A Dietary Supplement in the Management of Patients with Lumbar Osteochondrosis: A Randomized, Double-Blinded, Placebo-Controlled Study

Abstract

Various nutritional supplements are available over the counter, yet few have been investigated in randomized controlled trials. The rationale for using the specific mix of nutritional substances including collagen type II, hyaluronic acid, n-acetyl-glucosamine, bamboo extract, L-lysine, and vitamin C is the assumption that combining naturally occurring ingredients of the intervertebral disc would maintain spine function. This double-blinded, placebo-controlled randomized trial aimed to evaluate the efficacy of a nutraceutical supplement mix in the management of lumbar osteochondrosis. Fifty patients were randomly assigned to either the supplement or placebo group in a 1:1 ratio. Patient-Reported Outcome Measures (PROMs) included the Oswestry Disability Index (ODI), the visual analogue scale for pain (pVAS), short form-12 (SF-12) physical and mental component summary subscale scores (PCS and MCS, respectively), and global physical activity questionnaire (GPAQ). Magnetic resonance imaging (MRI) was used to evaluate degenerative changes of intervertebral discs (IVD) including Pfirrmann grades as well as three-dimensional (3D) volume measurements. Data were collected at baseline and after the 3-month intervention. None of the PROMs were significantly different between the supplement and placebo groups. Disc degeneration according to Pfirrmann classifications remained stable during the 3-month intervention in both groups. Despite no significance regarding the distribution of Pfirrmann grade changes (improvement, no change, worsening; p = 0.259), in the supplement group, one patient achieved a three-grade improvement, and worsening of Pfirrmann grades were only detected in the placebo group (9.1%). Furthermore, in-depth evaluations of MRIs showed significantly higher 3D-measured volume changes (increase) in the supplement (+740.3 ± 796.1 mm³) compared to lower 3D-measured volume changes (decrease) in the placebo group (-417.2 ± 875.0 mm³; p < 0.001). In conclusion, this multi-nutrient supplement might not only stabilize the progression of lumbar osteochondrosis, but it might also potentially even increase IVD volumes as detected on MRIs.

Keywords: L-lysine; bamboo extract; collagen type II; hyaluronic acid; lower back pain; magnetic resonance images (MRI); n-acetyl-glucosamine.

Figure 1

Schematic images of intervertebral discs (IVD) including structures and compositions adopted from [2]. The nucleus pulposus (NP), the annulus fibrosus (AF), and the endplate (EP) consist of collagen and proteoglycans. Aggrecan, a large proteoglycan, is composed of hyaluronic acid, chondroitin, and keratan sulfate.

Figure 2

Schematic images of spinal column (A) adopted from [2]; normal intervertebral discs (IVD; (B)), degenerated IVD (C), and herniated IVD (D).

Figure 3

Participant flowchart showing the numbers of participants who were recruited, randomly assigned, dropped out, and analyzed during the trial. * The patient, who was wrongly assigned to the supplement group, dropped out for follow-up. Abbreviations: MRIs, magnetic resonance images; PROMs, patient-reported outcome measures.

Figure 4

Box plots showing volumes of the intervertebral disc distances before (light gray) and after (dark gray) the 3-month intervention of the supplement and placebo groups. Circles indicate outliers.

Figure 5

Box plots showing volume changes from before to after the 3-month intervention of the supplement (dark gray) and placebo group (light gray). Circles indicate outliers.