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January 11, 2003 COCHRANE OVERVIEW RELEASE  * POWER TOOTHBRUSH RELEASE  *  FLUORIDE TOOTHPASTE RELEASE
January 21, 2003 COCHRANE CHALLENGES MANUFACTURERS : RELEASE  * STATEMENT
 

COCHRANE STATEMENT 1-21-03
  Contact: Anita Harris US harriscom@attbi.com
                 Luisa Fernandez, UK
Luisa.fernandez@man.ac.uk 011-44-1612757818

STATEMENT OF THE COCHRANE ORAL HEALTH GROUP ON POWER TOOTHBRUSH CLAIMS AND THE QUALITY OF MEDICAL EVIDENCE

January 21, 2003
It is interesting that the Royal Philips Electronics, the makers of Sonicare toothbrushes have criticised us for including older trials of side-to-side action toothbrushes. Ironically as Fig. 1 in our report shows (www.update-software.com/cochrane/abstracts), the oldest trial of side-to-side toothbrushes (published in 1964 by Lobene) was actually more favourable than most of the more recent trials!

When we excluded studies published prior to 1990, the results failed to detect any benefit of powered toothbrushes with a side-to-side action on plaque or gingivitis when compared with manual toothbrushes. In technical language, when all identified studies of Sonicare after 1990 were combined, plaque scores at 1-3 months at all sites showed a standardised mean difference (SMD) of -0.68 (95% confidence intervals (CI): -1.63, 0.27). The SMD for gingival scores at 1-3 months was -0.47 (95%CI: -1.03, 0.09). No long-term data were available on these brushes. (The Cochrane data are available at http://www.cochrane-oral.man.ac.uk).

Systematic reviews, such as those prepared in the Cochrane Collaboration, seek to bring together all the relevant research evidence in order to be as reliable as possible. They do not rely on the selective highlighting of just one or two research studies or the experiences of individuals. The review allows people to consider all of the relevant evidence, not just parts of it.

Yet our findings were not entirely negative for Royal Philips Electronics as their Philip Jordan HP735 was one of several of the rotation-oscillation brushes included in our review, a group whose action appeared to be superior.

Be that as it may, the 7 percent and 17 percent reductions of plaque and gingivitis we found for brushes in this group, may still be of borderline benefit for dental health. The American Dental Association recommends that only oral care products that can prove a 20% improvement may publish a claim for superiority over other products. (Imrey et al., 1994).

Fundamentally, our report highlights the poor quality of the toothbrush trials upon which every company’s marketing claims are based. Despite this being a multimillion dollar industry:

  1. No trial was of sufficient duration to allow the long term value of powered toothbrushes to be assessed.
  2. Even recent trials did not adhere to modern reporting standards such as the CONSORT guidelines (http://www.consort-statement.org)
  3. Companies have not agreed a collective policy on measuring outcome that would enable different studies to be compared. (It may even be supposed that some researchers had no intention of comparing results).
  4. There is no way of telling whether companies have suppressed negative trials that they may have conducted – a situation that will only be resolved when all trials are publicly registered at the outset, just as some forward looking pharmaceutical companies now do.

Regrettably, these same shortcomings affect the majority of research on medical devices, treatments, and medicines. It was for this reason that the Cochrane Collaboration was established in 1992, as part of the movement towards evidence based medicine. By producing and disseminating systematic reviews of the evidence, it aims to allow doctors, patients, third party agencies and governments to make well informed choices about healthcare.

Undoubtedly there will be other observations on this report and these will be welcomed. Part of the living nature of Cochrane reviews is that people can submit comments which will be considered when the review is updated and will be published alongside it in the future alongside. If new studies are done which might be relevant to the review, these will be assessed and, if relevant, included in the review when it is updated in two years time.

"The Cochrane Oral Health Group has more than 100 reviews in the pipeline," Shaw said. The first 29 completed ones cover diverse topics including orthodontic treatment, treatment of decay in primary teeth, fluoride varnish, dental implants, dentine sensitivity, treatment of temporomandibular joint problems, treatment of pre-cancerous conditions, and the oral care of children receiving cancer treatment. "For 27 of these, our reviewers found that the evidence upon which dentist round the world rely to make many important everyday decisions was weak and unreliable."

Lobene RR. The effect of an automatic toothbrush on gingival health. Journal of Periodontology 1964;35:137-9

Imrey PB, Chilton NW, Pihlstrom HW. Recommended revisions to American Dental Association guidelines for acceptance of chemotherapeutic products for gingivitis control. Journal of Periodontal Research 1994;29:299-304

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For more information contact: Professor Bill Shaw c/o Luisa Fernandez, Univeristy of Manchester Luisa.fernandez@man.ac.uk 011-44-1612757818, or c/o Anita Harris 617-354-0531 anitaharris@attbi.com.

The Cochrane Collaboration (www.cochrane.org) is an international nonprofit organization whose goal is to help consumers and clinicians make well-informed decisions about healthcare by preparing, maintaining and promoting accessibility of systematic reviews on the effects of healthcare interventions. The Collaboration comprises 49 topic-based collaborative review groups and 8000 contributors in more than 70 countries around the world. The Cochrane Collaboration’s US headquarters are located at Brown University, in Providence, Rhode Island with branches in Boston and San Francisco. The Cochrane Collaboration also has Centers in Australia, Brazil, Canada, China, South Africa, Holland, Germany, Italy, Spain, Norway, and the UK.

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NOTE TO JOURNALISTS:  For copies of the review go to http://www.update-software.com/cochrane/abstract.htm

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