[Outcome indicators in clinical trials on traditional Chinese medicine treatment of microvascular angina].

This study reviewed the current status of the use of outcome indicators in randomized controlled trial(RCT) on traditional Chinese medicine(TCM) treatment of microvascular angina(MVA) and analyzed the existing problems and possible solutions, aiming to provide a basis for the design of high-quality RCT and the establishment of core outcome sets for MVA. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, and 2 clinical trial registries were searched for the RCT on TCM treatment of MVA according to pre-defined criteria. The Cochrane's risk of bias assessment tool was used to evaluate the methodological quality of the included RCT and the use of outcome indicators was summarized. A total of 69 RCTs were included, from which 100 outcome indicators were extracted, with the frequency of 430. The extracted outcome indicators belonged to 8 domains: response rate, symptoms and signs, physical and chemical examinations, TCM efficacy, safety, quality of life, economic evaluation, and long-term prognosis. The indicators of physical and chemical examinations were the most(70 indicators with the frequency of 211), followed by those of response rate(7 indicators with the frequency of 73) and symptoms and signs(7 indicators with the frequency of 54). The outcome indicators with higher frequency were adverse reactions, angina attack frequency, clinical efficacy, endothelin-1, total duration of treadmill exercise, and hypersensitive C-reactive protein. The RCT on TCM treatment of MVA had the following problems: irregular reporting of adverse reactions, diverse indicators with low frequency, lack of attention to the application of endpoint indicators, insufficient use of TCM differentiation and efficacy indicators, non-standard evaluation criteria and failure to reflect the basic characteristics of TCM. A unified MVA syndrome differentiation standard should be established, on the basis of which an MVA treatment efficacy evaluation system and core outcome indicator set that highlights the characteristics of TCM with patient-reported outcomes as the starting point should be established to improve the clinical research and research value.

Efficacy and safety of Qi-Jing Hui-Xin Decoction in the treatment of coronary microvascular angina: study protocol for a randomized, controlled, multi-center clinical trial.

BACKGROUND: With the increased understanding of heart disease, microvascular angina (MVA) is receiving greater attention from clinicians. Studies have shown that patients with MVA have significantly higher major cardiovascular events and all-cause mortality than the control population, and the search for effective treatments is of great clinical importance. Both basic and clinical studies have shown that Qi-Jing Hui-Xin Decoction (QJHX) can relieve angina symptoms and improve clinical efficacy, but there is a lack of high-quality clinical studies to provide a research basis. This article introduces the evaluation protocol of QJHX for the adjunctive treatment of MVA. METHODS/DESIGN: This is a prospective randomized controlled trial. The trial will enroll 150 patients with MVA. On the basis of Western drug treatment, patients will be randomized into two groups, and the experimental group will receive QJHX treatment for 12 weeks and follow-up at 24 week. The primary indicators are the clinical efficacy of angina pectoris and the evidence of traditional Chinese medicine (TCM) efficacy. Secondary indicators are the Seattle Angina Scale score, serum lipid levels, electrocardiogram, and echocardiogram diagnosis. Additional indicators are endothelial function and immunoinflammatory factors. Adverse events will be monitored throughout the trial. DISCUSSION: Integrated traditional Chinese and Western medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of adding QJHX based on standardized Western medications. The results of the trial will provide high-level clinical research-based evidence for the application of QJHX in MVA. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900027015 . Registered on 28 October 2019.

[Mechanism of Ficus hirta-Hypericum perforatum in treatment of microvascular angina based on network pharmacology and molecular docking].

