Open-label, randomized, controlled pilot study of the effects of a glucosamine complex on Low back pain.

BACKGROUND

A series of studies has suggested some efficacy of glucosamine in arthrosis of the knee, but virtually no documentation exists regarding its effects on low back pain.

OBJECTIVES

The primary objective of this study was to examine whether a 12-week course of a glucosamine complex (GC) could benefit patients having low back pain despite a course of noninvasive physical therapy. In addition, we sought to delineate the subgroup of responders.

METHODS

This open-label, randomized, controlled study was conducted at the Division of Rheumatology and Physical Medicine, Erasme University Hospital, Brussels, Belgium. Male and female outpatients aged 40 to 80 years with low back pain (duration, ≥ 12 weeks; pain score on 10-cm visual analog scale [VAS] [0 = none to 10 = worst imaginable], ≥3 cm) despite noninvasive physical therapy (massage, stretching, heat application, and analgesics for ≥4 weeks) were included. Patients were randomly assigned to receive, in addition to conventional treatment (CT) (physical therapy plus analgesics/antiinflammatories), a GC (enriched with sulfonyl methane, silicon, and a botanical extract of Ribes nigrum) or CT alone (control) for 12 weeks. Pain at rest and on movement (effort) and early morning lumbar stiffness were measured every 4 weeks using the VAS. The primary end point was improvement in VAS score for pain at rest at 12 weeks. Two validated questionnaires were used to assess improvements in quality of life (QOL) (Oswestry Disability Questionnaire [ODQ] [10 items; scale: 0 = no disability to 60 = maximal disability] and Roland-Morris Disability Questionnaire [RMDQ] [24 items; scale: 0 = no disability to 24 = severe disability]). Responders were defined as patients who positively assessed the efficacy of the GC. At each visit, patients were also asked about possible adverse events.

RESULTS

Of 36 enrolled patients, 32 completed the study (18 men, 14 women; mean [SE] age, 64 [2] years; 17 in the GC group and 15 in the control group). Four patients were lost to follow-up. At week 4, changes from baseline VAS scores for pain at rest and lumbar stiffness were significantly greater in the GC group compared with the control group (P < 0.001 and P = 0.011, respectively). At week 4, QOL was found to be improved, as measured using the ODQ, in the GC group compared with the control group (P = 0.028), but the between-group difference as measured using the RMDQ was not significant. The improvements from baseline on the questionnaires were sustained over the 12-week period in the GC group (all, P < 0.001). Gastrointestinal adverse effects were reported by 1 GC-treated patient and 1 patient in the control group, but neither patient withdrew from the study. Of the 17 GC-treated patients, 9 considered themselves responders, but the profile of a responder could not be delineated.

CONCLUSIONS

In this study in patients with low back pain, analgesic effect and improvement in QOL were found with the use of GC. GC was well tolerated.