Use of Contraceptive Methods Among Women in the General Population and Female Gynecologists in Spain: the ELEGIAN Survey.

Background: The contraceptive preferences of obstetricians and gynecologists (OB/GYNs) are thought to influence the contraceptive counseling they provide. The purpose of this study was to assess contraceptive preferences of OB/GYNs and women in the general population (WGP) in the current Spanish contraceptive scenario. Materials and Methods: Anonymous online survey of 100 OB/GYNs and 1,217 WGP aged 23-49 years. Results: WGP were younger (35.3 ± 7.3 vs. 37.9 ± 6.2 years, respectively) and less likely to have stable partners (64.7% vs. 84.0%) and children (49.1% vs. 62.0%) (all p < 0.05 vs. OB/GYNs). Seventy-nine percent versus 82%, respectively, used contraceptive methods, with condoms used most frequently by WGP (37% vs. 22% by OB/GYNs; p < 0.05) and pills by OB/GYNs (26% vs. 21% by WGP; p > 0.05). Intrauterine devices (IUDs) were more frequently used by OB/GYNs (20% vs. 5%; p < 0.05), especially the levonorgestrel-releasing intrauterine devices (LNG-IUDs) (18% vs. 2.6%; p < 0.05). The highest-rated methods were condoms among WGP and LNG-IUDs among OB/GYNs. Effectiveness was the most valued attribute of contraceptive methods for both. Reasons related to convenience were the main reason for choosing IUDs. OB/GYNs prescribed the contraceptive method in 40% of cases. Conclusions: Our study reveals differences between female OB/GYNs and WGP in contraceptive methods use and rating. The use of LNG-IUDs was much higher among OB/GYNs.

Safety and Efficacy of Bone Marrow-Derived Mesenchymal Stem Cells for Chronic Patellar Tendinopathy (With Gap >3 mm) in Patients: 12-Month Follow-up Results of a Phase 1/2 Clinical Trial.

Background: In a previous study, the authors found that at 6 months after treatment with a 20 × 106 dose of bone marrow-derived mesenchymal stem cells (BM-MSCs), patients showed improved tendon structure and regeneration of the gap area when compared with treatment using leukocyte-poor platelet-rich plasma (Lp-PRP). The Lp-PRP group (n = 10), which had not seen tendon regeneration at the 6-month follow-up, was subsequently offered treatment with BM-MSCs to see if structural changes would occur. In addition, the 12-month follow-up outcomes of the original BM-MSC group (n = 10) were evaluated. Purpose: To evaluate the outcomes of all patients (n = 20) at 12 months after BM-MSC treatment and observe if the Lp-PRP pretreated group experienced any type of advantage. Study Design: Cohort study; Level of evidence, 2. Methods: Both the BM-MSC and original Lp-PRP groups were assessed at 12 months after BM-MSC treatment with clinical examination, the visual analog scale (VAS) for pain during daily activities and sports activities, the Victorian Institute of Sport Assessment-Patella score for patellar tendinopathy, dynamometry, and magnetic resonance imaging (MRI). Differences between the 2 groups were compared with the Student t test. Results: The 10 patients originally treated with BM-MSCs continued to show improvement in tendon structure in their MRI scans (P < .0001), as well as in the clinical assessment of their pain by means of scales (P < .05). Ten patients who were originally treated with Lp-PRP and then with BM-MSCs exhibited an improvement in tendon structure in their MRI scans, as well as a clinical pain improvement, but this was not significant on the VAS for sports (P = .139). Thus, applying Lp-PRP before BM-MScs did not yield any type of advantage. Conclusion: The 12-month follow-up outcomes after both groups of patients (n = 20) received BM-MSC treatment indicated that biological treatment was safe, there were no adverse effects, and the participants showed a highly statistically significant clinical improvement (P < .0002), as well as an improvement in tendon structure on MRI (P < .0001). Preinjection of Lp-PRP yielded no advantages.

Sensitivity to Change of the SAMANTA Questionnaire, a Heavy Menstrual Bleeding Diagnostic Tool, After 1 Year of Hormonal Treatment.

