The importance of intimate hygiene, pH and vaginal flora in keeping the vaginal ecosystem in good balance is known and widely described. No systematic, nation-wide, current study is up to now available, on the correlation between vaginal pH and intimate hygiene in the different ages and

condition of the woman, mainly considering the modified hygienic and clothing habits. A project aimed to collect systematically data related to intimate hygiene, in a representative sample of the Italian gynaecological population has been realised, helped by a specific website to insert the data. Lifestyle, vaginal pH, intimate hygiene compliance, presence of symptoms, gynaecological treatment stratified in different subgroups (prepubertal, fertile, pregnant, lactating, pre-menopause and menopause) have been recorded up to now on 119t women. The Study on pH and Hygiene (SOPHY) provides a strong educational impact, pushing doctors and women in considering pH and intimate hygiene an important moment of their professional and daily life. Each natural plant extract used in intimate hygiene (Sage, Thyme and Chamomile) confirmed its clinical activity on protecting against bacteria, mycoses and inflammation

Genazzani, Andrea Riccardo

Prato, B.

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Giorn. It. Ost. Gin. Vol. XXVII - n. 7-8 Luglio-Agosto 2005Sophy project: evidences intimate hygieneA.R. GENAZZANI, B. PRATOIntroductionVaginal ecosystem is apparently an isolated andprotected structure. The balance of this system iseasily altered by anatomic contiguity with rectum andbladder, hormonal profile, pregnancy, traumas, sexualintercourse, and pharmacological therapies. The importance of intimate hygiene, pH and vagi-nal flora in keeping the vaginal ecosystem in goodbalance is known and widely described. pH is a goodmarker of the healthy condition of vaginal ecosystemand allows to early detect borderline situations forappropriate actions.No systematic, nation-wide, current study is up tonow available, on the correlation between vaginal pHand intimate hygiene in the different ages and condi-tion of the woman, mainly considering the modifiedhygienic and life style habits.A project aimed to collect systematically data rela-ted to intimate hygiene with the target to build a largeand representative sample of the woman populationin the different ages and/or physiological conditions,has been realised. A scientific board was settled to agree on protocoland case report form and involved Genazzani A. R.Gynaecology and Obstetrics University Dept., Univer-sity of Pisa; Bruni V. Obstetrics and Gynaecology In-stitute Pol. Careggi, Firenze; Di Nicola C. PhysiciansSUMMARY: Sophy project: evidences intimate hygiene.A.R. GENAZZANI, B. PRATOThe importance of intimate hygiene, pH and vaginal flora in keeping thevaginal ecosystem in good balance is known and widely described.No systematic, nation-wide, current study is up to now available, on thecorrelation between vaginal pH and intimate hygiene in the different ages andcondition of the woman, mainly considering the modified hygienic and clothinghabits.A project aimed to collect systematically data related to intimate hygiene,in a representative sample of the Italian gynaecological population has beenrealised, helped by a specific website to insert the data.Lifestyle, vaginal pH, intimate hygiene compliance, presence of symp-toms, gynaecological treatment stratified in different subgroups (prepubertal,fertile, pregnant, lactating, pre-menopause and menopause) have been recordedup to now on 119t women.The Study on pH and Hygiene (SOPHY) provides a strong educationalimpact, pushing doctors and women in considering pH and intimate hygienean important moment of their professional and daily life. Each natural plant extract