Full length article
The effect of Matricaria chamomile on menstrual related mood disorders
Elham Naja fi Mollabashi, Tahereh Ziaie, Zahra Bostani Khalesi*
SchoolofNursingandMidwifery,GuilanUniversityofMedicalSciences,Rasht,Iran
ARTICLE INFO
Articlehistory:
Received2September2021
Receivedinrevisedform18September2021 Accepted24September2021
Availableonline1October2021
Keywords:
Menstruation Chamomile Matricaria Mooddisorders
ABSTRACT
Objective:Asignificantpercentageofreproductive-agewomenexperiencemoodsymptomsduringthe daysbeforemenstruationthatcanaffectdifferentaspectsofaperson'slife,theuseofsomemedicinal plantscanbehelpfulincontrollingpremenstrualemotionalsymptoms.Theaimofthisstudywasto evaluatetheeffectofchamomilecapsulesonmenstrual-relatedmooddisorders.
Studydesign:Thisclinicaltrialstudywasperformedon118studentsofGuilanUniversityofMedical Sciences.Participantsweredividedintotwogroupsofchamomileandplacebo.Bothgroupsreceivedone capsuleevery8hfor7daysbeforetheonsetofmenstrualbleeding.Thedatacollectiontoolwasa PremenstrualSymptomsScreeningTool(PSST).Dataanalysiswas performedusingMann-Whitney, independentt-test,Wilcoxon,andanalysisofcovariance.
Results:AccordingtotheresultsoftheMann-WhitneytestChamomilecapsulesweremoreeffectivethan placebo inreducing menstrual-related mooddisorders (p< 0/001).Theresults ofthe analysisof covarianceshowedthataftercontrollingtheassociatedvariables,thechangesintheseverityofmood symptomsbetweenthetwogroupsweresignificantlydifferent(p<0/05).
Conclusion:Theresultsofthis studyshowthattheuseofchamomilecapsulescan beaneffective treatmentinalleviatingemotionalsymptomsrelatedtomenstrualcycles.
©2021TheAuthors.PublishedbyElsevierB.V.ThisisanopenaccessarticleundertheCCBY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction
Menstruationisoneofthemostimportantindicatorsofwomen's health; it starts from puberty andcontinuesuntilmenopause[1]. The menstrualcycleisaseriesofbiophysicalandbiochemicalchanges, including hormonal changes, autocrine/paracrine factors that eventually lead to menstrualbleeding[2]. According to studies, abouttwo-thirdsofwomenexperiencearangeofmoodswingsand psychologicalsymptomsattheendofthemenstrualcyclethatare associatedwithnaturalchangesinthelevelsofsexhormonesthat areassociated withthemenstrualcycle[3]. It is estimated that 80 % of premenopausalwomenareaffectedbymenstrual-relatedmoodand physical symptoms [4]. Symptoms ofpremenstrual disorderare morecommoninwomenovertheageof20,andthesesymptoms maygetworseorbetterovertime[5].Premenstrualmooddisorders varyfrompersontoperson;however,thepatternofsymptomsfor eachpersonispredictableandisconstantinalmostallcycles[6].
Premenstrualmoodswingsusuallyoccuragainstabackgroundof generalmoodsuchasdepressionandanxiety[5],someofthemood
symptoms that women suffer from duringthe menstrual cycle include:irritabilityandanger,moralinstability,anxiety,decreased concentrationandefficiency[6].Premenstrualmooddisordershave economicconsequencessuchasdecreasedefficiency,educational consequencessuchastheeffectonacademicperformance,family consequencessuch asdisputesbetweencoupleandmotherand children,andsocialconsequencessuchascommittingaggressive behaviors[7].
