scholarly journals L-Carnitine supplementation ameliorates serum tumor necrosis factor-alpha and matrix metalloproteinase-3 in knee osteoarthritis women

2017 ◽  
Vol 12 (1) ◽  
pp. 28 ◽  
Author(s):  
Reza Mahdavi ◽  
Sousan Kolahi ◽  
Vahideh Ebrahimzadeh Attari ◽  
Aida Malek Mahdavi
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Global Assessment ◽  
Intervention Group ◽  
Controlled Study ◽  
Carnitine Supplementation ◽  
Double Blind ◽  
Necrosis Factor Alpha ◽  
Matrix Metalloproteinase 3 ◽  
Significant Difference

<p class="Abstract">Seventy-two females with mild to moderate knee osteoarthritis were included in this randomized double-blind placebo-controlled study. Patients in the intervention group (n=36) received L-carnitine supplement (750 mg/day) for two months. L-Carnitine supplementation led to decrease in serum TNF-α and MMP-3 levels significantly in comparison with the baseline (p&lt;0.001 and p&lt;0.001, respectively) and placebo group (p&lt;0.001 and p=0.03, respectively). In addition, physician’s global assessment of the severity of osteoarthritis decreased significantly in the L-carnitine group (p&lt;0.001) and placebo group (p=0.012) after supplementation. At the end of the study, a significant difference was observed between the two groups for mean physician’s global assessment of the severity of osteoarthritis (p&lt;0.001), adjusted for baseline values and duration of osteoarthritis. L-Carnitine supplementation has beneficial effects in reducing inflammatory biomarkers in knee osteoarthritis patients which subsequently leads to the alleviation of disease symptoms.</p>

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

scholarly journals Gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo-Controlled Double-Blind Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Myung Kwan Kim ◽  
Jungtae Leem ◽  
Young Il Kim ◽  
Eunseok Kim ◽  
Yang Chun Park ◽  
...  
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Subgroup Analysis ◽  
Primary Outcome ◽  
Pain Medication ◽  
Outcome Analysis ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Vas Score ◽  
Significant Difference

Background. Gyejigachulbutang (GUI-ZHI-JIA-SHU-FU-TANG, GCB) is an herbal formula widely prescribed in traditional East Asian medicine practice for arthritis and muscle pain. We evaluated the efficacy and safety of GCB for degenerative knee osteoarthritis (KOA). Methods. Eighty patients with KOA were randomly assigned to the GCB group or the placebo group in a 1 : 1 ratio in two Korean medicine hospitals. Patients took GCB or placebo three times a day for 4 weeks. Primary outcome was the change in the visual analogue scale (VAS) score for knee pain from baseline to 4th week. Secondary outcomes were the change in the VAS score from baseline to 2nd week and 8th week, Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), European Quality of Life Five Dimensions questionnaire (EQ-5D), and safety. Results. There was no significant difference between the compared indicators of the GCB and placebo groups. However, in subgroup analysis, GCB was effective for subjects with a BMI lower than 25 kg/m2. The dose of pain medication was significantly lower in the GCB group than in the placebo group after four weeks ( p = 0.016 ). There were no serious adverse events in the GCB group. Conclusions. GCB was not effective in primary outcome analysis. In exploratory subgroup analysis, GCB might be effective for individuals with BMI lower than 25 kg/m2 for the treatment of degenerative KOA. GCB may also help reduce the consumption of pain medication. Furthermore, research is required for our hypothesis. This trial is registered with KCT0003024.

scholarly journals Efficacy of Synbiotics for Treatment of Bacillary Dysentery in Children: A Double-Blind, Randomized, Placebo-Controlled Study

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Manijeh Kahbazi ◽  
Marzieh Ebrahimi ◽  
Nader Zarinfar ◽  
Mohammad Arjomandzadegan ◽  
Taha Fereydouni ◽  
...  
Keyword(s):  
Weight Loss ◽  
Placebo Group ◽  
Standard Treatment ◽  
Bacillary Dysentery ◽  
Controlled Study ◽  
Double Blind ◽  
Weight Losses ◽  
Significant Difference ◽  
Duration Of Hospitalization ◽  
The Mean

