Frequent heartburn and acid regurgitation: overview of the condition and available treatments
Patients with gastro-oesophageal reflux report a range of symptoms that disrupt quality of life in terms of sleep, social functioning, overall activity levels, and work [
1,
4,
6,
14,
15]. Reflux of stomach contents can cause burning sensations in the stomach, throat, oesophagus, and trachea, as well as pain in the stomach, middle of the chest, and in the back. Some patients describe regurgitation of food, an acid taste in the mouth, and halitosis; nausea or bloating; frequent and severe belching; or erosion of tooth enamel. Nocturnal symptoms, such as pain or coughing when lying down, can arouse patients and disturb sleep patterns.
Patients may describe having initially mild reflux-associated symptoms (such as hiccups, burping, mild heartburn), with the severity and frequency of symptoms increasing over time [
6]. As the condition worsens, patients seek healthcare advice [
6]. Reported triggers for consulting medical advice are symptom severity, interference with daily life, and questions about the potential for controlling symptoms [
6].
A systematic review of population-based studies found that reflux symptoms were prevalent worldwide: in population-based studies mean prevalence rates (for periods up to 12 months) of at least weekly heartburn and/or acid regurgitation (or a physician’s diagnosis of gastro-oesophageal reflux) ranged from 18.1 to 27.8 % in North America, 8.8–25.9 % in Europe, 2.5–7.8 % in East Asia, 8.7–33.1 % in the Middle East, 11.6 % in Australia and 23.0 % in South America [
16]. Frequent reflux is associated with typical symptoms, with 77 % of patients reporting heartburn, 63 % reporting acid regurgitation, and 41 % reporting both symptoms [
4]. Frequent symptoms are more disruptive than intermittent episodes, although some patients delay seeking medical attention because they feel that the condition is not serious [
4].
Symptomatic gastro-oesophageal reflux is treated with agents that counter the direct effects of the acid reflux on the oesophageal mucosa and/or medications that target gastric acid production associated with reflux, with different agents being more appropriate depending on the varying severity and frequency of episodes [
4,
7,
17]. The initial recommendation for management is diet and lifestyle changes, such as weight loss and avoidance of foods or other substances that may trigger reflux [
7,
11]. Antacids and alginates provide temporary, local relief of reflux symptoms and are recommended for intermittent symptoms of mild-to moderate intensity [
7]. Data suggest that some alginate-containing compounds may be more effective than traditional antacids in post-prandial acid control [
18]. Histamine receptor antagonists (H
2RAs) block one source of the signalling cascade that induces gastric acid secretion [
19]. H
2RAs are administered twice daily, and over time, patients may develop a tolerance to these agents [
7]. The most efficacious therapeutic class available for short-term treatment of acid reflux symptoms is PPIs [
11,
20], which covalently bind the proton pumps that control the final step of gastric acid production [
19]. The number of PPIs approved for OTC use is increasing [
21,
22], and it is important for pharmacists to understand their place in therapy relative to other heartburn remedies. Unlike options that require multiple daily doses, PPIs are administered once daily [
11] and provide a more complete and durable resolution of symptoms. In a head-to-head trial conducted in a general practice setting in France in patients with moderate heartburn with or without acid regurgitation occurring more than once weekly, 14-day treatment with an alginate (Gaviscon; Reckitt Benckiser Healthcare, Massy Cedex, France; 4 × 10 mL/day) was non-inferior to PPI treatment (omeprazole 20 mg/day) in time to onset but was less effective than omeprazole by day 7 in total heartburn-free days [
23].
Treatment algorithm for frequent reflux symptoms: when to use OTC PPIs
A short interview with a patient with symptoms consistent with acid reflux can identify the appropriate course of action: OTC medication or referral to physician for follow-up care [
12]. Asking patients to describe their symptoms, including the frequency, nature, and severity of episodes, can confirm the correct course of action [
12,
24]. It should be noted that the severity or frequency of symptoms is not necessarily a marker of underlying disease [
25,
26]. As with all patients presenting with symptoms suggesting heartburn or acid regurgitation, follow-up questions should rule out the presence of alarm symptoms that should prompt a referral for further medical assessment (Table
1). Alarm features that could be identified in the pharmacy based on the patient’s responses include symptoms suggestive of cardiac-type chest pain, difficulty in or painful swallowing, recurrent bronchial symptoms/cough, hoarseness, signs/symptoms of gastrointestinal bleeding, and progressive unintentional weight loss [
9]. Additionally, older patients who recently began experiencing reflux symptoms or patients who have a family history of gastrointestinal cancers should be referred to their physician [
12,
24]. Pharmacists also should be aware that certain medications (e.g., nitrates and calcium antagonists) can predispose patients to reflux events and potentially precipitate or exacerbate reflux symptoms [
27]. Suspicion of a drug-related cause of reflux symptoms would be a prompt for consultation with the prescribing physician.
