Long-term Pharmacological Therapy Research Articles

Procognitive, Anxiolytic, and Antidepressant-like Properties of Hyperoside and Protocatechuic Acid Corresponding with the Increase in Serum Serotonin Level after Prolonged Treatment in Mice.

Two polyphenols-hyperoside (HYP) and protocatechuic acid (PCA) were reported to exert antidepressant activity in rodents after acute treatment. Our previous study also showed that this activity might have been influenced by the monoaminergic system and the upregulation of the brain-derived neurotropic factor (BDNF) level. A very long-term pharmacological therapy is required for the treatment of a patient with depression. The repetitive use of antidepressants is recognized to impact the brain structures responsible for regulating both emotional and cognitive behaviors. Thus, we investigated the antidepressant, anxiolytic, and procognitive effects of HYP and PCA in mice after acute and prolonged treatment (14 days). Both polyphenols induced an anxiogenic-like effect after acute treatment, whereas an anxiolytic effect occurred after repetitive administration. PCA and HYP showed procognitive effects when they were administered acutely and chronically, but it seems that their influence on long-term memory was stronger than on short-term memory. In addition, the preset study showed that the dose of 7.5 mg/kg of PCA and HYP was effective in counteracting the effects of co-administered scopolamine in the long-term memory impairment model induced by scopolamine. Our experiments revealed the compounds have no affinity for 5-HT1A and 5-HT2A receptors, whereas a significant increase in serum serotonin level after prolonged administration of PCA and HYP at a dose of 3.75 mg/kg was observed. Thus, it supports the involvement of the serotonergic system in the polyphenol mechanisms. These findings led us to hypothesize that the polyphenols isolated from Impatiens glandulifera can hold promise in treating mental disorders with cognitive dysfunction. Consequently, extended studies are necessary to delve into their pharmacological profile.

The role of magnetic sphincter augmentation in the gastroesophageal reflux disease treatment pathway: the gastroenterology perspective.

Magnetic sphincter augmentation (MSA) is a surgical intervention for well-characterized gastroesophageal reflux disease (GERD), where the esophagogastric junction barrier is augmented using a bracelet of magnetized titanium beads. MSA could be an attractive option for patients with documented GERD who wish to avoid long-term pharmacologic therapy or whose symptoms are not adequately managed with lifestyle modifications and pharmacologic therapy. The 'ideal' MSA patient is one with prominent regurgitation, without dysphagia or esophageal motor dysfunction, with objective evidence of GERD on upper endoscopy and/or ambulatory reflux monitoring. Appropriate candidates with significant hiatus hernia may pursue MSA with concomitant hiatus hernia repair. The increasing adoption of MSA in the GERD treatment pathway reflects research that shows benefits in long-term outcomes and healthcare costs compared with other established therapies in appropriate clinical settings.

A randomized controlled trial evaluating the effectiveness of a self-management program for adolescents with a chronic condition: a study protocol

BackgroundSelf-management support is increasingly viewed as an integral part of chronic condition management in adolescence. It is well recognized that markers of chronic illness control deteriorate during adolescence. Due to the increasing prevalence of long-term chronic health conditions in childhood and improved survival rates of previously life-limiting conditions in children and adolescents, significant numbers of adolescents are having to manage their chronic condition effectively as they transition to adult health care. Therapy adherence has been identified as a major challenge for young people living with a chronic condition such as cystic fibrosis, diabetes, or asthma requiring long-term pharmacological therapy and/or lifestyle modifications. Most systematic reviews on self-management interventions address adult populations. Very few intervention studies are directed at adolescents with a chronic condition who are transitioning to adult health services. This protocol describes a prospective randomized controlled trial of a standardized self-management intervention program delivered to adolescents aged 15–18 years prior to their transfer to adult care. This study has been designed to provide evidence regarding self-management programs for adolescents and is the first study to use the Flinders Program with this important, under-researched age group.MethodsA randomized controlled trial is used to investigate the effectiveness of a modified adolescent-friendly version of an adult self-management program. This program is directed at improving self-management in an adolescent cohort 15–18 years of age with a chronic condition being treated in a specialist pediatric hospital. Participants will be randomized to either usual care or the modified Flinders Program plus usual care. Data collection will include measures of specific illness control, unscheduled hospital admissions, and questionnaires to record self-management competencies, quality of life, self-efficacy, and outcome measures specific to the chronic condition at baseline, 3 months, 6 months, and 12 months after delivery.DiscussionThis study will provide a better understanding of the elements required for effective self-management programs in adolescents with a chronic condition and address some important knowledge gaps in current literature. The study will be carried out in collaboration with the Discipline of Behavioural Health at Flinders University, Adelaide, Australia, in order to inform the development of an adolescent version of the successful and validated Flinders Program™.Trial registrationAustralian and New Zealand Clinical Trials Registry (ACTRN12621000390886). Registered on April 8, 2021.