The active ingredients of Ficus hirta and Hypericum perforatum were collected from Traditional Chinese Medicine Database and Analysis Platform(TCMSP) and related papers. The potential targets of these two medicinal herbs were searched from HERB database, and those associated with microvascular angina were screened out from GeneCards, Online Mendelian Inheritance in Man(OMIM), Therapeutic Target Database(TTD), and HERB. Cytoscape was used to construct a protein-protein interaction(PPI) network of the common targets shared by the two herbs and microvascular angina based on the data of String platform. Metascape was employed to identify the involved biological processes and pathways enriched with the common targets. Cytoscape was used to draw the "active ingredient-target-pathway" network. AutoDock Vina was used to dock the core ingredients with the key targets. A total of 19 potential active ingredients and 71 potential targets were identified to be associated with microvascular angina. Bioinformatics analysis showed that phosphatidylinositol-3-kinase/protein kinase B(PI3 K-AKT), interleukin-17(IL17), hypoxia-inducible factor 1(HIF-1) and other signaling pathways were related to the treatment of microvascular angina by F. hirta and H. perforatum. Molecular docking results showed that ß-sitosterol, luteolin and other ingredients had strong affinity with multiple targets including mitogen-associated protein kinase 1(MAPK1), epidermal growth factor receptor(EGFR) and so on. These findings indicated that F. hirta and H. perforatum may regulate PI3 K-AKT, IL17, HIF-1 and other signaling pathways by acting on multiple targets to alleviate oxidative stress, inhibit inflammatory response, regulate angiogenesis, and improve vascular endothelium and other functions. This study provides reference for in vitro and in vivo studies of the treatment of microvascular angina.

Mechanism of Ficus hirta-Hypericum perforatum in treatment of microvascular angina based on network pharmacology and molecular docking / 中国中药杂志

The active ingredients of Ficus hirta and Hypericum perforatum were collected from Traditional Chinese Medicine Database and Analysis Platform(TCMSP) and related papers. The potential targets of these two medicinal herbs were searched from HERB database, and those associated with microvascular angina were screened out from GeneCards, Online Mendelian Inheritance in Man(OMIM), Therapeutic Target Database(TTD), and HERB. Cytoscape was used to construct a protein-protein interaction(PPI) network of the common targets shared by the two herbs and microvascular angina based on the data of String platform. Metascape was employed to identify the involved biological processes and pathways enriched with the common targets. Cytoscape was used to draw the "active ingredient-target-pathway" network. AutoDock Vina was used to dock the core ingredients with the key targets. A total of 19 potential active ingredients and 71 potential targets were identified to be associated with microvascular angina. Bioinformatics analysis showed that phosphatidylinositol-3-kinase/protein kinase B(PI3 K-AKT), interleukin-17(IL17), hypoxia-inducible factor 1(HIF-1) and other signaling pathways were related to the treatment of microvascular angina by F. hirta and H. perforatum. Molecular docking results showed that β-sitosterol, luteolin and other ingredients had strong affinity with multiple targets including mitogen-associated protein kinase 1(MAPK1), epidermal growth factor receptor(EGFR) and so on. These findings indicated that F. hirta and H. perforatum may regulate PI3 K-AKT, IL17, HIF-1 and other signaling pathways by acting on multiple targets to alleviate oxidative stress, inhibit inflammatory response, regulate angiogenesis, and improve vascular endothelium and other functions. This study provides reference for in vitro and in vivo studies of the treatment of microvascular angina.

Effect of Chinese medicine for promoting blood circulation on microvascular angina: A systematic review and meta-analysis.

BACKGROUND: Blood-activating drugs (BADs) are widely used to treat microvascular angina in China. This study aims to summarize relevant evidence from randomized controlled trials (RCTs) to assess the efficacy and safety of BADs in the treatment of microvascular angina. METHODS: We searched for relevant studies before June 2019 from seven databases. Twenty-four studies were included of 1903 patients with microvascular angina. All studies compared the use of traditional Chinese medicine for activating blood circulation (BADs) and Western medicine (WM) with the use of Western medicine alone. RESULTS: In all, 15 trials reported a significant effect of BADs on improving clinical symptoms compared with the control treatment (P < .00001), and 8 trials reported significant effects of BADs on reducing the frequency of angina pectoris attacks compared with Western medicine treatment (P < .00001). The pooled results also demonstrated that BADs provided a significant benefit in reducing the dosage of nitroglycerin required (P = .02), the maximum range of ST-segment depression (P = .003) and the descending degree of the ST-T segment of ECG (P = .0002); prolonging the total time of treadmill exercise (P < .00001) and the time of ST-segment depression of 1 mm (P = .002); enhancing the total effective rate of Traditional Chinese Medicine (TCM) syndromes (P < .00001); improving endothelial function (P < .00001); and reducing the levels of high-sensitivity C-reactive protein (hs-CRP) (P < .00001). BAD treatment showed no statistically significant effect on the levels of TNF-a (P = .8) or IL-6 (P = .13). No severe adverse events were reported. CONCLUSION: This meta-analysis shows that BADs are effective for the treatment of microvascular angina. Although concerns regarding selective bias and low methodological quality were raised, our findings suggest that BADs are beneficial for patients with microvascular angina and should be given priority for future clinical studies.

