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• Comparison to placebo vs. comparison to nocebo: a chiropractic result in perspective.
  Travis L. Gee
  Published on: 29 November 2004
• Diluted treatment effects?
  George W Kukurin
  Published on: 23 February 2001
• Infantile colic and chiropractic spinal manipulation
  Niels Grunnet-Nilsson
  Published on: 10 February 2001

• Published on: 29 November 2004

  Comparison to placebo vs. comparison to nocebo: a chiropractic result in perspective.

  • Travis L. Gee, Research Fellow

  Dear Editor,

  There is a bias in research on treatments that sometimes manifests itself in odd ways. The preference for a one-tailed test, for instance, may lead us to focus on whether a treatment makes things better, but leads us to miss important details when a treatment makes things worse. This is an important point when testing treatments against such alternatives.

  Before turning to the central point,...

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  Dear Editor,

  There is a bias in research on treatments that sometimes manifests itself in odd ways. The preference for a one-tailed test, for instance, may lead us to focus on whether a treatment makes things better, but leads us to miss important details when a treatment makes things worse. This is an important point when testing treatments against such alternatives.

  Before turning to the central point, however, there is the issue of statistical power that was noticeable by its absence in the Olafsdottir study [1]. It is worth noting that if a clinically meaningful difference of .5 of a standard deviation was to be detected with a two-tailed test, then given this sample size, there was a 63% chance of doing so (or 74% with a one-tailed test). Such information is always worth including when a non- result of this order is reported.

  To the central point, Olafsdottir [1] et al note that a chiropractic manipulation performed significantly better than a drug, but did not note the plausible hypothesis that dimethicone is not only 'not better than placebo,' but for some infants may make things worse, perhaps because activated dimethicone used alone (ie., without an antacid component, as in Altacite Plus) causes the large bubbles to redistribute stomach acid along the esophagus when belching, thereby irritating the child more than the relief that is obtained from the expulsion of gas.

  The relatively high attrition rate and poor outcomes in the Wiberg [2] study's dimethicone group is consistent with the possibility that they used an alternative that not only doesn't work for some, but makes things worse instead of better for others. Thus, the the comparsion of chiropractic methods to *nocebo* is scarcely the same as a comparison against *placebo*. It is good to see the publication of a non-result such as that shown by Olafsdottir, et al[1] which uses a true placebo treatment to illustrate the non-effect of chiropractic methods.

  References

  (1). E Olafsdottir, S Forshei, G Fluge, and T Markestad. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. Arch. Dis. Child. 2001; 84: 138-141

  (2). Wiberg JMM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: A randomized controlled clinical trial with a blinded observer. J Manipulative Physiol Ther 1999;22:517-22.

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  Conflict of Interest:
  None declared.

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• Published on: 23 February 2001

  Diluted treatment effects?

  • George W Kukurin, Chiropractor/Neurologist
  • Other Contributors:
    • D C Dacan

  Dear Editor

  If my reading of this colic study is correct it appears that both groups received standand counciling and recommendations for the care of a colicky child. My question to the author(s) is, if standard recommendations are effective in the reduction of colic, does this not raise the possibility that any treatment effect in the CMT group could have been diluted by the introduction of a second active treatment...

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  Dear Editor

  If my reading of this colic study is correct it appears that both groups received standand counciling and recommendations for the care of a colicky child. My question to the author(s) is, if standard recommendations are effective in the reduction of colic, does this not raise the possibility that any treatment effect in the CMT group could have been diluted by the introduction of a second active treatment (standard recomendations) in the control group? Put another way, was the placebo intervention an inert intervention or was it a second active intervention?

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  Conflict of Interest:
  None declared.

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• Published on: 10 February 2001

  Infantile colic and chiropractic spinal manipulation

  • Niels Grunnet-Nilsson, Associate Professor

  Dear Editor,

  We congratulate Olafsdottir et al on their article “Randomized controlled trial of infantile colic treated with chiropractic spinal manipulation” (Arch Dis Child 2001;84:138-41). The sum of the evidence on spinal manipulative therapy (SMT) in the treatment of infantile colic now is, that there are 3 RCTs on the subject.

  Two RCTs demonstrated a significant positive effect of SMT,[1][2] and 1 RCT was unabl...

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  Dear Editor,

  We congratulate Olafsdottir et al on their article “Randomized controlled trial of infantile colic treated with chiropractic spinal manipulation” (Arch Dis Child 2001;84:138-41). The sum of the evidence on spinal manipulative therapy (SMT) in the treatment of infantile colic now is, that there are 3 RCTs on the subject.

  Two RCTs demonstrated a significant positive effect of SMT,[1][2] and 1 RCT was unable to demonstrate any treatment effect.[3] The reasons for this discrepancy of result are not known, but Olafsdottir et al suggest, that their finding no effect of SMT may be due to the blinding of the infants mother, and this may very well be the right explanation. But another, equally likely, explanation could be that we are witnessing a dose-response phenomenon.

  In their trial Olafsdottir et al[3] gave a treatment protocol consisting of a maximum of 3 sessions of SMT, whereas the other 2 RCTs, which found a positive treatment effect, used a treatment protocol relying more on the treating chiropractor's clinical judgement. This more pragmatic treatment approach resulted in 64% of the infants in one of the RCTs receiving 4 or more sessions of SMT (with a maximum of 7),[1] and the majority of infants in the other RCT receiving up to 6 sessions of SMT.[2]

  We believe that this dose-response problem should be addressed in future trials of SMT for infantile colic, and until then the jury is still out, in our opinion.

  Niels Grunnet-Nilsson
  University of Southern Denmark

  Jesper Wiberg
  Private practice, Copenhagen, Denmark

  References
  (1) Wiberg J, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: A randomized controlled trial with a blinded observer. J Manipulative Physiol Ther 1999;22:517-22.

  (2) Mercer C, Nook B. The efficacy of chiropractic spinal adjustments as a treatment protocol in the management of infantile colic. In: Haldeman S, Murphy B, eds. 5th Biennial Congress of the World Federation of Chiropractic. Auckland, New Zealand, 1999:170-1.

  (3) Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomized controlled trial of infantile colic treated with chiropractic spinal manipulation. Arch Dis Child 2001;84:138-41.

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  Conflict of Interest:
  None declared.

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