Tina Lavtar, Bojana Mitrović, Mihaela Rojac, Ronald Korthouwer, Breda Barbič-Žagar

Key words

Gastroesophageal reflux disease, market research, proton pump inhibitors, antacids, symptoms frequency, treatment duration

Abstract

Objectives: Gastroesophageal reflux disease (GERD) is one of the most common diseases with the increasing incidence due to the modern lifestyle connected with stress and unhealthy diet. It is important to recognise GERD symptoms, which are known to be very troublesome, and their frequency so that people can receive optimal care leading to the improved outcome and quality of life. The treatment options (i.e. antacids, histamine type 2 receptor antagonists (H2RAs), or proton pump inhibitors (PPIs)) for the management of GERD symptoms should be applied if lifestyle changes do not suffice.
The aim of this market research was to get insights into how individuals suffering from stomach problems, pharmacists and general practitioners (GPs) in their everyday practice understand and treat GERD symptoms. Such insights are crucial to understand challenges we need to address to optimise GERD treatment in the future.

Methods: The market research was conducted in three phases. During the first introductory phase, we reviewed the existing data using netnography research method, we conducted four interviews with Slovak and Polish pharmaceutical market specialists and carried out eight mystery shoppers interviews in Slovenian pharmacies. This phase helped developing a qualitative questionnaire used during interviews with 19 stakeholders (people having stomach problems, GPs and pharmacists) that followed in Slovenia as phase two. In phase three, quantification of results of the second, qualitative phase with an online survey was conducted among 627 suffering respondents (299 from Slovenia and 328 from Slovakia).

Results: More than 40% of people with stomach problems are under 40. In addition to heartburn, which is the most common GERD symptom experienced by 61% of respondents, they used additional 5–6 descriptions when talking about their stomach problems. 32% of respondents reported frequently occurring symptoms (more than once per week) and predominantly used antacids as a form of self-treatment. Unmonitored and prolonged use of antacids is common, while the treatment duration with a PPI (both, OTC and prescribed) is frequently shorter as recommended by guidelines.

Conclusion: Being aware of various descriptions used to describe stomach problems is important in the diagnosing process. The consultation about the frequency and severity of symptoms could be crucial in making a rational transition from antacid treatment to PPI treatment in order to improve patient outcome in case of GERD symptoms that occur more than once per week. Additionally, optimising the duration of treatment in accordance with guidelines is necessary for comprehensive patient care.

Introduction

GERD is the most common gastrointestinal (GI) diagnosis given by primary care providers, and it is arguably the most common problem encountered in a community pharmacy setting.¹ Considering the frequency and troublesome symptoms, GERD reduces the quality of life, increases the absence from work and decreases work productivity.^2,3 Improving knowledge of health-care professionals and lay public of GERD severity, common symptoms, its frequency and treatment options can help patients to receive optimal care leading to an improved outcome and quality of life.⁴

Treatment options (i.e. antacids, H2RAs, or PPIs) for the management of GERD symptoms should be applied if lifestyle changes do not suffice.^2,5

Infrequent heartburn (most common GERD symptom) occurring less than once per week will probably lead to self-treatment with an antacid.² Persons with symptoms occurring more than once per week, which is also the definition of GERD, require longer-term therapy with an acid inhibitor, PPI or, if unavailable, H2RA. If symptoms occurring frequently are not severe, the World Gastroenterology Organization (WGO) guidelines recommend a 2-week treatment with an overthe counter (OTC) PPI along with lifestyle and dietary modifications. If symptoms persist, persons should be recommended to visit a physician for diagnostic evaluation. Moreover, in case of severe GERD symptoms, persons should primarily seek physician’s advice. Physicians may prescribe a 8–12 week-long empirical PPI therapy if they assume that the OTC PPI treatment was inadequate to address the severity of GERD.²

Patient education about the differences between occasional heartburn and GERD is important so that the patients do not choose self-treatment and subsequently fail to achieve relief. It is also true that proper treatment of GERD should be preventive in nature rather than responsive.¹

The aim of this market research was to get insights into understanding GERD symptoms and treatment approach among individuals experiencing such symptoms, pharmacists and GPs in their everyday practice. We focused on the description and perception of GERD symptoms, when individuals normally start their treatment and factors that influence the medicine choice. Such findings are crucial to understand the challenges we need to address to optimise the GERD treatment in the future.