Index of microvascular resistance to assess the effect of rosuvastatin on microvascular function in women with chest pain and no obstructive coronary artery disease: A double-blind randomized study.

INTRODUCTION: Many women undergoing coronary angiography for chest pain have no or only minimal coronary artery disease (CAD). However, despite the lack of obstructive CAD, they still have an increased risk of major adverse cardiovascular events. Pleiotropic effects of statins may influence microvascular function, but if statins improve microvascular function in unselected chest pain patients is not well studied. This study assessed microvascular function by using the thermodilution-derived test "the index of microvascular resistance" (IMR) with the aim of determining the (i) IMR level in women with chest pain and non-obstructive CAD and if (ii) IMR is modified by high-dose statin treatment in these patients. Additional objectives were to identify the influence of statins on the health status as assessed with generic health questionnaires and on biomarkers of endothelial activation. MATERIALS AND METHODS: The study was a randomized, double-blind, single-center trial comparing 6 months of rosuvastatin treatment with placebo. In total, 66 women without obstructive CAD were included. Mean age was 52.7 years and 55.5 years in the placebo and rosuvastatin group, respectively. Microvascular function was assessed using the IMR, health status was assessed using the SF-36 and EQ-5D questionnaires, and biochemical values were assessed at baseline and 6 months later. RESULTS AND CONCLUSIONS: In the placebo group IMR was 14.6 (SD 5.7) at baseline and 14.4 (SD 6.5) at follow-up. In the rosuvastatin group IMR was 16.5 (SD 7.5) at baseline and 14.2 (SD 5.8) at follow-up. IMR did not differ significantly between the two study groups at follow-up controlled for preintervention values. C-reactive protein (CRP) was comparable between the groups at baseline, while at follow-up CRP was significantly lower in the rosuvastatin group compared to placebo [0.6 (±0.5) mg/L vs. 2.6 (±3.0) mg/L; p = 0.002]. Whereas rosuvastatin treatment for 6 months attenuated CRP levels, it did not improve microvascular function as assessed by IMR (Clinical Trials.gov NCT01582165, EUDRACT 2011-002630-39.3tcAZ).

Impact of Mindfulness Based Stress Reduction Therapy on Myocardial Function and Endothelial Dysfunction in Female Patients with Microvascular Angina

BACKGROUND: Mindfulness-based stress reduction (MBSR) is a structured group program that employs mindfulness meditation to alleviate suffering associated with physical, psychosomatic, and psychiatric disorders. In this study, we investigate the impact of MBSR on left ventricular (LV) and endothelial function in female patients with microvascular angina. METHODS: A total of 34 female patients (mean age 52.2 ± 13.8 years) diagnosed with microvascular angina underwent a MBSR program with anti-anginal medication for 8 weeks. The global longitudinal strain (GLS) of the LV was used as a parameter to assess myocardial function and reactive brachial flow-mediated dilatation (FMD) was used to assess endothelial function. Symptoms were analyzed by the Symptom Checklist 90 Revised to determine emotional stress. Changes in GLS and FMD between baseline and post-MBSR were analyzed. RESULTS: After 8 weeks of programmed MBSR treatment, stress parameters were significantly decreased. In addition, GLS (−19.5 ± 2.1% vs. −16.6 ± 2.5%, p < 0.001) and reactive FMD significantly improved (8.9 ± 3.0% vs. 6.9 ± 2.6%, p = 0.005) after MBSR compared to baseline. The changes in GLS correlated to changes in FMD (r = 0.120, p = 0.340) and with the changes in most stress parameters. CONCLUSION: MBSR has beneficial impacts on myocardial and endothelial function in female patients with microvascular angina.

Is there a relationship between non-obstructive coronary artery disease or cardiac syndrome X and migraine? An integrated multi-disciplinary approach.

Non-obstructive coronary artery disease (CAD) which is mostly called cardiac syndrome X (CSX) is noted in about 30% of men and 40%-60% of women and seems to be incremental. In addition, frequent myocardial perfusion defects with various levels of severity are often seen in this disease. Recently, we noticed that the frequency of migraine in patients with CSX was noticeably higher than in healthy people and in CAD patients. This may support the evolving story that CSX is related to migraine and to chest pain and that CSX and migraine may have a similar pathophysiology. Hence, myocardial perfusion imaging could be used as a complement any diagnostic test to support the relation between CSX and migraine.

Opium addiction as an independent risk factor for coronary microvascular dysfunction: A case-control study of 250 consecutive patients with slow-flow angina.

BACKGROUND: Approximately 20% to 30% of patients who undergo coronary angiography for assessment of typical cardiac chest pain display microvascular coronary dysfunction (MCD). This study aimed to determine potential relationships between baseline clinical characteristics and likelihood of MCD diagnosis in a large group of patients with stable angina symptoms, positive exercise test and angiographic ally normal epicardial coronary arteries. MATERIAL AND METHODS: This cross-sectional study included 250 Iranian with documented evidence of cardiac ischemia on exercise testing, class I or II indication for coronary angiography, and either: (1) angiographically normal coronary arteries and diagnosis of MCD with slow-flow phenomenon, or (2) normal angiogram and no evidence of MCD. All patients completed a questionnaire designed to capture key data including clinical demographics, past medical history, and social factors. Data was evaluated using single and multivariable logistic regression models to identify potential individual patient factors that might help to predict a diagnosis of MCD. RESULTS: 125 (11.2% of total) patients were subsequently diagnosed with MCD. 125 consecutive control subjects were selected for comparison. The mean age was similar among the two groups (52.38 vs. 53.26%, p=ns), but there was a higher proportion of men in the study group compared to control (42.4 vs. 27.2%, p=0.012). No significant relationships were observed between traditional cardiovascular risk factors (diabetes, hypertension, and dyslipidemia) or body mass index (BMI), and likelihood of MCD diagnosis. However, opium addiction was found to be an independent predictor of MCD on single and multivariable logistic regression model (OR=3.575, 95%CI: 1.418-9.016; p=0.0069). CONCLUSIONS: We observed a significant relationship between opium addiction and microvascular angina. This novel finding provides a potential mechanistic insight into the pathogenesis of MCD with slow-flow phenomenon.

Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy.

BACKGROUND: Recurrent chest pain in the absence of coronary artery disease is a common problem which sometimes leads to excess use of medical care. Although many studies have examined the causes of pain in these patients, few clinical trials have evaluated treatment. This is an update of a Cochrane review originally published in 2005 and last updated in 2010. The studies reviewed in this paper provide an insight into the effectiveness of psychological interventions for this group of patients. OBJECTIVES: To assess the effects of psychological interventions for chest pain, quality of life and psychological parameters in people with non-specific chest pain. SEARCH METHODS: We searched the Cochrane Library (CENTRAL, Issue 4 of 12, 2014 and DARE Issue 2 of 4, 2014), MEDLINE (OVID, 1966 to April week 4 2014), EMBASE (OVID, 1980 to week 18 2014), CINAHL (EBSCO, 1982 to April 2014), PsycINFO (OVID, 1887 to April week 5 2014) and BIOSIS Previews (Web of Knowledge, 1969 to 2 May 2014). We also searched citation lists and contacted study authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) with standardised outcome methodology that tested any form of psychotherapy for chest pain with normal anatomy. Diagnoses included non-specific chest pain (NSCP), atypical chest pain, syndrome X or chest pain with normal coronary anatomy (as either inpatients or outpatients). DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data and assessed quality of studies. We contacted trial authors for further information about the included RCTs. MAIN RESULTS: We included two new papers, one of which was an update of a previously included study. Therefore, a total of 17 RCTs with 1006 randomised participants met the inclusion criteria, with the one new study contributing an additional 113 participants. There was a significant reduction in reports of chest pain in the first three months following the intervention: random-effects relative risk = 0.70 (95% CI 0.53 to 0.92). This was maintained from three to nine months afterwards: relative risk 0.59 (95% CI 0.45 to 0.76). There was also a significant increase in the number of chest pain-free days up to three months following the intervention: mean difference (MD) 3.00 (95% CI 0.23 to 5.77). This was associated with reduced chest pain frequency (random-effects MD -2.26, 95% CI -4.41 to -0.12) but there was no evidence of effect of treatment on chest pain frequency from three to twelve months (random-effects MD -0.81, 95% CI -2.35 to 0.74). There was no effect on severity (random-effects MD -4.64 (95% CI -12.18 to 2.89) up to three months after the intervention. Due to the nature of the main interventions of interest, it was impossible to blind the therapists as to whether the participant was in the intervention or control arm. In addition, in three studies the blinding of participants was expressly forbidden by the local ethics committee because of issues in obtaining fully informed consent . For this reason, all studies had a high risk of performance bias. In addition, three studies were thought to have a high risk of outcome bias. In general, there was a low risk of bias in the other domains. However, there was high heterogeneity and caution is required in interpreting these results. The wide variability in secondary outcome measures made it difficult to integrate findings from studies. AUTHORS' CONCLUSIONS: This Cochrane review suggests a modest to moderate benefit for psychological interventions, particularly those using a cognitive-behavioural framework, which was largely restricted to the first three months after the intervention. Hypnotherapy is also a possible alternative. However, these conclusions are limited by high heterogeneity in many of the results and low numbers of participants in individual studies. The evidence for other brief interventions was less clear. Further RCTs of psychological interventions for NSCP with follow-up periods of at least 12 months are needed.

