RCN, CAM and the menopause – Part two – Credulous nonsense

In part one of this short series on the Royal College of Nursing’s “Complementary approaches to menopausal symptoms – RCN guidance for nurses, midwives and health visitors” I looked at the guidance on herbal remedies.  Now I’m moving on to cover what the document has to say about the role of acupuncture, aromatherapy, reflexology and homeopathy in treating symptoms of the menopause. 

Just like its approach to herbal remedies, we shall see that this document falls into the pitfalls of appeals to common practise and tradition; along with a predilection for cherry-picking dubious positive evidence; ignoring more credible negative evidence. 

Before we begin, it is worth remembering that the RCN counsels its members: 

“… You should not recommend products or therapies over others without a good evidence base …”

So, do any of these complementary therapies have a good evidence base?  The guide seems to answer in the affirmative. 

“A wide range of complementary therapies can be used to reduce or stop the short term symptoms of the menopause, but not to prevent or treat osteoporosis.” [Emphasis mine]

Therefore, we should expect to see the document provide details of a good evidence base which supports the assertion that, “complementary therapies can be used to reduce or stop the short term symptoms of the menopause”. 

Next the guide seems to have second thoughts, as it goes on to state:

“Each therapy has benefits and pitfalls. For the majority, there is a lack of RCTs or hard evidence of use, although many appear to have been used successfully for years.  Since many are taken by individuals, they are difficult to study in a traditional medical setting.” [Emphasis mine]

If there is, “a lack of RCTs or hard evidence of use” then how can the evidence base be described as “good”?  The RCN seems to accept that, “A wide range of complementary therapies can be used” and it insists that recommendations made by its members are supported by a good evidence base;  yet it concedes, “there is a lack of RCTs”, in other words – a lack of good evidence. 

The RCN, again, fall into the trap of an appeal to tradition.  Just because something has been used for years doesn’t mean that it actually works.  They also appear to be falling for a common CAM excuse – that there is something ‘special’ about the therapy or the way it is delivered which makes fair trials somehow difficult. 

After this preamble it assesses the evidence, such as they claim it to be, for each in turn. 

Acupuncture

This discussion starts in a way that we shall see is typical of its approach to these therapies: credulous acceptance of the putative mechanism of action. 

“Acupuncture uses needles put into the skin at specific points on the body, whereas acupressure uses pressure on these points. These points then correspond to meridian or energy channels, which are believed to link to internal organs and unblock energy and balance the flow, correcting illness and psychological problems. ” [Emphasis mine]

Needless to say, or rather it should be, that there are no such things as, “meridian or energy channels” except, perhaps, as some sort of metaphor: they have no objective reality.  The RCN should not be saying otherwise! 

“Although acupuncture has been used for thousands of years, there are few good quality trials on its use in treating menopause.” 

It would be more honest to say that there have been no good quality trials to support its use in treating the menopause.  The document goes on to inadvertently demonstrate this point. 

“Those studies that have been conducted have shown no harm, and have shown benefits in relieving hot flushes, night sweats and general mood, especially when site specific points for menopause have been used (Cohen, 2003). Acupuncture has also been used in women with breast cancer and tamoxifen-induced hot flushes, increasing general wellbeing (Walker et al., 2004).”  [Emphasis mine]

Cohen et al. was published in the prestigious Holistic Nurse Practitioner.  It is a trial based on all of 17 women (they started with 18 but one dropped out), comparing, “needling specific acupuncture body points related to menopausal symptoms such as hot flushes” with a control group given, “acupuncture treatment … designated as a general tonic (shen mein) … specifically designed to benefit the flow of Ch’i.”  What you have to dig into the paper to find is that by the fourth month of the trial (one month post-treatment) the headline outcome of ‘Hot Flash Severity’ is practically indistinguishable for the control and treatment groups; actually, the control group fared very slightly ‘better’.  The two groups were also practically indistinguishable for the ‘Sleep Disturbance’ outome.  As this can be seen very clearly in the two relevant figures from the paper; I have re-plotted the data and show them below.

