Table 2.

Tissue biomarkers at baseline and after 12 weeks of study treatment, (intention-to-treat population)

BaselinePosttreatmentPosttreatment vs. baseline changeaTreatment effecta
VariablesDHA (Mean ± SD)Placebo (Mean ± SD)DHA (Mean ± SD)Placebo (Mean ± SD)DHA (Mean ± SD)Placebo (Mean ± SD)Baseline adjusted change (95% CI)P
TNF-αb0.08 ± 0.780.26 ± 0.930.16 ± 0.950.06 ± 0.920.08 ± 0.99−0.22 ± 1.190.17 (−0.32–0.67)0.50
DHA N = 31
Placebo N = 26
COX-20.31 ± 0.970.49 ± 1.350.22 ± 1.16−0.11 ± 1.30−0.10 ± 1.23−0.61 ± 1.500.41 (−0.21–1.04)0.19
DHA N = 30
Placebo N = 26
IL1β0.28 ± 1.500.62 ± 2.000.19 ± 2.070.23 ± 2.06−0.09 ± 1.84−0.48 ± 1.610.29 (−0.61–1.18)0.52
DHA N = 31
Placebo N = 26
Aromatasec0.13 ± 2.38−0.38 ± 1.930.06 ± 1.89−0.59 ± 2.130.05 ± 2.12−0.41 ± 2.290.77 (−0.22–1.76)0.12
DHA N = 30
Placebo N = 22
  • NOTE: Log-transformed relative levels of TNFα, COX2, IL1β, and aromatase were determined by quantitative RT-PCR.

  • aThe change between baseline and posttreatment, as well as the treatment effect, was calculated for patients for whom data from both time points were available. Treatment-effect data and P values were obtained from analysis of covariance. N represents the number of patients in each arm with both pre-and post-treatment values for the measured tissue biomarkers.

  • bOf the intention-to-treat population, 2 patients in the placebo arm did not have adequate RNA for analysis, as defined by RNA integrity number >5.

  • cDue to the small volume of tissue obtained from core biopsies, some samples did not yield enough RNA to accurately measure aromatase expression which is known to be expressed at low levels in adipose tissue. Therefore, aromatase measurements are not available in a subset of cases.