used in intimate hygiene (Sage, Thyme andChamomile) confirmed its clinical activity on protecting against bacteria,mycoses and inflammation.RIASSUNTO: Progetto SophyA.R. GENAZZANI, B. PRATOL’importanza di igiene intima, pH e flora vaginale nel mantenere l’eco-sistema vaginale in buon equilibrio è nota e ampiamente descritta.A tutt’oggi non sono disponibili studi sistematici, su scala nazionale,relative alla correlazione tra pH vaginale e igiene intima nelle differenti età econdizioni della donna, soprattutto in considerazione delle modificate abitudi-ni igieniche e di abbigliamento.È stato realizzato un progetto mirato a raccogliere sistematicamente daticorrelati con l’igiene intima, in un campione rappresentativo della popolazioneginecologica italiana, con l’aiuto di uno specifico sito internet per inserire idati.Stile di vita, pH vaginale, igiene intima, presenza di sintomi, trattamen-to ginecologico stratificato in differenti sottogruppi (prepubere, fertile, gravi-danza, allattamento, pre-menopausa e menopausa) sono stati registrati in1197 donne.Lo studio “Study on pH and Hygiene” (SOPHY) fornisce un forteimpatto educazionale, spingendo medici e donne a considerare pH vaginale eigiene intima un importante momento della loro vita quotidiana e professiona-le. Ciascun estratto naturale vegetale usato nell’igiene intima (Salvia,Thymus e Camomilla) ha confermato la sua attività clinica nella protezionecontro batteri, micosi e infiammazione.KEY WORDS:  Intimate hygiene - Plant extracts - Vaginal pH - Bacterial vaginosis.Igiene intima - Estratti vegetali - pH vaginale - Vaginosi batterica.Ospedale Riuniti di Santa Chiara - PisaDivisione di Ginecologia e OstetriciaDipartimento di Medicina della Procreazione e dell’Età EvolutivaPaper presented at the 12th World Congress on Human Reproduction,10-13 March 2005, Venice, Italy© Copyright 2005, CIC  Edizioni Internazionali, RomaWomen Association, Roma; Cianci A. GynaecologyUniversity Dept, Ospedale Santo Bambino, Catania;Graziottin A. Medical and Gynaecological Sexology,Osp. S. Raffaele Resnati, Milano; Guaschino S. ClinicaObstetrics and Gynaecology University Dept., Trieste;Nicoletti G. Microbiology and GynaecologicalSciences Dept., University of Catania; Novellino E.Pharmaceutical Chemistry, Pharmacy, University ofNapoli; Schito G.C. Microbiology Istituto, Universityof Genova; Sismondi P. Oncological GynaecologyChair, Ospedale Mauriziano, Torino.Aim of the study is also to evaluate the impact ofintimate hygiene carried out with specific natural plantextracts on the vaginal ecosystem balance. In fact,natural plant extracts, namely the ones derived bySalvia officinalis, Thymus vulgaris, and Chamomilamatricaria, are endowed with pharmacological andmicrobiological activities, linked to their active princi-ples corresponding to salviol and pinene (1-13), thymoland carvacrol (1, 2, 14-30) and bisabolol (1, 2, 12, 31).Material and methodsMore than one thousand of Italian gynaecologistsare participating to the standardised protocol, fillingappropriate case report forms, with the help of a spe-cific website to insert the data. Each investigatorreceives individual login and password to have a pro-tected access to the website.Selection criteria. The investigators collect the dataon 12 consecutive women referring to the doctor’sobservation, 2 for each of the following physiologicalconditions: 2 adolescents (from menarche+following6 yrs), 2 fertile, 2 pregnant, 2 lactating, 2 pre-meno-pause, 2 menopause.To achieve an unbiased interpretation of the data,the sample has not be “chosen”, but collected fol-lowing the random order of the woman referring tothe doctor’s observation.Evaluation criteria. The investigator fills the CRFinserting data on history, lifestyle and diet, vaginal pH(a standard set for