 

Sleep Disturbance (data from Cohen SM, Rousseau ME and Carey BL (2003) Can acupuncture ease the symptoms of menopause? Holistic Nurse Practitioner, 17(6), pp.295–299.)

Hot Flash Severity (data from Cohen SM, Rousseau ME and Carey BL (2003) Can acupuncture ease the symptoms of menopause? Holistic Nurse Practitioner, 17(6), pp.295–299.)

My worries are compounded by the clear impression that the authors actually believe the underlying philosophy behind acupuncture.  For example, the control treatment is, “specifically designed to benefit the flow of Ch’i.”  There is no hint of healthy scepticism or objectivity; no caveats like ‘it is claimed that’ are in evidence.  It seems that the authors actually believe in Ch’i.  Of course, the name of the journal implies a particular bias – Holistic Nurse Practitioner is a statement of belief and intent. 

This is a junk study in a junk journal.  The RCN should not have given it the time of day; instead they make it look like respectable evidence for this intervention. 

Even worse, Walker et al. was actaully published in a less credible journal: European Journal of Oriental Medicine.  This august publication is not even listed in PubMed!  Neither is this publication a trial or a review: the abstract shows that it is a retrospective customer satisfaction survey. 

“A total of 16 women participated in focus groups held at least 9 months after their last acupuncture treatment. The discussions addressed the following topics: problems experienced before treatment; anticipation and expectation; experiences of the treatment session itself; effects of treatment; and overall impressions. It was found that traditional acupuncture is an acceptable treatment for women with menopause-like symptoms resulting from Tamoxifen. Patients found the overall experience enjoyable, and felt that their quality of life improved whether or not their symptoms were relieved.” (Walker et al., 2004).”  [Emphasis mine]

Asking women to recall the effects of a treatment nine months later doesn’t seem like a very good idea to me.  I have problems remembering what I was doing last week! 

The authors of this document not only included these two poor ‘studies’: they overlooked a review published in a prestigious journal the year before they released their guide. 

“Overall, controlled studies of acupuncture did not reliably improve hot flashes, sleep disturbances, or mood when compared with nonspecific acupuncture, estrogen therapy, or superficial needling” (Carpenter and Neal, 2005)  [Emphasis mine]

It is notoriously difficult to design a good placebo control for acupuncture; however some workers have at least made credible attempts.  The two acupuncture based controls commented on by Carpenter and Neal show that it doesn’t appear to matter where you stick the needles, or how deeply. 

There is no support for the RCN’s view that acupuncture has been shown to have benefits, “especially when site specific points for menopause have been used.” 

The way the evidence has been handled on this topic shows clear bias.  The RCN say that acupuncture has “shown benefits” and can improve “general wellbeing”; if making such judgements requires, “a good evidence base” as the RCN state, then the evidence provided has not “shown” that acupuncture provides “benefits” in the treatment of symptoms of the menopause. 

Aromatherapy

Aromatherapy oils do smell very nice.  However, the RCN would have us believe that:

“Aromatherapy treats illness with concentrated plant oils, most commonly applied through massage.”  [Emphasis mine]

What is the evidence base for the application of nice-smelling oils? 

“There is only one reported use of aromatherapy for menopausal symptoms, when a small study used oils and massage. All of the participants reported an increase in physical and mental health (Murakami et al., 2005)”  [Emphasis mine]

Just like the acupuncture evidence, this was a very small study (n=15).  It was also uncontrolled.  That this is cited seems slightly odd when the guide itself cautions that, “menopausal symptoms are usually, by their nature, self-limiting and will generally improve over time”.  This study does not provide good evidence by any stretch of the imagination. 

Given the RCN’s requirement for good evidence to back up recommended therapies, it is unfathomable that a table of, “…oils and their suggested uses for menopausal symptoms” is provided which, “is based on common usage, rather than an evidence base.”  Again, the RCN fall for the fallacy of appeal to common practise. 

