Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial

Per G Farup, Mathis Heibert, Victor Høeg, Per G Farup, Mathis Heibert, Victor Høeg

Abstract

Background: Alternative treatments are commonly used for various disorders and often taken on-demand. On-demand treatment of gastroesophageal reflux disease (GERD) with pharmaceutical products is an established, cost-effective strategy. Comparisons between alternative medicine and pharmaceutical products are rare. The aim of this trial was to compare on-demand treatment with a pectin-based, raft-forming, natural, anti-reflux agent (PRA) with that of esomeprazole 20 mg (Eso20) in patients with mild/moderate GERD.

Methods: Patients with mild/moderate GERD were randomised to a six weeks' on-demand treatment with PRA or Eso20 in a pragmatic, open, multicentre trial. Overall satisfaction with treatment, satisfactory relief on a weekly basis, reflux symptoms, and treatment preferences were noted.

Results: Seventy-seven patients were included in the analyses. Eso20 was significantly superior to PRA for proportion of overall satisfied patients (92% and 58% respectively; p = 0.001), reduction of symptoms (mean symptom scores at the end 5.9 and 8.0 respectively; p = 0.019), proportion of weeks of satisfactory relief (89% and 62% respectively; p = 0.008) and proportion preferring continuation with the same treatment (85% and 42% respectively; p < 0.001). Older patients were more satisfied than younger, and patients preferring on-demand treatment had lower symptom scores at inclusion than those preferring regular treatment.

Conclusion: On-demand treatment with esomeprazole 20 mg was clearly superior to the pectin-based raft-forming agent. Most patients preferred on-demand treatment to regular treatment. Those preferring regular therapy had significantly more symptoms at inclusion.

Trial registration: ClinicalTrials.gov NCT00184522.

Figures

Figure 1
Figure 1
The figure shows the flow of patients through the trial. (Eso20 = Esomeprazole 20; PRA = Pectin-based, raft-forming agent; ITT = Intention to treat; PP = Per protocol).
Figure 2
Figure 2
The box plot shows the reflux symptom scores (10th, 25th, 50th, 75th and 90th percentiles and outlying values) at the end of the study related to treatment group, overall satisfaction and preference for regular treatment. (Eso20 = Esomeprazole 20 mg; PRA = Pectin-based, raft-forming agent).

References

    1. Pace F, Tonini M, Pallotta S, Molteni P, Porro GB. Systematic review: maintenance treatment of gastro-oesophageal reflux disease with proton pump inhibitors taken 'on-demand'. Aliment Pharmacol Ther. 2007;26:195–204.
    1. Bardhan KD. Intermittent and on-demand use of proton pump inhibitors in the management of symptomatic gastroesophageal reflux disease. Am J Gastroenterol. 2003;98:S40–S48. doi: 10.1016/S0002-9270(03)00014-5.
    1. Jones R, Bytzer P. Acid suppression in the management of gastro-oesophageal reflux disease- an appraisal of treatment options in primary care. Aliment Pharmacol Ther. 2001;15:765–772. doi: 10.1046/j.1365-2036.2001.00985.x.
    1. Gerson LB, Robbins AS, Garber A, Hornberger J, Triadafilopoulos G. A cost-effectiveness analysis of prescribing strategies in the management of gastroesophageal reflux disease. Am J Gastroenterol. 2000;95:395–407. doi: 10.1111/j.1572-0241.2000.01759.x.
    1. Zacny J, Zamakhshary M, Sketris I, Veldhuyzen van Zanten S. Systematic review: the efficacy of intermittent and on-demand therapy with histamine H2-receptor antagonists or proton pump inhibitors for gastro-oesophageal reflux disease patients. Aliment Pharmacol Ther. 2005;21:1299–1312. doi: 10.1111/j.1365-2036.2005.02490.x.
    1. Hungin AP, Rubin G, O'Flanagan H. Factors influencing compliance in long-term proton pump inhibitor therapy in general practice. Br J Gen Pract. 1999;49:463–464.
    1. Van Soest EM, Siersema PD, Dieleman JP, Sturkenboom MCJM, Kuipers EJ. Persistence and adherence to proton pump inhibitors in daily clinical practice. Aliment Pharmacol Ther. 2006;24:377–385. doi: 10.1111/j.1365-2036.2006.02982.x.
    1. Norman Hansen A, Bergheim R, Fagertun H, Lund H, Moum B. A randomised prospective study comparing the effectiveness of esomeprazole treatment strategies in clinical practice for 6 months in the management of patients with symptoms of gastroesophageal reflux disease. Int J Clin Pract. 2005;59:665–671. doi: 10.1111/j.1368-5031.2005.00564.x.
    1. Havelund T, Aalykke C, Rasmussen L. Efficacy of a pectin-based anti-reflux agent on acid reflux and recurrence of symptom and oesophagitis in gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol. 1997;9:509–514.
    1. Washington N, Wilson CG, Greaves JL, Danneskiold-Samsøe P. An Investigation into the Floating Behaviour of a Pectin-Containing Anti-Reflux Formulation (FF5005) by Means of Gamma Scintigraphy. Scand J Gastroenterol. 1988;23:920–924. doi: 10.3109/00365528809090147.
    1. Havelund T, Aalykke C. The Efficacy of a Pectin-Based Raft-Forming Anti Reflux Agent in Endoscopy-Negative Reflux Disease. Scand J Gastroenterol. 1997;32:773–777. doi: 10.3109/00365529708996533.
    1. Waterhouse ET, Washington C, Washington N. An investigation into the efficacy of the pectin based anti-reflux formulation-Aflurax. Int J Pharm. 2000;209:79–85. doi: 10.1016/S0378-5173(00)00556-1.
    1. Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998;7:75–83. doi: 10.1023/A:1008841022998.
    1. Hayden CW, Bernstein CN, Hall RA, Vakil N, Garewal HS, Fass R. Usage of supplemental alternative medicine by community-based patients with gastroesophageal reflux disease (GERD) Dig Dis Sci. 2002;47:1–8. doi: 10.1023/A:1013264730992.
    1. Dettmar PW, Sykes J, Little SL, Bryan J. Rapid onset of effect of sodium alginate on gastro-oesophageal reflux compared with ranitidine and omeprazole, and relationship between symptoms and reflux episodes. Int J Clin Pract. 2006;60:275–283. doi: 10.1111/j.1368-5031.2006.00800.x.
    1. Bytzer P. On-demand therapy for gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol. 2001;13:s19–s22.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj