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1 Italian Journal of Gynaecol og y & Obstetrics The Official Journal of the Società Italiana di Ginecologia e Ostetricia (SIGO) June Vol N. 2 - Quarterly - ISSN Quarterly Partner-Graf 37

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3 Italian Journal of Gynae col og y & Obstetrics The Official Journal of the Società Italiana di Ginecologia e Ostetricia (SIGO) Quarterly Partner-Graf

4 Editor in Chief Paolo Scollo, Catania Editors Herbert Valensise, Roma Enrico Vizza, Roma Editorial Board Cervigni Mauro, Roma Chiantera Vito, Napoli Costa Mauro, Genova De Stefano Cristofaro, Avellino De Vita Davide, Salerno La Sala Giovanni Battista, Reggio Emilia Locci Maria Vittoria, Napoli Marci Roberto, Roma Monni Giovanni, Cagliari Ragusa Antonio Franco, Milano Sirimarco Fabio, Napoli Trojano Vito, Bari Viora Elsa, Torino Editorial Staff Roberto Zerbinati Serena Zerbinati Management, Administrative office Partner-Graf Srl - Via F. Ferrucci, Prato Tel Fax The Italian Journal of Gynaecology & Obstetrics is a digital magazine. You can download it freely from or

5 It. J. Gynaecol. Obstet. 2014, 26: N.4 Table of contents 41 Editorial. Alcohol and pregnancy: what actually the women should know Paolo Scollo Swineflu in reproductive age group female. Risk factors for high mortality in pregnant women Ripal Gevariya, Rohit Jain, Haresh Doshi, Pathik Parikh A successful hysteroscopic treatment of recurrent intrauterine adhesions using a balloon stent Ilaria Pisani, Pierluigi Russo, Giorgio Vittori, Emilio Piccione, Renato Zeloni Evaluation of the efficacy of dietary supplements based on Equisetum arvense, Soy Isoflavones, Lactoferrin and vitamin D3 on the control of climateric symptoms Ciro Sommella, Luca Bruni, Giovanni Cavallo, Katia Barrella, Franco Lelli Fetal death due to umbilical cord thrombosis in association with a swallowed amniotic string Laura Donati, Giulia Giovannini, Fiovo Marziani, Marta Sbaraglia, Giampaolo Passalacqua

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9 Editorial Alcohol and pregnancy: what actually the women should know Paolo Scollo The use of alcohol during pregnancy and lactation is a topic poorly known both among women and gynaecologists. This has been clearly resulted from a recent study done by DOXA and ASSOBIRRA on the use of Alcohol during pregnancy. 837 women aged between (412 pregnant, 425 not pregnant) were interviewed about their knowledgment on the use of alcohol during pregnancy and lactation. The present investigation hes showed clearly that meanwhile 70% women are aware that they should pay attention on nutrition and alcohol during prengnancy, they generally believe that a simple reduction or an occasional alcoholic beverage is still safe. The concept that a small amount of alcohol even occasionally should be not permitted is still not clear to the majority of women and perhalps of doctors. For this reason, SIGO and ASSOBIRRA have strarted a new campaign SE ASPETTI UN BAMBINO L ALCOL PUO ATTENDERE with a new web site ( ) addressed to both women and doctors giving information on that topic. The present campaign would makes known the women few clear concepts they should know: Use of alcohol during pregnancy can induce fetal damages The damages can be induce even during the first weeks of gestation The damages are not reversable or curable There is no alcohol dose safe during pregnancy Alcohol can induced damages even during lactation The campaign has been presented to the media during a press conference on 9 th june and will take place for the next sixt months supported by ASSOBIRRA. In addition, during the next SIGO congress in Milan a scientific session will be devoted on this topic, the data of the present survey will be presented as well as a scientific update on alcohol induced syndromes during prengnancy and lactation and an analisys of sociologic attitude to alcohol of the new generation. Prof. Paolo Scollo S.I.G.O. President 45

10 FARMACEUTICAMEV IN GINECOLOGIA LA NATURA CHE AIUTA ClimaMEV IncontinenzaMEV VenaMEV FARMACEUTICA MEV - Strada Cassia Sud, Siena (SI) Tel / Fax

