Abdominal Pain
Conditions
Keywords
abdominal pain, children
Brief summary
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.
Interventions
S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Sponsors
Huang, Jeannie, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 22 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wong-Baker FACES Pain Rating Scale | 0, 2 weeks, 1 month, 2 months | We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 0, 2 weeks, 1 month, 2 month | Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sam-e (Treatment) This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.
S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Sam-e (Treatment) |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 14 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Wong-Baker FACES Pain Rating Scale
We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).
Time frame: 0, 2 weeks, 1 month, 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAM-e | Wong-Baker FACES Pain Rating Scale | Wong-Baker FACES Pain Rating Scale (2-months) | 3 units on a scale | Standard Deviation 0 |
| SAM-e | Wong-Baker FACES Pain Rating Scale | Wong-Baker FACES Pain Rating Scale (1-month) | 3 units on a scale | Standard Deviation 0 |
| SAM-e | Wong-Baker FACES Pain Rating Scale | Wong-Baker FACES Pain Rating Scale (2 weeks) | 4 units on a scale | Standard Deviation 1 |
| SAM-e | Wong-Baker FACES Pain Rating Scale | Wong-Baker FACES Pain Rating Scale (baseline) | 4 units on a scale | Standard Deviation 0 |
p-value: 0.004MANOVA
Secondary
Safety
Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly.
Time frame: 0, 2 weeks, 1 month, 2 month