Spreading the word about GORD

white coat professional shouting into megaphone

Considering the key factors involved in proton pump Inhibitor therapy may assist pharmacists in initiating successful step-down attempts

Gastro-oesophageal reflux disease (GORD) is a common complaint among the general community. Despite the lack of data on the prevalence of the disease in Australia, it’s estimated to affect anywhere between 10–15% of the population.

While heartburn and regurgitation are hallmark symptoms of GORD, diagnosis is dependent on the frequency of these episodes. According to NPS MedicineWise, in cases where the reflux symptoms are frequent (i.e. two or more episodes per week) or are severe enough to significantly impact the person’s quality of life, GORD is the likely diagnosis.

Nonetheless, it can be useful for pharmacists to distinguish between GORD, general reflux symptoms (which aren’t necessarily a confirmed diagnosis of GORD) and other conditions.

Gastroenterologist and lecturer at Western Sydney University Dr Vincent Ho explains, “Heartburn is classically described as a burning, retrosternal, rising sensation associated with meals. This can be quite difficult to define for many people and it would be useful for pharmacists to clarify the nature of the symptoms when the term heartburn is used.

“For example, if a person states that their heartburn is a central heavy chest pain, which radiates to the left arm and is worse with exertion, that is much more likely to be cardiac angina than GORD.

“Occasionally, there may be alternative causes of heartburn—other than GORD. These include oesophageal cancers, peptic ulcer, large hiatus hernias and rare medical conditions such as eosinophilic oesophagitis and achalasia.”

Alongside heartburn and regurgitation, a person may experience atypical symptoms. These include excessive belching, nausea, dyspepsia, chest pain, hoarseness, coughing and asthma.

The red flags

Red flags to be aware of and that would warrant referral include:

  • difficulty swallowing (dysphagia);
  • painful swallowing (odynophagia);
  • unexplained weight loss;
  • persistent vomiting;
  • blood in vomit (haematemesis) or dark black, tarry, sticky faeces (melaena);
  • signs or symptoms of anaemia; and
  • new onset of persistent symptoms in those aged 55 years or older.

Risk factors associated with the symptoms of GORD include:

  • obesity (BMI >30kg/m2);
  • presence of hiatus hernia;
  • impaired oesophageal or gastric clearance;
  • the consumption of more than seven standard alcoholic drinks per week;
  • a first-degree relative with a history of heartburn;
  • pregnancy; and
  • certain medicines, such as non-steroidal anti-inflammatory drugs (NSAIDs), some antibiotics, as well as iron and potassium supplements.

Treatment guidelines

Proton pump inhibitors (PPIs) remain the mainstay of treatment for GORD. However, they should be prescribed at the lowest effective dose or “as needed” for patients with mild to moderate symptoms.

Geraldine Moses, senior medicines information pharmacist at Mater Public Hospital, South Brisbane, and adjunct associate professor at the School of Pharmacy, University of Queensland, advises, “Pharmacists should be clear and unambiguous with patients. They can explain that although PPIs are very safe and effective for short-term therapy (days to weeks), long-term use (weeks to years) is associated with a wide range of real and not uncommon potential adverse effects.

“These include increased risk of iron malabsorption, magnesium depletion, B12 deficiency, Clostridium difficile enterocolitis, calcium malabsorption leading to fracture risk, pneumonia, interstitial nephritis, stroke, dementia and diabetes mellitus. Not to mention the risk of drug interactions with PPIs.

Dr Ho adds that pharmacists are ideally placed to discuss any concerns the person might have about their therapy and ensure any medication is taken correctly.

“Certainly, there are some common mistakes that people make when taking PPIs and the pharmacist has a key role in the education of patients.

“One study that included 100 patients with GORD found that only 46% of patients prescribed a PPI for GORD were taking it as advised. A key piece of advice that should be given to patients is to take a PPI half an hour before a meal; it is known that administration of PPIs before a meal allows for better control of intragastric pH as compared with administering a PPI during or after a meal”.

However, some doctors may not specifically write “half an hour before a meal” or “30 mins AC” (shorthand) on their scripts. As such, sometimes this may not translate to specific dispensing instructions on timing of PPI administration given to the patient.

“So, when receiving a script that does not stipulate when a PPI should be taken, there is a good opportunity for the pharmacist to explore with the patient their understanding of the timing of PPI administration. When doubling the dose of a PPI the PPI should be taken half an hour before breakfast and before dinner. Furthermore, educating the patient about the importance of adhering to the full prescribed course is also important.”

Which medicines can exacerbate symptoms

Medicines that may induce or worsen reflux symptoms include:

  • anticholinergics
  • calcium channel blockers
  • barbiturates
  • nitrates
  • benzodiazepines
  • NSAIDs
  • beta-2 agonists
  • opioids
  • bisphosphanates
  • theophylline

Source: NPS MedicineWise. March 2015. Proton Pump Inhibitors: too much of a good thing?

Stepping down: 4 key considerations

Even when used appropriately, PPIs are only recommended for initial, short-term treatment of GORD. Following this, a treatment review should be conducted.

Ms Moses says, “It should always be confirmed whether the PPI helped with the symptoms or not, because ineffective medication should be ceased. If there is reason to think the GORD is medication induced, then that medication could also be ceased.”

“Basically, if GORD symptoms are controlled after an initial 4–8-week trial of a PPI, guidelines recommend that treatment is titrated down to the lowest dose and frequency that controls symptoms, or stopped.”