Problemas relacionados à farmacoterapia e intervenções farmacêuticas em indivíduos com tuberculose

Introdução: A Tuberculose (TB) é uma doença infecciosa cujo longo período de terapia farmacológica contribui para o abandono do tratamento e desfechos negativos em saúde. O cuidado farmacêutico tem demonstrado otimizar a adesão ao tratamento e reduzir o número de problemas relacionados à farmacoterapia (PRF). Objetivo: Identificar PRF e traçar o perfil das intervenções farmacêuticas (IF) em indivíduos com tuberculose assistidos em uma instituição hospitalar. Métodos: Tratou-se de um estudo transversal, prospectivo, intervencional e com abordagem quantitativa, realizado no período de fevereiro a outubro de 2017. Para a definição do método a ser utilizado na classificação dos PRF e das IF, utilizaram-se as recomendações do Ministério da Saúde para a implantação de Serviços de Clínica Farmacêutica. As prescrições medicamentosas e os prontuários dos participantes também representaram fonte de coleta de dados. Resultados: Trinta e três indivíduos com idade média de 40,41 (±13) anos participaram do estudo. Um total de 278 PRF foi identificado, sendo os mais frequentes os problemas envolvendo seleção e prescrição (n=215; 77,3%) e reação adversa a medicamento (n=13; 4,7%). Foram realizadas 296 IF, especialmente informações e aconselhamentos (n=99; 33,5%) e manejo de interação medicamentosa (n=80; 27%). Conclusão: PRF foram comuns neste estudo, assim como a necessidade de IF, o que sugere que os serviços clínicos farmacêuticos possuem o potencial de contribuir com a equipe multiprofissional na identificação e manejo de problemas relacionados à farmacoterapia, contribuindo com o alcance de melhores desfechos em saúde em pacientes com tuberculose.

Sex-Specific Associations Between Bipolar Disorder Pharmacological Maintenance Therapies and Inpatient Rehospitalizations: A 9-Year Swedish National Registry Study.

Background: Long-term pharmacological maintenance therapy is often essential among people with bipolar disorder to reduce the need for inpatient care. Sex-specific responses to maintenance therapies are expected but remain largely unknown. Here, we examined for sex-specific associations between common maintenance therapies for bipolar disorder with inpatient rehospitalizations following patients' index discharges during 2006–2014.Methods: Population-based data on maintenance therapies and rehospitalizations were extracted from Swedish national registries. We adopted the within-individual design to compare the time on- vs. off- maintenance therapy for males and females, respectively. Extended stratified Cox proportional hazards regression models were employed to quantify the rate of rehospitalization as a function of common maintenance drugs and other important time-varying control variables.Results: Our primary analysis included 22,681 bipolar disorder rehospitalizations by 6,400 males and 9,588 (60.0%) females over an observation time of 62,813 person-years. The time spent on- vs. off- maintenance lithium, lamotrigine, quetiapine, or olanzapine was statistically significant upon adjustment among either sex for reducing the rate of bipolar rehospitalizations. Adjusted sex-specific statistically significant associations were also observed. Among females, the time on- (vs. off-) long-acting injectable risperidone reduced the rate of bipolar rehospitalizations by 73% (56–84%), carbamazepine by 44% (18–62%), aripiprazole by 29% (13–42%), and valproate by 23% (11–33%); whereas among males, ziprasidone by 65% (41–79%).Conclusion: The effectiveness of most maintenance therapies is generally comparable and uniform among both males and females. Despite some statistically significant sex-specific associations, estimates for each drug were fairly consistent between sexes.

