Patients’ views on dyspepsia and acid suppressant drug therapy in general practice

Abstract

Objectives: To do an inventory on the opinion of long-term acid suppressant drug (ASD) users on their condition and drug treatment, and from that angle to reflect on possibilities to reduce usage and costs of long-term acid suppressant drug therapy. Methods: In the year 2001, in seven general practices, patients who chronically used ASDs without proper indication were identified. A postal questionnaire based on the literature was sent to these patients (n=498). Results: 318 (64%) returned questionnaires were fit for analysis. Patients experienced dyspepsia as unpleasant and restraining, and were extremely positive about ASDs without differences between H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). ASD use was very compliant. Patients smoked and drank less than the normal population. They did not continue unhealthy habits simply because ASDs enable them to. Most patients were not motivated to stop their ASDs.

Conclusion: Dyspeptic complaints should not be underestimated. Improving lifestyle is not likely to generate much effect on ASD use. Due to a lack of motivation, discontinuing long-term ASD use may not be an efficient way to reduce the use and costs of ASDs. Patient-centred possibilities are prescribing H2RAs instead of PPIs as a first step, as they are perceived by patients to be equally effective, and encouraging patients to self-regulate drug treatment through on-demand regimes.

• Anti-ulcer agents
• drug therapy
• patient satisfaction
• public health

Introduction

Functional dyspepsia and mild gastro-oesophageal reflux disease are common in Western Europe. Symptoms of these conditions are often treated with acid suppressant drugs (ASDs), i.e. H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs).

The prescribing of long-term ASD therapy is limited to a number of specific indications, which in most countries are described in practice guidelines. In the Netherlands, the principles of daily practice are described in the guideline on dyspepsia of the Dutch College of General Practitioners [1]. Generally speaking, proper indications for long-term ASD prescription are gastro-oesophageal reflux disease to the third or fourth degree, a history of peptic haemorrhage or stomach perforation, and a combination of risk factors, e.g. chronic NSAID use and old age. Functional dyspepsia and mild gastro-oesophageal reflux disease are not among the specific conditions for which long-term ASD prescription is indicated.

In the Netherlands and other European countries, there has been a large increase in the prescribing volume of ASDs in recent years [2], [3]. No evidence exists that the overall prevalence of gastro-intestinal morbidity has increased. The prevalence of peptic ulcers is declining due to widespread eradication of Helicobacter pylori, resulting in an increased proportion of non-ulcer functional dyspepsia and mild gastro-oesophageal reflux disease within the range of gastrointestinal conditions [3], [4]. It is therefore probable that ASDs are prescribed outside their registered indications.

It is sometimes thought that patients chronically use ASDs for relatively minor complaints, or as a means of not having to make lifestyle changes. Furthermore, ASDs are expensive drugs. The costs of ASDs have increased astronomically in the Netherlands and in other European countries, because more patients use ASDs and because more expensive ASDs, especially PPIs, are prescribed [2], [5]. Non-indicated long-term ASD use is, for these reasons, considered undesirable.

Several strategies to reduce non-indicated chronic ASD use and its associated costs have been developed [6], [7]. Most of these are doctor centred, for example discontinuing non-indicated long-term ASD use and substituting expensive and strong medicines with cheaper and less strong ones (e.g. H2RAs instead of PPIs, or generic instead of branded drugs). Some strategies are more patient centred, for example encouraging patients to self-regulate their drug treatment through on-demand regimes.

Since patient-centred medicine improves compliance and satisfaction with care, a doctor should not change long-term medication without taking patients’ opinions and preferences into account [8].

Therefore, our research aim was to explore the views of long-term ASD users on their condition and drug treatment, and to reflect on strategies to reduce usage and costs of non-indicated long-term acid suppressant drug therapy.

Methods

In the Netherlands, every person is registered in a primary care practice. GPs keep electronic files containing the medical history of all their patients. Village pharmacies keep additional information on patients’ drug use.

In this study, the practice and pharmacy electronic patient records of seven general practices were systematically searched for patients who chronically (i.e. longer than 12 wk) used ASDs. The general practices are situated in an urbanized rural area of the Netherlands, with an approximate combined population of 19 000 patients.

Patients who had a clear indication for the long-term use of ASDs were identified. Indications were defined according to the Dutch College of General Practitioners Guideline on Dyspepsia as chronic usage of NSAIDs with an additional risk factor (e.g. age >70 y), reflux-oesophagitis to the third or fourth degree, and having a history of (perforated) peptic haemorrhage [4]. Patients with a clear indication were excluded. Patients who chronically used ASDs without having a clear indication were included.

