Homeopathy Works for Menopausal Hot Flashes: Gold Standard Study

September 16, 2012 by admin in Science with 26 Comments

Why would you use hormone replacement therapy, which causes the conditions it’s given to prevent, when a scientific study shows that a homeopathic preparation is effective in menopause?

by Heidi Stevenson

Hot flashes are the bane of many women going through menopause. They can inconvenient, embarrassing, and even crippling. They are, in fact, a primary reason that many women are willing to risk taking hormone replacement therapy (HRT). The risks that go along with HRT, though, are not necessary. A new study documents that a combination of homeopathic remedies, currently marketed in France as Acthéane, is effective.

The study is what modern medicine likes to call the Gold Standard: double-blind and both placebo and randomly controlled. It compared two groups of women over 50 years of age, who had not had periods for at least one year, and who had spontaneously complained, during routine gynecological visits, of hot flashes that had lasted for at least two years and had caused significant repercussions in their social or professional lives.

The chart on the right shows how the patients were separated into two groups, 50 who were given the homeopathic prescription Acthéane (referred to as BRN-01 in the study) and 51 into the placebo group.

The two groups were quite similar in age, weight, smoking status, lifestyle, and urban-professional status. None had taken HRT therapy in the past.

The women were each given one dose (2-4 tablets) of either placebo or Acthéane every day starting on the third day of the study and continuing for 12 weeks.

The results on hot flashes were a significant reduction, as shown by the graph below:

Acthéane produced a near-immediate drop in the severity of hot flashes, which continued throughout the trial. The hot flash score (HFS) after the first week was 15.3 in the Acthéane group and 12.7 in the placebo group, a difference of 2.6, or 17% lower. Both groups’ HFS scores were reduced during the course of the trial, but the difference at the end amounted to 33% – a highly significant reduction.

The study also looked at other menopausal symptons, as the graph below shows:

Most symptoms were significantly reduced, especially noting libido disorders, nervousness and irritability, and headaches.

Adverse events were meticulously recorded. There were 5 in the active Acthéane group: diverticular intestinal abscess, thirst at night, cyst removal from bottom of left foot, pruritis, and migraine. The 4 adverse events in the placebo group were gastritis, headaches, left wrist fracture (from a fall), and recurrence of hot flashes. None of the adverse events were believed to be related to the homeopathic remedy.

How You Can Benefit from this Homeopathic Formulation

Acthéane is a combination of the following homeopathic preparations:

Actaea racemosa 4C
Arnica montana 4C
Glonoinum 4C
Lachesis muta 5C
Sanguinaria canadensis 4C

If you’re in France, you can buy this product in nearly any pharmacy or drugstore. It’s available without a doctor’s prescription. However, outside France, it’s not available. That, though, doesn’t mean you can’t get the equivalent.

Even better than that, you can figure out which of the homeopathic preparations helps you and take only it, rather than the rest. After all, even in homepathy, why would you want to take something that does nothing for you?

Even better that, though, is that you can experiment to figure out what dosage works best for you.

The most difficult part will likely be finding these remedies in the specified potencies. In France, homeopathic potencies cannot legally be greater than 30C, though potencies many times higher exist and have been used safely. Therefore, effects in lower potencies have been studied fairly extensively.

However, homeopaths elsewhere have found that potencies starting at 6C are a good starting point, so it is the most common low-level potency in most of the world. Therefore, you may wish to try any of these at a 6C potency. However, I strongly recommend that you try only one at a time, giving it a week before deciding that it’s useless for you.

If it’s effective, but not completely, you may try increasing the potency. One word of warning: Do not take any of these remedies more often than once a day, as it could trigger a strengthening of symptoms. Though it would be temporary, it would certainly be uncomfortable!

The best advice, though, is to see a homeopath, who may be able to tailor a prescription just for you, since you are an individual and a different homeopathic preparation may be best suited. In fact, one of the most commonly prescribed homeopathic remedies for menopausal symptoms isn’t included in Acthéane.

One of the most significant benefits of homeopathy is the ability to tailor treatment for you. After all, no one else in the world is just like you.

Source:

Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes doi: 10.2165/11640240-000000000-00000

Tagged homeopathic treatment for menopause, Homeopathy, homeopathy double blind placebo controlled study, homeopathy for menopause, homeopathy hot flashes, homeopathy menopause, homeopathy menopause study, hrt therapy dangerous, menopause study, menopause treatment, science

http://anarchic-teapot.net/ anarchic teapot

“However, outside France, it’s not available. That, though, doesn’t mean you can’t get the equivalent.”

