupwalks and massage therapy. Residents participate in theirown discharge planning meetings. Sessions with alcoholand drug support counsellors are available on the unit.Urine testing is not done. Babies room in with theirJanssen et al. Substance Abuse Treatment, Prevention, and Policy 2012, 7:48 Page 2 of 10http://www.substanceabusepolicy.com/content/7/1/48mothers unless neonatal intensive care is required. Allwomen admitted to the Chemical Dependency Unit atBC Women’s Hospital were offered participation in thecurrent study.SampleWomen admitted to the chemical dependency unit atBC Women’s Hospital, Vancouver, B.C. were consideredto be eligible for inclusion. Exclusion criteria consistedof inability to read or write English, having a pacemakeror other electrical implant, having a bleeding disorder, ora condition putting someone at particular risk for infec-tion, including for example, damaged heart valves, dia-betes requiring insulin, immunosuppressive drug therapyor open wounds.Outcome measuresNumber of days of treatment of the newborn with mor-phine was chosen as the primary outcome because it is aclinical measure of the time required for the newborn tocomplete withdrawal from opiates. In this unit, morphineis prescribed for the neonate by pediatricians if there is aconstellation of symptoms unresponsive to environmentalcontrol including: 1) convulsions, 2) inconsolability or cry-ing continuously for 3 hours, 3) persistent tremors or jit-teriness when undisturbed, 4) continuous central nervoussystem irritability including hyperactive Moro reflex, tre-mors, jitteriness, increased muscle tone and unprovokedmuscle jerks, 5) persistent vomiting or projectile vomitingover a 12 hour period, or 6) explosive diarrhea for 2–3consecutive episodes [44]. Additional clinical signs such astachycardia, tachypnea, watery stools, fever, or weight loss> 10% may justify use of morphine after consideration ofdifferential diagnoses. Morphine 1 mg/ml is started at arate of 0.03 mg/kg/dose every 3 hours. The dose is re-viewed daily and titrated based on daily weights andongoing symptoms.Secondary neonatal outcomes include gestational ageat birth, Apgar scores, days to regain birth weight, ratesof admission to a neonatal intensive care nursery, with-drawal symptoms and rates of transfer of the infant tofoster care. Infants experiencing NAS have been shownto require significantly longer time to regain their birth-weight [45]. Neonatal outcomes were ascertained fromthe hospital chart by a research assistant blinded to studyallocation. Withdrawal symptoms are routinely documen-ted by nurses using a modified version of the FinneganScale [46]. Nurses were not formally blinded to study allo-cation. The Finnegan scale has been widely used in studiesof NAS [47,48] and has been shown to be a valid standardagainst which pharmacologic treatment can be titrated[49,50]. The original 22-item-scale instrument consists ofvariables such as sleep duration after feeding, mottling,and nasal stuffiness. We report on a subset of moreobjective items that are documented daily on the unit in-cluding high pitched cry, inconsolable crying, tremors,muscle tone, sucking and swallowing, vomiting anddiarrhea.Study protocolWomen were recruited on the unit by a trial coordinator.After obtaining written informed consent a sequentiallynumbered opaque envelope was opened to reveal thestudy allocation by the study research assistant. Randomallocation to study arm was undertaken using statisticalsoftware, SPSS version 18.We used the National Acupuncture DetoxificationAssociation (NADA) five-point auricular acupunctureprotocol for treating symptoms of drug withdrawal [43].The protocol consists of inserting five stainless steel acu-puncture needles in both ears at points known as Sympa-thetic, Shen men, Liver, Kidney, and Lung. This pointcombination is believed to be specific for substance abuse.The acupuncturist swabbed the ears with alcohol andinserted sterile, disposable needles. Following the 45 mi-nute treatment, participants removed the needles andplaced them in