To help identify whether it would be appropriate to initiate the stepping down of treatment and support this process, Dr Ho recommends using open-ended questions.

“I usually use the following questions; ‘How are you finding the PPI treatment? Is the tablet working for you?’ This just helps to explore how effective the PPI therapy is for the person and can lead into a good line of further questioning.”

In terms of the questions to ask and the conversations pharmacists might have, Dr Ho identifies four main factors: clinical need for a PPI, severity of symptoms, difficulty in stepping down treatment, and patient concerns.

“Exploring these key factors should give a clear picture of the need for the patient to be on a PPI, the challenges they might face in attempting to wean off the medication and a sense of their expectations.”

1. Clinical need for a PPI

Questions a pharmacist might ask the patient include:

  • Has your doctor explained to you why you’re taking the medication?
  • How long do you feel that you should be taking the medication for?
  • How regularly have you been advised to take your medication?

“In clinical practice, patients with severe reflux symptoms (occurring at least 2–3 times a week) or complicated reflux disease (e.g. erosive oesophagitis, strictures or Barrett’s oesophagus) will often need to be on long-term therapy,” says Dr Ho.

“A patient may be unable to give the exact reason why they are taking the medication, but can recall that they have been advised by their doctor to take the medication on a regular basis for the long term—rather than as an ‘on-demand’ basis. If this is the case, it suggests there exists a compelling medical reason why they’ve been prescribed the PPI and it can be useful to find out that reason.”

2. Severity of symptoms

Questions a pharmacist might ask the patient include:

  • How often are you experiencing symptoms? When do you get your symptoms?
  • What dose of the medication have you been prescribed?
  • Do you need to take anything else for your symptoms (e.g. Gastrogel)?

Dr Ho explains, “These questions are targeted towards uncovering the severity of the patient’s symptoms. Patients that have severe symptoms, such as heartburn that is well controlled on a PPI, are more likely to be compliant with the medication and are also likely to want to stay on a PPI in the longer term. Dosing is very important.

Before a patient can be labelled as having refractory GORD they should have trialled a double dose PPI for at least eight weeks. Certainly, it will be more challenging for these patients on double dose PPI therapy to wean off a PPI completely. As such, a tailored strategy of weaning is critical in these patients.”

3. Potential difficulty in stepping down treatment

Questions a pharmacist might ask the patient include:

  • Have you ever attempted to go off your medication? How did that go?
  • Do you feel like you need to take your medication every day?
  • If you haven’t yet tried going off your medication, what do you think would happen if you did?

“One problem that we see with patients coming off their PPIs abruptly is rebound hyperacidity,” says Dr Ho. “This comes about because the lower stomach acidity on a PPI has increased gastric secretion, which results in hypertrophy of the enterochromaffin cells of the stomach.

These larger cells have now an increased capacity for acid secretion when the PPI is discontinued. We normally find that patients experience rebound dyspepsia as a consequence of rebound hyperacidity and usually this lasts for around 10–14 days.”

Ms Moses adds, “Those who wish to reduce the dose or cease their PPI use should be shown how to decrease the dose slowly—so they don’t experience these rebound symptoms. It’s important for pharmacists to explain that ceasing the PPI abruptly makes it more difficult to come off the medication.”

4. Patient concerns

Questions a pharmacist might ask the patient include:

  • What concerns do you have about staying on your medication in the long term?
  • Are you worried about any side effects of the medication?
  • How do you think you’ll go with another medication to replace your current one?

“Asking a patient about any concerns they might have about a PPI is relevant. Concerns about being on a PPI can lead to patient non-compliance, which in turn can result in sub-optimal control of their symptoms. A careful explanation of the rationale for medication use will be needed in a step-down plan that involves persuading patients to change over to another substitute medication, such as an H2-antagonist,” explains Dr Ho.


The evidence for lifestyle modifications

While certain lifestyle modifications may help reduce symptoms of GORD, there is very little evidence for their effectiveness.

Nevertheless, according to most of the literature, lifestyle treatment strategies that may be useful in controlling symptoms in some patients include:

  • Smoking cessation
  • Weight loss for overweight or obese patients
  • Avoiding eating 3-4 hours before bedtime
  • Avoiding or limiting spicy, high-fat and acidic foods
  • Reducing alcohol, caffeine intake and carbonated drinks
  • Elevating the head of the bed, providing it can be done safely

In January this year findings from the US-based Nurses’ Health Study were published in JAMA Internal Medicine. The study, which collected data from 43,000 women aged 42–62 identified five key lifestyle factors associated with independently lowering the risk of reflux symptoms by almost 40%.

The factors identified were: not smoking, drinking less than two cups of tea, coffee or soda per day, a “prudent” diet (i.e. high intake of fruits, vegetables, legumes, fish, poultry, and whole grains); more than 30 minutes of moderate-to-vigorous physical activity daily; and normal weight (body mass index, <25 kg/m2).

Adherence to more of these anti-reflux factors was associated with lower GORD risk. Women who adhered to all five factors reduced their GORD risk by about 40% compared to women who adhered to none. Similar results were seen for frequent users of histamine-2 (H2)-blockers and PPIs.

This suggests pharmacists and doctors alike should discuss and recommend these particular lifestyle factors, regardless of whether medication is being prescribed.

Dr Ho adds, “During this process of weaning patients off PPIs, lifestyle changes can be used to empower patients. In my experience this step-down strategy involving reducing the dose, lifestyle modifications and the use of antacids and H2-antagonists as needed is quite successful for patients with milder GORD symptoms

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