A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial

Abstract

Background: The purpose of this study was to assess the effect of 8-weeks ingestion of a commercialized joint pain dietary supplement (Instaflex™ Joint Support, Direct Digital, Charlotte, NC) compared to placebo on joint pain, stiffness, and function in adults with self-reported joint pain. Instaflex™ is a joint pain supplement containing glucosamine sulfate, methylsufonlylmethane (MSM), white willow bark extract (15% salicin), ginger root concentrate, boswella serrata extract (65% boswellic acid), turmeric root extract, cayenne, and hyaluronic acid.

Methods: Subjects included 100 men and women, ages 50-75 years, with a history (>3 months) of joint pain, and were randomized to Instaflex™ or placebo (3 colored gel capsules per day for 8 weeks, double-blind administration). Subjects agreed to avoid the use of non-steroidal anti-inflammatory drugs (NSAID) and all other medications and supplements targeted for joint pain. Primary outcome measures were obtained pre- and post-study and included joint pain severity, stiffness, and function (Western Ontario and McMaster Universities [WOMAC]), and secondary outcome measures included health-related quality of life (Short Form 36 or SF-36), systemic inflammation (serum C-reactive protein and 9 plasma cytokines), and physical function (6-minute walk test). Joint pain symptom severity was assessed bi-weekly using a 12-point Likert visual scale (12-VS).

Results: Joint pain severity was significantly reduced in Instaflex™ compared to placebo (8-week WOMAC, ↓37% versus ↓16%, respectively, interaction effect P = 0.025), with group differences using the 12-VS emerging by week 4 of the study (interaction effect, P = 0.0125). Improvements in ability to perform daily activities and stiffness scores in Instaflex™ compared to placebo were most evident for the 74% of subjects reporting knee pain (8-week WOMAC function score, ↓39% versus ↓14%, respectively, interaction effect P = 0.027; stiffness score, ↓30% versus ↓12%, respectively, interaction effect P = 0.081). Patterns of change in SF-36, systemic inflammation biomarkers, and the 6-minute walk test did not differ significantly between groups during the 8-week study

Conclusions: Results from this randomized, double blind, placebo-controlled community trial support the use of the Instaflex™ dietary supplement in alleviating joint pain severity in middle-aged and older adults, with mitigation of difficulty performing daily activities most apparent in subjects with knee pain.

Trial registration: ClinicalTrials.gov NCT01956500.

Figure 1

WOMAC joint pain in Instaflex compared to placebo (interaction effect, P = 0.025). The P-value in the graph represents the pre-to-post study contrast between Instaflex and placebo groups.

Figure 2

WOMAC total scores in subjects reporting knee pain (interaction effect, P = 0.018). The P-value in the graph represents the pre-to-post study contrast between Instaflex and placebo groups.

Figure 3

WOMAC function scores in subjects reporting knee pain (interaction effect, P = 0.027). The P-value in the graph represents the pre-to-post study contrast between Instaflex and placebo groups.

Figure 4

Joint pain symptom severity assessed bi-weekly using the 12-point Likert visual scale (12-VS) (2 × 5 interaction effect, P = 0.0125). P-values at each time point represent independent student’s t-test contrasts between groups for changes from pre-study.