Yep. Out of the tap. I notice the details of how the study was conducted are not provided, although the little that is does not encourage confidence. I would never trust “studies” conducted by doctors in their own practices; doctors are not trained in this.
- HeidiStevenson
  
  The details of the study are provided in the study report, which is available online through the link given. As stated, it’s double-blind, placebo controlled, and randomly controlled. The number of subjects is given and the results are given. If you want more detail, then read the study.
  - http://anarchic-teapot.net/ anarchic teapot
    
    It’s not a report, it’s an abstract, and what little is detailed points to a badly-designed study with a small number of subjects, the whoie thing being carried out by people who have no idea what they’re doing.
    
    AS for Dana: do grow up. People might respect you if you actually started providing evidence instead of childish sneers. You talk like a bad politician.
    - HeidiStevenson
      
      The abstract includes a link to the full report.
      
      Your assumption about whether the people know what they’re doing is just that – an assumption based on what you want to be true. You are making a libelous claim based on nothing.
      - http://anarchic-teapot.net/ anarchic teapot
        
        No, my assumption that they do not know what they’re doing is based on my knowledge (a) that doctors are not trained to perform clinical trials, (b) of what homeopathy is – superstition and magic – (c) of the process in question, and (d) of the French health system, in particular the difficulty in getting an appointment with medical gynecologists, who are no longer being trained.
        
        All of which adds up to: a study that finds in favour of homeopathy is a study that set out to do so, and is therefore badly designed and biased. It is a perfectly logical conclusion. Unlike homeopathy, it is not based on superstition but deduction. It cannot therefore be qualified as libellous
      - HeidiStevenson
        
        I see. So, you can find nothing wrong with the study, so you say it can’t be valid because you don’t like who the authors are.
        
        That’s nothing but an ad hominem attack. Your logic says that, because you don’t believe the authors are qualified (based on nothing but your assumption), the study is invalid. That’s not a valid argument. You claim that the authors are unqualified and had an ulterior motive – and that most assuredly is libelous, as you clearly have no basis on which to make those claims.
      - http://anarchic-teapot.net/ anarchic teapot
        
        Do learn to read. I say it is highly unlikely the study has any validity because (a) homeopathy is bull and (b) the people who carried out the ‘study’ were not in any way qualified to design or carry out such studies.
        
        “You claim that the authors are unqualified” – as doctors, to design and implement a clinical study? Yes, I do. It’s not their field.
        
        ” and had an ulterior motive” That much is evident. Science says homeopathy cannot and does not work. Anyone trying to show the opposite has an ulterior motive, or is very, very gullible. Which are you?
      - HeidiStevenson
        
        Your sarcasm and nastiness are uncalled-for. You don’t want to accept the results – but that doesn’t mean they’re false.
        
        You presume that the doctors had an ulterior motive and you tar anyone who is willing to look at the evidence, rather than his or her presumptions, as having an ulterior motive or being gullible.
        
        However, through all of this, you have not offered a single observation to indicate that there’s a single thing wrong with the study. Until you do, please have the courtesy not to comment again. You’ve offered nothing of value here, and future comments along these lines will be treated accordingly.
      - http://anarchic-teapot.net/ anarchic teapot
        
        “You don’t want to accept the results” Of course not, because they can only be meaningless. Homeopathy is just magic water. It heals, treats, alleviates NOTHING except the weight of the victims’ wallet.
        
        Homeopathy is a vast fraud that has been perpetuated by the cynical and the gullible for over 200 year. I ask again, quite naturally and pertinently: in which category do you fall? I hope the latter: ignorance can be cured.
      - HeidiStevenson
        
        You were warned, anarchic teapot. You clearly aren’t interested in evidence. You’re only interested in things that support your particular beliefs.
        
        Obviously, you have nothing of value to say.
- http://www.facebook.com/profile.php?id=683289964 Dana Ullman
  
  Close your eyes tighter…you do NOT want to infect yourself with knowledge.
yg

A couple of questions came to mind about this:

1. What do you think of the sd of the HFS scores at baseline?
2. Any idea what happened to the secondary evaluation criteria results (HFRDIS, MRS, and two VAS scores)? It would have been nice to see charts of those throughout the trial, rather than just the HFS scores.
3. For the Hot Flash Related Daily Interference Scale (HFRDIS), the study says:
“After 12 weeks of treatment, the HFRDIS score for QoL was not significantly lower in the BRN-01 group than in the placebo group (2.3 – 1.9 versus 2.8 – 2.4, respectively; p = 0.2430). The reduction in the HFRDIS score was significant in each group but did not differ significantly between the two groups (2.3 – 2.3 [95%CI 1.7, 3.0] for BRN- 01 versus 2.0 – 2.7 [95% CI 1.2, 2.8] for placebo; p= 0.5121).”
So, the authors are saying that there was no significant difference between the two groups in how the hot flushes affected the women’s daily lives, so it looks like any perceived effect was not significant. Do you agree that is a correct interpretation?
http://anarchic-teapot.net/ anarchic teapot

Oh what a surprise. Censored by cultists who’d rather believe in magic than reality.
- HeidiStevenson
  
  Clearly, you would rather call names than have a discussion. There’s no reason that anyone should put up with that.
Acleron

What a peculiar graph. What happened to the 0 time point? That particular point is absolutely necessary for the validity of the whole graph. Otherwise nobody can tell if there was a difference between the two groups at the start.
- yg
  
  Acleron
  
  I noticed that too, but the way their study defined it, baseline was week 1 (see the text on page 6 of the paper).
  
