Archive for Other Therapies

Black Cohosh Safety

Summary

  • Evidence shows herb considered safe for use in perimenopausal women
  • Liver damage as a result of black cohosh use is extremely rare
  • All black cohosh products must contain a warning identifying the potential risk of liver damage
  • If you experience any signs or symptoms of liver damage, cease use of black cohosh immediately
  • Patients should ensure that all of their health professionals are aware of any herbal medicines they are taking

Black cohosh

There have been some questions raised about the safety of black cohosh, specifically with regards to liver damage and breast cancer. Overall, an examination of the evidence in the research journals, detailed below, will show that this herb is considered to be safe to use for perimenopausal symptoms.

General evidence of safety of black cohosh use

In 2003, the Journal of the North American Menopause Society, Menopause, published two papers reviewing the safety of black cohosh. The first paper (a literature review) looked at black cohosh use in over 2,800 patients and concluded that black cohosh appears to be a safe option for women for the management of perimenopausal symptoms.

The second paper concluded that the side effects from black cohosh are rare, mild and reversible. The most common side effects reported were digestive upsets and rashes.  There were a few more serious side effects listed including thrombosis (blood clots), high blood pressure and slow heart rate. It concluded that the cause for these specific side effects could not be determined.

Black cohosh and liver damage

In October 2002, in the Medical Journal of Australia, there was a single case report of a 47 year old Australian woman who developed acute hepatitis (inflammation of the liver) and as a result, needed a liver transplant.  It was reported that this woman had been taking a black cohosh preparation for one week. The herbal product that was used was not analysed to show that the product did actually contain the herb black cohosh (which has been the case for the majority of reports of black cohosh and suggested liver damage) and therefore cannot conclude the herb as the cause of the liver damage. The type of hepatitis that was observed in this woman was a severe immune reaction typical of a particular individual immune reaction and not because of a direct toxic injury.

After this first report, other authors started to suggest black cohosh as the cause of liver damage when a liver reaction was seen in a person who was taking the herb.

By 2006, there had been around 40 cases of suspected liver reactions due to black cohosh worldwide, nine of which occurred in Australia. Of the Australian cases, four were hospitalised, with two requiring liver transplants.

This prompted the Australian Therapeutic Goods Administration (TGA) to issue a warning of the potential liver reaction from black cohosh, as they believed there was ‘sufficient evidence of a causal association between black cohosh and serious hepatitis’.  As a result of this, future labels of products containing black cohosh will read: ‘Warning: black cohosh may harm the liver in some individuals. Use under the supervision of a healthcare professional’.

The TGA more recently established an expert advisory group to review the existing regulatory controls on black cohosh. The expert group concluded that there appears to be an association between the use of black cohosh and liver damage, but it is very rare. They state that it was not possible to tell, with any certainty, the strength of the association, or any particular vulnerable group, type of preparation, dose, duration of use or specific products.

The expert group also determined that black cohosh is still suitable for use in complementary medicines, but recommended that the current warning statement on the medicine label be revised to better inform consumers about the risk and also to provide sufficient information to assist in the early detection of liver damage and, if detected, to seek medical attention.

The European Medicines Agency Committee on Herbal Medicinal Products (HMPC) also reviewed the evidence on black cohosh in a recent 2006 analysis (revised version January 2007).

The HMPC analysed all the reports of liver reactions due to black cohosh. Eight international experts formed the group dealing with hepatotoxicity (liver toxicity).

The report examined 15 clinical studies (between 1983 and 2005) and overall no case of significant liver dysfunction was reported. It was noted that long-term safety of black cohosh was not studied.

While the report overall demonstrated that there were only two cases where black cohosh was possibly related to liver damage the HMPC wanted to draw the attention of the public to the potential serious liver reaction that may occur in patients using products containing black cohosh. They offer the following advice:

Patients:

  • Patients should stop taking black cohosh and consult their doctor immediately if they develop signs and symptoms of liver injury. Symptoms of liver disease can include:
    • Jaundice (yellowing of the skin or whites of the eyes)
    • Dark urine
    • Nausea
    • Vomiting
    • Diarrhoea
    • Weight loss
    • Unusual tiredness
    • Appetite loss
    • Fever
    • Bloated abdomen or abdominal pain.
  • Patients using herbal medicinal products should tell their doctor about it.

