Dyspepsia, Gastroesophageal Reflux Disease (GERD), Heartburn
Conditions
Keywords
Gastroesophageal reflux disease (GERD), Heartburn, Dyspepsia
Brief summary
The purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (GERD). This study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.
Interventions
DRUGSupplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
DRUGPlacebo
Lactose tablets
BEHAVIORALExpanded Interview
BEHAVIORALStandard Interview
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult humans age 18-80. * Fluency in written and spoken English. * Heartburn symptoms 3 or more days per week for the past month.
Exclusion criteria
* Individuals taking a proton pump inhibitor (PPI) or H2 receptor blocker with a dose change within 2 weeks of the initial study visit. * Individuals with Crohns disease, systemic sclerosis, known active ulcer disease, gastric cancer, Barrett's esophagitis * Significant pain or difficulty with swallowing * Heavy alcohol use (defined by \> 6 drinks/week for women and \> 13 drinks/week for men) * Concurrent pregnancy * Dementia * Uncontrolled psychiatric disease * Individuals unable to complete a paper symptom diary for 6 of 7 days prior to their baseline visit * Subjects whose symptoms are predominantly dyspeptic more than heartburn or reflux * Subjects who have used homeopathy for GI symptoms or have received constitutional homeopathic treatment within the past 2 weeks * Subjects taking herbal products or other supplements for GERD or dyspepsia related symptoms (includes peppermint oil) * Subjects who have taken \> 12 doses of NSAIDS within the prior 30 days (aspirin ≤ 325 mg daily is allowed) * Subjects with lactose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Number of Participants Experiencing a Serious Adverse Event | 2 week follow-up | Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity | Second week of the trial compared to pre-trial baseline | Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated. |
| GERD Health-Related Quality of Life at Follow-up | Two weeks | The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo + Standard Interview Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Standard Interview | 6 |
| Supplement + Standard Interview Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview | 6 |
| Placebo + Expanded Interview Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Expanded Interview | 6 |
| Supplement + Expanded Interview Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Expanded Interview | 6 |
| Total | 24 |
Baseline characteristics
| Characteristic | Placebo + Standard Interview | Supplement + Standard Interview | Placebo + Expanded Interview | Supplement + Expanded Interview | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 5 Participants | 5 Participants | 17 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 14 | 64 years STANDARD_DEVIATION 6.3 | 54 years STANDARD_DEVIATION 9.9 | 53 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| GERD symptom severity | 4.2 scores on a scale STANDARD_DEVIATION 2.1 | 5.6 scores on a scale STANDARD_DEVIATION 2.6 | 3.6 scores on a scale STANDARD_DEVIATION 2.2 | 3.8 scores on a scale STANDARD_DEVIATION 2.3 | 4.3 scores on a scale STANDARD_DEVIATION 2.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 6 | 1 / 6 | 4 / 6 | 4 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Safety - Number of Participants Experiencing a Serious Adverse Event
Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.
Time frame: 2 week follow-up
Population: All enrolled study participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Standard Interview | Safety - Number of Participants Experiencing a Serious Adverse Event | 0 participants |
| Supplement + Standard Interview | Safety - Number of Participants Experiencing a Serious Adverse Event | 0 participants |
| Placebo + Expanded Interview | Safety - Number of Participants Experiencing a Serious Adverse Event | 0 participants |
| Supplement + Expanded Interview | Safety - Number of Participants Experiencing a Serious Adverse Event | 0 participants |
Secondary
GERD Health-Related Quality of Life at Follow-up
The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.
Time frame: Two weeks
Population: All enrolled study participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo + Standard Interview | GERD Health-Related Quality of Life at Follow-up | 18.2 units on a scale | Standard Deviation 4.5 |
| Supplement + Standard Interview | GERD Health-Related Quality of Life at Follow-up | 26.3 units on a scale | Standard Deviation 7.8 |
| Placebo + Expanded Interview | GERD Health-Related Quality of Life at Follow-up | 17.7 units on a scale | Standard Deviation 3.4 |
| Supplement + Expanded Interview | GERD Health-Related Quality of Life at Follow-up | 18.3 units on a scale | Standard Deviation 4.9 |
Secondary
Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity
Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.
Time frame: Second week of the trial compared to pre-trial baseline
Population: All enrolled study participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Standard Interview | Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity | 2 participants |
| Supplement + Standard Interview | Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity | 0 participants |
| Placebo + Expanded Interview | Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity | 5 participants |
| Supplement + Expanded Interview | Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity | 4 participants |
Comparison: All 4 arms were combined to compare the Standard Interview groups to the Expanded Interview groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.p-value: 0.01Regression, Logistic
Comparison: All 4 arms were combined to compare the Placebo groups to the Supplement groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.p-value: 0.33Regression, Logistic