Bioclinic Naturals, SAMe 30 Enteric Coated Tablets

Benefits

• Key factors in several biological pathways, including methylation reactions, glutathione formation, and glutathione S-transferase activity
• Delayed-release tablets promote optimal absorption
• 200 mg of SAMe per tablet allows for flexible dosing
• SAMe is produced through a natural fermentation process that yields higher active ingredients over synthetic variations
• Suitable for vegetarians

Feature Summary

S-adenosyl-L-methionine (SAMe) has been clinically studied to support healthy mood balance and relieve osteoarthritic pain as well as other conditions.1,2 SAMe influences both serotonin and dopamine levels, and for patients with low mood, it is effective when used alone or with other therapies, even among patients who have been unresponsive to previous treatments.3–5 Additionally, it has a very good safety profile, with remarkably few adverse effects reported.5,6 SAMe has also shown efficacy for osteoarthritis, with significant pain reduction observed in several clinical trials.7,8 Unlike most therapies for osteoarthritis that have only a single target, SAMe has multiple biological effects that may bring relief, such as increasing cartilage formation and glutathione synthesis and modulating the expression of genes related to joint health.9 Research also suggests SAMe’s benefit for supporting neurological function, and potentially for improving endothelial function.10–13

SAMe has several critical physiological functions and is the common thread between three key metabolic pathways. It is well recognized as a unique methyl donor for more than 100 biological reactions, including DNA methylation. It also links methylation to polyamine synthesis (necessary for cell survival and growth) and transsulfuration, which is responsible for cysteine production, the rate-limiting factor in glutathione synthesis.14–16 Its unique positioning within these intersecting pathways explains its role as a regulator of redox status, cellular metabolism, proliferation, and apoptosis.17,18

Non-Medicinal Ingredients

Microcrystalline cellulose, coating (talc, glycerin, arginine, vegetable grade magnesium stearate (lubricant), silica, sodium alginate), stearic acid, vegetable grade magnesium stearate (lubricant), magnesium hydroxide, silica, calcium oxide.

Dosage

Recommended Adult Dose: SAMe should always be taken on an empty stomach and for a minimum of 2 weeks, at which time effects should be observed.
For mood balance: 1-4 tablets 2 times per day or as directed by a health care practitioner. Consult a health care practitioner for use beyond 6 weeks.
For osteoarthritic pain: 2 tablets 3 times per day or as directed by a health care practitioner. Not to exceed 6 tablets per day. Consult a health care practitioner for use beyond 12 weeks.

Warnings

Consult a health care practitioner prior to taking SAMe if taking anti-depressants, hepatotoxic drugs, or monoamine oxidase (MA) inhibitors. Not recommended for use in children. Do not use if you are pregnant or breastfeeding or if you have bipolar disorder (manic-depressive illness). Do not take it at night as SAMe may cause anxiety, restlessness, and insomnia. Possible side effects are mild gastrointestinal upsets (such as stomach pain, nausea, diarrhea, and flatulence), anxiety, hyperactive muscle movement, insomnia, and hypomania. When these side effects occur, they often diminish with time or resolve with lower doses or cessation of use. Keep out of reach of children.

Allergens

Contains no artificial colors, preservatives, or sweeteners; no dairy, starch, sugar, wheat, gluten, soy, corn, egg, fish, shellfish, salt, tree nuts, or GMOs.

Contraindications

If you are taking antidepressants, hepatotoxic drugs, or monoamine oxidase (MAO) inhibitors, consult a health care practitioner prior to taking SAMe in place of or in addition to those medications. Not recommended for use in children. Do not use it if you are pregnant or breastfeeding. Do not take it at night as SAMe may cause anxiety, restlessness, and insomnia. People with bipolar disorder (manic-depressive illness) should not use SAMe unless under medical supervision. Possible side effects are mild gastrointestinal upsets (such as stomach pain, nausea, diarrhea, and flatulence), anxiety, hyperactive muscle movement, insomnia, and hypomania. When these side effects occur they often diminish with time or resolve with lower doses or cessation of use. There are no documented cases of allergies to SAMe. Keep out of reach of children.