The exact etiology of premenstrual mood swingsis not yet known,the possiblereason couldbe thereaction betweensex hormonesandcentralneurotransmitterssuchasendorphinsand serotonin[8].Aprevailingtheoryisthatsomewomenaremore sensitivetotheeffectsofestrogenandprogesteroneonserotonin levels[9].Serotoninisachemicalinthebrainthatplaysakeyrole inregulatingmood,appetite,andsleepcycle[10].Lowlevelsof serotonin lead tofeelings of anger, sadness, foodcravings, and sleep disorders [11]. There is currently no effective single treatment to control premenstrual mood swings [12]. Studies havereportedthatprostaglandininhibitors,Estrogen,progester- one, and oral contraceptives are effective in controlling these symptoms[13].
Withregardtotheeffectsofpremenstrualmooddisorderson women'sindividualandsociallife[4],also,consideringthatthis
*Correspondingauthor.
E-mailaddresses:elhamnajafi[email protected](E.NajafiMollabashi), [email protected](T.Ziaie),[email protected](Z.BostaniKhalesi).
http://dx.doi.org/10.1016/j.eurox.2021.100134
2590-1613/©2021TheAuthors.PublishedbyElsevierB.V.ThisisanopenaccessarticleundertheCCBY-NC-NDlicense(http://creativecommons.org/licenses/by-nc-nd/4.0/).
ContentslistsavailableatScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology: X
j o u r n a l h o m e p ag e : w w w . e l s e vi e r . c o m / l o c a t e/ e u r o x
disorderisusuallyachronicconditionandusuallypersistsduring women of childbearing age, and due to the side effects of chemicaldrugs[12],itisindispensabletouseeffectivetherapies with theleastsideeffectsforcontrollingthisdisorder.One of themostcommontreatmentsforanydiseasehasbeentheuseof medicinal plants [14]. Medicinal plants, due to the natural natureoftherawmaterialofplantsandduetotheirassociation withothercompounds,haveastateofbio-balancesothatthey donotaccumulateinthebodyandaremorecompatiblewiththe body compared to chemical drugs [15]. In recent years, significant scientific studies and clinical trials have been conducted to investigate the active ingredients in medicinal plantsandtheeffectoftheseplantsincontrollingthesymptoms ofvariousdiseases[16].Amongthemedicinalplantsthathave beenwidelyusedincomplementarymedicineand havebeen studiedinsignificantclinicalstudies,wecanmentionMatricaria chamomile[17].Thereputationofchamomileasasedativeand sedativehasascientificbasis,andnewresearchhasshownthat chamomileaffectsthecentralnervoussystemandhasacalming effect [18].Theeffectof chamomile onsleepquality,anxiety, anddepression,hasbeeninvestigatedandconfirmedinseveral clinicaltrials[17].
However,studieshaveshownbeneficialeffectsofchamomile extract, tea, or drops on dysmenorrhea and premenstrual syndromesymptoms[19,20],but,accordingtooursearches,no study has been done on the effect of chamomile capsules on premenstrualmooddisorders,thisstudyisthefirststudydonein the human model. Therefore, this study was performed to investigate the effect of chamomile capsuleson the control of menstrual-relatedmooddisorders.
Materialsandmethods
Thisstudywasadouble-blindcontrolledclinicaltrial.Inthe firststage,thesampleswereselectedbytheconveniencesampling methodfromthestudypopulation, andthen thesampleswere dividedintotwogroupsofinterventionandcontrolbytherandom samplingmethod.Accessandpermissiontoconductthisresearch studywereobtainedfromtheDeputyofResearchandTechnology ofGuilanUniversityofMedicalSciences.Theconsentformswere provided to Students. Students who gave written consent to participate in the study received thedata-gathering tool. After justifying the students on how to carry out the project, the confidentialityoftheinformation,thepurposeoftheproject,and thewrittenconsent,thestudywasstarted.
Inthefirststage,theresearcherwenttoeachofthedormitory roomsand,basedonaquestionnairethatcontainedtheinclusion criteria, identified the eligible students, through interviews.