  However, they say the treatment period was 12 weeks, so something isn’t right because that chart only covers 11 weeks. Very odd.
  
  And of course, the y-axis offset emphasises the difference between the two groups.
  
  But the really odd thing is the HFS difference at baseline:
  
  “The mean HFS at enrollment was 12.7 +/- 9.5 in the BRN-01 group compared with 15.3 +/- 14.7 in the placebo group (p = 0.2902).”
  
  Those figures are mean +/- SD. Those are mighty big SDs compared to the means. The paper says they compensated for the means at baseline, but it doesn’t seem right to me – and their conclusion hinges on that compensation being valid and appropriate.
  
  See also my other questions on this: http://gaia-health.com/gaia-blog/2012-09-16/homeopathy-works-for-menopausal-hot-flashes-gold-standard-study/#comment-654604789
  
  I’ve also just noticed that the HFS data were self-recorded, but ‘assisted by a telephone call from a clinical research assistant’. However, although the paper keeps repeating it was double blinded, it’s just not clear how the blinding was done and specifically whether this ‘clinical research assistant’ was blinded – if he/she wasn’t blinded, it is a serious potential source of bias.
  
  It’s easy to do clinical trials like this properly and get things right – why wasn’t more care taken with this one?
  - Acleron
    
    ‘why wasn’t more care taken with this one?’
    Boiron have a record of producing dodgy trials. Almost as if they know that rigorous trials will turn out badly for homeopathy.
- HeidiStevenson
  
  Acleron and yg – You guys had to work really hard to find that seeming discrepancy. I almost hate to break your bubble, but here it is:
  
  “To accommodate the fact that the baseline HFS was higher in the placebo group, the AUCs for each group were adjusted using Cole’s least mean square method, to provide normalized base-line values for the HFS at week 1 (before treatment) …”
  
  There is no mystery. The authors wrote week 1 meaning what you mean by week 0. It’s probably a cultural difference – something like floor 1 in the US being termed the ground floor in Europe, and floor 2 in the US being termed floor 1 in Europe.
  
  If you think that a great deal of variation in a hot flash score is meaningful, then you don’t know diddly about hot flashes.
  
  Give it up, guys! You’re digging very very hard to find flaws in this study. Surely your efforts could be put to better use somewhere else.
  
  yg – If you were serious about wanting answers to your questions, I’m sure you’d write to the authors, not post them here.
  - Acleron
    
    So the groups were different. That invalidates the study as rigorous right there. If you have two different populations how can you compare them for treatment?
    - yg
      
      Indeed. That alone invalidates their conclusion.
  - yg
    
    Heidi
    
    Finding flaws in studies is what scientists do – they try very hard to find flaws and point them out rather than simply accepting something without question. That’s the way we progress in knowledge, rather than blind acceptance of what’s presented.
    
    And I really didn’t have to try hard at all – the discrepancies are rather obvious. And if I can find them with no more than a cursory glance, what might someone who really wanted to understand this paper find?
    
    As I said, the authors did try to compensate for the difference in HFS scores at baseline, but they gave no explanation as to why they chose Cole’s method. That concerns me, but not having access to the data, I cannot say whether I agree their method was appropriate. Perhaps it was the best method, but they need to give reasons why.
    
    Without a bit more digging, my initial reaction is that Cole’s method probably isn’t appropriate because (IIRC) it’s generally used to normalise data that are skewed – but there is no indication that these data are skewed nor any reason why they might be, so why did they choose Cole’s method? The onus is on the authors to provide all the evidence and back up for any decisions they made, but they haven’t done that here.
    
    You seem to have missed the point about the number of weeks. We’re told it is a 12-week study, yet all we can see are the results for 11 weeks. Don’t discrepancies like that make you want to ask questions? There may be very innocent answers, but unless we ask those questions, we will never progress in understanding and knowledge.
    
    You also seem to have missed the point about the HFS scores at baseline. Regardless of what they mean in practice, there is a huge variation in them as shown by the SD values. That means they populations were significantly different at baseline and that makes comparisons extremely difficult.
    