Healthcare professionals:

Healthcare professionals are encouraged to ask patients about use of products containing black cohosh.
Suspected hepatic reactions should be reported to the national adverse reaction reporting schemes.

Several key factors need to be considered when looking at the evidence suggesting black cohosh as a cause of liver damage

  • In many of the cases, the presence of black cohosh has not been definitely established (i.e. the product was not tested to show that it actually contained the herb black cohosh).
  • In most cases the name and dosage of products has not been specified.
  • In some reports, the products used contained multiple ingredients; the patient was taking more than one medication, or was suffering from other medical conditions.
  • There are at least 20 common names for black cohosh making the likelihood of   mistaken substitution of this herb for another herb a possibility.
  • No information regarding plant part used, extraction medium, the amount of the herb taken or method of extraction has been listed in the reports.
  • Hepatitis, for which no cause can be identified, is not uncommon and cannot be excluded.
  • Overall there is a very low incidence of reported suspected liver damage considering the widespread use of black cohosh.
  • There is a potential for misinformation when an author who is not herbally qualified attempts to explain a possible reaction.
  • There is an ongoing study of black cohosh and menopause at the Columbia University, New York City, which is investigating liver function tests in subjects every 2-3 months.

In summary, while acute liver failure has been suspected with black cohosh, it is extremely rare and somewhat unpredictable.

Black cohosh and breast cancer

Of all the herbal medicines that a breast cancer survivor may consider using, black cohosh has the most research supporting its use and has the greatest amount of safety data.

There have been two clinical trials on black cohosh and breast cancer patients to date. In an open-label randomised clinical trial over 12 months, black cohosh reduced the number and severity of hot flushes in premenopausal (age 35-52) breast cancer survivors on Tamoxifen treatment.  In a second study of only two months duration, black cohosh was no better than placebo (dummy treatment) for reducing number and intensity of hot flushes, in women with a history of breast cancer. More than two thirds of the women were on Tamoxifen in this study and possibly the shortness of the study limited the results.

A recent review of the research looking at black cohosh and its safety and effectiveness in cancer has supported the information above. While the effectiveness of the herb for treatment of symptoms is inconclusive, the report states that black cohosh has a relatively good safety profile, does not show phytoestrogen activity and the concerns about liver damage are inconclusive. The paper also states that there are no studies suggesting that black cohosh has a protective role in cancer prevention.

The most important factor is to get the approval of the oncologist and breast specialist before commencing treatment with black cohosh. Of all the herbal medicines that a breast cancer survivor may consider using, black cohosh has the most research supporting its use and has the greatest amount of safety data. Longer trials of five years or more are needed to establish breast cancer safety data more conclusively. Black cohosh is only indicated for hot flushes, vaginal dryness and aches and pains and should only be taken for as long as symptoms persist.

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Paced Respiration

Hormone therapy after menopause is not needed or appropriate for many women. However hot flushes can still be bothersome. To address this problem, Professor Robert Freedman of Wayne State University in Detroit, has been researching a new non-pharmacological method for helping women control their hot flushes.

The basis of the treatment is a slow controlled diaphragmatic breathing technique or “paced respiration”.

To develop this skill you need to find a quiet, private place where you can sit and practice without distraction.

  • Diaphragmatic breathing involves keeping the rib cage still and inhaling and exhaling by using your stomach muscles (distending and retracting the abdominal muscles) which results in the diaphragm moving up and down.
  • Without moving your rib cage you should inhale for 5 seconds and then exhale over 5 seconds.
  • To master this technique Professor Freedman recommends practicing every morning and every evening for 15 minutes.

Once you are accustomed to the technique you can put it to use. As soon as you feel a flush developing you start the paced breathing and continue until you feel the experience has passed.

Obviously this will not be useful for women who are troubled by flushes disturbing their sleep.

Two small placebo controlled trials have now shown this to be an effective way of managing flushes with hot flush frequency being reduced on average by 50-60% with this technique.

Why this technique works is not understood, but indeed it is certainly worth a try.

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“Bio-identical” Hormones

Introduction

Women and health professionals are constantly being given information about ‘hormone imbalance’ and how to deal with menopause ‘naturally’. All this information should be carefully evaluated, giving consideration to its accuracy, and the reputation and vested financial interests of the group promoting the information.