Methods

The market research was conducted in three phases. In the first introductory phase, an independent market research agency reviewed the existing data. In October 2022, several Slovenian fora, blogs and social networks were examined using netnography research method with the aim to gain organic information what consumers reveal about stomach problems unasked and voluntarily in their online social interactions. In addition to netnography, four interviews with Slovak and Polish pharmaceutical market specialists were conducted and eight mystery shopper interviews were caried out in Slovenian pharmacies. This phase helped to develop a qualitative questionnaire for the second phase: in-depth interviews with certain individuals (n=9), and expert interviews with GPs (n=5) and pharmacists (n=5) that followed in November 2022 in Slovenia. The selection criteria for interviews with individuals included their age, gender and recent purchase of a medicine for the treatment of stomach problems. They were aged from 30 to 60, of mixed gender, have purchased such a medicine in the physical pharmacy in the last 6 months or had a prescribed medicine for the treatment of stomach problems at home. Online purchasers were excluded. Selected GPs and pharmacists were of mixed gender, with minimum 5 years of work experience in a public or private institution and located across Slovenia. Only those pharmacists were included in the research who could dispense both prescription and OTC medicines. Due to the post-coronavirus period, all interviews were conducted using video conferencing.

In the third phase, the quantification of results of the second phase, to analyse what stomach problems feel like and to obtain some demographic data, we conducted a quantitative phase with the online survey in Slovenia and Slovakia. Of 1460 individuals (639 from Slovenia and 821 from Slovakia), who started the online survey, 627 respondents (299 from Slovenia and 328 from Slovakia), met criteria for inclusion in the analysis. Respondents had to indicate in the survey that they had, in the last six months, experienced stomach problems (stomach pain/tightness, bloating, acid reflux, heartburn, epigastric pain beneath the xiphoid process, burning sensation in the throat/esophagus etc.) and/or bought a medicine to alleviate these problems in a physical or online pharmacy or had such a medicine at home. Persons aged 20–60 were included. Quotas were used to ensure national representation based on age, gender and region for each country’s online population.

Results

The introductory phase of the market research served as the basis for the second and third phases of the research, the main phases considered in analysing the results.

Findings from in-depth and expert interviews

Burden and perception of stomach problem

Interviewed GPs emphasised that the incidence of stomach problems has been increasing due to modern lifestyle. They are one of main three reasons people go to pharmacies, revealed answers from the pharmacists. Both, pharmacists and GPs, agreed that despite the growing awareness of seriousness of stomach problems related to acidreflux in the long run, general population still does not take this condition seriously enough.

The respondents mostly reported heartburn and burning sensation in the area of the esophagus as the most frequent symptoms associated with their stomach problems, known as GERD symptoms. Interviewees also described their symptoms with pain, heavy feeling and bloated stomach, and annoyance or irritation as the most frequent emotional states that it evokes.

Interestingly, in expert interviews we also identified that some persons mentioned heartburn without realising that it was caused by stomach acid reflux, and that in case of atypical symptoms, people didn’t know that they were caused by stomach acid in the first place (dry irritating cough, chest pain, discomfort in the throat and mouth).

Certain persons reported that in the beginning the GERD symptoms were usually milder and less frequent. The symptoms intensified over time if they had not acted against them. Diet in general seems to be the most obvious cause of stomach problems, heartburn in particular. They also emphasised other factors were to blame for the dietary choices they make: stress and lack of time.

