Beschreibung:
<jats:p><jats:italic>Objective</jats:italic>. This study aimed at investigating the therapeutic effect and mechanism of pioglitazone metformin complex preparation (PM) in polycystic ovary syndrome (PCOS) comorbid psychological distress. <jats:italic>Methods</jats:italic>. Seventy-five patients with PCOS comorbid psychological distress were randomly allocated into the PM, metformin, and placebo groups. The primary efficacy measure was the change from baseline to week 12 on the Symptom Checklist 90-R (SCL-90-R) scores. NLRP3 inflammasome, IL-1<jats:italic>β</jats:italic>, IL-6, TNF-<jats:italic>α</jats:italic>, and biochemical parameters were determined at baseline and at week 12. The participants were required to meet the criteria for PCOS (Rotterdam, NIH) and psychological distress (any factor scores of <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M1"><mml:mtext>SCL</mml:mtext><mml:mo>−</mml:mo><mml:mn>90</mml:mn><mml:mo>−</mml:mo><mml:mtext>R</mml:mtext><mml:mo>></mml:mo><mml:mn>2</mml:mn></mml:math>). <jats:italic>Results</jats:italic>. The participants had significantly high scores on the SCL-90-R scales of anxiety and depression. PM significantly decreased anxiety and depression symptom severity (from <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:mn>2.31</mml:mn><mml:mo>±</mml:mo><mml:mn>0.75</mml:mn></mml:math> to <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M3"><mml:mn>1.65</mml:mn><mml:mo>±</mml:mo><mml:mn>0.38</mml:mn></mml:math>, <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M4"><mml:mi>p</mml:mi><mml:mo><</mml:mo><mml:mn>0.001</mml:mn></mml:math>, and from <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M5"><mml:mn>2.08</mml:mn><mml:mo>±</mml:mo><mml:mn>0.74</mml:mn></mml:math> to <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M6"><mml:mn>1.61</mml:mn><mml:mo>±</mml:mo><mml:mn>0.46</mml:mn></mml:math>, <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M7"><mml:mi>p</mml:mi><mml:mo>=</mml:mo><mml:mn>0.010</mml:mn></mml:math>, at week 12, respectively). PM significantly decreased the expression of NRPL3 and caspase-1. Patients in the PM group experienced a significant reduction in IL-1<jats:italic>β</jats:italic> (from <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M8"><mml:mn>98.42</mml:mn><mml:mo>±</mml:mo><mml:mn>14.38</mml:mn></mml:math> to <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M9"><mml:mn>71.76</mml:mn><mml:mo>±</mml:mo><mml:mn>13.66</mml:mn></mml:math>, <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M10"><mml:mi>p</mml:mi><mml:mo>=</mml:mo><mml:mn>0.02</mml:mn></mml:math>), IL-6 (from <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M11"><mml:mn>87.51</mml:mn><mml:mo>±</mml:mo><mml:mn>8.74</mml:mn></mml:math> to <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M12"><mml:mn>71.98</mml:mn><mml:mo>±</mml:mo><mml:mn>15.87</mml:mn></mml:math>, <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M13"><mml:mi>p</mml:mi><mml:mo>=</mml:mo><mml:mn>0.02</mml:mn></mml:math>), and TNF-<jats:italic>α</jats:italic> (from <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M14"><mml:mn>395.33</mml:mn><mml:mo>±</mml:mo><mml:mn>88.55</mml:mn></mml:math> to <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M15"><mml:mn>281.98</mml:mn><mml:mo>±</mml:mo><mml:mn>85.69</mml:mn></mml:math>, <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M16"><mml:mi>p</mml:mi><mml:mo>=</mml:mo><mml:mn>0.04</mml:mn></mml:math>). PM was superior to metformin in reducing total testosterone (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M17"><mml:mn>2.24</mml:mn><mml:mo>±</mml:mo><mml:mn>0.74</mml:mn></mml:math> versus <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M18"><mml:mn>3.06</mml:mn><mml:mo>±</mml:mo><mml:mn>0.83</mml:mn></mml:math>, <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M19"><mml:mi>p</mml:mi><mml:mo>=</mml:mo><mml:mn>0.024</mml:mn></mml:math>, at week 12).<jats:italic>Conclusions</jats:italic>. This study is the first to reveal that PM alleviates psychological distress via inhibiting NLRP3 inflammasome and improves several markers, including total testosterone.</jats:p>