Bacillary dysentery is a major cause of children’s admission to hospitals. To assess the probiotic and prebiotic (synbiotics) effects in children with dysentery in a randomized clinical trial, 200 children with dysentery were studied in 2 groups: the synbiotic group received 1 tablet/day of synbiotic for 3–5 days and the placebo group received placebo tablets (identical tablet form like probiotics). The standard treatment was administered for all patients. Duration of hospitalization, dysentery, fever, and the weight loss were assessed in each group. It was concluded that there was no significant difference in both groups in the baseline characteristics. The mean duration of dysentery reduced (P<0.05). The mean duration of fever has been significantly reduced in the synbiotic group (1.64±0.87days) in comparison to the placebo group (2.13±0.94days) (P<0.001). Average amount of weight loss was significantly lower in the synbiotic group in comparison to that in the placebo group (129.5±23.388grams and278±28.385grams, resp.;P<0.001). There was no significant difference in the mean duration of hospitalization in both groups (P>0.05). The use of synbiotics as an adjuvant therapy to the standard treatment of dysentery significantly reduces the duration of dysentery, fever, and rate of weight losses. The trial is registered withIRCT201109267647N1.

scholarly journals Effect of vitamin D supplementation on selected inflammatory biomarkers in older adults: a secondary analysis of data from a randomised, placebo-controlled trial

2015 ◽  
Vol 114 (5) ◽  
pp. 693-699 ◽  
Author(s):  
Mary Waterhouse ◽  
Bich Tran ◽  
Peter R. Ebeling ◽  
Dallas R. English ◽  
Robyn M. Lucas ◽  
...  
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Post Intervention ◽  
Double Blind ◽  
Specific Patient ◽  
Significant Difference

AbstractObservational studies have suggested that 25-hydroxyvitamin D (25(OH)D) levels are associated with inflammatory markers. Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups. Thus, we aimed to determine the effect of supplementary vitamin D using secondary data from a population-based, randomised, placebo-controlled, double-blind trial (Pilot D-Health trial 2010/0423). Participants were 60- to 84-year-old residents of one of the four eastern states of Australia. They were randomly selected from the electoral roll and were randomised to one of three trial arms: placebo (n 214), 750 μg (n 215) or 1500 μg (n 215) vitamin D3, each taken once per month for 12 months. Post-intervention blood samples for the analysis of C-reactive protein (CRP), IL-6, IL-10, leptin and adiponectin levels were available for 613 participants. Associations between intervention group and biomarker levels were evaluated using quantile regression. There were no statistically significant differences in distributions of CRP, leptin, adiponectin, leptin:adiponectin ratio or IL-10 levels between the placebo group and either supplemented group. The 75th percentile IL-6 level was 2·8 pg/ml higher (95 % CI 0·4, 5·8 pg/ml) in the 1500 μg group than in the placebo group (75th percentiles:11·0 v. 8·2 pg/ml), with a somewhat smaller, non-significant difference in 75th percentiles between the 750 μg and placebo groups. Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation, we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels, with the possible exception of IL-6.

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

2010 ◽  
Vol 69 (11) ◽  
pp. 1926-1928 ◽  
Author(s):  
Nick Barkham ◽  
Laura C Coates ◽  
Helen Keen ◽  
Elizabeth Hensor ◽  
Alexander Fraser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Ankylosing Spondylitis ◽  
Clinical Outcomes ◽  
Job Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Gait Parameters ◽  
Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

scholarly journals Randomised, Double-Blind, Placebo-Controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis

2021 ◽  
Vol 8 ◽  
Author(s):  
Yan Li ◽  
Kunpeng Li ◽  
Zheng Zhao ◽  
Yanyan Wang ◽  
Jingyu Jin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Physical Function ◽  
Combined Treatment ◽  
Final Analysis ◽  
Spinal Mobility ◽  
Controlled Study ◽  
Double Blind ◽  
Significant Difference

Background and Purpose: The effect of Iguratimod in the treatment of rheumatoid arthritis was confirmed in past studies. In terms of the mechanism of the effect and clinical application experience, Iguratimod has a potential value in the treatment of spondyloarthritis (SpA). This study evaluated the efficacy and safety of Iguratimod on active SpA.Methods: Subjects with active SpA were enrolled and randomly divided into two groups at a ratio of 1:2 (placebo vs. Iguratimod). On the basis of non-steroidal anti-inflammatory drugs, combined treatment with Iguratimod or placebo, followed by follow-up every 4 weeks for 24 weeks. The primary efficacy endpoint was to evaluate the alleviation rate of ASAS20; the important improvement of ASDAS and the efficacy of spinal mobility, physical function and quality of life at the 24th week.Results: A total of 48 cases in the Iguratimod group and 25 cases in the placebo group were included in the final analysis. On the 24th week, the percentage of responders to ASAS20 (80 vs. 44%) and ASAS40 (56 vs. 20%) treated with Iguratimod were significantly higher than that in the placebo group (P &lt; 0.05). Twelve cases had gastrointestinal discomfort, of which eight were in the Iguratimod group (16.7%, one case withdrew from the study due to diarrhoea) and four were in the placebo group (16.0%). No significant difference was found between the two groups (P &lt; 0.05). Three cases of elevated transaminase were observed in the Iguratimod group and none in the placebo group, with no significant difference (P &lt; 0.05).Conclusion: Iguratimod could significantly reduce the symptoms and signs of patients with active SpA. It could improve the physical function and quality of life of these patients and the overall safety and tolerance are good.

scholarly journals Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial

2009 ◽  
Vol 69 (01) ◽  
pp. 113-119 ◽  
Author(s):  
X Chevalier ◽  
J Jerosch ◽  
P Goupille ◽  
N van Dijk ◽  
F P Luyten ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Outcome Measures ◽  
Global Assessment ◽  
Treatment Phase ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Double Blind ◽  
Repeat Treatment ◽  
Primary Osteoarthritis ◽  
Study Results

Objectives:The primary objective was to compare a single, 6 ml, intra-articular injection of hylan G-F 20 with placebo in patients with symptomatic knee osteoarthritis. The safety of a repeat injection of hylan G-F 20 was also assessed.Methods:Patients with primary osteoarthritis knee pain were randomly assigned to arthrocentesis plus a 6 ml intra-articular injection of either hylan G-F 20 or placebo in a prospective, double-blind (one injector/one blinded observer) study. Results were evaluated at 4, 8, 12, 18 and 26 weeks post-injection. The primary outcome criterion was change from baseline over 26 weeks in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index A pain. Secondary outcome measures included WOMAC A1 and C, patient global assessment (PGA) and clinical observer global assessment (COGA) and Outcome Measures in Rheumatology, Osteoarthritis Research Society International responder rates. A 4-week, open, repeat treatment phase evaluated safety only.Results:A total of 253 patients (Kellgren–Lawrence grade II or III) was randomly assigned. Patients receiving hylan G-F 20 experienced statistically significantly greater improvements in WOMAC A pain scores (−0.15, SE 0.076, p = 0.047), and several of the secondary outcome measures (WOMAC A1, PGA and COGA), than patients receiving placebo. There was no difference between the safety results of the two groups. No increased risk of local adverse events was observed in the open, repeat treatment phase.Conclusions:This placebo-controlled study demonstrated that, in patients with knee osteoarthritis, a single 6 ml intra-articular injection of hylan G-F 20 is safe and effective in providing statistically significant, clinically relevant pain relief over 26 weeks, with a modest difference versus placebo.Trial registration number:NCT00131352.