It is, perhaps, worth noting that a larger positive study on the use of aromatherapy has recently been published (Hur et al., 2008).  It is small: 25 women were in the treatment group and 27 were in the control group.  Neither was assignment to either treatment or control groups randomised.  This is a fatal flaw; the originator of significance testing, R A Fisher noted: 

“The theory of estimation presupposes a process of random sampling. All our conclusions within that theory rest on this basis; without it our tests of significance would be worthless.” [Fisher RA. Development of the theory of experimental design. Proceedings of the International Statistical Conferences 1947;3:434-39.]  [Emphasis mine]

Also, the control group was, “wait-listed”: they got no attention or therapy of any kind.  Contrast this with those who were treated; they enjoyed a thirty-minute, “massage on the abdomen, back and arms using lavender, rose geranium, rose and jasmine in almond and primrose oils once a week for 8 weeks.”  Sounds good to me;  it’s not that surprising then that eight weeks later they said they felt better than those women who were left to their own devices! 

I do hope that this new work doesn’t figure as ‘evidence’ the next time the RCN review this subject. 

So, again the RCN scrape the bottom of the barrel in what seems to be a desperate attempt to provide positive evidence. 

Reflexology

Now, I’m very fond of a foot massage: it feels very nice.  However, reflexology is just bizarre; the RCN says: 

“Reflexology uses the energy channels and meridians similar to those in acupuncture and acupressure, but contained within the feet or hands. It aims to help the body’s energy circulate effectively and claims to be effective in PMS and menopause, although there is little published data.  [Emphasis mine]

Again the RCN credulously accepts CAM myths at face value:  there are no energy channels or meridians.  Where is the evidence that a measurable flow of energy is being aided by fiddling with someone’s feet? 

Even the RCN don’t seem to have the heart to dredge up some awful positive ‘study’ to support this one.  Again, I wonder why they didn’t refer to the review by Carpenter and Neal: 

“… existing evidence does not indicate a beneficial effect of … reflexology in the treatment of hot flashes and other menopausal symptoms.” (Carpenter and Neal, 2005) [Emphasis mine]

Could it be that it reports a negative finding? 

They do find room, however, to provide a diagram mapping out mythical “reflecting areas”.  It has some entertainment value.  Looking at it makes me wonder why reflexology hasn’t spawned a lethal martial art; just look at what damage you could do attacking someone’s feet if it wasn’t nonsense! 

Homeopathy

Inevitably homeopathy is discussed.  The document makes some surprising claims:

“There are some studies that have shown that this is beneficial in women in the menopause, both natural menopause and where menopause has been induced. Homeopathic remedies have been demonstrated to reduce hot flushes and to improve quality of life (Jacobs et al., 2005; Thompson and Reilly, 2003).”  [Emphasis mine]

These are strong statements.  Do these studies actually show homeopathy to be “beneficial”?  Have, “Homeopathic remedies …been demonstrated to reduce hot flushes and to improve quality of life”? 

The short answer is no.  Contary to what the RCN claim, Jacobs et al. actually stated, “There was no significant difference found in the primary outcome measure, the hot flash severity score” 

In this trial subjects, “were randomized to receive an individualized homeopathic single remedy, a homeopathic combination medicine, or placebo”.  The authors did report a, “statistically significant improvement in general health score in both homeopathy groups” but concluded that, “Small sample size precludes definitive answers“. 

Ernst had this to say about Jacobs et al. 

“Jacobs and colleagues evaluated homeopathy for menopausal symptoms in 83 breast cancer survivors …No significant differences were found between the three groups in terms of symptom score over a 1-year period. A significant improvement in general health score was observed in both homeopathy groups as compared with the placebo group. A significant increase in headache was observed in the combination homeopathy group.” (Ernst, 2007) [Emphasis mine]

Odd that the RCN don’t mention the headaches!  In any event, all we have here is typical homeopathic noise rather than a therapeutic signal.  This is a small trial with a negative outcome on its primary measure.  It doesn’t “show” that homeopathy is beneficial or “demonstrate” that it can reduce hot flushed or, for that matter, improve general health! 

