Acupuncture: an interesting Canadian study

As I discussed in a previous post, so-called sham acupuncture is not a good control to use in clinical trials. I recent study in Canada used a different approach.

The trial

The researchers studied patients suffering from Bell’s palsy. This is a disease which comes on acutely (suddenly) and produces paralysis of the muscles on one side of the face. Patient smile unevenly and may have difficulty in closing their eye on the affected side. The cause is unknown, though it is thought to be a virus that has caused swelling of the facial (VIIth) nerve on one side. In most cases patients recover in a few weeks, although some do so incompletely or even not at all. It is usually treated with corticosteroids (prednisolone) and this seems to improve the chance of a good outcome.

All the patients received both prednisolone and acupucture. The control group’s acupuncture was done gently and superficially; the active group received acupuncture that was sufficiently deep and vigorous to elicit the typical acupuncture sensation (de qi).

The results were assessed by three neurologists who saw videos of the patients carrying out face exercises. The neurologists did not of course know which treatment each person had received.

Results

At six months recovery was assessed to be 70% in those who had received the presumably less effective acupuncture and 90% in those who had received the more effective acupuncture. The difference was statistically significant.

Comments

Most acupuncture trials are for pain, which is assesse largely subjectively, by the patients’ reports. In this case the assessment was based on objective criteria, the patients’ abilityto perform movements. Also, all the patients had been needled at the same sites; the only difference was in the vigour of the needling. The trial therefore gets round many of the objections that critics often raise. Of course, only a few kinds of disease are suitable for assessment in this way.

Reference

Xu et al., 2 April 2013; 185(6):459. See also accompanying article by John Fletcher

 

 

 

 

 

Acupuncturists: don’t be afraid of the placebo!

Critjcs of acupuncture always make much of the fact – and it is a fact – that clinical trials generally show little if any difference between so-called sham and real acupuncture. From this they conclude that acupuncture is “just a placebo”.But this statement conceals a lot and needs to be examined in more detail than is always done.

What is sham acupuncture?

So-called sham acupuncture often consists in inserting needles at “wrong” (non-acupuncture) points and/or penetrating only a short way, just below the skin. Another idea is to use a fake needle, in which a blunt probe recedes into the handle like a stage dagger. The trouble with all these techniques is that they all provide a stimulus to the nervous system; they are not neutral.

At most, therefore, they can compare more effective with less effective treatment. And they depend on the assumption that classic acupuncture points exist. That is, there are places in the body where a needle produces particular effects that would not be produced at a different site.

Many modern acupuncturists, of whom I am one, don’t accept the existence of acupuncture points in this sense. We therefore concede the critics’ case, at least in part; not that it makes no difference at all where a needle is inserted, but it doesn’t have to be done in the traditional way.

So are there any alternatives to sham? In a moment I shall suggest a couple, but first I want to take a moment to look at the placebo effect itself.

What is the placebo effect?

There seems to be a widespread idea that the placebo response is somehow unreal. It is supposed to depend on belief (probably untrue) and is not quite genuine in the way that the response to a drug is genuine. It’s “all in the mind”.

But if you think about it for a moment you will see that this can’t be right. It depends on the probably unspoken assumption that there is a ghostly mind hovering just outside the body and producing unreal effects by means of suggestion. But most scientifically minded people don’t accept this idea; they think of the mind as being a function of the brain. In a crude and probably misleading analogy, we could say that the brain is the hardware and the mind is the software.

On this view all mental phenomena are the result of brain activity. In that case the placebo effect depends on the brain and is quite as real as anything else the brain does. So even if acupuncture works partly at the mental level, this doesn’t mean that it doesn’t have a physiological basis.

At the same time we’d like to know more, and in fact there is a lot of evidence from other kinds of research to show that acupuncture has real effects. Here I shall mention two, which I discuss in separate posts. One is an interesting study carried out recently in Canada, and the other depends on the idea of using patients as their own controls.

