The effect of probiotic Lactobacillus casei Shirota on knee osteoarthritis: a randomised double-blind, placebo-controlled clinical trial

Knee osteoarthritis (OA) treatment is challenging due to inefficacy and adverse effects of current medications. Probiotic treatment has been shown to promote bone metabolism, reduce pain and inflammatory responses of age-related musculoskeletal disorders, including OA. We aimed to investigate the effect of probiotic Lactobacillus casei Shirota (LcS) on patients with knee OA. 537 patients with knee OA were enrolled in this double-blind, placebo-controlled trial, who were randomised to receive skimmed milk containing either LcS or placebo daily for 6 months. Primary outcome was defined as changes in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and VAS (visual analog scale) scores. Secondary outcome was defined as changes in serum levels of high sensitivity C-reactive protein (hs-CRP). After 6 months of treatment, both WOMAC and VAS scores were significantly improved in the LcS groups of patients compared to the placebo group. Serum levels of hs-CRP were also significantly lower in patients receiving LcS than placebo. Strong linear correlations were observed between serum hs-CRP levels and WOMAC and VAS scores. LcS consumption could serve as a novel therapeutic option in the clinical management of knee OA, improving treatment outcome likely through reducing serum hs-CRP levels.

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The probiotic Lactobacillus casei Shirota attenuates symptoms of vestibular migraine: a randomised placebo-controlled double-blind clinical trial

Beneficial Microbes ◽

10.3920/bm2020.0058 ◽

2020 ◽

Vol 11 (5) ◽

pp. 469-476

Author(s):

X. Qi ◽

G. Fan ◽

H. Jia

Keyword(s):

Depressive Symptoms ◽

Lactobacillus Casei ◽

Daily Basis ◽

Vestibular Migraine ◽

Double Blind ◽

Beneficial Effects ◽

Lactobacillus Casei Shirota ◽

Probiotic Lactobacillus ◽

Vestibular Symptoms

Vestibular migraine (VM) has emerged as one of the major vestibular syndromes. Although probiotics have exhibited beneficial effects on migraine headache, its effect on VM is not clear. This trial aimed to investigate the treatment efficacy of the probiotic Lactobacillus casei Shirota (LcS) on symptoms of VM. 247 VM patients were enrolled, of which 204 eligible patients receiving either LcS or placebo on a daily basis completed the 4 month study. They were re-visited at 2 and 4 months after study initiation to assess treatment outcomes. The primary endpoints were vestibular symptoms, evaluated by the number of vertiginous attacks during the past week, the Vertigo Severity Score (VSS), and Dizziness Handicap Inventory (DHI) scores. The secondary endpoints were anxiety and depressive symptoms, evaluated using Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) scores. Efficacy of LcS over placebo was not obvious at 2 month follow-up. At 4 month follow-up, while both LcS and placebo groups of VM patients displayed alleviated symptoms, the extents of the improvements were significantly better in LcS group than those of placebo group, with regard to vestibular symptoms using DHI and VSS, as well as anxiety and depressive symptoms using BAI and BDI. Although placebo effect cannot be ignored in intervention for VM patients, the probiotic LcS still exhibits considerable efficacy against VM symptoms over a 4 month study period, supporting further clinical study of a larger and more diverse cohort.

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Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

BMJ Open ◽

10.1136/bmjopen-2018-024065 ◽

2019 ◽

Vol 9 (5) ◽

pp. e024065 ◽

Cited By ~ 1

Author(s):

Henrik Gudbergsen ◽

Marius Henriksen ◽

Eva Ejlersen Wæhrens ◽

Anders Overgaard ◽

Henning Bliddal ◽

...