protective sharps boxes in order tominimize risk of needlestick injury to the acupuncturist.All needles were counted to ensure that all had beenretrieved and disposed of. A sham acupuncture procedurewas not used. Chinese traditional medicine does not in-clude the concept of a placebo [51]. Those who argue thatauricular acupuncture stimulates the vagus nerve, whichinnervates the ear concha, state that needles placed any-where in the concha should produce the same effects [52].Studies utilizing sham procedures have failed to show adifference between the control and active experimentalconditions [51,53].Women participating in the treatment group of ourstudy were given access to a quiet room furnished withcomfortable reclining chairs. The acupuncturist spentapproximately 30 minutes with them each day.Physicians prescribing morphine to newborns wereblinded as to treatment arm. Assignment to trial armwas not written in the chart. Women received acupunc-ture treatment at mid-day when pediatricians were notusually on the unit and in a room with the door shut.Mothers were asked not to tell physicians if they werereceiving acupuncture.Sample sizeWe planned to have 80% power to detect a 30% reduc-tion of days of neonatal morphine treatment, from 11.75(5.2) to 8.25 days (5.2) with 37 subjects per treatmentarm. The baseline rate of 11.75 days was derived from apilot study of this population at BC Women’s by one ofthe authors (RA) [54].Janssen et al. Substance Abuse Treatment, Prevention, and Policy 2012, 7:48 Page 3 of 10http://www.substanceabusepolicy.com/content/7/1/48Data analysisData analysis was by intention to treat. Outcomes of par-ticipants were analyzed within the trial arm that theywere randomly assigned to. Socio-demographic charac-teristics assessed at baseline included age, marital status,ethnicity, income, parity, housing (stable vs. transient),smoking status and education. Pregnancy-related charac-teristics assessed included pre-pregnant weight and weightgain, month of entry to prenatal care, and self-reportedsubstance use. Tests of normality (Kolmogorov-Smirnov)were applied to continuous variables. Normally distribu-ted continuous variables were compared betweengroups using the t-test. Non- normally distributed vari-ables were compared using the Mann–Whitney U testfor two groups and the Kruskal-Wallis test for threegroups. Discrete variables were compared betweengroups using the chi-square statistic when expected cellcounts were greater than five; otherwise the Fisher’sexact test was reported. Statistical analysis was under-taken using SPSS, version 18.ResultsAmong 190 eligible women approached to participate inthe study, 89 agreed to participate (Figure 1). Threewomen in the acupuncture group delivered prematurelyor precipitously prior to receiving a treatment. Out-comes could not be ascertained for 2 women in the acu-puncture group and one in the control group becausethey delivered outside of BC Women’s Hospital at anunknown location. Forty-seven women received acu-puncture treatments and 39 received standard ward care.Study groups were comparable with respect to demo-graphic status including age, presence of support per-sons, education, and sources of income (Table 1).Groups did not differ with respect to substance use inprevious pregnancies, retention of custody of previouslyborn children, and use of alcohol, tobacco, crack, cocaine,crystal meth, heroin or other opioids, benzodiazepines, orecstasy (Table 2). Women in each study arm did not differwith respect to pre-pregnant weight, height, weight gainduring the pregnancy, or gestational age at entry toExcluded                             219Not meeting inclusion criteria    118Refused to participate                 101Randomized89Allocated to acupuncture                             50Received allocated intervention            47Did not receive allocated intervention    3Delivered prematurely orprecipitously prior to acupuncture  3Allocated to standard care                             39Received allocated intervention              39Lost to