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Effectiveness of Aquatic Exercise and Balneotherapy: A Summary of Systematic Reviews Based on Randomized Controlled Trials of Water Immersion Therapies. PDF

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J Epidemiol 2010;20(1):2-12 doi:10.2188/jea.JE20090030 Review Article Effectiveness of Aquatic Exercise and Balneotherapy: A Summary of Systematic Reviews Based on Randomized Controlled Trials of Water Immersion Therapies Hiroharu Kamioka1, Kiichiro Tsutani2, Hiroyasu Okuizumi3, Yoshiteru Mutoh4, Miho Ohta5, Shuichi Handa3, Shinpei Okada6, Jun Kitayuguchi7, Masamitsu Kamada7, Nobuyoshi Shiozawa8, and Takuya Honda4 1FacultyofRegionalEnvironmentScience,TokyoUniversityofAgriculture,Tokyo,Japan 2DepartmentofDrugPolicyandManagement,GraduateSchoolofPharmaceuticalSciences,TheUniversityofTokyo,Tokyo,Japan 3MimakiOnsen(Spa)Clinic,Tomi,Nagano,Japan 4DepartmentofPhysicalandHealthEducation,GraduateSchoolofEducation,TheUniversityofTokyo,Tokyo,Japan 5LaboratoryofAqua,Health,andSportsMedicine,Sapporo,Japan 6PhysicalEducationandMedicineResearchFoundation,Tomi,Nagano,Japan 7PhysicalEducationandMedicineResearchCenterUnnan,Unnan,Shimane,Japan 8DepartmentofLongevityandSocialMedicine,OkayamaUniversityGraduateSchoolofMedicine, DentistryandPharmaceuticalSciences,Okayama,Japan ReceivedFebruary19,2009;acceptedJuly2,2009;releasedonlineOctober31,2009 ABSTRACT Background: Theobjectiveofthisreviewwastosummarizefindingsonaquaticexerciseandbalneotherapyandto assess the quality of systematic reviews based on randomized controlled trials. Methods: Studieswereeligibleiftheyweresystematicreviewsbasedonrandomizedclinicaltrials(withorwithout ameta-analysis)thatincludedatleast1treatmentgroupthatreceivedaquaticexerciseorbalneotherapy.Wesearched thefollowingdatabases:CochraneDatabaseSystematicReview,MEDLINE,CINAHL,WebofScience,JDreamII, and Ichushi-Web for articles published from the year 1990 to August 17, 2008. Results: We found evidence that aquatic exercise had small but statistically significant effects on pain relief and related outcome measures of locomotor diseases (eg, arthritis, rheumatoid diseases, and low back pain). However, long-term effectiveness was unclear. Because evidence was lacking due to the poor methodological quality of balneotherapy studies, we were unable to make any conclusions on the effects of intervention. There were frequent flawsregardingthedescriptionofexcludedRCTsandtheassessmentofpublicationbiasinseveraltrials.Twoofthe present authors independently assessed the quality of articles using the AMSTAR checklist. Conclusions: Aquatic exercise had a small but statistically significant short-term effect on locomotor diseases. However, the effectiveness of balneotherapy in curing disease or improving health remains unclear. Key words: systematic review; aquatic exercise; randomized controlled trial; balneotherapy facilitate muscle relaxation. In addition, the hydrostatic INTRODUCTION effect may relieve pain by reducing peripheral edema5 and Aquatic exercise has been referred to as pool therapy, by dampening sympathetic nervous system activity.6 hydrotherapy, and, in earlier literature, sometimes even as Bathing in water (balneotherapy or spa therapy) without balneotherapy.1 Exercise in warm water, usually called exercisehasalsobeenfrequentlyusedinalternativemedicine hydrotherapy or aquatic therapy, is a popular treatment for as a disease cure. Spa therapy is a very popular form many patients with painful neurologic or musculoskeletal of treatment for all types of arthritis in many European conditions.2 The warmth and buoyancy of water may block countries, as well as in Israel and Japan.7,8 In addition, nociception by acting on thermal receptors and mechano- recent reports have demonstrated that comprehensive health receptors,thusinfluencingspinalsegmentalmechanisms.3,4In education, which includes lifestyle education and exercise in addition, warm water may enhance blood flow, which is combinationwithspabathing,haspositiveeffectsformiddle- thought to help in dissipating algogenic chemicals, and aged and elderly people.9,10 Addressforcorrespondence.Dr.HiroharuKamioka,Ph.D,FacultyofRegionalEnvironment,TokyoUniversityofAgriculture,Sakuragaoka1-1-1,Setagaya-ku, Tokyo,Setagaya156-8502,Japan(e-mail:[email protected]). Copyright©2009bytheJapanEpidemiologicalAssociation 2 Kamioka H,et al. 3 Although many studies have reported the effects of water (IV) Search I or II or III exercise and balneotherapy, there is no review of systematic (V) Search I or II or III Limits: systematic reviews/meta- reviews of evidence from randomized controlled trials. The analysis objective of this review was to summarize evidence for the Only keywords related to intervention were used for effectiveness of aquatic exercise and balneotherapy and to searching. First, titles and abstracts of identified published assessthequality ofsystematicreviews based on randomized articles were reviewed to determine the relevance of the controlled trials of these therapies. articles.Next,thereferencesinrelevantreviewsandidentified randomized controlled trials (RCTs) were screened. Reference checking and hand searching METHODS We did not