Clinical Studies Of Move Free® Advanced

Works In Less Than 7 Days

Uniflex® - Solo Clinical Study

Two clinical studies have been conducted to investigate efficacy and tolerability of Move Free® Advanced. Adult men and women with mild to moderate joint discomfort (confirmed by physician diagnosis) were recruited into both studies. The Western Ontario and McMaster University (WOMAC) questionnaire was used to assess these subjects using 24 parameters (5 for Pain, 2 for Stiffness, and 17 for Activities of Daily Living). WOMAC questionnaires asked for ratings over the last 48 hours. SF-36v2 is a questionnaire tool to measure health outcomes. It includes a total of 36 mental and physical sub-scores that are combined to 10 total scores. Brief Pain Inventory (BPI) questionnaire was also used to assess discomfort of subjects. This questionnaire uses a Likert scale of 1-10 and focuses on pain as compared to 24 hours earlier. Visual Analogue Scales (VAS) ranging from 1-100 were used to additionally assess comfort. Pain Relief Diaries (PRD) were kept for the first and last weeks of Study 1. All questionnaires used in the studies have been accepted as the standards for determining and measuring joint symptoms and for SF-36, quality of life (Bellamy 1988; Bellamy 1989; Bellamy 1992, Dougados 2000; Hawker 1995, Lequesne 1991, Stucki 1998).

Study 1: Miami, 2004

A preliminary, prospective, randomized, double-blind, placebo-controlled, parallel-group clinical study comparing the efficacy of dietary supplements was conducted in 18 subjects per group with joint discomfort. Miami Research Associates conducted the study after IRB approval in 2004. WOMAC, SF-36v2, and BPI were determined at 0, 1, 2, 4, and 8 weeks. The average age of the subjects was 57 ± 10 years. The groups included placebo (Group 1), 1500 mg glucosamine HCl only (Group 2), 1500 mg Glucosamine HCl + 1200 mg chondroitin sulfate (Group 3), 1500 mg Glucosamine HCl + 1200 mg chondroitin sulfate + 3.3 mg Hyaluronic acid (Group 4), and Move Free® Advanced (Group 5). There was no difference among the groups at baseline for subject characteristics, safety parameters, WOMAC, SF-36v2, or BPI scores.

Group 5 was rated best by subjects for decreasing joint discomfort (80%) and muscle aches (67%) and showed the greatest amount of rapid-onset improvement in physical functioning (one week; p=0.041) and 72% showed a decrease in WOMAC Pain scores at one week. A significant change in PRD question 2 (joint discomfort) for Week 1 was observed for Group 5 (see Graph below). Joint discomfort was relieved up to 41% within 1 week. After 8 weeks, 100% of remaining subjects in Group 5 reported improvements in joint comfort and function (per protocol analysis). Intention-To-Treat analysis showed a 43% improvement in joint comfort as measured by WOMAC scores after 8 weeks for Group 5. Absolute change in scores and change from baseline values for WOMAC Pain and function subscales were used to determine clinically significant responder rates as per OARSI definition (Osteoarthritis Research Society International) after 8 weeks. The data showed that 66.7% of subjects in Group 5 were classified as responders, whereas typical analgesic responder rates are 52-62% (Dougados 2000).

Study 2: Los Angeles, 2008

Study 1 showed that Move Free ® Advanced showed efficacy within one week. This second study was performed to further explore the efficacy of Move Free® Advanced within 7 days as compared to a leading analgesic for joint discomfort and function. A preliminary, randomized, double-blind, double-dummy, active-comparator, parallel-group clinical study was conducted in 130 subjects with joint discomfort. Global Clinicals, Inc. conducted the study in Los Angeles in 2006-2008 after IRB approval. The average age of the subjects was 57 ± 10 years. The groups included an Active Comparator group (Group 1) and Move Free® Advanced (Group 2). WOMAC and SF-36v2 questionnaires were determined at baseline, 7 days and 56 days (for a subset of subjects). VAS scores were obtained at 0, 1, 2, 3, 4, 5, 6 and 7 days.

Group 2 showed statistically significant within-group improvements in all WOMAC and SF-36 scores on day 7. Total WOMAC scores improved 30% in the Group 2. Comparison between groups did not show significant differences, meaning that Group 2 was equivalent to Group 1 for improving joint comfort and function after 7 days. Subjects rated their joint discomfort compared to the first day of the study using VAS scales. Single factor ANOVA showed that Group 2 was significantly different from baseline at day 3 (p<0.05). This significance steadily increased until day 7 (p=0.0103). Thus Group 2 started working on joint discomfort in less than 7 days by WOMAC scores and VAS scales.

Two independently conducted, double-blind, controlled human clinical studies using Move Free® Advanced were conducted two years apart on opposite sides of the continent, lending robustness to the results. Both studies found essentially similar results for improvements in joint comfort and joint function after one week, with continued improvement at 8 weeks. Study protocols utilized the recommended and acceptable outcome measurements for joint health, and sample sizes were determined by statistical power analysis. Results from a first preliminary study were confirmed and extended to shorter time periods in a larger second study. Thus, Move Free® Advanced has been clinically tested and shown to improve joint health. The graph below shows the improvement in joint comfort (WOMAC scores) after 7 days for each study. Results from each study were not significantly different, illustrating the reproducible nature of how the formulation affects joint health.

References

Privacy Statement  Ι Terms Of Use Ι About Us
© 2010 Schiff Nutrition Group, Inc.