Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Does the evidence really support surgery at 8 weeks for radicular pain?
- Geetha Gunaratnam, Dr Mohannad Daood, Staff Grade in Anaesthetics and Pain Medicine; Dr Jon Norman, Consultant Anaesthetist and Pain Meidicine Specialist (19 June 2008)
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Is early surgery for radicular pain really better?
- stuart harrison james, Sashin Ahuja (3 July 2008)
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Author's reply to quick responses
- Wilbert van den Hout, 2300RC Leiden, Netherlands (16 January 2009)
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Geetha Gunaratnam, ST1 Anaesthetics Maidstone and Tunbridge Wells NHS Trust, Dr Mohannad Daood, Staff Grade in Anaesthetics and Pain Medicine; Dr Jon Norman, Consultant Anaesthetist and Pain Meidicine Specialist
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We read with interest the research papers by Hout et al and Peul et al, as well as the accompanying editorial by Fairbank. As both papers are from the same group we feel it is reasonable to comment on them both together. We note that a faster recovery is seen in patients in the surgical groups in both trials. Both, however, acknowledge that this is already known. The new knowledge would appear to be that early surgery does not improve results at 1 or 2 years, but surgery is cost effective none the less. The way that cost effectiveness is presented is curious. When patient diaries were not obtained the authors appear to state they have inserted what they suppose the patient would have said. This assumption of data may have lead to inaccuracies in their subsequent analysis of cost effectiveness Also when calculating surgical costs they give a range of prices from across 75 centres, the two highest and lowest prices were excluded. Is this meant to represent the interquartile range? In their second paper the control group appear to have received little in the way of care. Were they offered core stability physiotherapy, strong standard or anti-neuropathic therapy, acupuncture or an epidural placed in a translumbar or transforaminal approach (a so called “root block”) to attempt to treat their radicular symptoms? If 40% of patients in the control group went for surgery was their analysis on intention to treat and is this valid with such a high rate of unintentional crossover? We freely admit that the conservative therapies lack good evidence but we would suggest that transforaminal approaches have equivalent level of positive evidence as surgery. This trial demonstrates how difficult it is to select which patients should or should not go forward for early surgery. There is a desperate need for well controlled trials looking at surgery versus best practise conservative care. Surgery clearly has a role to play in these patient groups. Sadly despite considerable effort by the Hague group their studies add little to help us advise ours as well as we would wish. References: 1. Hout et al. Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomised controlled trial BMJ, Jun 2008; 336: 1351 - 1354 2. Peul et al. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial BMJ, Jun 2008; 336: 1355 – 1358 3. Fairbank, J. Prolapsed intervertebral disc. BMJ, Jun 2008; 336: 1317 – 1318 4. Jeung et al. Effectiveness of transforaminal epidural steroid injection by using a preganglionic approach: a prospective randomized controlled study. Radiology. 2007 Nov;245(2):584-90 5. Vad VB. Transforaminal epidural steroid injections in lumbosacral radiculopathy: a prospective randomized study. Spine. 2002 Jan 1;27(1):11- 6 Competing interests: None declared |
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stuart harrison james, Specialist Registrar in Spinal Surgery university Hospital Wales, Cardiff, cf14 4xw, Sashin Ahuja
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Dear Sirs, We read with interest the article by Wilert B van den Hout, Wilco C Peul et al titled Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomised controlled trial.BMJ 2008;336;1351-1354. We congratulate the authors on an elegantly presented paper on a difficult and emotive subject matter, however there are several points that we would like to make with regard to this paper. We found it interesting that the authors decided to randomise patients into either the conservative or operative groups at the range of 6 weeks to 12 weeks, which remain the basis of this paper. It seems in our opinion that this would be a rather aggressive management plan to undertake surgery at this time, as there is scope for spontaneous resolution of patients symptoms between these time periods, which give rise to a bias within the results due to a lack of standardisation. The premise of the study is that patients who undertake surgery have a quicker recovery and cost less in