Probiotic Supplementation and Systemic Inflammation in Relapsing-Remitting Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Author(s):  
Seyed Ahmad Hosseini ◽  
Shima Nematollahi ◽  
Durdana Husain ◽  
Nasrin Banaei-Jahromi ◽  
Nastaran Majdinasab ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Systemic Inflammation ◽  
Intervention Group ◽  
Serum Levels ◽  
Intestinal Microbiome ◽  
Control Group ◽  
Probiotic Supplementation ◽  
Double Blind ◽  
Factors Associated ◽  
Significant Difference

Abstract Background: Multiple sclerosis (MS) is a complex inflammatory disease in which demyelination occurs in the central nervous system affecting approximately 2.5 million people worldwide. Intestinal microbiome changes play an important role in the etiology of chronic diseases. This study aimed to investigate the effect of probiotic supplementation on systemic inflammation in patients with MS.Methods: A twenty-four-week double-blind clinical trial study was designed and seventy patients with MS were randomly divided into two groups receiving probiotics and placebo. Patients in the intervention group received two capsules containing multi-strain probiotics daily and patients in the control group received the same amount of placebo. Factors associated with systemic inflammation were assessed at the beginning and end of the study.Results: Sixty-five patients were included in the final analysis. There was no significant difference between the two groups in terms of baseline variables except for the duration of the disease (P>0.05). At the end of the study, probiotic supplementation compared to the placebo caused a significant reduction in the serum levels of CRP (-0.93± 1.62 vs. 0.05 ± 1.74, P=0.03), TNF-a ( -2.09 ± 1.88 vs. 0.48 ± 2.53, P=0.015) and IFN-γ (-13.18± 7.33 vs. -1.93± 5.99, P<0.001). Also, we found a significant increase in the FOXP3 and TGF-β levels in the intervention group (P<0.05).Conclusion: The results of our study showed that supplementation with probiotics can have beneficial effects on serum levels of some factors associated with systemic inflammation.Trial registration: Approved by the Ethics Committee of the Ahwaz Jundishapur University of Medical Sciences, Ahvaz, Iran. This study was registered within Iranian Registry of Clinical Trials (IRCT) ( http://www.irct.ir) under the number IRCT20181210041918N2.

scholarly journals Fatigue, Stigma, and Mood in Patients with Multiple Sclerosis: Effectiveness of Guided Imagery

2021 ◽  
Author(s):  
Mina Beitollahi ◽  
Mansooreh Azizzadeh Forouzi ◽  
Batool Tirgari ◽  
Yunes Jahani
Keyword(s):  
Multiple Sclerosis ◽  
Guided Imagery ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Cost Effective Method ◽  
Significant Difference ◽  
The Mean

Abstract Background and objectives : The present study aimed to assess the effectiveness of guided imagery on fatigue, stigma, and mood in patients with multiple sclerosis. Methods This clinical trial is a double-blind study that was conducted on 60 patients with multiple sclerosis referred to the largest center for special diseases in the southeast of Iran in 2020. The convenience sampling method was used to select the participants who were later divided into two groups of intervention (n=30) and control (n=30) using block randomization method. The intervention group listened to the guided imagery audio file at home for 25 minutes. The control group did not receive any intervention. Data were collected by demographic information questionnaires, Fatigue Severity Scale (FSS), Reece Stigma Scale for Multiple Sclerosis (RSS-MS), and the Profile of Mood States (POMS) before and one month after the intervention. Results According to the results, there was no significant difference between the two groups before the intervention in terms of the score of fatigue (P<0.0=67), stigma (P<0.64), and mood (P<0.17). However, after the intervention, a significant differences was observed in this regard (P<0.0001). In the intervention group, the mean score of fatigue decreased from 59.72±18.32 to 35.8±16.15, and the mean score of stigma decreased from 17.31±15.62 to 5.09±8.06, showing a significant reduction in the levels of fatigue (P<0.0001) and stigma (P<0.0001) compared to before intervention. Also, the mean score of mood decreased from 36.90±12.21 to 28.55±11.87, indicating an improvement in the mood of samples in the intervention group (P<0.0001). Conclusions The results indicated that guided imagery, as a cost-effective method, can decrease the fatigue and stigma, and enhance the mood of patients with MS. Therefore, nursing staff can use this method to improve MS patients’ mood and decrease their fatigue and stigma.

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

scholarly journals Is Systemic Inflammation Associated With Elevated PSA Serum Levels In Patients Submitted Chronic Hemodialysis?

