(S)-S-腺苷蛋氨酸治疗成年女性月经前期紊乱:开放标签试验研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Brendan Stevenson, Emorfia Gavrilidis, Yasmin Malik, Jayashri Kulkarni
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引用次数: 0

摘要

经前期紊乱,包括经前期综合症和经前期情感障碍,是育龄妇女的高发疾病。经前期紊乱与月经前几天出现的衰弱症状有关。荷尔蒙波动、细胞敏感性和社会心理压力之间复杂的相互作用可能是经前期紊乱的病理生理学基础。目前的治疗方法包括选择性血清素再摄取抑制剂、荷尔蒙疗法和社会心理支持。越来越多的证据表明,雌激素、孕激素、促性腺激素释放激素类似物以及补充和替代药物可用于治疗经前期紊乱症。(S)-S-腺苷蛋氨酸是一种补充和替代药物,据推测可用于治疗抑郁症,而且起效迅速,副作用极小。我们提出了一项方案,用于研究(S)-S-腺苷蛋氨酸治疗经前期紊乱症的疗效。拟议的研究是一项开放标签试验研究,将招募 30 名年龄在 18-45 岁之间、患有经前期紊乱的女性。每日和间歇性问卷调查将对四个月经周期(16 周)内的症状进行量化。在连续两个月经周期中,建议参与者在月经前期(月经前 14 天)口服 (S)-S- 腺苷蛋氨酸复合物 400 毫克,每天三次(每天总剂量为 1200 毫克)。对照组和治疗周期之间经前期紊乱症状的变化将有助于阐明(S)-S-腺苷蛋氨酸的临床疗效。这项研究有可能支持更大规模的双盲、安慰剂对照随机对照试验,旨在丰富有关经前期紊乱的知识。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
(S)–S-adenosylmethionine in the treatment of pre-menstrual disorders in adult women: A protocol for an open-label pilot study

Pre-menstrual disorders, including pre-menstrual syndrome and pre-menstrual dysphoric disorder, are highly prevalent disorders in women of reproductive age. Pre-menstrual disorders are associated with debilitating symptoms that onset in the days prior to menses. A complex interplay between hormonal fluctuations, cellular sensitivity, and psychosocial stressors likely underly the pathophysiology of pre-menstrual disorders. Current treatment options include selective serotonin reuptake inhibitors, hormonal therapies, and psychosocial support. There is growing evidence for oestrogen, progesterone, gonadotropin Releasing Hormone analogues and Complementary and Alternative Medicines in treating Pre-menstrual disorders. (S)–S-adenosylmethionine is a complementary and alternative medicine with postulated roles in the treatment of depression, with a rather rapid onset of action and minimal side effect profile. We propose a protocol for investigating the efficacy of (S)–S-adenosylmethionine in the treatment of pre-menstrual disorders. The proposed study is an open label pilot study, that will recruit thirty women between the ages of 18–45 who experience a pre-menstrual disorder. Daily and interval questionnaires will provide a quantification of symptoms across four menstrual cycles (16 weeks). During two consecutive menstrual cycles it is proposed that participants receive oral (S)–S-adenosylmethionine Complex 400 mg three times a day (total daily dose 1200 mg), during the pre-menstrual time-period (14 days prior to menses). Changes in pre-menstrual disorder symptoms between control and treatment cycles will assist in elucidating the clinical efficacy of (S)–S-adenosylmethionine. This study has the potential to support a larger double blinded, placebo controlled randomised control trial and aims to enrich the knowledge surrounding pre-menstrual disorders.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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