Evidence based medicine update

My relationship with evidence based medicine (EBM) has always been ambivalent. It is a limited system of enquiry but I love it when it confirms my own holistic world view and get exasperated when it does not!

But jokes aside, EBM is an overused tool. While it is easy to be seduced by the world of medical science, when we create the mother of all scientific analysis it tends to replicate rather than eradicate the flaws of the system in the first place.

There are a number of issues with the “gold standard”, placebo controlled, double blinded trials when applying them to an individual system of treatment such as naturopathy. How much of the client’s improved wellbeing is being catalysed by the diet changes, herbs, other natural medicine or the type of consultation itself? Longer than the average GP style visits, that most natural therapists choose, have been accused of creating a placebo effect. Others suggest that it is talk therapy and the process of ‘witnessing’ or acknowledging the clients journey that is a potent healing tool in itself.

We say that as naturopaths we “treat the individual, not the disease”, so while there may be commonalities in prescribing, for a common condition as basic as constipation, there may be dozens of frequently prescribed herbs who’s mode of action varies beyond being a straight laxative. This is because the underlying condition itself may be viewed as having many different causes and not all originating in the bowel itself.

Herbs are a complex mixture of chemicals that vary when sourced in different growing conditions and locations. The herbs can be used in a variety of ways. For internal treatment alone there are alcohol or glycerine extracts, tablets, capsules, powders, teas and combinations within all the above form. These combinations of herbs themselves can potentially have a synergistic reaction, meaning the herb itself may work slightly or even massively differently to when it is used on its own. So with EBM there are many issues that arise from the style and substance of treatment.


Whenever any system of enquiry limits itself in such a way, it is potentially problematic. The Cochrane Collaboration for example, leads the field with systematic reviews of medical literature. Basically it takes all the published research on a certain medical treatment and includes for analysis only studies that meet its rigorous criteria. Then they crunch the numbers and conclude the validity or otherwise of a particular drug, herb, surgery or other method of treatment. If Cochrane doesn’t give the tick to the treatment, it is often deemed unsuitable, ineffective and at worst dangerous by those who take the service at face value. Most reviews of complementary medicines are stamped with Cochrane's “no evidence to inform current practice”. All this means was they couldn’t find enough medical trials to analyze the effectiveness of the treatment.


Unfortunately if there is a lack of literature on the subject, usually due to the vast majority of this kind of research being funded by pharmaceutical companies, Cochrane is unable to recommend the treatment.

A recent example can be found regarding programs for people with dementia that focuses on physical activity rather than drugs. This is a brilliantly low cost treatment in terms of the public health coffers but without obvious profit it is hard to fund pilot programs, then bigger trials and finally reproduce the trial another time to show the first one wasn’t a fluke.

There is insufficient evidence to determine the effectiveness of physical activity programs in managing or improving cognition, function, behaviour, depression, and mortality in people with dementia

Summary: Few trials examined these important outcomes. In addition, family caregiver outcomes and use of health care services were not reported in any of the included studies. There is some evidence that physical activity delays the onset of dementia in healthy older adults and slows down cognitive decline to prevent the onset of cognitive disability. Studies using animal models suggest that physical activity has the potential to attenuate the pathophysiology of dementia. Four trials met the inclusion criteria. However, only two trials were included in the analyses because the required data from the other two trials were not made available. Further well-designed research is required.

The Cochrane Collaboration


But while some members of the medical community are quick to use lack of evidence as a way to discredit complementary health treatment, it can be deafeningly silent on putting it’s love of EBM where its mouth is when it comes to short comings of its own medicines and treatments.

What if the studies used for meta-analysis were fundamentally flawed in the first place? This has been recently discovered to be the case in much of the breast cancer research conducted in vitro, for many years. Due to an initial identification error, cell line 435, used in at least 650 studies of metastatic breast cancer for over quarter of a century was the wrong cancer. In 2000 it was discovered that cell line 435 had the characteristics of melanoma, a skin cancer. It was not breast cancer after all.

The consequences of this mistake must have ramifications on all current breast cancer treatment. But more of a concern is the 8 years it has taken from the first researcher raising the alarm, to the claim being widely accepted in the research community.

In the past month there have been a number of EBM reviews of treatments that have swung against current medical practice. Perhaps the most damning is a Cochrane review of prenatal care. How many women going to their GP to have their pregnancy confirmed are being told that current best practice would recommend that they leave the practitioner's office as fast as possible and consult a midwife, not a doctor or obstetrician for the health of their unborn child and the best chance of a low intervention birth?

