Sex differences in N-palmitoylethanolamide effectiveness in neuropathic pain associated with lumbosciatalgia.

BACKGROUND: Response to N-palmitoylethanolamide (PEA) appear to be influenced by hormonal changes. OBJECTIVE: To evaluate sex differences in the effectiveness of PEA. METHOD: Patients with neuropathic pain resulting from lumbosciatalgia were assigned to conventional treatment plus PEA or conventional treatment. The pain variables were measured using a visual analog scale and quality of life was assessed. RESULTS: One hundred and twelve patients were included. Significant differences were seen in men for all the variables. In women the differences were only significant for pain. A multivariate linear regression analysis showed a positive interaction between men and PEA treatment for the SF-12 mental component. CONCLUSION: Men treated with PEA are more likely to improve their quality of life regarding mental health, compared with women.

Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study.

BACKGROUND: Degenerative disc disease may cause severe low-back pain, a large public health problem with significant economic and life quality impact. Chronic cases often require surgery, which may lead to biomechanical problems and accelerated degeneration of the adjacent segments. Cell-based therapies may circumvent these problems and have exhibited encouraging results in vitro and in animal studies. We designed a pilot study to assess feasibility and safety and to obtain early indications on efficacy of treatment with mesenchymal stem cells (MSC) in humans. METHODS: Ten patients with chronic back pain diagnosed with lumbar disc degeneration with intact annulus fibrosus were treated with autologous expanded bone marrow MSC injected into the nucleus pulposus area. Clinical evolution was followed for 1 year and included evaluation of back pain, disability, and quality of life. Magnetic resonance imaging measurements of disc height and fluid content were also performed. RESULTS: Feasibility and safety were confirmed and strong indications of clinical efficacy identified. Patients exhibited rapid improvement of pain and disability (85% of maximum in 3 months) that approached 71% of optimal efficacy. This outcome compares favorably with the results of other procedures such as spinal fusion or total disc replacement. Although disc height was not recovered, water content was significantly elevated at 12 months. CONCLUSIONS: MSC therapy may be a valid alternative treatment for chronic back pain caused by degenerative disc disease. Advantages over current gold standards include simpler and more conservative intervention without surgery, preservation of normal biomechanics, and same or better pain relief.