11 Swineflu in reproductive age group female. Risk factors for high mortality in pregnant women Ripal Gevariya 1, Rohit Jain 1, Haresh Doshi 1, Pathik Parikh 2 1 Department of OBGY, Civil Hospital, Ahmedabad, India 2 Department of Medicine, Civil Hospital, Ahmedabad, India ABSTRACT OBJECTIVES: To study the risk factors for mortality in novel H1N1 positive women of reproductive age group admitted to our tertiary care centre. DESIGN & METHODS: In this descriptive study we included all H1N1 positive young women of reproductive age group admitted in our hospital. These women were managed as per standard protocol including detailed history, general, systemic and obstetrics examination, laboratory investigations and standard treatment was started. All parameters were analysed in details for relevance of clinical and laboratory parameters in terms of survival. RESULTS: Out of 70 patients 28 (40%) were pregnant and 42(60%) were non pregnant. Most commonly, women presented with fever, cough and breathlessness. The average duration of symptoms at the time of admission was 4.9 days. Out of 70 patients 37 expired, among them 23 were pregnant and 14 were non pregnant. Two patients were unconscious at the time of admission and both expired. Cyanosis was present in 4(5.7%) at the time of admission and all 4 patients expired (p=0.528). 31(44.2%) patients had SpO2 less than 90% on admission. In pregnant patients 20 (71.4%) had SpO2 <90% and among them 19 (95%) expired. While in non-pregnant patient 11 (26%) had Spo2 <90% out of which 6(54.5%) expired. Tachypnoea, anaemia, Pregnancy induced hypertension, consolidation on chest x-ray were other factors which were positively correlated with fatal outcome. CONCLUSION: H1N1 present as an acute onset respiratory illness presenting within 3 to 4 days with mainly fever, cough and breathlessness. H1N1 in pregnancy is associated with high maternal mortality as compared to non pregnant patients. Unconsciousness, cyanosis, low SpO2, anaemia, tachycardia, tachypnea and consolidation are the markers suggestive of high mortality. Keywords: Swineflu, H1N1 Influenza Virus, Pregnant Women SOMMARIO OBIETTIVI: Studiare I fattori di rischio di mortalità in un inusuale gruppo di donne in età fertile H1N1 positive ricoverate nel nostro centro di cura terziario. DISEGNO DELLO STUDIO: In questo studio di natura descrittiva abbiamo incluso tutte le giovani donne, H1N1 positive, in età fertile, ricoverate nel nostro ospedale. Queste donne sono state gestite seguendo un protocollo standard che includeva una anamnesi dettagliata, generale e sistemica; un esame ostetrico e analisi di laboratorio. E stato, inoltre, avviato il trattamento standard. Tutti i parametri sono stati analizzati in dettaglio seguendo il criterio di rilevanza dei parametri clinici e di laboratorio in termini di sopravvivenza. RISULTATI: 28 pazienti su 70 (40%) erano incinte e 42 (60%) non erano incinte. Solitamente, le donne presentavano febbre, tosse e stato di apnea. La durata media dei sintomi al momento del ricovero è stata di 4,9 giorni. Su 70 pazienti, 37 sono decedute, tra di loro 23 erano incinte e 14 no. Due pazienti, al momento del ricovero, erano in stato di incoscienza, entrambe sono poi decedute. 4 pazienti (5,7%) al momento del ricovero erano cianotiche e tutte e 4 sono decedute (p=0,528). 31pazienti (44,2%), presentavano SpO2 a meno del 90%, al momento del ricovero. Tra le pazienti incinte, 20 (71,4%) di loro presentavano SpO2<90% e tra queste 19 (95%) sono decedute; mentre nelle pazienti non incinte, 11 (26%) avevano SpO2<90%, 6 (54,4%) delle quali sono decedute. Tachipnea, anemia, ipertensione indotta dalla gravidanza e addensamento alla radiografia toracica sono altri fattori correlati con l esito fatale. CONCLUSIONI: L H1N1 si presenta inizialmente con acuti problemi respiratori, nei primi 3-4 giorni si rileva principalmente febbre, tosse e stato di apnea. Nelle pazienti incinte causa un alto tassi di mortalità in confronto a le pazienti non incinte. Lo stato di incoscienza, la cianosi, la SpO2 bassa, l anemia, la tachicardia, la tachipnea, e l addensamento polmonare sono marker che suggeriscono un alta probabilità di esito fatale. INTRODUCTION Influenza virus belongs to Family Orthomyxoviridae. It is sub classified into three main types, Type A (Multiple species), Type B (Humans), Type C (Humans and swine). Out of the three types A is the most virulent group (1). The virus is sub classified on the basis of surface antigens, Hemagglutinin (H or HA) and Neuraminidase (N or NA). There are 15 HA and 9 NA for influenza A. Within influenza A, Correspondence to: Copyright 2014, Partner-Graf srl, Prato because of reassortment, there have been transfers of genes among strains crossing swine, avian, and human species boundaries leading to epidemics (2). Annual influenza epidemics are estimated to affect 5 15% of the global population. Although most cases are mild, this still causes severe illness in 3 5 million people and around 250, ,000 deaths worldwide (3). In addition to these annual epidemics, Influenza A virus strains caused three major global epidemics during the 20th century: the Spanish flu in 1918, Asian flu in 1957 and Hong Kong flu in The influenza virus 47

12 It. J. Gynaecol. Obstet. 2015, 27: N.2 48 has also caused several pandemic threats over the past century, all caused by the H1N1 strains. However swine influenza is also known to be caused by influenza A subtypes sh1n2, H2N3, H3N1, and H3N2 (4-5). Influenza A, H1N1 swine flu is a strain of the flu that has moved from pigs to humans and can be transmitted from human to human. This strain contains genes from four different flu viruses, namely, North American swine influenza, North American avian influenza, Human influenza and two swine influenza viruses typically found in Asia and Europe (6-7). This 2009 flu pandemic is a global outbreak of a new strain of H1N1 influenza virus, commonly referred to as swine flu (8). But some authorities object to calling the flu outbreak swine flu and so various names have been suggested such as, H1N1 influenza virus, Novel influenza A (H1N1), Pig Flu, Mexican flu, Mexican virus, SI- swine influenza, H1N1 Flu, New Flu, North American influenza, In July 2009 WHO gave the name - pandemic H1N1/09 virus to distinguish it from the current seasonal H1N1 viruses (9-10). The virus kills about % of those infected and spreads in the same way sneezing (11). The disease is communicable from 1 day before to 7 days after the onset of symptoms with majority of cases being in healthy young. Ever since the detection of this virus, the virus has been spreading and the cases rising throughout the world. The first cases were seen in Mexico, but within no time the virus spread to rest of America and now has become a pandemic affecting most of the countries of the world (213 countries). It is known that this virus affects young people more as compared to the extremes of age unlike the seasonal flu which affects the later. Besides, pregnancy alters the state of immunity and also Centre for Disease Control stated in July 2009 that, while pregnant woman have always had a higher risk of severe disease from influenza in general, the new H1N1 virus is taking an exceptionally heavy toll. Even if previously healthy, pregnant women on getting H1N1 had poor outcome1. As swine flu carries exceptionally high mortality risks in pregnant females and there are limited studies reported addressing this issue, we carried out this study to see the outcome of such young, pregnant as well as non pregnant females admitted to tertiary care centre with H1N1 virus infection and epidemiological, clinical, biochemical, radiological and obstetric parameters were analysed in relation to mortality. METHODS AND MATERIALS In this descriptive study we had included all H1N1 positive young women of reproductive age group admitted in our hospital in isolation ward. All 70 women were detected novel H1N1 positive by virus isolation from their respiratory specimens. These tests were carried out by the WHO recognised Microbiology laboratory at our hospital via QIAGEN TM, PCR method. These women were then subjected to detailed history including their duration, type of symptoms, associated illness, menstrual history, obstetric history, details of delivery (if it occurred) in hospital, maternal and foetal outcome. General and systemic examinations including obstetrics examination were carried out. Various investigations like Haemoglobin, Total count, Platelet Count, random blood sugar, Blood Urea, Serum Creatinine and electrolytes were carried out in these patients Chest x-rays on admission (with shield in pregnant women) were taken. Antenatal Ultrasound was also carried out for foetal wellbeing, liquor, placenta and maturity of the foetus. Oseltamivir was started in these patients as advised by the physician. The duration for which the Oseltamivir was given before discharge or death was also noted. Based on these parameters at the time of admission the correlation of these parameters with the outcome was studied and calculated. The statistical significance was calculated on the basis of Chi square test. RESULTS Epidemiology A total of 70 patients were studied. Out of these 70 patients, 28 (40%) were pregnant and 40 (57.1%) belonged to the age group between 21 and 30. The mean age was 28.7 years. Among pregnant women 10 patients (35.7%) belonged to second trimester while 18 patients (64.3%) belonged to the third trimester. Twenty seven (38.5%) women came from Ahmedabad and rest came from other places in Gujarat like Sabarkantha, Banaskantha, Nadiad, Kheda, Kutch, Porbandar, Baroda, Junagadh and neighbouring state like Rajasthan. Clinical Features The average duration of symptoms at the time

