Effects of Synbiotic Supplementation and Lifestyle Modifications on Women With Polycystic Ovary Syndrome

Izabela Chudzicka-Strugała; Anna Kubiak; Beata Banaszewska; Barbara Zwozdziak; Martyna Siakowska; Leszek Pawelczyk; Antoni J. Duleba

Disclosures

J Clin Endocrinol Metab. 2021;106(9):2566-2573. 

In This Article

Results

Comparison of Groups at Baseline

The CONSORT flow diagram of the study (Figure 1) demonstrates that 60% of subjects randomized to individual treatments completed the 3-month trial. Table 1 presents baseline characteristics of 39 subjects who completed the study. It is apparent that the placebo group and the synbiotic group were comparable with regard to all tested parameters. Hyperandrogenism (defined as the Ferriman and Gallwey score ≥ 8 and/or total testosterone >0.50 ng/mL) was identified in 33 subjects (85%).

Effects of Treatments

Table 2 presents changes in clinical, endocrine, and metabolic parameters in both study groups over the 3-month period of intensive lifestyle modifications. The primary outcome, weight loss, was accomplished in 18/19 (95%) subjects in the placebo group and in all subjects in the synbiotic group. In the placebo group, significant decrease of BMI by 5% was accompanied by significant decreases in the waist, hip, and thigh circumferences. In the synbiotic group, the decrease of BMI by 8% was significantly greater that in the control group (P = 0.03) and was also accompanied by significant decreases in the waist, hip, and thigh circumferences. Notably, the decrease of waist circumference was significantly greater in the synbiotic group (P = 0.03). The percentage of body fat decreased significantly in both groups (P < 0.0001).

The secondary outcome identified before the commencement of the study was the change of total testosterone. Decline of total testosterone level was observed in 53% of women in the placebo group and in 90% of women in the synbiotic group; the difference between the groups was significant (P = 0.008). The level of testosterone decreased in the placebo group by 6% (not statistically significant) while in the synbiotic group testosterone decreased by 32% (P < 0.0001). The decrease of testosterone was significantly greater in the synbiotic group than in the placebo group (P = 0.016).

In the placebo group, intensive lifestyle modifications had no significant effect on other tested clinical, endocrine, and metabolic parameters except for a 15% decrease of triglycerides (P = 0.034). In the synbiotic group, dietary interventions led to a significant increase of dehydroepiandrosterone sulfate (by 14%; P = 0.012) and a decrease of triglycerides (by 23%; P = 0.022).

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