Obesity is associated with a higher prevalence of musculoskeletal pain in middle-aged women.

Musculoskeletal pain (MSP) has been recently linked with high plasma leptin levels. Our objective was to study if obese women, who have higher leptin levels, could have a higher frequency of MSP. We studied 6079 Latin-American women, 40-59 years old. Their epidemiological data were recorded and the Menopause Rating Scale (MRS), Golberg Anxiety and Depression Scale and Insomnia Scale were applied. MSP was defined as a score ≥2 on MRS11. Women with MSP were slightly older, had fewer years of schooling and were more sedentary. They also complained of more severe menopausal symptoms (29.2% versus. 4.4%, p < 0.0001). Furthermore, they had a higher abdominal perimeter (87.2 ± 12.0 cm versus 84.6 ± 11.6 cm, p < 0.0001) and a higher prevalence of obesity (23.1% versus 15.2%, p < 0.0001). Compared to normal weight women, those with low body weight (IMC <18.5) showed a lower risk of MSP (OR 0.71; 95%CI, 0.42-1.17), overweight women had a higher risk (OR 1.64; 95%CI, 1.44-1.87) and obese women the highest risk (OR 2.06; 95%CI, 1.76-2.40). Logistic regression analysis showed that obesity is independently associated to MSP (OR 1.34; 95%CI, 1.16-1.55). We conclude that obesity is one identifiable risk factor for MSP in middle-aged women.

[Clinical practice guideline for the diagnosis and treatment of hyperprolactinemia]. / Guía de práctica clínica para el diagnóstico y tratamiento de la hiperprolactinemia.

BACKGROUND: Hyperprolactinemia is a common finding within clinical practice in both endocrinology and general practice fields, amongst other specialties. The general practitioner and other specialists must know the indications and serum prolactin determination parameters in order to, once detected, derive the patient for a correct assessment and begin treatment. OBJECTIVE: Formulate a clinical practice guideline evidence-based for the diagnosis and treatment of hyperprolactinemia. METHOD: It took the participation of eight gynecologists, two pathologists and a pharmacologist in the elaboration of this guideline due their experience and clinical judgement. These recommendations were based upon diagnostic criteria and levels of evidence from treatment guidelines previously established, controlled clinical trials and standardized guides for adolescent and adult population with hyperprolactinemia. RESULTS: During the conformation of this guideline each specialist reviewed and updated a specific topic and established the evidence existent over different topics according their field of best clinical expertise, being enriched by the opinion of other experts. At the end, all the evidence and decisions taken were unified in the document presented here. CONCLUSIONS: It is presented the recommendations established by the panel of experts for diagnosis and treatment of patients with high levels of prolactin; also the level of evidence for the diagnosis of hyperprolactinemia, handling drug-induced hyperprolactinemia and prolactinomas in pregnant and non-pregnant patients.

An individualized approach to the management of vaginal atrophy in Latin America.

OBJECTIVE: In the absence of guidelines specific for Latin America, a region where the impact of menopause is becoming increasingly important, an evidence-based specialist opinion on management of vaginal atrophy will help improve outcomes. METHODS: An advisory board meeting was convened in São Paulo, Brazil, to discuss practical recommendations for managing vaginal atrophy in women in Latin America. Before the meeting, physicians considered various aspects of the condition, summarizing information accordingly. This information was discussed during the meeting. The expert consensus is now summarized. RESULTS: In Latin America, given the relatively early age of menopause, it will be beneficial to raise awareness of vaginal atrophy among women before they enter menopause, considering cultural attitudes and involving partners as appropriate. Women should be advised about lifestyle modifications, including attention to genital hygiene, clothing, and sexual activity, and encouraged to seek help as soon as they experience vaginal discomfort. Although treatment can be started at any time, prompt treatment is preferable. A range of treatments is available. By addressing the underlying pathology, local estrogen therapy can provide effective symptom relief, with choice of preparation guided by patient preference. An individualized treatment approach should be considered, giving attention to patients' specific situations. CONCLUSIONS: It is critical that women are empowered to understand vaginal atrophy. Educating women and healthcare providers to engage in open dialogue will facilitate appreciation of the benefits and means of maintaining urogenital health, helping to improve outcomes in middle age and beyond. Women should receive this education before menopause.

Impaired quality of life among middle aged women: a multicentre Latin American study.