What of Thompson and Reilly?  They report on a small trial (n=45) with no control.  As they say, “A placebo-controlled trial would be the next stage in this line of inquiry.” It’s hard to argue with this comment, other than to say that for symptoms that the RCN acknowledge tend to be self-limiting – a control group is essential.  It is disingenuous to claim that this trial can “show” or “demonstrate” anything; and it’s hard to see why the RCN claim that it can. 

As Carpenter and Neal observed, “Homeopathy significantly improved subjective measures of hot flash frequency and severity, mood, fatigue, and anxiety in uncontrolled, open-label studies.” (Carpenter and Neal, 2005).  If someone knows they are being treated and there are no controls, then expectation and regression to the mean, amongst other biases, can almost be guaranteed to deliver false positives. 

Given the weakness of the evidence presented, it really cannot be justified for the RCN to claim, “Most of the major homeopathic remedies may be used to treat the symptoms of menopause.”  Where is the evidence to back this up? 

To compound matters the document then lists homeopathic treatments and provides evidence-free assertions of their utility.  This is inciting their members to break their own code of practise. 

The elephant in the room with homeopathy is always it basic biological implausibility.  This includes, but is certainly not limited to, the extreme dilutions generally used.  The RCN do broach this topic, but with unimaginable cack-handedness: 

“Some scientists believe that the dilution of homeopathic preparations is so great that no active ingredient remains in the remedies prescribed.  They insist that positive effects observed are down to placebo effect or the benefits of one-to-one time spent with the practitioner. However, homeopathic treatments have been used successfully for the past 200 years and have been used to treat animals and children where the placebo effect is much less likely to occur.”  [Emphasis mine]

This is just straightforward homeopathic propaganda.  Some scientists do not, “believe that the dilution of homeopathic preparations is so great that no active ingredient remains in the remedies prescribed. ”  Anyone who understands the nature of matter, the Avogadro number and a bit of arithmetic can easily show that the chances of any of the original agent being present in commonly used homeopathic ‘potencies’ is so vanishingly small as to be, for practical purposes, zero! 

Anyone who contends otherwise is not a scientist at all.  Even some homeopaths accept this bit of science.  It is gravely insulting that the RCN call this a belief. 

The old canard about children and animals not being subject to a significant placebo effect (or at least, in the case of animals, classical conditioning) is false.  This also obscures another important issue: very young children and animals cannot describe how they are feeling – it is inferred by their carers.  This latter group is, of course, vulnerable to significant cognitive biases. 

And Finally … 

This document starts off quite well.  It has problems in how it handles the evidence for herbal treatments and is shot through with fallacious reasoning.  When it moves into the other CAM therapies it degenerates into a credulous propaganda piece. 

Is it a bit harsh to call this propaganda?  Well, I’m at a loss to see it any other way when: 

• Desperately poor quality studies are cited as long as they are ‘positive’. (Cohen, 2003; Walker et al., 2004; Murakami et al., 2005)
• The RCN has claimed that at least one trial was ‘positive’ when it was not. (Jacobs et al., 2005)
• Negative evidence has been ignored. (Carpenter and Neal, 2005; Hartley, 2004; Elsabagh, 2005; Tice, 2003)
• Interpretations are placed on studies that they cannot support.
• They scrupulously ignore their own warnings about the placebo effect and the natural history of these symptoms.
• They appear to accept at face value mythical concepts like energy channels and meridians.
• Straightforward science is classed as a minority belief.
• Standard CAM falsehoods are trotted out.

 Overall, I think that the conclusions reached by Kronenberg and Fugh-Berman in 2002 still hold: 

“…Clinical trials do not support the use of other herbs or CAM therapies.” (Kronenberg and Fugh-Berman, 2002)

I really think that the RCN ought to be saying that very clearly; or providing solid evidence to back up their claims.  As is stands, this document ill serves the needs of nurses, midwives, health visitors and the women they care for.

[BPSDB]

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