Response to Supplement and Placebo in GERD

N/ACompletedNCT01915173

Beth Israel Deaconess Medical Center24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Gastroesophageal Reflux Disease (GERD)Heartburn Dyspepsia

Interventions

SupplementDRUG

Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C

PlaceboDRUG

Lactose tablets

Expanded InterviewBEHAVIORAL

Standard Interview

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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