 

 

 

ME/CFS fails to respond to rituximab

ME/CFS is a disease of unknown cause with no confirmatory tests. It is therefore diagnosed on the basis of its symptoms, which include physical and mental fatigue which may be of overwhelming severity. There is no curative treatment so it is is managed symptomatically.

One theory is that it is an autoimmune diseases  (one in which the body reacts against its own tissues). There have been reports of improvement when patients were receiving chemotherapy for lymhoma or cancer. Also, elderlly patients with ME/CFS have an increased incidence of B cell lymphoma. For these reasons it seemed feasible to try treating ME/CFS with rituximab, a medication that is used to treat certain autoimmune diseases and some cancers.

Unfotunately, a 12-month trial in 151 patients in Norway has not shown a positive effect.  Overall respone rates were 35.1% for placebo and 26.0% for rituximab. Twenty patients (26.0%)  in the rituximab group and 14 (18.9%) in the placebo group had serious adverse events. Few patient in either group showed major improvements and 10% got worse.

Limitations of the trial: the patients were self-referred and outcome measurements were based on self=reported symptoms over two years, so there was possible recall bias.

This is a disappointing result. But at least it’s good that serious research is being done in this baffling and often devastating disease. Up to now there hasn’t been very much, and the quality of what has been done has been rather uneven.

Source: Ann Intern Med doi:10/7326/M18-1451

 

 

Breast cancer screening questions

Should breast cancer screening be routinely offered to women aged over 70? For that matter, is routine breast screening desirable anyway? These important questions are the subject of an important new BMJ  article by Susan Bewley and colleagues (BMJ 2019;364:!1293).

In 2009 Public Health England began recuiting millions of women to the Age Extension Trial of Breast Cancer Screening (AgeX). The trial has been criticised for its design, conduct, and lack of transparent scientific processes. which may render it not robust enough to inform policy decisions. Even more serious, “Participants’ understanding and consent to participate in research are not checked despite the risks of surgical and psychological harm.”

At the common-sense level screening for cancer looks like a no-brainer to many people.  The earlier it’s caught, the better the chance of a cure, right? Well,that is debatable, at least for breast cancer. Many breasr cancers, particularly in older women, would never cause them any problems during their natuurl life span, so treating them will involve them in unnecessary surgery and quite probably inflict psychlogical harm that will last for the rest of their lives.

The balance of benefits and harms from breast cancer screening remain contested.  Three years after Age X began, an architect of the breast cancer screening programmes argued that deaths after treatment of screen diagnosed breast cancer may exceed those in an unscreened population.  In 2014. the Swiss medical board advised its government to stop recommending mannography screening.  In 2016, an open letter from French scientists who had conducted a consultation into France’s breast cancer screening called for a halt to screening for low risk women under 50, and an end or thorough review of the programme for women over 50.

This is reminiscent of the question of PSA screening for prostate cancer in men.

 

 

An instructive acupuncture case

 

An alternative to sham?

 

For reasons I discussed in another post, research on whether acu “works” is bedevilled by the difficullty of finding a control procedure that doesn’t actually do anything. A different approach to the testing of treatments is to use patients as their own controls. This is not often done but it remains a possibility. The idea is to study individuals with long-term symptoms and compare what happens when they are receiving treatment to when they are not. In a paper titled “Patients as their own controls in studies of therapeutic efficacy: Can we trust the results of non-randomized trials?”, Noel S. Weiss and Susan R. Heckbert (Journal of General Internal Medicine July 1988, Volume 3, Issue 4, pp 381–383) endorsed its utility.

This approach has the potential to provide a valid measure of efficacy if the condition being treated is chronic, if the effect of the therapy given prior to the first evaluation of patient status does not linger into the second period of the study, and if the means by which the evaluation of patient status is performed at the two points in time are comparable.

Case report

I want to describe a case of this kind. The patient is myself so I can’t claim any kind of objectivity, but I think the long period of observation makes it interesting. Anyway, for what it’s worth, here it is. Continue reading “An instructive acupuncture case”