Background: The validated SAMANTA questionnaire allows identification of women with heavy menstrual bleeding (HMB); that is, with excessive menstrual bleeding that interferes with quality of life (QoL). We assessed its value for monitoring HMB treatment in clinical practice. Material and Methods: This is a prospective observational study conducted between December 2018 and March 2021 in consecutively recruited women with HMB attending gynecologists' offices who started a hormonal treatment. Sociodemographic characteristics were recorded at enrollment. At baseline and month 12, we assessed the HMB (SAMANTA questionnaire), the global impression of menstrual bleeding severity in patients (PGI-S) and clinicians (CGI-S), and the QoL (SF36). At month 12, we assessed the global impression of menstrual bleeding change in patients (PGI-C) and clinicians (CGI-C). Changes in SAMANTA questionnaire score at month 12 were compared with the presence of amenorrhea and changes in blood loss, menstrual period duration, and PGI-S, PGI-C, CGI-S, and CGI-C. Results: The study included 371 women aged 41.2 ± 6.5 years, 87% of whom were using the levonorgestrel intrauterine system. The SAMANTA questionnaire score significantly decreased in 97.3% of women. The decrease was greater in women reporting a reduction in blood loss, shorter menstrual bleeding duration, or a strong improvement in menstrual bleeding severity (PGI-S and CGI-S) or amount (PGI-C and CGI-C) (p < 0.001 for all), but not amenorrhea. SF-36 domains improved significantly; changes being inversely associated with changes in the SAMANTA questionnaire score. Conclusions: The SAMANTA questionnaire seems a valuable tool for monitoring hormonal treatment for HMB. ClinicalTrials.gov identifier NCT03751800.

Real-world satisfaction and menstrual bleeding pattern with available LNG-IUD among Spanish young women.

OBJECTIVE: The aim of this study was to evaluate the satisfaction and menstrual bleeding pattern with levonorgestrel-releasing intrauterine systems (LNG-IUD) in young women. METHODS: A prospective, multicentre, non-interventional study with 1-year follow-up was conducted in Spain. Participants were women between 18 and 30 years old who freely choose any available LNG-IUD for contraception. Satisfaction with LNG-IUD was measured with a 5-point Likert scale. Type of LNG-IUD, menstrual bleeding pattern and satisfaction with it, easiness of insertion and pain during procedure were collected. RESULTS: A total of 555 women (37.3% parous, 62.7% nulliparous) (mean age 25.8 ± 3.5) completed the study. After 12 months, 92.4% of women were satisfied or very satisfied with the LNG-IUD, with no differences by parity status, type of IUD or baseline menstrual bleeding pattern. Satisfaction with the LNG-IUD correlated with satisfaction with menstrual bleeding pattern at 12 months. Up to 88.7% of women were satisfied or very satisfied with their menstrual bleeding pattern at 12 months in comparison to 41.5% at baseline (p < 0.001). Adverse events (AE)-related discontinuation rate was low (2.2%). CONCLUSIONS: Satisfaction with LNG-IUD is very high among young Spanish women, regardless of parity and menstrual bleeding pattern at baseline.

Sangrado menstrual abundante y su detección en la práctica clínica / Heavy menstrual bleeding and its detection in clinical practice

El sangrado menstrual abundante (SMA) se define como una pérdida excesiva de sangre menstrual que interfiere con la calidad de vida. Se trata de una alteración infradiagnosticada e infratratada debido a la escasa correlación entre la percepción de la paciente y la pérdida hemática menstrual objetiva, así como a la escasez de herramientas diagnósticas validadas. La anemia causada por el SMA es un problema frecuente, infravalorado en muchas ocasiones y con consecuencias que van más allá del ámbito de la ginecología. A pesar de su efecto negativo sobre la calidad de vida, la mayoría de las herramientas validadas para detectar el SMA no tienen en cuenta este concepto. El objetivo de este trabajo es revisar los principales instrumentos disponibles para detectar el SMA, sus ventajas e inconvenientes, su aplicabilidad en la práctica clínica habitual y recomendar aquellos que reúnen las mejores características. (AU)

