OSTEOPOD

Hokum Potion

I was having a bath this evening and came across this article in The Guardian:

http://www.guardian.co.uk/lifeandstyle/2009/oct/06/probiotic-eu-ruling

It’s worth a read because it highlights the investigation by the European Food Safety Authority (EFSA) into health claims made by various food products which are marketed as being beneficial for health. Of note was the lack of evidence for probiotic drinks being beneficial for the immune system (goodbye Yakult?) and of particular interest to us osteopaths; the lack of evidence for Glucosoamine benefiting joints. This latter point made me drop my soap as I’ve often recommended Glucosamine to OA sufferers, thinking that it does what it says on the tin. Does the tin lie? Can it be true that its yet more smoke and mirrors and we’re getting hoodwinked by advertising hokum?

Well i didnt have to dig too deeply to find the source of The Guardian article:

http://209.85.229.132/search?q=cache%3AjS_Nqco4UA0J%3Awww.efsa.europa.eu%2FEFSA%

2FScientific_Opinion%2Fnda_op_ej1264_art13

Its a rather repetitive piece obviously written to some kind of specific, medical report template, but I’ll highlight the important bits:

A total of 11 human intervention studies (plus one sub-analysis of one of the interventions and one combination of two of the studies), three meta-analyses including most of the individual studies, 21 reviews and background papers, 2 animal studies, one in vitro study, one short report, and one case report were provided for the substantiation of the claimed effect.

No dietary requirement for the maintenance of the structure (e.g. of cartilage or other connective tissues) or function (e.g. maintenance of flexibility or mobility of the joints) of the joints in healthy humans has been demonstrated by the evidence provided.

A cause and effect relationship has not been established between the consumption of glucosamine (either as glucosamine hydrochloride or as glucosamine sulphate), either alone or in combination with chondroitin sulphate, and the maintenance of normal joints.

A cause and effect relationship has not been established between the dietary intake of glucosamine sulphate and reduction of inflammation in the general population.

So there it is. There’s no evidence that glucosamine makes any difference to maintenance  of normal joints, nor to reduced inflammation. Since much of the marketing of the products containing glucosamine make these claims it does seem that the evidence isn’t in place to back up the sales pitch.  It’s worth noting that all of the research reviewed in the EFSA document was on osteoarthritis (OA) and not on healthy/normal joints. EFSA state that OA does not represent the state of most peoples joints and is therefore unrepresentative of the general public. Without reading these original trials myself I’m not sure whether glucosamine is beneficial for OA since the EFSA document doesn’t say. This is work for another day. Whether glucosamine is effective in helping OA or not, it appears to make no difference in preventing normal joints degenerating.

Food for thought at least.

Pills, Thrills and Back Ache

Having recently stumbled upon a discussion on a “quackbusting” website mocking chiropractic’s warning about NSAID use due to the associated dangers, it reminded me of a piece i wrote a while back comparing the evidence for NSAID use and spinal manipulation for low back pain. Below is the section on systematic reviews:

None of these systematic reviews looked exclusively at direct comparisons of spinal manipulation and NSAID use in the treatment of back pain. Instead they compared a range of treatment modalities including, manipulation and NSAIDs, in the treatment of back pain.

Ferriera et al (2002) is a broad systematic review of RCTs, looking at the efficacy of spinal manipulation compared to many other treatment methods for chronic low back pain (LBP>3 months). “Spinal manipulation”, in this trial, included a broad range of techniques, not only HVLA thrusts. The review’s aims were clearly stated and the search methods were rigorously applied. 2 independent reviewers screened and selected the trials to be included. The PEDro (1999) scale was used to assess trial quality, with those scoring less than 3 out of 10 excluded.

The main results were that; no significant difference was found when comparing spinal manipulation to NSAIDs in the treatment of chronic low back pain. A 95% confidence interval was calculated for between-group differences to determine the treatment effect for each outcome. A relative risk of 0.7 or less was stated to be clinically significant. This was a good quality review although the literature directly comparing manipulation and NSAIDs to each other was very limited (Bronfort et al 1996; Giles & Muller 1999). Only 8 out of 117 RCTs were included which limits the scope of the review and only 5 trials scored more than 5 out of 10 on the PEDro scale with the Giles & Muller (1999) trial scoring only 4.