10.3823/2522 ◽  
2017 ◽  
Vol 10 ◽  
Author(s):  
Gilmar Pereira Silva ◽  
Vitor Pereira Xavier Grangeiro
Keyword(s):  
Systemic Inflammation ◽  
Serum Levels ◽  
Chronic Hemodialysis ◽  
Control Group ◽  
Inclusion Criteria ◽  
Reactive Protein ◽  
Free Psa ◽  
Significant Difference ◽  
Level Elevation ◽  
Hs Crp

Backgroundː whereas that systemic inflammation (SI) affects 40–60% of patients on hemodialysis (HD) is characterized by serum C-reactive protein (CRP) level elevation or proinflammatory interleukin production or both. We evaluated the association between SI and total (tPSA) and free PSA (fPSA) in patients on HD with tPSA <4ng / ml. Methodsː Sixty patients with chronic kidney disease (CKD) undergoing HD and 20 controls were included. Inclusion criteria were patients aged 18-60 years; tPSA < 4 ng/mL without clinically detectable prostate cancer; and patients undergoing HD for >6 months. Patients were excluded if they had local infections or SI. Hs-CRP was measured using turbidimetry, and tPSA and fPSA levels using immunochemoluminescence. Overall, 27 patients had inflammation (hs-CRP >5 mg/L) and 33 had no inflammation (hs-CRP was ≤5 mg/L). In the control group, hs-CRP was ≤ 1 mg/L. Resultsː there was no significant difference in mean levels among groups 3 and 4 for age (p=0,058), tPSA (p=0,74) and fPSA (p=0,30). The SI did not promote differences between groups 1, 2 and 4 for the levels of tPSA (0,71 ± 0,18  vs   0,67 ± 0,15  vs  0,67 ± 0,11; p=0,69) and fPSA (0,34  ±  0,01  vs  0,34  ±  0,01  vs   0,35  ±  0,01, p= 0,59) . As well as maintained no correlation with tPSA and fPSA (p>0,05). Conclusionː The systemic inflammation in hemodialytic patients without clinically detectable cancer (PSA<4ng/ml) is no associated with changes fractions of tPSA and fPSA.

The efficacy of multidisciplinary rehabilitation in stable multiple sclerosis patients

2006 ◽  
Vol 12 (2) ◽  
pp. 235-242 ◽  
Author(s):  
L K Storr ◽  
P S Sørensen ◽  
M Ravnborg
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Bodily Pain ◽  
Intervention Group ◽  
Inpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Multidisciplinary Rehabilitation ◽  
Upper Limb Function ◽  
Multiple Sclerosis Patients

Objective To evaluate the short-term efficacy of multidisciplinary, inpatient rehabilitation of multiple sclerosis (MS) patients. Methods A double-blind, randomized, parallel group design was used. The intervention group were offered comprehensive, multidisciplinary inpatient rehabilitation at the Haslev MS Hospital for an average of 35.5 days, while the control group received no treatment related to the study. All patients were examined in their homes twice with a 10-week interval. The rehabilitation of the intervention group started 2-3 weeks after the first examination and ended 2-3 weeks before the second examination. Impairment was assessed by the Multiple Sclerosis Impairment Scale and the Expanded Disability Status Scale. Disability was assessed by means of Guy’s Neurological Disability Scale. Two specific scales were used to assess upper limb function and ambulation: The Nine-Hole Peg Test and timed 10-metre walking. Patients’ own perception of bodily pain, bladder symptoms, spasticity, fatigue, impaired walking and transfers were recorded using visual analogue scales. Finally, quality of life was assessed using the Life Appreciation and Satisfaction Questionnaire and the Functional Assessment in Multiple Sclerosis. Patients Two hundred and thirty-three patients were screened and of those 38 were included for treatment and 52 as controls. Results We found no statistically significant differences between the two groups in any of the outcome measures. Conclusion Although the study was underpowered, the negative outcome exposes the difficulties in quantitative analyses of the efficacy of multidisciplinary rehabilitation, which is liable to confounding factors such as variation in the indication for treatment, in the placebo effect, and in the reliability and responsiveness of the outcome measures.

scholarly journals A Randomized Control Trial Study to Determine the Effect of Melatonin on Serum Levels of IL-1β and TNF-α in Patients with Multiple Sclerosis

2020 ◽  
Author(s):  
Masoomeh Yosefifard ◽  
Gholamhassan Vaezi ◽  
Ali Akbar Malekirad ◽  
Fardin Faraji ◽  
Vida Hojati
Keyword(s):  
Multiple Sclerosis ◽  
Interleukin 1 ◽  
Serum Levels ◽  
Inflammatory Factors ◽  
Control Group ◽  
Necrosis Factor Alpha ◽  
Treatment Groups ◽  
Tnf Α ◽  
Significant Difference ◽  
The Central Nervous System