Table 1
Questions to assist in identifying individuals who may benefit from over-the-counter proton-pump inhibitors versus those who should be referred [
9,
12]
Goal: Identify patient who may benefit from over-the-counter proton-pump inhibitor
|
Goal: Identify alarm symptoms that should prompt immediate referral
|
What is the nature of the symptoms you are experiencing? How frequently are the symptoms occurring? Have you tried any lifestyle changes or medications that have made your symptoms better or worse? | When did the symptoms start? Have you experienced any unintentional weight loss, difficulties in or painful swallowing, recurrent cough, hoarseness/changes in voice, blood in faeces or vomit? Do you have a family history of gastric and/or oesophageal cancer? |
Professional organizations and health authorities worldwide have similar guidance for the treatment of heartburn and other reflux symptoms [
7,
10,
11]. Patients with intermittent reflux symptoms should introduce lifestyle and dietary changes and use antacids, alginates, or low-dose H
2RAs on demand for symptom control [
7]. Patients with frequent typical reflux symptoms should receive a course of PPIs to provide relief of symptoms prior to further diagnostic work-up [
7,
11]. Endoscopy is not recommended for patients with typical symptoms unless they do not respond to PPI therapy [
7,
11].
Because many current guidelines were developed before widespread OTC availability of PPIs, until recently there were few resources directed toward pharmacists to provide guidance. Consensus statements and expert algorithms for pharmacists are beginning to be developed, however, and as clinical guidelines are updated, the important role that pharmacists can and should play in the management of heartburn and acid regurgitation is becoming more apparent [
12,
24].
Role of the pharmacist in the use of OTC PPIs
PPIs are widely acknowledged to be the most effective treatment for symptom relief of gastro-oesophageal reflux [
11,
24]. Compared with other options, OTC PPIs have demonstrated benefits to symptom resolution and quality of life [
24] and the practical advantage of more convenient once-daily dosing [
11]. As more formerly prescription medications enter the OTC market, the role of the pharmacist in heartburn therapy has expanded, prompting the development of specific guidance for pharmacists [
12,
24]. With their extensive knowledge of OTC drugs and their familiarity with their patients, pharmacists are ideally situated to assist in the selection of appropriate medication [
12]. By asking the correct questions (Table
1) as outlined previously, pharmacists can confirm the presence of frequent reflux and perform an important surveillance function by identifying patients with alarm symptoms who should be referred to a physician [
12]. These questions complement the available algorithms developed by expert gastroenterologists [
12,
24]; however, adherence to a particular structure is not necessary.
Notably, these suggested questions are ones that should be posed to patients with any severity of symptoms, including those with intermittent symptoms that might be adequately addressed with antacids and alginates [
7,
11]. It is important to remember that there is no correlation between frequency or intensity of the symptoms and the underlying severity of the condition [
25].
Upon confirming the presence of reflux symptoms, pharmacists should review instructions with the patient to ensure the proper use of OTC PPIs. Patients should also be reminded that, unlike antacids, PPIs are not to be taken symptomatically [
32]. Although the patients may feel better after a few days into the regimen, the mechanism of OTC PPIs is distinct from antacids, and consequently, the agents should be administered to their best advantage: antacids and alginates for local treatment of reflux symptoms; PPIs and H
2RAs for the inhibition of gastric acid secretion [
7,
19]. PPIs are administered once daily [
32,
40,
41,
55]; treatment should be taken at the same time every day [
40,
41,
55]. Currently available OTC PPIs are indicated for short-term regimens of 14–28 days [
32,
40,
41,
55]. Although some patients take PPIs for months or years [
62], a long-term treatment regimen should be monitored by a physician [
32,
40,
41,
55].
The pharmacist should set the expectations of treatment with OTC PPIs. Patients may seek complete resolution of symptoms yet also anticipate immediate relief of symptoms [
24]. Based on a meta-analysis of 18 studies with agents at different doses, approximately one-third of patients will experience relief of heartburn symptoms within a few days of starting a PPI regimen [
24,
63], and approximately 55–80 % of patients experience first resolution/relief of heartburn symptoms within the first week of treatment, according to clinical trial data [
32,
41]. Pharmacists should advise that lifestyle changes, including avoiding known triggers, are complementary to pharmaceutical treatments for gastro-oesophageal reflux and may increase the likelihood of treatment success [
7,
11].