Of the 723 patients (3.8% of the total population) who chronically used ASDs, 535 (74%) did not have a clear indication. Patients who were deceased, terminally ill or unable to complete the questionnaire (n=37) were excluded. The remaining patients (n=498) were sent a questionnaire, along with an explanatory letter from their GPs. The questionnaire consisted of three parts: 1) 10 questions on background information, including lifestyle and medical history; 2) 14 questions on complaints; and 3) 38 questions on ASD therapy, including the patient's opinion on discontinuing treatment. No payment was offered for participation. Patients were not approached a second time.

Data were analysed in SPSS version 10.1. Statistical calculations were carried out using the χ² test and the Student's t-test.

Results

Response

Three hundred and forty-nine questionnaires were returned. Thirty-one questionnaires were incorrectly or incompletely filled in; 318 (64%) were fit for analysis. No significant differences in sex and age between the 535 selected patients and the 318 analysed patients were found.

Characteristics of the responders

The mean age of our patients was 66 (SD 12) y, and 59% were female. Two hundred and fifty-two patients (80%) used a proton pump inhibitor, and 66 (20%) used an H2-receptor antagonist. Omeprazole was the most frequently prescribed PPI; ranitidine was the most frequently prescribed H2RA. For 58% of the PPI users (n=145), a PPI was the first treatment for dyspepsia. One hundred and seven (42%) patients had been tried on an H2RA first. Of the 66 H2RA users, 10 (15%) patients had first been tried on a PPI. Of the 249 patients (79%) who had undergone diagnostic investigations, 117 had had a gastroscopy, 33 a barium meal, and 99 both.

Complaints

Heartburn was the chief complaint of 75% of patients. Other common presenting features were pain in the upper abdomen, regurgitation, belching, chest pains, nausea and/or vomiting (Table I). Hiatal hernia was most frequently reported as a cause of the complaints (Table II). In most cases, the complaints were chronic in nature. Only 3% of patients had had complaints for less than a year at the time of this study, while 52% of patients had had complaints for more than 10 years. Most patients had waited between 1 and 5 years before seeking medical help.

Table I.  Presenting features (n=318).

Presenting features	n	%
Heartburn	236	75
Upper abdominal pains	137	44
Backflow	106	34
Belching	98	31
Chest pains	76	24
Nausea and/or vomiting	51	16
Foul taste in mouth	46	15
Bad breath	44	14
Slime	29	9
Hiccups	20	6

This table shows the number and percentage of patients presenting with a certain symptom or complaint.

The sum does not equal 100% because patients were allowed to tick more than one answer.

Table II.  Causes of functional dyspepsia or mild gastro-oesophageal reflux disease (n=313).

	n	%
Hiatal hernia	142	45
Gastritis	36	12
Peptic ulcer in history	31	10
Drug induced	10	3
Functional/unknown^a	32	10
Unknown^b	63	20

Causes of complaints are self-reported.

^aNo cause of complaints was found on gastroscopy or barium meal X-ray.

^bNo diagnostic investigations were performed.

Nearly all patients described their symptoms as very unpleasant and restricting. Forty-eight per cent said they were hindered in daily life by the symptoms. Most people did not think that their symptoms indicated the presence of a serious illness. Only 4% said that they were sometimes afraid of having stomach cancer or another serious disease. Twenty-nine per cent feared that their dyspepsia might harm their stomachs in the long run.

Views on ASDs

Ninety-six per cent of patients regarded their drug as “good” to “very good” and “effective” to “very effective”. Ninety-five per cent said that the drug had improved the quality of their lives. Ninety-nine per cent of patients trusted their drug to protect their stomachs. Seventy-six per cent thought that the drug would not have any harmful long-term effects. Ninety-five per cent experienced no side effects whatsoever.

Most patients took the drug exactly according to prescription; 44 patients (14%) used an on-demand schedule.

No differences were found between the characteristics of the users of H2RAs and PPIs, or in the ways they used ASDs. Neither were any differences found in the kind of complaints for which the ASDs were prescribed, nor in the perceived severity of symptoms before or after the ASDs were prescribed. Both drugs were rated equally high by patients. No differences were found in patients’ opinions about the drugs, their faith in the drugs, the perceived efficacy of the drugs or the experience of side effects. Patients of both groups scored equally regarding their lifestyle and willingness to stop the drug.

Self-initiated treatments and lifestyle

Before the start of ASD therapy, 60% of patients needed to use over-the-counter (OTC)-purchased drugs with an average of six times a week. With ASDs, only 11% used OTC drugs, with an average of three times a week. Before the use of ASDs, 76% of patients took other measures against their stomach complaints, such as lifting the head of the bed, drinking milk when experiencing complaints and wearing looser clothing. With the use of ASDs, 49% of patients still took these measures.

Thirteen per cent of patients smoked, and 5% consumed more than three alcoholic drinks a day. Thirty-five per cent of patients were overweight, i.e. with a BMI > 27 kg/m². Patients smoked and drank alcohol less than is average for their age group, but more ASD users were overweight. A comparison is shown in Table III.