terms of financial pressures to the healthcare system, and also have increased Quality adjusted life years. In our practice patients who fail to respond to conservative therapy, typically the first 6 weeks, would then proceed to undertake a nerve root block of the compressed nerve as demonstrated by radiology. The relief of symptoms allows active aggressive physiotherapy, which has been show to improve lumbar symptoms 1. A successfully treated patient in this way firstly costs less to the healthcare provider but also avoids the cost not to mention the morbidity associated with surgery. It is also imperative to know how many patients had concurrent back pain, a commonly associated symptom known to have an effect on the ability of patients to work, as well as final outcome of treatment. This is not mentioned and would affect the overall results of the study. The article also has to make several assumptions particularly with regards to return to work. No data as to the number of people employed is presented, and thus assumes all patients are employed with an average wage used as the model, thus is only attributable to people who are employed. Secondly return to the working environment relies not just on the patient’s physical symptoms, but also their motivation to return. A homogeneous cohort of patients with objective pain assessment, patient cooperation with the study and the patient’s psychosocial environment must be used for an accurate assessment 2 but is appreciably difficult to attain. Finally, the patients presenting a diary of visits for various appointments, and the costing of the time and financial implications of these visits is inherently open to inaccurate reporting, thus potentially skewing the results. 1. Weber H, Holme I, Amlie E. The natural course of acute sciatica with nerve root symptoms in a double-blind placebo-controlled trial evaluating the effect of piroxicam. Spine. 1993;18:1433–1438 2. Kool J, de BR, Oesch P, et al. Exercise reduces sick leave inpatients with non-acute non-specific low back pain: A metaanalysis. J Rehabil Med. 2004;36:49–62. Competing interests: None declared |
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Wilbert van den Hout, health economist Leiden University Medical Center, 2300RC Leiden, Netherlands
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We thank both authors of the quick responses for their valuable comments. Some of the comments were addressed earlier, in our reply to questions concerning our clinical paper. Here we will only address the comments that explicitly concern our health economic paper. Gunaratnam et al object that our imputation technique for missing patient diaries may have lead to inaccuracies. Since missing data cannot be analyzed it is impossible to entirely refute this objection, but the multiple imputation technique we used is state-of-the-art for dealing with missing data. By modeling the missing data, the method can prevent bias when data are not missing completely at random. And by using multiple imputation sets, also bias in the estimated p-values is prevented. In addition, Gunaratnam et al wonder what the average surgical costs across 75 centres (with the two highest and lowest prices excluded) represent. It represents the 2.5% trimmed mean, which is advocated as a robust measure of central tendency. Without trimming the estimated costs would not have been much different. James et al suggest that results may be biased by inaccurate reporting. Research has shown that quarterly diaries filled out by patients are reliable and accurate. Moreover, the cost difference in our study was mainly determined by the difference in the rate of surgery, for which patient reports did not differ from the study registration. In addition, James et al contest our premises and assumptions about recovery and return to work. However, we did not make any such premises or assumptions. What we presented is what we actually observed in the study. The 80% labor participation among our patients may be relatively high, but nevertheless the average difference in absenteeism was only 37 hours. Even from the medical perspective, which ignores any savings on productivity costs, the conclusion of the study would still be that early surgery need not be withheld for economic reasons. 1. Van den Hout WB, Peul WC, Koes BW, Brand R, Kievit J, Thomeer RT. Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomised controlled trial. BMJ 2008; 336:1351-1354. 2. Peul WC, Van den Hout WB, Brand R, Thomeer RT, Koes BW. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial. BMJ 2008; 336:1355-1358. 3. Van den Brink M, van den Hout WB, Stiggelbout AM, van de Velde CJH, Kievit J. Cost measurement in economic evaluations of health care: Whom to ask? Medical Care 2004; 42:740-746. Competing interests: None declared |
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