The Cochrane Review analysed 11 published trials, involving 12,276 women comparing midwife care to medical doctors. The evidence overwhelmingly supported Midwife care: it was associated with lower rates of both miscarriage and medical intervention as well as a greater likelihood of a vaginal delivery.

Midwife-led care was associated with several benefits for mothers and babies, and had no identified adverse effects. The main benefits were a reduced risk of losing a baby before 24 weeks. Also during labour, there was a reduced use of regional analgesia, with fewer episiotomies or instrumental births. Midwife-led care also increased the woman's chance of being cared for in labour by a midwife she had got to know. It also increased the chance of a spontaneous vaginal birth and initiation of breastfeeding. In addition, midwife-led care led to more women feeling they were in control during labour. There was no difference in risk of a mother losing her baby after 24 weeks. The review concluded that all women should be offered midwife-led models of care.

The current caesarian rate in Australia is 31%, close to a 1:3 of live births. It would be logical to conclude if every GP followed EBM best practice and recommended their client chose midwife based care, not only would more babies survive to 24 weeks but the cost of health care would be much lower.

A second clanger to be dropped by Cochrane this month is in regards to the effectiveness of St John’s Wort in the treatment of major depression. Herbalists have always known that good quality (and quality is the key for all herbal prescribing) St John’s Wort takes the edge of depression. Previously researchers grudgingly accepted it had some validity but only for mild depression. But the effectiveness of St John’s wort for treating mild to severe depression has finally shone through. Cochrane concluded that the herb is at least as good as antidepressant medication but without the nasty side effects.

Depression is characterized by depressed mood and/or loss of interest or pleasure in nearly all activities and a variety of other symptoms for periods longer than two weeks. Extracts of St. John's wort (botanical name Hypericum perforatum L.) are prescribed widely for the treatment of depression.

We have reviewed 29 studies in 5489 patients with depression that compared treatment with extracts of St. John's wort for 4 to 12 weeks with placebo treatment or standard antidepressants. The studies came from a variety of countries, tested several different St. John's wort extracts, and mostly included patients suffering from mild to moderately severe symptoms. Overall, the St. John's wort extracts tested in the trials were superior to placebo, similarly effective as standard antidepressants, and had fewer side effects than standard antidepressants. However, findings were more favourable to St. John's wort extracts in studies form German-speaking countries where these products have a long tradition and are often prescribed by physicians, while in studies from other countries St. John's wort extracts seemed less effective. This differences could be due to the inclusion of patients with slightly different types of depression, but it cannot be ruled out that some smaller studies from German-speaking countries were flawed and reported overoptimistic results.

Patients suffering from depressive symptoms who wish to use a St. John's wort product should consult a health professional. Using a St. John's wort extract might be justified, but important issues should be taken into account: St. John's wort products available on the market vary to a great extent. The results of this review apply only to the preparations tested in the studies included, and possibly to extracts with similar characteristics. Side effects of St. John's wort extracts are usually minor and uncommon. However, the effects of other drugs might be significantly compromised.

Cochrane Review: “St John's wort for major depression”, Linde K, Berner MM, Kriston L.

Beyond the scope of the Review were some of the actual issues with the commonly prescribed antidepressants.

As covered in a previous post, current evidence finds that common antidepressant drugs aren't very effective. In fact, the study reported in the link concludes, “Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance.“

A small study examining the effect of Paroxetine (a common SSRI) on sperm has just been published. Following earlier anecdotal evidence of men experiencing decreased fertility while taking SSRIs this study looked at sperm samples from healthy men before taking the drug and after four weeks of treatment. DNA abnormalities in the sperm rose from 13% before taking the medication to over 30% one month into the trial. This evidence suggests that this class of antidepressant has a significant negative effect on male fertility.

The use of SSRIs in adolescents has become increasingly controversial due to an apparent increase in suicides in young people taking these drugs. According the TGA: ” “None of the SSRIs, and indeed no antidepressant, is currently approved in Australia for the treatment of MDD (major depressive disorder) in children and adolescents (persons aged less than 18 years).”

Yet despite a long list of common side effects, let alone a worsening of symptoms or infertility, the vast majority of GPs and psychiatrists prescribe these drugs over an equally effective and less adversely reacting herb.

As a herbalist, I strongly suggest that you see both a qualified herbalist and registered psychologist for the treatment of depression. You may also be eligible for a Medicare rebate when seeing a psychologist in Australia.

EBM is an interesting tool. If your medical professionals subscribe to it, then you have a right to question their treatment in terms of current evidence.

Research update – music as medicine

Music's the medicine of the mind.

John A. Logan

While the quest is on for a pill to cure all ills, a simple remedy has been often over looked. It is inexpensive, easy to administer, has no worrying side effects and treats a wide variety of ailments. I’d say everyone reading this has some at home or with them right now.