Many women are turning away from approved pharmaceutical postmenopausal hormone therapy (HT) currently available as a tablet, patch, gel and/or implant and are using instead hormonal preparations made up as lozenges or troches or creams. These preparations are sucked in the cheek and are absorbed through the lining of thek cheek or through the skin.

The makers of these hormone preparations have stated that they are natural ‘bio-identical’ hormones. This description has been deemed to be “a marketing term that carries no scientific or medical merit” (U.S. Food and Drug Administration 2008) It may also be misleading as it implies they are non-synthetic. ‘Bio-identical’ hormones are all manufactured synthetically by a similar process as are most hormones including the pill. The process begins with a chemical substance from either the yam or soy. The hormones, once synthesised, are in forms that are produced in the body.

Compounded preparations

Compounded ‘bio-identical’ hormone preparations also require a doctor’s prescription and are made up by pharmacists who call themselves compounding pharmacists. There are no further training requirements for compounding pharmacists, who are likely to have had the same training as your family pharmacist.

The pharmacists making the ‘bio-identical’ preparations are not required to adhere to the codes of conduct of the professional pharmaceutical body, Medicines Australia, as these codes apply only to pharmaceutical companies. This means there is limited formal quality control or quality assurance on individual formulations. There has also been no formal research into dosage and the dose prescribed is the responsibility of the prescribing doctor.

Hormone formulations made in a pharmacy are expensive as they are individually prepared. The government department responsible for the approval of medicines is the Therapeutic Goods Administration (TGA), which requires vigorous safety and effectiveness data before approving any medications. But ‘bio-identical’ formulations are not subject to TGA rules, as they are compounded by pharmacists and not made by pharmaceutical companies.

Doctors prescribing ‘bio-identical’ HT monitor dosage by performing tests on the hormone levels in the saliva or blood; however, there is little correlation between blood levels and menopausal symptom relief and this practice is not based on evidence and is discouraged by academic specialist societies internationally.

About the hormones including oestrogen

The oestrogen present in many oral and all non-oral hormone therapies is the same oestrogen that occurs naturally in the human body – oestradiol, the same oestrogen preparation as most government-approved oral and non-oral hormone therapies (such as patches, implants and gels). It is misleading to suggest that these troches or lozenges and creams have advantages over TGA approved pharmaceutical oestrogen therapies.

The hormone preparations made in a pharmacy may contain a mix of the three major classes of oestrogen in the female body: oestradiol, oestrone and oestriol. There is no evidence to support that giving oestrogen in this way is better than giving oestradiol alone. It should be noted that our bodies automatically make the other two oestrogens from oestradiol.

Oestrogen mixes are sometimes combined with progesterone, testosterone or DHEA (a hormone made by the adrenal glands) or they can be each prescribed alone. Of note, DHEA is not approved for use in Australia by the TGA. Progesterone is not used in conventional pharmaceutical HT as it is filtered by the liver, therefore altered progestin compounds are used.

Safety and efficacy

We have no research evidence that the recommended doses of the hormone preparations made by compounding pharmacists are safe or effective. Currently there is no published data for these products, yet documents recommending various doses and equivalent doses to TGA-approved oestrogen therapies have been issued. It is important to note that these are not evidence based. It is also important to note that there is no adequate data to show what dose of progestin (progesterone) is necessary to protect the lining of the uterus (endometrium). No evidence is available from any published study to show that progesterone absorbed through the cheek will protect the lining of the uterus from conditions such as uterine cancer.

It has been claimed this form of HT does not cause side effects. This is unproven and unlikely, with many women presenting with known complications of oestrogen and testosterone therapy while on ‘bio-identical’ hormonal preparations. Blood levels of hormones can also be very elevated on troches therapy and until further research is done, women need to be cautious.

Summary

There are theoretical advantages to the use of hormonal preparations similar to the forms produced in the body, and in future, these preparations may be included in regulated HT; however further research and regulation is needed. Prescription of so-called ‘bio-identical’ hormones cannot be recommended until there is sound pharmacokinetic, efficacy and safety data.

