SAMe for Osteoarthritis

(SAMe Trial)

Overseen By Zoe M Daudier

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dartmouth-Hitchcock Medical Center

Must not be taking: Opioids, Gabapentin, Prednisone, SNRIs

Disqualifiers: Non-OA arthritis, Artificial joint, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate whether SAMe, a supplement, can reduce pain and improve daily hand function in people with hand osteoarthritis, compared to a placebo (a pill with no active ingredient). Participants will take either SAMe or the placebo for eight weeks. Ideal candidates have experienced hand pain or difficulty using their hands due to osteoarthritis and are willing to pause other pain medications during the study. The goal is to determine if SAMe can serve as a viable alternative for managing this condition. As a Phase 4 trial, SAMe has already received FDA approval and proven effective; this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current over-the-counter or prescription pain relievers for two weeks before the study and remain off them during the study. If you are taking certain other medications like daily opioids, gabapentin, or prednisone, you may not be eligible to participate.

What is the safety track record for S-Adenosyl-L-Methionine (SAMe)?

Research shows that SAMe is generally safe for use. Studies have found that SAMe can be as effective as common pain relievers like NSAIDs (non-steroidal anti-inflammatory drugs) in reducing pain and improving movement in people with osteoarthritis. Importantly, it achieves this without the usual side effects associated with NSAIDs.

However, some individuals might experience mild side effects such as constipation, stomach pain, or nausea. SAMe can also interact with certain medications, particularly antidepressants. Consulting a doctor before starting any new treatment is advisable. Overall, research has shown that SAMe is well-tolerated, making it a safe option for many people with osteoarthritis. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

S-Adenosyl-L-Methionine (SAMe) is unique because it is a naturally occurring compound in the body that may offer relief from osteoarthritis symptoms through a different mechanism than traditional treatments like NSAIDs and acetaminophen. SAMe boosts the production of cartilage and reduces inflammation, potentially offering a dual benefit without the gastrointestinal side effects often associated with common pain relievers. Researchers are excited about SAMe because it might provide a safer long-term option for managing osteoarthritis pain and improving joint function.

What evidence suggests that SAMe might be an effective treatment for osteoarthritis?

Research has shown that SAMe, a natural compound, can reduce pain in osteoarthritis patients as effectively as common pain relievers like NSAIDs, but without their usual side effects. Some studies found that SAMe not only eases pain but also improves joint function. It might also support the production of substances important for joint health. Patients have used SAMe safely for a long time, with many noticing improvements in their symptoms. In this trial, participants will receive either SAMe or a placebo to evaluate its effectiveness. Therefore, SAMe appears to be a promising option for managing osteoarthritis pain and enhancing daily activities. ^{1 6 7 8 9}

Who Is on the Research Team?

Scott C Jaynes, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 40 with hand osteoarthritis, who have swelling or deformity in certain joints and are patients within the Dartmouth Health system. They must be willing to stop taking current pain medications two weeks before and during the study. People with artificial joints, other types of arthritis, bipolar disorder, or on certain medications like daily opioids cannot participate.

Inclusion Criteria

Current primary care provider within the Dartmouth Health system

*Objective inclusion criteria (see poster schematic): Swelling or deformity of 2 of the following ten joints: the 2nd and 3rd distal interphalangeal (DIP) of each hand, the 2nd and 3rd proximal interphalangeal (PIP) of each hand, and the 1st carpometacarpal joints of both hands.

Office visit at Dartmouth Health in the past 3 years

Exclusion Criteria

Patients taking prescription medications other than NSAIDs for their OA who are unable to stop their medication

Patients with diagnoses of arthritis from conditions other than OA

Patients whose symptomatic joint is an artificial joint

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive SAMe or placebo for 8 weeks

8 weeks

Weekly surveys

Washout

Participants undergo a washout period to clear the previous treatment

1 week

Treatment Phase 2

Participants receive the alternate treatment (SAMe or placebo) for 8 weeks

8 weeks

Weekly surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• S-Adenosyl-L-Methionine (Sam-E)

Trial Overview The trial is testing if S-Adenosyl-L-Methionine (SAMe) can help relieve pain and improve daily function in people with hand osteoarthritis compared to a placebo. Participants will receive either SAMe or a placebo and their pain levels, functionality, and quality of life will be monitored.

How Is the Trial Designed?

Group I: S-Adenosyl-L-Methionine (SAMe) Experimental Treatment 2 Interventions

Participants receive S-Adenosyl-L-Methionine (SAMe) 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Group II: Placebo Placebo Group 2 Interventions

Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12019049/

Safety and efficacy of S-adenosylmethionine (SAMe ... - PubMed Conclusions: SAMe appears to be as effective as NSAIDs in reducing pain and improving functional limitation in patients with OA without the adverse effects ...

2. amjmed.com amjmed.com/article/0002-9343(87)90853-9/abstract

S-Adenosylmethionine in the treatment of osteoarthritis Experimental investigations suggest that the administration of SAMe exerts analgesic and antiphlogistic activities and stimulates the synthesis of proteoglycans ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7061276/

S‐Adenosylmethionine for osteoarthritis of the knee or hip - PMC S‐Adenosylmethionine may be a viable treatment option but the evidence about its effectiveness and safety is equivocal. Objectives. We set out to compare S‐ ...

4. acpjournals.org acpjournals.org/doi/10.7326/ACPJC-2003-138-1-021

Review: S-adenosylmethionine treats osteoarthritis as ... In patients with osteoarthritis, S-adenosylmethionine (SAMe) is as effective as nonsteroidal anti-inflammatory drugs in reducing pain and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/000293438790859X

A long-term (two years) clinical trial with S- ... SAMe administration showed good clinical effectiveness and was well tolerated. The improvement of the clinical symptoms during therapy with SAMe ...

6. mayoclinic.org mayoclinic.org/drugs-supplements-same/art-20364924

SAMe Generally safe. SAMe appears to be safe and might be effective in treating depression and osteoarthritis. However, SAMe might interact with antidepressants. Don ...

7. mdedge.com mdedge.com/jfponline/article/65390/safety-and-efficacy-s-adenosylmethionine-same-osteoarthritis

Safety and efficacy of S-adenosylmethionine (SAMe) for ... SAMe appears to be as effective as NSAIDs in reducing pain and improving functional limitation in patients with OA without the adverse effects often associated ...

8. examine.com examine.com/supplements/s-adenosyl-methionine/?srsltid=AfmBOooBtXnOpuftVgGDhpFCK00Ma0rMC1joy68gpkVZlwqIE7xjEvfe

S-adenosylmethionine benefits, dosage, and side effects Safety Summary · S-adenosylmethionine most commonly causes gastrointestinal side effects, including constipation, abdominal pain, and nausea. · Caution is ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC387830/

S-Adenosyl methionine (SAMe) versus celecoxib for the ... SAMe has a slower onset of action but is as effective as celecoxib in the management of symptoms of knee osteoarthritis. Longer studies are needed to evaluate ...