The effect of interferon-β on black holes in patients with multiple sclerosis

Multiple sclerosis (MS) is an immunological disorder of the CNS. Linked to an initial transient inflammation as the result of blood–brain barrier leakage, the disease progresses into a neurodegenerative phase. MRI is the most powerful paraclinical tool for diagnosing and monitoring MS. Although contrast enhancing lesions are the visible events of blood–brain barrier breakdown, accumulation of hypointense lesions, namely black holes, are recognised as irreversible axonal loss. IFN-β is administered as a first-line drug in MS patients. However, whether the effect of IFN-β extends beyond just prevention of blood–brain barrier leakage and further prevents the formation of black holes or promotes their recovery once formed, is not yet understood.     

Sustained onabotulinumtoxinA therapeutic benefits in patients with chronic migraine over 3 years of treatment

Background

Evidence on whether the therapeutic effect and good safety profile of onabotulinumtoxinA (Botox®) in chronic migraine (CM) patients is maintained over long term treatment is still limited. We herein aimed at assessing whether there is a sustained benefit and good safety with repeated onabotulinumtoxinA sessions in CM over more than three years of treatment.

Methods

We prospectively enrolled 65 CM patients, who were classified as responders after three sessions of onabotulinumtoxinA and were eligible to further continue treatment. Data documenting longitudinal changes from the trimester after the third onabotulinumtoxinA administration (T1) to the trimester after completing two years of treatment (T2) and eventually to the trimester after completing three years of treatment (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of >?4/10, and (iii) mean number of days with use of any acute headache medication, were prospectively collected from patients’ headache diaries.

Results

A total of 56 (86.1%) of 65 patients achieved to attain onabotulinumtoxinA over three years. At T3, a significant reduction in mean monthly headache days was evident, compared to T1 (3.4?±?1.7 vs 7.2?±?3.8; P <?0.001) with diminished mean number of monthly days with peak headache intensity of more than 4/10 and a significant change in days using acute headache medications per month between T1 and T3 (2.8?±?1.3 vs 4.7?±?3.2; P?<?0.001). Significant changes were also noticed in all efficacy variables from T2 to T3. Therapy was safe and well tolerated with low rates of adverse events or drop-outs.

Conclusion

The long -term treatment with onabotulinumtoxinA proved effective, safe and well tolerated over three years. Our findings support the strategy to consistently deliver sessions of use of onabotulinumtoxinΑ over long time in CM patients (Trial registration NTC03606356, registered retrospectively, 28 July 2018).

     

How to predict HCC development in patients with chronic B viral liver disease?

Hepatocellular carcinoma (HCC) is one of the major malignant diseases in Asia. Although no randomized controlled studies have demonstrated decreased mortalities, screening for HCC has become an accepted procedure in the high-risk population. Since the incidence of HCC is strikingly different according to geographical distribution of risk factors, especially chronic hepatitis B virus (HBV) infection, a surveillance strategy in high endemic areas should be established according to national conditions. Chronic necro-inflammation by persistent HBV infection per se can progress to cirrhosis and the occurrence of HCC. As in other chronic liver diseases, the more risk factors the chronic B viral patients have, the higher occurrence of HCC was shown. Based on the risk factors of 4,339 Korean patients, the individual prediction model (IPM) was made by the calculation of relative weighs of risk factors and a self-exploited screening program for HCC was established accordingly. US screening at 6-month intervals was beneficial for the early detection of HCC, especially in the high-risk group, and prolonged survival. The usefulness of a tailored screening program with IPM for HCC was prospectively confirmed. The effective screening system for diagnosis of HCC limited to patients with chronic hepatitis B might be necessitated in high endemic area.     

Health-related quality of life before and during adjuvant interferon-α treatment for patients with malignant melanoma (DeCOG-trial)

Adjuvant treatment with interferon-α (IFN-α) for patients with malignant melanoma can improve relapse-free and overall survival, but IFN-associated side effects may reduce patient's quality of life. The aim of the study was to prospectively evaluate health-related quality of life (HRQoL) in patients with melanoma before and during Low-Dose IFN-α therapy. In a prospective multicenter trial conducted by the Dermatologic Cooperative Oncology Group, 850 patients with cutaneous stage II malignant melanoma received a standard Low-Dose of IFN-α-2a. We evaluated HRQoL using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 questionnaire at baseline and after 3, 6, and 12 months of IFN-α treatment in 282 patients. Nine of 15 subscales showed significant poorer results after 3 months of adjuvant IFN treatment. Symptoms included reduced physical functioning, reduced cognitive functioning, fatigue, nausea, pain, dyspnea, insomnia, diarrhea, and loss of appetite. We did not find a significant change over time for role, emotional, or social functioning. Only cognitive functioning and dyspnea continuously worsened through the twelfth month. At baseline women had significantly lower scores for physical and emotional functioning and for fatigue compared with men. During treatment, women scored significantly poorer on physical functioning, emotional functioning, fatigue, pain, and constipation subscales. Patients who reported having a bad or very bad QoL before treatment were 5.8 times more likely to discontinue treatment early because of psychiatric problems. We conclude that adjuvant low-dose IFN treatment is associated with significant deterioration of HRQoL. Specific psychosocial care should be offered especially for patients who report lower HRQoL and emotional problems before treatment to prevent early discontinuation.     