Written consentto participatein the studywas obtainedfrom individualswhomettheinclusionrequirements.Then,inorderto determinetheincidenceandseverityofPMSsymptoms,thePSST questionnaire was distributed among students who met the inclusioncriteria.Inclusioncriteriaofthecurrentstudywereas follows: agebetween 15 and 45 years withregular menstrual cycles, having no history of legal marriage, no physical or psychological ill conditions (based on the individual's own statement), not on medication (hormones, vitamins, herbal, anti-depressant, aspirin,orWarfarin) (basedontheindividual's ownstatement),nohistoryofallergytoherbaldrugs(basedonthe individual'sownstatement),nosurgicaloperationduringthelast six months,not beinga professionalathleteand willingnessto participate in the study. Exclusion criteria were: taking any medication affecting premenstrual syndrome during the study, inadequate and irregular use of medications, unwillingness to continuecooperationduringthestudy,causingallergicreactions to chamomile and any symptoms of lack of drug tolerance
(respiratory, gastrointestinal, skin symptoms, etc.) during the study,failuretocompleteorsubmitquestionnaires.Eachpartici- pantalsogaveinformedwrittenconsent.Basedontheresultsof Sharifietal.[21]study,thesamplesize,takingintoaccountthe firstandseconderrors,respectively0.05and0.1.wasdeterminedto be53peopleineachgroup,which consideringthe10%sample loss,theappropriate number ofsamplesin each groupwas 59 people.118 students were selected as the participants. In the second stage, the research units were divided into two equal groupsbyrandomblockingmethodandthroughatableofrandom numbers,whichincluded59peopleintheinterventiongroupand 59 people in the control group.In theintervention group, the participantsreceived250mgchamomilecapsulesevery8h,and thecontrolgroupreceiveda 250mgplacebocapsuleevery8h, from 7 days before menstruation to the onset of menstrual bleeding,andUsedforonemonth.
Chamomile capsule contained 250 mg of dried chamomile powdermadebyBarijEssencepharmaceuticalcompany[22].Barij Essencepharmaceuticalcompanypreparedchamomileandthat companyturneditsdriedflowersintopowder.Itwasthenplaced in250mgcapsules.Theplacebocapsuleswerestarch-containing capsulesmanufacturedbyBarijEssencepharmaceuticalcompany and were quite similar in color, shape, size, and amount to chamomile capsules. The randomization process and blinding wereperformedasfollows:
An independent researcher made random allocation cards usingcomputer-generatedrandomnumbers.Hekepttheoriginal randomallocation sequencesin aninaccessible third placeand workwithacopy.Theindependentresearcherprinteditoneach sheet.Theinsideoftheenvelopewasnotvisiblefromtheoutside andprintedseparatelyforeach oneandplaced intheenvelope afterbeingfoldedseveraltimes.Therewasaserialnumberonthe outside oftheenvelopes. Inputdata,time,participant ID,post- interventionresults,etchadrecordedonanothersheetinsidethe envelope.
Drugs both were prepared by Barij Essence pharmaceutical company intheformof one-colorcapsulesand werepackaged withthesameappearanceandmarkedwithcodes AandBand gavetotheresearcherfordistribution.PeopleingroupAreceived packageswithcodeA andpeopleingroupBreceivedpackages withcodeB.Theresearcherandparticipantswereunawareofthe typeofcapsulesuntiltheendofthestudyandonlyattheendofthe study;thepackagecodewasannouncedtotheresearcher.
Afteronemonthofintervention,questionnaireswerecollected and the mean severity of premenstrual mood symptoms was calculated.Attheendofthestudy,outof118peoplewhoreceived thecapsules,fivewereexcludedfromthestudyduetoimproper useofthecapsules,1duetounwillingnesstocontinuetreatment, and4duetoincompletecompletionofthequestionnaires.