13 R. Gevariya et al. of admission was 4.9 days. Twenty six (37.1%) women presented between the time periods of 3 to 4 days while 20 women (28.5%) presented between 5 to 7 days. Less commonly women also presented acutely (22.8%) in 2 days duration from onset of illness. Only 8 (11.4%) women presented after 7 days of onset. Most commonly, women presented with fever, cough and breathlessness. Out of 70 patients 63(90%) women had cough, 62(88%) had fever and 42(62%) had breathlessness. Other symptoms like chest pain, diarrhoea, sore throat and headache were less common. Sixteen of non pregnant patients had associated co morbid conditions, one being Rheumatic Heart Disease, 2 women had hypertension and 13 had anaemia. Among pregnant women 5 had pregnancy induced hypertension and 10 had anaemia. At the time of admission, 2 patients presented with unconsciousness and four patients (pregnant = 3) had cyanosis. Overall, thirty seven patients (52.8%) had tachycardia (pulse > 100/min), being higher in pregnant patients [n=20(71.4%)] as compared to non pregnant women [n=17(40.4%)]. Fifty two (74.2%) had tachypnoea overall (respiratory rate greater than 20), again being higher in pregnant patients [n=22(78.5%)] as compared to non pregnant patients [30(71.4%)]. Out of 28 pregnant patients, 5 patients (17.8%) had PIH. 3 patients (4.2%) had hypotension (blood pressure <100). Investigations Thirty one (44.2%) patients had SpO2 less than 90% on admission of which 20 were pregnant. Twenty Three patients (32.8%) had haemoglobin levels of 9 g/dl. Four pregnant patients (14.2%) had Hb <7 g/dl and six (21.4%) pregnant patient had haemoglobin levels of 7-9 g/dl. While in nonpregnant patients 3(7.1%) had haemoglobin <7g/ dl and 9(21.4%) had haemoglobin levels of 7-9 g/ dl. Twenty Eight (40%) patients had total count per cumm, among which 14(50%) were pregnant and 14(50%) were non pregnant. Sixty three patients (90%) had some abnormality on chest x- ray. In pregnant patient 12(44.4%) had unilateral consolidation and 13(48%) had bilateral consolidation. In non-pregnant patients 18(50%) had unilateral consolidation and 10(27.7%) had bilateral consolidation. Management All admitted patients received Oseltamivir, Antibiotics, Intravenous fluid as per Central Venous Pressure. Forty Two patient required ventilatory support. Four patients required only non invasive support in the form of BIPAP, while 38 patients require intubation and volume or pressure controlled ventilation with low PEEP. Overall Outcome The mortality rate was 52.8%, being higher in pregnant women, 82.1%. Both unconscious patients and all four cyanosed patients at presentation expired. Of patients presenting with tachycardia, 19 of 20 pregnant women Parameters Total patients (n=70) Pregnant (n=28) Non-Pregnant (n=42) P value Unconscious Cyanosis Tachycardia (pulse 100) Tachypnoea (RR 20) High BP ( 140) Low BP (<100) Low SpO2 (< 90%) < Hb < Hb Total Count ( 10,000) Unilateral consolidation on CXR Bilateral Consolidation on CXR < Expired < Table I: Table showing comparison of all parameters in swine flu patients in the two groups, pregnant and non pregnant. Student s t test is utilized for continuous variable while chi square test is used for discrete variables. P value < 0.05 is considered significant 49

14 It. J. Gynaecol. Obstet. 2015, 27: N.2 (95%) expired, while in non-pregnant patients, 7 patients (41.1%) had expired. 21(95.4%) pregnant patients with tachypnoea expired, while in nonpregnant patient 10(33.3%) expired. Sixty Seven percent of patients with hypotension expired. 95% of pregnant patients with hypoxia at presentation expired (19 out of 20) as compared to 54.5% (6 out of 11) mortality in non pregnant women. All ten pregnant women with anemia expired as compared to 46.1% mortality in non pregnant women. 85.7% pregnant and 42.8% non pregnant women with leucocytosis (TC >10000 per cumm) expired. 70% of pregnant women with unilateral consolidation and 100% with bilateral consolidation expired as compared to 16.6% with unilateral consolidation and 27.7% with bilateral consolidation in non pregnant women respectively. All four patients who required just non invasive ventilator support survived as compared to only one of 38 patient requiring invasive ventilation survived. Outcome of Foetus Three (10.7%) pregnant patients developed intra uterine death of the foetus during the course of admission. Seven patients of all these 28 women delivered. Five (71.4%) babies were alive while the rest two (28.5%) were still birth. The foetal survival rate was 17.8% (5/28). Outcome of Postpartum females Seven patients underwent labour and delivered the baby. Six of these were delivered vaginally, while one underwent LSCS. One patient had convulsion on 5th postpartum day and expired. Overall, five patients (71.4%) expired after delivery. Only two of these postpartum females were discharged after delivery and came healthy one month after discharge on followup. Parameters Total expired patients (n=37) Expired Pregnant (n=23) Expired Non-Pregnant (n=14) P value Unconscious Cyanosis Tachycardia (pulse 100) Tachypnoea (RR 20) High BP ( 140) Low BP (<100) Low SpO2 (< 90%) Hb < Hb Total Count ( 10,000) Unilateral consolidation on CXR Bilateral Consolidation on CXR Table II: Table shows comparison between pregnant and non pregnant females in terms of mortality. Student s t test is utilized for continuous variable while chi square test is used for discrete variables. P value < 0.05 is considered significant 50 Outcome of Pregnant Women Twenty Eight pregnant patients had been admitted overall. Out of total 70 patients, 37(52.8%) patients expired. Of these 37 expired patients, 23 (62.16%) were pregnant, implying that the mortality in pregnant women was 82.1% (23 of 28 expired). Among 23 expired pregnant patients, 7 belonged to second trimester and 16 belonged to third trimester. None of the women in first trimester expired. All patients who developed PIH, expired. DISCUSSION In our study the disease mainly affects the young women with majority being affected were between 20 and 30 unlike the seasonal flu which mainly affects the extreme of age. Anaemia, Hypertension and Rheumatic heard disease were comorbid diseases in our patients. Like any other respiratory disease which spreads through aerosols and respiratory secretions, the patients here had acute onset