These are the fundamentally similar hormones to HT but given in a different way and we would expect them to convey similar risks to conventional pharmaceutical HT, potentially though, side effects may be exacerbated as appropriate doses are not known.

Some health practitioners are promoting ‘bio-identical’ hormone therapy not only as safe, but also as preventing cancer. There is no published evidence that this is true and women should be cautious about taking any hormonal preparations that have not been subjected to careful research evaluation.

Recent Developments: January 9, 2008

The U.S. Food and Drug Administration (FDA) announced that it has begun enforcement action against compounding pharmacies making false and misleading claims about the safety and efficacy of ‘bioidentical hormones’. The FDA also announced that it considers the term ‘bioidententical’ a marketing term and not one of scientific or medical merit.  FDA officials stated that claims made about safety and efficacy of compounded ‘bioidentical hormones’ are false and misleading, with no credible scientific evidence to support them.  The FDA has now posted a Consumer Update, titled “Bio-identicals: Sorting Myths from Facts”. The new online publication also provides links to long-standing information available on the website.

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Treating Symptoms

Herbal remedies are an option for many women in the management of perimenopausal symptoms, such as hot flushes, night sweats and vaginal changes.
Not all the symptoms experienced by women in midlife are the result of declining oestrogen levels. Herbal therapies can help to manage mood changes such as anxious thoughts and depressed feelings, as well as help with fatigue and low energy.

Stress Reducing Herbal Remedies

Hops, Motherwort, Kava-Kava, Skullcap, Lime Blossom and Valerian may be useful in reducing stress and nervousness throughout the body and treat anxiety by calming the nervous system.

Herbal Remedies for Low Libido

Many cultures use herbs that traditionally have had a reputation for increasing libido. It is not clear whether these herbs actually stimulate a sexual urge, or act as general tonics – increasing energy and vitality and supporting a steady emotional state, thus making the idea of sex more appealing.
There are many factors that can influence a woman’s libido including her relationship with her partner, medications, general health and wellbeing, vaginal dryness causing painful sex and body image. It is important to address lifestyle, nutrition and relationship factors that may be playing a role in low libido and not just rely on a herbal medication.
Damiana, Saw Palmetto and Sarsparilla, Korean Ginseng, Tribulus, Shatavari and Horny Goat Weed are some of the herbs that can be used for treating low libido. Ylang Ylang, Neroli and Patachouli are essential oils that are said to be aphrodisiac in nature.

Progesterone Cream and Wild Yam Creams

Progesterone creams

Progesterone creams were once available from health food stores but are now only available on prescription. There is no evidence that progesterone creams can be safely substituted for progestins as part of hormone therapy .

There is no evidence from the research conducted that progesterone creams provide adequate endometrial protection (protection of the lining of the uterus) for women who are post-menopausal and are using oestrogen replacement therapy. The amount of progesterone actually absorbed through the skin is totally inadequate to protect the endometrium.

A woman could be putting herself at risk if she substitutes progestogen tablets or patches prescribed for hormone therapy with a progesterone cream, while continuing oestrogen. It is worth discussing these issues with your health practitioner.

Wild Yam Creams

Wild Yam creams are available from health food stores and from direct distributors.

Wild Yam is not a progesterone, does not contain progesterone and cannot be converted to progesterone in the body. Wild Yam cream contains diosgenin that can be converted in a laboratory to progesterone and oestrogen in the contraceptive pill and hormone therapy but it is not converted to progesterone in the body.
Even though diosgenin may have oestrogen-like actions it has not been shown to be beneficial in terms of relieving hot flushes, vaginal dryness or other common symptoms of menopause.

Traditionally, Wild Yam has not been used as a cream but rather taken internally.

Evening Primrose Oil

Evening Primrose Oil is widely self-prescribed and is prescribed by health professionals to treat hot flushes.  In a small (56 women) six month trial using 2000mg twice a day it was shown to be no better than a placebo (dummy pill).

Relaxation and paced respiration

A small trial showed that relaxation (20 minutes per day) significantly reduced the intensity, but not the frequency, of hot flushes. Relaxation techniques also reduce tension anxiety and depression.
Another small trial of paced respiration (slow deep breathing) was shown to significantly reduce the number of hot flushes.

