Re: Formulation of Olive Oil, Olive Fruit, and Fig Improves Global Health and Well-being in Patients with Rheumatoid Arthritis; Effects on Remission Indicators Are Positive but Not Significant

PDF (Download) Olive (Olea europaea, Oleaceae) Oil Fig (Ficus carica, Moraceae) Rheumatoid Arthritis Date: 08-15-2017 HC# 021734-574 Bahadori S, Salamzadeh J, Kamalinejad M, Shams Ardekani MR, Keshavarz M, Ahmadzadeh A. Study of the effect of an oral formulation of fig and olive on rheumatoid arthritis (RA) remission indicators: a randomized clinical trial. Iran J Pharm Res. 2016;15(3):537-545. Rheumatoid arthritis (RA) is characterized by synovitis and joint bone damage, which cause swelling, pain, morning stiffness, fatigue, and disability, and currently no prevention or cure exists. Treatment to limit permanent joint damage includes the use of disease-modifying antirheumatic drugs (DMARDs) and biologic agents; however, these drugs are not always effective and can cause adverse effects. Olive (Olea europaea, Oleaceae) and fig (Ficus carica, Moraceae) have been found to have beneficial anti-inflammatory, immunomodulatory, antimicrobial, anticancer, analgesic, and antioxidant properties. The goal of this randomized, controlled, parallel-group, clinical trial was to examine the effects of a formulation of olive oil, olive fruit, and fig fruit on RA remission. Conducted from September 2014 to August 2015, the study included patients aged 18 years and older diagnosed with RA and attending the inpatient and outpatient rheumatology departments of Loghman-e Hakim University Hospital at Shahid Beheshti University of Medical Sciences in Tehran, Iran. The patients were randomly assigned to take routine DMARDs in the control group (n=36) or to take routine DMARDs plus a formulation of fig and olive in the intervention group (n=36). The 16-week study included a baseline visit and follow-up visits every 4 weeks, for a total of 5 study visits. The herbal formulation, a semisolid mixture, included olive oil, olive fruit, and fig fruit in a ratio of 2:5:1. Olives and olive oil from trees cultivated at Rudbar City in the Gilan province in north Iran were used for the study. The purchased, dried fig fruits were from trees in Estahban in Iran's Fars province. Patients were instructed to consume 15 grams (approximately 1 tablespoon) of the mixture 3 times daily with meals and to continue their usual diet. The primary outcome was the Disease Activity Score with 28-joint counts based on erythrocyte sedimentation rate (DAS28-ESR) recommended by the American College of Rheumatology. Four components of the score―tender joint count, swollen joint count, ESR, and patient global assessment of disease activity (PtGA)―were measured at each study visit. Also assessed were demographic characteristics, medical and medication history, and any adverse effects. At baseline, all patients had a DAS28-ESR greater than 2.6. Of the 72 patients who were assigned to a study group, 29 in the intervention group and 27 in the control group completed the study. In the intervention group, 7 were lost to follow-up for the following reasons: 3 discontinued treatment, 1 had severe hiccups as an adverse drug reaction, 2 were transient residents, and 1 complained of an unpleasant taste. From the control group, 6 discontinued the intervention, 2 traveled from the area, and 1 was a transient resident. Baseline demographic characteristics, as well as medication and medical histories, were similar between the 2 groups. The authors report a compliance rate of 93.88% ± 7.06% in the intervention group. Results reveal no significant between-group differences in the indicators of RA remission, although positive trends were seen in the intervention group. A greater reduction in PtGA in the intervention group compared with the control group beginning at week 12 indicated a nonlinear significant relationship between PtGA and time (P=0.03). This finding supports "the assumption that a longer course of supplement usage could lead to greater remission in RA, which can be reflected in the values of the disease activity measures," write the authors. No significant between-group differences were observed in the number of patients needing intra-articular glucocorticoids or nonsteroidal anti-inflammatory drugs or in total cumulative dose of steroids during the study. The only adverse event reported was the one patient who withdrew from the intervention group because of severe unclassified hiccups. The authors conclude that although changes in the DAS28-ESR were not significantly different between the 2 study groups, the positive trends in the intervention group and the significant improvements in PtGA scores in the intervention group compared with the control group "convince us to suggest further investigations on the supplementary olive and fig products, with … longer follow up periods." ―Shari Henson