Management of microvascular angina pectoris.

Microvascular angina (MVA) is defined as angina pectoris caused by abnormalities of small coronary arteries. In its most typical presentation, MVA is characterized by angina attacks mainly caused by effort, evidence of myocardial ischemia on non-invasive stress tests, but normal coronary arteries at angiography. Patients with stable MVA have excellent long-term prognoses, but often present with persistent and/or worsening of angina symptoms. Treatment of MVA is initially based on standard anti-ischemic drugs (beta-blockers, calcium antagonists, and nitrates), but control of symptoms is often insufficient. In these cases, several additional drugs, with different potential anti-ischemic effects, have been proposed, including ranolazine, ivabradine, angiotensin-converting enzyme (ACE) inhibitors, xanthine derivatives, nicorandil, statins, alpha-blockers and, in perimenopausal women, estrogens. In patients with 'refractory MVA', some further alternative therapies (e.g., spinal cord stimulation, pain-inhibiting substances such as imipramine, rehabilitation programs) have shown favorable results.

Traditional Chinese medicine syndrome patterns and qi-regulating, chest-relaxing and blood-activating therapy on cardiac syndrome X.

OBJECTIVE: To master the syndrome patterns characteristics and explore the effective therapy methods of Traditional Chinese Medicine (TCM) for cardiac syndrome X (CSX). METHODS: The TCM syndrome characteristics were mastered and the TCM intervention programs were determined by clinical investigations for TCM syndrome patterns characteristics of CSX patients. Then, the clinical efficacy studies on TCM intervention for CSX were carried out through randomized controlled trials. RESULTS: CSX is a clinical syndrome with the main manifestations of chest pain and chest stuffiness, and Qi stagnation, phlegm retention and blood stasis are the basic symptoms of CSX. As a result, the Qi-regulating, chest-relaxing and blood-activating therapy integrated with some Western Medicines was adopted for treatment. The effect of Qi-regulating, chest-relaxing and blood-activating therapy can reduce the frequency and degree of angina, improve the symptoms and exercise the tolerance of patients, inhibit the inflammatory response of vascular walls and protect the function of vascular endothelial cells, which is better than that of the simple and conventional Western Medicine alone. CONCLUSION: A good effect was achieved in the integration of Chinese and Western Medicines for CSX. The therapy is worthy to be applied further in clinical practice. On the other hand, more long-term and randomised controlled studies with large samples are still required to further determine the clinical efficacy and safety of the therapy.

Potential effectiveness of traditional Chinese medicine for cardiac syndrome X (CSX): a systematic review and meta-analysis.