Table III.  Adverse lifestyles.

Risk factor	% of patients	% of comparable population^a	p
Smoking	13	33	<0.0005
Drinking	57	88	<0.0005
Overweight	59	45	<0.0005

^aNumbers obtained from Statistics Netherlands (CBS).

Discontinuing or changing drug therapy

One hundred and thirty-four patients (43%) had tried to stop their ASDs at a certain time, and 96% of these patients had restarted drug therapy because their symptoms returned. After the attempt to stop, 110 patients used their medication in the exact same way as they had done before. The remaining 24 patients started using their drugs on demand. Less than half (42%) of the patients were willing to try to stop their ASDs if their GPs were to propose this, but reluctantly so, and only under certain conditions, such as restarting the medication if symptoms were to reoccur. Only 6% said they would really like to try to stop. Sixty-eight per cent of patients said they would not accept any (minor) symptoms after stopping the medication, even if they were assured that their dyspeptic complaints were not harmful to their stomachs.

Discussion

Critics suggest that ASDs may be frequently prescribed for relatively minor and trivial complaints. Our results show that dyspepsia is not perceived as trivial and minor by the patients who suffer from it. Other studies confirm this [5], [6], [9–11]. Patients with dyspepsia experience serious impairments in daily life, including social life and work. Dyspepsia is a condition that needs to be adequately treated.

Some physicians believe that treatment of mild gastro-oesophageal reflux disease and functional dyspepsia should start with lifestyle changes [10], [11]. Of course, a general practitioner should always encourage healthy lifestyles in patients, but evidence from trials shows a questionable therapeutic benefit of lifestyle measures on dyspepsia [12].

Moreover, it appears that the majority of long-term ASD users do not have unhealthy lifestyles. They smoke and drink less than average, and no indication was found that patients use ASDs as a way of avoiding lifestyle changes [10], [11], [13]. ASDs, on the other hand, enable patients to introduce fruits and vegetables to their diets, to participate in sports, and to work with less sick-leave than before [11]. We therefore believe that lifestyle changes will only benefit a small number of patients, and that a large group will have to be treated in other ways.

Patients appear to be extremely positive about ASDs [3], [6], [9–11]. They experience almost no side effects. Most patients have tried other treatments, including antacids and lifestyle measures, before taking ASDs, and found out that they did not work [14]. Most patients regard their drugs as the only way to live a life without constantly having complaints [10], [11], [14], [15].

This study shows that this patient group is not very motivated to stop or to taper ASD medication, which is probably the main reason why stopping attempts have proved unsuccessful in the past [6], [9], [14]. In a study published in 2001 [16], however, ASDs were stopped in 40% of a selected patient group (n=174) with 24 wk follow-up. This was achieved by coaching the patients on more than one occasion, and by taking care of the so-called “rebound effect”, the phenomenon of temporary acid hypersecretion that occurs when ASDs are stopped. Stopping attempts turned out to be more successful in patients using H2RAs than in patients using PPIs, in younger patients, in motivated patients, and in patients suffering from functional dyspepsia rather than reflux disease [11], [16]. However, the question arises whether this will be manageable for GPs who are already under a great deal of time pressure.

In our group, many patients used PPIs and most patients suffered from reflux-like symptoms rather than complaints indicating functional dyspepsia (i.e. heartburn [1], [17]). Our patients were relatively old, and most patients had a negative attitude towards stopping ASDs. Considering these characteristics and the opinion of our patients, stopping attempts will probably not have a high chance of success in the major part of our group. We foresee a large group of patients who will continue to need long-term ASD therapy, even if this is not indicated according to current guidelines. Reducing the volume and cost of ASD therapy will have to be achieved by strategies other than discontinuing them.

A striking outcome was the fact that patients perceive H2RAs as equally effective as PPIs in the treatment of dyspeptic complaints. As stated in the results, no differences were found between the two groups in user characteristics, diagnosis, nature and duration of the complaints, and the patients’ opinion on the drug. Therefore, general practitioners should consider prescribing low-dose H2RAs as a first treatment for mild reflux disease and dyspepsia. Prescribing PPIs and high-dose H2RAs can then be limited to therapy-resistant complaints [16]. In this situation, PPIs can be given in a low maintenance dose, which may be a better and cheaper option than high-dose H2RAs, according to the NICE guideline [18].

Since mild gastro-oesophageal reflux disease and functional dyspepsia are chronic symptoms to be relieved, rather than diseases to be cured, patients should be involved in the decision-making around their treatment. Their opinions on dyspeptic complaints and their treatment should be taken into account to ensure effective treatment.

Encouraging patients to self-regulate their ASD treatment may help to reduce the amount of drugs used and the costs, while still adequately treating patients.