S-Adenosyl-L-Methionine (SAMe) vs Placebo for Discomfort and Functional Limitations Associated With Osteoarthritis of the Hands: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Objective findings of at least one hand meeting diagnostic criteria based on the American College of Rheumatology (ACR)* or
- •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.
排除标准
- •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:
- •daily opioids (including tramadol or buprenorphine)
- •gabapentin or pregabalin
- •Prescription NSAIDs that they are unable to stop or topical diclofenac
- •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
研究组 & 干预措施
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.
干预措施: S-Adenosyl-L-Methionine (Sam-E) (Drug)
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.
干预措施: Placebo (Drug)
Placebo
Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.
干预措施: S-Adenosyl-L-Methionine (Sam-E) (Drug)
Placebo
Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.
干预措施: Placebo (Drug)
结局指标
主要结局
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
时间窗: Weekly for 17 weeks
Scores range from 0-10, 0 being no discomfort and 10 being maximum discomfort
次要结局
- 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(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(Weekly for 17 weeks)
研究者
Scott C. Jaynes
Physician Investigator
Dartmouth-Hitchcock Medical Center