follow-up                         2 Lost to follow-up                1Analyzed                                    48 Analyzed                                   38Assessed for eligibility308Figure 1 Flow chart of Participant Eligibility, Recruitment, and Compliance.Janssen et al. Substance Abuse Treatment, Prevention, and Policy 2012, 7:48 Page 4 of 10http://www.substanceabusepolicy.com/content/7/1/48prenatal care (Table 3). The average length of stay on theunit was similar in the acupuncture and control groups.Dosage of methadone on admission to hospital washigher on average by 10 mg in the acupuncture group.Mode of delivery and rates of breastfeeding did not differbetween groups. Analyzed by intention to treat, therewere no differences in days of morphine treatment be-tween treatment groups. Similarly, groups did not differwith respect to newborn Apgar scores at one or five min-utes, admission to neonatal intensive care unit (ICU),days to regain birthweight, apprehension of the baby tofoster care, or symptoms of neonatal abstinence (Table 4).Compliance with the acupuncture regime varied greatlyamong participants, as did time spent on the hospital unit.When we compared compliant participants, defined asthose who received the highest quartile of acupuncturetreatments, (nine or more treatments), (n=13) with thosewho did not (n=27) in the acupuncture group, and con-trols (n=32) in a post hoc analysis, those in the compliantgroup were taking higher doses of methadone at delivery(Table 5). The reduction in use of methadone from firstadmission to hospital to delivery was larger in theacupuncture-compliant group compared to the acupunc-ture non-compliant group and the control group. Thesefindings would suggest that women who require higherdoses of methadone were more compliant with treatment,perhaps because they believed it to be helpful. On thisbasis we undertook an additional “as treated” analysis,comparing women who had nine or more acupuncturetreatments with those who were non-compliant (less thannine) and control subjects. We further restricted this ana-lysis to women who had some ingestion of opioid, as therewere fourteen women in the study who ingested onlycrack or cocaine and two who were exposed only to crys-tal meth.In this analysis newborns of women in the acupuncture-compliant group experienced a reduction of 2.1 and 1.5days in length of treatment for neonatal abstinencesyndrome compared to the non-compliant and controlgroups, respectively. These differences were not statisti-cally significant (Table 5). With the exception of inconso-lable crying, their newborns exhibited symptoms of NASfor fewer days. These differences were not statisticallysignificantly different.DiscussionWe report that the offer of acupuncture to hospitalizedchemically dependent women in a randomized design isnot associated with improved perinatal outcomes. In thecurrent study, only 28% of women in our acupuncturearm were protocol-compliant. Women in our study whowere compliant were found to be receiving higher dosesof methadone on admission to hospital and reducedtheir dosage of methadone to a greater degree than ei-ther the non-compliant women in the acupuncture-group or the control group. This would suggest thatwomen who would be expected to suffer most fromwithdrawal symptoms remained compliant becausethey believed that the acupuncture was helping them.Indeed they were able to tolerate larger reductions intheir methadone dose prior to delivery and their babiesrequired almost two fewer days of morphine treatment.As well, the babies in this small group were documen-ted by nurses using a standardized symptom log tohave had symptoms of neonatal withdrawal for shorterperiods of time.Factors promoting compliance have been understudiedin women who are addicted to illicit drugs. Women in ourstudy who were non-compliant most often told theTable 1 Sociodemographic profile of study participantsAcupuncturen= 50Controln= 39P-valueAge (years), mean (sd) a 28.2 (5.6) 29 (5.9) 0.44Support, n (%) bLone Parent 19 (38.0) 13 (33.3) 0.65Birth Father involved 23 (46.0) 