scholarly journals Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Homoeopathic Arnica C30 for Pain and Infection after Total Abdominal Hysterectomy

1997 ◽  
Vol 90 (2) ◽  
pp. 73-78 ◽  
Author(s):  
Oliver Hart ◽  
Mark A Mullee ◽  
George Lewith ◽  
John Miller
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Total Abdominal Hysterectomy ◽  
Abdominal Hysterectomy ◽  
Postoperative Recovery ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Controlled ◽  
Significant Difference

Homoeopathic potencies of arnica have been used for many years to aid postoperative recovery. The effects of arnica C30 on pain and postoperative recovery after total abdominal hysterectomy were evaluated in a double-blind, randomized, controlled study. Of 93 women entered into the study, 20 did not complete protocol treatment: nine were excluded because they failed to comply with the protocol, nine had their operations cancelled or changed within 24 h and two had to be withdrawn because of the recurrence of previously chronic painful conditions. Those who did not complete protocol treatment were equally divided between the arnica (nine patients) and placebo groups (11 patients). 73 patients completed the study, of whom 35 received placebo and 38 received arnica C30. The placebo group had a greater median age and the arnica group had slightly longer operations; nevertheless, no significant difference between the two groups could be demonstrated. We conclude that arnica in homoeopathic potency had no effect on postoperative recovery in the context of our study.

scholarly journals Tacrolimus in the treatment of myasthenia gravis in patients with an inadequate response to glucocorticoid therapy: randomized, double-blind, placebo-controlled study conducted in China

2017 ◽  
Vol 10 (9) ◽  
pp. 315-325 ◽  
Author(s):  
Lei Zhou ◽  
Weibin Liu ◽  
Wei Li ◽  
Haifeng Li ◽  
Xu Zhang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Myasthenia Gravis ◽  
Glucocorticoid Therapy ◽  
Controlled Study ◽  
Inadequate Response ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Significant Difference ◽  
Post Hoc

Background To determine the efficacy of low-dose, immediate-release tacrolimus in patients with myasthenia gravis (MG) with inadequate response to glucocorticoid therapy in a randomized, double-blind, placebo-controlled study. Methods Eligible patients had inadequate response to glucocorticoids (GCs) after ⩾6 weeks of treatment with prednisone ⩾0.75 mg/kg/day or 60–100 mg/day. Patients were randomized to receive 3 mg tacrolimus or placebo daily (orally) for 24 weeks. Concomitant glucocorticoids and pyridostigmine were allowed. Patients continued GC therapy from weeks 1–4; from week 5, the dose was decreased at the discretion of the investigator. The primary efficacy outcome measure was a reduction, relative to baseline, in quantitative myasthenia gravis (QMG) score assessed using a generalized linear model; supportive analyses used alternative models. Results Of 138 patients screened, 83 [tacrolimus ( n = 45); placebo ( n = 38)] were enrolled and treated. The change in adjusted mean QMG score from baseline to week 24 was −4.9 for tacrolimus and −3.3 for placebo (least squares mean difference: –1.7, 95% confidence interval: −3.5, −0.1; p = 0.067). A post-hoc analysis demonstrated a statistically significant difference for QMG score reduction of ⩾4 points in the tacrolimus group (68.2%) versus the placebo group (44.7%; p = 0.044). Adverse event profiles were similar between treatment groups. Conclusions Tacrolimus 3 mg treatment for patients with MG and inadequate response to GCs did not demonstrate a statistically significant improvement in the primary endpoint versus placebo over 24 weeks; however, a post-hoc analysis demonstrated a statistically significant difference for QMG score reduction of ⩾4 points in the tacrolimus group versus the placebo group. This study was limited by the low number of patients, the absence of testing for acetylcholine receptor antibody and the absence of stratification by disease duration (which led to a disparity between the two groups). ClinicalTrials.gov identifier: NCT01325571

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