Keyword(s):

Weight Loss ◽

Body Weight ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Single Centre ◽

Double Blind ◽

Double Blind Placebo ◽

Knee Oa ◽

Parallel Group ◽

Pain Subscale

IntroductionWith an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.Methods and analysis150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.Ethics and disseminationThe trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numbers2015-005163-16,NCT02905864, U1111-1171-4970Based on protocol versionV.6; 30 January 2017, 15:30 hours

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The effect of probiotic treatment on elderly patients with distal radius fracture: a prospective double-blind, placebo-controlled randomised clinical trial

Beneficial Microbes ◽

10.3920/bm2016.0067 ◽

2016 ◽

Vol 7 (5) ◽

pp. 631-637 ◽

Cited By ~ 19

Author(s):

M. Lei ◽

L-M. Hua ◽

D-W. Wang

Keyword(s):

Clinical Trial ◽

Elderly Patients ◽

Distal Radius Fracture ◽

Distal Radius ◽

Lactobacillus Casei ◽

Radius Fracture ◽

Double Blind ◽

Double Blind Placebo ◽

Lactobacillus Casei Shirota ◽

Probiotic Treatment

Probiotic treatment has been shown to improve bone formation, increase bone mass density and prevent bone loss. We aimed to assess the effect of probiotic treatment on functional recovery in elderly patients with a distal radius fracture. A total of 417 elderly patients with an acute distal radius fracture were enrolled in this double-blind placebo-controlled clinical trial. They were randomised to receive skimmed milk containing either a commercial probiotic (Lactobacillus casei Shirota) or placebo daily for a period of 6 months after the fracture. Treatment outcomes were the DASH (disabilities of the arm, shoulder and hand) score, pain, complex regional pain syndrome (CRPS) score, active range of motion and grip strength, all of which were measured on a monthly basis. Throughout the duration of the study, DASH score, pain, CRPS score, wrist flexion and grip strength of patients receiving probiotics exhibited a significantly faster pace of improvement than those on placebo, with treatment outcomes of patients receiving Lactobacillus casei Shirota at month 4 at comparable levels with those of patients receiving placebo at month 6. In elderly patients with a fracture of the distal radius, administration of the probiotic could greatly accelerating the healing process.

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Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017652 ◽

2017 ◽

Vol 7 (9) ◽

pp. e017652 ◽

Cited By ~ 4

Author(s):

Christelle Nguyen ◽

Isabelle Boutron ◽

Gabriel Baron ◽

Emmanuel Coudeyre ◽

Francis Berenbaum ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Knee Pain ◽

Rating Scale ◽

Controlled Trial ◽

Tertiary Care ◽

Double Blind ◽

Double Blind Placebo ◽

Knee Oa ◽

The Mean ◽

Anti Inflammatory

IntroductionOsteoarthritis (OA) pathophysiology is driven in part by joint inflammation. Resveratrol has in vitro anti-inflammatory properties. We aim to assess the efficacy of oral resveratrol for knee pain at 3 months in people with knee OA.Methods and analysisWe will conduct a randomised double-blind placebo-controlled trial. Overall, 164 individuals with knee OA fulfilling 1986 American College of Rheumatology criteria will be recruited in three tertiary care centres in France and randomised to receive oral resveratrol, 40 mg (two caplets) two times per day for 1 week, then 20 mg (one caplet) two times per day or a matching placebo for a total of 6 months. Randomisation will be centralised and stratified by centre. The allocation ratio of assignments will be 1:1. The primary outcome will be the mean change from baseline in knee pain on a self-administered 11-point pain Numeric Rating Scale at 3 months. Secondary outcomes will be the mean change in knee pain at 6 months, the function subscore of the Western Ontario and McMaster Universities Arthritis Index score, patient global assessment, proportion of responders according to the Osteoarthritis Research Society International–Outcome Measures in Rheumatology criteria at 3 and 6 months, and self-reported number of intra-articular injections of corticosteroids or hyaluronic acid and consumption of analgesics and non-steroidal anti-inflammatory drugs since the last contact. Other interventions will be allowed and self-reported. Adherence will be monitored by capsule counts and a booklet and adverse events recorded at 3 and 6 months. Statisticians, treating physicians and participants will be blinded to the allocated treatment.Ethics and disseminationThe oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by theAgenceNationale de Sécurité du Médicament et des Produits de Santéand ethics were approved by theComité deProtection des Personnes Île-de-FranceIII. The findings of the study will be published in a peer-reviewed journal and disseminated at conferences. The design of ARTHROL will warrant the translation of its findings into clinical practice.Trial registration numberClinicalTrials.gov identifier:NCT02905799. Pre-results. First received: 14 September 2016. Last updated: 16 September 2016. Status: not yet recruiting.