check the references of included studies, nor did Criteria for study inclusion we perform any hand searches or contact institutions, Types of studies societies, specialists with expertise in aquatic exercise or Systematic reviews based on randomized clinical trials (with balneotherapy, or the authors of included studies to identify or without a meta-analysis) were eligible. any additional published or unpublished data. Types of participants Studies were not excluded based on the disease status of Review methods participants (ill vs healthy people). Selection of trials Types of intervention and language Forthefinalselectionofstudiesforthisreview,2authors(HK Studies that included at least 1 treatment group in which and TH) independently applied all criteria to the full text of aquatic exercise or balneotherapy were included. A study of the articles that had passed the initial eligibility screening anytype ofexercise usedinatherapeuticindoor pool orbath (Figure 1). Disagreements and uncertainties were resolved by (rangeofmotionexercise,dynamicexercise,aerobicexercise, discussion between the authors. immersion only, etc.) was acceptable. Studies had to include Studieswereselectedwhen(1)thedesignwasasystematic information on use of medication, alternative therapies, and review of RCTs, and (2) one of the interventions was a lifestyle changes, and these had to be comparable among form of aquatic exercise or balneotherapy. Effectiveness of groups.Whencomparingdifferentprograms,typeofexercise, cure or health improvement was used as a primary outcome type of water, water depth, and water temperature were measure. Health improvement was defined broadly, and considered.Therewasnorestrictiononthebasisoflanguage. encompassed improvements in blood pressure, serum lipid profile,immunity,andqualityoflife.Weexcludedsystematic Methods used to identify studies reviewsofnon-RCTsorobservationalstudies.Trialsthatwere Bibliographic database excluded are shown, along with the reason for exclusion, in We searched the following databases: Cochrane Database the Appendix. Systematic Review, MEDLINE via PubMed from 1990, Quality assessment of included studies CINAHL from 1990, Web of Science from 1990, JDream II Toensurethatvariationwasnotcausedbysystematicerrorsin (inJapanese)from1990,andIchushi-Web(inJapanese)from study design or execution, 2 review authors (MK and HK) 1990,forarticlespublisheduptoAugust17,2008.Thesearch independently assessed the quality of articles. A full quality was limited to studies published in or after 1990, the time appraisal of these papers was made using the AMSTAR,11 period during which the systematic review methodology which was developed to assess the methodological quality of became accepted. All searches were performed by 2 hospital systematic reviews. Disagreements and uncertainties were librarians who were qualified in medical information resolved by discussion between the review authors. management and were highly trained in the retrieval of Summary of studies and data extraction clinical trials. One author (HK) selected the summary from each of the Search strategies structured abstracts and extracted the results for statistical The search strategies used for all databases contained the analysis. The primary outcome measurement was always following elements and terms: chosen for analysis. (I) Search“aquatictherapy”or“aquaticexercise”or“water Benefits and harms exercise” The GRADE Working Group12 reported that the balance (II) Search (“water”[Majr] or “swimming”[Majr]) and betweenbenefitsandharms,qualityofevidence,applicability, exercise therapy/methods and the probability of baseline risk were all considered in (III) Search “water gymnastic” or “water training” or “water judgments of the strength of recommendations. Adverse aerobics” or “pool exercise” or “pool therapy” events and withdrawals are particularly important for or “aerobic aquatics” or “hydrotherapy” or researchers and users of clinical practice guidelines, and “thalassotherapy” or “aquatics” or “balneotherapy” or we present this information with the description of each “spa therapy” article. J Epidemiol 2010;20(1):2-12 4 Effectivenessof Aquatic Exerciseand Balneotherapy Potentially relevant abstracts (n=111) Excluded Not relevant (n=76) Retrieved for detailed evaluation (n=35) Appendix . Not SR (n=7) Excluded . Not SR based on RCTs (n=12) . Not SR based on water therapy (n=7) . Not reviewed according to protocol (n=2) Systematic reviews meeting inclusion criteria (n=7) Figure 1. Flowchart oftrial process SR: systematic review.RCT: randomizedcontrolled trial. and6.6%relativereductionfrombaselinewerefoundforpain RESULTS (P<0.05; SMD, 0.19; 95% CI, 0.04 to 0.35; n=638). No Study characteristics statistically significant differences were found for walking The literature searches identified 111 potentially relevant ability or stiffness. articles (Figure 1). Abstracts from those articles were Next,weexaminedtheeffectivenessofaquaticexercisefor assessed and 35 studies were retrieved for further evaluation pain relief.2 Aquatic exercise was significantly inversely (assessment of relevant literature). Twenty-eight publications associated with pain (P<0.05; SMD, −0.17; 