BACKGROUND: Several studies indicate that quality of life (QoL) is impaired in middle aged women. Assessment of QoL using a single validated tool in Latin American climacteric women has not been reported to date at large scale. OBJECTIVE: The Menopause Rating Scale (MRS) was used to assess QoL among middle aged Latin American women and determine factors associated with severe menopausal symptoms (QoL impairment). METHODS: In this cross-sectional study, 8373 healthy women aged 40-59 years, accompanying patients to healthcare centres in 18 cities of 12 Latin American countries, were asked to fill out the MRS and a questionnaire containing socio-demographic, female and partner data. RESULTS: Mean age of the entire sample was 49.1+/-5.7 years (median 49), a 62.5% had 12 or less years of schooling, 48.8% were postmenopausal and 14.7% were on hormonal therapy (HT). Mean total MRS score (n=8373) was 11.3+/-8.5 (median 10); for the somatic subscale, 4.1+/-3.4; the psychological subscale, 4.6+/-3.8 and the urogenital subscale, 2.5+/-2.7. The prevalence of women presenting moderate to severe total MRS scorings was high (>50%) in all countries, Chile and Uruguay being the ones with the highest percentages (80.8% and 67.4%, respectively). Logistic regression determined that impaired QoL (severe total MRS score > or =17) was associated with the use of alternatives therapies for menopause (OR: 1.47, 95% CI [1.22-1.76], p=0.0001), the use of psychiatric drugs (OR: 1.57, 95% CI [1.29-1.90], p=0.0001), attending a psychiatrist (OR: 1.66, 95% CI [1.41-1.96], p=0.0001), being postmenopausal (OR: 1.48, 95% CI [1.29-1.69, p=0.0001]), having 49 years or more (OR: 1.24, 95% CI [1.08-1.42], p=0.001), living at high altitude (OR: 1.43, 95% CI [1.25-1.62, p=0.0001]) and having a partner with erectile dysfunction (OR: 1.69, 95% CI [1.47-1.94, p=0.0001]) or premature ejaculation (OR: 1.34, 95% CI [1.16-1.55, p=0.0001]). Lower risk for impaired QoL was related to living in a country with a lower income (OR: 0.77, 95% CI [0.68-0.88], p=0.0002), using HT (OR: 0.65, 95% CI [0.56-0.76], p=0.0001) and engaging in healthy habits (OR: 0.59, 95% CI [0.50-0.69], p=0.0001). CONCLUSION: To the best of our knowledge this is the first and largest study assessing QoL in a Latin American climacteric series with a high prevalence of impairment related to individual female and male characteristics and the demography of the studied population.

[Mixed vaginitis prevalence in Latin-American women, according to physician perception. Preference, effectiveness and security of clindamycin plus ketoconazole]. / Prevalencia de vaginitis mixta en mujeres latinoamericanas según la percepción de los médicos. Preferencia, efectividad e inocuidad de clindamicina más ketoconazol.

BACKGROUND: Vaginitis is an inflammatory process in vaginal mucosa that affects millions of woman worldwide. OBJECTIVE: To evaluate prevalence perception and prescription preference among Latin-American gyneco-obstetricians in mixed vaginitis, and to identify attributes of various active principles. MATERIAL AND METHODS: multicentric and transversal study during January 2008. Close Up was used to poll gyneco-obstetricians prescribing clyndamicin plus ketoconazole. 1,198 gyneco-obstetricians were selected to answer a poll (scales and measuring attributes) to identify differences among various therapeutic schemes to mixed vaginitis. RESULTS: 34% of gyneco-obstetricians consider that 30 to 50% of them patients had mixed vaginitis, 38% consider a 50 to 70% of its prevalence, and 20% a 70% or higher figure. In a bad to excellent scale, 97% had very good to excellent results with antimycotic and antibacterial mix, 73% had a bad to good result with antimycotics alone and 79% with antibacterial alone. Clyndamicin plus ketoconazole had a meaningful difference from mean results (standard), and from the second best mix (metronidazole plus nystatin), with a rapid itch healing, efficacy, and relapse decrease. Metronidazole plus nystatin had the highest score in tolerance and treatment period. CONCLUSION: 90% of polled Latin-American obstetricians prescribe clyndamicin plus ketoconazole as the best available treatment to mixed vaginitis.

Association between waist-to-height ratio and anxiety in middle-aged women: a secondary analysis of a cross-sectional multicenter Latin American study.