Data collection tools based on the objectives of the study included demographic and menstrual characteristics question- naire (age, age of onset of menstruation) and Premenstrual SymptomsScreeningTool(PSST).PSSTisastandardquestionnaire designedbySteinerin2003(Steineretal.,2003).Siahbazietal.[23]
TranslatedandvalidatedtheIranianversionofthisquestionnaire in2011.Thisquestionnaireisa19-iteminstrumentconsistingof two domains: the first domain includes 14 items related to psychological,physical,andbehavioralsymptomsandthesecond domain(fiveitems)evaluatestheimpactofsymptomsonwomen’s functioning.Eachitemisratedonafour-pointscale(notatall=0, mild = 1,moderate = 2,severe = 3).In this study, the content validitymethodwasusedtodeterminethevalidityoftheinclusion criteria questionnaire and the demographic questionnaire. The reliabilityofthisinstrumentwithCronbach'salphavaluesof0.9 wasobtained.Toevaluatethevalidityofthequestionnaire,both apparentand content methods wereused, thecontent validity
ratioandcontentvalidityindexof0.7and0.8,respectively,indicate thecontentvalidityofthisquestionnaire.
Data were analyzed using descriptive statistics (mean and standard deviation)and inferential statistics.Wilcoxontest was usedforcomparisonbeforeandaftertheinterventionineachof thechamomileandplacebogroups.Mann-Whitneytestwasused tocomparebetweenthetwogroupsofchamomileandplacebo.
Covarianceanalysiswasusedtodeterminetheeffectofchamomile and placebo capsules on premenstrual mood symptoms by controlling age and menarche age variables. SPSS version 23 wasusedtoenterthedata.Differenceswithasignificancelevel(p
<0.05)wereconsideredsignificant.
Results
Table1hasbeensetupinordertodetermineandcomparethe demographiccharacteristicsofthetwogroupsofchamomileand placebocapsulestocheckthesimilarityofthetwogroupsinterms ofdemographiccharacteristics.
Thistableshowsthatmostoftheparticipants(27.8%)inthe chamomilegroupwere24yearsoldandintheplacebogroup,most of the participants (20.4 %) were 22 years old. Based on the independentt-test,therewasnostatisticallysignificantdifference betweentheparticipantsinthetwogroupsofchamomilecapsule and placebo capsulein terms of ageand the two groupswere homogeneousintermsofage(p>0.05).
Menarche age ofmost participantsin the chamomilegroup (40.7%)was12yearsandmenarcheageofmostparticipants(37%) in the placebo capsule group was 11 years. Based on the independentt-test,therewasnostatisticallysignificantdifference betweentheparticipantsinthetwogroupsofchamomilecapsule andplacebocapsuleintermsofmenarcheageandthetwogroups werehomogeneousintermsofmenarcheage(p>0.05).
Table 2 has been set in order to determine and compare menstrual related mood disorders before and after taking the capsuleintwogroups:chamomilecapsuleandplacebocapsule.
TheTable2showsthatinbothgroupsofchamomilecapsules and placebo capsules, menstrual related mood disorders after takingthecapsulecomparedtobeforetakingthecapsuleshoweda statisticallysignificantdifference(p<0.05).Inotherwords,both capsules, chamomile and placebo capsules, reduce the overall severityofpremenstrualmoodsymptoms.
AccordingtotheresultsofMann-Whitneytest,thereductionin the severity of mood symptoms in the chamomile group was significantlygreater thantheplacebo group(p<0.001). Inthe chamomile capsule group,overeatingand hypersomniadidnot change aftertaking thecapsule compared tobefore takingthe capsule (p >0.05). In the placebo group,decreased interest in homeactivities,decreasedinterestinsocialactivities,overeating, insomnia, oversleeping, after taking the capsule compared to beforetakingthecapsuleDidnotchange(p>0.05).
TheTable3showsthataftercontrollingtheageandmenarche ageas associatedvariables, changesin menstrual-relatedmood disordersweresignificantlydifferentbetweenthechamomileand
placebogroups (p<0.05),andthechamomilegrouphadmore changesintheseverityofmoodsymptomsthantheplacebogroup, inotherwords,thechangesintheseverityofmoodsymptomsin thechamomilegroupwere-10.37and-8/95unitslessthanthe placebogroup.