95% CI, were excluded either because they were not a systematic −0.33 to −0.01; n=594). However, meta-analysis showed review (SR), not an SR based on RCTs, not an SR in which no differences between aquatic exercise and land exercise waterwasafactor,orwerenotreviewedaccordingtoprotocol (P=0.56; SMD, 0.11; 95% CI, −0.27 to 0.50; n=103). (see Appendix). Seven trials1,2,13–17 met all inclusion criteria We then examined the effectiveness of spa therapy (Tables 1 and 2). These included 3 SRs on aquatic exercise (with physiotherapy) and balneotherapy for treating low (spa therapy)1,2,16 and 5 SRs on balneotherapy13–17; one of back pain.16 Pain was assessed using a 100-mm VAS. Spa these concerned both balneotherapy and spa therapy (with therapy was significantly inversely associated with pain physiotherapy). The target diseases and disorders included (P<0.001; SMD, 26.6; 95% CI, 20.4 to 32.8; n=442), as knee and hip osteoarthritis,1,14,15 rheumatoid arthritis,13 low was balneotherapy (P<0.001; SMD, 18.8; 95% CI, 10.3 to back pain,16 and neurologic or musculoskeletal disease 27.3; n=138). Results on the Schober index and assessment (ie, rheumatoid arthritis, fibromyalgia, low back pain, and of lumbar flexibility suggested there were no significant osteoarthritis), along with a number of other diseases intergroup differences. and disorders.2 Studies on health improvement were also included.17 The SRs of aquatic exercise showed a curative Withdrawals and adverse events effect in all studies; however, the SRs of balneotherapy Withdrawals (dropouts) were reported in 3 studies, and provided no clear evidence of curative effect (Table 3). adverse events were reported in 4 studies (Table 4). No fatal accidents or serious adverseeffects were noted instudiesthat Results of meta-analysis reported adverse events. Only3SRs1,2,16provideddatathatweresuitableforstatistical pooling. Regarding the effectiveness of aquatic exercise for Quality assessment the treatment of knee and hip osteoarthritis,1 there was a A list of excluded studies (3 trials, 43%) and the use of small but statistically significant favorable effect for aquatic graphic aids to assess publication bias (1 trial, 14%) were exercise on function (P<0.001; weighted standardized mean evaluated by using the AMSTAR checklist (Table 5). difference[SMD],0.26;95%confidenceinterval[CI],0.11to 0.42; n=648), quality of life (P<0.05; SMD, 0.32; 95% CI, DISCUSSION 0.03 to 0.61; n=599), and mental health (P<0.05; SMD, 0.16; 95% CI, 0.01 to 0.32; n=642) measured immediately We identified only 7 published SRs on aquatic exercise and after the intervention period. Pain was assessed using a 100- balneotherapy, which indicates that there is little evidence mm visual analogue scale (VAS). A 3% absolute reduction demonstratingtheeffectivenessofthewarmth,buoyancy,and J Epidemiol 2010;20(1):2-12 Kamioka H,et al. 5 Dataextraction/Datacollectionandanalysis Tworeviewauthorsindependentlyselectedtrialsforinclusion,assessedtheinternalvalidityofincludedtrialsandextracteddata.Pooledresultswereanalyzedusingstandardizedmeandifferences(SMD). Twoauthorsindependentlyassessedqualityandextracteddata.Disagreementsweresolvedbyconsensus. Twoauthorsindependentlyassessedqualityandextracteddata.Disagreementsweresolvedbyconsensus.Intheeventofclinicalheterogeneityorlackofdatatheyrefrainedfromstatisticalpooling. :Continuedonnextpage Selectioncriteria/periodofintervention Randomizedcontrolledtrialsorquasi-randomizedclinicaltrials.Thedurationofinterventionswasfrom6weeksto12months. Selectioncriteria:randomizedcontrolledtrialscomparingbalneotherapywithanyotherinterventionorwithnointervention.IncludedpatientsfiwereallsufferingfromdeniteorclassicalrheumatoidarthritisfiasdenedbytheAmericanRheumatismAssociationCriteriaorbythecriteriaofSteinbrocker.AtleastoneoftheWHO/ILARcoresetofendpointsforRAclinicaltrialshadtobeamongthemainoutcomemeasures.Thedurationofinterventionswasfrom14weeksto6monthsand4weeks. Randomizedcontrolledtrials(RCT)comparingbalneotherapywithanyinterventionornointervention.Atleast90%ofthepatientpopulationhadtobediagnosedwithosteoarthritis;durationofinterventionswasfrom15daysto27weeks. Datasource/Searchstrategy MEDLINEfrom1949,EMBASEfrom1980,CENTRAL(Issue2,2006),CINAHLfrom1982,WebofSciencefrom1945,alluptoMay2006.Therewasnolanguagerestriction. TheysearchedthefollowingdatabasesuptoOctober2006:CENTRAL(Issue3,2006),PubMed,CINAHL,thedatabasefromtheCochrane“RehabilitationandRelated”TherapiesFieldandPedro,andperformedreferencecheckingandpersonalcommunicationswithauthorstoretrieveeligiblestudies. TheysearchedthefollowingdatabasesuptoOctober2006:EMBASE,PubMed,the“CochraneRehabilitationand”RelatedTherapiesFielddatabase,PEDro,CENTRAL(Issue3,2006),andperformedreferencecheckingandcommunicatedwithauthorstoretrieveeligiblestudies. e aimandmethods) Aim/Objective Tocomparetheeffectivenessandsafetyofaquaticexerciseinterventionsinthetreatmentofkneandhiposteoarthritis. Toassesstheeffectivenessofbalneotherapyforrheumatoidarthritis. Toassesstheeffectivenessofbalneotherapyforpatientswithosteoarthritis(OA). ( e s hd structuredabstract Title Aquaticexerciseforttreatmentofkneeanhiposteoarthritis. Balneotherapyforrheumatoidarthritis. Balneotherapyforosteoarthritis. n