BACKGROUND: Treatment of cardiac syndrome X with unknown pathological mechanism remains a big challenge for clinicians. Complementary and alternative medicine may bring a new choice for its management. The aim of this study is to evaluate the clinical effects of traditional Chinese medicine on cardiac syndrome X patients. METHODS: We systematically searched databases such as Cochrane CENTRAL, PubMed, EMBASE, CBM, Chinese National Knowledge Infrastructure (CNKI), WanFang and VIP, and handsearched relevant journals to identify randomized controlled trials. Following the steps of systematic review recommended by the Cochrane group, we assessed the quality of included studies, extracted valid data and undertook meta-analysis. RESULTS: Twenty one moderate-to low-quality randomized controlled trials involving 1143 patients were included. The results showed that traditional Chinese medicine could improve angina [OR=1.34, 95% CI: 1.2 to 1.50], electrocardiogram (ECG), endothelin-1 (ET-1) levels, prolong exercise duration in treadmill tests, and reduce angina frequency per week compared with routine treatment. No other side effect was reported except two cases of stomach pain. CONCLUSION: Compared with conventional treatment, traditional Chinese medicine shows the potential of optimizing symptomatic outcomes and improving ECG and exercise duration. The efficacy of TCM may find explanation in its pharmacological activity of adjusting the endothelial function. TCM, as a kind of alternative and complementary medicine, may provide another choice for CSX patients.

ω-3 fatty acid treatment in cardiac syndrome X: a double-blind, randomized, placebo-controlled clinical study.

OBJECTIVE: We conducted a clinical trial to examine the effect of ω-3 fatty acids in patients with cardiac syndrome X (CSX). We aimed to evaluate the potential impact of ω-3 fatty acids on endothelial function, oxidative stress, and symptom relief in the CSX. METHODS AND RESULTS: Eighteen patients with CSX were enrolled according to a double-blind, randomized, placebo-controlled design. Patients were randomized to ω-3 fatty acids (1440 mg/day, n=8) or placebo (n=10) for 4 months. We assessed plasma levels of malondialdehyde (MDA), endothelium-dependent vasodilatation [flow-mediated dilatation (FMD)], endothelium-independent vasodilatation [nitroglycerin-mediated dilatation (NMD)], and status of symptom [score with Seattle Angina Questionnaire (SAQ)] before and after the treatment. After 4 months, patients who were treated with ω-3 fatty acids showed significant increases in the FMD (from 47±48 to 104±23%, P<0.05) and NMD (from 51±53 to 93±35%, P<0.05) values, and significant decreases in the plasma MDA levels (4.4±0.86 to 3.35±0.33 µmol/l, P=0.012). SAQ scores were increased significantly in both groups (from 60±14 to 73±15%, P<0.05 placebo, from 67±10 to 81±9%, P<0.05 treatment group). NMD was correlated negatively with the plasma MDA levels. CONCLUSION: Four months of therapy with a moderate dose of ω-3 fatty acids improved the endothelial function and reduced oxidative stress in patients with CSX.

Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy.

BACKGROUND: Recurrent chest pain in the absence of coronary artery disease is a common problem that sometimes leads to excess use of medical care. Although many studies examine the causes of pain in these patients, few clinical trials have evaluated treatment. The studies reviewed in this paper provide an insight into the effectiveness of psychological interventions for this group of patients. OBJECTIVES: To update the previously published systematic review. SEARCH METHODS: We searched the Cochrane LIbrary (CENTRAL and DARE) (Issue 3 of 4 2011), MEDLINE (1966 to August Week 5, 2011), CINAHL (1982 to Sept 2011) EMBASE (1980 to Week 35 2011), PsycINFO (1887 to Sept Week 1, 2011), and Biological Abstracts (January 1980 to Sept 2011). We also searched citation lists and approached authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) with standardised outcome methodology that tested any form of psychotherapy for chest pain with normal anatomy. Diagnoses included non-specific chest pain (NSCP), atypical chest pain, syndrome X, or chest pain with normal coronary anatomy (as either inpatients or outpatients). DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, extracted data and assessed quality of studies. The authors contacted trial authors for further information about the RCTs included. MAIN RESULTS: Six new RCTs were located and added to the existing trials, therefore, a total of 15 RCTs (803 participants) were included. There was a significant reduction in reports of chest pain in the first three months following the intervention; fixed-effect relative risk = 0.68 (95% CI 0.57 to 0.81). This was maintained from three to nine months afterwards; relative risk = 0.59 (95% CI 0.45 to 0.76). There was also a significant increase in the number of chest pain free days up to three months following the intervention; mean difference = 2.81 (95% CI 1.28 to 4.34). This was associated with reduced chest pain frequency (random-effects mean difference = -2.26 95% CI -4.41 to -0.12) but there was no evidence of effect of treatment on chest pain frequency from three to twelve months (random-effects mean difference -0.81 95% CI -2.35, 0.74). There was no effect on severity (random-effects mean difference = -4.64 (95% CI -12.18 to 2.89) up to three months after the intervention. Overall there was generally a low risk of bias, however, there was high heterogeneity and caution is required in interpreting these results. Wide variability in outcome measures made integration of studies for secondary outcome measures difficult to report on. AUTHORS' CONCLUSIONS: This review suggests a modest to moderate benefit for psychological interventions, particularly those using a cognitive-behavioural framework, which was largely restricted to the first three months after the intervention. Hypnotherapy is also a possible alternative. The evidence for brief interventions was less clear. Further RCTs of psychological interventions for NSCP with follow-up periods of at least 12 months are needed.