Heavy menstrual bleeding (HMB) is defined as excessive menstrual blood loss that interferes with quality of life. It is an under-diagnosed and under-treated disorder due to the poor correlation between patient perception and objective menstrual blood loss, as well as the scarcity of validated diagnostic tools. Anaemia caused by HMB is a common problem, underestimated on many occasions and with consequences that go beyond the scope of gynaecology. Despite the condition's negative effect on quality of life, most of the tools validated to detect HBM do not take this into account. The aim of this paper is to review the main instruments available to detect HMB, their advantages and disadvantages, their applicability in routine clinical practice, and to recommend those with the best characteristics. (AU)

Heavy menstrual bleeding and its detection in clinical practice. / Sangrado menstrual abundante y su detección en la práctica clínica.

Heavy menstrual bleeding (HMB) is defined as excessive menstrual blood loss that interferes with quality of life. It is an under-diagnosed and under-treated disorder due to the poor correlation between patient perception and objective menstrual blood loss, as well as the scarcity of validated diagnostic tools. Anaemia caused by HMB is a common problem, underestimated on many occasions and with consequences that go beyond the scope of gynaecology. Despite the condition's negative effect on quality of life, most of the tools validated to detect HBM do not take this into account. The aim of this paper is to review the main instruments available to detect HMB, their advantages and disadvantages, their applicability in routine clinical practice, and to recommend those with the best characteristics.

Effect of Autologous Expanded Bone Marrow Mesenchymal Stem Cells or Leukocyte-Poor Platelet-Rich Plasma in Chronic Patellar Tendinopathy (With Gap >3 mm): Preliminary Outcomes After 6 Months of a Double-Blind, Randomized, Prospective Study.

BACKGROUND: Patellar tendinopathy is common. The success of traditional management, including isometric or eccentric exercises combined with shockwave therapy and even surgery, is limited. Therefore, it is important to determine whether biological treatments such as ultrasound-guided intratendinous and peritendinous injections of autologous expanded bone marrow mesenchymal stem cells (BM-MSCs) or leukocyte-poor platelet-rich plasma (Lp-PRP) improve clinical outcomes in athletic patients with patellar tendinopathy. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: A prospective, double-blinded, randomized, 2-arm parallel group, active controlled, phase 1/2 single-center clinical study was performed in patients who had proximal patellar tendinopathy with a lesion >3 mm. A total of 20 participants (age 18-48 years) with pain for >4 months (mean, 23.6 months) and unresponsive to nonoperative treatments were randomized into 2 groups. Of these, 10 participants were treated with BM-MSC (20 × 106 cells) and 10 with Lp-PRP. Both groups performed the same postintervention rehabilitation protocol. Outcomes included the Victorian Institute of Sport Assessment for pain (VISA-P), self-reported tendon pain during activity (visual analog scale [VAS]), muscle function by dynamometry, tendon thickness and intratendinous vascularity by ultrasonographic imaging and Doppler signal, ultrasound tissue characterization (UTC) echo type changes, and magnetic resonance imaging (MRI) T2-weighted mapping changes. Participants were followed longitudinally for 6 months. RESULTS: The average VAS scores improved in both groups at all time points, and there was a significant reduction in pain during sporting activities (P < .05). In both groups, the average mean VISA-P scores at 6 months were significantly increased compared with baseline (66 BM-MSC group and 72.90 Lp-PRP group), with no significant differences in VAS or VISA-P scores between the groups. There were statistically significant greater improvements in tendon structure on 2-dimensional ultrasound and UTC in the BM-MSC group compared with the Lp-PRP group at 6 months. Similarly, the BM-MSC group demonstrated significant evidence of restoration of tendon structure on MRI compared with the Lp-PRP group at 6 months. Only the participants in the BM-MSC group showed evidence of normalization of tendon structure, with statistically significant differences between the groups on T2-weighted, fat-saturated sagittal and coronal scans and hypersignal in T2-weighted on spin-echo T2-weighted coronal MRI scan. Both treatments were safe, and no significant adverse events were reported in either group. CONCLUSION: Treatment with BM-MSC or Lp-PRP in combination with rehabilitation in chronic patellar tendinopathy is effective in reducing pain and improving activity levels in active participants. Participants who received BM-MSC treatment demonstrated greater improvement in tendon structure compared with those who received Lp-PRP. REGISTRATION: 2016-001262-28 (EudraCT identifier); NCT03454737 (ClinicalTrials.gov identifier).