e e e basedo ear;Vol.; Databas D005523.h) Databas D000518.h) Databas D006864.h) maryofarticles JournalYPage. etal.CochraneSystRev2007;4:C(inEnglis P,etal.CochraneSystRev2008;3:C(inEnglis P,etal.CochraneSystRev2007;4:C(inEnglis m M, A A 1.Su uthor artelsE erhagen erhagen e A B V V Tabl No. 1 13 14 J Epidemiol 2010;20(1):2-12 6 Effectivenessof Aquatic Exerciseand Balneotherapy Dataextraction/Datacollectionandanalysis Theyusedachecklistfispecicallydesignedtoevaluatetheinternalvalidityofnonpharmacologicaltrials.Externalvalidityandthequalityofthestatisticalanalysiswerealsoevaluated. Dataabstractionwasperformedsystematicallyandindependentlyaccordingtodesign,quality,samplesize,intervention,watercharacteristics,results,adverseeventsandconcomitanttreatment. Informationontheparticipants,interventions,andoutcomeswasextractedfromtheincludedstudies.QualityappraisalwasassessedusingtheScottishIntercollegiateGuidelinesNetworkcriteriaforRCTs. Thequalityofindividualarticleswasevaluatedona13-pointfimodiedPEDroscalethatwasconstructedbyaddingthreeterms,representingthenumberofsubjects,theobservationperiod,andwatercharacteristicstothe10-pointPEDroscale. Selectioncriteria/periodofintervention Studiesthatcomparedcrenobalneotherapytootherinterventionsortonointerventionwereconsidered.Massage(usuallyanintegralpartofspaprograms)isnotfispecictospatherapyandthereforewasnotstudiedhere.Onlystudiesofpatientswithosteoarthritisoftheknee,hip,and/orhandswereselected.Thedurationofinterventionswasfrom16daysto1yearand3months. Alltrialsreportingthatthesequenceofallocationwasrandomized(RCTs).Testingbalneotherapyorspatherapyfortreatingpatientswithlowbackpainwereincluded.Trialsreportedinduplicatewereexcluded.Thedurationofinterventionswasfrom3weeksto4weeks. Randomizedcontrolledtrials(RCTs)thatincludedadultswithneurologicormusculoskeletaldisease,painasanoutcomemeasure,andexerciseinwaterwereincluded.Thedurationofinterventionswasfrom4weeksto12months. Keywordsforstudyselection“wererandomizedcontrolled”“”trialandspaor“”balneotherapy.Nocriteriaweresetupconcerningthenumberofsubjects,theobservationperiod,orthekindofdiseasestudied.Thedurationofinterventionswasfrom3weeksto12months. Datasource/Searchstrategy TheysearchedtheMedlinedatabase.TheyalsoreviewedthereferencelistsofarticlesretrievedbytheMedlinesearch.ThestudieshadtobewritteninEnglishorFrench. SystematicsearcheswereconductedonMedline,Embase,AmedCochraneCentral,theUKNationalResearchRegisterandClincalTrials.gov(alluntilJuly2005). Asystematicliteraturesearchof14databaseswasexaminedforresearchonaquaticexerciseovertheperiodfromJanuary1980toJune2006. TheysearchedthePubMeddatabasetwice:inSept.2004andinApril2005.Articlespublishedafter1990andwritteninEnglishweresearched. Aim/Objective Toconductasystematicliteraturereviewoncrenobalneotherapyforlimbosteoarthritisandtodiscussthestudymethodsusedtoevaluatethistreatmentmodality. Toassesstheevidencefororagainsttheeffectivenessofspatherapyandbalneotherapyfortreatinglowbackpain. Toevaluatetheliteratureontheeffectivenessofaquaticexerciseinrelievingpaininadultswithneurologicormusculoskeletaldisease. Toreviewrandomizedcontrolledtrialsoftheeffectsoftreatmentinspas,therebyclarifyingtherapeuticeffectsofthesetreatmentsonindividualdiseases,anditshealth-promotingeffects. Title Crenobalneotherapyforlimbosteoarthritis:Systematicliteraturereviewandmethodologicalanalysis. Spatherapyandbalneotherapyfortreatinglowbackpain:meta-analysisofrandomizedtrials. Doesaquaticexerciserelievepaininadultswithneurologicormusculoskeletaldisease?Asystematicreviewandmeta-analysisofrandomizedcontrolledtrials. Asystematicreviewofrandomizedcontrolledtrialsonthetherapeuticandhealth-promotingeffectsofspas. JournalYear;Vol.;Page. JointBoneSpine–2008;75:138148.(inEnglish) Rheumatol–2006;45:880883.(inEnglish) ArchPhysMedRehabil–2008;89:873883.(inEnglish) JJpnSocBalneolClimatolPhysMed–2006;69:155166.(inJapanesewithEnglishabstract) R,etal. H,etal. al. H,etal. :ntinued Author Forestier PittlerM HallJ,et Kamioka Co No. 15 16 2 17 J Epidemiol 2010;20(1):2-12 Kamioka H,et al. 7 Conclusion fiAquaticexerciseappearstohavesomebenecialshort-termeffectsforpatientswithhipand/orkneeOA;nolong-termeffectsweredocumented.Thecontrolledandrandomizedstudiesinthisareaarestilltoofewtogivefurtherrecommendationsonhowtoapplythetherapy,andstudiesofficlearlydenedpatientgroupswithlong-termoutcomesareneeded. Silverlevelevidencewasfoundforonestudyinfavorofmineralbathscomparedtodrugtreatmentfifiateightweeks.Insufcientevidencewasfoundforallothercomparisons.Howeverthescienticfi“evidenceisinsufcientbecauseofpoormethodologicalquality.Therefore,thenotedpositivefi”ndingsshouldbeviewedwithcaution. fiTheyfoundsilverlevelevidenceconcerningthebenecialeffectsofmineralbathscomparedtonotreatment.Regardingallotherbalneologicaltreatments,nocleareffectswerefound.However,thefiscienticevidenceisweakbecauseofthepoormethodologicalqualityandtheabsenceof“fi”adequatestatisticalanalysisanddatapresentation.Thenotedpositivendingsshouldbeviewedwithcaution. Althoughtheconsistencyoftheresultssuggestsatherapeuticeffectofcrenobalneotherapyinlimbosteoarthritis,availablestudiesaremethodologicallyinadequateandsamplesizestoosmalltofiallowdenitiveconclusions.Theysuggestanumberofsolutionstotheseshortcomings.Carefullydesignedstudiesinlargerpatientpopulationsareneededtodeterminetheroleofcrenobalneotherapyinkneeosteoarthritis. Eventhoughthedataarescarce,thereisencouragingevidencesuggestingthatspatherapyandbalneotherapymaybeeffectivefortreatingpatientswithlowbackpain.Thesedataarenotcompellingbutwarrantrigorouslarge-scaletrials. Thereissoundevidencethattherearenodifferencesinpain-relievingeffectsbetweenaquaticandlandexercise.Comparedwithnotreatment,aquaticexercisehasasmallpain-relievingeffect;however,thesmallnumberofgood-qualitystudiesandinconsistencyofresultsmeansthatfifiinsufcientevidencelimitsrmconclusions. “”Theydeviseda3-layermodelofevidencetobeaccumulatedinbalneotherapyandconcludedthatRCTquality,evidencelevel,andexpectationofgoodresultswerehighfor,indescendingorder,pain-relievingeffect,functionalrecoveryandimprovementinqualityoflife,andhealth-promotingeffects. ofarticlesbasedonstructuredabstracts(resultsandconclusion) Mainresults Intotal,sixtrials(800participants)wereincluded.Attheendoftreatmentforcombinedkneeandfihiposteoarthritis,therewasasmall-to-moderateeffectonfunction(SMD0.26,95%condenceinterval(CI)0.11to0.42)andasmall-to-moderateeffectonqualityoflife(SMD0.32,95%CI0.03to0.61).Aminoreffectofa3%absolutereduction(0.6fewerpointsona0to20scale)and6.6%relativereductionfrombaselinewasfoundforpain.Onlytwostudiesreportedadverseeffects,thatis,theinterventionsdidnotincreaseself-reportedpainorsymptomscores. Oneextrastudyisincludedinthisupdate.Nowseventrials(412patients)wereincludedinthisfireview.Mosttrialsreportedpositivendingsontheirmainoutcomes,butweremethodologicallyfl‘’awedtosomeextent.Aqualityoflifeoutcomewasreportedbytwotrials.Noneofthetrialsperformedanintention-to-treatanalysisandonlytwoperformedacomparisonofeffectsbetweengroups.Poolingofthedatawasnotperformedbecauseofheterogeneityofthestudies,multiplefifioutcomemeasurements,andtheoverallpoordatapresentation.WefoundasignicantbenetofmineralbathscomparedtoCyclosporineAateightweeksonpaininonestudy(RR=2.4;95%CI:fi1.4,3.8).Overallthereisinsufcientevidencethatbalneotherapyismoreeffectivethannotreatment,thatonetypeofbathismoreeffectivethananother,orthatonetypeofbathismoreeffectivethanmudpacks,exercise,orrelaxationtherapy. Seventrials(498patients)wereincludedinthisreview.Twostudiescomparedspatreatmentwithnotreatment.Onestudyevaluatedbathsasanadd-ontreatmenttohomeexerciseandtheauthorcomparedthermalwaterfromCserkeszolowithtapwater(placebo).ThreestudiescomparedsulphurorDeadSeabathswithnotreatmentormineralbathswithtapwaterbathsornotreatment.Onlyoneofthetrialsperformedanintention-to-treatanalysisandtwostudiesprovidedenoughdata‘’toperformourownintention-to-treatanalysis.Aqualityoflifeoutcomewasreportedbyonetrial. Crenobalneotherapywasassociatedwithimprovementsintheevaluationcriteria(pain,function,andqualityoflife)comparedtobaseline.However,inadequateinternalvalidityprecludedtheestablishmentofacausallinkbetweentheseimprovementsandcrenobalneotherapy.Externalfifivaliditywasoftenpoorlydened.Somestudiesfoundnosignicantdifferenceswiththecontrolgroupbutfailedtoincludeasample-sizecalculation,suggestinginadequatestatisticalpowerasapossibleexplanationfortheresult.Inseveralstudies,theuseofmultipleevaluationcriteriaandmeasurementsledtoahighriskofTypeIerror. Fiverandomizedclinicaltrialsmetallinclusioncriteria.Quantitativedatasynthesiswasperformed.fiThedataforspatherapy,assessedona100-mmvisualanaloguescale(VAS),suggestsignicantfibenecialeffectscomparedwithwaitinglistcontrolgroups(weightedmeandifference26.6mm,fi–n95%condenceinterval20.432.8,=442)forpatientswithchroniclowbackpain.Forfibalneotherapy,thedata,assessedona100-mmVAS,alsosuggestbenecialeffectscomparedfi–withcontrolgroups(weightedmeandifference18.8mm,95%condenceinterval10.327.3,n=138). Nineteenstudiesmettheinclusioncriteria;8hadamoderate-to-lowriskofbias,and5ofthesehaddatasuitableformeta-analyses.Thisshowedthataquaticexercisehasasmallposttreatmenteffect−Pinrelievingpaincomparedwithnotreatment(=.04;standardizedmeandifference[SMD],.17;fi−−fi95%condenceinterval[CI],.33to.01),butitisnotpossibletodrawarmconclusionbecauseofthelackofconsistencyofevidenceacrossstudies.Comparablepain-relievingeffectswerefound−Pbetweenaquaticandland-basedexercise(=.56;SMD=.11;95%CI,.27to.50). Atotalof17articleswerereviewed.Diseasesstudiedinthesearticlesweremostlylocomotor’disorders,withpainasamainsymptom:rheumatism,osteoarthritis,lumbago,Parkinsonsdisease,fivaricosis,psoriasis,andhealth-promotion.Themeanscoreonthe13-pointmodiedPEDroscalewas7.5(SD,2.3),withaminimumscoreof2pointsandamaximumscoreof12points.Inadditiontobalneotherapy,exercisetherapy,mudpacktreatment,anddouchemassagewereemployedinnumerousstudies.Improvementsintheindicatorswerealwaysmoremarkedinbalneotherapyinterventiongroupsthanincontrolgroups,irrespectiveofthediseasestudied. e2.Summary Author BartelsEM,etal. VerhagenAP,etal. VerhagenAP,etal. ForestierR,etal. PittlerMH,etal. HallJ,etal. KamiokaH,etal. Tabl No. 1 13 14 15 16 2 17 J Epidemiol 2010;20(1):2-12 8 Effectivenessof Aquatic Exerciseand Balneotherapy Table 3. Briefsummaryof7systematicreviews No. Author Yearofpublication Interventiontype Meta-analysis Objectdisease Effectsnoted 1 BartelsEM,etal. 2007 Aquaticexercise Performed Hipandknee Short-termeffects Osteoarthritis 13 VerhagenAP,etal. 2008 Balneotherapy Notperformed Rheumatoidarthritis Unclear,buteffectsin sometrials 14 VerhagenAP,etal. 2007 Balneotherapy Notperformed Osteoarthritis Unclear,buteffectsin sometrials 15 ForestierR,etal. 2008 Balneotherapy Notperformed Limbosteoarthritis Unclear,buteffectsin sometrials 16 PittlerMH,etal. 2006 Balneotherapyand Performed Lowbackpain Effectforboth aquaticexercise interventions 2 HallJ,etal. 2008 Aquaticexercise Performed Neurologicor Smalleffect musculoskeletal disease 17 KamiokaH,etal. 2006 Balneotherapy Notperformed Locomotordiseaseand Unclear,buteffectsin healthimprovement sometrials Table 4. Descriptionofadverseeventsandwithdrawalsinarticles Withdrawals Adverseevents No. Author Title (dropouts)described? described? 