Effect of royal jelly capsule on quality of life of patients with multiple sclerosis: A double-blind randomized controlled clinical trial

Abstract

Background: Among the most important chronic diseases is multiple sclerosis (MS) leading to physical disability and decrease in the patientsʼ quality of life. Objectives: The present study aimed to investigate the effect of the royal jelly capsule on the life quality of patients with MS. Methods: This randomized clinical trial study was conducted on a total of 100 patients referring to the MS Society of Hamadan, Iran, in 2018. Allocation sequences were determined using block randomization with a block size of 4, and the subjects were assigned to the intervention and control groups according to a predetermined sequence. The intervention group received one royal jelly capsule (500 mg) daily, and the control group received a placebo capsule for 90 days. The life quality of the patients and their daily activities were evaluated using the specific questionnaire for the life quality of the patients with MS and Barthel Index of Daily Living Activities before and after the intervention. Data analysis was performed by Stata software (version 13) and appropriate statistical tests with a significance level of 0.05. Results: The comparison of the mean score of the patientsʼ life quality showed that it was higher in the experimental group in the post-intervention (66.51±15.08) than that reported for the control group (51.31±15.08) after controlling possible confounding factors, which was statistically significant (P<0.001). Furthermore, Cohen's d (1.01; 95% CI: 0.59-1.42) also indicated the intended large effect size of the intervention. The comparison of daily activity status scores between the two groups also demonstrated an improvement in the experimental group (18.76±1.44), compared to that of the control group (16.96±3.01), which was statistically significant (P=0.001). Conclusions: Based on the findings of the current study, it can be concluded that the use of the royal jelly supplement can be effective in the improvement of the life quality of the patients with MS.