fertility nurses first chinese medicine

8/20/2019 Fertility Nurses First Chinese Medicine

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Fertility Nurses First

The Evolution of a Revolution: How Traditional ChineseMedicine Brings IVF into Modern Times Author: Paul C. Magarelli, MD, PhD, FACOGCoauthor: Diane K. Cridennda, LAc, FABORM

China’sCulturalRevolutionmarkedamovefromthepast

intoanewplanforthefuture.Asmallpaperpublished

in2002inFertility & SterilitybyPaulusWE,etal.1

showedasimilar,thoughrelativelysilentrevolution.The

researchsuggestedthataddingacupunctureunderastrict

protocoltopatientsundergoingin vitrofertilization(IVF)

demonstratedimprovementsinreproductiveoutcomes,

i.e.,morepregnancies.Theimpactofthissmallstudywas

notfullyrealizedforseveralyears.However,itsresults

promptedDianeK.Cridennda,LActochallengePaulC.Magarelli,MD,PhDtoquestionhowhecouldhelphis

patientsbystretchingforsolutionsoutsidetherealmof

allopathicmedicine.

CridenndametwithMagarelliin2002todiscussher

beliefthatbyaddingTraditionalChineseMedicine

(TCM)intheformofacupuncture,morepatientscould

getandstaypregnant.Magarelli’spositionwasthatany

medicaltreatmentmustethicallyhavescientificbasis

beforesubjectingpatientstoit.Heaskedhertoprovidedatatosupportherposition.Shereturnedwiththepaper

byPaulusWE,etal.1andaddedanewstudybyStener

Victorin’sgroupdiscussingafavorablephysiologicchange

inbloodflow[pulsatilityindex(PI)]throughtheuterine

arteryinIVFpatientstreatedwithacupuncture.2

ACUPUNCTURE PHYSIOLOGY

Acupunctureistheplacementoffineneedlesintospecific

acupointsalongthepathwaysofenergyinthebody.

Acupointsrelieveblockagesandrestoretheflowof“Qi”,

pronounced[CHEE]orenergy,encouragingthebody’s

naturalabilitytohealitself.WhenQiisbalancedand

organsare“nourished,”thebodywillbeabletofunctionat

theircapacityand,inthiscase,forprocreation.

Thisprocessworksbysendingmessagestothebrain

almostlikeprogrammingacomputer.Qiisconducted

throughproteinmoleculesgivingusenergyandlife.Qi

movesbywayofmeridians—awebornetworkofchannels

whichsetsupcommunicationbetweeneveryorganinthe

body.TCMpractitionershavemappedthesechannelsout

overthecourseofthousandsofyearsofexperimentation

andobservation.Theinsertionoffineneedlesintothe

acupointsalongthemeridiansproducesmeasurableeffects

ondifferentpartsofthebody.Thisishowacupuncture

canaffectabdominalorgans,suchasthekidneys,liveranduterusbyplacingneedlesinthearmsandlegs.Thereare

specificacupuncturepointswhichrelatetofertility,but

thesinglemostimportanttheoryisthis:WhenQiflows

throughthebodyinthecorrectdirectionattherighttime,

thebodywillreturntohealth.

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ACUPUNCTURE AND IVF: RESEARCH PROTOCOLS

Overthenextyear,IVFpatientswithpoorprognosisfor

success–includinghavingpreviousIVFfailures,being

olderthan35yearsofage,orhavingseveremalefactororpoorovarianreserveasmeasuredbyday3follicle

stimulatinghormone(FSH)levels,weretoldthatalocal

acupuncturistexperiencedsomesuccessinimproving

IVFoutcomesandcouldtreatthemwithacupunctureif

interested.ManypatientsdecidedtoseeCridenndafor

acupuncturetreatmentsandsomereturnedtoMagarelli’s

clinicfortreatmentforIVFonly.Uponobservation,more

patientsweregettingpregnant.Inresponsetothese

results,Magarelli,CridenndaandCohendecidedtocreate

researchprotocolstoproveordisprovetheefficacyof

acupuncturetreatmentinIVFpatients.

