Another IRB Failure: Acupuncture for Appendicitis

Another IRB Failure: Acupuncture for Appendicitis

The purpose of Institutional Review Boards, IRB, is to protect patients, especially vulnerable patients such as children. To quote the FDA

the clinical investigation may proceed only if:

The IRB finds and documents that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children…

When it comes to pseudo-medicine they fail. All the time. I can see no way that acupuncture could ever meet that criteria. Especially for post-operative pain.

As I discussed over at Science-Based Medicine, you can get the same effect as real acupuncture from sham acupuncture, toothpicks, phantom acupuncture, and acupuncture on a rubber hand. The bulk of the information from well done clinical trials suggests that acupuncture is a theatrical placebo.

I cannot understand how any IRB could approve acupuncture in children. First was tonsillectomy. And now?

Effects of Acupuncture on Pain and Inflammation in Pediatric Emergency Department Patients with Acute Appendicitis: A Pilot Study .

 

They used yet another from of acupuncture, Kiiko Matsumoto Style, which, of course, is the wrong style of the dozens of forms of acupuncture. Why this form of acupuncture? Pure BS:

This is done by a systematic palpation of the abdomen, acupuncture channels, and points—revealing specific patterns that are associated with the patient’s presenting symptoms. A successful treatment in KMS acupuncture reduces the discomfort found in these diagnostic areas and, as a result, reduces the patient’s presenting symptoms. Most cases of acute appendicitis fit the pattern identified as “spleen and immunity deficiency,” and commonly present with the following reflexes: right side St–26 and St–27 area; one side or bilateral Tw–16 area; and left subcostal region. These reflexes can be treated with a combination of two or more of the following points listed in the order of most effective first: “Master Nagano’s immune points” located on the radial side of the forearm about 5 cm below the elbow: Ki–6; Sp–5; Sp–9; Tw–16; St–40; Ki–16; and Ren–6.

I know. Lets take a half dozen Hispanic kids with a acute appendicitis and try and relieve their pain based on a pre-scientific fantasy. Sounded good to the IRB. No blinding, no placebo, no nothing to make the results even remotely valid given the nature of acupunctures mechanism of action.  And the results.  Meaningless.

And now?

Our hope in the future is to conduct a large randomized controlled trial in the PED, whereby patients would receive KMS acupuncture treatment, sham acupuncture, or morphine for pain relief. This design would allow us to more rigorously investigate serum biomarkers and the overall utility of PED acupuncture.

Given prior plausibility, I would expect such a study, if properly done, to do nothing. It is a study that does not need to be done based on the last 50 years of acupuncture research. And I bet the IRB will have no problem with the study.

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