Predicting Treatment Response with Sensory Phenotyping in Post-Traumatic Neuropathic Pain.

OBJECTIVE: Currently available treatments for neuropathic pain are only modestly efficacious when assessed in randomized clinical trials and work for only some patients in the clinic. Induced-pain or gain-of-function phenotypes have been shown to predict response to analgesics (vs placebos) in patients with neuropathic pain. However, the predictive value of these phenotypes has never been studied in post-traumatic neuropathic pain. METHODS: Mixed-effects models for repeated measures were used to evaluate the efficacy of pregabalin vs placebo in subgroups with induced-pain phenotypes (i.e., hyperalgesia or allodynia) in data from a recent, multinational randomized clinical trial (N = 539) that identified phenotypic subgroups through the use of a structured clinical exam. RESULTS: The difference in mean pain score between the active and placebo groups (i.e., delta) after 15 weeks of treatment for the subgroup with hyperalgesia was -0.76 (P = 0.001), compared with 0.19 (P = 0.47) for the subgroup that did not have hyperalgesia. The treatment-by-phenotype interaction, which tests whether subgroups have statistically different treatment responses, was significant (P = 0.0067). The delta for the subgroup with allodynia was -0.31 (P = 0.22), compared with -0.30 (P = 0.22) for the subgroup that did not have allodynia (treatment-by-phenotype interaction P = 0.98). CONCLUSIONS: These data suggest that hyperalgesia, but not allodynia, predicts response to pregabalin in patients with chronic post-traumatic neuropathic pain. This study extends the growing data supporting the utility of induced-pain phenotypes to predict response to analgesics in post-traumatic neuropathic pain. Sensory phenotyping in large, multisite trials through the use of a structured clinical exam has the potential to accelerate the development of new analgesics and improve the generalizability of clinical trial results.

Fungal types and concentrations from settled dust in normal residences.

Analysis of settled dust collected from carpeting and furnishings is occasionally used by investigators to determine whether an environment contains unusual fungi. Little information is available concerning the types and concentrations of culturable fungi present on textile surfaces in normal residential settings not affected by unusual mold reservoirs, such as from fungal growth sites within the built environment. This study presents the results of the collection and analysis of surface dust from 26 residential environments that were prescreened by interview, physical inspection, and air sampling to limit the surface dust collection to structures in which there was no history of water intrusion, flooding, plumbing leaks, signs of mold growth, or evidence of unusual airborne fungal spore types or concentrations. In those structures found to have no history or indications of water events or unusual fungi, surface dust was vacuumed from prescribed horizontal areas on carpet and textile-covered furnishings. These samples were then subjected to fungal culture, from which viable colonies were enumerated and identified. Based on the study results, it does not appear reasonable that the frequently quoted total fungi concentration exceeding 10(5) CFU/g is definitive evidence that a residential surface is contaminated with unusual amounts of culturable fungi. Collocated samples collected from eight side-by-side carpets sections revealed poor reproducibility. While settled dust sampling may be appropriate for determining the fungal status of a localized area, or as a gross screening tool, using settled dust results alone to establish the presence of unusual fungal types or concentrations within a structure appears to be inappropriate, and using settled dust results with other investigative methods, such as visual observations and air sampling, requires cautious interpretation.