So what is this elixir?

It is music.

There is now a substantial body of work showing that music can influence our brain, motivate us, even help us breath or deal better with pain.

While music therapy is a specialized field that involves highly trained therapists working with different techniques, the studies I am looking at simply involve music, as distinct from “music therapy”. (To find out more about music therapy contact the Australian Music Therapy Association)

Research has shown that a 20 week old foetus can hear fully and they may recognize music they were exposed to in the womb, even one year after they were born.

Once babies are born, there experience of music can continue to be therapeutic. Parents singing lullabies, or just playing them, have been shown to reduce pain levels and increase oxygen saturation especially in research into premature babies who have a high risk of potentially fatal complications.

While some of the research needs to be reproduced using greater numbers, there is enough evidence to encourage the use of lullabies as therapy at home and in the hospital.

Does listening to music make us smarter?

If you trawl the net on the subject of music and IQ pretty soon you will come across ”the Mozart effect. This is a much hyped and misquoted reference to a 1993 paper published in “Nature” showing increased spatial reasoning in children performing the study tasks while listening to Mozart.

While listening to classical music is not proven to make us smarter the beat and rhythm of music can affect us in many different ways.

One of the latest studies shows that playing the right kind of music while exercising can increase endurance, meaning you can run or work out longer and harder.

The researcher, Dr Costas Karageorghis, has nailed down the musical formula to get us moving more – ABBA’s “Dancing Queen”, or if you prefer any other music with 120-140 beats per minute. His research found this could improve exercise endurance by 15% or more. But only with this particular beat rate.

Music for Pain Relief

There have been over 50 studies that look at listening to music for pain relief. The responses have varied. Some suggested up to a 50% reduction in pain and a flow on need for less analgesia (such as morphine).

The Cochrane Review of these studies found the results to be mixed and concluded, “Listening to music reduces pain intensity levels and opioid requirements, but the magnitude of these benefits is small and, therefore, its clinical importance unclear”.

It also noted that music is a low-cost, safe and easy to use therapy. Personally I’ve had a good response to lowered perception of pain from listening to music and would recommend giving it a go.


Links

Max Headroom, RRR 18th September 2008
Playlist - Labour Not In Vain, presented by Hermione Gilchrist. Hermione’s fantastic labour ‘mixed tape’.

A Journal of the American Medical Association article on ”Brain Music”

Third trimester pregnancy

Human gestation is niftily divided into three major growth segments, or trimesters, of about twelve weeks. The final three months of a textbook full term pregnancy is referred to as the third trimester.

By this point most women are more than well aware that they are pregnant, with all and sundry asking when they are due and how do they feel? While many women appear to breeze through pregnancy, by the 28th week the growth of the baby is noticeable. While the best thing to do at this time is to continue suitable forms of exercise such as walking, yoga, pilates, swimming etc, eating well and getting adequate sleep (which may not always be as easy as it sounds) – complementary therapies may be useful to help with some of the common health issue of this time.

Cramps and restless legs

While this often occurs in the later stages of pregnancy, a frequent cause is really no big mystery (as some popular texts allude). As the baby has been getting first dibs on the mother’s nutrition over the last six or so months, at this point if supply is not meeting demand, deficiency symptoms occur. Cramps and restless legs are often a sign of not having enough magnesium. So much of the information about calcium directs women to eat more dairy products, which are comparatively low in magnesium. Low magnesium is sometimes a factor in pre-eclampsia.

Good sources of magnesium include: nuts, avocado, bran, unrefined grains (eg, brown rice) and bananas. The celloid or tissue salt form of magnesium phosphate (MP, mag phos), a cross between a homoeopathic and mineral dose, is one of the safest forms of magnesium to take in pregnancy. Take two tablets before bed.

Other deficiencies can also cause restless legs – especially iron and zinc (see the link above for more details).

Backache

While niggling aches and pains are common in pregnancy it doesn’t mean there is nothing you can do to help ease them. Sciatica (a shooting pain, often from the buttocks down the legs) and other musculo-skeletal discomfort can be helped with a couple of osteopathic treatments, acupuncture, physiotherapy or pilates. (For more information and links about these therapies go to the show on aches and pains). Yoga and pilates can also help prevent and treat some back problems. Unless you are advised not to, keep as active as possible throughout this stage of pregnancy.

Try to be aware of your posture as the baby grows. Slumping on the couch not only increases your chance of musculo-skeletal problems but many midwives connect this with a higher chance of a posterior presentation at birth (this is where the baby is head down but facing towards the mother’s spine, so the largest part of the head is prominent.) This often leads to a longer labour.