15 R. Gevariya et al. Total pregnant (n=28) Survived (n=5) Expired (n=23) P value Unconscious Cyanosis Tachycardia (pulse 100) Tachypnoea ( RR 20) < High BP ( 140) Low BP (<100) Low SpO2 (< 90%) Hb < Hb Total Count ( 10,000) Unilateral consolidation on CXR Bilateral Consolidation on CXR IUD on USG Delivered Post-partum Complication Maternal outcome of delivery Fetal outcome of delivery Table III: Table shows comparison between pregnant and non pregnant females in terms of mortality. Student s t test is utilized for continuous variable while chi square test is used for discrete variables. P value < 0.05 is considered significant with most of them presenting between 3 and 4 days. The symptoms of the disease are similar to other respiratory viral diseases like cough, breathlessness, fever, sore throat, running nose. Clinical features indicating poor prognosis are altered sensorium, cyanosis, tachypnoea, hypotension, PIH and anaemia in pregnant patient, Spo2<90% and bilateral consolidation. Unconsiousness is an indicator of hypoxia and hypercarbia, the patient presenting with it had severe respiratory decompensation. Pregnancy has poor outcome in swine flu especially those who associated with poor prognostic factors. The mother as well foetus is adversely affected. All the extrapulmonary manifestations of H1N1 are because of secondary bacterial infection or systemic inflammatory response syndrome(sirs), which affect the mother as well as the child, making the prognosis grave not only for the mother but also for the foetus. Twenty three (82.1%) out of 28 pregnant patient had expired. The reason for poor Figure 1: Figure showing mortality in pregnant women as compared to non pregnant women (p<0.05). Figure 2: Figure showing the difference in mortality among delivered and non delivered pregnant females. 51

16 It. J. Gynaecol. Obstet. 2015, 27: N.2 outcome in pregnant women as compared to non pregnant women is as pregnancy is already a hyperventilated state with decrease functional residual capacity, residual volume and total lung capacity thereby, being more prone to respiratory insufficiency. Also it is an immunosuppressed state so as to act as a risk factor for secondary bacterial infection and worsening of course of the illness. Most of our patients had consolidation, which acted as a source for sepsis and septicaemic shock explaining the significantly high mortality in pregnant women. Regina Phelps in 2009 concluded that Pregnancy is a risk factor for critical illness related to 2009 H1N1 influenza, which causes maternal and neonatal morbidity and mortality. Compared with non-pregnant women of childbearing age, pregnant or postpartum women with 2009 H1N1 influenza were at increased risk of admission to an intensive care unit (11). The mortality appears to be higher in anaemic patient especially in pregnancy. Also the outcome in patients with chest x ray showing bilateral consolidation is less favourable than the patients with normal chest x ray. Outcome of patient on ventilator in our study was dismal, that could be explained by the fact that, only those with severe respiratory acidosis, in whom there was already onset of SIRS, were given ventilatory support. The overall case fatality rate was 52.8% which is much higher. While in pregnancy it was 82%. Most of the patients had duration of illness less than 10 days suggesting the rapid course of the illness. There a similar study carried out by Singhal et al. (12) which included 24 patients with pregnancy. Six patients (25%) had associated co-morbidities. Nine patients (37.5%) presented within 48 h of onset of symptoms and 15 (62.5%) reported after 48 h. In 17 (70.83%) patients treatment was delayed by >48 h. ICU admission was needed in 20.8 per cent patients and mortality rates was 8.3 per cent. The study states that the presenting symptoms of pregnant women with H1N1 were similar to that of general population. Acquiring infection in late trimester, late initiation of antiviral treatment and presence of co-morbid illness were high risk factors for developing critical illness. The findings resemble what we have observed in our own study. CONCLUSION Novel H1N1 is a new strain of Influenza A virus that presents as an acute onset respiratory illness with the patients presenting within 3 to 5 days of onset of illness. It affects young people However, the presentation is similar to the seasonal flu virus, as the patients presents with acute onset fever, cough and breathlessness. The mortality is much higher in pregnant women. Pregnant women also don t present with classical symptoms. Unconsiousness, cyanosis, lowspo2, anaemia, tachycardia, tachyponea, consolidation on chest-x ray are various markers associated with high mortality in pregnant women. These findings emphasize on early detection of the clinical features of swine flu and having a high degree of suspicion and low threshold for carrying out tests in pregnant women and also the treatment as the outcome in such patients is poor. ACKNOWLEDGEMENTS We wish to acknowledge the patients and the institution for support in carrying out this study. 52 REFERENCES 1) Julie Steenhuysen, Swine flu striking pregnant women hard ; CDC, ) Heinen PP. Swine influenza: a zoonosis. Veterinary Sciences Tomorrow. ISSN ) Influenza: Fact sheet. World Health Organization. March ) Gangurde HH, Gulecha VS, Borkar V et al. Swine Influenza A (H1N1 Virus): A pandemic disease. Syst Rev Pharm 2011;2: ) Ma W, Vincent AL, Gramer MR, Brockwell CB et al. Identification of H2N3 influenza A viruses from swine in the United States. Proc Nat Acad Sci USA (52): ) Stephanie Desmon. Expert: Swine flu virus more complex than typically seen. Baltimore Sun ) Debora MacKenzie. Pork industry is blurring the science of swine flu - Short Sharp Science. New Scientist ) Shin JY, Song MS, Lee EH, Lee YM et al. Isolation and characterization of novel H3N1 swine influenza viruses from pigs with respiratory diseases in Korea. Journal of Clinical Microbiology (11): ) Interim Novel Influenza A (H1N1) Guidance for Cruise Ships. Centers for Disease Control and Prevention ) Renamed swine flu certain to hit Taiwan. The China Post ) Regina Phelps. H1N1 (Swine Flu): Flu During Pregnancy: British Medical Journal, 2010; 340: ) Singhal S, Sarda N, Arora R, et al. Clinical profile & outcome of H1N1 infected pregnant women in a tertiary care teaching hospital of northern India. Indian J Med Res 139, March 2014, pp