Alteración del sodio y potasio en pacientes hospitalizados por insuficiencia cardíaca / Alteration of sodium and potassium levels in patients hospitalized for heart failure

La insuficiencia cardíaca es un síndrome ocasionado por múltiples factores y va produciendo un proceso de remodelado ventricular. Es un verdadero problema de salud pública que incrementa el número de hospitalizaciones. Los diuréticos siguen siendo útiles en el tratamiento, aún así se producen alteraciones de los electrólitos que pueden ocasionar arritmias, empeoramiento de la insuficiencia cardíaca y disminución de la fracción de eyección. Este trabajo evalúa la alteración del sodio y potasio en pacientes hospitalizados por este síndrome. Se revisaron las historias de pacientes con insuficiencia cardíaca ingresados al servicio de Cardiología, registrando datos en base a un protocolo. Se revisaron 33 historias de las cuales 11 pacientes eran mujeres y 22 eran hombres, con un promedio de edad de 72,64 y 71,52 años respectivamente. Días de hospitalización promedio de 14,91 días. Todos los pacientes tenían dieta hiposódica excepto uno debido a diarrea. El 57,6% tenían una sola patología y el resto dos o tres. La hipertensión arterial es la patología más frecuente en un 81,8%, seguido de cardiopatía isquémica en un 30,3%. Recibieron tres diuréticos (furosemida, espirolactona, hidroclorotiazida) el 48,5% de los pacientes y dos diuréticos el 48,5%. El 51,5% de los pacientes tenían potasio bajo y el 57,6% sodio bajo. En un 50% de los pacientes se encuentra que el potasio y sodio están bajos que se relaciona con el uso de diuréticos y una dieta hiposódica. Habría que considerar el uso de suplemento de potasio en estos casos.

Heart failure a syndrome caused by multiple factors engenders a process of ventricular remodeling. It is an enormous public health problem, with an increasing number of hospitalizations. Diuretics, still useful for treatment, produce electrolyte abnormalities can cause arrhythmias, worsening heart failure and larger reduction in the ejection fraction. This study evaluated the alteration of sodium and potassium levels in patients hospitalized with this syndrome. We reviewed the charts of patients with heart failure admitted to the cardiology service, recording data with the use of a standardized form. We reviewed 33 records for 11 women and 22 men with a mean age of 72.64 and 71.52 years respectively. The average number of days of hospitalization was 14.91 days. All patients had a low sodium diet except one because of diarrhea. A single pathology was present in 57.6% with the rest having two or three. Hypertensión was the most frequent pathology in 81.8% , followed by ischemic heart disease in 30.3%. Three diuretics (furosemide, spironolactone, hydrochlorothiazide) were used in 48.5% of patients and two diuretics in 48.5%. In 51.5 of patients there was low potassium and in 57.6% low sodium. Potassium and sodium were low in 50% of patients, which was associated with the use of diuretics and a low salt diet. Potassium supplements should be considered in these cases.

Enhanced external counterpulsation: mechanisms of action and clinical applications.

