A canna’ change the laws of physics

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Mail menopause myths

Posted by apgaylard on March 26, 2009

bigstockphoto_hand_outstretched_with_a_pile__1993865It is no great surprise when the Daily Mail gets it wrong on health (or other scientific) issues.  They have a long and inglorious record in this regard.  A recent article on the menopause continues this fine tradition. 

Neither is it unusual to find therapies of no, and even disproven, worth promoted for the treatment of the symptoms of the menopause.   This topic seems to provide rich pickings for people promoting treatments ranging from the sensible but speculative through to downright outrageous quackery.  The confluence of a condition which potentially affects more than half of the world’s population, self limiting symptoms and the difficulties associated with weighing the risks of HRT make for a potent mix.  The market is large, the media are generally credulous, efficacy is difficult to establish and there are fears to play on.  In many ways an ideal target for so-called CAM.

Setting aside the discussion of HRT – which I’m not going to cover – what interested me about this article is the number of medical professionals who appeared to endorse products that are most likely worthless.  (Note: this comment does not refer to the associated piece by Catherine Collins, “How healthy diets help control the symptoms”.  For sensible advice on HRT see NHS Choices, “HRT and the menopause“) 

To start with, I didn’t much care for the article’s title (not the journalist’s fault I know): “The experts’ guide to menopause (and they should know … they’ve all been there)”.  Although it is a commonly expressed sentiment that something can only be understood by someone who has experienced it: just a little thought shows it to be false.  

First, experiencing symptoms does not necessarily confer the knowledge required to understand how they may be made better.  These are different kinds of knowledge.  Also, not having direct experience of an illness does not prevent us from studying it and understanding how it may be cured. 

Second, our own limited subjective experience can mislead us.  For instance, if we feel unwell, take a pill and feel better there is no way for us to be sure that the pill actually worked.  Was it coincidence?  We cannot tell; perhaps we were going to get better anyway.  Has our condition actually improved?  We don’t really know; maybe we just feel better.  

Sometimes we cannot even be sure that there was anything really wrong with us in the first place. Finally, our own experience alone can never tell us whether someone else taking the same remedy for would experience the same apparent improvement. 

To limit the chances of being misled we need the systematic aggregation of many consistently recorded experiences: appropriately designed clinical trials.  This is vital when discussing symptoms associated with menopause, as the RCN point out: 

“It is also important to recognise that menopausal symptoms are usually, by their nature, self-limiting and will generally improve over time.”

Hence an appropriately designed trial must contain a well-matched control.  Given the difficulty in studying interventions to relieve symptoms of this kind it is also important to set some objective criteria to help gauge the reliability of any published studies and look at the picture painted by the literature as a whole. 

These niceties seem to have been forgotten by some of the Mail‘s medical ‘experts’. 

For example a GP, Dr Sally Hope, was quoted as recommending dietary phytoestrogens (“plant molecules found in beans, peas, lentils, flax, linseed and soya products that act weakly on the body’s oestrogen receptors”) and red clover tablets.  Of the latter she opined they “have been found to be quite effective.” 

Yet, the evidence that supplements containing phytoestrogens help with menopausal symptoms is not persuasive.  For instance, the US NIH consensus statement (2005) (pdf) summarised the evidence in this way: 

“Isoflavones and Other Phytoestrogens

A substantial number of studies of phytoestrogens and isoflavones have been conducted, motivated by epidemiologic data showing differences in levels of menopausal symptoms in countries with different levels of these nutrients in their diets. Because most of these products are not manufactured in a standardized way, they may differ in composition from trial to trial. Several studies of soy extracts suggested that they may have some mitigating effect on hot flashes. Trials of dietary soy are mixed; the majority of studies did not indicate benefit. Adverse event information provided in these studies is very limited, and long-term side effects have not been investigated.” [Emphasis mine]

The more recent Cochrane Review of “Phytoestrogens for vasomotor menopausal symptoms” (Lethaby et al, 2007) stated: 