17 A successful hysteroscopic treatment of recurrent intrauterine adhesions using a balloon stent Ilaria Pisani 1 ; Pierluigi Russo 2 ; Giorgio Vittori 1 ; Emilio Piccione 1 ; Renato Zeloni 2 1 Section of Gynaecology and Obstetrics, Academic Department of Biomedicine and Prevention, University of Tor Vergata, Rome 2 Division of Gynaecology, San Carlo IDI Hospital, Rome ABSTRACT A 43-year-old woman was referred to our Department for secondary amenorrhea. Her clinical history showed a spontaneous abortion followed by dilatation and curettage and a previous hysteroscopic adhesiolysis for Asherman s syndrome. A diagnostic hysteroscopy was performed and revealed an hematometra and a uterine cavity obliteration with multiple adhesions. An ultrasound-guided hysteroscopic adhesiolysis was performed and a balloon stent was inserted in the uterine cavity to prevent the reformation of adhesions. The intrauterine catheter was kept in place for five days with antibiotic coverage. The menstrual period presented regularly. A diagnostic hysteroscopy was performed one and two months after the procedure. Both exams revealed a regular uterine cavity without reformation of adhesions. SOMMARIO Una paziente di 43 anni è afferita presso il nostro Dipartimento per amenorrea secondaria. La sua storia clinica mostrava un aborto spontaneo seguito da revisione della cavità uterina ed una precedente adesiolisi isteroscopica per sindrome di Asherman. E stata eseguita un isteroscopia diagnostica che ha rivelato una ematometra ed una cavità uterina obliterata da numerose aderenze. E stata quindi sottoposta ad un adesiolisi isteroscopica sotto guida ecografica con inserimento di uno stent per la prevenzione delle recidive. Il catetere intrauterino è stato mantenuto in situ per cinque giorni con copertura antibiotica. I cicli mestruali successivi si sono presentati regolarmente. Un isteroscopia diagnostica di controllo è stata eseguita sia il primo che il secondo mese post-operatori. Entrambi gli esami hanno rivelato una cavità uterina regolare e priva di aderenze. Keywords: Asherman s syndrome; Hysteroscopic treatment of adhesions; Intrauterine balloon stent; Hysteroscopy; Recurrent intrauterine adhesions INTRODUCTION The diagnosis of intrauterine adhesions also known as Asherman s syndrome has been increasing over the last few decades (1). Most cases are associated with surgical trauma to the basalis layer of the endometrium. They frequently occur following dilatation and curettage of the pregnant uterus after spontaneous abortion, although any uterine insult or surgery may lead to adhesions development. Lesions are characterized by fibrous connective tissue bridges that can vary from filmy to dense and may cause partial or complete obliteration of the uterine cavity. Intrauterine adhesion can affect menstrual function and fertility: most women with Asherman s syndrome have alterations in duration and amount of the menstrual flow such as amenorrhea or hypomenorrhea. Those who have amenorrhea may also have severe pelvic pain and retrograde Correspondence to: Copyright 2014, Partner-Graf srl, Prato menstruation caused by outflow obstruction. In addition to abnormal menses, patients may present infertility and pregnancy disorders such as recurrent spontaneous abortion, placenta accreta and intrauterine growth restriction (2). Nowadays hysteroscopy is the standard method to diagnose, treat and follow up this condition (3). Various techniques for adhesiolysis and for prevention of adhesion reformation have been studied. We described a case of successful treatment of recurrent intrauterine adhesions using a balloon stent. CASE PRESENTATION A 43-year-old woman was referred to our Department for secondary amenorrhea. She reported a spontaneous abortion followed by dilatation and curettage (D&C). Her history started after D&C: she presented secondary amenorrhea and, after diagnostic hysteroscopy which diagnosed an Asherman s syndrome, 53

18 It. J. Gynaecol. Obstet. 2015, 27: N.2 she performed an hysteroscopic adhesiolysis. Two months after adhesiolysis she came to our Department since she noted again a reduction of menstrual flow followed by amenorrhea. Her vaginal examination and transvaginal ultrasound revealed no abnormalities. Hysteroscopy was then performed in outpatient bases using CO2 as the distension medium and a 4 mm sheathed diagnostic hysteroscope. The exam revealed an hematometra and a uterine cavity obliteration with multiple fibrous adhesions. Asherman s syndrome was classified according to the Modified Classification of European Society of Hysteroscopy (ESH) as moderate (ESGE grade III). An ultrasound-guided hysteroscopic adhesiolysis was performed under general anaesthesia. A 9 mm resectoscope with 0 optical system (Karl Storz, Germany) equipped with a hysteroscopic monopolar (Collin s) knife was introduced into the uterine cavity. Glycine 1.5% was used as distending media instilled from a flexible ml bag wrapped in a pressure cuff connected to a manometer and pumped up to mmhg. All the synechiae were removed and a silicon Foley catheter (Rusch, No. 22) inflated with 4 cc of saline solution was inserted into the uterine cavity to prevent the reformation of adhesions. No complication occurred during the procedure. The day after the procedure transvaginal ultrasound was performed to control the correct positioning of the balloon (Figure 1). with no discomfort for the patient. The menstrual period presented regularly after fifteen days and she didn t complain any pelvic pain. A diagnostic hysteroscopy was performed one month after the procedure during the proliferative phase. The exam revealed a regular uterine cavity. A second diagnostic hysteroscopy was then performed to evaluate the uterine cavity two months after the procedure. Also at the second hysteroscopy, there was no reformation of adhesions (Figure 2) and the patient didn t complain any symptom. Figure 2: Postoperative diagnostic hysterescopy showing a regular uterine cavity. 54 Figure 1: Intrauterine ballon stent. The intrauterine catheter was kept in place for five days using ciprofloxacin for antibiotic prophylaxis. The patient was discharged on the third postoperative day and came back on the fifth postoperative day to remove the balloon DISCUSSION The exact prevalence of Asherman s syndrome is difficult to determine, but the incidence has been increasing over the last few decades, probably influenced by the number of abortion performed, the increase in intrauterine surgery as well as better diagnostic techniques like transvaginal ultrasound, sonohysterography and hysteroscopy (4). Hysteroscopy allows direct inspection of the uterine cavity for diagnosis, classification and treatment: accurately confirms the presence, extent and degree of adhesions, and assess the quality of the endometrium (5). Many classifications have been proposed, mainly based on hysteroscopic findings as the principal parameter for assessment of the condition and prediction of the results. Most published