Swelling/Fluid retention

Standing on your feet all day or being in a warm environment can make the struggling circulation system leak fluid into the tissues. This might present as rings becoming too tight to wear on the usual fingers or swollen ankles, legs or feet. As this can also be a symptom of pre-eclampsia, it is important that your blood pressure is being monitored as well.

For simple fluid retention avoid unnecessary salt. This means cutting out processed foods, avoiding pre-made and restaurant meals and keeping away from the saltshaker. Fresh vegetables, brown rice and steamed or baked fish make a great basic diet, especially if your blood pressure is starting to rise.

If you are working with a herbalist who is helping you with your pregnancy, it is usually safe to have a couple of simple, nutritive diuretic herbs. The two favoured in traditional herbalism are nettle and dandelion leaves (not roots). Half to one teaspoon each per cup, three cups a day is the dosage. Always choose organic, loose-leaf green herbs.

Keeping your legs cool also helps – sitting with your feet in a tub of cool water or using a cold compress gives a little, instant relief.

Varicose veins and haemorrhoids

Cool water can also help raised or bulging veins. Using a shower attachment, spray cold water on the area twice a day.

For haemorrhoids (enlarged, sometimes protruding, swollen veins in the rectum) keeping the bowels working well is an absolute priority. Make sure you drink at least 2 litres of water a day, avoid caffeine and soft drinks and try to get more than the required 5 serves of vegetables and 2 fruits a day. Brown rice, beans, figs, prunes and kiwi fruit are also great to include but pull back on dairy, bread and red meat.

A cream or ointment made from witch hazel, applied to the area, may also be effective.

”Partus Prep”

For centuries traditional herbalists have used plants that help ‘prepare’ for birth. These are herbs that don’t necessarily make stronger contractions, rather they encourage the uterus to contract and relax properly.

Raspberry leaf is the most well known. Research suggests that it has a paradoxical relationship with the smooth muscle of the uterus – astringing it (helping it tighten or contract) as well as relaxing the fibres. This may aid recovery between contractions, helping an active birth.

A “partus prep” is best prescribed by a well trained herbalist, however good quality, organic raspberry leaf tea can be taken at one teaspoon per cup, three times a day from week 28.

More birth preparation

As it is now not unusual for a woman to head into having her first child having never been present at a birth before, it is not unusual that the fear factor can start to grow. We all need mentors in life and having witnessed a positive birthing is useful preparation, as is having a support group around you of people you trust. If you are unable to have a close friend or mother who makes you feel strong and calm with you, consider working with a doula (a professional birth support person).

Hypnosis for a calm, active birth is becoming increasingly popular. One form of training is “hypnobirthing” but others forms exist. As this is a growing, unregistered industry ask around and speak to a few practitioners if you are interested. If interested in hypnotherapy for birth it is often recommended you start as early as possible in pregnancy to get the best results.

Certainly talking through your concerns or fears is important for some women. Midwives are your ally in pregnancy, birth and beyond so get to know who you will be working with. They are the experts, so make use of them during your prenatal check ups. If you are seeing a private obstetrician, you can hire your own midwife or ask to speak to one in the practice if you wish.

Birth preparation classes are usually held in most public and private hospitals. There are also some other excellent private providers, like Lina Clerk who now works in the UK, as well as Melbourne.

Breech presentation

By about weeks 36-37 the baby has settled into position for the last bit of its gestation. If the head is not down, there is a small window of opportunity at this point to try to encourage it to turn around. Increasingly few obstetricians offer manual turning now. If this is not an option or seems risky, try acupuncture and moxibustion. In Victoria you can search for a registered Chinese medicine practitioner at the registration board website

Homoeopathy for birth

Homoeopathic remedies are safe to take to help instigate labour, through the birthing process and after a vaginal delivery or caesarean. The biggest issue is knowing what to take and this requires some knowledge for the birth partner (rather than the woman in labour). A useful guide is available from the Society of Homoeopaths (UK).

If nothing else, the all-purpose remedy is arnica (at a 30 c or higher potency). This helps ease bruising like pain and is useful during and after birth. It is also used for shock.

Planned and emergency caesareans

While complementary medicine aims to support active, natural births – this is not always possible. Sometimes a C-Section is planned as it is the best option for both mother and child, for a wide variety of medical reasons. At other times the baby is in distress or the labour too long for it to safely continue. When you know in advance that a caesarean is planned there are things you can do to help. Certainly pack the homoeopathic arnica and continue to eat well. A multi-vitamin may also be useful.

When a C-Section is unplanned some women experience shock, for which the flower essence formula Rescue Remedy may be useful.

