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Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. References

Background:

There is need for an evidence-based comparison of clinical management strategies to provide the rationale for selection of a particular therapeutic approach to treatment. Ideal dyspepsia treatment should quickly and conveniently alleviate patient symptoms whilst also minimizing the use of healthcare resources.

Aim:

To examine dyspepsia symptom relief over 16 weeks and compare an omeprazole clinical management strategy with a commonly used combination of antacid–alginate followed by H2-antagonist.

Methods:

Seven hundred and twenty-five patients participated in this randomized, open, parallel group comparison over 16 weeks. Patients were randomized to receive either an omeprazole treatment strategy (363) consisting of omeprazole 10 mg stepping up to 20 mg and 40 mg as required, or an antacid–alginate/ranitidine treatment strategy (362) consisting of antacid–alginate 10 mL q.d.s. stepping up to ranitidine 150 mg b.d. and 150 mg q.d.s. as required.

Results:

A greater proportion of patients receiving the omeprazole clinical management strategy had achieved the stringent health target of complete symptom relief (61 vs. 40%, < 0.0001) at 16 weeks. Forty-six per cent of omeprazole-treated patients were symptom free after the first 10 mg step compared to only 17% in the antacid–alginate treated group (P = 0.0001). Total relief of heartburn, the most common symptom at entry, was achieved by more patients in the omeprazole treatment group than the antacid–alginate/ranitidine treatment group, 62 vs. 36%, respectively, at 4 weeks, and 81 vs. 60% at 16 weeks (P = 0.0001).

Conclusion:

Treatment with the omeprazole clinical management strategy was superior to the antacid–alginate/ranitidine management strategy in providing relief of acid-related dyspepsia symptoms after 16 weeks. In addition, the omeprazole treatment strategy involved fewer GP consultations and thus minimized the use of other healthcare resources.


INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. References

Dyspepsia is a common problem encountered in general practice and an assessment in the community by means of a postal questionnaire has suggested the prevalence over a 6-month period is 41%.1, 2 The majority of patients (91%) will try self-medication first with either antacids or antacid–alginates bought over-the-counter, and only when dyspepsia symptoms become more frequent or more severe will the patient consult their general practitioner for further advice and treatment.2 As a result of this high prevalence of dyspepsia, presentation with upper gastrointestinal tract related symptoms accounts for ≈ 3–4% of all general practitioner consultations.3[4]–5 Therapy is generally initiated based on presentation of symptoms alone. Antacid–alginates (e.g. Gaviscon) are commonly prescribed as first line treatment, but other treatment options include a histamine H2-receptor antagonist (e.g. ranitidine) or a proton pump inhibitor (e.g. omeprazole).

Clinical management strategies which follow logical progression of treatment are becoming more common and may prove more cost-effective. Treatment guidelines and protocols are now frequently used in general practice but there is a clear need for these to be evidence-based. It has recently been reported that only 15–20% of current medical treatments have been proven to be effective,6 and the Department of Health has now set out a framework to promote evidence-based medicine and develop a health service based on knowledge.7 Therefore, for medicinal treatments to be included in local formularies or considered as part of clinical management strategies, products will have to be rigorously researched to evaluate effectiveness of intervention and enable prioritizing of healthcare.7, 8

There have been many dyspepsia management strategies and guidelines published in recent years.9[10][11][12][13][14]–15 All recommend lifestyle changes, but subsequent treatment recommendations are varied and depend upon personal preference and experience. The British Society of Gastroenterology (BSG) Dyspepsia Management Guidelines state that it is acceptable to initiate a single course of treatment with an antisecretory agent, for 2–4 weeks, in patients under the age of 45 years who are experiencing troublesome dyspepsia but exhibit no alarm symptoms.15 Endoscopy is not recommended in this group of patients without evidence of the presence of Helicobacter pylori together with persistent symptoms. Treatment without investigation is therefore appropriate in many cases.9, 15

Recent studies have shown omeprazole 10 mg o.m. to be an effective maintenance treatment in reflux oesophagitis,16, 17 it has also been shown to significantly reduce oesophageal acid exposure18 and is more effective than antacid–alginate in reducing dyspepsia symptoms over a 4-week period.19 As an extension to this work, this study aimed to examine dyspepsia symptom relief over a longer time period, incorporating dosage titration regimens based on individual patient need.

