S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands (SAMe)

S-Adenosyl-L-Methionine (SAMe) vs Placebo for Discomfort and Functional Limitations Associated With Osteoarthritis of the Hands: a Pilot Study

The primary objective of this study is to demonstrate the feasibility of evaluating SAMe tolerability, analgesic benefits, and daily functional improvement in patients with osteoarthritis of the hands compared to placebo. The secondary objective of this study is to generate preliminary data on discomfort, function, quality of life in patients with osteoarthritis of the hands when taking SAMe compared to placebo.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis Hand
• Intervention / Treatment: Drug: S-Adenosyl-L-Methionine (Sam-E); Drug: Placebo

Detailed Description

At week 0, all patients giving written informed consent and meeting eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to SAMe (400mg orally, twice daily) or placebo (400mg, twice daily) for 8 weeks. Followed by a one week wash out period followed by another 8 weeks of SAMe (400mg, twice daily) or placebo (400mg, twice daily) for 8 weeks (whichever was not given during the first 8 week period).

Participants will complete weekly surveys during the entire study regarding hand discomfort, functional limitations and side effects

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dorothy H Barker; Phone Number: 603-653-6830; Email: Dorothy.H.Barker@Hitchcock.org
• Study Contact Backup: Name: Zoe M Daudier; Email: Zoe.M.Daudier@Hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
      • Contact: Dorothy H. Barker; Phone Number: 603-653-6830; Email: dorothy.h.barker@hitchcock.org
      • Contact: Zoe M. Daudier; Email: zoe.m.daudier@hitchcock.org
      • Principal Investigator: Scott C. Jaynes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current primary care provider within the Dartmouth Health system
• Office visit at Dartmouth Health in the past 3 years
• Participants must be 40 or older at the time of signing the informed consent

• Participants have discomfort or functional limitations of one or both hands AND either:

  1. Objective findings of at least one hand meeting diagnostic criteria based on the American College of Rheumatology (ACR)* or
  2. Existing radiographic evidence of osteoarthritis as judged by a radiologist
• Patients taking OTC or prescription analgesics who are willing to stop their current analgesics for two weeks prior to study entry and remain off those medications over the course of the study
• *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.

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
• Patients with Bipolar Disorder

• Patients taking any of the following medications at study entry OR starting any of these medications during the study period:

  1. daily opioids (including tramadol or buprenorphine)
  2. gabapentin or pregabalin
  3. prednisone
  4. Prescription NSAIDs that they are unable to stop or topical diclofenac
  5. SNRI drugs (Effexor, Cymbalta, Fetzima, Pristiq)
• The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S-Adenosyl-L-Methionine (SAMe); Participants receive S-Adenosyl-L-Methionine (SAMe) 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.	Drug: S-Adenosyl-L-Methionine (Sam-E); 400 mg capsule; Drug: Placebo; 400 mg identically appearing placebo
Placebo Comparator: Placebo; Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.	Drug: S-Adenosyl-L-Methionine (Sam-E); 400 mg capsule; Drug: Placebo; 400 mg identically appearing placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the effect of SAMe supplements on hand discomfort relative to placebo, as measured by the change in discomfort scores over time on a visual analog scale	Scores range from 0-10, 0 being no discomfort and 10 being maximum discomfort	Weekly for 17 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the effect of SAMe supplementation on quality of life measures regarding hand arthritis, as measured by DASH (Disability of Arm, Shoulder and Hand) survey responses done weekly for 17 weeks	Survey using descriptors of disability and function ranging from no disability to complete disability with 3 other levels of disability in between done weekly for 17 weeks	Weekly for 17 weeks
Determine tolerability of SAMe supplementation compared to placebo, as measured by a survey of 14 common symptoms one may experience from a supplement	14 symptoms queried for occurrence over the week ranging from "Not at All" to "Very Much" with three additional options in between	Weekly for 17 weeks

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Scott C Jaynes, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: SAMe; S-Adenosyl-L-Methionine
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: STUDY02001354

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No