TheauthorshavepublishedachapterinaWestern

textbookonreproductiveendocrinologyandinfertility

inwhichtheylayoutthefoundationsoftheirresearch.

Excerptsarebelow:3

Background

Assistedreproductivetechnologies(ART)provide

reproductiveservicestoinfertilecouplesthroughoutthe worldintheformofIVF.TheprocessofIVFbeganwith

theBirth of Louise Brownin1978byEdwardsandSteptoe.4

Theprocesshasevolvedsignificantlyovertheyears.Like

thefirsthearttransplant,IVFhasgonefrommedical

wonderto“standardofcare.”Todayover1millionIVF

cycles5areperformedeachyeararoundtheworldfora

populationof6billionmenandwomen.Mostestimates

ofinfertilitywhencalculated,represent15percentof

married/bondedcouples.Thiswouldpredictmanymore

couplesinneedofreproductivecarewhoarenotableto

createthefamilytheyhavedreamedof,probablyduetothe

expensesassociatedwiththecomplexityofcarerequired.

PartoftheproblemofpoorutilizationofIVFiscostand

accesstocare.Othersincludethedepersonalizationof

theprocessandresistanceonthepartofthecouples

themselves.Fertilityisapersonalmatter,whichispublicly

monitored.Itisinthenatureofacommunityto“require”

reproductionforsurvival.Thepeakofhumanfertility

isat25yearsofage,allowingfora25percentchanceto

conceiveeachmonth.Formostcouples,thishoversat

10percentsincetheymaynotevenstartthinkingofhavingchildrenuntilaftereducationiscomplete,jobsareintact

andhousesarepurchased.Bythistime,mostcouplesare

nearing30yearsofageandjustbeginningtoconsider

havingababy.6

Aftermonthsoftryingtoconceive,issuesofpersonal

identity,frustration,guiltandlosingfaithintheirbody

setsin.Mostcouplesloseasenseoffreedomastheyno

longerhaveintercourseforthereasonsofloveandtrue

intimacy.Intercoursenowturnsintoajob,timedatbest.Couplesbegintolosesightofthereasonforhavingachild

togetherastheyexperiencesorrowandfrustrationmonth

aftermonthwhenthemensesoccurs,despitethevigorous

attemptstoachievepregnancy.Technologymaybeableto

help,butataprice.

Historical Perspective

IntheUnitedStates,IVFprogramsstartedinthe1980s,

proliferatedduringthemidtolate90s,andhavegrown

torepresentover150,000treatmentcyclesintheearlypartofthe21stcentury.IVFprograms,accordingtothe

CentersforDiseaseControlandPrevention,havereported

reproductiveoutcomesfrom1986to2005.Theaverage

improvementeachyearrepresents1percentto2percent

gainpertreatmentinpositiveoutcomes,pregnancyor

babies,from1985to2001.After2001,noimprovement—

butonlyamodestdecreaseinoutcomes(34percentto

33percent)hasbeenseen.Althoughthecurrentresults

arelaudable,Cridenndasoughttoenhancetherateof

improvementbychallengingWesterntreatmentsforIVF.

Magarelli,CridenndaandCohen,encouragedbytheabove

backgroundandhistoricperspective,developedastudy

protocol,publishedastheCridennda/MagarelliTCM

protocol.Thislaterservedasthebasisforallsubsequent

studiestheyreported.KeyelementsareshowninTable1.

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Table 1. Key Elements of the Cridennda/Magarelli TCM Protocol

KEY ELEMENTS REASONING

Recruitment was prospective. Eliminates historical comparisons and strengthens

study applicability.

Recruitment for acupuncture was hidden or “blinded” to the physician. Reduces physician bias.

IVF treatment protocols were hidden or “blinded” to the acupuncturist. Reduces acupuncturist bias.

