Meissner H O, Kapczynski W, Mscisz A, Lutomski J
Faculty of Health Studies, Charles Sturt University & TTD International Pty Ltd, Sydney, Australia;
Int J Biomed Sci. 2005 Jun;1(1):33-45.
This double-blind, placebo-corrected clinical pilot study was aimed at assessing the use of hypocotyls of cruciferous Andean plant Maca (Lepidium peruvianum Chacon), in alleviating symptoms of menopausal discomfort experienced by women in early post menopause as measured by profiles of serum hormones: Luteinizing Hormone (LH), Follicle-stimulating Hormone (FSH), Estrogen (E2) and Progesterone (PG) and as assessed by Greene's Menopausal Index.
Study was conducted on 20 Caucasian healthy early-postmenopausal women volunteers during the three months period (Trial I) and on eight women during nine months period (Trial II). Hormone levels were determined in blood with a simultaneous assessment of menopausal index at the start of study, after one month use of placebo, and after two and eight months administration of 2g gelatinized Maca root powder (Maca-GO) in the form of two 500mg hard gel capsules, twice daily.
In comparison to placebo, after both, two and eight months administration of Maca-GO capsules to EPMW, level of FSH significantly (P<0.05) decreased with a simultaneous significant (P<0.05) increase in the LH level, resulting in significant (P<0.05) increase in both E2 and PG, after eight months of Maca-GO treatment only. There was a significant (P<0.05) placebo effect resulting in an elevated PG level after one month administration of placebo capsules. Changes in hormone levels was accompanied by substantially-reduced feeling of discomfort associated with menopause, although, there was a distinctive, positive placebo effect as judged by responses to Greene's questionnaire.
It is reasonable to suggest that Maca-GO when used in EPMW, depending on the length of use, was acting as a toner of hormonal processes as reflected by decrease in FSH and increased LH secretion, which stimulated production of both ovarian hormones, E2 and PG and resulted in a substantial reduction of menopausal discomfort felt by women participating in the study, with a distinctive placebo effect, thus, fully justifying further, more complex study on effectiveness of Maca-GO as a reliable alternative to HRT program.
本双盲、安慰剂对照的临床先导研究旨在评估十字花科安第斯植物玛咖(秘鲁独行菜查孔变种)下胚轴在缓解绝经后早期女性更年期不适症状方面的作用,这些症状通过血清激素水平(促黄体生成素(LH)、促卵泡激素(FSH)、雌激素(E2)和孕酮(PG))以及格林更年期指数进行衡量。
在三个月期间(试验一)对20名白种健康绝经后早期女性志愿者进行研究,在九个月期间(试验二)对8名女性进行研究。在研究开始时、使用安慰剂一个月后以及以两粒500毫克硬胶囊形式每日两次服用2克胶化玛咖根粉(Maca - GO)两个月和八个月后,测定血液中的激素水平,并同时评估更年期指数。
与安慰剂相比,在对绝经后早期女性服用Maca - GO胶囊两个月和八个月后,FSH水平显著降低(P<0.05),同时LH水平显著升高(P<0.05),仅在Maca - GO治疗八个月后,E2和PG水平显著升高(P<0.05)。服用安慰剂胶囊一个月后有显著的(P<0.05)安慰剂效应,导致PG水平升高。激素水平的变化伴随着与更年期相关的不适感大幅减轻,尽管根据对格林问卷的回答判断存在明显的阳性安慰剂效应。
有理由认为,Maca - GO用于绝经后早期女性时,根据使用时间长短,可作为激素调节因子,表现为FSH降低和LH分泌增加,刺激卵巢激素E2和PG的产生,从而使参与研究的女性更年期不适症状大幅减轻,且有明显的安慰剂效应,因此,完全有必要对Maca - GO作为激素替代疗法可靠替代品的有效性进行进一步、更复杂的研究。