Multiple sclerosis (MS) is the most common neurological disease that happens at a young age. MS is an inflammatory disease; associated with the demyelination of the central nervous system. Therefore, some inflammatory factors are effective in the mechanism and progression of the disease. Melatonin, as a multi-effect substance including anti-inflammatory effects, can reduce symptoms of MS in patients with a change in their inflammatory factors level. In this study, 50 MS patients who were referred to the MS Society of Markazi Province were randomly selected. All patients were treated with routine MS treatment (interferon) and were divided into control (25 placebo recipients) and treatment (25 recipients of 3 mg melatonin per day for 24 weeks) groups. Anthropometric data of patients including height, weight, and age were determined. Blood samples were collected after fasting in order to determine serum levels of interleukin 1 beta (IL-1β) and tumor necrosis factor-alpha (TNF-α). Then, samples were immediately centrifuged for serum separation and sera were transferred to a freezer at -80°C and serum levels of these factors were determined; using ELISA kit. The results of this study showed that there was no significant difference between the control and treatment groups in terms of serum levels of TNF-α. However, the level of IL-1β was significantly reduced in the treatment group compared to the control group, indicating that melatonin decreases this inflammatory substance. Our findings suggest a valuable strategy in the treatment of patients who suffer from MS

scholarly journals Impact of supplementation with "multivitamin-mineral" specially formulated to improve fatigue and inflammatory state in patients with multiple sclerosis: A triple-blind, randomized, placebo-controlled trial

2021 ◽  
Author(s):  
Sama Bitarafan ◽  
Elmira Karimi ◽  
Abdorreza Naser Moghadasi ◽  
Razieh Sadat K Kazemi-Mozdabadi ◽  
Zinat Mohammadpour ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Complementary Therapy ◽  
Interleukin 4 ◽  
Control Group ◽  
Fatigue Score ◽  
Number Of Patients ◽  
Significant Difference ◽  
Inflammatory State

Background: Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) with the most common complaint of fatigue. A high number of patients with MS are interested in taking dietary supplements as a complementary therapy. We propose a specially formulated supplement for patients with MS and aim to evaluate its effects on fatigue. Methods: This study was a triple-blind, randomized, placebo-controlled trial using a stratified randomization method according to sex. 46 eligible patients participated in the study, 23 in the placebo group and 23 in the intervention group. The intervention group received two capsules of multivitamin-mineral (MVM) daily for 3 months. Measurements of fatigue and cytokines were performed in all patients at the baseline and after the 3-month intervention Results: Finally, information of 41 participants was used for data analysis. However, fatigue was decreased after supplementation than before, in the intervention group (P = 0.005). There was no significant difference (P = 0.090) between the change of fatigue score in the MVM group (-3.00 ± 4.42) and the control group (-0.40 ± 5.14). Among cytokines, Interleukin 4 (IL-4) significantly increased in the intervention group compared to the placebo (P = 0.030). Conclusion: Our study showed that the present MVM probably could improve the inflammatory state and fatigue in patients with MS.

Orem’s Self-Care Model with Multiple Sclerosis Patients’ Balance and Motor Function

2019 ◽  
Vol 33 (1) ◽  
pp. 46-54
Author(s):  
Ardashir Afrasiabifar ◽  
Zahra Mehri ◽  
Hamid Reza Ghaffarian Shirazi
Keyword(s):  
Multiple Sclerosis ◽  
Motor Function ◽  
Intervention Group ◽  
Self Care ◽  
Nursing Intervention ◽  
Control Group ◽  
Care Model ◽  
Significant Difference ◽  
The Mean ◽  
Multiple Sclerosis Patients

Orem’s self-care model has been introduced as a nursing model to empower participants with chronic diseases. This study aims to investigate the effectiveness of nursing interventions using Orem’s self-care model with multiple sclerosis participants’ balance and motor function. Sixty-three participants with multiple sclerosis were randomly assigned to intervention and control groups. The nursing intervention using Orem’s self-care model was performed for eight sessions of 45–60 minutes in the intervention group. In the intervention group, a significant increase (improvement) was observed in the mean scores of balance before (17.09 ± 1.97) and after the intervention (33.75 ± 6.01). A significant decrease (improvement) was observed in the mean of motor functions before (4.12 ± 0.34) and after the intervention (1.59 ± 0.71) ( p = 0.001). However, no significant difference existed in the mean scores of balance ( p = 0.10) and motor function in the control group ( p = 0.20). The nursing intervention using Orem’s self-care model improved balance and motor function of participants with multiple sclerosis.