“Many women have started using therapies that they perceive as ‘natural’ and safe but they often do not have good information about the potential benefits and risks. This review has evaluated the benefits, risks and acceptability of treatments based on phytoestrogens, a group of plant-derived chemicals that are thought to prevent or treat diseases. Phytoestrogens are found in a wide variety of plants some of which are foods, particularly soy, red clover and alfalfa. Most of the trials in this review were small, of short duration and poor quality. Some trials found a slight reduction in hot flushes and night sweats with phytoestrogen-based treatment but overall there was no indication that phytoestrogens worked any better than no treatment.” [Emphasis mine]

As for red clover, the NIH consensus statement (2005) said:

“Red clover leaf (Trifolium pretense) contains phytoestrogens compounds and is believed to work as a weak estrogen.  However, studies suggest that it is not effective in reducing hot flashes. “[p.20] [Emphasis mine] 

Perhaps the best study done to date was reported by Tice, et al. (2003).  This tested two commercially available supplements containing red clover extract (Promensil and Rimostil).  The authors concluded: 

“Although the study provides some evidence for a biological effect of Promensil, neither supplement had a clinically significant effect on hot flashes or other menopausal symptoms when compared with placebo.”  [Emphasis mine] 

This is consistent with NCAM’s current summary of the evidence: “… five controlled studies found no consistent or conclusive evidence that red clover leaf extract reduces hot flashes.” 

So red clover pills are not “quite effective”.  The best evidence suggests that they are ineffective.  It is shocking to see a GP get this so badly wrong in print. 

A radiologist didn’t do much better.  Dr Sarah Burnett offered, “Wild yam root – a West Indian, non-oestrogenic remedy, (£3.69, http://www.hollandand barrett.com) – helped.” 

There is not much research listed on PubMed: just three relevant papers.  One concludes that there was insufficient data (Haimov-Kochman and Hochner-Celnikier 2005).  A review by Carroll (2006) cites Komesaroff et al (2001)  who conducted a, “double-blind, placebo-controlled, cross-over study” on 23 women, “suffering from troublesome symptoms of the menopause.”  They concluded: 

“This study suggests that short-term treatment with topical wild yam extract in women suffering from menopausal symptoms is free of side-effects, but appears to have little effect on menopausal symptoms.”  [Emphasis mine]

Now, maybe she feels that it did help.  In the absence of robust trial data she cannot be sure.  She can have absolutely no idea if it would help anyone else.  Under these circumstances promoting a Holland and Barrett product using her professional credentials seems untoward, even if it is one of the cheaper supplements. 

The silliest piece of advice from a medically qualified contributor came from Jan Brockey, “a menopause specialist nurse at the John Radcliffe Hospital, Oxford”.  I really hope that she was misquoted and didn’t really say: 

“I’ve also started to use a magnetic device called LadyCare (£19.95, www.magno-pulse.com), which clips on to my underwear near the pelvis area. The magnet is thought to balance moods and help hot flushes and insomnia by boosting hormone levels.'”  [Emphasis mine]

There is no reason to suppose that magnets like this can have any effect on the body, let alone improve specific symptoms.  Now, it is true that the manufacturers claim some supportive evidence, but it’s just a worthless consumer survey.  

Looking for some credible evidence by entering “menopause AND magnets” into PubMed returned two review articles: a survey of research opportunities (Sherman et. al., 2005) and a review of the evidence base for using various so-called CAM interventions to treat menopausal symptoms (Carpenter and Neal, 2005) who had this to say about ‘magnetic therapy': 

“A single pilot study investigated the use of magnets for hot flash relief.  In this small randomized, placebo-controlled, crossover study, 11 breast cancer survivors completed a 24-hour baseline hot flash monitoring session, wore the magnetic or placebo devices for 3 days, completed a post treatment 24-hour hot flash monitoring session, experienced a 10-day washout period, and then crossed over to the opposite study arm. Magnetic devices [...] and placebos were placed over 6 acupressure sites that are used in the treatment of hot flashes. There is no known mechanism of action for magnet therapies for the treatment of hot flashes. Magnetic therapy was no more effective than placebo in decreasing hot flash severity and, contrary to expectations, placebo was significantly more effective than magnets in decreasing objective measures of hot flash frequency (e.g., sternal skin conductance) and subjective hot flash distress (e.g., self reported measures of distress). Whether improvement was related to a placebo effect or naturally occurring variation in objective hot flashes throughout the study period is unknown. In addition, the treatment and placebo devices were not completely benign: 55% of participants experienced itching and/or skin reactions due to the adhesive used to affix the magnetic and placebo devices to the skin.” [Emphasis mine]