Paciente con xerostomía posradioterapia por cáncer de cabeza y cuello tratado con células madre mesenquimales autólogas expandidas de tejido adiposo: una nueva oportunidad terapéutica / Radiation-induced xerostomia in a patient with head and neck cancer treated with Injection of autologous expanded adipose tissue-derived mesenchymal stem cells: A new therapeutic opportunity

No disponible

Abordaje terapéutico del SARS-CoV-2 (COVID-19) mediante células mesenquimales de médula ósea alogénica expandidas. Conceptos a propósito de un primer caso en España / Expanded Mesenchymal Stem Cells: a novel therapeutic approach of SARS-CoV-2 pneumonia (COVID-19). Concepts regarding a first case in Spain

No disponible

Expanded mesenchymal stem cells: a novel therapeutic approach for SARS-CoV-2 pneumonia (COVID-19). Concepts regarding a first case in Spain / Abordaje terapéutico del SARS-CoV-2 (COVID-19) mediante células mesenquimales de médula ósea alogénica expandidas. Conceptos a propósito de un primer caso en España

No disponible

La diabetogenicidad de las estatinas: ¿son todas iguales? Estado de la cuestión / Statins diabetogenicity: are all the same? state of art

Las estatinas tienen un papel fundamental en la prevención cardiovascular de la población general, así como en los pacientes con diabetes mellitus tipo 2 (DM2). Sin embargo, el tratamiento con estatinas predispone a la DM2, especialmente en los pacientes con predisposición a la misma. Algunas estatinas se han asociado a aumentos de la glucemia en pacientes con o sin DM2, y otras han demostrado tener efectos neutros, variando de unas a otras su capacidad hiperglucemiante o diabetogénica. En muchos estudios clínicos con estatinas la incidencia de DM2 no se ha evaluado sistemáticamente, y otros carecen de la potencia necesaria para detectar diferencias entre estatinas. Las evidencias disponibles de mayor calidad provienen de los metaanálisis de los ensayos clínicos controlados. El único ensayo clínico controlado para evaluar la incidencia de DM2 de nueva aparición es el J-PREDICT realizado con pitavastatina en pacientes con tolerancia anormal a la glucosa. Los resultados preliminares de este estudio muestran que la pitavastatina se asocia a una disminución significativa de la incidencia de nuevos casos de DM2 en comparación con la modificación del estilo de vida exclusivamente. Por tanto, la pitavastatina podría constituir una adecuada alternativa terapéutica de elección para disminuir el riesgo vascular del paciente con DM2 o en situación de riesgo de presentarla

Statins are the cornerstone of cardiovascular prevention for general population, and in patients with type 2 diabetes mellitus (T2DM). However, statin therapy predisposes to type 2 diabetes, particularly in patients with predisposition to this condition. Some statins have been associated with increases in blood glucose in patients with or without DM2, and others have shown to have neutral effects, varying from one another their glucose or diabetogenic capacity. In many statin trials the incidence of DM2 has not been systematically evaluated and others the power to detect differences between statins is lacking. Evidence highest quality available comes from the meta-analysis of controlled clinical trials. The only controlled clinical trial to evaluate the incidence of new-onset T2DM is the J-PREDICT conducted with pitavastatin in patients with abnormal glucose tolerance. Preliminary results of this study show that pitavastatin is associated with a significant decrease in the incidence of de novo T2DM compared to only modification lifestyle. Therefore, pitavastatin may be an appropriate therapeutic alternative of choice to reduce vascular risk in patients with T2DM or at risk of presenting it

[Statins diabetogenicity: are all the same? state of art]. / La diabetogenicidad de las estatinas: ¿son todas iguales? Estado de la cuestión.