scholarly journals The effect of Melissa officinalis syrup on patients with mild to moderate psoriasis: a randomized, double-blind placebo-controlled clinical trial

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Alireza Yargholi ◽  
Leila Shirbeigi ◽  
Roja Rahimi ◽  
Parvin Mansouri ◽  
Mohammad Hossein Ayati
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Herbal Medicines ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Skin Area ◽  
Melissa Officinalis ◽  
Double Blind ◽  
Significant Difference ◽  
Pre Treatment

Abstract Objective Psoriasis is an immune-mediated inflammatory skin disease. It can involve any body skin area, particularly the scalp, lower back, elbows, and knees. There are several topical and systemic therapies for the treatment. Nowadays, herbal medicines are popular treatments for dermatologic conditions. This two-arm parallel, randomized placebo-controlled clinical trial was conducted to examine the hypothesis of the efficacy of Melissa officinalis syrup on patients with mild-to-moderate Plaque psoriasis. Result Among 100 patients, 95 participants completed the trial and five of them withdrew. The mean pruritus intensity and PASI scores decreased significantly in the intervention group compared to the placebo group (P < 0.001). The DLQI score in the intervention group increased post-treatment compared to pre-treatment (P = 0.029); however, there was no significant difference between the intervention and control group at the end of the study (0.065). Trial registration: The trial was registered in the Iranian registry of clinical trials on November 9th, 2019 (https://www.irct.ir/trial/43434; registration number: IRCT20191104045326N1).

scholarly journals Effectiveness of Distraction Therapy on Pain Relief among Children Undergoing Vein-Puncture in a Selected Hospital, Bhubaneswar

2020 ◽  
Vol 07 (02) ◽  
pp. 15-21
Author(s):  
Soumika Debnath ◽  
Keyword(s):  
Intervention Group ◽  
Sampling Technique ◽  
Pain Scale ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Significant Difference ◽  
Post Test ◽  
And Control ◽  
Experimental Group

Aim: The present study is aimed to assess the effect of distraction therapy during venipuncture in reducing pain among 6-12 years children in the selected hospital at Bhubaneswar. Methods: The study was a double blind; Randomized control trial design was used and the formal consent was obtained from Pradyumna Bal Memorial Hospital and the investigator selected 182 samples using consecutive sampling technique and then randomized into experimental and control groups. The intervention group and the control were having 91 samples each. Measurement of pain experienced by the school going children was assessed with the help of Wong-Baker Faces Pain Scale. Descriptive and inferential statistics were used to analyze the data. Result: The mean pain score of children in experimental group was 2.571 and the standard deviation was 2.006. The p value in comparing the pain level of children in control and experimental group was <0.01, which was statistically significant at p<0.05 (confidence interval 95%) level indicating that there was significant difference in the post test level of pain between the experimental and control group. Conclusion: Hence the distraction therapy was responsive in reducing the vein-puncture pain among school going children.

scholarly journals The effects of pulsatile flushing on phlebitis and peripheral intravenous catheters patency

2020 ◽  
pp. 16-25
Keyword(s):  
Clinical Setting ◽  
Intervention Group ◽  
Practical Method ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
And Control ◽  
Intravenous Catheters

Background and Aim: Thrombophlebitis is considered as a major cause of peripheral intravenous catheters (PICs) failure. The flushing technique in the laboratory has been effective in clearing the catheter duct, but its effectiveness in the clinical setting is unknown, therefore, the aim of this study was to determine the effect of pulsatile flushing on phlebitis, type, and duration of PICs patency in patients. Materials and Methods: In this double-blind clinical trial, 71 patients admitted to the inpatient and surgical wards of Imam Khomeini Esfarayen Hospital were randomly assigned to the intervention and control groups after sampling by available methods. In the intervention group, the flushing technique was performed by injecting 1 ml of the normal saline solution for one second, then interrupting less than one second and repeating the injection and interrupting until the end of 5 ml of the solution. The Consequences of this study were phlebitis, duration, and type of PICs patency, which were evaluated every 12 hours by using Jackson's phlebitis instrument and direct observation of the catheter. Results: The incidence of phlebitis in the intervention group was lower than the control group (P<0.001). In addition, two groups had a statistically significant difference in the type of PICs (P<0.001). The median duration of PICs patency in the intervention group was significantly higher than the control group (P<0.001). Conclusion: Pulsatile flushing is an effective technique to increase longevity of PICs and recommended as a practical method in clinical setting.

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