There is no known way that magnets could improve these symptoms and no evidence that they do.  I would have expected a menopause specialist nurse to know that – it would be a worry if she does not.  Though, if does know that magnets have no merit, then why is she using her professional credentials to plug them in a newspaper? 

Given the RCN’s credulous view of other alternative therapies; their appeal to very poor evidence, perhaps it’s not too surprising that a nurse might mirror these failings.  It is still disappointing though. 

Another fascinating aspect of the Mail piece is that some of the ‘experts’ who had no medical background gave advice that was apparantly no less reliable. 

It is true that Kim Knight, a life coach from surrey, chose to promote a supplement for her symptoms.  However, a life coach is no sort of medical authority.  It has to be said that her favoured approach: “Solgar PM Phytogen Complex (£20.35 for 60 tablets, www.solgarvitamins.co.uk)” is more plausible than magnets! 

The PM in the product name refers to the Korean herb Pueraria mirifica.  There are a few published relevant trials.  PubMed currently lists two trials of PM for the alleviation of menopausal symptoms. 

Chandeying and Sangthawan (2007) reported a phase III trial which compared PM against conjugated equine estrogen (CEE) both with and without medroxyprogesterone acetate (MPA) for the alleviation of menopausal symptoms in perimenopausal women.  Of the 71 patients enrolled, 11 were excluded, “for failing to complete the initial work-up and follow-up.”  The PM group (A) were given a daily dose of 50 mg “raw material” the control group (B) received, “0.625 mg of conjugated equine estrogen (CEE) with/without 2.5 mg of medroxyprogesterone acetate (MPA)”  The results for PM and CEE were not significantly different.  Chandeying and Lamlertkittikul (2007) published a very small open-label study (n=10, with only 8 cases evaluated).  This involved administering, “oral 50 and 100 mg capsule, once daily for six months”.  Improvements in symptoms were seen over the trial, but, as the authors noted, “the data is insufficient to draw definite conclusions regarding the estrogenic effect.” 

In addition, there are currently three which look at the possible health benefits of PM for post-menopausal women.  Okamura et al. (2008) reported on a small randomized, double-blind, placebo-controlled clinical trial (n=19) which showed a, “beneficial effect on lipid metabolism in postmenopausal women”.  Manonai et al. (2008) looked at lipid profiles and biochemical markers of bone turnover rates in healthy postmenopausal women.  Their trial comprised 51 women in the treatment group and a further 20 assigned to placebo.  They concluded, “Pueraria mirifica at a dose of 20, 30, and 50 mg/d for a 24-week period demonstrated an estrogen-like effect on bone turnover rate.”  But it did not, “demonstrate an estrogen-like effect on endometrial thickness and endometrial histology”. Manonai et al. (2007) had previously reported separately on the effect of Pueraria mirifica on vaginal symptoms.  They claimed that PM, “was proven to exhibit estrogenicity on vaginal tissue, to alleviate vaginal dryness symptoms and dyspareunia, to improve signs of vaginal atrophy, and to restore the atrophic vaginal epithelium in healthy postmenopausal women.” 

It might just be that Pueraria Mirifica (PM) can help with menopausal symptoms.  However, these are small preliminary trials published in a relatively minor medical journal (J Med Assoc Thai).  Given that it is early days for research into the use of this herb – it’s probably best not to get carried away.  The historic trend in this area is for initial enthusiasm melt away as larger and better studies are performed – black cohosh and red clover are prime examples. 

So, the life coach makes much more sense, on this issue, than the “menopause specialist nurse”.  As does a “natural health author” called Maryon Stewart.  She suggests relaxation and moderate exercise (“a walk in the park”) to “combat [...] hot flushes”. 