Differences in the Incidence of Pathologic Lesions on the Oral Mucosa in Patients Undergoing Hemodialysis vs Renal Organ Transplant Recipients Subjected to Long-term Pharmacologic Immunosuppressive Therapy

Disorders of homeostasis and an increased incidence of infection in patients undergoing hemodialysis causes frequent appearance of pathologic changes in the oral mucosa. The organ transplant and subsequent pharmacologic immunosuppression may result in systemic disorders manifesting by pathologic oral lesions. MethodsThe study was conducted on 18 patients undergoing hemodialysis and 18 patients after renal transplant. The study comprised case taking and physical examination, including detailed intraoral and extraoral examination. ResultsThe intraoral examination revealed gingivitis in 61.1% of patients in both groups. In the renal transplant group compared with the hemodialysis group 55.6% vs 38.9% of patients had gingival recession, 55.6% vs 44.4% had periodontitis, 27.8% vs 22.2% had macroglossia, and 11.1% vs 5.6% had geographic tongue, respectively. In the patients on hemodialysis leukoplakia and pallor or pathologic pigmentation of oral mucosa were more frequently observed lesions. Other significant findings in the renal transplant group were lingual papillary atrophy, aphthae, and erythroplakia. Patients of both group reported xerostomia, halitosis, gum bleeding, dysgeusia in their history. DiscussionBoth groups of patients after renal transplant and patients undergoing hemodialysis presented pathologic lesions in the oral cavity. The study revealed the differences between type and frequency of these pathologic changes, which shows different effect of the above methods of treatment of end-stage renal failure on the oral cavity.

Current interventional management of gastroesophageal reflux disease

Gastroesophageal reflux disease (GERD) is a chronic condition with a tremendous negative impact on both health-related quality of life and healthcare resource utilization. It is also a progressive disease that may lead to Barrett’s esophagus and adenocarcinoma. In addition, more than one third of GERD patients are partially responders/ non-responders to proton-pump inhibitors and there is growing concern regarding the safety of long-term pharmacological therapy. Interventional therapy in these patients can be performed either through laparoscopy or flexible endoscopy. Both methods have the potential to reinforce the lower esophageal sphincter and to protect the esophageal mucosa from retrograde flow of both acid and alkaline gastric contents. However, a concomitant hiatal repair is feasible only through a laparoscopic approach.

Evaluation of β-endorphin concentration, mood, and pain intensity in men with idiopathic hip osteoarthritis treated with variable magnetic field.

Osteoarthritis is the most frequently diagnosed disease of the musculoskeletal system. Growing number of patients waiting for surgical treatment and the possible negative consequences resulting from long-term pharmacological therapy lead to the search for non-pharmacological methods aimed at alleviating pain and reducing doses of analgesics, among them physical therapy with use of magnetic fields.The study involved 30 men aged 49 to 76 (mean age, 61.7 years) treated for idiopathic osteoarthritis of the hip joint. The subjects were divided into 2 groups (15 patients each) and underwent a cycle of magnetostimulation and magnetoledtherapy procedures, respectively. During the exposure cycle concentrations of β-endorphin were assessed 3 times and the mood was assessed 2 times. In addition, the assessment of pain intensity and the dose of analgesic drugs was performed before and after the end of therapy.Statistically significant increase in plasma β-endorphins concentration was observed in both groups of patients (magnetostimulation—P < .01 vs magnetoledtherapy—P < .001). In the assessment of mood of respondents, no statistically significant differences were found. Significant reduction in intensity of perceived pain was observed in both groups of patients (P < .05). In the group of patients who underwent magnetoledtherapy cycle, the analgesic drug use was significantly lower by 13% (P < .05) as compared with initial values, which was not noted in group of patients who underwent magnetostimulation procedures.The use of magnetic field therapy in the treatment of men with idiopathic osteoarthritis of hip joints causes a statistically significant increase in the concentration of plasma β-endorphins resulting in statistically significant analgesic effect in both magnetostimulation and magnetoledtherapy treated groups of patients, with accompanying decrease of need for analgetic drugs in magnetoledtherapy group, but without any significant changes regarding the patient's mood.

