Marco Gambacciani
@casadicurasanrossore.it
Menopause and Osteoporosis Unit
San Rossore Clinical Center
RESEARCH, TEACHING, or OTHER INTERESTS
Obstetrics and Gynecology
229
Scopus Publications
Scopus Publications
- Expert opinion by the Italian Society of Gynecology of the Third Age (SIGiTE) and the Italian Society of Menopause (SIM) on hormone therapy with bioidentical hormones
Stefano Lello, Anna Capozzi, Angelo Cagnacci, Marco Gambacciani, Lino Del Pup, and Costantino Di Carlo
Elsevier BV - Systemic hormone therapy after breast and gynecological cancers: an Italian expert group consensus opinion
Angelo Cagnacci, Paola Villa, Giuseppina Paola Grassi, Nicoletta Biglia, Marco Gambacciani, Costantino Di Carlo, Francesca Nocera, Salvatore Caruso, Angelamaria Becorpi, Stefano Lello,et al.
Informa UK Limited
The specific Italian Group of Study of the Menopause formulated a consensus opinion on the use of estrogen therapy (ET) or combined estro-progestin hormone therapy (HT) after breast and gynecological cancers. This consensus is based on the risk of recurrence of the specific cancer during ET/HT, the presence of steroid receptors in cancer cells, the use of adjuvant hormone therapies and data on the use of ET/HT after cancer. The following positions were reached. ET/HT can be used after vulvar cancers and melanoma, but with great caution after the rare adenocarcinomas. ET/HT can be used after cervical cancer, but ET should be used with caution after adenocarcinomas. ET/HT can be used after International Federation of Obstetrics and Gynecology (FIGO) stage I-II estrogen-dependent endometrial cancers, except in Black women, and can probably be used after estrogen-independent endometrial cancers. ET/HT cannot be administered or should be used with great caution after most uterine sarcomas. ET/HT can probably be used after ovarian neoplasms except for granulosa cell tumors, and with great caution after low-grade serous ovarian carcinoma and serous borderline ovarian tumors. ET/HT can be used with great caution in women after estrogen receptor (ER)/progesterone receptor (PR)-positive breast cancer and is probably allowed after ER/PR-negative breast cancer. - Hyaluronic acid and erbium laser for the treatment of genitourinary syndrome of menopause
Tiziana Fidecicchi and Marco Gambacciani
Informa UK Limited
OBJECTIVE This study aimed to evaluate the effect of the vaginal erbium laser (VEL) in association with vaginal hyaluronic acid (HA) in postmenopausal women suffering from genitourinary syndrome of menopause (GSM). METHODS One hundred sexually active postmenopausal women were selected and divided into three groups using a block randomization method; 10 women declined to participate. The remaining women received three laser applications at 30-day intervals; 22 women dropped out for personal reasons or protocol violations. Group 1 (n = 25) received VEL treatment (XS Fotona Smooth®; Fotona, Slovenia) alone; Group 2 (n = 22) received daily vaginal HA tablets for 10 days after VEL treatment, followed by a twice a week administration during the follow-up period; and Group 3 (n = 21) received daily HA tablets for 10 days before the first VEL treatment and for 10 days after each laser application, followed by a twice a week administration for the follow-up period. Vaginal dryness and dyspareunia were assessed at the screening visit, before VEL treatment, after 1 and 3 months from the last laser treatment, using the visual analog scale. Data were analyzed using one-way analysis of variance and a linear mixed model for repeated measures. The post-hoc test for the interaction between time and treatment was performed using Bonferroni correction. RESULTS A significant (p < 0.001) improvement in both vaginal dryness and superficial dyspareunia was evident, with greater (p < 0.001) improvement in Group 2 and Group 3. CONCLUSIONS The results suggest that vaginal HA administration can improve the VEL effects on GSM in postmenopausal women. - Indications for the use of menopausal hormone therapy after cancer: on what data should we rely on?
Angelo Cagnacci, Marco Gambacciani, Stefano Lello, and Anna M. Paoletti
Informa UK Limited - POESIT recommendations on management of body-identical hormones in menopausal symptoms
Santiago Palacios, Cláudio Rebelo, Ana Casquilho, Ana Rosa Costa, Angelo Cagnacci, Antonio Cano, Camil Castelo-Branco, Costantino Di Carlo, Fátima Romão, Fernanda Geraldes,et al.