Only “standardized” acupuncture treatments were allowed (no differentiation ofsyndromes as a basis of treatments were done).

Eliminates treatment selection bias.

All data was collected by a third party, Mel Cohen, PhD, and kept from thephysician and acupuncturist for three years.

Reduces investigator bias.

Contracts were written and signed by all TCM practitioners to follow the

prescribed protocols for treatments.

Eliminates treatment variability.

TCM practitioners agreed to provide coverage for patients in the study 24/7.For example, embryo transfers occurred on weekends and holidays and patientsneeded to access their acupuncturist.

Reduces timing or convenience bias.

Patients, without coercion, selected whether or not to participate. Does NOT eliminate selection bias (a weakness ofmost TCM studies).

No monetary gain was provided to participate. Reduces selection bias for monetary gain.

No reduction in IVF fees for participation in the study was given. Reduces treatment bias based on monetary gain.

No reduction in TCM treatment fees for participation in the study was given. Reduces treatment bias based on monetary gain.

Most study data collected from 2002 were reviewed in 2005. Reduces impact of positive outcomes on patient choice toperform acupuncture.

Study of cortisol/prolactina Although not randomized, the study was blinded to theacupuncturists, physicians and statistician until analyzed.

a MagarelliPC,CridenndaDK,CohenM.Changesinserumcortisolandprolactinassociatedwithacupunctureduringcontrolledovarian

hyperstimulationinwomenundergoinginvitrofertilization-embryotransfertreatment.Fertil Steril.2009;92(6):1870-1879.

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TheCridennda/MagarelliTCMprotocolhasbeen

usedtoanalyzemorethan800IVFcyclessince2002.

Theprotocol’sdatasetmaybethelargestintheworld

correlatingaspecificTCMprotocol’simpactonIVFoutcomes.Researchusingtheprotocolwascategorizedby

patienttypeandscientificprincipalinthestudiesshown

inTable2:

Table 2. Categories Studied Using Cridennda/Magarelli

TCM Protocol

1 Poor prognosis7 Elevated FSH•

Severe sperm factor•

Advanced maternal age•

Poor PI (i.e., uterine artery•blood flow)

2 Improvedprognosis8

Anything not listed in “poor prognosis”section above

3 All IVF patients9 Regardless of prognosis

4 Number ofacupuncturetreatments10

Ideal number of needed for favorableoutcome (i.e., pregnancy)

5 Embryologyand eggs11

Impact of TCM

6 Demographicsand patientinfertilitydiagnosis12

Effects regarding pregnancies,•

miscarriages, ectopics, multiples andlive births

Impact of patient infertility diagnosis•on effects of TCM

7 Cortisol/prolactin13

Mechanism of action responsiblefor impact of TCM treatment (i.e.,changes in stress hormones cortisolor prolactin)

Outcomes Data Revealed Per Category

1. Poor Prognosis Category (Figure 1)

Key Points

• Improvements

in

reproductive

outcomes

were

demonstratedwhenpoorprognosispatientsreceived

acupuncturetreatmentsbefore,duringandafter

theirIVFtreatments.

• A

“standardized”

acupuncture

treatment

protocol

inlieuoftreatmentsutilizingdifferentiationof

syndromescanbeusedtoimprovereproductive

outcomes(i.e.,pregnancyandlivebirth).

Conclusion

Poorprognosispredictionsofoutcomescouldbe“corrected”andoutcomescouldbecreatedclosertoand

insomecasestosurpass“improvedprognosis”patient

outcomesforpregnancyandespeciallylivebirth.

2. Improved Prognosis Category

Key Points

• Pregnancy

outcomes

were

equal

between

the

acupuncturegroupandthenonacupuncturegroup,

notunlikethePoorPrognosiscategory.

• Birth

outcomes

were

improved

between

theacupuncturegroupandthe

nonacupuncturegroup.