Frequency of Human Papilloma Virus Occurrence Among Pathological Changes of the Oral Cavity in Kidney Allotransplant Recipients Undergoing Long-Term Pharmacological Immunosuppressive Therapy

Recipients of allotransplants are more susceptible to viral infections, among which the human papilloma virus infection is an independent factor inducing precancerous lesions and cancers of both the anogenital and the cervicocephalic region. Materials and methodsThe study included a group of 69 allogenic kidney transplantation recipients aged 20 to 70, who were treated with cyclosporine, azathioprine, and prednisone. The patients in whom the macroscopic examination of the oral mucosa revealed lesions were qualified for a biopsy. The infection with human papilloma virus (HPV) was confirmed by a histopathological examination and genotyping with the use of polymerase chain reaction (PCR) and Hybrid Capture II test. ResultsPapillomatous lesions in the oral cavity occurred in 36.1% of the research group participants. The HPV16 virus was the most common genotype in this group of patients (25%). The pathologic changes in the oral cavity were predominantly situated on the gingivae. In the group of transplant recipients, clinical changes resulting from HPV infection occurred within a period of 2 years following the transplantation.Cyclosporine used in the immunosuppression scheme has correlated in as many as 53.7% of cases of allogenic kidney transplant recipients with the appearance of clinical signs and symptoms of HPV infection. In 50% of cases there was a correlation with acute kidney transplant rejection. When induction therapy (anti-thymocyte globulin [ATG] and muromonab-CD3 [OKT3]) was applied, at least 1 oral cavity lesion in each case of allogenic transplant recipients was reported. ConclusionsTyping of HPV with the use of molecular methods should be a standard diagnostic technique.

Frequency of Pathologic Changes in the Oral Cavity in Patients Subjected to Long-term Pharmacologic Immunosuppressive Therapy After Kidney, Liver, and Hematopoietic Cell Transplantation

IntroductionPatients subjected to long-term immunosuppressive therapy after organ and cells transplantation are more susceptible than healthy people to the development of the pathologic changes in the oral cavity, including precancerous lesions, oral cancers, lesions following viral infections (herpes simplex virus, Epstein-Barr virus, and cytomegalovirus), fungal infections mainly caused by Candida albicans, drug-induced gingival overgrowth, stomatitis, and tongue disorders. Material and methodsClinical case material included 38 patients after kidney, liver, or blood-forming cells transplantation subjected to various immunosuppressive therapy schemes. The study comprised standard case taking and physical examination of the patient, including detailed intraoral and extraoral stomatological examinations. ResultsExtraoral examination confirmed 1 case of multifocal basal cell carcinoma in the auricular region and one case of systemic lupus erythematosus. Intraoral examination revealed gingivitis (60.5%), gingival recession (58%), periodontitis (55.26%), macroglossia (15.8%), lingual papillary atrophy (13.16%), leukoplakia aphthae/ulcerations (10.5%), lichen planus, pallor of mucous membranes (7.9%), pathologic pigmentation of oral mucosa, geographic tongue (5.26%) and erythroplakia (2.6%). When their histories were taken, patients reported xerostomia (68.42%), halitosis (23.68%), gum bleeding while brushing teeth (18.42%), and dysgeusia (15.78%). DiscussionBoth the patients after organ and hematopoietic stem cells transplantations and those qualified for a transplant should undergo multispecialty treatment, particularly dental treatment, to enable the detection of pathologies at an early stage and commencement of effective therapy. Cooperation between the main doctor and the dentist is crucial in the process of treatment of this group of patients.

