Clinical Review for Flex Connect
(NOW Published in the June 2011 Townsend Letter!: View)
The Safety and Efficacy of Flex-Connect Plus™ and MSM-Vitamin C on Patients with osteoarthritis of the knee
This multi-center, prospective, randomized, placebo-controlled, double-blind clinical trial on the efficacy and safety of Flex-Connect Plus™ and MSM-Vitamin C has been submitted the Journal of Alternative and Complementary Medicine. The manuscript has passed all revisions and is pending publication. The purpose of the clinical study was to test the analgesic potential and functional improvement offered by the ingestion of the products Flex-Connect Plus™ and MSM-Vitamin C on patients with osteoarthritis of the hip.
Investigators (Haddad et al) tested the efficacy and safety of the products by assessing the following symptoms and physical findings: joint flexibility (range of motion), stiffness reduction, pain relief, cartilage support, blood flow, and inflammation.
Materials and methods
Sixty patients from three centers underwent randomization and were divided into two groups to receive either the active investigational products (Flex-Connect Plus™ & MSM-Vitamin C) or a placebo with a non-active recipient. The duration of the clinical trial was 90 days. Patients were screened to meet the inclusion and exclusion criteria for the study protocol. Thereafter, three follow-up visits were scheduled at week 4, week 8, and week 12 to ascertain the subjects' symptoms and physical findings.
Flex-Connect Plus™ and MSM-Vitamin C demonstrated a collective improvement of 97.8% in the following tested markers/parameters:
1. Joint pain
3. Range of motion
4. Cartilage support
The proportions of responders within 1 week of treatment were as follows: 22.3% for placebo and 49.6% for the active supplement (Figure 2). Noteworthy is that after 4 weeks of treatment, the placebo group was still significantly lower from baseline for any of the WOMAC scores, compared with the group ingesting the active supplement. Response to treatment to the Flex-Connect Plus™and MSM-Vitamin C group continued to increase for the duration of the study protocol. The response rate at week 4 was significantly higher for the group ingesting the active supplement group (69.2%), compared with the placebo (28.6%) (Table 2). At the conclusion of the study, week 12, the response rate for the active supplement group continued to increase compared with the placebo: 95.6% and 29.8%, respectively.
Laboratory tests were unchanged from baseline to week 12 for both the active treated group and the placebo group with the following exception: The erythrocyte sedimentation rate (ESR) at week 12 was in the actively treated group was mildly reduced from 33.2 +/- 4.2 to 30.6 +/- 3.0 (p < .05).
Jack Haddad, MD, MBA, Orthopedic Surgeon, UCSF Medical Center, San Francisco
Nicole Sharkey, MD, Chief OBGYN Surgeon, Kern Medical Center, Bakersfield, CA
Cindy Maloore, Ph.D., Nutritionist, private practice, San Jose, CA
Phillip Shinnick, Ph.D., Research Institute of Physiology, Behavior and Treatment, New York, NY