Study of the effectiveness of hippotherapy on the symptoms of multiple sclerosis - Outline of a randomised controlled multicentre study (MS-HIPPO)

Background: Hippotherapy is a form of therapeutic riding which is used in the treatment of neurological and muscular disorders. Until now there has not been any high- quality randomised study that has proven its effectiveness. Objective: The aims of this study are to evaluate whether hippotherapy (as add-on to physiotherapy and/or pharmacotherapy) is superior to the standard treatment (physiotherapy and/or pharmacotherapy as prior to the study) in terms of balance function and other patient relevant outcomes in patients with multiple sclerosis. Methods: The MS-HIPPO study is a prospective, randomised, examiner-blinded, controlled multicentre study. Patients were randomised to one of two groups: 12 weeks of hippotherapy accompanied by physiotherapy and/or pharmacotherapy (intervention) or 12 weeks of physiotherapy and/or pharmacotherapy as prior to the study (control). The primary endpoint is the change in balance function, as measured by the Berg Balance Scale (BBS). The treatment comparison is evaluated using a covariance analysis with baseline BBS, centre, age, gender and EDSS as covariates. Secondary endpoints include fatigue, quality of life, pain intensity and spasticity. Results and conclusions: The described study is the first randomised study evaluating the benefits of hippotherapy for patients with multiple sclerosis. In 5 national centres ten study physicians will screen potential participants. The expected results will help to improve the knowledge on non- pharmaceutical therapeutic options in this field. (C) 2016 The Authors. Published by Elsevier Inc

Hippotherapy for patients with multiple sclerosis: A multicenter randomized controlled trial (MS-HIPPO)

Background: Evidence-based complementary treatment options for multiple sclerosis (MS) are limited. Objective: To investigate the effect of hippotherapy plus standard care versus standard care alone in MS patients. Methods: A total of 70 adults with MS were recruited in five German centers and randomly allocated to the intervention group (12weeks of hippotherapy) or the control group. Primary outcome was the change in the Berg Balance Scale (BBS) after 12weeks, and further outcome measures included fatigue, pain, quality of life, and spasticity. Results: Covariance analysis of the primary endpoint resulted in a mean difference in BBS change of 2.33 (95% confidence interval (CI): 0.03-4.63, p=0.047) between intervention (n=32) and control (n=38) groups. Benefit on BBS was largest for the subgroup with an Expanded Disability Status Scale (EDSS)5 (5.1, p=0.001). Fatigue (-6.8, p=0.02) and spasticity (-0.9, p=0.03) improved in the intervention group. The mean difference in change between groups was 12.0 (p<0.001) in physical health score and 14.4 (p<0.001) in mental health score of Multiple Sclerosis Quality of Life-54 (MSQoL-54). Conclusion: Hippotherapy plus standard care, while below the threshold of a minimal clinically important difference, significantly improved balance and also fatigue, spasticity, and quality of life in MS patients

Time to diagnosis in multiple sclerosis: Epidemiological data from the German Multiple Sclerosis Registry

Objective: To investigate the time to diagnosis in multiple sclerosis (MS) in Germany. Methods: Analysis of real-world registry data from the German Multiple Sclerosis Registry (GMSR) and performing a primary analysis in patients where month-specific registration of the dates of onset and diagnosis was available. Results: As of January 2020, data of a total of 28,658 patients with MS were extracted from the GMSR, with 9836 patients included in the primary analysis. The mean time to diagnosis was shorter following the introduction of the first magnetic resonance imaging (MRI)-based McDonald criteria in 2001. This effect was most pronounced in younger adults below the age of 40 years with relapsing onset multiple sclerosis (ROMS), with a decrease from 1.9 years in 2010 to 0.9 years in 2020, while unchanged in patients aged 40-50 years (1.4 years in 2010 and 1.3 years in 2020). In the limited number of paediatric onset MS patients, the time to diagnosis was longer and did not change (2.9 years). Conclusion: The current sensitive MRI-based diagnostic criteria have likely contributed to an earlier diagnosis of MS in Germany in younger adults aged 18-39 years with ROMS. Whether this translated to earlier initiation of disease-modifying treatment or had a beneficial effect on patient outcomes remains to be demonstrated