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Evaluation of the effects of roselle (Hibiscus sabdariffa L.) on oxidative stress and serum levels of lipids, insulin and hs-CRP in adult patients with metabolic syndrome: a double-blind placebo-controlled clinical trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2015-0030 ◽

2016 ◽

Vol 13 (2) ◽

Cited By ~ 13

Author(s):

Sedigheh Asgary ◽

Rasool Soltani ◽

Mohsen Zolghadr ◽

Mahtab Keshvari ◽

Nizal Sarrafzadegan

Keyword(s):

Oxidative Stress ◽

Serum Levels ◽

Adult Patients ◽

Controlled Clinical Trial ◽

Hibiscus Sabdariffa ◽

Daily Consumption ◽

Double Blind ◽

Double Blind Placebo ◽

Hs Crp ◽

To Receive

Abstract: Roselle (: Forty adult patients with MetS were randomly assigned to receive either 500 mg of:: Daily consumption of 500 mg of

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Evaluation of the Effects ofVaccinium arctostaphylosL. Fruit Extract on Serum Lipids and hs-CRP Levels and Oxidative Stress in Adult Patients with Hyperlipidemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2014/217451 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 21

Author(s):

Rasool Soltani ◽

Mustafa Hakimi ◽

Sedigheh Asgary ◽

Syed Mustafa Ghanadian ◽

Mahtab Keshvari ◽

...

Keyword(s):

Oxidative Stress ◽

Clinical Trial ◽

Serum Levels ◽

Adult Patients ◽

Controlled Clinical Trial ◽

Fruit Extract ◽

Double Blind ◽

Double Blind Placebo ◽

Hs Crp ◽

And Oxidative Stress

Background.Dyslipidemia produces atherosclerosis, which in turn results in coronary artery disease (CAD). Atherosclerosis is being considered as an inflammatory disease.Vaccinium arctostaphylosL. is a plant with fruits rich in anthocyanins. The aim of this study was to evaluate the effects of fruit extract of this plant on serum levels of lipids, hs-CRP, and malondialdehyde (MDA) as a marker of oxidative stress, in hyperlipidemic adult patients.Methods.In this randomized, double-blind, placebo-controlled clinical trial, 50 hyperlipidemic adult patients were randomly and equally assigned to receive either medicinal (V. arctostaphylosfruit extract) or placebo capsules twice daily for 4 weeks. Each medicinal capsule contained 45 ± 2 mg of anthocyanins. Fasting serum levels of total cholesterol, TG, LDL-C, HDL-C, hs-CRP, and MDA were obtained before and after the intervention and compared.Results. V. arctostaphylosfruit extract significantly reduced total cholesterol (P<0.001), LDL-C (P=0.004), TG (P<0.001), and MDA (P=0.013) compared to placebo but did not have any significant effect on HDL-C (P=0.631) and hs-CRP (P=0.190).Conclusion.Fruit extract ofVaccinium arctostaphyloshas beneficial effects on serum lipid profile and oxidative stress in hyperlipidemic adult patients. Therefore, it could be considered as a supplement for treatment of dyslipidemia and prevention of atherosclerosis development.

