No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial

Journal of Negative Results in Biomedicine

Ansgar Espeland²  Linda Berg²  Inger Scheel¹  Kjersti Storheim⁴  Philip Wilkens³ 

[1] Norwegian Knowledge Centre for the Health Services, PO Box 7004 St. Olav’s plass, 0130 Oslo, Norway;Section for Radiology, Department of Surgical Sciences, University of Bergen, Jonas Lies vei 65, 5021, Bergen, Norway;Norwegian Research Centre for Active Rehabilitation (NAR), Hjelp24 NIMI, Pb. 3843 Ullevål Stadion, Sognsveien 75 D, 0805 Oslo, Norway;Communication- and Research Unit for Musculoskeletal Disorders, FORMI, Oslo University Hospital, Ullevål, Building 37b, 0407 Oslo, Norway

关键词: Treatment effect;    Randomized trial;    Modic changes;    Magnetic resonance imaging;    Lumbar spine;    Low back pain;    High intensity zone;    Glucosamine sulfate;   

Others  :  815294
DOI  :  10.1186/1477-5751-11-13

 received in 2012-02-21, accepted in 2012-08-07,  发布年份 2012

【 摘 要 】

Background

The underlying pathology and natural course of Modic changes (MC) in the vertebral body marrow and high intensity zones (HIZs) in the annulus fibrosus is not completely clarified. These findings on magnetic resonance imaging (MRI) have initiated different treatments with little or unclear effect. In a randomized trial (n = 250), glucosamine sulfate (GS) had no effect on low back pain related disability. GS could still have an effect on MC and HIZ. In this sub-study, 45 patients from the trial who had MC and/or HIZ at pre-treatment underwent follow-up MRI. The aim was to examine the course of MC and HIZ and to compare this course between groups treated with 6-month intake of oral GS versus placebo.

Results

Of 141 pre-treatment MC in 42 (of 45) patients, 29 (20.6%) MC in 18 patients had altered type and 14 MC in 9 patients had altered size (decreased for 1 MC) 6-18 months later: odds ratio (OR) for type vs. size alterations 4.0; 95% confidence interval (CI) 1.2-17.7. No MC resolved. HIZ vanished from 3 of 23 discs in 3 of 21 patients with pre-treatment HIZ. Ten new MC (all type I or I/II) occurred in 8 patients and 2 new HIZs in 2 patients. The GS group (n = 19) and placebo group (n = 26) did not differ in proportions of MC with decreased (OR 1.6; 95% CI 0.4-6.1) or increased type I dominance at follow-up (OR placebo:GS 2.4; 95% CI 0.6-9.7), or with increased size (OR 1.0; 95% CI 0.2-4.7). HIZ vanished from 1 of 8 discs in 1 of 8 patients in the GS group vs. 2 of 15 discs in 2 of 13 patients in the placebo group (OR 0.8; 95% CI 0.02-12.2).

Conclusions

In this sub-group analysis of a placebo-controlled trial, the effect of GS on MC and HIZs was no different from the effect of the placebo intervention. MC and HIZs remained mostly unchanged during the 6-18 months study period. Some short term changes did occur and MC more often altered type than size.

Trial registration

NCT00404079 at http://www.clinicaltrial.gov webcite.

【 授权许可】

   
2012 Wilkens et al.; licensee BioMed Central Ltd.

【 图 表 】

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