• Improved

pregnancy

outcomes

for

all

patients

• Improved

pregnancy

outcomes

for

pregnant

patients

• Signicantly

fewer

spontaneous

abortionss

• Signicantly

fewer

ectopic

pregnancies

Conclusion

EvengiventheGoodPrognosiscategory,patients

treatedwiththeCridennda/MagarelliTCMprotocol

benefitedwithimprovedoutcomes.

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Pregnancy SAB Ectopic Take HomeBabies

MultipleBabies

0%

20%

50%Rates/

Transfer 40%

30%

10%

60%

70%

80%

90% Control

Acupuncture

Pregnancy0%

20%

50%Rates

40%

30%

10%

60%

70%

80%

90%

SAB Ectopic Birth/OngoingPregnancy

Std IVF Control

PPr Control

PPr Acupuncture

p < 0.001

p < 0.05

0% 0%

FIGURE 1. IMPACT OF ACUPUNCTURE ON IVF POOR RESPONDER PATIENTS

FIGURE 2. IMPACT OF ACUPUNCTURE ON IVF PATIENTSa

Data based on n = 147.

Std = Standardized.

PPr = Poor prognosis.

IVF = In vitro fertilization.

SAB = Spontaneous abortion.

Used with permission from

Paul C. Magarelli, MD, PhD, FACOG.

Patients = 203

FSH range = 2 - 20

Age range = 25 - 46

Pulsatility Index range = 0.6 - 3.1

Basal metabolic index range = 18 - 56


SAB = Spontaneous abortion.aData are based on over five years of

IVF monitored cycles.b p < 0.05.



b

b

b

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3. All IVF Patients Category (Figure 2)

Key Points

• Pregnancy

outcomes

were

superior

in

the

acupuncturegroupvs.nonacupuncturegroup(p


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Conclusion

Changesineggsorembryoqualitywereruledout.

Changewasattributedtothe“host”thatwasinfluenced

byacupuncture.

6. Demographics and Patient Infertility

Diagnosis Category

Key Points

• Acupuncture

supports

pregnancy

outcomes

for

IVFpatients

• This

study

segregates

which

IVF

patients

would

best

benefitfromacupuncture.Theyarethosewith:

– Advancedages

– Polycysticovariansyndrome

– Malefactor

– Tubalfactor

Conclusion

Patientswiththehighestopportunityforsuccesswith

IVF,includingthosewhoareyoungerandwithgood

prognosis,mayNOTbehelpedasmuchbyacupuncture.

7. Cortisol/Prolactin Category (Figures 3 and 4)

Key Points

• IVF

treatments

appear

to

create

nonphysiologic

changesinprolactinandcortisollevelsthroughthe

stimulationphaseoftheIVFcycle.

• Acupuncture

appears

to

reverse

this

nonphysiologic

changeandreturnIVFpatient’shormoneprofilesto

morephysiologic/reproductivelevels.

• One

mechanism

of

action

of

acupuncture

on

IVF

outcomesmaybethe“normalization”ofcortisol

andprolactinduringthestimulationphaseoftheIVFcycle.

Conclusion

TheDecember2009studybyMagarelli,Cridenndaand

Cohen13inFertility & Sterilityprovidesaroadmapfor

arevolutionintheintegrationofWesternandEasternmedicalpractices.Theauthorswereabletoreducebias

toaminimumbyutilizingserumlevelsofcortisoland

prolactinthatwerecollectedinablindedfashion,over

aprotractedperiodoftime.Thiswasdonewithout

knowledgeofthetypesoffertilitytreatments,including

acupuncture.Theresultsdemonstratedthatbyusing

theCridennda/Magarelliacupunctureprotocol,TCM

reportedthatmorepregnanciescouldbeexplained

bybeneficialchangesinserumlevelsofcortisol

andprolactin,whichmimickednormalpregnancy

menstrualcycles.

