Publication:
The study of effectiveness of high-fiber multigrain supplementation among rheumatoid arthritis patients in Hospital USM Kubang Kerian: A randomized open label clinical trial

No Thumbnail Available
Date
2021
Authors
Supramaniam, Thamarai
Journal Title
Journal ISSN
Volume Title
Publisher
Research Projects
Organizational Units
Journal Issue
Abstract
Background: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease that attacks human joints, leading to joint destruction. Early treatment can help to delay joint destruction and maintain joint function. Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological DMARDs (bDMARDs) are the cornerstones of RA treatment. However, they are associated with various side effects. Evidence suggests that dietary factor plays an important role in RA management. Therefore, dietary therapy should be considered as part of the treatment regimen for RA patients. This study intended to explore the complementary effects of multi-grained powder supplementation on the clinical severity of the disease activity, inflammatory blood molecules and the changes in the nutritional status of RA patients , and to monitor general well being of participants compared to those who are receiving conventional drug therapies. Methods: This study was an open randomized supplementation trial conducted between March 2019 and June 2019 on RA patients who followed up at the Hospital Universiti Sains Malaysia (HUSM) Rheumatology clinic. A total of 51 patients were recruited in this study. Patient information such as age, comorbidities, drug history, body mass index (BMI), waist circumference, duration of RA, disease activity (disease activity score [DAS]), health assessment questionnaire disability index (HAQ-DI) score, morning stiffness rating scale, visual analogue scale (VAS) score, as well as biochemical parameters such as renal function test, liver function test, total cholesterol, erythrocyte sedimentation rate (ESR) and full blood count was obtained. The pre and post-DAS 28, VAS score, HAQ-DI score, morning stiffness rating scale and biochemical parameters were assessed. Results: The mean ages of the participants in the intervention and control groups were 54.68 (SD=8.28) and 51.88 (SD=14.09) respectively. The collected data showed that the majority of the participants in both the intervention and control groups were female, with 19 (37.2%) and 24 (47.1%) female participants respectively. There were no significant differences in the baseline characteristics between the two groups. For both the intervention and control groups, the analysis of the clinical characteristics showed that 29.4% of the participants had low disease activity (DAS between 2.6 to 3.2), 54.9% had moderate disease activity (DAS between 3.2 to 5.1) and 15.7% had high disease activity (DAS higher than 5.1). The results of the pre and post-tests of the intervention and control groups were compared to evaluate the efficacy of high-fiber multigrain supplementation in reducing inflammatory markers and clinical disease activity among the participating RA patients. For the intervention group, it was observed that the mean scores of the BMI (p<0.001), waist circumference (p=0.005), DAS 28 (p<0.001), HAQ-DI (p=0.034), morning stiffness scale (p=0.010) and VAS pain scale (p=0.003) in the pre-test were significantly different from those of the post-test However, there were no significant differences in the mean scores of the variables in both the pre and post-tests between the intervention and control groups, except for the HAQ-DI score (p=0.009), morning stiffness scale (p=0.035) and VAS pain scale (p=0.003) in the post-test. The mean score of the HAQ-DI of the intervention group in the post-test was lower by 0.32 (95% CI=-0.56, -0.08) than that of the control group. For the morning stiffness scale, the mean score of the control group was higher by 1.42 (95% CI=-2.75, -0.10) as compared to the intervention group.As for the VAS pain scale, the mean score of the intervention group was lower by 2.03 (95% CI=-3.34, -072) than the control group. As for the assessment of side effects of high-fiber multigrain supplement , it was observed that twenty participants developed satiety, six participants had flatulence, three participants developed nausea, three participants experienced headache, three participants suffered from heartburn and a small number of participants experienced intestinal rumbling and constipation. None of the participants from the control group developed diarrhea. As far as compliance assessment was concerned, all the participants in the intervention group achieved a target compliance percentage of 80%. Conclusion: In conclusion, the physical functioning and quality of life (QoL) of the participating RA patients in this study were significantly improved with the multigrain-enriched powder supplementation. Furthermore, the data of this study has clearly demonstrated the potential of multigrain-enriched powder supplementation as nutritional medicine to support current standard therapies for RA patients. Although the data might not be conclusive enough, dietary advice has its place in rheumatology as part of an integrated approach for RA patients
Description
Keywords
-
Citation