BackgroundThis study was designed to determine if a natural mineral supplement, sierrasil, alone and in combination with a cat's claw extract (Uncaria guianensis), vincaria, has therapeutic potential in mild to moderate osteoarthritis of the knee.MethodsPatients (n = 107) with mild to moderate osteoarthritis of the knee were randomly assigned to one of 4 groups; high dose sierrasil (3 g/day), low dose sierrasil (2 g/day), low dose sierrasil (2 g/day) + cat's claw extract (100 mg/day) or placebo, administered for 8 weeks. Treatment was double blinded. Primary efficacy variables were WOMAC scores (A, B, C and total). Visual analog score (VAS) for pain, consumption of rescue medication (paracetamol), and tolerability were secondary variables. Safety measures included vital signs and laboratory-based assays.ResultsNinety-one of the 107 patients successfully completed the protocol. All four groups showed improvement in WOMAC and VAS scores after 8 weeks (p < 0.001), in all 3 groups receiving sierrasil the magnitude of benefits were greater vs. placebo (WOMAC Total 38–43% vs. 27%) but this was not statistically significant. In reference to baseline values sierrasil treated groups had a considerably faster onset of benefits. Placebo-treated individuals failed to show significant benefits at 4 weeks (11% reduction in total WOMAC). In contrast, after 1 or 2 weeks of therapy all the sierrasil groups displayed significant reductions in WOMAC scores (p < 0.05) and at week 4 displayed a 38–43% improvement. VAS was significantly improved at 4 weeks in all groups (p < 0.001) but was significantly greater in all sierrasil groups compared to placebo (p < 0.05). Rescue medication use was 28-23% lower in the herbomineral combination and high dose sierrasil groups although not statistically different from placebo (P = 0.101 and P = 0.193, respectively). Tolerability was good for all groups, no serious adverse events were noted and safety parameters remained unchanged.ConclusionThe natural mineral supplement, sierrasil alone and in combination with a cat's claw extract, improved joint health and function within 1–2 weeks of treatment but significant benefits over placebo were not sustained, possibly due to rescue medication masking. Sierrasil may offer an alternative therapy in subjects with joint pain and dysfunction.
Background Digital health solutions have been shown to enhance outcomes for individuals with chronic medical illnesses, but few have been validated for surgical patients. The digital health platform ManageMySurgery (MMS) has been validated for spine surgery as a feasible method for patients along their surgical journey through in-app education and completion of patient-reported outcomes surveys. Objective The aim of this study is to determine the rates of 90-day emergency room (ER) visits, readmissions, and complications in patients undergoing spine surgery using MMS compared to patients using traditional perioperative care alone. Methods Patients undergoing spine surgery at a US-based academic hospital were invited to use MMS perioperatively between December 2017 and September 2021. All patients received standard perioperative care and were classified as MMS users if they logged into the app. Demographic information and 90-day outcomes were acquired via electronic health record review. The odds ratios of having 90-day ER visits, readmissions, mild complications, and severe complications between the MMS and non-MMS groups were estimated using logistic regression models. Results A total of 1015 patients were invited, with 679 using MMS. MMS users and nonusers had similar demographics: the average ages were 57.9 (SD 12.5) years and 61.5 (SD 12.7) years, 54.1% (367/679) and 47.3% (159/336) were male, and 90.1% (612/679) and 88.7% (298/336) had commercial or Medicare insurance, respectively. Cervical fusions (559/1015, 55.07%) and single-approach lumbar fusions (231/1015, 22.76%) were the most common procedures for all patients. MMS users had a lower 90-day readmission rate (55/679, 8.1%) than did nonusers (30/336, 8.9%). Mild complications (MMS: 56/679, 8.3%; non-MMS: 32/336, 9.5%) and severe complications (MMS: 66/679, 9.7%; non-MMS: 43/336, 12.8%) were also lower in MMS users. MMS users had a lower 90-day ER visit rate (MMS: 62/679, 9.1%; non-MMS: 45/336, 13.4%). After adjustments were made for age and sex, the odds of having 90-day ER visits for MMS users were 32% lower than those for nonusers, but this difference was not statistically significant (odds ratio 0.68, 95% CI 0.45-1.02; P=.06). Conclusions This is one of the first studies to show differences in acute outcomes for people undergoing spine surgery who use a digital health app. This study found a correlation between MMS use and fewer postsurgical ER visits in a large group of spine surgery patients. A planned randomized controlled trial will provide additional evidence of whether this digital health tool can be used as an intervention to improve patient outcomes.
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