Management of stomach problems in everyday practice

We noted that people’s reaction to the GERD symptoms and management depended on understanding the problem.

From the interviews with pharmacists, we may conclude that persons suffering from GERD symptoms can be divided into 3 groups: 1 – those who act on habit, 2 – those with frequent symptoms who want long-lasting symptom relief, and 3 – those in need of doctors’ advice.

1. Those from the first group underestimate GERD as they are aware that symptoms, which are occasional, mostly arise from inappropriate diet – so they have a feeling of in control of symptoms. The group typically includes antacid users who usually come to the pharmacy with a predetermined medicine and without the need for conversation about their problems. They do not consider antacids as a ‘serious medicine’, but rather as a food supplement. In contrast, PPIs elicit a sense of illness, leading to its avoidance. Even though individuals’ symptoms become more and more frequent, they postpone visiting doctors until their condition becomes really serious. They would visit the doctor only if problems persisted for a longer period of time, if they experienced difficulty sleeping, if they noticed blood or suspect they had ulcer or if symptoms affected other parts of the body (not just the stomach).
2. The second group consists of individuals who reported about frequent GERD symptoms (more than once per week). No diagnosis has been made by a doctor yet, but they realise and admit to have a stomach problem especially because the diet and lifestyle optimisation does not prevent symptoms. In addition to the fast relief, they also search for long-term solutions and are more receptive to pharmacist’s suggestions. In such cases, pharmacists either recommend visiting a doctor or initiating the short-term treatment with an OTC PPI, as they wish to prevent symptom repetition. They suggest taking the medicine for 7 to a maximum of 14 days, bearing in mind that 2–3 days are needed for full effect. However, as the effect can be achieved faster with antacids, antacids are preferred by the general population and the price can influence people’s choice. GPs are, however, highly critical of the massive use of antacids. They agree that antacids may be a part of every home first aid kit, but are concerned with possible overuse and the possibility of hiding more severe conditions.
3. During expert interviews with pharmacists, we noted that the last group includes individuals with severe or atypical GERD symptoms with a certain need of doctors’ advice. Interviewed GPs consistently emphasised a proactive approach towards GERD treatment, highlighting their commitment to making a diagnosis and differentiating it from other conditions as soon as possible. GPs stated that when presuming the presence of GERD, their standard protocol involves prescribing a PPI for a longer period of time. They usually prescribe a PPI once or twice a day for at least a month. Their first choice among PPIs is mostly pantoprazole. If symptoms persist, another PPI is prescribed (most likely esomeprazole) and the therapy is prolonged for additional two months. In case of severe symptoms, PPIs are prescribed for up to two months, twice a day with a higher dose. Prolonging the therapy is quite frequent, but the dose is often decreased.

Results of an online survey

The quantitative phase of the market research revealed that 534 (37%) persons had stomach problems in the last six months. They were experienced by 53% of men and 47% of women. 44% of individuals suffering from such problems were under 40 (more details in Table 1).

Table 1: Demographic characteristics of persons with stomach problems.

Nearly all of them (96%) complained of symptoms in their stomach, most frequently associated with bloating and stomach heaviness, followed by the symptoms in the esophagus, felt by 80% persons (mostly mentioning acid rising into the esophagus, reflux) and problems related to gastric acid (79%) mainly manifested as heartburn. In addition, more than half of persons (54% and 52%) reported about other problems and pain elsewhere, respectively. More detailed symptoms are available in Table 2.

Table 2: Symptoms persons experienced related to their stomach problems.

With regard to the symptom frequency, the majority of individuals (68%) reported symptoms occurring once per week or less often. Frequent symptoms (occurring more than once per week) were felt by 32% of persons (Table 3). 60% of persons felt symptoms throughout the whole year.

Table 3: Frequency of stomach problems suffered by persons.

