| NUTRACEUTICALS | ARTICLE 15 10 5 0 -5 -10
FEMALES Diet
FEMALES Diet + OPE
Figure 2 IL-6 variation in diet versus diet plus OPE in women Scale (CES-D) questionnaire was used to assess how
the subject felt and behaved during the previous week. For example, the CES-D scores the mood with a possible value of 0–60, with higher scores indicating more depressive symptoms, while scores between 0 and 15 indicate no depressive symptoms. All results were analysed comparing day 1 to day 56.
Statistical analysis All data are presented as mean ± standard error of the mean (SEM). Statistical analyses were carried out using the Statview 5 statistical package (SAS Institute Inc., USA) and MedCalc Software (Mariakerke, Belgium). Data at day 1 and day 56 were compared using paired StudentÕs t-Tests, ANOVA or MannÐ Whitney U-tests. For all comparisons, differences were considered to be significant at the level of P<0.05.
Results Biological parameters When analysing the biological parameters of males and females it appeared that only ESR was significantly
-10 -12
MALES Diet
FEMALES Diet
MALES Diet + OPE Figure 3 Gender partition and CES-D variation in diet versus diet plus OPE When subjects were
divided according to their inflammatory status, low or
high, at baseline, no significant difference was seen in patients receiving diet only.
improved at day 56 in females receiving diet only (P=0.02) and in males receiving diet plus OPE (P=0.03). No difference was seen for CRP, fibrinogen, WBC or TNF-α. When subjects were divided according to their inflammatory status, low or high, at baseline (as described in the Materials and Methods section), no significant difference was seen in patients receiving diet only. A significant improvement was, however, observed in patients with high inflammatory status receiving diet plus OPE for ESR (P=0.02), WBC (P=0.05) and fibrinogen (P=0.02). Furthermore, IL-6 levels increased in
patients with diet only, while it decreased in both inflammatory subgroups for patients supplemented with OPE (Figure 1). IL-6 levels also increased in females receiving diet only, while it decreased in those receiving OPE supplementation (Figure 2).
Effects on QoL and mood parameters With regard to the CES-D scale, most individuals in the RISTOMED study were within the absence of symptoms range, with a mean value of 8.05 ± 7.77. No statistically significant differences were observed between centres (P=0.06). A significantly higher score was observed at baseline in females (9.96 ± 8.71) compared with males (5.84 ± 5.86; P=0.003). Although scores improved (i.e. decreased) in both genders, at the end of the study they diverged (F=6.67 ± 6.39 vs M=3.96 ± 5.22; P=0.012). This gender-significant difference was confirmed only in the French sub-group before (P=0.033) and in the German sub-group after the diet period (P=0.026), but not in the other groups (data not shown). When the analysis was made, stratifying by both centre and gender, it was observed that the significant differences between day 1 and day 56 were confirmed in the German males (P=0.002) and French females (P<0.001), but not in the other groups (data not shown). When comparing QoL and mood parameters with
regard to gender status, it appeared that only SF 36-v2 MCS improved in males receiving diet only (P=0.009) or OPE
prime-journal.com | July/August 2012 ❚ 35
FEMALES Diet + OPE
2 0 -2 -4 -6 -8
IL-6 difference
CESD difference
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