This study compared an omeprazole clinical management strategy with an antacid–alginate/ranitidine clinical management strategy. This allowed a comparison of the efficacy of both treatment regimens, in a manner that reflects the treatment of dyspepsia in general practice as closely as possible. It was important that treatment failures were investigated further, in case there was underlying disease that needed further treatment, so endoscopic examination was offered to all patients whose symptoms failed to respond sufficiently to treatment by the end of the 16-week study period.

METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. References

Patients

Patients aged 18–89 years were recruited at 131 general practice centres in the UK and Republic of Ireland. Local Research Ethics Committee approval was gained for the study at each centre and all patients gave written informed consent prior to participation in the trial.

Patients were required to have had a minimum 1-month history of dyspepsia (including heartburn and/or epigastric pain) to be eligible for entry. They also had to experience dyspepsia symptoms on at least 2 days during the last 7 and have shown benefit from antacid use during the previous month. Patients were excluded if they had a proven history or diagnosis of: oesophagitis, oesophageal ulceration or stricture, Barrett’s oesophagus, proven peptic ulcer, oesophageal, gastric or duodenal surgery, biliary tract disease, pancreatitis, colitis, inflammatory bowel disease or symptoms suggestive of irritable bowel syndrome. Those patients who had any clinically significant concurrent disease, warranted immediate investigation, who were pregnant, drug or alcohol abusers or suffered any other condition associated with poor compliance were excluded from the study. Patients who had previously been included or who had participated in any other clinical trial within the last month were also not eligible for entry as were patients who had been treated with H2-receptor antagonists, proton pump inhibitors or prokinetic agents for more than 3 consecutive days in the last month. Habitual antacid users, patients requiring a low sodium diet and patients who required regular daily treatment with NSAIDs were also unsuitable for entry.

Study design

Seven hundred and twenty-five patients from 131 general practice centres in the UK and Republic of Ireland were randomized into this study and received medication. Patients were blindly randomized to receive open treatment, either omeprazole 10 mg o.m. (Losec; Astra, UK) increasing to 20 mg o.m. and 40 mg o.m. as required, or antacid–alginate 10 mL q.d.s. (Gaviscon; Reckitt and Colman Products Ltd, UK) followed by ranitidine 150 mg b.d. and 150 mg q.d.s. as required (Zantac; Glaxo, UK) for 16 weeks. Patients in both treatment arms were supplied with antacids (Rennie; Roche Nicholas Consumer Healthcare, UK) as relief medication to be taken as required.

Clinic visits were carried out at 2, 4, 8, 12 and 16 weeks. At each clinic visit patients were asked ‘How would you grade the severity of your dyspepsia symptoms in general?’ Symptoms were graded: none = complete absence of dyspepsia symptoms; mild = awareness of signs or symptoms but easily tolerated and not interfering with normal daily activities; severe = symptoms causing discomfort sufficient to interfere with normal activities. Patients were additionally asked ‘How many days in the last 7 have you felt these symptoms?’ and replies recorded as 0–1 day, 2–4 days, 5–6 days or 7 days. Patients graded specific symptoms of heartburn, epigastric pain, regurgitation, odynophagia, abdominal distension and nausea in the same manner and confirmed the presence or absence of vomiting.

At the first clinic visit, a symptom questionnaire was completed to eliminate patients in whom symptoms of irritable bowel syndrome were predominant.20 Patients reporting the presence of lower abdominal pain and at least three out of the following symptoms: abdominal distension, mucus per rectum, abdominal pain eased on bowel movement, loose stools with the onset of abdominal pain, frequent bowel movement with the onset of abdominal pain, or incomplete evacuation, were considered to have irritable bowel syndrome.