19 I. Pisani et al. classifications on intrauterine adhesions, except for the American Fertility Society one, have not stressed the correlation between the menstrual function and the severity of the condition. This is an important prognostic point because menstrual pattern may reflect the amount of endometrium available for regeneration after adhesiolysis (6). We had chosen to classify according to ESGE classification (1995 modifed version) of intrauterine adhesions, as it clearly reflects the severity of adhesions (7). Treatment of moderate Asherman s syndrome is still a challenge (4). Nowadays hysteroscopy is considered the standard method for treating intrauterine adhesions. Lysis under direct vision is safer and more complete than blind curettage and may minimize the destruction of the normal endometrium. Continuous maintenance of distension is a key to success. Filmy and central adhesions should be cut first, in order to allow adequate distension of the uterine cavity, while marginal and dense adhesions should be attacked last, keeping in mind the greater risk of uterine perforation and bleeding. Guidance during difficult hysteroscopic surgeries is necessary to avoid uterine perforation, therefore we decided to perform a transabdominal ultrasoundguided adhesiolysis because of the lower uterine perforation rate and the lower cost (8). The main challenge of hysteroscopic adhesiolysis is the high rate of reformation of adhesions, especially in severe-type Asherman s syndrome, in which the recurrence rate may be up to 62.5% (9). A number of strategies have been proposed to reduce the recurrence of adhesions after surgery. The first approach was the use of IUD after hysteroscopic adhesiolysis. Many studies reported different outcome but no comparative studies have confirmed the type or size of IUD or duration of placement. Moreover several investigators reported an increase of intrauterine adhesion reformation associated with local inflammation (10). Many author have also examined the use of hyaluronic acid gel into the uterine cavity after adhesiolysis (11,12). There are some preliminary evidence that hyaluronic acid gel may be of benefit in reducing intra-uterine adhesions, although as of now there is no firm evidence to confirm its value. Myers et al. (13) first introduced the Foley balloon catheter after surgery to prevent adhesion reformation, and achieved satisfactory results. Amer et al. (14) assessed the efficacy of a Foley catheter balloon which was inserted after the hysteroscopic adhesiolysis procedure and removed one week later. Kodaman and Arici proposed that adhesions, if they were to recur, would be formed by the 5th postoperative day, after the time called lag period of wound healing (15). Consequently, they supposed that the balloon should stay within the uterine cavity for at least a week prior to its removal. Nevertheless in our case we achieved a satisfactory result after only five days of permanence of the catheter. To the best of our knowledge, no other authors reported data on the efficacy of the balloon stent on recurrent Asherman s syndrome. Office hysteroscopy is useful for follow-up after treatment of intrauterine adhesions. Several studies showed that an early second-look office hysteroscopy may diagnose and eventually lyse new filmy adhesions before they become dense and significantly reduce their reformation (16). Many authors studied the reproductive outcome in patients who underwent hysteroscopic adhesiolysis. Particularly, Yu et al reported that the chances of conception in women who remained in amenorrhea were significantly lower than those who continued to have menses and that at second look hysteroscopy, the conception rate in women who had reformation of intrauterine adhesions was significantly lower (17). Therefore the outcome of hysteroscopic adhesiolysis for Asherman s syndrome is significantly affected by recurrence of intrauterine adhesions. In consideration of these results, appropriate counseling should be given to the patients with severe or recurrent intrauterine adhesions who desire pregnancy. In conclusion, currently several methods have been evaluated for the prevention of adhesions but none has proven its effectiveness for moderate and severe Asherman s syndrome particularly in case of recidives. Further research in Asherman s syndrome should be directed toward reduction of the incidence of adhesion reformation after intrauterine surgery in order to improve the outcome particularly in patients who desire pregnancy. 55

20 It. J. Gynaecol. Obstet. 2015, 27: N.2 REFERENCES 1) March CM. Asherman s syndrome. Semin Reprod Med Mar;29(2): ) Deans R, Abbott J. Review of intrauterine adhesions.j Minim Invasive Gynecol Sep-Oct;17(5): ) Roge P, D Ercole C, Cravello L, Boubli L, Blanc B. Hysteroscopic management of uterine synechiae: a series of 102 observations. Eur J Obstet Gynecol Reprod Biol (1996) 65: ) Yu D, Wong YM, Cheong Y, Xia E, Li T, Asherman Syndrome one century later. Fertility and sterility Vol 89, 4 April 2008, ) Wamsteker K, Intrauterine adhesions (synechiae). In: Brosens I, Wamsteker K,editors. Diagnostic imaging and endoscopy in gynecology: a practical guide. London: WB Saunders; p ) Hesham Al-Inany. Intrauterine adhesions. An update. Acta Obstet Gynecol Scand 2001; 80: ) Wamsteker K, De Block S (1998) Diagnostic hysteroscopy: technique and documentation. In: Sutton C, Diamond M (eds) Endoscopic surgery for gynecologists. Saunders, London, pp ) Kresowik JD, Syrop CH, Van Voorhis BJ, Ryan GL. Ultrasound is the optimal choice for guidance in difficult hysteroscopy. Ultrasound Obstet Gynecol 2012;39: ) KK Roy, Jinee Baruah, Jai Bhagwan Sharma, Sunesh Kumar, Garima Kachawa, Neeta Singh. Reproductive outcome following hysteroscopic adhesiolysis in patients with infertility due to Asherman s syndrome. Arch Gynecol Obstet (2010) 281: ) Haimov-Kochman R, Doviner V, Amsalem H, Prus D, Adoni A, Lavy Y. Intraperitoneal levonorgestrelreleasing intrauterine device following uterine perforation: the role of progestins in adhesion formation. Hum Reprod 2003;18: ) Guida M, Acunzo G, Sardo Di Spiezio A, Bifulco G, Piccoli R, Pellicano M. Effectiveness of autocrosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod (2004) 19: ) Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol Oct;170(2): ) Myers EM, Hurst BS. Comprehensive management of severe Asherman syndrome and amenorrhea. Fertil Steril 2012;97: ) Amer MI, Nadim AE, Karim H. The role of intrauterine balloon after operative hysteroscopy in the prevention of intrauterine adhesions: a prospective controlled study. Middle East Fertil Soc J 2005;10: ) Kodaman PH, Arici A. Intra-uterine adhesions and fertility outcome: how to optimize success? Curr Opin Obstet Gynecol Jun;19(3): Review. 16) Pabuccu R, Onalan G, Kaya C, Selam B, Ceyhan T, Ornek T, et al. Efficiency and pregnancy outcome of serial intrauterine device-guided hysteroscopic adhesiolysis of intrauterine synechiae. Fertil Steril 2008;90: ) Yu D, Li TC, Xia E, Huang X, Liu Y, Peng X. Factors affecting reproductive outcome of hysteroscopic adhesiolysis for Asherman s syndrome. Fertil Steril Mar;89(3): Epub 2007 Aug 6. 56

