Response to Supplement and Placebo in GERD

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 Overview

• Status: Completed
• Conditions: Dyspepsia; Heartburn; Gastroesophageal Reflux Disease (GERD)
• Intervention / Treatment: Drug: Supplement; Behavioral: Expanded Interview; Drug: Placebo; Behavioral: Standard Interview

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Supplement + Expanded Interview; Supplement, 2 tablets sublingually 3 times a day for 2 weeks.	Drug: Supplement; Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C; Behavioral: Expanded Interview
PLACEBO_COMPARATOR: Placebo + Standard Interview; Placebo, 2 tablets sublingually 3 times a day for 2 weeks.	Drug: Placebo; Lactose tablets; Behavioral: Standard Interview
EXPERIMENTAL: Supplement + Standard Interview; Supplement, 2 tablets sublingually 3 times a day for 2 weeks.	Drug: Supplement; Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C; Behavioral: Standard Interview
PLACEBO_COMPARATOR: Placebo + Expanded Interview; Placebo, 2 tablets sublingually 3 times a day for 2 weeks.	Behavioral: Expanded Interview; Drug: Placebo; Lactose tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Two weeks

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Study Director: Michelle Dossett, MD, PhD, MPH, Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• Dossett ML, Mu L, Davis RB, Bell IR, Lembo AJ, Kaptchuk TJ, Yeh GY. Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial. PLoS One. 2015 Sep 30;10(9):e0136855. doi: 10.1371/journal.pone.0136855. eCollection 2015.

Helpful Links

• study manuscript

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (ESTIMATE): August 2, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Heartburn; Dyspepsia; Gastroesophageal reflux disease (GERD)
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Dyspepsia; Gastroesophageal Reflux; Heartburn
• Other Study ID Numbers: 2012P000409; IND 117358 (OTHER: FDA)