Exercise is a generally good thing.  The Royal College of Obstetricians and Gynaecologists says that “regular sustained aerobic exercise may help with menopausal symptoms”. This is based on large-scale observational studies, which have generally shown a positive correlation between exercise and control of vasomotor symptoms.  

Unfortunately there isn’t any good evidence from intervention studies that it will help with hot flushes directly.  A recent Cochrane Review on the topic concluded: 

“Searches revealed only one very small trial which found HRT was more effective than exercise. We found no evidence from randomised controlled trials on whether exercise is an effective treatment relative to other interventions or no intervention in reducing hot flushes and night sweats in menopausal women.” [Daley et al., 2007

This review highlighted that most of the published trials were of low quality – of the nineteen reports initially considered eligible, all but one was excluded from the review on pre-determined quality-control criteria.  Perhaps it was one of these that, “shows [exercise] can reduce hot flushes by 60 per cent. ” 

Relaxation is a generally good thing as well.  But can this really help with menopausal hot flushes?  This is a topic which has received a fair amount of attention (PubMed search for ‘menopause AND relaxation’) 

According to a review by Umland (2008)

“Relaxation techniques may also provide relief of VMS; however, only paced respiration (i.e., slow, controlled, diaphragmatic breathing) has been proven effective in clinical trials.” 

There are lots of other good reasons to exercise; it’s very cheap and low-risk.  Similarly, it’s nice to relax.  However, there’s no good evidence to show that, aside from paced respiration, either will combat hot flushes. 

Stewart also claimed to take “an alternative remedy called Femenessence (£19.99, http://www.nutricentre.com), made from organic Peruvian Maca root, which has been shown to raise oestrogen and progesterone levels, resulting in fewer hot flushes and night sweats, and improved sleep and mood.” 

As we shall see this is substantially over-stating the evidence for beneficial effects from taking Maca (Lepidium meyen).  For instance, searching PubMed for both ‘Maca AND menopause’ and ‘Lepidium meyen AND menopause‘ only yielded a single reference: Brooks et al. (2008).  The authors concluded: 

Preliminary findings show that Lepidium meyenii (Maca) (3.5 g/d) reduces psychological symptoms, including anxiety and depression, and lowers measures of sexual dysfunction in postmenopausal women independent of estrogenic and androgenic activity.” 

Although this trial was a, “a randomized, double-blind, placebo-controlled, crossover trial” it included just fourteen participants.  This is very small – no doubt why the authors called their findings, “preliminary”.  Anyway, even if Maca does help – according to this study – it doesn’t do it by raising oestrogen and progesterone levels. 

However, two recent papers in the open access International Journal of Biomedical Science, which is not listed on PubMed, do report favourable outcomes from the use of “Pre-Gelatinized Organic Maca” (Maca-GO).  Meissner et al (2005) reported on two small, “double-blind, placebo-corrected clinical pilot stud[ies]“. 

These used a 2g/day dose of Maca-GO.  Four serum hormones (LH, FSH, E2 and PG) were measured along with Greene’s Menopausal Index.   In each case the experimental design had a one-month placebo phase.  These were followed by a two month treatment phase for the first trial and an eight month treatment phase for the second.

This trial design is clearly problematic for assessing the impact of an intervention on symptoms which are self-limiting and generally improve over time. 

Of the 20 subjects who started the first trial; eight dropped out (40%).  This alone calls into question the results.  The reasons given by the authors were: sickness (2), personal reasons/holidays (2) and compliance (4).  These were all excluded from the analysis.  So the analysis was not conducted on an “intention to treat” basis.

The second trial studied just eight women over a nine month period (one month on a placebo and eight on Maca-Go). 

The authors concluded that most of the women in the studies had experienced a “substantial reduction of menopausal discomfort”; they noted that there was a, “distinctive placebo effect” and that a, “more complex study” was required. 