OBJECTIVE: The aim of the study was to evaluate the association between waist-to-height ratio (WHtR) and anxiety in middle-aged women. METHODS: We carried out a secondary analysis of data from a multicenter study of women between 40 and 59 years old from 11 Latin America countries. Anxiety was assessed using the Goldberg Anxiety and Depression Scale. WHtR was calculated according to World Health Organization standards and categorized in tertiles: upper, middle, and lower using 0.45 and 0.6 as cutoff values. Prevalence ratios (PRs) and 95% CIs were calculated by generalized linear models of Poisson family with robust standard errors, both crude and adjusted models based on statistical and epidemiological criteria. RESULTS: Data of a total of 5,580 women were analyzed. Mean age was 49.7 ±â€Š5.5 years, and 57.9% were postmenopausal. The 61.3% of women had anxiety and mean WHtR was 0.54 ±â€Š0.1. In the crude model, compared with women in lower tertile, those in the middle (PR: 1.07; 95% CI, 1.01-1.13) and upper (PR: 1.23 95% CI, 1.07-1.29) WHtR tertile were significantly more likely to have anxiety. In the adjusted models, only women in upper tertile were, however, more likely of displaying anxiety than those in lower tertile (PR: 1.13; 95% CI, 1.08-1.18). CONCLUSIONS: In this series, WHtR was associated with anxiety in middle-aged women. It is advisable to further study this anthropometric measure in order for it to be incorporated in the routine clinical practice and evaluation of middle-aged women.

Association between anxiety and severe quality-of-life impairment in postmenopausal women: analysis of a multicenter Latin American cross-sectional study.

OBJECTIVE: To evaluate associations between anxiety and severe impairment of quality of life (QoL) in Latin American postmenopausal women. METHODS: This was a secondary analysis of a multicenter cross-sectional study among postmenopausal women aged 40 to 59 from 11 Latin American countries. We evaluated anxiety (The Goldberg Depression and Anxiety Scale), and QoL (Menopause Rating Scale [MRS]), and included sociodemographic, clinical, lifestyle, and anthropometric variables in the analysis. Poisson family generalized linear models with robust standard errors were used to estimate prevalence ratios (PRs) and 95% CIs. There were two adjusted models: a statistical model that included variables associated with the outcomes in bivariate analyses, and an epidemiologic model that included potentially confounding variables from literature review. RESULTS: Data from 3,503 women were included; 61.9% had anxiety (Goldberg). Severe QoL impairment (total MRS score ≥17) was present in 13.7% of women, as well as severe symptoms (MRS subscales): urogenital (25.5%), psychological (18.5%), and somatic (4.5%). Anxiety was independently associated with severe QoL impairment and severe symptoms in the epidemiological (MRS total score: PR 3.6, 95% CI, 2.6-5.0; somatic: 5.1, 95% CI, 2.6-10.1; psychological: 2.8, 95% CI, 2.2-3.6; and urogenital: 1.4, 95% CI, 1.2-1.6) and the statistical model (MRS total score: PR 3.5, 95% CI, 2.6-4.9; somatic: 5.0, 95% CI, 2.5-9.9; psychological: 2.9, 95% CI, 2.2-3.7; and urogenital: 1.4; 95% CI, 1.2-1.6). CONCLUSIONS: In this postmenopausal Latin American sample, anxiety was independently associated with severe QoL impairment. Hence, screening for anxiety in this population is important.

Age at menopause in Latin America.

OBJECTIVE: To assess the age at menopause (AM) in Latin America urban areas. DESIGN: A total of 17,150 healthy women, aged 40 to 59 years, accompanying patients to healthcare centers in 47 cities of 15 Latin American countries, were surveyed regarding their age, educational level, healthcare coverage, history of gynecological surgery, smoking habit, presence of menses, and the use of contraception or hormone therapy at menopause. The AM was calculated using logit analysis. RESULTS: The mean age of the entire sample was 49.4 +/- 5.5 years. Mean educational level was 9.9 +/- 4.5 years, and the use of hormone therapy and oral contraception was 22.1% and 7.9%, respectively. The median AM of women in all centers was 48.6 years, ranging from 43.8 years in Asuncion (Paraguay) to 53 years in Cartagena de Indias (Colombia). Logistic regression analysis determined that women aged 49 living in cities at 2,000 meters or more above sea level (OR = 2.0, 95% CI: 1.4-2.9, P < 0.001) and those with lower educational level (OR = 1.9, 95% CI: 1.3-2.8, P < 0.001) or living in countries with low gross national product (OR = 2.1, 95% CI: 1.5-2.9, P < 0.001) were more prone to an earlier onset of menopause. CONCLUSIONS: The AM varies widely in Latin America. Lower income and related poverty conditions influence the onset of menopause.