Sonic Hedgehog and WNT Signaling Promote Adrenal Gland Regeneration in Male Mice

The atrophy and hypofunction of the adrenal cortex following long-term pharmacologic glucocorticoid therapy is a major health problem necessitating chronic glucocorticoid replacement that often prolongs the ultimate return of endogenous adrenocortical function. Underlying this functional recovery is anatomic regeneration, the cellular and molecular mechanisms of which are poorly understood. Investigating the lineage contribution of cortical Sonic hedgehog (Shh)+ progenitor cells and the SHH-responsive capsular Gli1+ cells to the regenerating adrenal cortex, we observed a spatially and temporally bimodal contribution of both cell types to adrenocortical regeneration following cessation of glucocorticoid treatment. First, an early repopulation of the cortex is defined by a marked delamination and expansion of capsular Gli1+ cells, recapitulating the establishment of the capsular-cortical homeostatic niche during embryonic development. This rapid repopulation is promptly cleared from the cortical compartment only to be supplanted by repopulating cortical cells derived from the resident long-term-retained zona glomerulosa Shh+ progenitors. Pharmacologic and genetic dissection of SHH signaling further defines an SHH-dependent activation of WNT signaling that supports regeneration of the cortex following long-term glucocorticoid therapy. We define the signaling and lineage relationships that underlie the regeneration process.

Novel oral anticoagulants in the management of coronary artery disease.

Despite advances in interventional and pharmacologic therapy, survivors of myocardial infarction remain at an increased risk of subsequent cardiovascular events. Initial pharmacological management includes both platelet inhibition and parenteral anticoagulation, whereas long-term pharmacological therapy relies on antiplatelet therapy for prevention of thrombotic complications. Biomarkers showing ongoing thrombin generation after acute coronary syndromes suggest that anticoagulants may provide additional benefit in reducing cardiovascular events. We review the pharmacokinetics of novel anticoagulants, clinical trial results, the role of monitoring, and future directions for the use of novel oral anticoagulants in the treatment of coronary artery disease. Clinical trials have shown that long-term use of oral anticoagulants decreases the risk of cardiovascular events, but they do so at a cost of an increased risk of bleeding. Future studies will need to identify optimal treatment combinations for selected patients and conditions that address both the appropriate combination of therapy and the appropriate dosage of each agent when used in combination.

The Surgical Management of Parkinson’s Disease

SUMMARY Parkinson’s disease (PD) is one of the most frequently encountered neurodegenerative disorders in terms of worldwide prevalence. Although medications are typically effective at treating motor symptoms in early to moderately advanced stages, the efficacy of these agents often wanes as the disease progresses. With long-term pharmacologic therapy, many PD patients will also experience motor fluctuations, dyskinesias and unpredictable wearing off of the therapeutic benefit. Deep brain stimulation, the preferred surgical treatment for PD, often improves many of these complications. New surgical options are currently under clinical investigation for advanced PD patients including gene and cell-based therapies.

Nutritional stretegies to prevent Urolithiasis in Animals

Urolithiasis is a common problem in both ruminants and non-ruminants and nutrition plays a significant role in predisposing urolithiasis. The nutritional factors mainly influence urinary constituents and pH, which affect stone nucleation and growth. While surgery can render a patient stone-free, non-operative treatment modalities are required to prevent and reduce the risk of recurrent urolithiasis. Moreover, long-term pharmacological therapy and its potential side effects often lead to subsequent failure. In this regard, nutritional management is the best preventive strategy against urolithiasis.