Symptomatic coronary artery disease (CAD) and heart failure (HF), either of ischaemic or nonischaemic aetiology, are common medical problems. Despite optimal medical treatment and improved revascularisation techniques, a significant number of patients are not successfully managed.Among the non-pharmacological, alternative, non-invasive treatments suggested for these patients, enhanced external counterpulsation (EECP) is considered the most effective one. EECP, administered in an outpatient setting, consists of three pneumatic cuffs applied to each of the patient's legs that are sequentially inflated and deflated synchronised with the cardiac cycle. Numerous clinical trials have shown that EECP is safe and effective in patients with ischaemic heart disease, with or without left ventricular dysfunction, improving their quality of life. EECP appears to be beneficial as an adjunctive therapy in patients with HF of any aetiology. Cardiac syndrome X has been shown to be effectively treated with EECP. Research in EECP expanded in its potential use for entities other than heart disease. More trials are necessary, including sham-controlled trials, to further establish EECP among medical society.

Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy.

BACKGROUND: Recurrent chest pain in the absence of coronary artery disease is a common problem that sometimes leads to excess use of medical care. Although many studies examine the causes of pain in these patients, few clinical trials have evaluated treatment. The studies reviewed in this paper provide an insight into the effectiveness of psychological interventions for this group of patients. OBJECTIVES: To investigate psychological treatments for non-specific chest pain (NSCP) with normal coronary anatomy. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2008, Issue 4), MEDLINE (1966 to December 2008), CINAHL (1982 to December 2008) EMBASE (1980 to December 2008), PsycINFO (1887 to December 2008), the Database of Abstracts of Reviews of Effectiveness (DARE) and Biological Abstracts (January 1980 to December 2008). We also searched citation lists and approached authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) with standardised outcome methodology that tested any form of psychotherapy for chest pain with normal anatomy. Diagnoses included non-specific chest pain, atypical chest pain, syndrome X, or chest pain with normal coronary anatomy (as either inpatients or outpatients). DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, extracted data and assessed quality of studies. The authors contacted trial authors for further information about the RCTs included. MAIN RESULTS: Ten RCTs (484 participants) were included. There was a significant reduction in reports of chest pain in the first three months following the intervention; fixed effects relative risk = 0.68 (95% CI 0.57 to 0.81). This was maintained from 3 to 9 months afterwards; relative risk = 0.59 (95% CI 0.45 to 0.76). There was also a significant increase in the number of chest pain free days up to three months following the intervention; mean difference = 2.81 (95% CI 1.28 to 4.34). This was associated with reduced chest pain frequency (mean difference = -1.73 (95% CI -2.21 to -1.26)) and severity (mean difference = -6.86 (95% CI -10.74 to -2.97)). However, there was high heterogeneity and caution is required in interpreting these results. Wide variability in outcome measures made integration of studies for secondary outcome measures difficult to report on. AUTHORS' CONCLUSIONS: This review suggests a modest to moderate benefit for psychological interventions, particularly those using a cognitive-behavioural framework, which was largely restricted to the first three months after the intervention. Hypnotherapy is also a possible alternative. The evidence for brief interventions was less clear. Further RCTs of psychological interventions for NSCP with follow-up periods of at least 12 months are needed.

Persistent chest pain and no obstructive coronary artery disease.

Patients with persistent chest pain and no obstructive coronary artery disease are often labeled as having noncardiac pain and not offered further cardiologic testing or treatment. Diagnostic uncertainty for persistent chest pain is associated with adverse quality of life, morbidity, and health care costs. Two underdiagnosed cardiac causes for persistent chest pain include microvascular coronary disease and abnormal cardiac nociception. Microvascular coronary disease is associated with an increased risk of adverse cardiovascular events such as myocardial infarction, congestive heart failure, and sudden cardiac death, and treatment directed at improving endothelial function can improve outcomes. Abnormal cardiac nociception is also a cause for persistent chest pain caused by heightened coronary pain perception. Coronary reactivity testing allows for direct measurement of blood flow characteristics in response to vasoactive agents for the diagnoses of microvascular coronary disease and can be a useful tool to differentiate causes of chest pain. Coronary reactivity testing is an invasive method for assessing coronary vascular function, with current evidence suggesting that its associated risk is relatively low compared with the adverse prognosis associated with microvascular coronary dysfunction. Accurate diagnosis in patients with persistent chest pain and normal coronary arteries can be challenging and deserves adequate investigation in light of the associated morbidity, mortality, and health care costs.