    That can’t simply be explained away with a wave of the hand. Do you understand what those SD values mean and can you see why they are a problem?
    - HeidiStevenson
      
      If you spent your time trying to find flaws and reporting them to the science journals, you might be taken seriously. But you don’t do that. You come here because you’re offended by the results. And you call yourself a scientist? What a farce!
      
      Any study can be picked apart, but you take the cake for it. Then, you and another fellow talk back and forth between yourselves. That’s more than a bit weird.
      
      This study is far better than most that are produced by Big Pharma.
      
      You seem to think that calling the study 12 weeks long when week one was the baseline is somehow meaningful. That’s like attacking the Japanese for being dishonest by saying they’re X years old when, by the reckoning of western methods, they’re really a year younger. The information is provided, so where’s the beef?
      
      Focusing on not every detail being reported in full is equally absurd, since that’s virtually never done in such studies. The highlights are reported. This one was unique in providing information that appeared less than stellar – unlike the typical Big Pharma study, which literally hides negative information.
      
      If the results had been too good, you’d have attacked the study for that, calling it suspicious. Now, you attack the study for not having perfect results.
      
      If you were honest, you’d want to find a way to do the equivalent study again. But you don’t do that. You just act like the attack dogs that you are. Go back to your masters.
      - yg
        
        Heidi said:
        
        “If you spent your time trying to find flaws and reporting them to the science journals, you might be taken seriously. But you don’t do that. You come here because you’re offended by the results. And you call yourself a scientist? What a farce!”
        
        Woah! Slow down there! A whole load of unwarranted assumptions and insults in just that one paragraph! If you’re not interested in discussing the merits or otherwise of a paper, then I suggest you don’t highlight it and claim it to be:
        
        “The study is what modern medicine likes to call the Gold Standard: double-blind and both placebo and randomly controlled.”
        
        …then object when someone points out that it might not live up to that billing.
        
        However, that’s all irrelevant. The study looks flawed for the reasons given and I note that no one here has been able to answer any of the questions I had about it.
        
        “If you were honest, you’d want to find a way to do the equivalent study again.”
        
        Do you realise the implications of what you said? How can anyone even attempt to replicate that study when it doesn’t give all the details and data necessary to do so?
        
        Besides, the onus isn’t on me to replicate the results: it’s not me who is trying to show that homeopathy is efficacious.
        
        But you’ve still missed the simple point about the 12 weeks. The paper clearly states that the treatment lasted 12 weeks:
        
        “Data were collected (i) during the first 2 days after enrollment and before any medication had been taken; (ii) then every Tuesday and Wednesday of each week until the 11th week of treatment, inclusive; and (iii) finally, every day of the 12th week of treatment.”
        
        This really isn’t as clear as it might have been, but these data, plus the baseline measurements (unless they mean the data obtained in (i)), gives more than that shown on the chart. There may well be an innocent explanation for the missing data, but it could also be that they are hiding it – I don’t know which it is and, I suggest, neither do you. But to simply have faith in what they say and take it for granted, isn’t scientific.
      - lauriej1
        
        The ultimate challenge for those who call themselves “skeptics” is to do exactly as you suggest — repeat the experiment and publish the results. That’s real science — not the petty/arrogant/smirking nonsense these people repeatedly post. Problem is that none of these characters are actually researchers and seem to think that their philosophical rants should be taken seriously. Um, no.
http://www.facebook.com/chris.cole.7967 Chris Cole

Hi Heidi,

At the risk of repeating others’ comments, it is worth emphasising that there mere fact of publication does not ensure good quality research. And in this case, the statistical analysis in the paper has some serious shortcomings, mostly related to the problems generated by the fairly small sample size.

Even if one ignores the baseline discrepancies between the two groups, with the sample size involved, the only reported variable in the graph that showed anything like significant benefit from the intervention was libido disorders, and then only _just_, in a very subjectively fuzzy criterion.

Given the difference in baseline between the two groups, and the inappropriate use of Cole’s method to “correct” for it, the only sensible outcome for discussion here is how much each group improved over the course of the study, as compared to their group’s own baseline state.

This shows that for Hot Flash Score (HFS), the treatment group improved 56.7% from baseline, and the placebo group improved 46.4% from baseline.

For the sample size involved, this is unfortunately not statistically significant, as the study is powered to detect a difference (with 95% confidence) of greater than or equal to 14.1%.

So, even if one ignores the statistical adventures embarked upon by the authors, the basic data still do not support the conclusion. If they could repeat the study and both increase the sample size and reduce the potential bias of the phone “helper”, this could produce some more concrete and meaningful results.
danica003

Natural menopause help can be so useful for women who suffer from discomforts due to this condition. Hot flashes are one of the several symptoms of menopause. It can really affect a woman physically and emotionally especially when she don’t have an idea about the treatments for this condition.