When choosing an OTC medicine, the majority of respondents (53%) emphasise personal experience, while 45% appreciate the guidance of pharmacists. 37% mentioned recommendations made by friends and relatives as an important source of information, while 34% of them chose an OTC medicine based on doctors’ recommendations/prescription. Other answers were less significant (Table 4). In the context of stomach problem management, a notable 64% of people expressed relative dissatisfaction with the current treatment (Table 5).

Table 4: The source of information respondents perceive as important when selecting OTC treatment.

Table 5: Respondents’ perception of treatment success.

The most notable results related to the administration of Nolpaza control (Table 6) were that 46% of users opt for a single-pill (or two-pill) approach during symptomatic period, 26% adhere to a consecutive daily regime until they have a problem, while a modest 9% consistently follow the entire course of treatment.

Table 6: People’s administration of Nolpaza control.

Discussion

Findings from this market research help us to elucidate the impact of stomach problems on people’s lives and how individuals and health-care professionals manage it in daily practice.

Many faces of GERD

The qualitative phase of the research revealed that people tend to use more symptoms when describing their stomach problems. This observation was further substantiated during the quantitative phase where it was found that people use 6-7 descriptive symptoms. We need to be aware of various symptoms for correct diagnosis process.⁶ Together with heartburn which is associated with a burning sensation, bloating was interestingly also the most commonly chosen symptom in both, Slovenia and Slovakia, with 61% of individuals in total. Compared to literature, bloating is not frequently recognised as the predominant symptom of GERD in addition to heartburn. Instead, regurgitation emerges as a more prevalent manifestation in this context.^{5, 7} In in-depth interviews and the online survey, we also identified pain (predominantly stomach pain felt by 40% of individuals) that might also be the result of bloating, and heavy feeling as commonly reported. However, we need to take into account that the symptoms or descriptions of problems that were available for selection in our online survey may overlap. Because of this and the lack of the statistical data analysis, it is not possible to exactly determine the symptom frequency.

Market research limitations

There are some limitations as to the current analysis, in addition to including a limited population from 2 countries only. Market research is based on trust and accuracy. At any stage of the market research, accuracy is a vital issue. The extent of inaccuracy influences the reliability of market research results. We are aware that completely bias-free responses or results are not possible. In addition, we asked the participating individuals the questions about stomach problems and not directly about the GERD. Different stomach problem symptoms could reflect also in some other illnesses. Nevertheless, based on the results, we can conclude that the majority of people described acid-reflux related stomach problems.

Antacids remain the mainstay of self-treatment

Being aware of limitations, based on market research results, we can see that the antacids are most commonly used for self-treatment. This is in line with the review article by Garg V et al. stating that among OTC medicine users, 85% of individuals treat their stomach problems with antacids.⁸ Antacids are valuable medicines recommended for infrequent GERD symptoms. They provide quick relief of symptoms by neutralising excess hydrochloric acid (HCl) in gastric juice and inhibit the proteolytic enzyme pepsin.^{2, 8} However, antacids have a short duration of action of up to 3 hours, meaning that the patients need to take multiple daily doses, which was established also in the present market research.^{9, 10} We established that the users of antacids are normally not concerned about their stomach problems as they are convinced to know the cause of their problems, know how to prevent it, manage and control it. They usually don’t seek pharmacists’ advice and postpone visiting a doctor until their condition becomes really serious. We found that people normally start realising they have a problem when they experience an escalation of frequency and severity of their symptoms. However, questioned individuals who benefited with antacids were mostly confident they are ‘not there’ yet and do not need to take ‘serious’ medicines (like PPIs). They treat antacids like must-have ‘vitamins’.