Discussion
According totheresults ofthis study, chamomile wasmore effective than placebo in reducing menstrual-related mood disorders (p < 0.001). Flavonoids, one of the most important compoundsinchamomile,increaseprogesterone levelsthrough their direct effect on the pituitary gland, so this plant can be effectiveinmodulatingpremenstrualmoodsymptoms[24],also, thesoothingandanti-anxietyeffectsofchamomileareduetothe presenceofcompoundssuchascamazolineandflavonoidsinthis plant [25] can be useful in the effectiveness of this plant in relievingpremenstrualmoodsymptoms.InSharifietal.'sstudy, administrationofchamomileextractreducedtheseverityofPMS symptoms, and compared to mefenamic acid, its effect on the overallseverityandpsychologicalsymptomsofPMSwasgreater [21],whichwasInlinewiththeresultsofthepresentstudy.Alsoin the Dadfar's study with the aim of investigating the effect of chamomileextractinrelievingdysmenorrheaandpremenstrual syndrome symptoms, there was a significant reduction in the severityof physicaland mental symptomsof thepremenstrual syndrome after consuming chamomile extract [26], which is similartotheresultsofthisstudy.Inastudycomparingtheefficacy of a phytotherapeutic complex (Angelica Sinensis, Dioscorea villosa, Matricaria chamomilla, Viburnum opulus, and Zingiber Officinalis) with homeopathic similimum in the treatment of primary dysmenorrheal, Shang showed that the use of drops containing herbs expressed the severity of dysmenorrhea and physicalsymptomssignificantlyreduce[27],whichissimilarto theresultsofthepresentstudy.Inaddition,theresultsofthestudy ofMaoetal.,Whichaimedtoinvestigatelong-termChamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder, showed a significant reduction in anxiety in people receiving chamomile extract [28]. This expresses the soothing effectsofchamomileonthecentralnervoussystem,sincesomeof themonthlymoodsymptomsinwomenareincludedsymptomsof anxiety and depression; it is not extravagant to expect that effectivetreatmentsfordepressionandanxietycanbeeffectivein thissyndrome.
Conclusions
Thechamomilecapsuleisanaturaldietaryagentwithprofound biologicaland pharmacologicalpropertiesthatamelioratemen- strual-relatedmooddisorders.Ourdataopenupfutureworkfor theuseand/oradditivitysynergismofchamomilecapsulesforthe developmentofmorepotenttherapieswithminimalsideeffects.
SomeachievementshavebeenmadeontheeffectofMatricaria chamomile on pre-menstrual syndrome and menstrual-related
Table1
Demographiccharacteristicsfortwogroupsofchamomilecapsulesandplacebo.
Variables ChamomileGroup Placebogroup Statisticaltest*
Age(years) Minimum 20 19 P=0.097
Maximum 28 28
MeanSD 22.812.11 23.542.36
Menarcheage(years) Minimum 10 10 P=0.079
Maximum 14 14
MeanSD 12.150.95 11.810.99
*IndependentT-test.
mood disorders. However, the understanding of the complex nature of the premenstrual dysphoric disorder behind these processesisstilllimited,andthefollowingaspectsdeservemore research works in the future. Future studies can compare the effectivenessofChamomilecapsuleswithnativeplantsandwith other methods suggested by alternative medicines for the treatmentofmenstrual-relatedmooddisorders.
Also, furtherinvestigationswithlargersamplesize,among femalesfrom differentagesof thecommunity,usingdifferent dosesofChamomilecapsuleforlongerperiodsoftimeaswell as studies without using a placebo, are suggestedto achieve more definitive results about the effectiveness and safety of Chamomile capsule for alleviating menstrual-related mood disorders.
Limitations in this study include four-week monitoring of menstrual-related mood disorders, which may indicate that certaintrendsmayhavebeenmissed.
There was no attempt to control the diet of the subjects, althoughallsubjectswereinstructedtomaintainallaspectsof theirusual lifestyles duringtheir participationin this research project.