At the second and subsequent clinic visits, patients were also asked to rate their current treatment from the statements: ‘the treatment made me a lot worse’, ‘the treatment made me slightly worse’, ‘the treatment made no change to my symptoms’, ‘the treatment made me slightly better’, ‘the treatment made me a lot better’ or ‘the treatment completely relieved my symptoms’. The convenience of their current treatment was rated from the statements: ‘very convenient’, ‘convenient’, ‘inconvenient’ or ‘very inconvenient’ to use.

The criteria for increasing the level of treatment were based on symptom severity scores at clinic visits. If patients’ symptoms had worsened, i.e. overall symptom grade and/or frequency of symptoms was worse than at the previous clinic visit an increase in dose was initiated by the general practitioner. Patients whose symptoms stayed the same or showed an improvement from the previous clinic visit remained on the same level of treatment.

Patients completed a daily diary recording the number of antacids taken during the day and night, severity of overall dyspepsia symptoms experienced during the day and night, and whether they had taken their study medication as instructed.

Endoscopic examination was offered to all patients whose symptoms failed to sufficiently respond to treatment by the end of the study period. To fulfil the criteria for endoscopy, patients must have reached the 4-week study visit and had at least one step up in treatment. Additionally they had to have either worsening dyspepsia symptoms, experienced no improvement in their dyspepsia symptoms or shown other clinical signs that endoscopic investigation was needed. Patients had to give informed consent prior to endoscopy.

Adverse events were recorded in response to a standard, open question.

Statistical analyses

Analyses were performed on an all-patients-treated basis using all available data. In addition, the primary efficacy was analysed by a per protocol approach. This method was applied to data from patients who had completed their time in the study with no major protocol violations. It was planned that 712 patients would be recruited, 356 per treatment group. At the 5% significance level, this would provide 80% power of detecting a 10% difference in the proportion of patients symptom-free following 16 weeks treatment with the two clinical management strategies. The actual power of the study is presented in the results section. The statistical packages used for the analyses were SAS version 6.04 (PC) and STATXACT version 2.11.

Complete relief of dyspepsia symptoms (severity of dyspepsia symptoms reported as ‘none’ and the frequency of symptoms as ‘0–1’ in the last 7 days) and sufficient relief of dyspepsia symptoms (severity of dyspepsia symptoms reported as ‘none’ or ‘mild’ and the frequency of symptoms as ‘0–1’ in the last 7 days) were each compared between the two treatment groups by a χ2 test. The severity of individual symptoms was compared between treatments at the final visit by the Wilcoxon rank sum test. The number of treatment steps to complete symptom relief was compared between regimens by the Wilcoxon rank sum test. Patient compliance with study medication and the patient’s assessment of effectiveness and convenience of treatment was compared between treatments by the Wilcoxon rank sum test. Average daily antacid consumption, symptom severity and the percentage of days with no symptoms and no use of antacids were compared between treatments by the Wilcoxon rank sum test. Time to disappearance of symptoms and no use of antacids was analysed between groups by the log rank test.

All data are presented as mean ± standard deviation (s.d.) unless stated otherwise.

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. References

A total of 725 patients were randomized into the study to receive either the omeprazole treatment strategy or the antacid–alginate/ranitidine treatment strategy. Twenty-two patients, 13 from the omeprazole treatment group and nine from the antacid–alginate/ranitidine treatment group recorded only baseline symptom assessment and were excluded from the analysis on the basis that no study medication had been taken and subsequent visit data were not available.

Four patients were erroneously allocated the incorrect treatments at randomization. Two patients received omeprazole when they should have received antacid–alginate/ranitidine, and two patients received antacid–alginate/ranitidine when they should have received omeprazole. The data from these four patients were analysed according to the treatment they received. Overall, 354 patients in the omeprazole group and 349 in the antacid–alginate/ranitidine group were eligible for the all-patients-treated analysis (APT). Two hundred and twenty-eight patients in the omeprazole group and 185 from the antacid–alginate/ranitidine group were eligible for the per protocol analysis (PP). The study had a power of 99% in detecting the observed 21% difference between treatment regimens at the 5% significance level.

The two patient groups were comparable with respect to demographic details at entry to the study ( Table 1). The treatment groups were also well matched in relation to dyspepsia history and symptom severity at entry ( Table 1).