pH determination is given to eachdoctor), presence of signs/symptoms at start, or theones appeared during the treatment, stratified in dif-ferent subgroups - adolescents, fertile, pregnant, lac-tating, pre-menopause and menopause - possible dia-gnosis of bacterial vaginosis, current pharmacologicaltherapies.Treatments. The investigator, beside the possiblepharmacological prescription required by the currentclinical conditions, recommends the woman the mostappropriate product for a correct intimate hygiene,according to the following scheme: Sage extractdetergent for adolescents, fertile and pre-menopause,Fig. 2 - Signs and symptoms in Bacterial vaginosis before and after 4weeks of Thyme extract daily use for intimate hygiene (b = before, a =after; * p < 0.05; *** p < 0.0001 vs baseline at χ2 2x4 test).Fig. 1 - Life style: frequent use of clothing and specific hygienic actions.Thyme extract detergent for pregnancy and lactation,Chamomile extract detergent for menopause.Moreover, independently from the physiologicalcondition, Thyme extract detergent is recommendedfor intimate hygiene in presence of suspected orascertained bacterial vaginosis, mycosis or attendanceof environments at risk and Chamomile extract deter-gent is advised for itching and vulvar burning due tohyperacidity Each detergent is used 1 or 2 times/day for 4weeks.Statistical analysis. Chi square test and Student’s ttest were applied when appropriate to calculate thestatistical significance of the 4-week effect comparedto baseline values.Timing of the study. The observational study startedwith the delivery of login and password. The study iscurrently running and the preliminary results are herepresented.ResultsThe characteristics of the 1197 women studied arereported in Table I. Body Mass Index (BMI) is positi-vely correlated with increasing age, as expected, bac-terial vaginosis is more frequent in fertile age andCandida in adolescents. The frequent use of clothing at risk of vaginalinfections was generally by far more linked to adole-scents and less in menopause. Intimate hygiene isreported more frequently in fertile age and is lower inmenopaused women (Fig. 1). TABELLA I - CHARACTERISTICS OF THE POPULATION STUDIED (MEAN ± SD)Adolescents Fertile Pre-menopause Menopause Pregnancy Puerperiumn 109 360 126 228 225 149Age (years) 17.3 ± 3.0 32.7 ± 7.9 47.8 ± 5.4 56.4 ± 10.5 30.7 ± 4.8 31.6 ± 6.1BMI (kg/m2) 20.6 ± 2.9 22.3 ± 4.0 23.6 ± 3.4 25.6 ± 4.4 24.3 ± 4.4 24.2 ± 6.2Bacterial Vaginosis (%) 14.7 19.2 18.3 11.8 12.9 16.1Candida (%) 28.4 21.9 15.9 8.3 20.9 11.4TABELLA II - PH BEFORE AND 4 WEEKS AFTER DAILY USE OF PLANT EXTRACTS (SAGE. THYMUS AND CHAMOMI-LE) FOR INTIMATE HYGIENE IN DIFFERENT AGES AND PATHOPHYSIOLOGIC GROUPS: ADOLESCENT (A), FER-TILE (F), PRE-MENOPAUSE (PM), MENOPAUSE (M), PREGNANCY (P), PUERPERIUM (Pu), BACTERIAL VAGINOSI(BV) AND CANDIDA (C) (MEAN ± SD).Sage Chamomile Thymus% A F Pm M P Pu BV C4.88 4.88 4.94 5.04 4.91 5.17 5.35 5.2before ± 0.84 ± 0.76 ± 0.60 ± 0.85 ± 0.66 ± 0.8 ± 0.70 ± 0.894.48 4.59 4.58 4.96 4.62 4.60 4.61 4.57after ± 0.55 ± 0.61 ± 0.50 ± 0.67 ± 0.55 ± 0.72 ± 0.79 ± 0.64pt test < 0.01 < 0.01 < 0.01 NS < 0.01 < 0.01 < 0.01 < 0.01Fig. 3 - Signs and symptoms in Candida infection before and after 4weeks of Thyme extract daily use for intimate hygiene (b = before, a =after; * p < 0.05, **  p < 0.01, *** p < 0.0001, vs baseline at χ2 2x4 test).Contraceptive methods were more used in fertileage (52.8%) than in adolescents (42.2%) pre-meno-pause (32.5%) and puerperium (26.9), being oralcontraceptive (OC) the preferred by adolescentsand fertile women (30%) versus condom (C), andno difference between the two methods in pre-menopause (7.9% OC, 11.1%C) and puerperium(11.4% OC, 8.1% C). As concomitant treatmentthat could interact with the results, only less than1% of local antimycotics in thyme treated groupFig. 