Ethicscommitteeapproval
Thispaperistakenfromthemasterthesisstudentofmidwifery trainingwithethicscode(IR.GUMS.REC.1395.396).Thisisa RCT study (clinical trial code: IRCT201705214295N3). We have obtained consent before the participant enters the research.
Participantsprovidedwritteninformedconsentpriortothestudy.
Authors'contributions
Z.B.andE.NparticipatedintheConceptualization,design,and implementationoftheintervention,analysisofthefindings,and Table2
Comparisonofmenstrualrelatedmooddisordersinparticipantsbeforeandaftertheuseofcapsules.
Variables Changes ChamomileGroup Placebogroup
Number Averagerating Intragroupcomparison** Number Averagerating Intragroupcomparison**
Anger/irritability Decrease 41 22.29 P**<0.001 22 11.50 P**<0.001
Increase 3 25.33 0 000
Unchanged 10 – 32 –
Anxiety/tension Decrease 38 20.71 P**<0.001 13 8.15 P**=0.005
Increase 2 16.50 2 7.00
Unchanged 14 – 39 –
Tearful Decrease 22 15.95 P**=0.002 5 10.00 P**=0.039
Increase 7 12.00 14 10.00
Unchanged 25 – 35 –
Depressedmood Decrease 22 15.15 P**<0.001 7 13.00 P**=0.009
Increase 7 13.00 20 14.35
Unchanged 25 – 27 –
Interestinworkactivities Decrease 21 12.00 P**<0.001 11 7.50 P**=0.033
Increase 2 11.00 3 7.50
Unchanged 31 – 40 –
Interestinhomeactivities Decrease 20 11.60 P**<0.001 7 7.50 P**=1.000
Increase 2 10.50 7 7.50
Unchanged 32 – 40 –
Interestinsocialactivities Decrease 21 12.46 P**<0.001 6 7.50 P**=0.346
Increase 3 11.50 9 8.33
Unchanged 30 – 39 –
Difficultyconcentrating Decrease 28 15.16 P**<0.001 2 11.50 P**<0.001
Increase 1 10.50 22 12.59
Unchanged 25 – 30 –
Fatigue/lackofenergy Decrease 32 17.66 P**<0.001 18 12.00 P**=0.007
Increase 2 15.00 5 12.00
Unchanged 20 – 31 –
Overeating/foodcravings Decrease 17 13.26 P**=0.159 11 11.00 P**=0.841
Increase 9 13.94 11 12.00
Unchanged 28 – 32 –
Insomnia Decrease 16 10.47 P**=0.002 5 6.00 P**=782
Increase 3 7.50 5 5.00
Unchanged 35 – 44 –
Hypersomnia Decrease 10 12.15 P**=0.580 12 9.69 P**=0.309
Increase 13 11.18 7 10.07
Unchanged 31 – 35 –
Feelingoverwhelmed Decrease 39 20.00 P**<0.001 7 11.00 P**=0.023
Increase 0 000 17 13.12
Unchanged 15 – 30 –
**Wilcoxontest.
Table3
Determiningtheeffectofgroupafterremovingtheeffectofassociatedvariables.
Measure Meandifference(Placebo-Chamomile) F P**
Aftertakingthecapsule Removingtheeffectofage 10.37* 0.20 <0.001
Removingtheeffectofmenarcheage 8.95* 0.08 <0.001
Analysisofcovariance**.
draftingofthemanuscript.T.Z.participatedinthedesignofthe study and writing—review and editing of the manuscript. All authorsreadandapprovedthefinalmanuscript.
DeclarationofCompetingInterest Therewasnoconflictofinterest.
Acknowledgments
Authorswouldliketoexpresstheirgratitudetoresearchcenter of GuilanUniversityof medical sciencesand Kowsar dormitory administrators. Thanks are also extended to the Barij Essence pharmaceutical company (Kashan, Iran) support in supplying chamomileandplacebocapsules.
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