Table 1.  . Demographic details/dyspepsia history/baseline symptoms Thumbnail image of

Relief of dyspepsia symptoms

After 16 weeks of treatment, a greater proportion of patients receiving the omeprazole treatment strategy, 61%, compared to the antacid–alginate/ranitidine group, 40%, had achieved complete relief of dyspepsia symptoms (PP analysis 74 vs. 48%, < 0.0001). Looking at sufficient relief of dyspepsia symptoms, the percentage of patients was again higher in the omeprazole group, compared to the antacid–alginate/ranitidine group at 16 weeks (70 vs. 51% for the APT analysis and 81 vs. 60% for the PP, < 0.0001) ( Figure 1).

image

Figure 1. Proportion of patients with complete and sufficient symptom relief at 16 weeks (APT: all-patients-treated, n = 703; PP: per protocol, n = 413). Complete symptom relief was defined as the patient reporting the severity of dyspepsia symptoms as ‘none’ and the frequency of symptoms as ‘0–1 day’ in the last 7 days. Sufficient symptom relief was defined as the patient reporting the severity of dyspepsia symptoms as ‘none’ or ‘mild’ and the frequency of symptoms as ‘0–1. day’ in the last 7 days.

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At entry into the study the most common dyspepsia symptoms were heartburn and epigastric pain, experienced by more than 93% and 77% of patients, respectively, in both treatment groups. The omeprazole treatment strategy was better than the antacid–alginate/ranitidine treatment strategy in providing relief of heartburn and epigastric pain at 4, 8 and 16 weeks ( Table 2). In particular, 62% (207/332) of the patients in the omeprazole treatment group were free from heartburn following 4 weeks of treatment, compared to 36% (121/335) of patients in the antacid–alginate/ranitidine treatment group (P = 0.0001). Similarly after the full 16 weeks of treatment, only 60% (162/269) of patients in the antacid–alginate/ranitidine treatment group were free from heartburn, compared to 81% (237/291) in the omeprazole treatment group (= 0.0001). Looking specifically at epigastric pain, 67% (224/332) of patients in the omeprazole treatment group were free from epigastric pain following 4 weeks of treatment compared to 53% (177/335) of patients in the antacid–alginate/ranitidine treatment group (P = 0.001). Again after 16 weeks of treatment, only 75% (203/269) of patients in the antacid–alginate/ranitidine treatment group compared to 86% (251/291) in the omeprazole treatment group were free from epigastric pain (P = 0.001).

Table 2.  . Severity of heartburn and epigastric pain at entry, 4 and 16 weeks; all-patients-treated (APT) Thumbnail image of

Number of treatment levels

Patients in the omeprazole treatment group required fewer treatment steps or dosage increases to achieve symptom relief than patients in the antacid–alginate/ranitidine treatment group. Forty-six per cent of the omeprazole-treated patients compared to 17% of the antacid–alginate/ranitidine-treated patients achieved symptom relief on level 1 (P = 0.0001). The number of patients who achieved complete symptom relief at each of the treatment levels is presented in Table 3.

Table 3.  . Percentage of patients with complete symptom relief at each treatment step, all-patients-treated (APT) = 0.0001 Thumbnail image of

Endoscopic examination

At study completion, 40 patients, having fulfilled the qualifying criteria, attended for endoscopy. Fourteen patients in this group had been treated with omeprazole compared with 26 patients treated with the antacid–alginate/ranitidine strategy.

Following endoscopy of these 40 patients, 15 had normal findings, the remaining 25 (7 omeprazole, 18 antacid–alginate/ranitidine) displayed a mixture of reflux oesophagitis, hiatus hernia, duodenitis and gastritis.

Treatment assessment

The patients’ assessment of omeprazole treatment was better than that of antacid–alginate/ranitidine treatment at 16 weeks (P = 0.0001). Sixty-three per cent (182/289) of the omeprazole-treated patients stated that omeprazole had completely relieved their symptoms, compared to 35% (93/269) of the antacid–alginate/ranitidine-treated patients ( Figure 2). Examination of the 12–16 week data shows that for patients who reached this final stage in the study, 23% (69/298) required the maximum dose of omeprazole compared to 56% (152/270) requiring the maximum dose in the antacid–alginate/ranitidine strategy (< 0.0001) ( Figure 3).

image

Figure 2. . Patients’ assessment of effectiveness of treatment at 16 weeks, APT.