Statins are the cornerstone of cardiovascular prevention for general population, and in patients with type 2 diabetes mellitus (T2DM). However, statin therapy predisposes to type 2 diabetes, particularly in patients with predisposition to this condition. Some statins have been associated with increases in blood glucose in patients with or without DM2, and others have shown to have neutral effects, varying from one another their glucose or diabetogenic capacity. In many statin trials the incidence of DM2 has not been systematically evaluated and others the power to detect differences between statins is lacking. Evidence highest quality available comes from the meta-analysis of controlled clinical trials. The only controlled clinical trial to evaluate the incidence of new-onset T2DM is the J-PREDICT conducted with pitavastatin in patients with abnormal glucose tolerance. Preliminary results of this study show that pitavastatin is associated with a significant decrease in the incidence of de novo T2DM compared to only modification lifestyle. Therefore, pitavastatin may be an appropriate therapeutic alternative of choice to reduce vascular risk in patients with T2DM or at risk of presenting it.

Efectividad y satisfacción del tratamiento de la dislipidemia con pitavastatinastudio observacional, postautorización, descriptivo y multicéntrico (estudio REINA) / Effectivity and satisfaction with the treatment for dyslipidemia with pitavastatin. Multicentric, descriptive, post authorised and observational study (REINA study)

Introducción: Evaluar la adherencia terapéutica y la satisfacción del paciente con el tratamiento son medidas a considerar para optimizar el control lipídico. El estudio REINA evalúa el grado de satisfacción en pacientes dislipidémicos tratados con pitavastatina. Métodos Estudio observacional, descriptivo, transversal y multicéntrico de ámbito nacional. Se recogieron los siguientes datos: test Morisky-Green y TSQM-9 de pacientes mayores de 18 años con dislipidemia tratada con pitavastatina en las últimas 12 semanas. Resultados Se estudiaron 6.489 pacientes (60,0% varones) de atención primaria (52,7%) y especializada (47,3%), con edad media de 60,9 ± 11,2 años, mediante muestreo aleatorizado. El 72,3% de los pacientes consiguieron un adecuado control con 2 mg/día de pitavastatina. La satisfacción global con la medicación fue de 73,20 (IC 95%: 58,17-87,23) puntos. Los pacientes cumplidores (65%) presentaron mejores datos de satisfacción tomando la medicación (77,70 [IC 95%: 65,20-90,20]), están globalmente más satisfechos (75,00 [IC 95%: 61,50-88,50]) y su satisfacción fue mayor con la eficacia de la medicación (72,50 [IC 95%: 57,70-87,30]) que los no cumplidores (72,70 [IC 95%: 59,30-85,74]; 68,5 [IC 95%: 53,20-83,80] y 67,80 [IC 95%: 53,70-81,90], respectivamente), p < 0,0001, sin diferencias entre los 2 sistemas asistenciales. Conclusiones: La valoración de la satisfacción es un indicador indispensable en la evaluación de servicios dispensados en salud. Los usuarios con mayor grado de satisfacción presentan una mejor adherencia terapéutica, siendo esta relación bidireccional. Las personas satisfechas y cumplidoras obtienen mejores resultados clínicos. Pitavastatina constituye una eficaz alternativa terapéutica en pacientes con dislipidemia

Introduction: Evaluating the therapeutical adherence as well as the patient' satisfaction with the treatment should be considered to optimize lipidic control. The REINA Study evaluates the grade of satisfaction in dyslipidemic patients treated with pitavastatin. Methods: The current study was observational, descriptive, transversal and multi-centric with patients from our country only. The following data were collected in each case: Morisky-Green test and TSQM-9 for patients older than 18years old, with dyslipidemia treated with pitavastatin in the last 12 weeks. Results: We studied 6,489 patients (60.0% males) from Primary Health (52.7%) and Specialised Health (47.3%), with age (mean) = 60.9 ± 11.2 years by aleatory sampling. 72.3% of patients achieved an adequate control with 2 mg/day of pitavastatin. General satisfaction with the treatment was 73.20 points (95% CI: 58.17-87.23). Patients who followed the treatment (65%) showed better data of satisfaction with the drug (77.70 [95% CI: 65.20-90.20]), of global satisfaction (75.00 [95% CI: 61.50-88.50]) and their satisfaction with the drug efficiency was higher (72.50 [95% CI: 57.70-87.30]) than in the patients who did not finish the treatment (72.70 [95% CI: 59.30-85.74]; 68.5 [95% CI: 53.20-83.80] and 67.80 [95%CI: 53.70-81.90], respectively), P < .0001, without any difference between the two primary care systems. Conclusions: The validation of the satisfaction is a crucial indicator in the evaluation of the services offered in health. Patients with the highest grade of satisfaction present better therapeutical adherence, and such a relation is bidirectional. The individuals who are satisfied and who followed the treatment obtained better clinical results. Pitavastatin is an effective therapeutic alternative for patients with dyslipidemia

