scholarly journals COMPARISON OF PAIN SCORE IN OSTEOARTHRITIS PATIENTS TREATED WITH A COMBINATION OF DIACEREIN AND MELOXICAM AND MELOXICAM ALONE

2017 ◽  
Vol 9 (6) ◽  
pp. 69
Author(s):  
Ni Made Oka Dwicandra ◽  
Antonious Adji Prayitno Setiadi
Keyword(s):  
Randomized Controlled Trial ◽  
Articular Cartilage ◽  
Combination Therapy ◽  
Pain Intensity ◽  
Pain Score ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Randomized Controlled ◽  
Pain Outcome ◽  
Inflammatory Drugs

Objective: Osteoarthritis (OA) is a progressive chronic disease with the loss of articular cartilage. In managing OA, inadequate pain relief (IPR) often occurs, particularly with a single non steroidal anti-inflammatory drugs (NSAIDs) therapy. In this research, pain outcome of OA patients treated with a combination of diacerein and meloxicam vs meloxicam alone was evaluated.Methods: This research was conducted at rumah sakit umum daerah (RSUD) Dr. Mohammad Soewandhie Surabaya by using randomized controlled trial (RCT) design. Pain outcome was evaluated by pain intensity and area under the curve (AUC) of pain score in week 0-4th.Results: There were a significantly different (p<0.05) in pain intensity seen in 3rd and 4th weeks after treated with a combination of diacerein and meloxicam, and with meloxicam only. However, there were no different in AUC pain score between combination and single therapy.Conclusion: Combination therapy of diacerein and meloxicam was more effective than meloxicam alone. A significant effect of a combination therapy of diacerein and meloxicam occurred at 3rd weeks. The prolong study in order to get the differences in AUC pain score are needed.

Baseline pain characteristics predict pain reduction after physical therapy in women with chronic pelvic pain. Secondary analysis of data from a randomized controlled trial

2020 ◽  
Vol 20 (4) ◽  
pp. 793-800
Author(s):  
Ane S. Nygaard ◽  
Gro K. Haugstad ◽  
Tom Wilsgaard ◽  
Pål Øian ◽  
Mona Stedenfeldt
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
Regression Model ◽  
Pain Intensity ◽  
Pelvic Pain ◽  
Chronic Pelvic Pain ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Randomized Controlled ◽  
Pain Duration

AbstractBackground and aimsWomen with chronic pelvic pain represent a heterogeneous group, and it is suggested that the existence of sub-groups can explain varying results and inconclusiveness in clinical trials. Some predictors of treatment outcome are suggested, but the evidence is limited. The primary aim of this study was to explore if selected pre-treatment characteristics of the participants in a recently conducted randomized controlled trial were associated with treatment outcome.MethodsIn this study secondary analysis of data collected in a randomized trial were conducted. The participants were women with chronic pelvic pain randomized to two different physical therapy treatments. Analyses in this study were performed for the whole group as a cohort. The primary outcome measure was change in pain intensity from baseline to 12 months, measured with the numeric rating scale (0–10). The women were asked to rate their mean pelvic pain intensity during the last 7 days. Based on previous research and on available variables from the randomized controlled trial four potential predictive factors were derived from the baseline data and assessed one by one in a linear regression model, adjusted for age and treatment group. The variables with strongest association (p < 0.10) with the primary outcome were further included in a multivariable linear regression model with backward selection, adjusted for age and treatment group.ResultsFifty women (mean age 38.1, SD = 12.2) were included in the analysis. For these women the mean change in pain intensity was −1.2 points (95% CI −1.8 to −0.7) from baseline to 12 months. The multivariable regression model showed that pelvic pain duration of 6 years or more was associated with less decrease in pain intensity with a regression coefficient of 1.3 (95% CI 0.3–2.4). Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of −0.6 (95% CI −1.1 to −0.1). None of the women with main pain site other places than in the pelvis reported any pain reduction after physical therapy treatment, but due to the small numbers the predictor was not included in the regression analysis.ConclusionsWe identified that pelvic pain duration of 6 years or more was associated with less pain reduction, and that higher baseline pain intensity was associated with higher pain reduction after physical therapy treatment in this sample of women with chronic pelvic pain. For the variable main pain site other places than the pelvis the results are unsure due to small numbers.ImplicationsBased on our finding of long pain duration as a negative predictor for pain reduction, we emphasize that early intervention is important. Many of the participants in our RCT reported pelvic surgeries or other treatments prior to referral for PT, and we suggest that referral to a non-invasive intervention such as PT should be considered at an earlier stage. In order to tailor interventions to the individual women’s needs, thorough baseline assessments, preferably in a multidisciplinary setting, should be performed.

scholarly journals Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Edward C. Deehan ◽  
Eloisa Colin-Ramirez ◽  
Lucila Triador ◽  
Karen L. Madsen ◽  
Carla M. Prado ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Combination Therapy ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Metabolic Effects ◽  
Microbiota Composition ◽  
Randomized Controlled ◽  
Secondary Outcomes

Abstract Background Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the gut microbiome. Pre-clinical animal models have established that the addition of fiber to metformin monotherapy improves glucose tolerance. However, possible synergistic effects of combination therapy (metformin plus fiber) have not been investigated in humans. Moreover, the underlying mechanisms of synergy have yet to be elucidated. The aim of this study is to compare in adolescents with obesity the metabolic effects of metformin and fermentable fibers in combination with those of metformin or fiber alone. We will also determine if therapeutic responses correlate with compositional and functional features of the gut microbiome. Methods This is a parallel three-armed, double-blinded, randomized controlled trial. Adolescents (aged 12–18 years) with obesity, insulin resistance (IR), and a family history of type 2 diabetes mellitus (T2DM) will receive either metformin (850 mg p.o. twice/day), fermentable fibers (35 g/day), or a combination of metformin plus fiber for 12 months. Participants will be seen at baseline, 3, 6, and 12 months, with a phone follow-up at 1 and 9 months. Primary and secondary outcomes will be assessed at baseline, 6, and 12 months. The primary outcome is change in IR estimated by homeostatic model assessment of IR; key secondary outcomes include changes in the Matsuda index, oral disposition index, body mass index z-score, and fat mass to fat-free mass ratio. To gain mechanistic insight, endpoints that reflect host-microbiota interactions will also be assessed: obesity-related immune, metabolic, and satiety markers; humoral metabolites; and fecal microbiota composition, short-chain fatty acids, and bile acids. Discussion This study will compare the potential metabolic benefits of fiber with those of metformin in adolescents with obesity, determine if metformin and fiber act synergistically to improve IR, and elucidate whether the metabolic benefits of metformin and fiber associate with changes in fecal microbiota composition and the output of health-related metabolites. This study will provide insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for T2DM prevention. Trial registration ClinicalTrials.gov NCT04578652. Registered on 8 October 2020.

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