Controversies in the Use of Drug-Eluting Stents for Acute Myocardial Infarction: A Critical Appraisal of the Data

Acute myocardial infarction is a common and life-threatening presentation of coronary artery disease in adults. In the settings of ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction, significant mortality benefit has been observed in randomized trials of coronary stent procedures compared with medical therapy alone. However, data regarding procedural choices, and particularly stent choices, are limited, and significant controversy exists. Drug-eluting stents were introduced in the United States in 2003 and have been widely adopted based on profound reduction in restenosis. Yet recent years have witnessed a decline in use of drug-eluting stents in the setting of myocardial infarction due to long-term safety concerns. We review the current data regarding drug-eluting stent performance relative to bare metal stents in the setting of acute myocardial infarction with regard to effectiveness, safety, and the need for adjunctive long-term pharmacologic therapy.

Myocardial infarction with normal coronary arteries: a case report and review of the literature

IntroductionAlthough acute myocardial infarction is generally associated with obstructive coronary artery disease, myocardial infarction associated with normal coronary arteries is a well-known condition. The overall prevalence rate of myocardial infarction with normal coronary arteries is considered to be low, varying from 1% to12% depending on the definition of "normal" coronary arteries.Case presentationWe describe here a case of a 49-year-old woman with a history of prior myocardial infarction who continued to be asymptomatic after a 10-year follow-up, in the absence of a high-risk profile for adverse outcomes. She was studied with multi-slice coronary computed tomography and whole-body angiography, which showed normal coronary and extra-coronary arteries.ConclusionThis case report raises two important issues. First, the possible role of multi-slice computed tomography/coronary angiography in the risk- and prognosis assessment of patients with known or suspected coronary artery disease. Second, the important role played by long-term pharmacological therapy in patients with prior myocardial infarction and normal coronary arteries.

Catheter Ablation for the Treatment of Electrical Storm in Patients With Implantable Cardioverter-Defibrillators

Electrical storm (ES) caused by recurrent episodes of ventricular tachycardia (VT) can cause sudden death in patients with implantable cardioverter-defibrillators and adversely affects prognosis in survivors. Catheter ablation has been proposed for treating ES, but its long-term effect in a large population has never been verified. Ninety-five consecutive patients with coronary artery disease (72 patients), idiopathic dilated cardiomyopathy (10 patients), and arrhythmogenic right ventricular dysplasia/cardiomyopathy (13 patients) undergoing catheter ablation for drug-refractory ES were prospectively evaluated. Short-term efficacy was defined by a complete protocol of programmed electric stimulation and by in-hospital outcome; long-term analysis addressed ES recurrence, cardiac mortality, and VT recurrence. Pleomorphic/nontolerated VTs required electroanatomic and noncontact mapping in 48 and 22 patients, respectively, and percutaneous cardiopulmonary support in 10 patients. An epicardial approach was used in 10 patients. After 1 to 3 procedures, induction of any clinical VT(s) by programmed electrical stimulation was prevented in 85 patients (89%). ES was acutely suppressed in all patients; a minimum period of 7 days with stable rhythm was required before hospital discharge. At a median follow-up of 22 months (range, 1 to 43 months), 87 patients (92%) were free of ES and 63 patients (66%) were free of VT recurrence. Eight of 10 patients with persistent inducibility of clinical VT(s) had ES recurrence; 4 of them died suddenly despite appropriate implantable cardioverter-defibrillator intervention. All together, 11 of 95 patients (12%) died of cardiac-related reasons. In the group of patients presenting with all clinical VTs acutely abolished, no ES recurrence was documented, and cardiac mortality was significantly lower compared with the group of patients showing > or = 1 clinical VT still inducible after catheter ablation. Advanced strategies of catheter ablation applied to a large population of patients are effective in the short-term treatment of ES. By preventing ES recurrence, catheter ablation may play a protective role over the long term and, together with long-term pharmacological therapy, may favorably affect cardiac mortality.

