Georgiev Dimiter B, Metka Marcus, Huber Johannes C, Goudev Assen R, Manassiev Nikolai
Second Obstetrics and Gynecology Hospital, Sofia, Bulgaria.
MedGenMed. 2004 Dec 16;6(4):46.
Fifty-five postmenopausal women with menopausal complaints were treated with the food supplement Melbrosia for 3 months. Menopausal symptom evaluation scales and psychological questionnaires were administered, and cardiovascular disease markers in blood were analyzed at the beginning and the end of the trial.
The perimenopausal care unit of Second Obstetrics and Gynecology Hospital, Sofia, Bulgaria.
The study was an open, multicenter, uncontrolled, prospective observation study. The subjective symptoms questionnaires administered before Melbrosia treatment and after 3 months of treatment were Kupperman Score, Zerssen Symptom List, Zung Depression Score, and Frankfurt Self-concept Scale (self-assessment test, problem-solving test, self-esteem test, and irritability test). The blood levels of high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides (TG), total cholesterol (TC), vascular cell adhesion molecule-1 (VCAM-1), and C-reactive protein (CRP) levels were measured in a subgroup of patients.
Treatment of postmenopausal women with Melbrosia led to a statistically significant reduction in the Kupperman score, Zerssen's Symptoms List, and Zung Depression Score. The Frankfurt Self-concept Scale revealed significant improvement in problem-solving, no change in self-assessment and self-esteem, and worsening of irritability. Treatment with Melbrosia significantly reduced TC and LDL and significantly elevated HDL and TG. There were nonsignificant changes of serum VCAM-1 and CRP levels in patients treated with Melbrosia.
The presented data suggest that Melbrosia may offer a potential alternative to hormone therapy for the treatment of menopausal symptoms. However, because of this study's uncontrolled, open- label methodology, no cause-and-effect inferences can be drawn until a larger, longer-term, blinded, placebo-controlled, randomized clinical trial is performed.
55名有更年期症状的绝经后女性接受了食品补充剂Melbrosia治疗3个月。在试验开始和结束时，进行了更年期症状评估量表和心理问卷调查，并分析了血液中的心血管疾病标志物。
保加利亚索非亚第二妇产科医院围绝经期护理单元。
该研究为开放、多中心、非对照、前瞻性观察研究。在Melbrosia治疗前和治疗3个月后使用的主观症状问卷有库珀曼评分、泽尔森症状清单、zung抑郁评分和法兰克福自我概念量表（自我评估测试、解决问题测试、自尊测试和易怒测试）。对部分患者测量了高密度脂蛋白（HDL）、低密度脂蛋白（LDL）、甘油三酯（TG）、总胆固醇（TC）、血管细胞粘附分子-1（VCAM-1）和C反应蛋白（CRP）的血液水平。
绝经后女性使用Melbrosia治疗后，库珀曼评分、泽尔森症状清单和zung抑郁评分在统计学上显著降低。法兰克福自我概念量表显示解决问题能力有显著改善，自我评估和自尊无变化，易怒情况恶化。Melbrosia治疗显著降低了TC和LDL，显著提高了HDL和TG。使用Melbrosia治疗的患者血清VCAM-1和CRP水平无显著变化。
所呈现的数据表明，Melbrosia可能为治疗更年期症状提供一种替代激素疗法的潜在选择。然而，由于本研究采用的是非对照、开放标签方法，在进行更大规模、更长期、双盲、安慰剂对照、随机临床试验之前，无法得出因果推断。