[Effectivity and satisfaction with the treatment for dyslipidemia with pitavastatin. Multicentric, descriptive, post authorised and observational study (REINA study)]. / Efectividad y satisfacción del tratamiento de la dislipidemia con pitavastatinastudio observacional, postautorización, descriptivo y multicéntrico (estudio REINA).

INTRODUCTION: Evaluating the therapeutical adherence as well as the patient' satisfaction with the treatment should be considered to optimize lipidic control. The REINA Study evaluates the grade of satisfaction in dyslipidemic patients treated with pitavastatin. METHODS: The current study was observational, descriptive, transversal and multi-centric with patients from our country only. The following data were collected in each case: Morisky-Green test and TSQM-9 for patients older than 18 years old, with dyslipidemia treated with pitavastatin in the last 12 weeks. RESULTS: We studied 6,489 patients (60.0% males) from Primary Health (52.7%) and Specialised Health (47.3%), with age (mean) = 60.9 ± 11.2 years by aleatory sampling. 72.3% of patients achieved an adequate control with 2mg/day of pitavastatin. General satisfaction with the treatment was 73.20 points (95% CI: 58.17-87.23). Patients who followed the treatment (65%) showed better data of satisfaction with the drug (77.70 [95% CI: 65.20-90.20]), of global satisfaction (75.00 [95% CI: 61.50-88.50]) and their satisfaction with the drug efficiency was higher (72.50 [95% CI: 57.70-87.30]) than in the patients who did not finish the treatment (72.70 [95% CI: 59.30-85.74]; 68.5 [95% CI: 53.20-83.80] and 67.80 [95% CI: 53.70-81.90], respectively), P < .0001, without any difference between the two primary care systems. CONCLUSIONS: The validation of the satisfaction is a crucial indicator in the evaluation of the services offered in health. Patients with the highest grade of satisfaction present better therapeutical adherence, and such a relation is bidirectional. The individuals who are satisfied and who followed the treatment obtained better clinical results. Pitavastatin is an effective therapeutic alternative for patients with dyslipidemia.

Atención farmacéutica del paracetamol: ¿tienen sentido en España las medidas británicas? Razonamientos, opinión y debate / No disponible

El paracetamol figura entre los fármacos más comunes de la Atención Farmacéutica. En los últimos años las autoridades sanitarias de varios países occidentales han advertido de los riesgos del paracetamol asociados a un uso inadecuado, así como de la gravedad de las intoxicaciones por paracetamol. En Gran Bretaña, en 1998, se legislaron unas medidas restrictivas para evitar el fácil acceso y racionalizar su uso. Publicaciones recientes han valorado tales medidas como muy positivas. Esta revisión pretende revisar el problema del uso indiscriminado del fármaco en cuestión en nuestro país y el papel de la Atención Farmacéutica en el manejo racional desde una perspectiva objetiva, sustentada por la evidencia científica (AU)

Paracetamol is one of the most common drugs of the Pharmaceutical care. In the last years health authorities in several western countries warned about the risks of paracetamol associated to an inadequate use, as well as about the severity of paracetamol poisoning. In Great Britain, in 1998, restrictive measures were legislated to avoid the easy access and to rationalize their use. Recent publications have evaluated such measures very positively. This revision tries to review the problem of the indiscriminate use of this compound, in our country and, the role of the Pharmaceutical Care in the rational management from an evidence based perspective (AU)