Informa UK Limited
Many women seek treatment to improve menopausal vasomotor symptoms (VMS). The selection of women most likely to benefit from menopause hormone therapy (MHT) is crucial in clinical practice. There is general agreement that women younger than 60 years or who initiate MHT within the first 10 years of menopause, with no contraindications, have greater benefits considering symptomatic relief and additional advantages. This group may have the advantage of protection from osteoporosis and from other chronic diseases that affect postmenopausal women, namely cardiovascular disease (CVD). Cumulating evidence supports MHT for symptomatic women. However, inadequate use according to the needs of symptomatic women led to a burden of suffering worldwide. In recent years, the emergent use of non-regulated body-identical hormones (non-rBHT) can expose patients to potential harms. These hormone preparations are not regulated through the same tests of safety, efficacy or dosing consistency as regulated-BHT (r-BHT). The POESIT (Portugal + Spain + Italy) recommendations highlight the use of 17β-estradiol (E2) and micronized progesterone (P4) as the real r-BHT. In addition, the group emphasizes as an example the data from the REPLENISH study with 1 mg E2/100 mg P4. The combination of the two hormones in one convenient pill showed a clear reduction or elimination of hot flashes and an improvement in sleep quality and, consequently, quality of life. At the same time, this combination has shown high rates of amenorrhea and no significant impact on lipid, glucose or coagulation parameters. Both the REPLENISH study and a real-life retrospective study pointed to the possibility of a lower risk of venous thromboembolism (VTE) with this formulation than with other combinations. - Oestrogens in oral contraception: considerations for tailoring prescription to women’s needs
Franca Fruzzetti, Tiziana Fidecicchi, and Marco Gambacciani
Informa UK Limited
BACKGROUND The oestrogenic component of combined oral contraceptives (COCs) has changed over years with the aim of reducing oestrogen-related side effects and risks, whilst maintaining oestrogen beneficial effects, particularly on cycle control. PURPOSE To describe the pharmacological profiles of different oestrogens commonly used in COCs to provide insights on contraceptive prescription tailored to women's needs. RESULTS All COCs ensure a high contraceptive efficacy. COCs containing the natural oestrogens oestradiol (E2), oestradiol valerate (E2V) and estetrol (E4) have limited impact on liver metabolism, lipid and carbohydrate metabolism, haemostasis and sex hormone binding globulin levels, compared with ethinylestradiol (EE). COCs with E2 and E2V appear also to entail a lower elevation of the risk of venous thromboembolism vs. EE-containing pills. No epidemiological data are available for E4-COC. E2- and E2V-containing COCs seem to exert a less stabilising oestrogenic effect on the endometrium compared with EE-COCs. The E4-COC results in a predictable bleeding pattern with a high rate of scheduled bleeding and minimal unscheduled bleeding per cycle. Based on in vitro and in vivo animal data, E4 seems to be associated with a lower effect on cell breast proliferation. CONCLUSION Today various COCs contain different oestrogens. Prescribers must be familiar with the different properties of each oestrogen for a tailored contraceptive recommendation, considering their safety and contraceptive efficacy, as well as women's needs and preferences. - Treating where it hurts: tailoring the genitourinary syndrome of menopause treatments
Marco Gambacciani
Ovid Technologies (Wolters Kluwer Health) - EMAS position statement: Vitamin D and menopausal health
Panagiotis Anagnostis, Sarantis Livadas, Dimitrios G. Goulis, Silvia Bretz, Iuliana Ceausu, Fatih Durmusoglu, Risto Erkkola, Ivan Fistonic, Marco Gambacciani, Marije Geukes,et al.