Sedentary lifestyle in middle-aged women is associated with severe menopausal symptoms and obesity.

OBJECTIVE: The aim of the study was to evaluate the association between sedentary lifestyle and the severity of menopausal symptoms and obesity in middle-aged women. METHODS: The Menopause Rating Scale, the Goldberg Anxiety and Depression Scale, and the Athens Insomnia Scale were administered to 6,079 Latin American women aged 40 to 59 years. Sedentary lifestyle was defined as fewer than three weekly, 30-minute periods of physical activity. RESULTS: Sedentary women had more severe menopausal symptoms (total Menopause Rating Scale score: 9.57 ±â€Š6.71 vs 8.01 ±â€Š6.27 points, P < 0.0001) and more depressive symptoms (Goldberg), anxiety (Goldberg), and insomnia (Athens Scale) compared with non-sedentary women. They also had greater mean waist circumference (86.2 ±â€Š12.3 vs 84.3 ±â€Š1.8 cm, P < 0.0001) and a higher prevalence of obesity (20.9% vs 14.3%, P < 0.0001). Logistic regression analysis showed that both obesity (odds ratio [OR] 1.52; 95% CI, 1.32-1.76) and severe menopausal symptoms (OR 1.28; 95% CI, 1.06-1.53), including insomnia and depressive mood, were positively associated with a sedentary lifestyle. Having a stable partner (OR 0.85; 95% CI, 0.76-0.96), using hormone therapy (OR 0.75; 95% CI, 0.64-0.87) and having a higher educational level (OR 0.66; 95% CI, 0.60-0.74) were negatively related to sedentary lifestyle. CONCLUSIONS: There was a high prevalence of sedentary lifestyle in this middle-aged Latin American female sample which was associated with more severe menopausal symptoms and obesity.

Obesity and its relation to depressive symptoms and sedentary lifestyle in middle-aged women.

BACKGROUND: The prevalence of obesity increases during female mid-life and although many factors have been identified, data from Latin America is lacking. OBJECTIVE: To assess factors related to obesity among middle-aged women and determine the association with depressive symptoms, sedentary lifestyle and other factors. METHODS: A total of 6079 women aged 40-59 years of 11 Latin American countries were asked to fill out the Goldberg Anxiety and Depression Scale, the Menopause Rating Scale, the Athens Insomnia Scale, the Pittsburgh Sleep Quality Index and a general questionnaire containing personal socio-demographic data, anthropometric measures and lifestyle information. Obesity was defined as a body mass index (BMI) ≥30 kg/m(2). RESULTS: Obesity was observed in 18.5% and sedentary lifestyle in 63.9%. A 55.5% presented vasomotor symptoms, 12.2% had severe menopausal symptoms and 13.2% used hormone therapy for the menopause. Prevalence of depressive symptoms was 46.5% and anxiety 59.7%. Our logistic regression model found that significant factors associated to obesity included: arterial hypertension (OR: 1.87), depressive symptoms (OR: 1.57), sedentary lifestyle (OR: 1.50) diabetes mellitus (OR: 1.34), higher number of individuals living at home (OR: 1.31), sleep problems (OR:1.22), anxiety (OR: 1.21), having a stable partner (OR: 1.20), parity (OR: 1.16) and vasomotor symptoms (OR:1.14). A lower risk for obesity was found among women using hormonal contraceptives (OR: 0.69). CONCLUSION: Obesity in middle-aged women is the consequence of the interaction of multiple factors. It was associated to hypertension, depressive symptoms, sedentary lifestyle, climacteric symptoms and other factors.

Menopause could be involved in the pathogenesis of muscle and joint aches in mid-aged women.