21 (53.8) 0.46Other Partner 5 (10.0) 5 (12.8) 0.68Family 21 (42.0) 14 (35.9) 0.56Education, n (%)bElementary 1 (2.0) 0 (0.0) 0.83Some high school 25 (51.0) 22 (61.1)High School Diploma 9 (18.4) 5 (13.9)Some post-secondary 7 (14.3) 5 (13.9)Diploma for Trade School 5 (10.2) 4 (11.1)Some university 1 (2.0) 0University Degree 1 (2.0) 0Ethnicity, n (%)bCaucasian 36 (72.0) 23 (59.0) 0.23First Nations 10 (20.0) 14 (35.9)Chinese 2 (4.0) 0South Asian 2 (4.0) 1 (2.6)African Canadian 0 1 (2.6)Income, n (%)bEmployed 3 (6.0) 1 (2.6) 0.98Social Assistance 31 (62.0) 26 (66.7)Reliant on partner 3 (6.0) 1 (2.6)No source of income 3 (6.0) 3 (7.7)Source unknown 2 (4.0) 2 (5.1)Disability 3 (6.0) 3 (7.7)Sex trade 3 (6.0) 2 (5.1)Incarcerated 2 (4.0) 1 (2.6)a Mann–Whitney U test.b Chi square test, 2df, except education (6df), ethnicity, (4df), income (8df).Janssen et al. Substance Abuse Treatment, Prevention, and Policy 2012, 7:48 Page 5 of 10http://www.substanceabusepolicy.com/content/7/1/48acupuncturist that they were “too busy” to receive a treat-ment, although there was no apparent reason to be busyon the hospital ward. In a previous study of acupuncturein a non-pregnant population, the authors demonstrated areduction in use of illicit drugs among participants whocame consistently for acupuncture, but only 15 percent ofattendees to the clinic remained compliant [34].Non-compliance further limits our study by reducingthe number of exposed subjects in our study arm and thusour power to detect differences. The non-statistically sig-nificant reduction in duration of morphine treatmentamong newborns whose mothers were compliant withacupuncture should be confirmed in future studies. Thisclinically relevant difference, if confirmed, could result inearlier discharge for mother-infant dyads. Investigatorsworking with similar populations would be well advised toTable 2 Substance use profile of study participants onadmission to hospitalAcupuncturen= 50Controln= 39P-valueSmoking, n (%) aCurrent 44 (88.0) 37 (94.9) 0.50Former 4 (8.0) 1 (2.6)Never 2 (4.0) 1 (2.6)Cigarettes per day, mean (sd) b 13.0 (8.0) 12.4 (5.6) 0.83Alcohol, n (%)aDaily 2 (4.1) 3 (7.7) 0.52Weekly 0 1 (2.0)Sporadically during month 8 (16.3) 8 (20.5)None 39 (79.8) 27 (69.2)Heroin, n (%)aDaily 19 (38.0) 14 (35.9) 0.63Weekly 2 (4.0) 0Sporadically 5 (10,0) 4 (10.3)None 24 (48.0) 21 (53.8)Methadone, n (%)aDaily 21 (42.9) 14 (35.9) 0.61Weekly 14 (28.8) 15 (38.5)None 14 (28.6) 10 (25.8)Other Opioid, n (%)aDaily 2 (4.0) 3 (7.7) 0.74Sporadically 1 (2.0) 1 (2.8)None 47 (94.0) 35 (89.7)Cocaine, n (%)aDaily 12 (24.0) 8 (20.5) 0.86Weekly 2 (4.0) 2 (5.1)Sporadically 6 (12.0) 3 (7.7)None 30 (60.0) 26 (66.7)Crack, n (%)aDaily 23 (46.0) 15 (38.5) 0.78Weekly 1 (2.0) 2 (5.1)Sporadically 8 (16.0) 6 (15.4)None 18 (36.0) 16 (41.0)Cannabis, n (%)aDaily 2 (4.0) 7 (17.9) 0.08Weekly 3 (6.0) 0Sporadically 8 (16.0) 5 (12.8)None 37 (74.0) 27 (69.2)Crystal Meth, n (%)aDaily 4 (8.0) 4 (10.3) 0.96Weekly 2 (4.0) 1 (2.6)Sporadically 6 (12.0) 4 (10.3)Table 2 Substance use profile of study participants onadmission to hospital (Continued)None 38 (76.0) 30 (76.9)Benzodiazepine, n (%)aDaily 0 3(7.7) 0.14Sporadically 3 (6.0) 2 (5.1)None 47 (94.0) 34 (87.2)Ecstasy, n (%)aDaily 0 1 (2.8) 0.52Sporadically 3 (6.0) 2 (5.1)None 47 (94.0) 36 (82.3)Antidepressant, n (%)aDaily 4 (8.2) 2 (5.1) 0.85Sporadically 1 (2.0) 1 (2.5)None 44 (89.8) 36 (92.3)Methadone dose (mg), mean (sd) b (n=36,28)During pregnancy 52.9 (49.7) 49.2 (47.2) 0.85Admission to hospital 48.8 (50.6) 40.0 (39.0) 0.62At delivery 58.1 (53.6) 48.4 (50.4) 0.45Gestational age when started(wks)14.8 (12.3) 13.5 (13.2) 0.42Non-opioid users, n (%)a 10 (20) 11 (24.2) 0.32Use of substances whenpregnant with other children, n (%)a22/38 (57.9) 19/31(61.3)0.78Retained custody of atleast one child, n (%)a19/36 (52.8) 16/29(55.2)0.85Treatment Goal, n (%)aAbstinence 36 (72.0) 30 (76.9) 0.57Decrease methadone 13 (26.0) 7 (17.9)Decrease other drug 0 1 (2.6)No goal 1 (2.0) 1 (2.6)a Chi square test, 2df (smoking, methadone, other opioid, benzodiazepine,ecstasy, antidepressant) 