[Spinal cord stimulation in Failed-Back-Surgery-Syndrome. Preliminary study for the evaluation of therapy by functional magnetic resonance imaging (fMRI)]. / Epidurale Rückenmarkstimulation bei Postnukleotomiesyndrom. Pilotstudie zur Therapieevaluation mit der funktionellen Magnetresonanztomographie (fMRT).

BACKGROUND: Spinal cord stimulation (SCS) is an effective alternative treatment in patients with chronic neuropathic pain and mainly radicular distribution. The aim of this prospective study was to investigate changes in BOLD signal with fMRI during active SCS and to correlate the results with the clinical pain intensity, measured with a visual analogue scale (VAS). PATIENTS AND METHODS: Three patients with failed back surgery syndrome were tested during the clinical trial of SCS. A first fMRI was performed with marked pain and a high VAS score. Before the second fMRI a therapeutic stimulation phase with pain reduction was carried out. RESULTS: With high pain levels SCS activated the cingulate gyrus, thalamus, prefrontal cortex, supplementary motor area and postcentral gyrus. After pain reduction, SCS did not elicit these activations in the second fMRI, using the same stimulation parameters. CONCLUSIONS: In patients with chronic neuropathic pain and high VAS levels, SCS elicited BOLD activation in the cingulate gyrus, thalamus, prefrontal cortex, and primary and secondary somatosensory area. Pain reduction by SCS resulted in a reduction of functional activity in these areas as revealed by follow-up fMRI.

A randomized trial of the efficacy and tolerability of the COX-2 inhibitor rofecoxib vs ibuprofen in patients with osteoarthritis. Rofecoxib/Ibuprofen Comparator Study Group.

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). It is not known whether a specific inhibitor of COX-2 will provide efficacy in osteoarthritis (OA) comparable with NSAIDs. Therefore, we compared the efficacy and safety of the rofecoxib, which specifically inhibits COX-2, with those of the NSAID ibuprofen in patients with OA. OBJECTIVE: To compare the clinical efficacy and tolerability of rofecoxib (12.5 and 25 mg once daily) with ibuprofen (800 mg 3 times daily). METHODS: A randomized, double-blind trial of 809 adults with OA was conducted. Patients with OA in whom the knee or hip was the primary source of pain were randomized to 1 of 4 treatment groups on demonstration of disease activity: placebo; rofecoxib, 12.5 or 25 mg once daily; or ibuprofen, 800 mg 3 times daily. Clinical efficacy and safety were monitored during a 6-week treatment period. RESULTS: Both doses of rofecoxib demonstrated efficacy clinically comparable with ibuprofen as assessed by 3 primary end points (pain walking on a flat surface [Western Ontario and McMaster Universities Osteoarthritis Index], patient global assessment of response to therapy, and investigator global assessment of disease status) according to predefined comparability criteria. Both rofecoxib doses and the ibuprofen dose provided significantly (P<.001) greater efficacy than placebo on all primary end points. Results from secondary end points were consistent with those of the primary end points. All treatments were well tolerated; the overall incidence rates of clinical adverse experiences were not significantly different (P>.05) among the treatment groups. CONCLUSION: Rofecoxib was well tolerated and provided clinical efficacy comparable with a high dose of the NSAID ibuprofen.

Use of bone alkaline phosphatase to monitor alendronate therapy in individual postmenopausal osteoporotic women.

BACKGROUND: Biochemical bone markers are sensitive to the changes in bone turnover that result from treatment of postmenopausal osteoporotic women with antiresorptive therapies. Although information is available on the use of bone markers in monitoring therapy in groups of subjects, less is known regarding how these markers perform in individual patients. METHODS: Serum bone alkaline phosphatase (bone ALP) concentrations, measured with the Tandem(R) Ostase(R) assay, were used to monitor the biochemical response of bone in postmenopausal women with osteoporosis receiving either 10 mg/day alendronate therapy (n = 74) or calcium supplementation (n = 148) for 24 months. RESULTS: Bone ALP decreased significantly from baseline at 3 months (P