1 BartelsEM,etal. Aquaticexerciseforthetreatmentofkneeandhip Yes Yes osteoarthritis 14 VerhagenAP,etal. Balneotherapyforrheumatoidarthritis Yes Yes 15 VerhagenAP,etal. Balneotherapyforosteoarthritis Yes Yes 16 ForestierR,etal. Crenobalneotherapyforlimbosteoarthritis:Systematic Yes No literaturereviewandmethodologicalanalysis 17 PittlerMH,etal. Spatherapyandbalneotherapyfortreatinglowbackpain: No Yes meta-analysisofrandomizedtrials 2 HallJ,etal. Doesaquaticexerciserelievepaininadultswith Yes Yes neurologicormusculoskeletaldisease?Asystematic reviewandmeta-analysisofrandomizedcontrolledtrials 18 KamiokaH,etal. Asystematicreviewofrandomizedcontrolledtrialsonthe No No therapeuticandhealth-promotingeffectsofspas hydrostatic effects of water for curing disease or improving during water immersion. This suggests that an intervention health.OnereasonforthelimitednumberofSRsmaybethat requiring exercise is more effective for the treatment of aquatic exercise and balneotherapy are similar practices and musculoskeletal diseases, as compared to balneotherapy, distinguishing between them in RCTs is thus difficult. In which involves passive immersion. However, it should be addition,participantsmayfindtheinterventionprocess,which noted that this was only the immediate effect of intervention, requires them to undress and wear a swimsuit, to be and not the long-term result. The intervention period ranged troublesome. Furthermore, it is difficult to perform meta- from 3 weeks to 12 months in aquatic exercise studies, and analyses because, in the case of balneotherapy, the chemical from 15 days to 12 months in studies of balneotherapy. contentandtemperatureofthewatersstudieddifferinvarious This might reflect the difficulty of maintaining long-term countries and the data are therefore not easily integrated. participation in an RCT. Whatever the case, the long-term effects are not clear. Aquatic exercise versus balneotherapy (without We did not pool data from SRs of balneotherapy13–15,17 exercise) because of their heterogeneity, multiple and varied outcome Wedistinguishedbetweenaquaticexerciseandbalneotherapy measurements,andpooroverallquality.SRsofbalneotherapy to determine which was more effective, because many suggestedthatthescientificevidencewasinsufficientbecause studies do not do so. Aquatic exercise had a small but ofthepoormethodologicalqualityofRCTsofbalneotherapy. statistically significant effect on pain, function, QOL and Thus, it is difficult to determine the independent effect of mental health, and included more voluntary movements balneotherapy without exercise. J Epidemiol 2010;20(1):2-12 Kamioka H,et al. 9 (%) (100)(0)(0)(0) (86)(0)(14)(0) (71)(29)(0)(0) (100)(0)(0)(0) (43)(57)(0)(0) (100)(0)(0)(0) (100)(0)(0)(0) (100)(0)(0)(0) (71)(14)(14)(0) (14)(86)(0)(0) (71)(29)(0)(0) n 7000 6010 5200 7000 3400 7000 7000 7000 5110 1600 5200 e e e e e e e e e e e erbl erbl erbl erbl erbl erbl erbl erbl erbl erbl erbl wa wa wa wa wa wa wa wa wa wa wa er anspplic anspplic anspplic anspplic anspplic anspplic anspplic anspplic anspplic anspplic anspplic nsw eso’antota eso’antota eso’antota eso’antota eso’antota eso’antota eso’antota eso’antota eso’antota eso’antota eso’antota A YNCN YNCN YNCN YNCN YNCN YNCN YNCN YNCN YNCN YNCN YNCN 11EvaluationofthequalityofsystematicreviewsbyusingtheAMSTARchecklist Items ‘’Wasanaprioridesignprovided?Theresearchquestionandinclusioncriteriashouldbeestablishedbeforetheconductofthereview. Wasthereduplicatestudyselectionanddataextraction?Thereshouldbeatleasttwoindependentdataextractorsandaconsensusprocedurefordisagreementsshouldbeinplace. Wasacomprehensiveliteraturesearchperformed?Atleasttwoelectronicsourcesshouldbesearched.Thereportmustincludeyearsanddatabasesused(e.g.,Central,EMBASE,andMEDLINE).Keywordsand/orMESHtermsmustbestatedandwherefeasiblethesearchstrategyshouldbeprovided.Allsearchesshouldbesupplementedbyficonsultingcurrentcontents,reviews,textbooks,specializedregisters,orexpertsintheparticulareldofstudy,andbyreviewingthereferencesinthestudiesfound. Wasthestatusofpublication(i.e.,greyliterature)usedasaninclusioncriterion?Theauthorsshouldstatethattheysearchedforreportsregardlessoftheirpublicationtype.Theauthorsshouldstatewhetherornottheyexcludedanyreports(fromthesystematicreview),basedontheirpublicationstatus,languageetc. Wasalistofstudies(includedandexcluded)provided?Alistofincludedandexcludedstudiesshouldbeprovided. Werethecharacteristicsoftheincludedstudiesprovided?Inanaggregatedformsuchasatable,datafromtheoriginalstudiesshouldbeprovidedontheparticipants,interventionsandoutcomes.Therangesofcharacteristicsinallthestudiesanalyzede.g.,age,race,sex,relevantsocioeconomicdata,diseasestatus,duration,severity,orotherdiseasesshouldbereported. fiWasthescienticqualityoftheincludedstudiesassessedanddocumented?