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AB1261 DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF PULSED ELECTROMAGNETIC FIELD THERAPY IN KNEE OSTEOARTHRITIS (PRELIMINARY RESULTS)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.6396 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1922.2-1922

Author(s):

D. Karateev ◽

A. Makevnina ◽

A. Tangieva ◽

E. Luchikhina ◽

H. Hamhoeva

Keyword(s):

Electromagnetic Field ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Low Frequency ◽

Clinical Parameters ◽

Pulsed Electromagnetic Field ◽

Double Blind ◽

Double Blind Placebo ◽

Knee Oa ◽

Pulsed Electromagnetic

Background:Pulsed electromagnetic field (PEMF) therapy is widely used in different areas of medicine. There are a lot of portable PEMF therapeutic devices on the market around the world. Nevertheless, the role of PEMF in treatment of rheumatic conditions is not clear. Current evidence is of low and very low quality.Objectives:To study efficacy and safety of PEMF therapy in primary and secondary osteoarthritis (OA) of the knee in controlled clinical trial.Methods:This abstract presents the preliminary results of an ongoing double-blind placebo-controlled trial of PEMF portable therapeutic device “ALMAG+” (Certificate EN ISO 13485:2012+AC:2012 reg.-No 44221 117836, Yelatma Instrument-Making Enterprise, Russian Federation, Reg. Num.: 3007075140). The device is intended for physiotherapeutic treatment and rehabilitation with a low-frequency low-intensity PEMF in medical institutions, as well as at home after the recommendation of a doctor. Patients with primary and secondary (as a part of inflammatory rheumatic disease) OA of knee with Kellgren-Lawrence Grade I-III included in the study (in patients with inflammatory conditions disease activity should be minimal on stable drug therapy). Three courses of PEMF of 20 procedures for 1 year planned in active treatment group and placebo (inactive device) group of 35 patients each. Efficacy is evaluated by pain VAS, WOMAC, Lequesne index, and quality of life studied using SF-36, EuroQoL 5D tools. Instrumental control with knee ultrasound and MRI investigations will be performed. The study protocol was approved by local Ethical Committee.Results:To date 23 patients (7 males, 16 females, age 54,6±11,2 years, primary knee OA – 16 pts, RA- 6 pts, AS – 1 pt) completed 1stcourse of PEMF. Table presents differences (Δ) in the main clinical parameters in active treatment and placebo device groups. No significant difference in ESR or CRP levels was found. No treatment-related adverse events has been reported.Table.Differences (Δ) in the main clinical parameters after a 1stcourse of PEMF.ParameterActive device (n=11)Placebo device (n=12)pΔ VAS pain in movement15 [0; 38,5]5 [1,25; 10,5]0,053Δ VAS pain in rest10 [0; 34]1 [0; 2,75]0,043Δ WOMAC3 [2; 10]2 [0; 4,5]0,174Δ Lequesne index3 [0; 4]1 [0,25; 2,5]0,258Conclusion:In this preliminary analysis pulsed electromagnetic field (PEMF) therapy showed significant impact on pain in rest in knee OA after one course of procedures.References:Negm A, Lorbergs A, Macintyre NJ. Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis. Osteoarthritis Cartilage. 2013 Sep;21(9):1281-9. doi: 10.1016/j.joca.2013.06.015Disclosure of Interests:Dmitry Karateev Consultant of: Abbvie, Pfizer, Biocad, Sanofi, Novartis, Lilly, Speakers bureau: Abbvie, Roche, Pfizer, Biocad, MSD, Sanofi, Johnson & Johnson, Glaxo, UCB, Celgene, Novartis, Lilly, Bayer, Alexandra Makevnina Speakers bureau: Sanofi, Aminat Tangieva: None declared, Elena Luchikhina Consultant of: Abbvie, Biocad, Sanofi, Celgene, Speakers bureau: Abbvie, Roche, Pfizer, Biocad, MSD, Sanofi, Johnson & Johnson, Glaxo, UCB, Celgene, Novartis, Hava Hamhoeva: None declared

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