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Herbal Remedies

herbalHerbal remedies are used throughout the world and many have been used for centuries.

Herbs or herb mixtures can be dried and combined with boiling water to make teas (infusions and decoctions), concentrated in alcohol and water to make tinctures or extracts, or made into tablets and powders.

Herbal remedies are an option for many women in the management of perimenopausal symptoms, such as hot flushes, night sweats and vaginal changes.

Not all symptoms experienced by women in midlife are the result of declining oestrogen levels. Herbal therapies can help to manage mood changes such as anxious thoughts and depressed feelings, as well as help with fatigue and low energy.

Over the Counter Herbal Products

It is important for women buying herbal products over the counter to remember:

  • Some of the herbal products available over the counter are not what a traditional herbalist would prescribe.
  • While the quality of some Australian-manufactured herbal medicines made for naturopaths and herbalists is considered excellent, the quality of medicines made for over the counter use may vary.
  • Some herbal products may contain herbs which should not be used in conjunction with pharmaceutical hormone therapies but do not carry any warning.
  • Experimenting with over the counter preparations may be more costly than seeing a trained herbalist / naturopath.

The best way to use herbal remedies for the treatment of symptoms at menopause is under the guidance and advice of a trained natural therapist.

Herbal Remedies for Use in Menopause

Black Cohosh, Cimicifuga racemosa

Black cohosh is a North American plant which the native Americans originally used for menstrual cramps and menopausal symptoms. Extracts of the root have been used in Europe, particularly in Germany, for over 50 years. It is primarily used for hot flushes. 

Black cohosh is the most researched of all herbs used for the management of menopausal symptoms. The research on this herb includes animal data, in vitro studies and clinical trials. Almost all of the clinical studies of black cohosh have used the commercially available product. Remifemin.

Trials using Remifemin have shown it to be effective in the treatment of many menopausal symptoms, including hot flushes. It can be combined with other herbs to tailor a formula specifically for hot flushes. It is also used for vaginal dryness, aches and pains associated with menopause, and formication (sensation as if ants crawling on skin), although evidence of benefits in these areas is lacking.

The herb is generally well tolerated, although higher doses may cause headaches for some women. These usually cease when the dose is reduced.

Black cohosh, taken orally as well as topically (as a cream or pessary), has been shown to be effective for vaginal dryness.

Warning: Toxicity may occur from black cohosh. For more information see: Safety of Black Cohosh

St John’s Wort

St John’s Wort is not an oestrogen-like herb and is usually combined with other herbs such as black cohosh for more effective treatment.

St John’s Wort can be useful for hot flushes that are triggered by anxiety or stress. It can also be used for mild to moderate anxiety and depression – specifically depression associated with menopause.

A recent analysis of randomised clinical trials demonstrated that St John’s Wort was more effective than a placebo (dummy or sugar treatment) for the treatment of mild to moderately severe depressive disorders, was as effective as standard antidepressant treatment and had fewer side effects.

Warning: St John’s Wort should be avoided by people on a number of different medications, including:

  • Warfarin (blood thinning medication)
  • Digoxin (medication taken for heart rhythm)
  • Anti convulsants (anti seizure drugs)
  • Antidepressant drugs referred to as SSRIs (Selective Serotonin Re-uptake Inhibitor)
  • Cyclosporin (an immune suppressing drug)
  • HIV medication

Because of the risk of adverse reactions between St John’s Wort and other medications, it should only be prescribed by a qualified natural therapist.

A natural therapist would seek to find the cause of mood changes and would encourage dietary and lifestyle changes, with the use of herbal remedies or nutritional supplements where necessary.

Herbal Remedies for Use in Perimenopause

Red Clover

Red Clover is a herb that in recent years has been promoted for use in perimenopause. Traditionally, herbalists and naturopaths have not used this herb for perimenopausal complaints, but rather for skin conditions like eczema.

Most of the research that has been conducted on Red Clover is in the form of the over the counter product Promensil. Some of the research suggests that this herb may be beneficial for hot flushes. Other researchers (who have reviewed all Red Clover research) suggest that there is not enough evidence to show that this herb is effective for hot flushes.

Promensil has been shown to lower LDL-cholesterol (‘bad’ cholesterol) but other researchers suggest that there is not enough evidence to support this. The safety of this herb for patients with breast or endometrial cancer has not been established.