‘’Apriorimethodsofassessmentshouldbeprovided(e.g.,foreffectivenessstudiesiftheauthor(s)chosetoincludeonlyrandomized,double-blind,placebocontrolledstudies,orallocationconcealmentasinclusioncriteria);forothertypesofstudiesalternativeitemswillberelevant. fiWasthescienticqualityoftheincludedstudiesusedappropriatelyinformulatingconclusions?fiTheresultsofthemethodologicalrigorandscienticqualityshouldbeconsideredintheanalysisandtheconclusionsofthereview,andexplicitlystatedinformulatingrecommendations. fiWerethemethodsusedtocombinethendingsofstudiesappropriate?Forthepooledresults,atestshouldbedonetoensurethestudieswerecombinable,toassesstheirhomogeneity(i.e.Chi-squaredtestforhomogeneity).Ifheterogeneityexistsarandomeffectsmodelshouldbeusedand/ortheclinicalappropriatenessofcombiningshouldbetakenintoconsideration(i.e.,isitsensibletocombine?). Wasthelikelihoodofpublicationbiasassessed?Anassessmentofpublicationbiasshouldincludeacombinationofgraphicalaids(e.g.,funnelplot,otheravailabletests)and/orstatisticaltests(e.g.,Eggerregressiontest). flWastheconictofintereststated?Potentialsourcesofsupportshouldbeclearlyacknowledgedinboththesystematicreviewandtheincludedstudies. 5. ble No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. a T J Epidemiol 2010;20(1):2-12 10 Effectivenessof Aquatic Exerciseand Balneotherapy Table 6. Overallevidenceandfutureresearchagenda Intervention Evidence Specificagenda Commonagenda Aquaticexercise Smallbutsignificanteffect 1.Long-termeffect 1.Randomizedcontrolledtrialsforvarious (nodifferencesbetweenaquatic 2.Typeofdose diseases exerciseandlandexercise) (intensity,frequencyandduration) 2.Cost-benefitanalysis 3.Descriptionofadverseeffects Balneotherapy Poor/Unclear Satisfactorymethodology (intention-to-treatanalysis,blinding, adequatecontrolgroup,etc.) Quality assessment complex review “from scratch” even if there are existing Seven of the included SRs were published after 2006 and, reviews? hence, relatively recent. We used the AMSTAR checklist because its content validity is high and the number of Study limitations articles reviewed to evaluate SR quality was as few as 11. There were several limitations to the present study. Some The requirements of the AMSTAR checklist were generally selection criteria were common to the studies, as described satisfied; however, an assessment of publication bias was above; however, bias remained due to differences in the frequentlyomitted.TheAMSTARrequiresthatanassessment eligibility for participation in each study. ofpublicationbias includeacombinationofgraphic aids(eg, Publicationbiaswasalsoalimitation.Althoughwedidnot funnel plot other available tests). One important publication limit our search to English language articles, we found no reported that authors were more likely to publish RCTs in an articles published in other languages. Also, we were not able English-language journal if the results were statistically to check references by means of hand searches. Nor were we significant.18 English language bias may therefore be present able to contact institutions, societies, or specialists with in reviews and meta-analyses that include only trials reported expertise in aquatic exercise or balneotherapy or authors of in English. included studies to identify any additional published or There were few lists of excluded studies: only 3 Cochrane unpublished data. Another limit of the study was that we Reviews1,13,14 reported this information. If the format of SRs were not able to search the PEDro database, which is used in adheres to that of the Cochrane Review, recording omissions fields such as rehabilitation medicine and physiotherapy. would be minimal. However, many scientific journals limit In terms of quality assessment, disagreements and the length of submissions, so such descriptions may not uncertainties were resolved by discussion between 2 be published. We believe it is necessary to include a list authors; discussions with a third expert and contact with of excluded studies in order to improve the certainty and authors for the purpose of clarification were not allowed. transparency of studies. Conclusion Overall evidence and future research agenda There were relatively few SRs of RCTs on aquatic exercise Table 6showstheoverallevidenceandfutureresearchagenda andbalneotherapy.Wefoundthataquaticexercisehadasmall foraquaticexerciseandbalneotherapy.Aquaticexercisehada but statistically significant effect on pain relief and related small but statistically significant effect. Future RCTs should outcome measurements for locomotor diseases. However, the investigate the long-term effectiveness of aquatic exercise long-term effectiveness of these treatments remains unclear. or its effectiveness with respect to type or duration of Because there was insufficient evidence due to the exercise. Then, SRs based on such RCTs can be conducted. poor