Elsevier BV - Superficial dyspareunia treatment with hyperstacking of erbium:yttrium-aluminum-garnet SMOOTH laser: a short-term, pilot study in breast cancer survivors
Tiziana Fidecicchi, Adrian Gaspar, and Marco Gambacciani
Ovid Technologies (Wolters Kluwer Health)
Abstract Objective This prospective pilot study aimed to evaluate the effects of a modified vaginal erbium laser (VEL) protocol, using the hyperstack mode on the vaginal vestibulum and introitus to treat superficial dyspareunia in postmenopausal breast cancer survivors suffering from the genitourinary syndrome of menopause. Methods In this pilot, prospective, randomized study, two groups of postmenopausal women suffering from superficial dyspareunia were included: 34 women (VEL group) were treated with erbium laser crystal yttrium-aluminum-garnet (XS Fotona SMOOTH; Fotona, Ljubljana, Slovenia) with a wavelength of 2,940 nm; for the other 34 (hyperstack group), a modified second step of the VEL protocol for the treatment of vestibulum and introitus was used, with hyperstacked (repeating a number of) subablative, long pulses with very low fluences. For each group, three laser applications at 30-day intervals were performed. Symptoms were assessed before, after each application, and after 1 and 3 months from the last laser application, using the visual analog scale score for superficial dyspareunia. Results Superficial dyspareunia improved in both groups over time (P < 0.001), regardless of age and years since menopause status. The reduction in visual analog scale score after the third laser application was 58% in VEL versus 73.5% in hyperstack. The hyperstack group, since the first laser application, showed a greater (P < 0.001) and persistent improvement of superficial dyspareunia. Conclusions The hyperstack treatment of the introitus and vestibulum in breast cancer survivors leads to a more significant improvement in superficial dyspareunia than the VEL alone. - Breaking down barriers for prescribing and using hormone therapy for the treatment of menopausal symptoms: an experts’ perspective
Serge Rozenberg, Nick Panay, Marco Gambacciani, Antonio Cano, Sarah Gray, and Katrin Schaudig
Informa UK Limited
ABSTRACT Introduction Around 80% of women suffer menopause-related symptoms that affect their daily activities and quality of life. Menopausal hormone therapy (MHT) has proven to be beneficial in relieving these symptoms. Nevertheless, only 20/30% of symptomatic women seek treatment. This has resulted in neglect of a generation of healthcare professionals’ (HCPs) education in menopausal medicine and a reduction in the prescription of MHT in menopausal women for over two decades. Areas covered The aim of this article was to identify the main barriers that HCPs face for prescribing MHT and menopausal women for using it. Six European experts in menopause agreed on the profiles of women that benefit from MHT and proposed strategies to break down these barriers. Expert opinion The most important barrier for HCPs was deficient knowledge of the true evidence-based information, with inadequate training regarding the efficacy and safety of personalized MHT and the real benefit/risk ratio in the treatment of symptomatic women. For patients, fear of developing breast cancer was identified as the single most important barrier. Breaking down barriers is possible, by providing appropriate training and education to HCPs and women. This should result in fully informed, evidence based, shared treatment decisions by women and their physicians. - SUI in postmenopausal women: advantages of an intraurethral + intravaginal Er:YAG laser
C. T. Erel, M. Gambacciani, I. B. Ozcivit Erkan, N. Gokmen Inan, K. Hamzaoglu Canbolat, and T. Fidecicchi
Informa UK Limited
OBJECTIVE This study aimed to compare the efficacy of concomitant application of an intraurethral (IU) + intravaginal (IV) non-ablative Erbium (Er):YAG laser with IV application in improving the symptoms of stress urinary incontinence (SUI) in women. METHODS This observational retrospective cohort study included 122 patients with SUI, 60 women in the IU + IV laser arm and 62 in the IV laser arm. The primary outcome was the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form score at entry and at 3, 6 and 12 months from baseline. RESULTS Demographic characteristics were comparable in both arms. Significant improvement in SUI symptoms was seen 3 months after the intervention and was sustained until the end of month 12 in both arms. The women who had severe SUI symptoms initially showed greater improvement. A higher number of women who initially had mild to moderate SUI symptoms were dry after treatment. Patients treated with IU + IV Er:YAG laser showed significant improvement in SUI symptoms compared to IV laser only, especially at postmenopausal state (p = 0.003). CONCLUSIONS The Er:YAG laser appears to be an efficient treatment method for SUI. Concomitant application of an IU + IV Er:YAG laser is more effective in relieving SUI symptoms at postmenopausal state. - HRT in a new light: Thanks UK
Marco Gambacciani and Angelo Cagnacci
Elsevier BV - Menopause, wellbeing and health: A care pathway from the European Menopause and Andropause Society
Irene Lambrinoudaki, Eleni Armeni, Dimitrios Goulis, Silvia Bretz, Iuliana Ceausu, Fatih Durmusoglu, Risto Erkkola, Ivan Fistonic, Marco Gambacciani, Marije Geukes,et al.
