METHODS: This study was a single-blind, RCT conducted at Teaching Bay of Rehmatul-Lil-Alameen Post Graduate Institute of Cardiology between February and November 2020. 114 knee OA patients who were overweight and obese were randomly divided by a computer-generated number into the rehabilitation group with mHealth (RGw-mHealth) to receive LLRP + instructions of daily care (IDC) combined with mHealth intervention, rehabilitation group without mHealth (RGwo-mHealth) to receive LLRP + IDC intervention and control group (CG) to receive IDC intervention. All three groups were also provided leaflets explaining about their intervention. The primary outcome measure was knee pain measured by the Western Ontario and McMaster Universities Osteoarthritis Index score. The secondary outcome measures were mobility measured by the Timed up and go (TUG) test, functional activity measured by the patient-specific functional scale (PSFS), and ADL measured by the Katz Index of independence in ADL scores.

METHODOLOGY: The Cochrane central register of controlled trials, Medline (1966 to April week 1, 2020), Embase (1966 to April week 1, 2020) and trial registries for relevant randomized clinical trials were used. Published and unpublished randomized clinical trials were reviewed and evaluated. Random effects models were used to estimate the continuous outcomes and mean differences (MDs); both with 95% confidence intervals (CIs). The primary outcomes were changes in systolic and diastolic BP. The secondary outcomes were changes in lipid profile, glucose metabolism, inflammatory markers for CVD, kidney and liver functions safety parameters. We assessed the data for risk of bias, heterogeneity, sensitivity, reporting bias and quality of evidence.

RESULTS: Five trials were included involving 325 patients aged 18-80 years. Two trials involved high-income countries and three trials involved moderate-income countries. The analysis performed was based on three comparisons. No significant changes were found between systolic or diastolic blood pressure (BP) for the first comparison, 1,000 mg per day for a combined formulation of olive leaf extract versus a placebo. The second comparison, 500 mg per day of olive leaf extract versus placebo or no treatment, showed a significant reduction in systolic BP over a period of at least 8 weeks of follow up (MD -5.78 mmHg, 95% CI [-10.27 to -1.30]) and no significant changes on diastolic BP. The third comparison, 1,000 mg per day of olive leaf extract versus placebo shows no significant difference but an almost similar reduction in systolic BP (-11.5 mmHg in olive leaf extract and -13.7 mmHg in placebo, MD 2.2 mmHg, 95% CI [-0.43-4.83]) and diastolic BP (-4.8 mmHg in olive leaf extract and -6.4 mmHg in placebo, MD 1.60 mmHg, 95% CI [-0.13-3.33]). For secondary outcomes, 1,000 mg per day of olive leaf extract versus captopril showed a reduction in LDL (MD -6.00 mg/dl, 95% CI [-11.5 to -0.50]). The 500 mg per day olive leaf extract versus placebo showed a reduction in inflammatory markers for CVD IL-6 (MD -6.83 ng/L, 95% CI [-13.15 to -0.51]), IL-8 (MD -8.24 ng/L, 95% CI [-16.00 to -0.48) and TNF-alpha (MD -7.40 ng/L, 95% CI [-13.23 to -1.57]).

CONCLUSIONS: The results from this review suggest the reduction of systolic BP, LDL and inflammatory biomarkers, but it may not provide a robust conclusion regarding the effects of olive leaf extract on cardiometabolic profile due to the limited number of participants in the included trials.

RESULTS: Participants in the RPG and CG reported a statistically significant reduction in knee pain and stiffness (p ≤ 0.05) within the group. The reduction in the scores of knee pain was higher in participants in the RPG than that in participants in the CG (p=0.001). Additionally, participants in the RPG reported greater satisfaction (p=0.001) and higher self-reported exercise adherence (p=0.010) and coordinator-reported exercise adherence (p=0.046) than the participants in the CG.