3df (all other categorical variables).b Mann–Whitney U test.Janssen et al. Substance Abuse Treatment, Prevention, and Policy 2012, 7:48 Page 6 of 10http://www.substanceabusepolicy.com/content/7/1/48consider a “run-in” period to measure compliance prior torandomization. As well, our power to detect differences instudy outcomes was further limited by the fact that oursample size calculations were based on longer periods ofmorphine treatment than those observed in our study.We conducted our study in a hospital unit designedspecifically for chemically dependent women. As such,women readily disclosed the nature of their drug de-pendency without fear of retribution or random urinetesting for themselves or their newborns. There is nocoercion to participate in the study as the unit is fundedthrough our provincial health care program and istherefore free of charge. However, the variety of servicesavailable to women on the ward, such as Narcotics An-onymous meetings, yoga, and other activities, may havereduced the potency of the acupuncture intervention.Controversy regarding the relationship betweenmethadone dose and the incidence and severity of(NAS) [23] raises new challenges for evaluating theeffectiveness of measures aimed at reducing maternalsubstance use. It also begs the question of whether ornot there are more subtle measures of opioid sequelaein the newborn that could be measured or whetherlong term sequelae may exist in the absence of NAS.Some authors have noted that opioid exposed infants mayexhibit subacute NAS symptoms for weeks to monthsTable 3 Pregnancy-related characteristics of participantsAcupuncturen= 50Controln= 39P-valueGravidity, mean (sd) a 3.9 (2.2) 3.8 (2.2) 0.75Parity, n (%) b0 14 (28.0) 10 (25.6) 0.971 14 (28.0) 11 (28.2)2+ 22 (44.0) 18 (46.2)Pre-Pregnancy Weight (kg),mean (sd)a61.1 (13.7) 64.8 (17.7) 0.39Height (cm), mean (sd) a 164.2 (7.9) 164.1 (5.8) 0.81Weight Gain (kg),mean (sd) a15.7 (14.0) 13.9 (12.4) 077Gestational age at hospitaladmission (weeks), mean (sd) a19.1 (9.4) 19.2 (9.5) 0.90Prenatal Classes, n (%)bYes 4 (8.3) 4 (10.8)No 33 (68.9) 27 (73.0)In previous pregnancy 11 (22.9) 6 (16.2) 0.72Psychiatric Diagnosis, n (%)bNone 23 (46.0) 25 (64.1) 0.07Depressed 9 (18.0) 7 (17.9)Bipolar 10 (20.0) 1 (2.6)Anxiety Disorder 5 (10.0) 4 (10.3)Psychosis 2 (4.0) 0Borderline personality 1 (2.0) 0Days AWHOL, mean, (sd) a 15 (30.8) 10 (25.6) 0.89a Mann –Whitney U test.b Chi square test, 2df.Table 4 Maternal and newborn outcomesAcupuncturen= 48Controln= 38P-valueBreast Feeding, n (%) aExclusive 12 (25.5) 7 (20.0)Combined 17 (36.2) 15 (42.9)Formula 18 (38.3) 13 (37.1) 0.78Missing 1 3Mode of Delivery, n (%)aSpontaneous Vaginal 30 (62.5) 25 (65.9)Assisted Vaginal 4 (8.3) 2 (5.3)Cesarean 14 (29.2) 11 (28.9) 0.85Gestational Age at Delivery (weeks),mean (sd) b38.0 (2.8) 38.0 (2.6) 0.37Days in Hospital, mean (sd) b 28.7 (23.9) 29.3(25.6)0.39Apgar Score < 7 @ 1 minute, n (%) c 10 (20.4) 8 (22.2) 1.00Apgar Score < 7 @ 5 minute, n (%)c 1 (2.0) 3 (8.3) 0.31Missing 1 3Birth Weight, mean (sd)b 2985.7 (594.7) 3074.9(557.1)0.26Birth Length, mean (sd) b 49.12 (5.1) 48.8 (4.3) 0.47Head Circumference,mean (sd) b33.3 (1.6) 33.9(1.90)0.22Days to regain birth weight,mean (sd)b11.2 (4.7) 10.6 (3.9) 0.57Days of treatment with morphine,mean (sd) b2.7 (6.3) 2.8 (7.0) 0.97Admitted to NICU, n (%)c 19 (38.0) 11 (28.2) 0.37Mother lost custody, n (%)c 18 (36.7) 16 (44.4) 0.51Symptoms of Neonatal AbstinenceSyndrome (days), mean (sd) bHigh pitched cry 3.5 (5.0) 3.4 (6.1) 0.46Crying inconsolably 0.3 (0.9) 0.4 (1.1) 0.94Tremors/jitteriness when disturbed 8.6 (5.5) 8.7 (7.2) 0.58Tremors/jitteriness whenundisturbed1.8 (3.0) 1.5 (2.8) 0.68Abnormal muscle tone 5.0 (6.3) 5.7 (8.7) 0.61Disorganized sucking/swallowing 2.2 (4.5) 2.6 (5.8) 0.57Weak or absent suck 1.9 (3.8) 2.4 (5.3) 0.75Vomiting 0.2 (1.0) 0.3 (1.0) 0.69Loose, watery, or explosive stools 1.5 (3.5) 1.8 (3.0) 0.29a Chi square test , 2df.b Mann–Whitney U test.c Fisher’s Exact Test.Janssen et al. Substance Abuse Treatment, Prevention, and Policy 2012, 7:48 Page 7 of 