21 Evaluation of the efficacy of dietary supplements based on Equisetum arvense, Soy Isoflavones, Lactoferrin and vitamin D3 on the control of climacteric symptoms Ciro Sommella 1, Luca Bruni 1, Giovanni Cavallo 2, Katia Barrella 1, Franco Lelli 1 1 U.O. Ginecologia ed Ostetricia, ospedale Santa Maria alla Gruccia, USL 8 Arezzo zona Valdarno 2 U.O. Ginecologia ed Ostetricia ospedale di Modica ABSTRACT The purpose of our study was to assess the impact of a food supplement of Equisetum arvense, Soy Isoflavones, Lactoferrin and vitamin D3 on climacteric symptoms. Were enrolled 85 patients of which 78 have completed the study. It has been administered to patients the modified Kupperman index (Modified Kupperman Index) and then we evaluated the climacteric symptoms, with the scale Menopause Rating Scale at the beginning of treatment, at 45 days (T45) and 90 days (T90). Statistical analysis showed a reduction in all parameters between T0 and T45, between T0 and T90 and to a lesser degree between T45 and T90. The product has been also evaluated by patients effective and well tolerated. The study shows that supplementation with a herbal and quantitative features such as used by us is effective in controlling the symptoms associated with menopause. SOMMARIO Lo scopo del nostro studio è stato quello di valutare l impatto di un integratore alimentare a base di Equisetum Arvense, Isoflavoni di Soia, Lattoferrina e Vitamina D3 sulla sintomatologia climaterica. Sono state arruolate 85 pazienti di cui 78 hanno concluso studio. È stato somministrato alle pazienti l indice modificato di Kupperman (Modified Kupperman Index) e poi abbiamo valutato la sintomatologia climaterica con la scala Menopause Rating Scale all inizio del trattamento, a 45 giorni (T45) e a 90 giorni (T90). L analisi statistica ha mostrato una riduzione di tutti i parametri tra T0 e T45, tra T0 e T90 e in minor parte tra T45 e T90. Il prodotto è stato inoltre valutato dalle pazienti efficace e ben tollerato. Lo studio dimostra che l integrazione con un fitoterapico con le caratteristiche quali e quantitative come quello usato da noi è efficace nel controllo dei sintomi associati al climaterio. Keywords: menopause, climacteric, lactoferrin, isoflavones, Equisetum INTRODUCTION Climacteric represents the transition from fertile to menopause and it is due to a progressive depletion of ovarian function. This results, in addition to the known alterations of the menstrual cycle, in varied and multi-organ symptoms. The climacteric is marked by physiological and psychological changes that may impact heavily on the woman s life, sometimes affecting his social relations. It is characterized by the presence of vasomotor symptoms (VMS, hot flashes and night sweats), bone loss, urogenital atrophy of the mucosa, as urinary tract infections and urinary incontinence, increased cardiovascular risk, somatic symptoms and sexual dysfunction with decreased libido (1). The social cost of the climacteric is high if we consider, for example, that bone mass is reduced, on average, of 1-2% year after menopause and that about 25% of postmenopausal women have severe osteoporosis and 50% of women not taking oestrogen will suffer a bone fracture in the course of life (2). The impact of climacteric symptoms has gained importance Correspondence to: Copyright 2014, Partner-Graf srl, Prato with the rise in life expectancy of women, since they can expect to spend a significant part of their lives after menopause. This period should be a time highly productive and the maintenance of functional capacity and a good quality of life is of utmost importance. In recent years, following the publication of the Million Women Study (MWS) the use of hormone replacement therapy has decreased significantly (3-4) and clinicians have tried to avoid using preparations soy isoflavones (5) and other herbal components with the objectives of reducing autonomic symptoms associated with menopause. Among the herbal ingredients scientifically recognized for comprehensive management of symptoms literature arises from time attention on soy isoflavones. As amply demonstrated Soy isoflavones have the important property of binding the ER-beta oestrogen receptor expressed predominantly on the vaginal mucosa, on the heart and bone tissue. Given the specific affinity for the beta oestrogen receptor, isoflavones may be considered natural selective modulators (SERMs) so treatment with these drugs may be useful to control vasomotor symptoms associated with perimenopause and menopause, to improve the serum lipid profile and the metabolism of the bone tissue (6-8). 57

22 It. J. Gynaecol. Obstet. 2015, 27: N.2 58 Supplementation with vitamin D3 (Vit D3) plays a key role on the stabilization of the bone. It is known as the dominant function of vitamin D3 is related to the elevation of plasma calcium and phosphate levels, necessary for bone mineralization. Vitamin D3 stimulates the absorption of calcium especially at the level of the duodenum and jejunum and acts on the distal renal tubule ensuring greater retention of calcium itself. It is also demonstrated an effect of immunoregulation mediated by Vit D3, in which calcitriol apparently promotes the proliferation of regulatory T cells and their accumulation in the sites of inflammation (9). Equisetum arvense, rich in silicon, it is known in the literature to reduce osteoclast activity as to be suggested in the bone regeneration (10). Our study evaluated the integration of soy isoflavones (from Glycine max), vitamin D3, silicon and lactoferrin. Lactoferrin stimulates the proliferation and differentiation of osteoblasts, and on the other hand inhibits osteoclasts. In addition, lactoferrin may act on bone cells through the inhibition of osteolytic cytokines such as TNFa, IL-1β and other cytokines that increase in concentration during the inflammatory processes. For these properties, lactoferrin can be used as a regulator for the control of bone physiology and supplementation of lactoferrin may thus help to improve the bone mineral density and bone strength (11-13). MATERIALS AND METHODS The study was conducted at the U.O. of Gynecology and Obstetrics of Montevarchi in collaboration with the study group consisting of: Gabriele D Egidion MD; Gabriella Scorpio MD; Giovanni Cavallo MD - Gynecology and Obstetrics U.O. of Modica (RG). After acquisition of adequate informed consent were recruited 85 women in these centers. The criteria for inclusion and exclusion are shown in Table I. The patients were subjected to a preliminary test for the evaluation of climacteric symptoms using the modified Kupperman index (Modified Kupperman Index) as shown in Table II (14). The patients were given a dietary supplement of soy isoflavones, lattofferrina, vitamin D3 and Equisetum arvense with the compositions shown in Table III. The product was recommended at a dose of one tablet per day for a total of ninety days. The patients were subjected to the evaluation of the clinical symptoms at baseline (T0), after 45 days (T45) and after 90 days (T90) using the scale Menopause Rating Scale, Table IV (15). Tolerability to treatment was investigated asking to indicate the degree of nothing, poor, fair, good and excellent to 90 days (T90). The efficacy perceived by patients was investigated asking them how they judged it at T90 in terms of: excellent, good, fair, poor or null. RESULTS Were included 85 postmenopausal women from 43 to 63 years (mean: 51.3 ± 3.6 years); of these 78 have concluded the study. All subjects included had a normal physical examination. Among the subjects included 15 patients out of 85 (17.6%) were taking drugs. Among those who completed the survey that number stood at 13 of 78 (16.6%). In particular: 8 taking drugs for thyroid disease (6 excluding the drop-out) 1 was taking drugs for thyroid disease, anti-inflammatories and antioxidants 3 taking drugs for hypertension 1 took steroids (0 excluding drop-out) 1 took steroids and metamizol 1 had undergone hormone replacement therapy The Kupperman index of the included patients Table I: Inclusion and exclusion criteria. INCLUSION CRITERIA Outpatients aged between 45 and 55 years of age Perimenopause with oligomenorrhea and autonomic symptoms associated Patients with index of Kuperman between Informed consent to participate in the study EXCLUSION CRITERIA Ongoing treatment with hormone replacement therapy, with products similar pharmacological effect or individual components to similar action Diseases compromising the cooperation of patients for evaluation (cognitive deficits, psychiatric illness, alcoholism, drug abuse) Diabetes mellitus Renal insufficiency (serum creatinine> 2.0 mg / dl) Severe hepatic impairment (GOT and / or GPT> 2 times the upper limit of normal)

