Extended Abstract
1. Objectives
Osteoarthritis is the most prevalently reported joint disease [1]. It is even more prevalent than heart disease, hypertension, and diabetes [2]. Knee osteoarthritis is among the 5 leading causes of physical disability in the elderly [3]. There are different methods to reduce its symptoms in the patients [4-6]. One of the main goals in the treatment of osteoarthritis is pain relief. Pain medications usually have significant side effects, particularly in the elderly; due to age-related physiological changes, the coincidence of several chronic diseases, drug interactions, changes in drug metabolism, and polypharmacy, the odds of undesired adverse effects of these drugs is more significant than that of other age groups [7, 8]. Therefore, in the aging period, these medications should be used with caution [9, 10]. Complementary therapies are cheaper, more accessible, and less complicated. Moreover, the majority of elderly have the tendency to use them; thus, the present study aimed to assess the effect of Melilotus officinalis on the pain and stiffness of joints in the elderly with primary knee osteoarthritis.
2. Methods & Materials
This was a clinical double-blind, randomized controlled trial study. It was conducted on 61 older adults aged ≥60 years residing in nursing homes in Tehran City, Iran. The samples were clinically diagnosed with mild to moderate knee osteoarthritis by an orthopedic surgeon. After signing written informed consent form, we surveyed their demographic information as well as the pain and stiffness of joints using the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). By block randomization technique, Melilotus officinalis was provided to the intervention group (n=34) and diclofenac gel to the control group (n=27). The intervention group used 5 drops of Melilotus officinalis and the controls used 5 drops of diclofenac gel in the front side of their knees, twice a day (morning and night). The required data were collected at baseline, as well as the end of the second and fourth weeks. The obtained data were analyzed in SPSS. To describe the study variables, descriptive statistics (frequency, percentage, mean, and standard deviation) were used. Moreover, to analyze the research hypotheses and examine the effect of Melilotus officinalis, repeated measures Analysis of Variance (ANOVA) and Bonferroni post-hoc test were applied. Before analysis, the normality of data distribution was examined by measuring their kurtosis and skewness. The obtained data were normally distributed; thus, parametric tests were employed. The significance level was set at 0.05.
3. Results
The Mean±SD age of the study participants was 78±7.8 years, ranging from 63-93 (mode=81). In intervention groups, there were 19 women and 15 men, while in the control group, there were 16 women and 11 men. Most study participants were illiterate or only able to read and write; suffered from at least one chronic disease, and reported the consumption of at least one medication. There was no significant difference between the study groups at the baseline in terms of gender, marital status, employment status, smoking, physical activity level, chronic diseases, and drug use. Furthermore, since the frequencies for some of the factors was <5, Fisher's exact test was used.
The obtained data suggested that the right knee pain level (F1, 58=439.70, P<0.001) and the left knee pain level (F1, 58=368.8, P<0.001) significantly reduced in both groups from the first to the third stage of the study. The mean scores of the right knee pain severity (F2, 58=62.6, P<0.001) and the left knee pain severity (F2, 58=85.1, P<0.001) also significantly reduced in both groups at three stages. Moreover, the mean values of joint stiffness (F2, 58=69.9, P<0.001) also significantly reduced in both groups. Based on the effect size of pain level, pain severity, and joint stiffness, the changes from the first to the third stage were more considerable in the intervention group. Bonferroni post-hoc test results suggested that changes between the first and second stages as well as between the first and third stages were significant in both groups; however, between the second and third stages, changes were only significant in the intervention group. This can be because of the maintenance of the used drug therapy in reducing pain and joint stiffness.
4. Conclusion
Melilotus officinalis use, as a cheap, available, and uncomplicated treatment method is recommended for reducing the knee pain severity. It is also beneficial in improving joint stiffness in patients with mild to moderate osteoarthritis. Considering the study findings and no detected side effects, the use of Melilotus officinalis can even be effective in a short time. Herbal therapies are cost-effective and associated with limited complications.
Moreover, the elderly are highly desired to use these methods; therefore, by providing scientific evidence similar to this study, these treatments can be recommended to the health services managers. Further detailed studies are required to determine the effect mechanism of Melilotus officinalis on reducing joint pain and stiffness in patients with mild to moderate osteoarthritis. Future investigations could also help with determining the exact required dose for this purpose.
Ethical Considerations
Compliance with ethical guidelines
All ethical principles were considered in this article. The participants were informed about the purpose of the research and its implementation stages; they were also assured about the confidentiality of their information; Moreover, They were allowed to leave the study whenever they wish, and if desired, the results of the research would be available to them (Code: IRCT2016082129461N1).
Funding
The present paper was extracted from the MSc thesis of the first author, Gholamreza Ansari, Iranian Research Center on Aging, University of Social Welfare and Rehabilitation Sciences.
Authors' contributions
Conceptualization: Gholamreza Ansari, Ahmad Delbari, Mehrdad Karimi, Ahmad Ali Akbari Kamrani; methodology: Mehrdad Karimi, Yadollah Abolfathi Momtaz, Seyran Mohamadi, Robab Sahaf; analyzing: Gholamreza Ansari, Ahmad Delbari, Mehrdad Karimi, Yadollah Abolfathi Momtaz, Seyran Mohamadi, Robab Sahaf; writing-original draft and finalization: All authors.
Conflicts of interest
The authors declared no conflict of interest.
Acknowledgements
The authors are grateful to staff and director of Kahrizak Charitable Hospice and Department of Traditional Medicine of Tehran University of Medical Sciences.