There is also some limited evidence suggesting a possible effect on maintaining bone health and improving blood vessel health which is a risk factor for atherosclerosis (build up of fatty plaque on the arteries which contributes to heart disease).

Hops

Hops may be useful for hot flushes associated with anxiety or stress. It may also be useful for associated insomnia (sleeplessness).

Warning: If severe depression is experienced, it is strongly recommended that Hops should not be taken.

Passionflower, Chamomile, or Valerian

Passionflower, Chamomile, or Valerian in the form of a herbal tea or tablet may also be considered to help with sleeplessness.

However, in a very small number of people, Valerian has a stimulating effect, rather than inducing sleep.

Panax Ginseng

Panax Ginseng, a traditional Chinese herb, increases the body’s ability to cope with physical and mental stress. The Ginsengs are useful for hot flushes that are aggravated by fatigue and overwork.

Panax Ginseng increases vitality and physical performance. It may be useful as part of the treatment for night sweats.

Warning: Panax Ginseng should only be taken short-term, two to four weeks at a time and under the supervision of a herbalist or naturopath. It can raise blood pressure and therefore should be avoided if you suffer from hypertension. It should never be taken during an acute infection (as this may worsen the condition), or with high doses of caffeine.

Siberian Ginseng

Like Panax Ginseng this herb may improve stamina and vitality during times of increased physical and mental demands, though it is generally considered to be less stimulating. It can be taken for a longer time than Panax, over several months.

Warning: Siberian Ginseng should not be taken during an acute infection.

Dong Quai

Dong Quai may be useful for hot flushes associated with fatigue and overwork.

Licorice

Licorice, may also be used for night sweats.

(The herb Licorice root should not be confused with confectionery liquorice. Licorice should not be taken long-term or by people with high blood pressure.)

Linseed or Flaxseed

Linseed or flaxseed has been shown to reduce vaginal dryness. The correct dose for ground linseed is 25 g, or about two heaped dessertspoons, which can be sprinkled on breakfast cereals or added to smoothies.

Linseeds are also a good source of the oils we cannot make in our bodies (essential fatty acids).  When seeds are ground, these good oils are lost over time (oxidise) – two weeks after grinding, the oils are completely destroyed.  To avoid the loss of these good oils, it is suggested that you freshly grind the amount of seeds you would eat within two weeks (in a food processor, nut grinding attatchment of a blender or an electric coffee grinder) and store in the fridge in an airtight container.

Lavender

Lavender, as a herb rather than as an essential oil, is used to help to clear depression. There are many varieties of Lavender, therefore it is essential that it be prescribed to ensure the correct type. Lavender is a strengthening tonic to the nervous system, and is useful for headaches and migraines, especially those associated with menopause.

Lemon Balm

Lemon balm, used as a herbal tea, has traditionally been considered to ‘lighten depression’. It helps relieve tension and stress, and is easy to grow as a home remedy.

Oat Straw

Oat Straw ‘feeds the nervous system’ and is different to the rolled oats we have for breakfast.  However, women should be encouraged to eat oats in the form of porridge or muesli to gain benefit.  If you are gluten intolerant, you should avoid oats as it is a gluten-containing grain.

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Other Therapies

Women who experience perimenopausal symptoms may decide to try a variety of other (complementary) therapies to manage symptoms or create more comfort for themselves.

About Other Therapies

People may choose therapies such as acupuncture, homeopathy, naturopathy, manual therapies, traditional Chinese medicine and herbal medicine among other options to to assist in managing their health.

These therapies can be described as either ‘complementary’ or ‘alternative’. Complementary therapy suggests that any of the disciplines of healthcare, including Western medicine, can be used together for the management of health issues.  This term has become more popular than ‘alternative medicine’ which suggests that natural therapies are an alternative to mainstream Western medicine.

Natural therapies are often referred to as complementary medicines, that is, they work in conjunction with, or alongside, other treatments.

A preference for non-pharmaceutical therapy is sometimes based on the idea that natural therapies are safe and that side effects do not occur. This is not always the case. It is important to understand that with any therapy, natural or pharmaceutical, careful review of potential side effects should be undertaken together with your health practitioner before use.

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