10http://www.substanceabusepolicy.com/content/7/1/48after birth [55]. If the severity of NAS remains problematicas a measure of maternal drug exposure, then ongoingstudies will benefit from more accurate measures of ma-ternal substance use that would not in turn deter womenfrom participation in research studies. Ideally such studieswould be conducted in an outpatient setting in which as-sessment of maternal exposure could include self report,voluntary testing, and observation by outreach/case work-ers and counsellors.ConclusionsOur findings, while not conclusive, should encouragethe continuing study of acupuncture as a safe and “lowtech” intervention which can be administered duringpregnancy. Our findings of potentially shorter durationof NAS among newborns of mothers who received acu-puncture, while limited to a small group, deserve furtherstudy. Potential investigators should be aware that whilechemically dependent women are willing to participatein a randomized controlled trial of acupuncture, attritionrates are high and measures should be taken to enrolwomen who have demonstrated the ability to remaincompliant with acupuncture protocols.AbbreviationNAS: Neonatal Abstinence Syndrome.Competing interestsThe authors declare that they have no competing interests.Authors’ contributionsPJ, LD, AK, PT, and RA contributed to the conception and design of thestudy. PJ, LD, and AK, contributed to the analysis and interpretation ofdata. All authors undertook critical revision of the manuscript forintellectual content and approved the final version of the manuscriptsubmitted for publication.Authors’ informationPJ is a registered nurse and perinatal epidemiologist whose researchfocus is aimed at birth outcomes among women from marginalizedpopulations. LD is a practicing doctor of traditional Chinese medicine. AKis a perinatal epidemiologist whose research focus is addiction inpregnancy. PT is a pediatrician. RA is a family practice physician andMedical Director, Perinatal Addictions, BC Women’s Hospital in Vancouver,British Columbia, Canada.AcknowledgementsPJ is supported as a Research Scientist Level III Investigatorship from theChild and Family Research Institute, in Vancouver, British Columbia. Thisstudy was funded by the Sick Kids Foundation, Toronto, Ontario, Canada.Author details1School of Population and Public Health, Child and Family Research Institute,University of British Columbia, 2206 East Mall, Vancouver, BC, CanadaV6T-1Z3. 2Toronto Central Local Health Integration Network, Toronto, ON,Table 5 Maternal and newborn outcomes in an “as treated” analysis among mothers exposed to opiatesAcupuncture compliantn= 13Acupuncture non-compliantn=27Controln=32P-valueMaternal methadone dose at delivery (mg), mean (sd) a 75.2 (63.7) 67.0 (45.5) 64.5 (48.3) 0.86Change in methadone dose from admission- until delivery, (mg),mean (sd)a−15.9 (37.7) −8.9 (34.8) −11.6 (25.7) 0.85Days of newborn treatment with morphine, mean (sd) a 1.9 (4.5) 4.0 (7.8) 3.5 (7.7) 0.71Apgar Score < 7 @ 1 minute, n (%) b 2 (15.4) 7 (26.9) 6 (20.7) 0.80Apgar Score < 7 @ 5 minute, n (%) b 1 (7.7) 0 2(6.9) 0.41Missing 0 1 3Admitted to NICU, n (%) b 4 (30.8) 12 (44.4) 9 (28.1) 0.44Mother lost custody, n (%) b 5 (38.5) 7 (26.9) 12 (40/0) 0.54Missing 0 1 2Symptoms of Neonatal Abstinence Syndrome (days), mean (sd) aHigh pitched cry c 2.1 (3.5) 4.0 (5.4) 3.4 (6.1) 0.83Crying inconsolably 0.3 (1.0) 0.3 (1.0) 0.4 (1.1) 0.52Tremors/jitteriness when disturbed 5.7 (2.5) 9.5 (5.9) 8.7 (7.2) 0.28Tremors/jitteriness when undisturbed 0.4 (1.0) 2.3 (3.4) 1.5 (2.8) 0.24Abnormal muscle tone 3.1 (4.0) 5.7 (6.9) 5.7 (8.7) 0.83Disorganized sucking/swallowing 1.8 (4.4) 2.3 (4.6) 2.6 (5.8) 0.89Weak or absent suck 1.3 (2.9) 2.1 (4.1) 2.4 (5.3) 0.98Vomiting 0.1 (0.3) 0.3 (1.0) 0.3 (1.0) 0.86Loose, watery, or explosive stools 0.6 (1.2) 1.9 (4.0) 1.8 (3.0) 0.21a ANOVA, Methadone dose at delivery, Change in methadone df 2, 48; Days of newborn treatment with morphine df 2, 64.b Fisher’s exact test.c Kruskall-Wallis test, 2df.Janssen et al. 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