Predictive and criterion validity of the Cervantes-SF menopause quality of life questionnaire

Coronado, Pluvio; Monroy, Manuel; Fasero, María; Baquedano, Laura; Mendoza, Nicolás; Llaneza, Plácido; Rejas, Javier; Ruiz, Miguel Á.

doi:10.1097/gme.0000000000001790

Cited by 4 publications

(6 citation statements)

References 34 publications

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“…In particular, the FLAVIE study revealed a significant reduction in the vasomotor, psychosocial and physical domains of the MENQoL scale, both at 4 weeks and 12 weeks since treatment was initiated. Likewise, the Cervantes Scale is the most frequently used validated menopause-QoL scale in the Spanish population and in Spanish-speaking countries [ 26 30 ]. Strikingly, an overall significant decrease in the global score of this scale, exceeding 25 points, was found at 12 weeks (35.4% improvement); it was noteworthy in the M&H domain (mean 17.4 points), and specifically in the reduction of VMS subdomain (–47.3%, mean 6.8 points).…”

Section: Discussionmentioning

confidence: 99%

“…All this fulfils the study objectives. In the analysis by the AEEM [ 26 ], a change of 6.7 points in the global Cervantes Scale score involved a significant improvement in accomplishing working/daily activities, a reduction in healthcare needs and alleviation of the economic burden resulting from menopausal symptoms and lost productivity. According to this analysis, the effectiveness of this food supplement containing soy isoflavones, 8-PN and melatonin would appear to be of notable clinical relevance, as the benefits in the vasomotor subdomain alone reached that score.…”

Section: Discussionmentioning

confidence: 99%

“…Calculations were performed with the PASS package, 2011 version (NCSS LLC.). Of note, from a clinical perspective, as it is established in the analysis by the Spanish Association for the Study of Menopause (AEEM) [ 26 ], a change of 6.7 points in the global Cervantes Scale score involved a significant improvement in accomplishing working/daily activities, a reduction in healthcare needs and alleviation of the economic burden resulting from menopausal symptoms and lost productivity [ 26 ].…”

Section: Methodsmentioning

confidence: 99%

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Combination of Soy Isoflavones, 8-Prenylnaringenin and Melatonin Improves Hot Flashes and Health-Related Quality of Life Outcomes in Postmenopausal Women: Flavie Study

Estrugo,

Rodríguez,

de Guevara

et al. 2023

J Menopausal Med

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Objectives This study aims to investigate the effects of a combination of soy isoflavones, 8-prenylnaringenin (8-PN), and melatonin in postmenopausal women suffering from moderate-to-severe hot flashes (HFs). Methods A multicenter, prospective, open-label study enrolled 44 postmenopausal women suffering from moderate-to-severe HFs (≥ 5 daily or ≥ 35 weekly) to receive 54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks. The primary clinical outcomes included changes in health-related quality of life (HRQoL) scores (Menopause-Specific QoL questionnaire [MENQoL] and Cervantes Scale) and HFs following 4 and 12 weeks of treatment. Other analyses included treatment adherence, acceptability, tolerability, and safety. Results All of the four domains of MENQoL questionnaire significantly improved at 4 weeks ( P < 0.05) and 12 weeks ( P < 0.001), affecting significantly the vasomotor, psychosocial, and physical spheres (41.2%, 26.3%, and 25.0%; 12 weeks improvements, respectively). Similarly, in the menopause (39.3%) and psychic (51.7%) domains (both P < 0.05 at 12 weeks), the global score of the Cervantes Scale significantly increased at 4 weeks (18.6%) and 12 weeks (35.4%). Accordingly, moderate-to-severe HFs significantly decreased at 4 weeks compared to baseline (41.7% reduction) and further reduced at 12 weeks (76.5%), including the total number of episodes. Conclusions Food supplements containing soy isoflavones, 8-PN, and melatonin showed an early and progressive benefit for reducing clinically significant HFs and for improving HRQoL across all domains, favorably affecting postmenopausal women’s overall well-being.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Combination of Soy Isoflavones, 8-Prenylnaringenin and Melatonin Improves Hot Flashes and Health-Related Quality of Life Outcomes in Postmenopausal Women: Flavie Study

Estrugo,

Rodríguez,

de Guevara

et al. 2023

J Menopausal Med

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“…It is scored on a Likert scale from 0 to 5. 38 For negative questions, 0 indicates the best situation and 5 indicates the worst one. For positive questions, 0 is the worst possible situation and 5 is the best one.…”