methodological quality of balneotherapy studies, Regardingbalneotherapy,RCTsbasedonappropriateresearch we are unable offer any conclusions about the effects of methodologyareneededbecausenocleareffectwasfoundin this intervention. Common flaws included an inadequate thepresentstudy. Acommon problem with RCTs isthat they description of excluded RCTs and insufficient assessment of donotproperlyevaluateadverseeffects;futurestudiesshould publication bias. include these data. Arecentstudy suggestedthatthemostimportantquestions ACKNOWLEDGEMENTS that authors of systematic reviews face are as follows19: (1) Howcanincorporatingexistingreviewsintonewworkadhere This study was supported by Health and Labour Sciences to the principles of comprehensive, transparent, and unbiased Research Grants (Research on Health Security Control: methods required for systematic reviews? (2) If an effort is ID No. H20-007) from the Japanese Ministry of Health, made to incorporate existing reviews, will it save time and Labour and Welfare in 2008. We would like to express our resources? (3) Are there instances where an independent, appreciationtoM.Makishi, Y.Yamada,andS.Moriyama for critical assessment of the evidence warrants conducting a their assistance in this study. J Epidemiol 2010;20(1):2-12 Kamioka H,et al. 11 Appendix. Studiesexcludedinthepresentreview No. Author.Journal(Year) Title Reasonforexclusion E1 CardosoJR,etal.CochraneDatabaseSystcRev Aquatictherapyexercisefortreatingrheumatoidarthritis Notrevieweddueto (2008) (Protocol) protocol E2 BeamonS,etal.CochraneDatabaseSystRev Hydrotherapyforasthma(Protocol) Notrevieweddueto (2008) protocol E3 DziedzicK,etal.BestPracticeResearchClin Land-andwater-basedexercisetherapiesfor NotSR Rheumatol(2008) musculoskeletalcondition E4 GetzM,etal.ClinRehabili(2006) Effectsofaquaticinterventionsinchildrenwithneuromotor NotSRbasedonRCTs impairments:asystematicreviewoftheliterature E5 TejirianT,etal.DiseasesColonRectum(2005) Sitzbath:whereistheevidence?Scientificbasisofa NotSR commonpractice E6 HermanPM,etal.BMCComplementaryAlternative Iscomplementaryandalternativemedicine(CAM)cost- NotSRbasedonwater Med(2005) effective?asystematicreview E7 KaragulleMZ,etal.ForschKomplementarmed Balneotherapyandspatherapyofrheumaticdiseasesin NotSRbasedonRCTs KlassNaturheilkd(2004) Turkey:asystematicreview(inGerman) E8 MeremikwuM,etal.CochraneDatabaseSystRev Physicalmethodsfortreatingfeverinchildren NotSRbasedonwater (2008) E9 LiaoWC.IntJNursingStudies(2002) Effectsofpassivebodyheatingonbodytemperatureand NotSRbasedonRCTs sleepregulationintheelderly:asystematicreview E10 PennickVE,etal.CochraneDatabaseSystRev Interventionsforpreventingandtreatingpelvicandback NotSRbasedonwater (2007) paininpregnancy E11 TeschendorfME,etal.AmJMaternal/ChildNursing Hydrotherapyduringlabor:anexampleofdevelopinga NotSRbasedonRCTs (2000) practicepolicy E12 VerhagenAP,etal.JRheumatol(1997) Takingbaths:theefficacyofbalneotherapyinpatientswith NotSRbasedonRCTs arthritis.Asystematicreview E13 SimJ,etal.ClinJPain(2002) Systematicreviewofrandomizedcontrolledtrialsof NotSRbasedonwater nonpharmacologicalinterventionsforfibromyalgia E14 RosiminiC,etal.JAmAcademyNurse Benefitsofswimtrainingforchildrenandadolescentswith NotSRbasedonRCTs Practitioners(2003) asthma E15 SchiltenwolfM,etal.Schmerz(2008) Physiotherapy,exerciseandstrengthtrainingandphysical NotSRbasedonRCTs therapiesinthetreatmentoffibromyalgiasyndrome (inGerman) E16 ToumaireM,etal.eCAM(2007) Complementaryandalternativeapproachestopainrelief NotSR duringlabor E17 BouchamaA,etal.CriticalCare(2007) Coolingandhemodynamicmanagementinheatstroke: NotSRbasedonRCTs practicalrecommendations E18 IarustovskaiaOV,etal.VoprKurotolFizioterLech Thermocontrasthydrotherapyinthetreatmentof NotSRbasedonRCTs FizKult(2006) neuroendocrinedisordersinfemalesofreproductiveage (inRussian) E19 BalintG,etal.OrvHetil(2006) Rehabilitationandbalneotherapy,wellness2004 NotSRbasedonRCTs (inHungarian) E20 AdilovVB,etal.VoprKurotolFizioterLechFizKult Mineralwatersforexternal(balneological)application. NotSR (2006) Guideforphysicians(inRussian) E21 MarkelW.WienKilnWochenschr(2006) Cantheeffectsofradontherapybescientifically NotSR substantiated?(inRussian) E22 GetenbrunnerC.WienKlinWochenschr(2006) Couldbalneologyandmedicalclimatologyhavemorethan NotSR historicimportanceinthetherapyofchronicdiseases? (inRussian) E23 DavydovaDB,etal.VoprKurotolFizioterLechFiz Hydrobalneotherapyofpatientswithcardiovascular NotSR Kult(2006) disease.Manualforphysicians(inRussian) E24 HodgsonS.ClinOrthopaedicsRelatedResearch Proximalhumerusfracturerehabilitation NotSRbasedonRCTs (2006) E25 LiuY,etal.CurrentOpinionRheumatol(2004) Recentadvancesinthetreatmentofthe NotSRbasedonwater spondyloarthropathies E26 WattsR,etal.IntJNursingPractice(2003) Nursingmanagementoffeverinchildren:asystematic NotSRbasedonwater review E27 PengelHM,etal.ClinRehabili(2002) Systematicreviewofconservativeinterventionsfor NotSRbasedonwater subacutelowbackpain E28 ConstantF,etal.BullSocSciMedGrandDuche Criticalbibliographicanalysisofinternationalmedical NotSRbasedonRCTs Luxemb(1995) literatureinthedomainofthermalresearch J Epidemiol 2010;20(1):2-12

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