23 C. Sommella et al. Table II: Modificated Kupperman Index. Name: Date: Which of the following symptoms apply to you at this time? Please provide the raw score according to the severity of each symptom. For symptoms that do not apply, please fill in 0 SYMPTOMS WEIGHTING FACTOR SEVERITY SCALE SCORE RAW SCORE WEIGHTED SCORE Sweating hot flusches X4 None <3 times/day 3-9 times/day 10 times/day Paresthesia X2 None Relationship with climate Fell tingling, burning, pricking or numbness frequently Lose sense of warm and pain Insomnia X2 None Once in a while Frequent need sleping pill Affects life and work Nervousness X2 None Once in a while Frequent Frequent, cannot control Melancholia X1 None Once in a while Frequent, can self-control Losing faith in life Vertigo X1 None Once in a while Frequent Affects daily life Fatigue X1 None Once in a while Fell difficult when climbing the 4th floor Arthralgia myalgia X1 None Once in a while Frequent, not affecting function Affects daily life Affects function Headache X1 None Once in a while Frequent Requires treatment Heart palpitation X1 None Once in a while Frequent, not affecting daily life Requires treatment Formication X1 None Once in a while Frequent Requires treatment Sexual complaints X2 Normal Reduced libido Sexual problems Loss of Libido Urinary tract infection X2 None Once in a while More than 3 times per year, not requiring medication More than 3 times per year, needing medication Notes: Raw score, severity score of each symptom; weighted score, raw score x weighting factor; total score, sum of the weighted score. Classification of the modified Kupperman Index is no complaint (total score 0-6), mild (total score 7-15), moderate (total score 16-30) or severe (total score >30) Table III: Composition of phytotherapic used. Average content of ingredients characterized by daily amount components Equisetum arvense dry extract 10% Intake of silica Glycine Max dry extract 40% Intake of soy isoflavones Lactoferrin tit. min 90% Vitamin D3 1 tablet 400 mg 40 mg 200 mg 80 mg 100 mg 0.02 mg Table IV: Menopause Rating Scale (MRS). 59

24 It. J. Gynaecol. Obstet. 2015, 27: N.2 was on average 25.3 ± 5.0, with values between a minimum of 15 (1 case) and a maximum of 35 (1 case). For statistical analysis of the results we used the software STATISTICA 12 (StatSoft, Inc. 2013). To test the differences in the questionnaire MRS (Menopause Rating Scale) at T0 and T45, T0 and T90 and T45 and T90 has used the Wilcoxon signed-rank test for paired samples, nonparametric test that does not use the media and does not require additional assumptions of normal distribution. In Tables V-VII shows the averages (used for the graphic representation 1 and 2), the number of non-null differences used for the test, and the significance (p) of the observed differences between T0 and T45 (Table V), between T0 and T90 (Table VI) and between T45 and T90 (table VII). Scores MRS have been reported on the chart number 1 while the graph number 2 we reported MRS scores at T0, T45 and T90 grouped by group of symptoms (somatic, psychological and urogenital). The tolerability of phytotherapic was investigated asking to indicate the degree in terms of: poor, fair, good and excellent. For 53.9% of the patients tolerability was excellent, it was good for 32.9%, discrete for 9.2% and low only for 3.9%. The data are shown in Figure 3. Regarding the perception efficacy the food supplement in the T90 patients have assigned the following ratings: excellent (51.3%), good (31.6%), moderate (10.5%), poor (5.3%) or null (1.3%). The results are reported in Figure 4. Statistical analysis shows that between T0 and T45 all variables showing differences extremely significant. Almost all p values are <0.001; exception Question 9 (bladder problems) that still gives rise to a p of about 0.003, which it is also significant. Between T0 and T90 all variables showing differences extremely significant. It is also repeated here the partial exception of the application 9, which still gives a value of p = slightly greater than Between T45 and T90, the situation is slightly more varied than the previous tables, with some differences non significant, a significant difference at the 5% (question 5, irritability) and other extremely significant, well over 1%. The results of this third test, compared with the previous two, could indicate that in some cases (applications 5,6,9) treatment effects were already achieved after 45 days and that little has changed after another 45, which intuitively can be confirmed by comparing the average response to these questions. DISCUSSION. The results show how the use of a food supplement with the qualitative and quantitative characteristics of the one we used has an important role on climacteric symptoms. In particular, it shows that the impact on both the somatic symptoms, psychological on the urogenital manifest already after 45 days of use. This benefit persists over time and is implemented, albeit slightly to 90 days. The degree of compliance to the integration with the product was high with about 80% of the patients participating in the study which was considered tolerable between very good and good. This percentage corresponds to the number of patients who considers the product efficently with a grade between excellent and good in controlling the climacteric symptoms. In conclusion, climacteric is even more a crucial period for the psychological well-being of women and is a social duty and therapeutic to address complaints related to it. The compliance of patients to hormone replacement therapy in recent years has decreased substantially while alternative therapies have made their way especially based on herbal remedies. The literature abounds with studies on the rational use of food supplements for the control of climacteric disorders. Unfortunately, few studies have been conducted evaluating the effectiveness of the integration with products based on active principles. In particular, for example, would be useful studies to assess the impact of these products on the bone profile of the patients and on cardiovascular risk in the long term. These, however, require a long period of observation, and a considerable economic cost to perform examinations and laboratory control. 60

25 C. Sommella et al. Figure 1: MRS Score - media at T0, T45, T90. Figure 2: Score for the group of symptoms. Table V: MRS score Significant differences at T0 and T45. Item MRS (score 0-4) Media T0 (N=78) (*) Media T45 (N=78) (*) Number of difference non-null P (Test di Wilcoxon) 1. Hot flushes, sweating (episodes of sweating) < Heart discomfort (unusual awareness of heart beat, heart skipping, heart racing, tightness) 3. Sleep problems (difficulty in falling asleep, diffi culty in sleeping through, waking up early) 4. Depressive mood (feeling down, sad, on the verge of tears, lack of drive, mood swings) 5. Irritability (feeling nervous, inner tension, feeling aggressive) < < < < Anxiety (inner restlessness, feeling panicky) < Physical and mental exhaustion (general decrease in performance, impaired memory, decrease in concentration, forgetfulness) 8. Sexual problems (change in sexual desire, in sexual activity and satisfaction) 9. Bladder problems (difficulty in urinating, increased need to urinate, bladder incontinence) 10. Dryness of vagina (sensation of dryness or burning in the vagina, difficulty with sexual intercourse) 11. Joint and muscular discomfort (pain in the joints, rheumatoid complaints) < < < <0.001 Somatic MRS score (sum of items 1,2,3,11) <0.001 Psychological MRS score (sum of items 4,5,6,7) <0.001 Urogenital MRS score (sum of items 8,9,10) <0.001 MRS total score (sum of all 11 items) <

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