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image

Figure 3. . Proportion of patients on each treatment level by visit interval, all-patients-treated (APT): (a) omeprazole 10 mg, 20 mg and 40 mg, (b) antacid–alginate 10 mL q.d.s., ranitidine 150 mg b.d. and ranitidine 150 mg q.d.s.

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At the 16-week assessment, when patients were asked to rate the convenience of their current treatment, 84% (243/289) of the omeprazole patients reported they found the treatment very convenient compared to 43% (117/269) of the antacid–alginate/ranitidine-treated patients (P = 0.0001).

Compliance with study medication

Patient compliance with study medication, calculated from returned liquid or tablet counts, was higher for the omeprazole treatment group compared to the antacid–alginate/ranitidine treatment group, 95 vs. 88% (P = 0.0001).

Withdrawals and adverse events

A total of 166 patients discontinued the study before the final 16-week clinic visit (74 omeprazole, 92 antacid–alginate/ranitidine). Fifty-eight of these patients withdrew due to an adverse event, 32 whilst receiving omeprazole and 26 whilst receiving antacid–alginate/ranitidine, and 25 due to worsening symptoms, eight whilst receiving omeprazole and 17 whilst receiving antacid–alginate/ranitidine. The remainder were largely withdrawn due to non-compliance with the protocol or study schedule.

A total of 1345 adverse events was reported, 662 of these from 267 patients receiving omeprazole and 683 from 259 patients receiving antacid–alginate/ranitidine. The most commonly reported adverse event was headache for both patient groups (59 omeprazole, 55 antacid–alginate/ranitidine).

Twelve serious adverse events were reported throughout the entire study, 10 in the omeprazole group and two in the antacid–alginate/ranitidine group. None of the serious adverse events was considered to be causally related to the study treatment.

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. References

Dyspepsia is a common problem encountered in general practice and the ideal treatment should quickly and conveniently alleviate patient symptoms. This study demonstrates that an omeprazole clinical management strategy is more effective in reducing the symptoms of acid-related dyspepsia in a general practice population than an antacid–alginate/ranitidine clinical management strategy.

Dyspepsia manifests itself as a variety of abdominal symptoms and generally includes heartburn and/or epigastric pain. A higher proportion of patients in this study population reported each of these individual symptoms than in previous work.1 Additionally, a higher proportion of patients reported overlap of symptoms with experience of both.1 It has been assumed that since elevated reporting was observed across several individual symptom criteria that this was a normal dyspepsia patient population but that symptoms were more prolific than in previous studies.

The definition of symptomatic success is extremely important when evaluating and comparing clinical trial data. The target of complete symptom relief set for this study was very stringent and should be taken into account when examining the results. The less demanding and more attainable target of sufficient symptom relief may be more comparable with definitions used by other researchers and was included for reference purposes. Nevertheless, despite a demanding treatment goal, higher levels of omeprazole-treated patients than antacid–alginate/ranitidine-treated patients achieved complete symptom relief after 16 weeks (61 vs. 40%, < 0.0001). Furthermore, approximately half, 51%, of the patients in the antacid–alginate/ranitidine treatment arm achieved sufficient symptom relief, which is less than the proportion of patients who achieved complete symptom relief with omeprazole. This demonstrates the superior efficacy of the omeprazole regimen.