There are some great suggestions about making a caesarean a postive experience at the CARES (SA) site.

While the first six weeks of care post partum is crucial for all women after birth, it is even more so when combined with major surgery. All women should avoid exercise until their ligaments have returned to normal. Post-caeser all abdominal strength is lost, so more hands on help is needed for lifting, doing the washing and so many aspects of daily life. This is even more reason to ask for help from those who are practical and to put a sign on the door to not be disturbed when you and the baby are sleeping during the day. It is normal to be tired, listen to your body and say no to extra activities until you feel ready.

…and some help for the non-pregnant parent

At this time it is not unusual for the non-pregnant parent to have a few of their own health issues, something I tend to think of as “Third Trimester Father Syndrome”. The non-pregnant partner (be it a man or woman) may also be experiencing some stresses and fears, which naturopathy can help support. I’ve written a short article with lots of links, that may be useful.

Gay and lesbian parenting is booming. Rainbow families is the peak support group and offers a range of resources.


For more pregnancy resources check out this previous show, which includes some links to local midwives and doulas.

Caffeine and miscarriage

A study released this week has confirmed that caffeine intake in the first trimester of pregnancy increases the chance of early miscarriage. Most naturopaths advise women planning to become pregnant to stop drinking caffeine related drinks, especially coffee, and to resist drinking it again til after they have ceased breastfeeding. Yet conventional medicine has continued to declare that up to 300 mg of caffeine a day in pregnancy does no harm. While American literature equates this to 4 cups of coffee a day, it would be closer to 2 decent cups from a Melbourne barista.

But now a study published in the American Journal of Obstetrics and Gynaecology has found more than 200mg of caffeine a day doubled the risk compared to abstainers. That means just half the presumed ‘safe’ intake of caffeine doubles the chance of a miscarriage in the first 12 weeks of pregnancy.


Link to BBC report

Coffee 'raises miscarriage risk'

Pregnant women should consider avoiding caffeine, say researchers who found even moderate consumption in early pregnancy raises the miscarriage risk.
Currently, the Food Standards Agency sets an upper limit during pregnancy of 300mg - or four cups of coffee a day.
But an American Journal of Obstetrics and Gynaecology study found more than 200mg of caffeine a day doubled the risk compared to abstainers.
Experts said they would review the data to see if advice needed changing.

Women probably should consider stopping caffeine consumption during pregnancy. Study author Dr Li

Pat O'Brien, consultant obstetrician and spokesman for the Royal College of Obstetricians and Gynaecologists, said based on the findings he would now be advising women in their first 12 weeks of pregnancy to abstain from caffeine altogether.
"The first 12 weeks is a very vulnerable time for the baby. It's when most miscarriages occur," he explained.
He said most women in early pregnancy went off the taste of caffeinated drinks anyway and so should not find abstaining from them too difficult.
But he said it was unclear whether pregnant women needed to avoid caffeine in later pregnancy.
Miscarriage risk
An estimated one in five pregnancies in the UK will end in miscarriage, affecting around 250,000 women in the UK every year.
There are a number of well-established risk factors, such as increased maternal age, a previous history of miscarriage, and infertility.
But the causes of the majority of miscarriages are not fully understood.
Caffeine has been mooted as a risk factor before, but studies have yielded conflicting results.
For the latest research, Dr De-Kun Li and colleagues at the Kaiser Permanente Division of Research, studied 1,063 women who had become pregnant in the last month or two.

300 mg of caffeine is roughly equivalent to:

Four average cups or three average mugs of instant coffee
Three average cups of brewed coffee
Six average cups of tea
Eight cans of regular cola drinks
Four cans of so-called "energy" drinks
400g (eight standard 50g bars) of normal chocolate
Caffeine content in a cup of tea or coffee varies by different brands and brewing methods
Source: Food Standards Agency

They asked the women to provide a detailed diary about their caffeine intake up to their 20th week of pregnancy.
When they compared this information with how many of the women had miscarried by 20 weeks gestation, 172 of the women in total, they found a link.
Compared with non-users, women who consumed up to 200mg of caffeine a day had an increased risk of miscarriage - 15% versus 12%.
For women who drank more than 200mg, the risk increased to 25%.
Abstinence
The increased risk appeared to be related to the caffeine itself, rather than other coffee ingredients because other caffeinated beverages such as tea and hot chocolate showed a similar trend to coffee.
Caffeine is able to cross the placenta to the foetus, but it is not clear what affect this has on the growing baby.
Dr Li said: "The main message for pregnant women from these findings is that they probably should consider stopping caffeine consumption during pregnancy."

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7195500.stm

Published: 2008/01/21 05:06:05 GMT