Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
| Status: | Completed |
|---|---|
| Conditions: | Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 8 - 22 |
| Updated: | 4/17/2018 |
| Start Date: | June 2007 |
| End Date: | July 2012 |
A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent
abdominal pain in children. This will be an open-labeled study and all participants will
receive SAM-e therapy. Given that SAM-e has been demonstrated to improve symptoms of
depression and pain with minimal side effects as compared to other antidepressant therapy, we
hypothesize that SAM-e will reduce pain symptoms among children with recurrent abdominal
pain.
abdominal pain in children. This will be an open-labeled study and all participants will
receive SAM-e therapy. Given that SAM-e has been demonstrated to improve symptoms of
depression and pain with minimal side effects as compared to other antidepressant therapy, we
hypothesize that SAM-e will reduce pain symptoms among children with recurrent abdominal
pain.
Inclusion Criteria:
- 8 to 22 years old
- Diagnosed with RAP as verified by a physician, and having at least twice weekly
episodes of abdominal pain which cause the patient to withdraw from normal activities.
- At least one month trial on a high fiber diet without resolution of abdominal pain.
- Ambulatory
Exclusion Criteria:
- Focal abdominal pain by history or physical exam, unless a negative (including
endoscopic) evaluation has been performed
- Current diagnosis of inflammatory bowel disease, pancreatitis (acute or recurrent),
peptic ulcer disease, gastrointestinal infection (unresolved), or ongoing
gastrointestinal inflammation.
- Current or recent (within the past year) pregnancy and/or current breastfeeding.
- Current diagnosis of nephropathy or genitourinary disease.
- Blood in stools or emesis (EXCEPTION: blood in the stool secondary to hemorrhoids is
not an exclusion criterion).
- Unintentional loss of over 10% body weight over the past 3 months or weight < 100%
ideal body weight.
- Recurrent fevers (T>100F) at least once a week or with abdominal pain episodes.
- Recurrent dehydration with abdominal pain episodes requiring intravenous rehydration.
- Current personal diagnosis of depression or report of suicidality, mania or bipolar
disorder.
- Family history of mania or bipolar disorder.
- Current use of opiates or other prescription pain medications and/or refusal to remain
off opiate/prescription pain medications during the study period.
- Currently receiving additional therapies besides diet for recurrent abdominal pain
and/or refusal to remain off such therapies during the study period, including but not
limited to anticholinergic medications, antidepressant medications, biofeedback
therapy, cognitive behavioral therapy.
- Hypersensitivity to SAM-e.
- Inability of child to provide assent and/or inability of parent/custodian to give
consent.
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