Tier 2 — strong

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

Francesco Di Pierro, Roberto Settembre
International journal of general medicine 2015 8:73-78

Bibliography

PubMed
PMID 25678811
PubMed Central
PMC4322882
DOI
10.2147/IJGM.S79518
Funding
Funding was not specified in the indexed record or accessible funding metadata.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignOpen-label randomized pilot
ModelHuman participants
Sample64 adults with mild depression
InterventionSAMe 500 mg/day plus betaine 250 mg/day versus amitriptyline 75 mg/day
Duration12 months
EndpointsDepressive symptoms; Remission; Tolerability

What the study showed, in plain terms

Published in 2015, this source examined brain health and combination interventions. Design: Open-label randomized pilot. Sample/model: 64 adults with mild depression. The exposure or intervention was SAMe 500 mg/day plus betaine 250 mg/day versus amitriptyline 75 mg/day. Follow-up or treatment period: 12 months.

The combination group had more favorable symptom and tolerability results at later assessments.

Open-label, small and without placebo. The findings concern SAMe plus betaine and do not establish betaine as a replacement for depression treatment.

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Key findings

  • The combination group had more favorable symptom and tolerability results at later assessments.
  • The recorded outcome domains were Depressive symptoms; Remission; Tolerability.
  • The result applies to the tested exposure: SAMe 500 mg/day plus betaine 250 mg/day versus amitriptyline 75 mg/day; 12 months.

What this study can and cannot tell us

  • Open-label, small and without placebo. The findings concern SAMe plus betaine and do not establish betaine as a replacement for depression treatment.
  • Without a sufficiently blinded concurrent control, time effects, expectations, co-interventions and regression toward the mean can explain part of an apparent improvement.
  • Source basis: Accessible full-text extract plus indexed bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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Editorial review

Reviewed by the Biohack Blueprint research team

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology