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Gastro-Oesophageal Reflux Disorder Case Study

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Gastro-oesophageal reflux disorder (GORD) is a common medical condition, which results in an abnormal reflux of gastric contents into the oesophagus1. GORD normally occurs because of the ring of muscle at the bottom of the oesophagus weakening2. The most common symptoms of GORD include heartburn and regurgitation. In this clinical trial, participants have non-erosive GORD, which does not have any visible oesophageal injury1, however non-erosive GORD can progress to erosive disease in susceptible patients3. Recommended treatment for non-erosive GORD is stated as offering patients a full-dose proton pump inhibitor (PPI) for 4 or 8 weeks4. NICE states that if symptoms recur after the initial treatment, offer a PPI at the lowest dose possible…show more content…
Within this trial, patients will be assigned at random to one of the two groups, with a 1:1 ratio5. The participants will be taking one capsule at the same time everyday throughout the 4 weeks, and will be asked to record any time they experience heartburn symptoms into an e-diary. This study will be conducted in China, with the overall participation time being 11 weeks5. Participants will make 4 visits to the health clinic, and will also be contacted by phone 5-10 days after their last dosage for a follow up assessment. To be enrolled onto this clinical trial, patients must be able to identify their main symptom as a burning feeling in the mid-epigastric area and/or chest area and they must have had a history of GORD for 6 months or longer prior to Screening with GORD symptoms that were responsive to acid-suppressive therapy5. Furthermore, they must have episodes of heartburn for 4 or more days during the 7 days prior to Day 1, as recorded in their diary. This clinical trial is a randomised, placebo-controlled as well as being a double-blind study, which reduces the likelihood of prescriber bias. There are no ethical issues involved with this trial, as participants must be aged over 18, and there is a large sample size of 200 participants, which increases the significance and reliability of the results. In my opinion, there could have been a larger sample size, as compared to this study, another trial evaluating the efficacy of
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