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首页> 外文期刊>International Journal of General Medicine >Preliminary results of a randomized controlled trial carried out with a fixed combination of S-adenosyl-L-methionine and betaine versus amitriptyline in patients with mild depression
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Preliminary results of a randomized controlled trial carried out with a fixed combination of S-adenosyl-L-methionine and betaine versus amitriptyline in patients with mild depression

机译:S-腺苷-L-蛋氨酸和甜菜碱固定联合阿米替林与轻度抑郁症患者进行的随机对照试验的初步结果

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Background: S-adenosyl-L-methionine (SAMe), a safe, endogenous, pleiotropic methyl donor well known for its antidepressant role, has been assumed to have a possible role in increasing plasma levels of compounds known to be able to raise cardiovascular risk. Although the issue is still being debated, betaine (trimethylglycine), a specific methyl donor involved in the homocysteine circuit, may be able to reduce such a risk and/or, by determining a sparing effect on endogenous SAMe, may be able to improve the clinical efficiency of SAMe itself. Indeed, preliminary results have shown clinical improvement determined by an add-on therapy with betaine administered along with SAMe, versus SAMe alone, to patients affected by mild/moderate depression. Aim: To evaluate the safety and antidepressant role played by the association of SAMe plus betaine versus amitriptyline administered in untreated individuals with a recent diagnosis of mild depression. Methods: This small, open-label, randomized, observational study enrolled 64 individuals with a diagnosis of mild depression according to the Zung Self-Rating Depression Scale. After randomization, they were treated with either Laroxyl? (amitriptyline, 75 mg/day) or DDM Metile? (enteric-coated SAMe, 500 mg/day, plus betaine, 250 mg/day) for 12 months. Assessment of clinical scores and tolerability was performed at T=0 and after 3, 6, and 12 months. Results: After 3 months, both treatments showed a small and not statistically significant improvement. After 6 and 12 months, both treated groups demonstrated a more noticeable improved response, although the group treated with SAMe plus betaine showed better results in terms of score, number of individuals in remission, and side effects. Compliance was overlapping in both treatments. Conclusion: The association of SAMe plus betaine seems to be a safe and effective tool to counteract mild depression and also when used as monotherapy in subjects with a recent diagnosis.
机译:背景:S-腺苷-L-蛋氨酸(SAMe)是一种安全,内源,多效的甲基供体,以其抗抑郁作用而闻名,已被认为在增加血浆中可能引起心血管疾病的化合物的水平中可能发挥作用。尽管这个问题仍在争论中,但甜菜碱(三甲基甘氨酸),一种参与高半胱氨酸回路的特定甲基供体,可能能够降低这种风险,和/或通过确定对内源性SAMe的保护作用,可以改善这种风险。 SAMe本身的临床效率。的确,初步结果表明,对受轻度/中度抑郁症影响的患者,甜菜碱与SAMe联合使用,与单独使用SAMe相比,可通过附加疗法确定临床改善。目的:评估在最近诊断为轻度抑郁症的未经治疗的个体中,SAMe加甜菜碱与阿米替林联用所起的安全性和抗抑郁作用。方法:这项小型的,开放性,随机,观察性研究纳入了64位根据Zung自评抑郁量表诊断为轻度抑郁症的患者。随机分组后,用拉莫西尔(Laroxyl)治疗它们。 (阿米替林,75毫克/天)或DDM Metile? (肠溶性SAMe,500毫克/天,加甜菜碱,250毫克/天)持续12个月。在T = 0和3、6和12个月后评估临床评分和耐受性。结果:3个月后,两种治疗均显示出微小改善,但无统计学意义。 6个月和12个月后,两个治疗组均表现出更明显的改善反应,尽管用SAMe加甜菜碱治疗的组在评分,缓解人数和副作用方面显示出更好的结果。两种治疗方法的依从性重叠。结论:SAMe和甜菜碱联用似乎是抵抗轻度抑郁症的安全有效工具,并且在近期诊断为对象的单药治疗中也可使用。

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