It is true that antacids are generally considered to have a good safety profile, but high doses and chronic consumption can cause acid rebound.⁸ They should not be taken regularly as a substitute for prescription medicines, also because their use may hide a more serious underlying condition and they have a little effect on preventing the recurrence of symptoms or allowing an injured esophagus to heal.^{9, 11}

A need for treatment and compliance optimisation

As stated in a recently updated online book by Salisbury BH et al., there is a need to educate patients regarding the importance of a correct antacid administration.¹² This is very important also from the perspective that more than 40% of individuals with stomach problems appear to be under 40, meaning they can potentially misuse antacids for further decades. The results from the quantitative phase of the market research show individuals’ great trust in recommendations by pharmacists when choosing OTC products, which indicates that pharmacists can help to break the vicious cycle of thoughtlessly using antacids when symptoms are frequent (more than once per week). Notably, we found that more than 1/3 of persons with stomach problems experience frequent symptoms. By proactively asking about the frequency of symptoms, pharmacists could educate individuals to benefit more from self-treatment with OTC PPIs for 7–14 days, in case of mild symptoms appearing frequently, also due to offering the whole-day-long acid control and long-lasting symptom-free period.^{3, 13} A long-lasting solution is namely revealed to be recognised as a predominantly desired objective in individuals with frequent GERD symptoms.

For complete resolution of mild GERD symptoms which is the criteria for long-lasting relief of symptoms, clinical data show that 7 days of consecutive OTC PPI (i.e. pantoprazole) intake may be needed.¹⁴ Additionally, clinical studies show a significantly larger share of individuals with complete resolution after the OTC pantoprazole treatment for 14 days as compared to 7 days.¹⁴ In contrast, results indicate that only 9% of Nolpaza control users (OTC pantoprazole) consistently follow the entire course of treatment (7–14 days), but rather opt for a responsive treatment approach taking tablets just during a symptomatic period. However, in case of persisting GERD symptoms after 14 days of self-treatment with an OTC PPI, individuals should visit a doctor.² Doctors may prescribe a longer-term prescription PPI therapy to achieve better symptom relief and confirm the diagnosis of the GERD, in case the OTC PPI treatment was too short to adequately address the severity of GERD symptoms.²

The present market research revealed that in addition to education about the optimal duration of treatment with an OTC PPI, education for doctors about optimal duration of treatment with a prescribed PPI is also a place for improvement in the daily clinical practice. Expert interviews namely revealed that some doctors prescribe the initial empiric PPI therapy for a shorter period as recommended by the guidelines. In the process of diagnosing GERD, it is important to persist in the empiric treatment with a PPI for 8 weeks once daily in case of typical symptoms, and for 8–12 weeks twice daily in case of typical and extraesophageal symptoms to ensure enough time for proper healing to prevent GERD relapses in maintenance therapy.⁵ This was confirmed also in the PAN-STAR clinical study where patients with GERD were treated 4 to 8 weeks with Krka’s pantoprazole (Nolpaza 40 mg). In the study, it was proven that prolonging the treatment from 4 to 8 weeks is beneficial, as more patients reached the healing criteria, experienced further relief of symptoms and improvement of the quality of life.¹⁵

By considering choosing a PPI instead of an antacid in case of frequent GERD symptoms and the optimal duration of OTC and prescribed PPI treatment, it can be predicted that a greater number of individuals would experience satisfaction with their stomach problem treatment; data from the market research reveal that over 60% of individuals are relatively unsatisfied with existing treatment. Optimisation of the therapy according to the guidelines cannot only improve satisfaction with the treatment by improving individuals’ outcome, but also medicines safety by preventing an unnecessary use.¹⁶

Conclusion

The market research revealed that a large proportion of individuals suffering from stomach problems are under 40. Moreover, more than 1/3 of respondents reported about frequent symptoms (occurring more than once per week). Commonly, respondents use various symptoms when describing their stomach problems beyond the typical heartburn sensation. They mostly rely on antacids as a form of self-treatment. Unmonitored and prolonged use of antacids is common, making education about self-care and health-care guidance important in cases of frequent symptoms. The consultation about frequency and severity of symptoms could be crucial for making the transition from antacid treatment to PPI treatment in order to improve patients outcomes. Furthermore, we recognise that the duration of intake of both, OTC and prescription PPIs, is frequently shorter than recommended. Optimising treatment in accordance with the guidelines is necessary for comprehensive patient care.¹⁶

