MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

In this study, the impact of a multimodal integrative oncology pre- and intraoperative intervention on pain and anxiety among patients undergoing gynecological oncology surgery was explored.

Study participants were randomized into three groups:

  • Group A received preoperative touch/relaxation techniques, followed by intraoperative acupuncture, plus standard care;
  • Group B received preoperative touch/relaxation only, plus standard care;
  • Group C (the control group) received standard care.

Pain and anxiety were scored before and after surgery using the Measure Yourself Concerns and Wellbeing (MYCAW) and Quality of Recovery (QOR-15) questionnaires, using Part B of the QOR to assess pain, anxiety, and other quality-of-life parameters.

A total of 99 patients participated in the study: 45 in Group A, 25 in Group B, and 29 in Group C. The three groups had similar baseline demographic and surgery-related characteristics. Postoperative QOR-Part B scores were significantly higher in the treatment groups (A and B) when compared with controls (p = .005), including for severe pain (p = .011) and anxiety (p = .007). Between-group improvement for severe pain was observed in Group A compared with controls (p = .011). Within-group improvement for QOR depression subscales was observed in only the intervention groups (p <0.0001). Compared with Group B, Group A had better improvement of MYCAW-reported concerns (p = .025).

The authors concluded that a preoperative touch/relaxation intervention may significantly reduce postoperative anxiety, possibly depression, in patients undergoing gynecological oncology surgery. The addition of intraoperative acupuncture significantly reduced severe pain when compared with controls. Further research is needed to confirm these findings and better understand the impact of intraoperative acupuncture on postoperative pain.

Regular readers of my blog know only too well what I am going to say about this study.

Imagine you have a basket full of apples and your friend has the same plus a basket full of pears. Who do you think has more fruit?

Dumb question, you say?

Correct!

Just as dumb, it seems, as this study: therapy A and therapy B will always generate better outcomes than therapy B alone. But that does not mean that therapy A per se is effective. Because therapy A generates a placebo effect, it might just be that it has no effect beyond placebo. And that acupuncture can generate placebo effects has been known for a very long time; to verify this we need no RCT.

As I have so often pointed out, the A+B versus B study design never generates a negative finding.

This is, I fear, precisely the reason why this design is so popular in so-called alternative medicine (SCAM)! It enables promoters of SCAM (who are not as dumb as the studies they conduct) to pretend they are scientists testing their therapies in rigorous RCTs.

The most disappointing thing about all this is perhaps that more and more top journals play along with this scheme to mislead the public!

 

10 Responses to More acupuncture promotion (sponsored by a top journal) masquerading as research

  • I mostly agree with your take here, but is that really true for studies with more objective endpoints? In oncology “A+B versus B” is a very standard study design for new chemotherapy regimens, in which the new chemotherapy is added to standard-of-care chemotherapy and then compared to standard-of-care chemotherapy alone.

    • probably depends on what precisely you mean by ‘more objective’.

    • Even if the outcome measure is hard and objective – say survival time – not using a placebo in the control group is not optimal, in my opinion. It assumes that the placebo effect does not influence the outcome, and that the disappointment of control patients of not having the add-on therapy has no impact on the result.
      I simply see no good reason to not include placebos in the control group in such trials.
      The only exception, I assume, might be a situation where the patients cannot even tell in which group they are, but more often than not they can.

      • @Edzard

        Even if the outcome measure is hard and objective – say survival time …

        Even survival time isn’t always a hard objective measure, with potential confounders such as lead time bias that need to be controlled for. But it is certainly more objective and less placebo-sensitive(*) than outcome measures such as anxiety and pain.

        *: Maybe trials where placebo arms are a problem for technical and/or ethical(**) reasons should try to indicate to what degree an outcome measure is sensitive to placebo effects and such? As you already suggest, placebo effects may still influence ‘hard’ outcome measures in roundabout ways. Or is this already taken into account when assessing trial results?

        **: I think this also relates to the discussion about a more Bayesian approach, where prior plausibility is taken into account — the more plausible it is that the trial drug has an effect, the bigger the ethical problem of using a placebo in the control group. Then again, I’m not a researcher but just an onlooker, watching the game so to speak, so chances are that I am wrong about one or more things here.

    • David Gorski wrote “In oncology “A+B versus B” is a very standard study design for new chemotherapy regimens, in which the new chemotherapy is added to standard-of-care chemotherapy and then compared to standard-of-care chemotherapy alone.”

      In that case, there is an objective outcome measure, directly related to treatment B; also, A and B are in the same dimension (chemotherapy) therefore they are commensurable [see below]: they can be legitimately added/summed and compared.

      In the case of the article on which we are commenting, treatments A (touch/relaxation techniques and intraoperative acupuncture) are in different dimensions from treatment B (oncology surgery); also, the subjective outcome measures are in different dimensions from the objective outcome of treatment B. Therefore treatment A is incommensurable [see below] with treatment B; and the subjective outcome measures are incommensurable with the outcome of treatment B: they cannot be legitimately added/summed and compared.

      QUOTE
      Dimensional analysis, Wikipedia
      [my formatting for clarity]

      Commensurable physical quantities are of the same kind and have the same dimension, and can be directly compared to each other, even if they are expressed in differing units of measure, e.g. yards and metres, pounds (mass) and kilograms, seconds and years.

      Incommensurable physical quantities are of different kinds and have different dimensions, and can not be directly compared to each other, no matter what units they are expressed in, e.g. metres and kilograms, seconds and kilograms, metres and seconds. For example, asking whether a kilogram is larger than an hour is meaningless.

      Any physically meaningful equation, or inequality, must have the same dimensions on its left and right sides, a property known as dimensional homogeneity. Checking for dimensional homogeneity is a common application of dimensional analysis, serving as a plausibility check on derived equations and computations. It also serves as a guide and constraint in deriving equations that may describe a physical system in the absence of a more rigorous derivation.

      https://en.m.wikipedia.org/wiki/Dimensional_analysis

  • This important research (published in Cancer) proves quite conclusively that if patients are treated with TLC, they report they feel better.
    Who’d have guessed?

    • good summary!

    • Well put! And to be honest, since being nice can be considered a valid therapeutic approach in terms of peoples mental state and perceptions, I would not use the term placebo affect. In my view it opens up a channel for the woo merchants to exploit. As we know some results in the placebo arm of a trial are due to regression to the mean; spontaneous remission. I have yet to see a trial where a “hard end point” such as shrinkage of tumour; physical improvement in heart valve etc are anything more than due to the above factors. BUT when soft end points are involved being nice or keeping patients informed and involved are in my view recognised therapeutic approaches so demonstrated improvements here may be seen in the placebo ARM but they do not represent some underlying placebo EFFECT but rather the impact of good patient. In my view there is no such thing as a placebo effect; we ought to be careful in not giving woo merchants access to a get out of jail card. Ethically – this might give us an issue if we need the theatricality of a bogus treatment to provide a valid therapeutic boost to people’s perceptions. Edzard has I think written about this.

  • QUOTE
    American Cancer Society Journals: Cancer (Early View)
    EDITORIAL
    Integrative oncology in cancer care: Reaching a tipping point
    Ana Maria Lopez MD, MPH, MACP, FRCP
    First published: 17 January 2023
    https://doi.org/10.1002/cncr.34539

    Abstract
    Preoperative relaxation techniques decrease anxiety. The addition of intraoperative acupuncture reduced severe perioperative pain associated with gynecological oncology surgery.

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