Figures3and4onthefollowingpage,showthechange

inserumlevelsofprolactinandcortisolassociatedwith

acupuncture(soliddiamonds)inwomenundergoing

controlledovarianhyperstimulationforIVF-embryo

transfer.Acupuncturewasassociatedwithsignificant

increaseinprolactinlevels(soliddiamonds)on

stimulationdays4,5,6and7.However,cortisollevels

weresignificantlyhigheronstimulationdays7,8,9,11,

12and13inassociationwiththeacupuncture

treatedgroup.

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Stimulation Day

1 2 3 4 5 6 7 8 9 10 110

10

25

Prolactin(Ng/mL)

20

15

5

30

35

40

Control

Acupuncture


ET = Embryo transfer.a p < 0.05.



FIGURE 3. PROLACTIN LEVELS IN CONTROLLED OVARIAN HYPERSTIMULATION FOR IVF-ET

a

a

a

a

Stimulation Day

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

4

10Cortisol(Ng/mL) 8

6

2

12

14

16

18

Control

Acupuncture

0

a p < 0.05.



FIGURE 4. CORTISOL LEVELS IN CONTROLLED OVARIAN HYPERSTIMULATION

a

a

a

a

aa

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EVOLUTION OF A REVOLUTION

IVFoutcomesdemonstratedbystudiesfromMagarelli,

CridenndaandCohenarecomparedonseveralreputable

sitesontheWorldWideWebandserveasresourcesfornewsreportingagenciesandregulatorybodies.These

studiesstriveforpatientsafetyandefficacyofART.

Over3,000,000babieshavebeenbornbecauseofART.

Issuesrelatedtomultipleandectopicpregnancies,

miscarriagesandcostsforcarecanaffectpatientdecisions

toproceedwithseekingoutinfertilitytreatment.

AlthoughEasternmedicinehasprovensuccessfulfor

theseIVFpatientsforthousandsofyears,manyWestern

medicalprofessionalsmaystruggletounderstandhowit works.Magarelli,CridenndaandCohen,aswellasothers,

havedemonstratedthatacupunctureforIVFimproves

pregnancyoutcomeswhenaddedtoIVFprotocols.The

Cridennda/MagarelliTCMprotocolwasdesignedfromits

inceptiontomeetthenullhypothesisof“Acupuncturedoes

NOThelp.”Thatnullhypothesiswasprovenincorrect,as

wasexplainedbythecortisolandprolactindata.Magarelli,

CridenndaandCohenhopetheirprimitiveworkstimulates

universitiesandtheNationalInstitutesofHealthto

investigatethelinkandconfirmtheirdata.

About the author:

PaulC.Magarelli,MD,PhD,FACOGisboard

certifiedinreproductiveendocrinologyand

infertility(REI)inthestateofColoradoand

hasbeeninpracticesince1998.Heisfounder

andmedicaldirectorofReproductiveMedicine

&FertilityCentersinbothColoradoandNew

Mexicoandisnationallyrecognizedforhis

expertiseinREIandthedevelopmentofcost-

effectiveplansforfertilitycare.Theseplans

includePlanning4Pregnancy™andHighTech withaPersonalTouch™.Dr.Magarelliisalso

applaudedforhisground-breakingresearch

integratingEastern(TraditionalChinese

Medicine,includingacupuncture)andWestern

medicaltreatmentsforinfertility.Hehas

presentednumerouslecturesatorganizations

suchastheAmericanAssociationofMedical

Acupuncturists,SocietyforAcupuncture

ResearchandAmericanAssociationof

Acupuncture&OrientalMedicine.Hehasalso

publishedseveralworksonthesubjectincluding

thefirstEasternmedicinechapterinaWestern

medicaltextbookonreproductivemedicine

(InfertilityandAssistedReproduction).

Dr.Magarelliiscurrentlyanadvisortothe

AmericanBoardofOrientalReproductive

MedicineandisamemberoftheAmericanSocietyforReproductiveMedicine,Societyof

AssistedReproductiveTechnologiesandPacific

CoastFertilitySociety.

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SterzikK.Influenceofacupunctureonthepregnancy

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