4 - Signs and symptoms in Pregnancy before and after 4 weeks ofThyme extract daily use for intimate hygiene (b= before, a=after; * p <0.05, **  p < 0.01, ***p < 0.0001, vs  baseline at χ2 2x4 test).Fig. 7 - Microbiological evaluation in Bacterial vaginosis and Pregnancybefore and after 4 weeks of Thyme extract daily use for intimate hygiene (b=before, a=after; * p < 0.05; ** p < 0.01 *** p < 0.0001 vs baseline at χ2 2x3 test).Fig. 5 - Signs and symptoms in Puerperium before and after 4 weeks ofThyme extract daily use for intimate hygiene (b= before, a=after; ** p <0.01, °°°  p < 0.001, ***  p < 0.0001, vs baseline at χ2 2x4 test).Fig. 6 - Signs and symptoms in Menopause before and after 4 weeks ofChamomile extract daily use for intimate hygiene (b= before, a=after; *** p< 0.0001 vs baseline χ2 2x4 test).was reported.Vaginal pH responded to the action of the diffe-rent plant extracts, showing that in all the stratifiedages, but menopause, pH was statistically reducedafter 4 weeks use of Sage extract in adolescents, ferti-le age and pre-menopause, and Thyme extract in bac-terial vaginosis, candida, pregnancy and puerperium(Tab. II).Signs and symptoms in bacterial vaginosis, candi-da, pregnancy, puerperium and menopause weresignificantly reduced as severity and frequency(Figg. 2-6).Microbiological evaluation showed a statisticallysignificant normalisation in bacterial vaginosis, pre-gnancy, puerperium and in candida too, even if notsignificantly (Fig. 7). Leucorrhoea determined asquantity was significantly reduced in bacterial vagino-sis, candida, pregnancy and puerperium (Fig. 8).The physician’s judgment on treatment and theoverall conditions of the woman vs pre-treatmentconfirmed the positive results on the natural extractdaily use for intimate hygiene (Figg. 9-10).ConclusionsThe Study on pH and Hygiene (SOPHY) is provi-ding a strong educational impact. The study protocol,beyond the data on the activity of natural plantextracts in intimate hygiene, achieved the goal to pushdoctors and women in considering pH and intimatehygiene an important moment of their professionaland daily life. Each natural plant extract used (Sage, Thyme andChamomile) confirmed clinically the experimental dataof activity on bacteria, mycoses and inflammation.As consequence of the antibacterial and antimyco-tic action expressed at vulvovaginal level by the activeprinciples contained in Thyme and Sage extract, meanvaginal pH was reduced to normal values.The positive physician’s judgment on treatmentand favourable response of the overall conditions ofthe woman vs pre-treatment were in agreement withthe results observed on signs and symptoms respecti-Fig. 8 - Leucorrhoea in Bacterial vaginosis, Candida, Pregnancy and Puerperium before and after 4 weeks of Thyme extract daily use for intimate hygiene(b= before, a=after; *** p < 0.0001; NS statistically not significant vs baseline at χ2 2x3 test).vely in Bacterial vaginosis, Candida, Pregnancy andPuerperium before and after 4 weeks of Thymeextract daily use and in menopause before and after 4weeks of Chamomile extract daily use.These data confirm the usefulness to practiceintimate hygiene with appropriate active princi-ples aimed to protect against vulvovaginal infec-tions.AcknowledgementsThanks are given to the Scientific Board for theparticipation in the design of the study and the Sophystudy group for the careful compliance to the proto-col.microbial activity of essential oils and other plant extracts. 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Sophy project: evidences intimate hygiene

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Sophy project: evidences intimate hygiene

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