Predictors and dynamics of postpartum relapses in women with multiple sclerosis

Background: Several studies have shown that pregnancy reduces multiple sclerosis (MS) relapses, which increase in the early postpartum period. Postpartum relapse risk has been predicted by pre-pregnancy disease activity in some studies. Objective: To re-examine effect of pregnancy on relapses using the large international MSBase Registry, examining predictors of early postpartum relapse. Methods: An observational case-control study was performed including pregnancies post-MS onset. Annualised relapse rate (ARR) and median Expanded Disability Status Scale (EDSS) scores were compared for the 24 months pre-conception, pregnancy and 24 months postpartum periods. Clustered logistic regression was used to investigate predictors of early postpartum relapses. Results: The study included 893 pregnancies in 674 females with MS. ARR (standard error) pre-pregnancy was 0.32 (0.02), which fell to 0.13 (0.03) in the third trimester and rose to 0.61 (0.06) in the first three months postpartum. Median EDSS remained unchanged. Pre-conception ARR and disease-modifying treatment (DMT) predicted early postpartum relapse in a multivariable model. Conclusion: Results confirm a favourable effect on relapses as pregnancy proceeds, and an early postpartum peak. Preconception DMT exposure and low ARR were independently protective against postpartum relapse. This novel finding could provide clinicians with a strategy to minimise postpartum relapse risk in women with MS planning pregnancy

Seasonal variation of relapse rate in multiple sclerosis is latitude dependent

Objective: Previous studies assessing seasonal variation of relapse onset in multiple sclerosis have had conflicting results. Small relapse numbers, differing diagnostic criteria, and single region studies limit the generalizability of prior results. The aim of this study was to determine whether there is a temporal variation in onset of relapses in both hemispheres and to determine whether seasonal peak relapse probability varies with latitude. Methods: The international MSBase Registry was utilized to analyze seasonal relapse onset distribution by hemisphere and latitudinal location. All analyses were weighted for the patient number contributed by each center. A sine regression model was used to model relapse onset and ultraviolet radiation (UVR) seasonality. Linear regression was used to investigate associations of latitude and lag between UVR trough and subsequent relapse peak. Results: A total of 32,762 relapses from 9,811 patients across 30 countries were analyzed. Relapse onset followed an annual cyclical sinusoidal pattern with peaks in early spring and troughs in autumn in both hemispheres. Every 10° of latitude away from the equator was associated with a mean decrease in UVR trough to subsequent relapse peak lag of 28.5 days (95% confidence interval = 3.29–53.71, p = 0.028). Interpretation: We demonstrate for the first time that there is a latitude-dependent relationship between seasonal UVR trough and relapse onset probability peak independent of location-specific UVR levels, with more distal latitude associated with shorter gaps. We confirm prior meta-analyses showing a strong seasonal relapse onset probability variation in the northern hemisphere, and extend this observation to the southern hemisphere

Multiple sclerosis in Latin America: A different disease course severity? A collaborative study from the MSBase Registry

Limited data suggest that multiple sclerosis (MS) in Latin America (LA) could be less severe than in the rest of the world. The objective was to compare the course of MS between LA and other regions. Methods: Centers from 18 countries with &gt;20 cases enrolled in the MSBase Registry participated. Patients with MS with a disease duration of &gt;1 year and &lt;30 years at time of EDSS measurement were evaluated. The MS Severity Score (MSSS) was used as a measure of disease progression. Comparisons among regions (North America, Europe, Australia and LA), hemispheres and countries were performed. Results: A total of 9610 patients were included. Patients were from: Europe, 6290 (65.6%); North America, 1609 (16.7%); Australia, 1119 (11.6%); and LA, 592 (6.1%). The mean MSSS in patients from LA was 4.47±2.8, 4.53±2.8 in North America, 4.51±2.8 in Europe and 4.49±2.7 in Australia. Mean MSSS in the northern hemisphere was 4.51±1.6 compared to 4.48±1.9 in the southern hemisphere. No differences were found for MSSS among hemispheres (p ¼ 0.68), regions (p ¼ 0.96) or countries (p ¼ 0.50). Conclusions: Our analyses did not discover any difference in mean MSSS among patients from different regions, hemispheres or countries

Baseline demographic and clinical data in patients unmatched and matched by the propensity score.

<p>CIS, clinical isolated syndrome; EDSS, Expanded Disability Status Scale; MS, multiple sclerosis; PPMS, primary progressive multiple sclerosis; RRMS, relapsing-remitting multiple sclerosis; SD, standard deviation; SPMS, secondary progressive multiple sclerosis.</p