Supraventricular arrhythmias: investigation and treatment

Supraventricular arrhythmias (SVAs), with the exception of atrial fibrillation, are a group of rapid, regular tachycardias that use the atria and/or the atrioventricular (AV) node as part of their arrhythmia mechanism. This chapter examines the different electrophysiological mechanisms behind the most common SVAs. Atrial flutter is the result of macrore-entry, confined to the atria. Atrial tachycardia is focal in origin, commonly from muscle sleeves within the pulmonary veins. AV nodal reciprocating tachycardia is the most common form of junctional re-entrant tachycardia. Accessory pathways give rise to the other form of junctional re-entrant tachycardia, AV reciprocating tachycardias. When associated with ventricular preexcitation it gives rise to Wolff-Parkinson-White syndrome. Risk stratification for individuals with ventricular preexcitation may be attempted using non-invasive criteria. The different 12-lead ECG characteristics of each arrhythmia are described together with examples. The acute treatment of SVAs typically involves intravenous adenosine, which should terminate all arrhythmias that depend on the AV node (AVNRT and AVRT) and transiently unmark those that are confined to the atrium (atrial flutter and atrial tachycardia). Alternative acute and long-term pharmacological therapy is also discussed. Curative treatment with radiofrequency ablation is a realistic option for most SVAs. The procedure, outcomes and risks are explained.

Thromboangéite oblitérante ou maladie de Buerger

Buerger's disease or thromboangiitis obliterans is an inflammatory, segmental and occlusive disease that most commonly affects the small and medium-sized arteries and veins of limbs. The disease typically occurs in young male smokers. The cause is unknown; however tobacco consumption is central to the initiation and progress of the disease. Some immunological processes could be involved and recently, an impaired endothelium-dependent vasorelaxation has been observed. The diagnosis is based on exclusion of another vascular disease, on clinical features and on arteriography. Concomitant Raynaud's phenomenon, or digital arteriopathy, or superficial thrombosis may be arguments for a diagnosis of Buerger's disease. To date, no long-term pharmacological therapy has shown any efficacy and the only efficient strategy to prevent disease progression is complete smoking discontinuation.

Effect of consumption of soy isoflavones on behavioural, somatic and affective symptoms in women with premenstrual syndrome

Up to 80 % of the Western female population experience premenstrual syndrome (PMS). Long-term pharmacological therapy is unacceptable to most women, and is not warranted for moderate symptoms. Nutritional therapies are popular, but lack a clear evidence base. Anecdotal evidence suggests beneficial effects of soy isoflavones because of their influence on endogenous oestrogen and actions on specific tissues. The effect of isolated soya protein (ISP) containing 68 mg/d (aglycone equivalents) soy isoflavones (IF) on premenstrual symptom severity was studied in a seven-menstrual cycle, double-blind, placebo-controlled, crossover intervention study in twenty-three women with prospectively confirmed PMS aged 18-35 years and BMI 19-30 kg/m(2). ISP containing IF or milk protein placebo was consumed for two complete menstrual cycles. ISP containing IF (genistein, daidzein, equol) were measured in 24 h urine samples. After two cycles of ISP containing IF intervention, total symptoms (F(2,36) 8.20, P=0.000) and physical symptoms (F(2,36) 8.18, P=0.000) were significantly reduced compared with baseline after both active and placebo treatments, although differences between active and placebo treatment were non-significant. Specific premenstrual symptoms, headache (F(2,32) 4.10, P=0.026) and breast tenderness (F(2,32) 4.59, P=0.018), were reduced from baseline after soy IF, but not milk protein placebo. Cramps (F(2,32) 4.15, P=0.025) and swelling (F(2,32) 4.64, P=0.017) were significantly lower after active treatment compared with placebo. Concentrations of genistein and daidzein were increased following soy IF consumption, but equol production did not enhance symptom reduction. The present study showed that ISP containing IF may have potential to reduce specific premenstrual symptoms via non-classical actions.