A systematic review by Van Tulder et al (1997) and a more recent systematic review, of systematic reviews, by the same authors (Van Tulder et al 2005) looked at the effectiveness of the most common types of treatment for patients with non-specific low back pain (LBP). These included patients with acute (<6weeks) and chronic (>12 weeks) LBP and studies involving at least one of several other treatment interventions, as well as placebo and sham treatment comparisons. These were much larger systematic reviews than the Ferriera et al (2002) trial, including 150 RCTs in the Van Tulder et al (1997) review. Both reviews had clearly expressed aims, and rigorously applied search methods. In the Van Tulder et al (1997) trial, 2 independent reviewers assessed each study, out of 100, based on previously accepted criteria. A study was judged to be of high quality if it scored more than 50 points. Only 59% of the RCTs were found to be of high quality. Two independent reviewers in the Van Tulder et al (2005) review assessed trial quality using the Cochrane Back Review Group (CBRG) criteria. A trial was judged to be of high quality if it scored 6 points or more out of 11 on the CBRG scale.

There was no discussion about the self-limiting nature of acute LBP, in these studies, and the clinical relevance of its inclusion must be questioned (Cedraschi et al 1999; Waddell 2004). For this reason the fact that Van Tulder et al (1997) found that for acute LBP, NSAIDs were more effective than placebo whereas manipulation was not, is not clinically relevant. This also applies to the findings by Van Tulder et al (2005) that NSAIDs were significantly better than placebo for acute LBP and that manipulation had statistically significant short term improvements in pain compared to sham therapy for acute LBP (Van Tulder et al 2005).

Both these systematic reviews included the use of either a placebo or sham treatment, which is inappropriate when assessing manipulation. It is not clear how a practitioner would apply a placebo/sham manipulation, nor is it clear whether a patient would believe the treatment was genuine (Andersson et al 1999). In a recent study by Hancock et al (2006) to select an appropriate placebo to use in RCTs assessing spinal manipulation, there was widespread disagreement amongst the experts as to the suitability of placebo use. For this reason the findings of Van Tulder et al (1997), that manipulation was more effective than placebo for chronic LBP, are of little clinical relevance. This also applies to the claim that, manipulation was statistically significant in its effective reduction for short and long term pain relief and improved function compared to sham treatment for chronic LBP (Van Tulder 2005). The methodology of both reviews by Van Tulder et al (1997 & 2005), was generally appropriate, however because of the poor clinical relevance of the studies outlined above, it is difficult to apply any of the findings to clinical use.

There were a limited number of relevant trials comparing these 2 interventions for back pain and a clear lack of high quality reviews which carried enough methodological weight to change current practice. Many of the weaknesses were common to all the studies e.g. lack of blinding of patients and practitioners, small group numbers, multiple osteopaths/medics providing treatment and the potential for non-disclosure of self-medicating/exercise by patients. Most trials found no significant difference between the two types of treatment and those that did suffered from methodological weaknesses which reduced their quality. These methodological weaknesses might have been reduced if qualitative instead of quantitative research were carried out.

In looking at spinal manipulation in isolation from its usual therapeutic context, the clinical relevance is reduced. However to compare a multi faceted osteopathic treatment with other interventions would fail to isolate the effective components of the osteopathic consultation.Given the well documented risks associated with NSAID use and since NSAID is evidenly no more effective than manipulation for LBP, i sugggest spinal manipulation is the safer and therefore preferable option.

Refs:

Andersson, G; Lucente, T; Davis, A; Kappler, R; Lipton, J; Leurgans, S. (1999).                             A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. The New England Journal of Medicine, Volume 341(19), pp 1426-1431.

Bronfort G. Goldsmith C. Nelson C. Boline P. Anderson A. (1996). Trunk exercise combined with spinal manipulative or NSAID therapy for chronic low back pain: a randomized, observer-blinded clinical trial. Journal of Manipulative & Physiological Therapeutics. 19(9):570-82.

Cedraschi C, Robert J, Goerg D, Perrin E, Fischer W, Vischer T. (1999) Is chronic non-specific low back pain chronic? Definitions of a problem and problems of a definition. British Journal of General Practice, 49(442):358-62.

Ferreira M, Ferreira P, Latimer J, Herbert R, Maher C. (2002) Does spinal manipulative therapy help people with chronic low back pain? Australian Journal of Physiotherapy Vol. 48. pp 277-284.

Giles L, Muller R. (1999) Chronic spinal pain syndromes: A clinical pilot trial comparing acupuncture, a non-steroidal anti-inflammatory drug, and spinal manipulation. J Manipulative Physiological Therapeutics. 22:376–81.

Hancock M, Maher C, Latimer J, McAuley J. (2006) Selecting an appropriate placebo for a trial of spinal manipulative therapy. Australian Journal of Physiotherapy. 52(2):1358.

Van Tulder M, Koes B, Bouter L. (1997) Conservative treatment of acute and chronic non-specific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine. 15; 22(18):2128-56.

Van Tulder M,  Koes B, Malmivaara A. (2005) Outcome of non-invasive treatment modalities on back pain: an evidence-based review. European Spine Journal.  Sup1: 64-81.

Waddell G. (2004) The Back Pain Revolution. 2^nd Edition, Churchill Livingstone. p.33.

Core Concerns

Core stability and core stabilising exercises are much talked about within the world of physical and manual therapy but what is the evidence base for their use? Below i have briefly reviewed the existing systematic reviews on the subject.

Four systematic reviews assessed the efficacy of SSE for LBP (Rackwitz et al 2006; Hauggaard & Persson 2007; Macedo et al 2009) and for spinal and pelvic pain (Ferreira et al 2006).

Rackwitz et al (2006); Ferreira et al (2006) and Hauggaard & Persson (2007) found that for acute LBP, SSE were equally effective in reducing short-term disability and pain and more effective in reducing long-term recurrence (12– 24 months) of LBP than treatment by General Practitioners. For chronic LBP, SSE were more effective for reducing pain and disability than usual medical care in short, medium and long term. SSE reduced pain and disability the same amount as spinal manipulation and physiotherapy including SSE was more effective than medical management or education for reducing pain and disability in the short term. Due to the limited number of existing trials available on the subject, all three reviews covered the same trials and generally came to the same conclusions. Ferreira et al (2006) also reviewed studies on pelvic, cervical and headache pain which are not relevant to this particular discussion.

The more recent review by Macedo et al (2009) updated the previous reviews and used a meta-analytical approach missing in the trials by Rackwitz et al (2006); Ferreira et al (2006) and Hauggaard & Persson (2007). Macedo et al (2009) found SSE significantly reduced pain at short term and intermediate follow-up and significantly reduced pain and disability  at long-term follow-up compared to minimal intervention (no treatment, GP care or education) or SSE as a supplementary treatment. Pooled effects for SSE compared with manual therapy favoured SSE for the reduction of pain and disability but significant difference was small and found in only 2 out of 6 studies. Similarly, only 1 out of 6 studies found SSE to be significantly more efficacious than other forms of exercise and this was only for the reduction of disability at short-term follow-up. No statistically significant difference between SSE and lumbar fusion was found at long-term follow-up for pain, disability or quality of life.

These systematic reviews were of good methodological quality. Their aims were clearly stated with comprehensively searched appropriate databases. Inclusion criteria were stated and the validity of included studies was assessed and validity criteria reported. Treatments were similar enough to combine given  the nature of the subject matter, although as noted by Rackwitz et al (2006) , heterogeneity  of length of intervention, follow ups, comparison groups, scales of measurement and acute/chronic subjects is a concern. The fact that these study groups lack homogeneity, suggests that the results may lack clinical relevance. Since there are so many unaccounted for variables within the treatments  in the studies reviewed, it is difficult, if not impossible to define whether SSE are actually any better for LBP than other management approaches.  This is at odds with the general summation by Ferreira et al (2006), Rackwitz et al (2006) and Hauggaard (2007) who feel that, despite these methodological weaknesses, SSE have a moderate benefit for both acute and chronic LBP compared to other types of care. Whether these methodological flaws are enough to discount all the findings from these studies is debatable. Further studies into more specific sub-groups of LBP sufferers with tighter control of treatment during follow up, more effective means of identifying muscle activity and control for psychological variables, particularly in chronic pain, are needed.

Refs:

Ferreira P, Ferreira M, Maher C, Herbert R and Refshauge K (2006) Specific stabilisation exercise for spinal and pelvic pain: A systematic review. Australian Journal of Physiotherapy 52:  79-88.

Hauggaard A, Persson L (2007) Specific spinal stabilisation exercises in patients with low back pain - a systematic review. Physical Therapy Reviews. 12: 233-248.

Macedo L, Maher C, Latimer J  et al (2009) Motor control exercise for persistant, nonspecific low back pain: A systematic review. Physical Therapy. 89:1

Rackwitz B, De Bie R, Limm H, Von Garnier K, Ewert T, Stucki G (2006) Segmental stabilizing exercises and low back pain. What is the evidence? A systematic review of randomized controlled trials. Clinical  Rehabilitation 20: 553-567.

I’ve decided to change the focus of this blog.

Having completed my MSc in Pain Management this week, i now have more time to blog.  Since i now have access to over 1000 full text journals via my membership of the Royal Society of Medicine ive decided to start regularly reviewing published studies and trials which catch my eye and are relevant, however loosely related, to osteopathy. Ive deleted pretty much all the previous postings on here, so this is a fresh start.

Less waffle.