Section: Cervantes Short Formmentioning

confidence: 99%

Resilience and sexual health among menopausal women: a cross-sectional study

et al. 2022

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Objectives: Resilience can be defined as the capacity to overcome stressful situations, such as menopausal transition. Female sexual dysfunction is a problem that prevents women from experiencing satisfaction from sexual activity. In this study, we assessed resilience, sexual function, and quality of life among a sample of mid-aged Spanish menopausal women.Methods: This cross-sectional study was performed in 101 symptomatic menopausal women. Participants filled out the 14-item Wagnild and Young Resilience Scale, the 19-item Female Sexual Function Index (FSFI), the 16item Cervantes-SF form, and a sociodemographic questionnaire.Results: Resilience scores were significantly higher among women with high sexual function scores (FSFI > 26), with a 14-item Wagnild and Young Resilience Scale total valuation of 86 [80][81][82][83][84][85][86][87][88][89][90][91][92][93][94] versus 74 [66-79.50] (P < 0.001). Sexual function was significantly worse in the low resilience subgroup of participants, with an FSFI total score of 18. 90 [14.10-24] versus 29.40 [24.60-33] in the mid-high resilience one (P < 0.001). Menopauserelated quality of life was significantly worse among low resilient women, with a Cervantes-SF total score of 42.50 [34.17-56.70] versus 30.80 [20.80-44.90] in the mid-high resilience one (P ¼ 0.004).Conclusions: In our sample, resilience was related to sexual health. Higher resilience scores seem to be linked to a better quality of life during the menopausal transition.

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“…Menopausal hormone therapy (HT) could be used to improve health-related quality of life in perimenopausal and postmenopausal women 1-3 according to the statements of international scientific societies 4-6 . Many midlife women are taking or will take medications for other conditions when HT is recommended; however, data about possible interactions are scarce.…”

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confidence: 99%

Pharmacological interactions and menopausal hormone therapy: a review

et al. 2023

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Importance and Objective Menopausal hormone therapy (HT) is widely used, and there are several statements of international scientific societies to guide prescribers; however, a summary of existing literature about possible drug interactions with HT does not exist, although many midlife women take medications for other conditions. Therefore, our objective was to create a document that presents and synthesizes the most relevant interactions. The impact of the interaction itself and the number of candidates for HT who are likely to use other treatments are considered based on the best available evidence. Methods A systematic review was performed to determine the best evidence of interaction effects on relevant outcomes of interest for decision making. A working framework was developed to formulate explicit and reasoned recommendations according to four predefined categories for coadministration: (1) can be used without expected risks, (2) acceptable use (no evidence of negative interaction), (3) alternative treatment should be considered, and (4) nonuse without express justification. The project protocol was registered in the Open Science Framework platform (doi: 10.17605/OSF.IO/J6WBC) and in PROSPERO (registration number CRD42020166658). Results Studies targeting our objective are scarce, but 23 pharmacological groups were assigned to one of the predefined categories of recommendation for concomitant use of HT. Vaginal HT was assigned to category 1 for 21 of the analyzed pharmacological groups. For oral and transdermal HT (estrogen-only or combined) and tibolone, there were 12 pharmacological groups assigned to category 1, 12 to category 2, 5 to category 3, and 4 to category 4. Results are shown in crossed-tables that are useful for counseling and prescription. Discussion and conclusions Available evidence of HT interactions with other drugs is scarce and mainly indirect. It comes from biological plausibility, knowledge of extensive concomitant use without reported incidents, and/or extrapolation from hormonal contraception, but there are pharmacological groups in all categories showing that information is useful. These eligibility criteria summarize it and can help in the decision process of HT coadministration with other drugs. Decisions should be taken based on these recommendations but also individualized risk/benefit evaluation, according to underlying pathology, patient's clinical requirements, and the existence or nonexistence of alternatives.

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Predictive and criterion validity of the Cervantes-SF menopause quality of life questionnaire

Abstract: The AEEM group responsible for the development of the Cervantes-SF scale is composed of: Pluvio J.

Cited by 4 publications

References 34 publications

Combination of Soy Isoflavones, 8-Prenylnaringenin and Melatonin Improves Hot Flashes and Health-Related Quality of Life Outcomes in Postmenopausal Women: Flavie Study

Combination of Soy Isoflavones, 8-Prenylnaringenin and Melatonin Improves Hot Flashes and Health-Related Quality of Life Outcomes in Postmenopausal Women: Flavie Study

Resilience and sexual health among menopausal women: a cross-sectional study

Pharmacological interactions and menopausal hormone therapy: a review

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