Observations Medicine and the Media

Antibiotics for back pain: hope or hype?

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3122 (Published 14 May 2013) Cite this as: BMJ 2013;346:f3122
  1. Margaret McCartney, general practitioner, Glasgow
  1. margaret{at}margaretmccartney.com

The media went crazy for a recent research paper that showed some benefit in long term antibiotic use for some patients with back pain. But was this science or sensationalism, is talk of a Nobel prize premature, and what of the author’s potential conflicts of interest? Margaret McCartney investigates

“Up to 40% of patients with chronic back pain could be cured with a course of antibiotics rather than surgery, in a medical breakthrough,” began a story in the Guardian on 7 May. It continued, “One of the UK’s most eminent spinal surgeons said the discovery was the greatest he had witnessed in his professional life, and that its impact on medicine was worthy of a Nobel prize.”1

This surgeon, Peter Hamlyn, was also quoted in the Daily Mail as saying, “more work needs to be done but make no mistake, this is a turning point, a point where we will have to rewrite the textbooks.”2 The Guardian hosted a live webchat with Hanne Albert, the Danish researcher who made the discovery, and Hamlyn.3 The excitement was picked up by the global media.

Sky television featured a patient who said that antibiotics had cured her back pain. Albert was described by the presenter as “having to endure the ridicule of sceptical colleagues” before she described how, for a subgroup of people with back pain, antibiotics could “give them a happy life again.”4

A public relations company held a press conference to publicise the research on 7 May at the Royal Society of Medicine in London. The invitation said that the research paper was being “published in a pre-eminent medical journal on May 7th”: though it was published online in February in the European Spine Journal.5

The invitation to members of the press began, “Announcement of breakthrough medical cure for the cause of one of the world’s most debilitating diseases.” And it described the research as a “world exclusive” with outcomes that were “a highly effective treatment and cure” that would reduce the economic damage of back pain: “patients will be relieved of their pain and able to return to their daily work and lives.”

The research study was registered at clinicaltrials.gov in March 2006. The primary completion date was October 2009.6 It was a randomised double blind controlled trial of 162 patients with a history of at least six months of low back pain and previous disc herniation that was visible with magnetic resonance imaging (MRI). In all, 347 patients meeting these criteria had a repeat MRI scan. Of these, 178 were excluded because they had no new modic changes or only type 2 modic changes, and seven chose not to take part (modic changes are changes in MRI signals in bone that have been used in research to investigate back pain, though their clinical meaning is not fully understood7).

The participants were randomised to 100 days of co-amoxiclav or placebo, with follow-up at 100 days and then after a year.5 The patients in the antibiotic group reported statistically significant reductions in night pain, intensity of pain, and pain during flexion and extension of the spine. There was a reduction of 55.8% in the number of patients complaining of constant pain in the antibiotic group, compared with 5.9% in the placebo group. However, at recruitment the two groups differed substantially in distribution of the size of modic changes up to baseline.

The researcher and trained physiotherapist Neil O’Connell blogged about the paper on 22 March to point out that the lack of response to placebo after one year was unusual.8 However, after 100 days of treatment or placebo, patients in both groups reported similar reductions in hours of pain. But after a year, patients in the placebo group reported more hours of pain compared with patients in the intervention group. Yet the difference in reduction in time off work was not statistically significant after a year. So can we be certain of the size and type of treatment effect?

This is not the first study to investigate the potential of treating some chronic low back pain with antibiotics. In 2001 the Lancet published a research letter mooting the possibility of an association between bacteria and sciatica.9 Other studies have failed to find bacteria in biopsy material taken from the lumbar spine—for example, in a paper published in 2009.10 Albert and colleagues published an uncontrolled pilot study of antibiotics in low back pain in 2008.11

A few news reports urged caution. The Canadian Globe and Mail quoted a physician who said that there were “dozens of causes of back pain” that would not respond to antibiotics.12 The Independent reported from the press conference: “The examination can only be carried out by a practitioner trained to recognise the changes and distinguish pain caused by infection from that due to other causes.”13

It also reported that the launch had been organised for Hamlyn, director of a private clinic, and that he and Albert had set up a website “to promote the therapy known as MAST—Modic Antibiotic Spinal Therapy,” a fact missing from many reports. Indeed, the website, which was referred to by Albert in the Guardian webchat and was registered by her in February of this year,14 says that “only careful scrutiny” can identify patients who will benefit from treatment; that “possible side effects” need care because of the “complicated disease process”; and that a “MAST certified doctor and/or therapist will ensure that optimal results are obtained and can transform you [sic] life into a relatively pain free status.”

Hamlyn is a doctor at the only UK centre listed. An advantage of becoming a “MAST certified doctor” is a listing on its homepage; the cost of the course is £200, and two retakes in the exam are allowed before reapplying a minimum of three weeks later. The training and multiple choice test can be taken online.

Could the potential for financial reward in the build up of this network of clinics represent a conflict of interest? Albert told the BMJ that she didn’t believe so because the research had been completed well before the website was launched. She said, “I think I should be praised for doing this. Most researchers sit in an ivory tower—I spend time and energy in how to engage clinical staff in spreading the knowledge, and make sure that antibiotics are not given to the wrong patients.”

She agreed that replication studies should be done but did not agree that it was too early to launch the training website. “The alternative is tonnes of painkillers, a disability pension, and no life,” she said.

These findings are interesting and merit large scale, well designed trials. But the theory of microbes causing back pain is not new, and the hype created by a public relations company for a paper already published and yet to be replicated is remarkable. Setting up an academy to teach, examine, and certify practitioners seems premature.

Martin Underwood, professor of primary care research at Warwick Medical School and who has chaired National Institute for Health Care Excellence (NICE) guidelines on low back pain, told the BMJ, “These are promising preliminary findings, but it is too soon to start changing practice on their basis until they have been replicated in other studies and in other populations.” He went on, “These findings are only relevant to a small minority of people with chronic back pain who have both degenerative changes and evidence of modic changes.”

Albert confirmed to the BMJ the difficulty in getting the study published. Hamlyn told the Independent that this was down to “a number of professional rivalries—dark forces.” Perhaps this should also include potential commercial conflicts of interest.

Notes

Cite this as: BMJ 2013;346:f3122

Footnotes

  • Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.

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

References