The objective of this study was to assess the efficacy of paracetamol (acetaminophen) in the treatment of pain and disability in patients with non-specific low back pain. We conducted a systematic review of randomized controlled trials to assess the efficacy of paracetamol in the treatment of pain and disability in patients with non-specific low back pain. A search for randomized controlled trials was conducted using the Medline, Embase and CINAHL databases. Trials were eligible if they were randomized controlled trials comparing paracetamol to no treatment, placebo or another treatment in patients with non-specific low back pain. Two of the authors independently assessed trials for methodological quality on the PEDro Scale and extracted data. Continuous pain and disability data were converted to a common 0–10 scale; ordinal data were dichotomized (e.g., no pain, pain). The data was analyzed using the MIX version 1.61 meta-analysis software. Out of 205 unique articles found in the searches, 7 eligible trials were identified. The trials enrolled a total of 676 participants with 5 investigating acute low back pain, 1 investigating chronic low back pain and 1 investigating both. No trial provided data comparing paracetamol to placebo and only one trial compared paracetamol to no treatment. In general the trials were small (only 1 trial had >25 subjects per group) and of low methodological quality (only 2 had a score above 6 on the quality scale). All but one of the trials provided imprecise estimates of the effects of treatment with confidence intervals spanning clinically important beneficial and also harmful effects of paracetamol. No trial reported a statistically significant difference in favor of paracetamol. There is insufficient evidence to assess the efficacy of paracetamol in patients with low back pain. There is a clear need for large, high quality randomized controlled trials evaluating paracetamol, to provide reliable evidence of paracetamol’s effectiveness in patients with low back pain and to establish the validity of the recommendations in clinical guidelines.
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The authors would like to thank A/Professor Jane Latimer for critical review of the study protocol, A/Professor Rob Herbert for his assistance with statistical analyses and Brendan Wilson and Grant Mackay for assistance with proof reading of the manuscript. Chris Maher’s Research Fellowship is funded by the National Health and Medical Research Council of Australia. Mark Hancock’s Primary Care Post Graduate Scholarship was funded by the National Health and Medical Research council of Australia.
Search strategies (adapted from van Tulder et al. )
01. randomized controlled trial.pt, 02. controlled clinical trial.pt, 03. Randomized Controlled Trials/, 04. Random Allocation/, 05. Double-Blind Method/, 06. Single-Blind Method/, 07. or/1–6, 08. Animal/not Human/, 09. 7 not 8, 10. clinical trial.pt, 11. explode Clinical Trials/, 12. (clinic$ adj25 trial$).tw, 13. ((singl$ or doubl$ or treb$ or tripl$) adj (mask$ or blind$)).tw, 14. Placebos/, 15. placebo$.tw, 16. random$.tw, 17. Research Design/, 18. (latin adj square).tw, 19. or/10–18, 20. 19 not 8, 21. 20 not 9, 22. Comparative Study/, 23. explode Evaluation Studies/, 24. Follow-Up Studies/, 25. Prospective Studies/, 26. (control$ or prospective$ or volunteer$).tw, 27. Cross-Over Studies/, 28. or/22–27, 29. 28 not 8, 30. 29 not (9 or 21), 31. 9 or 21 or 30, 32. low back pain/, 33. low back pain.tw, 34. backache.tw, 35. lumbago, 36. or/32–35, 37. paracetamol.tw, 38. paracetamol/, 39. acetaminophen.tw, 40. acetaminophen/, 41. APAP.tw, 42. APAP/, 43. chemadol.tw, 44. duatrol.tw, 45. dymadon.tw, 46. febridol.tw, 47. panadol.tw, 48. panamax.tw, 49. parahexal.tw, 50. paralgin.tw, 51. parmol.tw, 52. perfalgan, 53. tylenol.tw, 54. or/37–53, 55. 31 and 36 and 54.
01. randomized controlled trial.pt, 02. controlled clinical trial.pt, 03. Randomized Controlled Trials/, 04. Random Assignment/, 05. Double-Blind Studies/, 06. Single-Blind Studies/, 07. or/1–6, 08. Animal/not Human/, 09. 7 not 8, 10. clinical trial.pt, 11. exp Clinical Trials/, 12. (clinic$ adj25 trial$).tw, 13. ((singl$ or doubl$ or treb$ or tripl$) adj (mask$ or blind$)).tw, 14. Placebos/, 15. placebo$.tw, 16. random$.tw, 17. Research Design/, 18. (latin adj square).tw, 19. or/10–18, 20. 19 not 8, 21. 20 not 9, 22. Comparative Study/, 23. exp Evaluation Studies/, 24. Follow-Up Studies/, 25 Prospective Studies/, 26. (control$ or prospective$ or volunteer$).tw, 27. Cross-Over Design/, 28. or/22–27, 29. 28 not 8, 30. 29 not (9 or 21), 31. 9 or 21 or 30, 32. low back pain/, 33. low back pain.tw, 34. backache.tw, 35. lumbago, 36. or/32–35, 37. paracetamol.tw, 38. paracetamol/, 39. acetaminophen.tw, 40. acetaminophen/, 41. APAP.tw, 42. APAP/, 43. chemadol.tw, 44. duatrol.tw, 45. dymadon.tw, 46. febridol.tw, 47. panadol.tw, 48. panamax.tw, 49. parahexal.tw, 50. paralgin.tw, 51. parmol.tw, 52. perfalgan, 53. tylenol.tw, 54. or/37–53, 55. 31 and 36 and 54.
(‘low back pain’ or ‘backache’ or lumbago’) and (‘paracetamol’ or ‘acetaminophen’ or ‘APAP’ or ‘chemadol’ or ‘duatrol’ or ‘dymadon’ or ‘febridol’ or ‘panadol’ or ‘panamax’ or ‘parahexal’ or ‘paralgin’ or ‘parmol’ or ‘perfalgan’ or ‘tylenol’).
Selecting the following limits: “Map to preferred terminology”, “Also search as free text”, “Include sub-terms/derivatives”, “All Years”, “Humans”, “EMBASE only”, “Controlled Clinical Trial” and “Randomized Controlled Trial”.
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Davies, R.A., Maher, C.G. & Hancock, M.J. A systematic review of paracetamol for non-specific low back pain. Eur Spine J 17, 1423 (2008). https://doi.org/10.1007/s00586-008-0783-x
- Low back pain