Elsevier BV - Examining vaginal and vulvar health and sexual dysfunction in patients with interstitial cystitis (UNICORN-1 study)
Nobuo Okui, Machiko Okui, and Marco Gambacciani
Springer Science and Business Media LLC - The essential menopause curriculum for healthcare professionals: A European Menopause and Andropause Society (EMAS) position statement
Margaret Rees, Kathy Abernethy, Gloria Bachmann, Silvia Bretz, Iuliana Ceausu, Fatih Durmusoglu, Risto Erkkola, Ivan Fistonic, Marco Gambacciani, Marije Geukes,et al.
Elsevier BV - Short-term effects of an erbium/neodymium laser combination in superficial dyspareunia: a pilot study
M. Gambacciani and T. Fidecicchi
Informa UK Limited
Abstract Objective This prospective pilot study aimed to evaluate the effects of associating a neodymium:yttrium–aluminum–garnet (Nd:YAG) laser with a vaginal erbium laser (VEL), as a non-ablative photothermal therapy for superficial dyspareunia in postmenopausal women (PMW) suffering from genitourinary syndrome of menopause (GSM). Methods Two groups of sexually active PMW reporting superficial dyspareunia were selected: one (15 patients, VEL) was treated using an erbium:yttrium–aluminum–garnet laser crystal (XS Fotona SMOOTH; Fotona, Ljubljana, Slovenia) with a wavelength of 2940 nm; in the other group (15 patients, VEL + Nd:YAG) this treatment was followed by Nd:YAG laser (Fotona SP Dynamis, PIANO mode) treatment. Treatment consisted of three laser applications at 30-day intervals. Symptoms were assessed before, after each laser application and after 1 and 3 months from the end of the treatment, using the subjective visual analog scale (VAS) for superficial dyspareunia. Results Both groups showed a rapid and significant improvement of superficial dyspareunia over time (p < 0.001) independently from age and years since menopause. The VEL + Nd:YAG group showed a greater improvement of superficial dyspareunia (p < 0.001); this difference was evident since the first treatment and remained stable over time. Conclusions The addition of Nd:YAG to VEL may induce greater improvement in superficial dyspareunia in PMW with GSM. - What women think about menopause: An Italian survey
Concetta Maria Vaccaro, Anna Capozzi, Giuseppe Ettore, Roberto Bernorio, Angelo Cagnacci, Marco Gambacciani, Vittoria Coletta, Silvia Maffei, Rossella Elena Nappi, Giovanni Scambia,et al.
Elsevier BV - Re: Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham-controlled trial
Adrian Gaspar and Marco Gambacciani
Wiley
Sir, We thank colleagues Tamer Erel and Ozcivit for their comments on our experimental assessment of the effects of vaginal Er:YAG laser application in menopausal ewes and are happy to clarify some details. First, our colleagues were surprised that our findings did notmatch those of a recent study by Gaspar et al., who reported a 2.4-fold increase in vaginal epithelial thickness (base line: 45 33 lm to 153 45 lm 3 months after second non-ablative Er:YAG laser) and a three-fold increase in vaginal cell layers. We included that study in our discussion, also reporting an increase in glycogen and neo-angiogenesis. This study included ten women used as their own control; it lacked definition of primary and secondary endpoints, nor did it have a power calculation, or details on the pathology methods used. Apart from that, to better understand how those results would compare to our findings, the inclusion of a sham control and/or estrogen-exposed group would be necessary. Further, we wholeheartedly agree with Tamer Erel and Ozcivit, who have ample clinical experience with clinical laser application, that animal models have their limitations, hence also the ewe. These animals are often used to study menopause-associated disorders, including genito-urinary atrophy as described in our manuscript. More precisely, ewes have vaginal dimensions close to that of women, and when they undergo ovariectomy, their vaginal epithelium thins to 34–118 μm, which is perhaps not identical, but is close to the range observed in women (50– 180 μm). We agree that the vaginal pH is not comparable and that this may have consequences on vaginal secretions and the microbiome, which unfortunately were not studied in our experiment. Although animal models are not a perfect representation of a human, our observations prompt the need for properly controlled clinical trials, which – wherever ethically acceptable – include outcome measurements that permit comparison and understanding of these experimental findings. We, as well as others, are currently running such studies and would suggest reaching formal conclusions from them (clinical trial gov number: NCT04021966).& - The European Vulvovaginal Epidemiological Survey (EVES) in Italy. Impact of vulvovaginal atrophy on the quality of life and sexual function in breast cancer survivors
R. Nappi, N. Biglia, E. Cicinelli, T. Paolantonio, S. Luisi, M. Stomati and P. Villa
MRE Press
27100Pavia, Italy University of Turin, Department of Surgical Sciences,MaurizianoUmberto I Hospital, 10128 Turin, Italy 2ndUnit of Obstetrics andGynecology, Department of Biomedical andHumanOncological Science (DIMO), University of Bari, 70121 Bari, Italy Shionogi srl, 00193 Rome, Italy Department ofMolecular andDevelopmentalMedicine, Division of Obstetrics andGynecology, University of Siena, 53100 Siena, Italy Division of Obstetrics andGynecology, Department of Gynecology andObstetrics, "D. Camberlingo"Hospital, Francavilla Fontana, ASL Brindisi, 72100 - Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms–an update on the evidence
C. Castelo-Branco, M. Gambacciani, A. Cano, M. J. Minkin, D. Rachoń, X. Ruan, A.-M. Beer, J. Schnitker, H.-H. Henneicke-von Zepelin, and S. Pickartz
Informa UK Limited
Abstract A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of −0.694 in favor of iCR (p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John’s wort (Hypericum perforatum [HP]) were given (−1.020 and −0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit–risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms. - Sexual function after vaginal erbium laser: the results of a large, multicentric, prospective study
M. Gambacciani, E. Albertin, M. G. Torelli, G. L. Bracco, A. C. Casagrande, L. Martella, G. Baiocchi, S. Alfieri, N. Russo, M. Cervigni,et al.
Informa UK Limited
Abstract The aim of this multicentric, prospective study was to evaluate the effects of vaginal erbium laser (VEL-SMOOTH®) on sexual function in postmenopausal women suffering from the genitourinary syndrome of menopause (GSM). This study was performed on an outpatient basis without anesthesia or drug use before or after the intervention, using an erbium laser (XS Fotona Smooth®, Fotona, Ljubljana, Slovenia) in 1081 postmenopausal women (age 54.3 ± 3.9 years) treated with up to three laser applications every 30 days. Patients were assessed using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). No adverse events were recorded during the study. The FSDS-R scores (n = 554), from basal values of 25.5 ± 3.5, were 11.5 ± 3.0, 10.5 ± 3.5 and 11.5 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Individual FSFI domain scores (n = 569) significantly (p < 0.001) increased after VEL-SMOOTH® treatment and remained significantly higher up to the 24th week after the end of treatment. The total scores, from basal values of 15.5 ± 1.5, were 27.5 ± 2.5, 27.6 ± 2.7and 27.0 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Albeit not randomized, this large, prospective study shows that VEL-SMOOTH® treatment may improve sexual function in postmenopausal women suffering from GSM. - Light the way for women's health
M. Gambacciani and M. Cervigni
Informa UK Limited
More than 7 years ago, we started a new experience in our gynecologic professional life, influenced by the seminal paper by Stefano Salvatore et al.1. They reported the results of a study clearly d... - The VELA experience: a strategic format
G. Grassiri, M. Cervigni, G. L. Bracco, M. Gambacciani, and
Informa UK Limited
VELA is an acronym for Vaginal Erbium Laser Academy. The VELA is an independent scientific organization born in 2013 and devoted to women’s health and quality of life1. The purpose of the VELA is t... - Safety of vaginal erbium laser: A review of 113,000 patients treated in the past 8 years
M. Gambacciani, M. Cervigni, A. Gaspar, A. Novakov Mikić, J. Gaviria, N. Koron, and Z. Vizintin
Informa UK Limited
Abstract Background: Energy-based devices are becoming a popular option for minimally invasive vaginal procedures. The aim of this study was to obtain information on the frequency of occurrence of adverse effects (AEs) related to vaginal erbium laser (VEL™) treatment. Materials and methods: The global survey was conducted among practitioners using the non-ablative VEL™ (Fotona, Ljubljana, Slovenia). Users were invited to provide the number of patients treated with VEL™ and the number of observed laser-related AEs. Results: The survey was conducted from August 2018 to April 2019. Responses from 535 practitioners were collected, with a total of 113,174 patients treated in the period from 2012 to 2019. Out of 535 respondents, 160 (30%) shared detailed information about the indications they treated in a population of 62,727 patients, whereas 188 (35%) respondents provided information on the frequency of AEs observed in their treated population of 43,095 patients. All observed AEs were mild to moderate, transient and appeared with low frequencies. Conclusions: Minimally invasive thermal-only laser treatment using the non-ablative VEL™ procedures appears to be safe and the incidence of AEs is low.