BACKGROUND: Muscle and joint aches (MJA) are frequently observed among menopausal women. They impair quality of life and are a burden to the healthcare system. OBJECTIVE: To analyze the relation between MJA and several variables related to the menopause. METHODS: In this cross-sectional study, 8373 healthy women aged 40-59 years, accompanying patients to healthcare centers in 18 cities of 12 Latin American countries, were asked to fill out the Menopause Rating Scale (MRS) and a questionnaire containing personal data. RESULTS: Mean age of the whole sample was 49.1±5.7 years, 48.6% were postmenopausal and 14.7% used hormone therapy (HT). A 63.0% of them presented MJA, with a 15.6% being scored as severe to very severe according to the MRS (scores 3 or 4). Logistic regression model determined that vasomotor symptoms (OR: 6.16; 95% CI, 5.25-7.24), premature menopause (OR: 1.58; 95% CI, 1.02-2.45), postmenopausal status (OR: 1.43; 95% CI, 1.20-1.69), psychiatric consultation (OR: 1.93; 95% CI, 1.60-2.32) and the use of psychotropic drugs (OR: 1.35; 95% CI, 1.08-1.69) were significantly related to the presence of severe-very severe MJA. Other significant variables included: age, tobacco consumption and lower education. Self perception of healthiness (OR: 0.49; 95% CI, 0.41-0.59), private healthcare access (OR: 0.77; 95% CI, 0.67-0.88) and HT use (OR: 0.75; 95% CI, 0.62-0.91) were significantly related to a lower risk for the presence of severe-very severe MJA. CONCLUSION: In this large mid-aged sample the prevalence of MJA was high, which was significantly associated to menopausal variables, especially vasomotor symptoms. This association may suggest a potential role of mid-life female hormonal changes in the pathogenesis of MJA.

A multinational study of sleep disorders during female mid-life.

BACKGROUND: Although sleep disturbances are common during female mid-life, few studies have described in detail the prevalence of this problem and related risk factors. OBJECTIVE: To determine the prevalence of sleep disturbances in mid-aged women using validated tools. Assessment of determinants capable of influencing the prevalence of insomnia and poor sleep quality was also performed. METHODS: A total of 6079 women aged 40-59 of 11 Latin American countries were invited to fill out the Athens Insomnia Scale (AIS), the Pittsburgh Sleep Quality Index (PSQI), the Goldberg Anxiety and Depression Scale, the Menopause Rating Scale (MRS), the Brief Scale of Abnormal Drinking and a general socio-demographic questionnaire. RESULTS: Overall, 56.6% of surveyed women suffered of either insomnia, poor sleep quality, or both. Specifically, 43.6% and 46.2% presented insomnia and poor sleep quality in accordance to the AIS and the PSQI respectively. The prevalence of insomnia increased with female age (from 39.7% in those aged 40-44 to 45.2% in those aged 55-59, p<0.0001) and menopausal stage (from 39.5% in premenopausal aged 40-44 to 46.3% in late postmenopausal ones, p<0.0001). "Awakening during the night" (AIS: Item 2) was the most highly rated of all items and contributing in a higher degree (mean 16%) to the total score of the scale in all menopausal phases. Sleep quality also worsened with age and menopausal status, impairment particularly affecting sleep efficiency and latency and the increased use of hypnotics. Vasomotor symptoms (VMS), depressive mood and anxiety were associated to sleep disturbances. Women presenting sleep disturbances displayed a 2-fold increase in the severity of menopausal symptoms (higher total MRS scores) which was translated into a 6-8 times higher risk of impaired quality of life. Logistic regression analysis determined that female age, the presence of chronic disease, troublesome drinking, anxiety, depression, VMS, drug use (hypnotics and hormone therapy) were significant risk factors related to the presence of sleep disturbances. Higher educational level related to less insomnia and better sleep quality. CONCLUSION: Insomnia and poor sleep quality were highly prevalent in this mid-aged female sample in which the influence of age and the menopause was only modest and rather linked to menopausal symptoms already occurring since the premenopause.

A large multinational study of vasomotor symptom prevalence, duration, and impact on quality of life in middle-aged women.