Following this, two of the same authors (Meissner et al., 2006) published the results of another small (n=20) trial.  In this case a, “double blind, crossover, randomized” design was used.  The women were split into two groups.  One group was given a placebo, the other 2g/day of Maca-Go.  After two months the groups were swapped: those taking Maca-Go were put on the placebo and vice versa.  The authors summarised the results: 

 “Two months administration of Maca-GO significantly alleviated symptoms of discomfort observed in majority of women involved in the study (74%-87%) as assessed by Kupperman’s Menopausal index. This was associated with significant increase in E2 and FSH, Progesterone and ACTH levels, and reduction in blood pressure, body weight, Triglycerides and Cholesterol levels. There was a distinctive placebo effect observed at the beginning of the study.” 

This is a small study which assessed a lot of parameters over time; consequently, it is quite likely that some statistically significant results could have arisen by chance.  Sensibly, the authors concluded that: 

“Preliminary observations outlined in this paper justify further clinical study on use of Maca-GO in perimenopausal women, so as to assess effectiveness of Maca as a potential non-hormonal therapeutic supplement which may help women to reduce discomfort associated with perimenopause as an alternative to, or lessening dependence on HRT program.” 

There do not appear to have been any significant studies published since.  So, again, there might be something in this: but the evidence isn’t really there.  All we have are preliminary findings from small trials. 

Stewart’s suggestions are a bit speculative.  Still, a “natural health author” is not an authority on health – though people may expect otherwise. 

Fiona Kirk, a nutritionist, suggested dietary phytoestrogens (particularly soy).  We have already seen that the NIH concluded, “Trials of dietary soy are mixed; the majority of studies did not indicate benefit.”  Again, nutritionists are not medical experts (anyone can call themselves a nutritionist) but the advice is no worse than Dr Hope’s. 

Overall, this provides one more piece of evidence (as if any more were needed!) that the Mail cannot be trusted to provide reliable reporting on important medical issues.  

It also shows that some medical professionals aren’t as careful with public statements as they should be.  That’s no great surprise either. 

More fundamentally, this piece stands as a reminder that personal experience on its own doesn’t confer insight; neither should authority outweigh evidence.

Acknowledgements

dvnutrix for having the stomach to read the Mail, and the kindness to point out articles of interest.

Note

I don’t give medical advice.  If you need that consult a properly qualified medical doctor. 

Edits

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5 Responses to “Mail menopause myths”

  1. [...] Mail <b>menopause</b> myths A canna change the laws of physics [...]

  2. jdc325 said

    Nice work. You seem to be fast becoming the badscienceblogs.net resident expert on the menopause – search.

  3. Very impressive.

    Re the harm issue and phytoestrogens. There has always been one thing that has always bothered me about phytoestrogens that doesn’t get mentioned much. When GPs prescribe HRT to women we don’t give unopposed oestrogens to women without a uterus ie you always give it with a progestogen at some point in the cycle. This is cos you get more uterine cancer if you don’t. It took some major digging to winkle out that kind of epidemiological wrinkle.

    Even if there were some effect (and you have been through the absence of such) I would remain chary about the risks without similar large studies.

    It also shows that some medical professionals aren’t as careful with public statements as they should be. That’s no great surprise either.

    I’m beginning to think what we need is a dedicated name-and-shame blog for some doctor/GP statements. Might not make me too popular though…

  4. apgaylard said

    Thanks for the kind comments. I have also had an e-mail from Natural Health International, providing some more reference material on Maca-Go which it looks like my searches missed – though they don’t seem to be referenced in PubMed. Anyway, I may do a more complete piece on Maca.

    jdc325 Can’t disagree too much (though I’d call myself a curious layman rather than an ‘expert’). It’s odd where this blogging thing can take you.

    northerndoctor Interesting take on the potential for harm. It often seems to be assumed that ‘natural’ means risk free – or at least lower risk.

    The name/shame thing is interesting. I’m sure that no professional would be popular taking that tack within their profession. Doesn’t mean it shouldn’t be done though. I did wonder whether the overt commercialism in the contributions would raise any ethical concerns at the GMC?

  5. badania said

    badania…

    [...]Mail menopause myths « A canna’ change the laws of physics[...]…

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