Important considerations for the patient, the physician and the healthcare purchaser are the number and frequency of prescriptions and consultations. The latest dyspepsia management guidelines by the British Society of Gastroenterology, published in 1996 after this study was completed, recommend titrated therapy and are consistent with the design of the present study. This is the first comparative omeprazole clinical management strategy study conducted in general practice, and a higher proportion of omeprazole patients required fewer treatment steps to achieve symptom relief. Over double the number of patients treated with omeprazole compared to antacid–alginate achieved symptom relief on the first treatment level (46 vs. 17%). In addition, more than half the antacid–alginate/ranitidine patients, 56%, remained symptomatic on the second treatment level (ranitidine 150 mg b.d.) and required the maximum level (150 mg q.d.s.) prior to study completion or withdrawal. Since patients generally return to their general practitioner if relief of symptoms is not achieved, a 4-week course of omeprazole 10 mg will reduce the overall number of consultations required vs. antacid–alginate, because more than double the number of patients will be rendered asymptomatic following the first consultation and prescription. Patients prescribed antacid–alginate will be more likely to remain symptomatic and return for a second consultation and prescription (83%), and over half will return again for a third consultation and prescription. This confirms the findings of an earlier study which showed omeprazole 10 mg daily to be more than twice as effective as antacid–alginate liquid 10 mL q.d.s.19

Clearly, a clinical management strategy which achieves symptom relief rapidly with few changes in medication is likely to be more acceptable and less time-consuming to both the doctor and the patient. The omeprazole clinical management strategy documented in this study appears to meet these criteria.

In addition to superior efficacy, patient preference of medication may result in an overall improvement in compliance, thus avoiding unnecessary treatment failures and reducing consultation rates. It was demonstrated that the omeprazole treatment strategy made the patient feel better and was more convenient than the antacid–alginate/ranitidine treatment strategy.

The BSG Dyspepsia Management Guidelines recommend further investigation in this patient population only if the presence of Helicobacter pylori has been identified and dyspepsia symptoms persist. After 16 weeks of treatment, patients who had shown little or no improvement and were still experiencing dyspepsia symptoms, were offered endoscopic investigation. The omeprazole treatment group presented fewer treatment failures than the antacid–alginate ranitidine treatment group (4 vs. 7%) and this again highlighted the higher success rate afforded by the omeprazole treatment strategy.

In summary, this study indicates that an omeprazole clinical management strategy is more effective than an antacid–alginate/ranitidine management strategy in providing relief of acid-related dyspepsia symptoms in a general practice population. It is more convenient and preferred by patients, and ultimately may result in fewer return consultations, than the antacid–alginate/ranitidine clinical management strategy.

ACKNOWLEDGEMENTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. References

The following general practitioners also contributed to the study: Dr W. D. Carr, Dr R. J. Scott, Dr A. J. Dawson, Dr J. P. Vernon, Dr W. R. C. Aitchison, Dr G. I. McLaren, Dr J. S. Hutchison, Dr C. McKinnon, Dr P. S. Wiggins, Dr S. B. Imam, Dr D. Kerr, Dr E. Wilson, Dr D. A. Black, Dr T. McConnell, Dr M. Choudhury, Dr S. K. Patel, Dr F. Costello, Dr G. M. Firth, Dr J. Levine, Dr S. D. Gunn, Dr G. Shaw, Dr M. Addlestone, Dr A. C. Patel, Dr N. H. Patel, Dr S. Chatterjee, Dr M. Glazier, Dr M. Stapleton, Dr M. F. McGhee, Dr J. K. Oldring, Dr T. N. Gooding, Dr D. A. Weston, Dr S. K. Jain, Dr M. J. Camm, Dr J. B. Collier, Dr P. J. Ingham, Dr R. D. P. Newland, Dr P. Goodson, Dr D. Sweeney, Dr S. W. Thomas, Dr H. L. Thomas, Dr J. A. Chapman, Dr T. J. Harris, Dr M. B. Jackson, Dr S. J. Cooper, Dr A. Middleton, Dr A. Dun, Dr J. G. Hole, Dr V. C. Catt, Dr N. A. Gough, Dr A. S. Cowie, Dr M. J. B. Duckworth, Dr R. L. Kneebone, Dr A. B. Berger, Dr M. A. H. Cohen, Dr N. D. Kennedy, Dr W. I. C. Clark, Dr A. M. George, Dr T. P. Rees, Dr A. R. Kemp, Dr J. Mounty, Dr I. I. Adoki and Dr P. Shepherd.

Emma Beresford analysed the study.

Financial support for this study was provided by Astra Pharmaceuticals Ltd.

References

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. References
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