When IRBs Fail, Babies Suffer

When IRBs Fail, Babies Suffer

I have been practicing medicine for 30 years. I spent most of my time in acute care hospitals, so I am well acquainted with the many ways people can suffer. Being 58 I have also had my share of medical problems that have caused a reasonable amount of pain and suffering.

As a result I have a list of processes that I do not want to experience. At the top of the list is kidney stones, followed by a disk infection. Another disease on the list is opiate withdrawal. I always have a heroin addict or two under my care with one infection or another from injection drug use and going cold turkey looks really miserable.

There are children who are born to addicted mothers and after birth will go through withdrawal unless treated. Poor little things, their first experiences in life the misery of withdrawal and unable to really ask for help.

There is a horrible, unconvincing literature on using ear acupuncture for withdrawal in adults; the literature for children is even worse

This study, a painfully unnecessary attempt to determine the feasibility and efficacy of acupuncture in neonatal and pediatric intensive care unit patients at risk of withdrawal, was a complete waste of time. You cannot determine efficacy at all based on it and the question of feasibility was answered a long time ago. This study added nothing to our understanding of withdrawal or even of acupuncture.

Considering the reams of research showing that there are no benefits associated with the insertion of needles into, or pressing on, particular points on the body beyond placebo, it never should have happened. 

The preponderance of the literature suggests that acupuncture is a theatrical placebo and that  it is belief in acupuncture that is the main predictor of a response. Newborns, of course, can't have a belief in the efficacy of acupuncture nor can they complain if they are suffering. So why would you try acupuncture on babies with withdrawal? Or laser acupuncture?

It didn't stop Laser Acupuncture for Neonatal Abstinence Syndrome: A Randomized Controlled Trial.

So here is the reasoning: ear acupuncture may help withdrawal so we will use laser acupuncture.

Why, oh why, would anyone would who lives in reality would think that shining a red light on the skin would do anything for drug withdrawal? I wouldn't. And the reason the authors think it would help?

There isn't any. None. They best they can offer is that it would safe.

But there is zero plausible reason offered by the authors that laser acupuncture, an intervention even more worthless and implausible than needle acupuncture, would help babies with addiction symptoms.

It did not stop the Ethics Committee of the Medical University of Graz from approving it.

So children in withdrawal were assigned to laser acupuncture or control.

There was no blinding.

The kids who received laser acupuncture had fewer drug treatment days although they had the same Finnegan score, an objective and subjective measurement of withdrawal symptoms in children.

So I read the study as newborns with equal amounts of withdrawal symptoms and suffering had less medication for their withdrawal as the staff thought they were being treated with the laser acupuncture. The laser treated kids were detoxed faster than their non laser controls. And probably suffered more. My wife, who worked for years in addictions, thinks it is a reasonable explanation that the laser treated were detoxed more rapidly.

Every time a read a pediatric acupuncture study I realize just how broken the IRB system is when it come to protecting vulnerable populations from being abused by pseudo-medical providers.   And how peer review seems to be peer as in 'to look at'. I imagine an old person, peering over the top of their glasses, saying 'that 'peers to be an acupuncture paper. Lets publish it. Or, in this case, publishit.

Points of Interest 11/05/2015
Points of Interest 11/04/15

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