Published 15 December 2008, doi:10.1136/bmj.a2747
Cite this as: BMJ 2008;337:a2747

Research

Commentary: Randomised trials of surgical and non-surgical treatment: a role model for the future

¹ Department of Social Medicine, University of Bristol, Bristol BS9 2PS, ² Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW

Research, doi: 10.1136/bmj.a2664

Symptoms of acid reflux and heartburn are increasingly common, and doctors need to understand the benefits and risks of surgical and medical treatment from the patients’ perspective when offering treatment. Obtaining reliable information from randomised controlled trials to fully inform patients is difficult, however, because of the many recognised obstacles to undertaking such trials of diverse treatments, including difficulties with recruitment and standardising treatments and the inability to provide blinding. In the linked study (doi:10.1136/bmj.a2664), Grant et al carried out a multicentre pragmatic randomised trial of minimal access surgery (laparoscopic fundoplication) compared with optimised medical management (standard proton pump inhibition) for chronic gastro-oesophageal reflux disease (GORD).¹ The results were clear: up to 12 months after starting treatment, surgery was more effective than medical treatment at relieving symptoms related to reflux and improving general health.

This is an excellent model of how to design and conduct a robust and pragmatic randomised trial within the complexity of the NHS.¹ For example, the comprehensive cohort design—including eligible participants who chose their treatment as well as those randomised—ensured a large and wide ranging group of participants and analyses were performed by intention to treat, per protocol, and preference groups. To facilitate participation of clinicians and centres, clinical judgment was permitted in relation to inclusion and exclusion criteria and the type of surgical procedure or best medical management. The design was flexible, the sample size large enough to cope with variable organisational delays in surgery, and patients could decide to defer or decline their allocated or chosen treatment. Outcome was assessed with a validated patient reported outcome measure of symptoms and health, rather than outcomes measured and interpreted by an observer.^{2 3} All these factors ensure that the findings are relevant to patients and clinicians by reflecting real world experiences of clinical practice.

By 12 months, patients randomised to surgery reported better outcomes than patients randomised to medical management, and in all analyses patients undergoing fundoplication reported fewer symptoms of general discomfort, wind, nausea, and vomiting and less limitation in activity than the medical group. Dysphagia scores were similar in both groups. The use of antireflux medication after 12 months was 38% in those randomised to surgery (14% among those who had fundoplication) compared with 90% of medical participants.

Although these robust results support the use of laparoscopic surgery for the control of acid reflux in the short term, there are three further issues that might affect whether patients opt for surgery in future. The study followed up participants for 12 months, but longer term outcomes will be needed. Whether surgery is cost effective will be critical to providers of health care. Surgical complications were rare, but wide confidence intervals mean uncertainty about the true magnitude of risk, and other studies have shown that, when experienced, complications from surgery can be severe. Even with these robust results, patients and clinicians will still need to weigh up the clear symptomatic benefit likely to result from fundoplication with the (albeit rare) risk of complication and unknown longer term outcome.

Cite this as: BMJ 2008;337:a2747

Research, doi: 10.1136/bmj.a2664

---

Competing interests: JMB is an upper GI surgeon who does not undertake laparoscopic fundoplication. CPB is an upper GI surgeon who regularly undertakes laparoscopic fundoplication. Both authors have gastro-oesophageal reflux but neither has had surgery. CPB has received payments from Ethicon Endo-Surgery for organising educational training sessions in minimally invasive oesophagectomy.

Provenance and peer review: Commissioned; not externally peer reviewed.

References

1. Grant AM, Wileman SM, Ramsay CR, Mowat A, Krukowski ZH, Heading RC, et al.Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial. BMJ 2008;337:a2664.[Abstract/Free Full Text]
2. US Food and Drug Administration. Guidance for industry. Patient reported outcome measures: use in medical product development to support labelling claims. 2006. www.fda.gov/cber/gdlns/prolbl.htm.
3. Macran S, Wileman S, Barton G, Russell I. The development of a new measure of quality of life in the management of gastro-oesophageal reflux disease: the Reflux questionnaire. Qual Life Res 2007;16:331-43.[CrossRef][Web of Science][Medline]

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    StumbleUpon    Technorati    What's this?

Relevant Articles

Laparoscopic fundoplication compared with medical management for gastro-oesophageal reflux disease: cost effectiveness study

David Epstein, Laura Bojke, Mark J Sculpher, and The REFLUX trial group
BMJ 2009 339: b2576. [Abstract] [Full Text] [PDF]

Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial

Adrian M Grant, Samantha M Wileman, Craig R Ramsay, N Ashley Mowat, Zygmunt H Krukowski, Robert C Heading, Mark R Thursz, Marion K Campbell and the REFLUX Trial Group
BMJ 2008 337: a2664. [Abstract] [Full Text] [PDF]

This article has been cited by other articles:

• Epstein, D., Bojke, L., Sculpher, M. J, The REFLUX trial group, (2009). Laparoscopic fundoplication compared with medical management for gastro-oesophageal reflux disease: cost effectiveness study. BMJ 339: b2576-b2576 [Abstract] [Full text]  

Online poll

Find out more here>> and here>>