OBJECTIVE: The aim of this study was to determine vasomotor symptom (VMS) prevalence, duration, and impact on quality of life in middle-aged women using a validated menopausal tool. METHODS: The Menopause Rating Scale (MRS) and an itemized questionnaire containing personal sociodemographic data were used to examine 8,373 women aged 40 to 59 years from 22 healthcare centers in 12 Latin American countries. RESULTS: Less than half (48.8%) of all women studied were postmenopausal, 14.7% used hormone therapy (HT), 54.5% presented VMS of any degree, and 9.6% presented severe/bothersome symptoms. The rate of VMS (any degree) significantly increased from one menopausal stage to the next. HT users presented more VMS (any degree) than did nonusers (58.6% vs 53.8%, P = 0.001). When surgical postmenopausal women were compared, non-HT users displayed a higher prevalence of severe VMS (16.1% vs 9.0%, P = 0.0001). The presence of VMS of any degree was related to a more impaired quality of life (higher total MRS score; odds ratio, 4.7; 95% CI, 4.1-5.3). This effect was even higher among women presenting severe VMS. Logistic regression analysis determined that the presence of severe psychological/urogenital symptoms (MRS), lower educational level, natural perimenopause-postmenopause status, nulliparity, surgical menopause, and living at high altitude were significant risk factors for severe VMS. HT use was related to a lower risk. A second regression model determined that surgical menopause, intense psychological/urogenital symptoms, and a history of psychiatric consultation were factors related to severe VMS persisting into the late postmenopausal stage (5 or more years). CONCLUSIONS: In this Latin American middle-aged series, VMS prevalence was high, persisting into the late postmenopausal phase in a high rate and severely impairing quality of life. HT use was related to a lower risk of severe VMS.

Aspectos fisiopatológicos del síndrome de amenorrea galactorrea-normoprolactinémico / The physiopathological aspects of teh normoprolactinemic amenorrhea-galactorrhea syndrome

Para entender en parte la fisiopatología de mujeres con amenorrea-galactorrea-normoprolactinémica (Grupo I: N=5), se establecieron comparaciones Vs. Mujeres con moderada (II; N = 4) y severa hiperprolactinemia y evidencia de tumor (III; N = 4). Se midio PRL y LH en condiciones basales y se valoró la influencia indirecta de dopamina (DA) sobre hipófisis e hipotálamo al emplear un bloqueador a nivel de receptor de DA, metoclopramida (MCP). Fue evidente una mayor disponibilidad de DA a nivel de los lactótropos, ya que después de MCP el grupo I incremento enormemente los niveles de prolactina (PRL), aunque los niveles de PRL basales eran normales. Indirectamente y por la respuesta de LH se detectó una influencia negativa de DA sobre las neuronas productoras de hormona liberadora de gonadotropinas (GnRH) ya que MCP incremento LH en los tres grupos (mayor en I y III) lo cual ha sido relacionado a un mayor recambio de DA a nivel tuberoinfundibular propio de los estados hiperprolactinémicos. La respuesta de LH - PRL a bromocriptina no mostro diferencias que consignar en ninguno de los tres grupos

Efecto analgésico antiespasmódico y seguridad del clonixinato de lisina y bromuro de L-Butilhioscina en el tratamiento oral de la dismenorrea / Antispasmodic-analgesic effect and safety of Lysene clonixinate and Butylhioscine broide for dysmenorrhea oral treatment

Fue realizado un estudio clínico longitudinal abierto, no comparativo, en 30 mujeres con diagnóstico de dismenorrea primaria o secundaria a dispositivo intrauterino. El objetivo del estudio fue evaluar la eficacia y seguridad del compuesto terapéutico, Clonixinato de lisina y Bromuro de butihioscina 125 y 10 mg respectivamente, en cápsulas, durante un periodo de observación de tres ciclos menstruales. El tiempo de evolución de la dismenorrea primaria fue de 4.46 años; para la secundaria fue de 1.77 años. A la dismenorrea le acompañaron síntomas asociados como: náusea 92 por ciento, vómito 92 por ciento, malestar general 82.1 por ciento, pesantez abdominales 85.7 por ciento y cefalea 46.4 por ciento. Respecto a la intensidad del dolor menstrual, al inicio fue muy severo en el 10.7 por ciento, severo en 42.9 por ciento y moderado 46.4 por ciento. Al final del estudio sólo una paciente de las 28, presentó dolor menstrual de intensidad moderada. Encontramos sólo tres menciones de efectos secundarios de intensidad leve y que no requirieron tratamiento; que correspondieron a dos menciones de gastralgía y una de somnolencia. La conclusión del estudio es que la asociación analgésica espasmolítica del Clonixinato de lisina y Bromuro de butilhioscina en el tratamiento de la dismenorrea primaria o secundaria, reduce y previene el dolor menstrual, así como las manifestaciones asociadas con pocos efectos secundarios. Esta asociación analgésica espasmolítica, es eficaz y segura