Current Status of Development of Methods to Assess Effects of Cumulative or Aggregated Underwater Sounds on Marine Mammals.

There are no standards for assessment of the cumulative effects of underwater sound. Quantitative assessments typically consider a single source, whereas qualitative assessments may include multiple sources but rarely identify response variables. As a step toward understanding the cumulative effects of underwater sound, we assessed the aggregated sounds of multiple sources received by migrating bowhead whales (Balaena mysticetus). The quantitative method models the sound field from multiple sources and simulates movement of a population through it. The qualitative method uses experts to assess the responses of individuals and populations to sound sources and identify the potential mechanisms. These methods increase the transparency of assessments.

Stochastic Modeling of Behavioral Response to Anthropogenic Sounds.

The effect of anthropogenic sounds on marine wildlife is typically assessed by convolving the spatial, temporal, and spectral properties of a modeled sound field with a representation of animal distribution within the field. Both components benefit from stochastic modeling techniques based on field observations. Recent studies have also highlighted the effect of context on the probability and severity of the animal behavioral response to sound. This paper extends the stochastic approach to three modeling scenarios, including key contextual variables in aversion from a given level of sound and as a means of evaluating the effectiveness of passive acoustic monitoring.

Changes in humpback whale song occurrence in response to an acoustic source 200 km away.

The effect of underwater anthropogenic sound on marine mammals is of increasing concern. Here we show that humpback whale (Megaptera novaeangliae) song in the Stellwagen Bank National Marine Sanctuary (SBNMS) was reduced, concurrent with transmissions of an Ocean Acoustic Waveguide Remote Sensing (OAWRS) experiment approximately 200 km away. We detected the OAWRS experiment in SBNMS during an 11 day period in autumn 2006. We compared the occurrence of song for 11 days before, during and after the experiment with song over the same 33 calendar days in two later years. Using a quasi-Poisson generalized linear model (GLM), we demonstrate a significant difference in the number of minutes with detected song between periods and years. The lack of humpback whale song during the OAWRS experiment was the most substantial signal in the data. Our findings demonstrate the greatest published distance over which anthropogenic sound has been shown to affect vocalizing baleen whales, and the first time that active acoustic fisheries technology has been shown to have this effect. The suitability of Ocean Acoustic Waveguide Remote Sensing technology for in-situ, long term monitoring of marine ecosystems should be considered, bearing in mind its possible effects on non-target species, in particular protected species.

Effects of mid-frequency active sonar on hearing in fish.

Caged fish were exposed to sound from mid-frequency active (MFA) transducers in a 5 × 5 planar array which simulated MFA sounds at received sound pressure levels of 210 dB SPL(re 1 µPa). The exposure sound consisted of a 2 s frequency sweep from 2.8 to 3.8 kHz followed by a 1 s tone at 3.3 kHz. The sound sequence was repeated every 25 s for five repetitions resulting in a cumulative sound exposure level (SEL(cum)) of 220 dB re 1 µPa(2) s. The cumulative exposure level did not affect the hearing sensitivity of rainbow trout, a species whose hearing range is lower than the frequencies in the presented MFA sound. In contrast, one cohort of channel catfish showed a statistically significant temporary threshold shift of 4-6 dB at 2300 Hz, but not at lower tested frequencies, whereas a second cohort showed no change. It is likely that this threshold shift resulted from the frequency spectrum of the MFA sound overlapping with the upper end of the hearing frequency range of the channel catfish. The observed threshold shifts in channel catfish recovered within 24 h. There was no mortality associated with the MFA sound exposure used in this test.

Civamide cream 0.075% in patients with osteoarthritis of the knee: a 12-week randomized controlled clinical trial with a longterm extension.

OBJECTIVE: To evaluate the safety and efficacy of civamide cream 0.075% for the treatment of osteoarthritis (OA) of the knee. METHODS: We conducted a 12-week, multicenter, randomized, double-blind study with a 52-week open-label extension. Patients with OA of the knee received either civamide cream 0.075% or a lower dose of civamide cream, 0.01%, as the control. The 3 co-primary endpoints in the double-blind study were the time-weighted average (TWA) of change from baseline to Day 84 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and the Subject Global Evaluation (SGE). In the 52-week open-label extension study, the Osteoarthritis Pain Score and SGE were assessed. RESULTS: A total of 695 patients were randomized to receive civamide cream 0.075% (n = 351) or civamide cream 0.01% (control; n = 344) in the double-blind study. Significance in favor of civamide cream 0.075% was achieved for the TWA for all 3 co-primary efficacy variables: WOMAC pain (p = 0.009), WOMAC physical function (p < 0.001), and SGE (p = 0.008); and at Day 84 for these 3 variables (p = 0.013, p < 0.001, and p = 0.049, respectively). These analyses accounted for significant baseline-by-treatment interactions. In the 52-week open-label extension, efficacy was maintained. Civamide cream 0.075% was well tolerated throughout the studies. CONCLUSION: These studies demonstrate the efficacy of civamide cream for up to 1 year of continuous use. Civamide cream, with its lack of systemic absorption, does not have the potential for serious systemic toxicity, in contrast to several other OA treatments.