References

1. Zeid Y. Standards of Care for GERD. US Pharmacist [internet]. 2016 [cited 2023 Nov 23]; 41 (12): 24–9. Available from: https://www.uspharmacist.com/article/standards-of-care-for-gerd
2. Hunt R, Armstrong D, Katelaris P et al. World Gastroenterology Organisation Global Guidelines: GERD Global Perspective on Gastroesophageal Reflux Disease. WGO 2015; 1–37.
3. Freedberg DE, Kim LS, Yang YX. The Risks and Benefits of Long-term Use of Proton Pump Inhibitors: Expert Review and Best Practice Advice From the American Gastroenterological Association. Gastroenterology. 2017; 152(4): 706–15.
4. Liker H, Hungin P, Wiklund I. Managing gastroesophageal reflux disease in primary care: the patient perspective. J Am Board Fam Pract. 2005 Sep-Oct; 18(5): 393-400.
5. Katz PO, Dunbar KB, Schnoll-Sussman FH et al. American College of Gastroenterology (ACG) Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol 2021; 117(1): 27–56.
6. Balogh EP, Miller BT, Ball JR. Improving Diagnosis in Health Care. National Academies Press (US) [internet]. 2015 [cited 2023 Nov 23]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK338593/
7. Lee SW, Lien HC, Lee TY et al. Heartburn and regurgitation have different impacts on life quality of patients with gastroesophageal reflux disease. World J Gastroenterol. 2014 Sep 14; 20(34): 12277–82.
8. Garg V, Narang P, Taneja R. Antacids revisited: review on contemporary facts and relevance for self-management. J Int Med Res. 2022; 50(3).
9. Maton PN, Burton ME. Antacids revisited: a review of their clinical pharmacology and recommended therapeutic use. Drugs. 1999 Jun; 57(6): 855–70.
10. Ching CK, Lam SK. Antacids. Indications and limitations. Drugs. 1994 Feb; 47(2): 305–17.
11. IFFGD: Antacids [internet]. Mount Pleasant: International Foundation for Gastrointestinal Disorders [cited 2023 Nov 23]. Available from: https://iffgd.org/manage-your-health/diet-and-treatments/antacids/
12. Salisbury BH, Terrell JM. Antacids. StatPearls [internet] 2023 [cited 2023 Nov 23]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK526049/
13. Bernshteyn MA, Masood U. Pantoprazole. [Updated 2023 Jul 10]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK499945/
14. Nolpaza control SmPC
15. Korthouwer R., Lebar N. and Barbič-Žagar B. Clinical studies with Krka’s proton pump inhibitors in the treatment of gastroesophageal reflux disease reviewed. Krka Med Farm 2014; 26(38): 92–102.
16. NHS: Medicines optimisation [internet]. [cited 2023 Nov 23]. Available from: https://www.england.nhs.uk/medicines-2/medicines-optimisation/.

Appendix

Table 7: Usual timing of stomach problem symptoms occurrence

Table 8: Typical nutrition-related causes for stomach problems

Table 9: Common stomach problem related worries of suffering individuals

Table 10: Respondents’ perceptions of the cause of their stomach problems

Table 11: Respondents’ main objective with their stomach problems

Table 12: Where respondents show their negative emotions evoked by stomach problems (this includes being in a bad mood, feeling annoyed, irritable or nervous)

Author

Tina Lavtar
Krka d. d., tina.lavtar@krka.biz

Bojana Mitrović
Krka d. d., bojana.mitrovic@krka.biz

Mihaela Rojac
Krka d. d., mihaela.rojac@krka.biz

Ronald Korthouwer
Krka d. d., ronald.korthouwer@krka.biz

Breda Barbič-Žagar, dr. med.
Krka d. d., breda.zagar@krka.biz

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Published: January, 2024