Drug Interactions

Deficiency of vitamins B6, B12, and other methyl donors may exacerbate SAMe deficiency. Theoretically, SAMe may have additive serotonergic effects when used with antidepressants, but when used simultaneously, no increase in adverse effects was noted compared to placebo.3

References

1. Bottiglieri, T. (2002). S-adenosyl-L-methionine (SAMe): From the bench to the bedside, a pleiotrophic molecule's molecular basis. Am J Clin Nutr, 76(5), 1151S-7S.
2. Jacobsen, S., Danneskiold-Samsøe, B., & Andersen, R.B. (1991). Oral S-adenosylmethionine in primary fibromyalgia. Double-blind clinical evaluation. Scand J Rheumatol, 20(4), 294‐302.
3. Papakostas, G.I. Mischoulon, D., Shyu, I., et al. (2010). S-adenosyl methionine (SAMe) augmentation of serotonin reuptake inhibitors for antidepressant nonresponders with major depressive disorder: A double-blind, randomized clinical trial. Am J Psychiatry, 167(8), 942-8.
4. Williams, A.L., Girard, C., Jui, D., et al. (2005). S-adenosylmethionine (SAMe) as treatment for depression: A systematic review. Clin Invest Med, 28(3), 132-9.
5. Cuomo, A., Beccarini Crescenzi, B., Bolognesi, S., et al. (2020). S-adenosylmethionine (SAMe) in major depressive disorder (MDD): A clinician-oriented systematic review. Ann Gen Psychiatry, 19, 50.
6. Dording, C.M., Mischoulon, D., Shyu, I., et al. (2012). SAMe and sexual functioning. Eur Psychiatry, 27(6), 451‐4.
7. Kim, J., Lee, E.Y., Koh, E.M., et al. (2009). A comparative clinical trial of S-adenosylmethionine versus nabumetone for the treatment of knee osteoarthritis: An 8-week, multicenter, randomized, double-blind, double-dummy, Phase IV study in Korean patients. Clin Ther, 31(12), 2860-72.
8. Najm, W.I., Reinsch, S., Hoehler, F., et al. (2004). S-adenosyl methionine (SAMe) versus celecoxib for the treatment of osteoarthritis symptoms: A double-blind cross-over trial. [ISRCTN36233495]. BMC Musculoskelet Disord, 5(1), 6.
9. Hosea Blewett, H.J. (2008). Exploring the mechanisms behind S-adenosylmethionine (SAMe) in the treatment of osteoarthritis. Crit Rev Food Sci Nutr, 48(5), 458-63.
10. Shea, T.B., & Chan, A. (2008). S-adenosyl methionine: A natural therapeutic agent effective against multiple hallmarks and risk factors associated with Alzheimer’s disease. J Alzheimers Dis, 13(1), 67-70.
11. Sharma, A., Gerbarg, P., Bottiglieri, T., et al. (2017). S-adenosylmethionine (SAMe) for neuropsychiatric disorders: A clinician-oriented review of research. J Clin Psychiatry, 78(6), e656‐67.
12. Román, G.C., Mancera-Páez, O., & Bernal, C. (2019). Epigenetic factors in late-onset alzheimer’s disease: MTHFR and CTH gene polymorphisms, metabolic transsulfuration and methylation pathways, and B vitamins. Int J Mol Sci, 20(2), 319.
13. Gao, J., Cahill, C.M., Huang, X., et al. (2018). S-adenosyl methionine and transmethylation pathways in neuropsychiatric diseases throughout life. Neurotherapeutics, 15(1), 156‐75.
14. Tchantchou, F., Graves, M., Falcone, D., et al. (2008). S-adenosylmethionine mediates glutathione efficacy by increasing glutathione S-transferase activity: Implications for S-adenosyl methionine as a neuroprotective dietary supplement. J Alzheimers Dis, 14(3), 323-28.
15. Park, L.K., Friso, S., & Choi, S.W. (2012). Nutritional influences on epigenetics and age-related disease. Proc Nutr Soc, 71(1), 75-83.
16. Martínez-López, N., Varela-Rey, M., Ariz, U., et al. (2008). S-adenosylmethionine and proliferation: New pathways, new targets. Biochem Soc Trans, 36(Pt 5), 848-52.
17. Finkelstein, J.D. (2007). Metabolic regulatory properties of S-adenosylmethionine and S-adenosylhomocysteine. Clin Chem Lab Med, 45(12), 1694-9.
18. Lu, S.C., & Mato, JM. (2008). S-Adenosylmethionine in cell growth, apoptosis, and liver cancer. J Gastroenterol Hepatol, 23 Suppl 1(Suppl 1), S73-7.