Effects of homœopathic dilutions of China rubra on intradialytic symptomatology in patients treated with chronic haemodialysis

The effect of the homœopathic medicine China rubra 9CH on symptoms reported by 35 patients with end stage renal failure on regular haemodialysis was investigated. The trial was double-blind, placebo-controlled with a run-in phase and crossover. Assessment was by a questionnaire of symptoms. Statistically significant improvements of asthenia, lethargy and headache were detected on active treatment compared to placebo. There was no significant change in nausea and vomiting.     

Autonomic imbalance in patients with takotsubo cardiomyopathy: cause or association?

Sir, In a recent paper, Akashi et al.¹ examined cardiac autonomicfunctions in patients with reversible takotsubo cardiomyopathy(TC), and suggested that this disorder might be caused by neurogenicstunning of the myocardium due to acute autonomic dysfunction.While these findings are very interesting, and may provide usefulinsight into the pathogenesis of this poorly understood disorder,certain ethical issues and suggested interpretations of thestudy     

Osteopathic treatment in addition to standard care in patients with Gastroesophageal Reflux Disease (GERD) – A pragmatic randomized controlled trial

BackgroundLong-term Proton Pump Inhibitor use is associated with low response rates and the risk of adverse events.ObjectiveThe objective of this study was to assess the effectiveness of Osteopathic Treatment in patients with Gastroesophageal Reflux Disease (GERD).MethodsThis study was a randomized controlled trial with a series of osteopathic interventions and an untreated control group. Patients in the osteopathic group (OG) received 4 osteopathic treatments within a time of eight weeks. The control group (CG) did not receive any osteopathic treatment. Primary outcome parameters were gastrointestinal symptoms, assessed by means of the Reflux Disease Questionnaire (RDQ). Secondary outcome parameters were Quality of life with regards to GERD symptoms, assessed by means of the Quality of Life in Reflux and Dyspepsia (QUOLRAD) questionnaire, medication use and osteopathic dysfunctions.ResultsSeventy patients were randomized. RDQ mean scores decreased statistically significantly in the OG but did not change in the CG; however, these data cannot be interpreted due to a large number of incorrectly completed questionnaires. The between group difference of the changes for the QOLRAD score was statistically significant 0.69 [95%CI = 0.35 to 1.0]. At week 20, changes in the QOLRAD of the OG were sustainable. Medication use decreased substantially in the OG whilst it remained the same in the CG.ConclusionA series of osteopathic treatments might potentially be beneficial for patients suffering from GERD. Future studies should include longer follow-up times and establish the clinical significance of results by introducing a global rating of change measurement.     

Is there an influence of hepatic steatosis on fibrosis and necroinflammation in young patients with chronic viral hepatitis B?

Objectives: Our aim was to investigate the association of liver fibrosis and necroinflammation with HS in untreated young patients with chronic hepatitis B (CHB).

Materials and methods: A retrospective study was conducted in a military hospital in Turkey. A total of 254 subjects with CHB were included in this study. These subjects were divided into two groups: group 1 consisted of patients with hepatic steatosis (HS) according to ultrasonography (USG) and group 2 consisted of non-HS subjects. Sociodemographic, biochemical, histopathological, virological and USG results were recorded for both groups retrospectively. Statistical analysis was performed using SPSS 22.0.

Results: The prevalence of HS was found to be 11.4%. A significant statistical difference was found between group 1 and group 2 regarding the fibrosis degree (p = 0.045). No statistically significant difference was noted between two groups for age, levels of ALT, AST, HBeAg, HBV-DNA levels, HAI scores, diagnosis age and duration of CHB. No difference was noted between the grade of HS and variables. A positive correlation was found between fibrosis groups and the grade of HS (p = 0.012, r = 0.158) and between HAI groups and the grade of HS (p = 0.029, r = 0.137).

Conclusion: The prevalence of steatosis was not higher in patients with CHB. HS is associated with advanced hepatic fibrosis, but not viral liver disease.     

Homœopathy in treatment of patients with fibromyoma of the uterus

The efficacy of homœopathic treatment of patients with firomyoma of the uterus has been studied. Eighty-four patients with various clinical manifestations of the disease were under our observation. All patients received homœopathic therapy only. Besides pelvic examination, real-time ultrasonic scanning was used for evaluation of tumour volume. The period of observation varied from one to three years.In our opinion homœopathy used alone is an effective method of treatment of patients with fibromyoma of the uterus. It is possible to stop the growth of a tumour and even to reduce its size, as well as to control pain and abnormal endometrial bleeding. In the course of investigation certain patterns of response to treatment were found. These require further investigation.     

Anxiety trait in patients with stress-induced cardiomyopathy: a case–control study

Background  

Stress-induced Tako-tsubo cardiomyopathy (TTC) is an acute cardiac syndrome, mimics ST elevation myocardial infarction (STEMI), largely confined to postmenopausal women, frequently precipitated by a stressful event. The pathogenesis of TTC is still unknown. Some authors hypothesized a possible connection between TTC and anxiety disease, but no previous study analyzed the relationship between anxiety trait and TTC. This study sought to assess the potential role of anxiety trait in the development and clinical course of TTC.     

Limited utility of Kinesio Taping® in the physiotherapy treatment for patients with chronic obstructive pulmonary disease exacerbation

Background: Kinesio Taping® has been used as a physiotherapy treatment in musculoskeletal disorders. However, few studies have evaluated its effectiveness in patients with chronic obstructive pulmonary disease (COPD). Objectives: To analyze the effects of Kinesio Taping® associated with conventional physiotherapy, on the maximal inspiratory and expiratory pressures (MIP and MEP), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), and pulse oxygen saturation (SpO2) of patients hospitalized for COPD exacerbation. Methods: Prospective, randomized, single-blinded study. Sixty-two participants who were randomized into two groups: 1) control (medication and standard physiotherapy treatment); and 2) Kinesio Taping® (standard treatment plus application of Kinesio Taping® on the respiratory muscles). The outcomes were assessed 24 hours after the treatment. Results: After the intervention, the Kinesio Taping® group showed a statistically significant increase in all outcomes assessed. However, when the mean differences between groups were analyzed, there were no statistically significant differences in MIP, MEP, FEV1, and PEF. Differences were found only in SpO2 that was improved in the Kinesio Taping® group. Conclusions: The application of Kinesio Taping® associated with physiotherapy improved SpO2 of non-hypoxemic patients with COPD exacerbation. Further studies should be conducted to evaluate the method in the long run and in another outcome.     

Ranolazine (Ranexa®) in the treatment of chronic stable angina

Ischemic heart disease is the major cause of morbidity and mortality in the Western world. Patients often suffer a reduction in quality of life due to chronic stable angina, but therapeutic options can be limited due to concerns for heart rate and blood pressure, as well as side effect profiles. Even revascularization therapy has its limitations and newer agents are required to help in this battle for symptomatic relief. Ranolazine (Ranexa®, A. Menarini Pharma UK, High Wycombe, UK) is a drug with a novel mechanism of action that has been shown in several large trials to be an efficacious adjunctive agent in reducing symptoms of chronic stable angina. It is thought to work by inhibiting the late sodium current in cardiac myocytes, thereby reducing sodium and calcium overload that follows ischemia. This improves myocardial relaxation and reduces left ventricular diastolic stiffness, which in turn enhances myocardial contractility and perfusion. The drug is generally well tolerated and the evidence so far is encouraging, with a clear clinical benefit achieved in the target groups. Its main strength is that it does not appear to affect either heart rate or blood pressure. This review provides an insight into this treatment option, describes the clinical trials evidence, proposed mechanism of action, and pharmacokinetics, and outlines the indications for its use in chronic stable angina.     

The addition of cervical unilateral posterior–anterior mobilisation in the treatment of patients with shoulder impingement syndrome: A randomised clinical trial

Shoulder impingement syndrome (SIS) is a complex, multi-factorial problem that is treated with a variety of different conservative options. One conservative option that has shown effectiveness is manual therapy to the thoracic spine. Another option, manual therapy to the cervical spine, has been studied only once with good results, evaluating short-term outcomes, in a small sample size. The purpose of this study was to investigate the benefit of neck manual therapy for patients with SIS. The study was a randomised, single blinded, clinical trial where both groups received pragmatic, evidence-based treatment to the shoulder and one group received neck manual therapy. Subjects with neck pain were excluded from the study. Comparative pain, disability, rate of recovery and patient acceptable symptom state (PASS) measures were analyzed on the 68 subjects seen over an average of 56.1 days (standard deviation (SD) = 55.4). Eighty-six percent of the sample reported an acceptable change on the PASS at discharge. There were no between-groups differences in those who did or did not receive neck manual therapy; however, both groups demonstrated significant within-groups improvements. On average both groups improved 59.7% (SD = 25.1) for pain and 53.5% (SD = 40.2) for the Quick Disabilities of the Shoulder and Hand Questionnaire (QuickDASH) from baseline. This study found no value when neck manual therapy was added to the treatment of SIS. Reasons may include the lack of therapeutic dosage provided for the manual therapy approach or the lack of benefit to treating the neck in subjects with SIS who do not have concomitant neck problems.