Table of Contents

Q 33. 1 What might I need to know about drugs frequently used in gynaecology?

You may be interested to learn:
• how these drugs are thought to work.
• about the possible indications (uses).
• how they may be administered (taken).
• their possible side-effects and risks.
• the dose of the medication that you can take.

To answer these questions fully even for the more frequently used drugs in gynaecology would require a book dedicated to the subject. The objective of this chapter is to provide a brief explanation of some of the basic issues. It should be emphasised that when prescribing for women during their reproductive years, great care is taken to avoid medication that could have an adverse effect on a possible pregnancy.

Q 33. 2 How do hormone treatments work?

A brief understanding of the way hormones work (Q2.8) is required if you wish to follow how they are used in treatment. Most drugs in general and hormones in particular, work by their action on receptor sites (Q2.8). Biological mechanisms maintain a balance within the cells, tissues, organs of individuals and species. Over the last three or four decades there has been an explosion in the depth of knowledge relating to reproductive physiology (function). Pharmacologists (those who study drugs or medicines) have been able to develop drugs of incredible power, allowing the clinician to prescribe treatments that were unimaginable even at the conclusion of the Second World War.

Cortisol, progesterone, testosterone and other androgens (male hormones) and oestradiol and other oestrogens are on a common biological pathway (Figure 2.5).

Q 33. 3 In what situations may hormone treatments be indicated?

Abnormalities in the balance of hormones that may respond to treatment with one or a combination of sex hormone treatments include:

• precocious (early onset) or delayed puberty (Q5.6).
• amenorrhoea (absence of periods (Q6.21).
• hirsutism (excess body hair) (Q8.13).
• anovulatory (eggs are not being released) infertility (Q10.6 – 10.14 ).
• heavy periods (Q24.16)
• premenstrual syndrome (Q25.6).

They may also be used:

• as contraception (Q14.3).
• as an option in the management of recurrent early pregnancy loss (Q12.16).
• to replace ovarian hormones after the menopause (Q28.3).
• in the treatment of cancer (Q32.33D).

The basic considerations of prescribing in reproductive medicine are presented in Figure 33.1.

 Q 33. 4  What are the sources of hormone treatments?

 Hormonal therapy uses drugs that are:            

 Hormones found in nature and purified. Examples include:

 ·        human menopausal gonadotrophin (used for some women with infertility  (Q10.13).

 ·        conjugated equine oestrogens (Q28.5).

 ·        ‘natural progesterone’  (Q28.16)

.           Synthetic hormone replicas:

 ·        recombinant FSH (used for infertility (Q10.15)

.           Synthetic agents that are similar to natural hormones:

 ·        the progestogens dydrogesterone and medroxyprogesterone acetate (Q24.17B).

 ·        GnRH agonists (Q24.17E)

.  Agents that have part of their structure resembling that of a natural hormone:

 ·        clomiphene (Q10.6).

 ·        danazol (Q24.17G).

 Q 33. 5 What determines the effect of a hormone treatment?

The action of one hormone treatment may be altered by that of another:

·        a course of progestogen will not result in a withdrawal bleed in a patient with amenorrhoea and low oestrogen levels after the menopause. The same woman, however, would have a positive result if she were given oestrogen before the progestogen. A drug may act by blocking a receptor.

 ·        Clomiphene (Q10.6) blocks the oestrogen feedback mechanism. Gonadotrophin releasing hormone agonists may initially have a positive action with a temporary increased output of the gonadotrophins FSH and LH (flare response) from the pituitary. They then block the receptor sites suppressing FSH and LH levels (down-regulation); this action is used in IVF regimens (Q10.24), as one possible treatment of endometriosis (Q23.21) and as pre-surgical preparation for removing fibroids (Q23.17). Some drugs have actions on different receptor sites and these combined actions can be utilised therapeutically.

 ·        Tibolone (Q28.13) activates both oestrogen and progesterone receptors so that it has the benefits of providing hormone replacement therapy whilst conferring endometrial protection. It may also have some beneficial androgenic activity.

 ·        Tamoxifen has anti-oestrogenic activity, which enhances the treatment of patients with breast cancer. Its anti-oestrogenic action is also used in the treatment of anovulatory infertility (Q10.10). Tamoxifen also has some oestrogenic activity so that it may relieve some menopausal symptoms. Its oestrogenic activity may adversely affect the endometrium (uterine lining) leading to hyperplasia (thickening) and rarely malignancy.

Q 33. 6 When are hormones used in combination?

Combinations of hormones are frequently prescribed. The combined oral contraceptive pills are combinations of oestrogen and progestogen (Q14.3). Pre-menopausal women who have not had a hysterectomy (hysterectomy) and who are taking hormone replacement therapy are given oestrogen daily and a progestogen for ten days or more each month (Q28.9).

The most complex of combinations used in reproductive medicine is probably in IVF (Q10.24); GnRH agonists suppress the reproductive hormones and gonadotrophins (FSH or FSH and LH) are used to stimulate multiple follicular development.

When the follicles are ready HCG is administered about 36 hours before egg collection. The pregnancy is supported by progesterone administration for the next three or four months.

Q 33. 1 What might I need to know about drugs frequently used in gynaecology?
Q 33. 2 How do hormone treatments work?
Q 33. 3 In what situations may hormone treatments be indicated?
Q 33. 4 What are the sources of hormone treatments?
Q 33. 5 What determines the effect of a hormone treatment?
Q 33. 6 When are hormones used in combination?
Q 33. 7 Why do hormone treatments sometimes cause side-effects?
Q 33. 8 When are oestrogens prescribed?
Q 33. 9 What are the possible side effects and risks of oestrogen therapy?
Q 33. 10 When are progestogens prescribed?
Q 33. 11 What are the possible side effects and risks of progestogen therapy?
Q 33. 12 How is the relative potency (strength) of progestogens measured?
Q 33. 13 When is danazol prescribed?
Q 33. 14 When are androgens prescribed?
Q 33. 15 What are the possible side effects of androgens?
Q 33. 16 What are gonadotrophin releasing hormone analogues and gonadotrophins?
Q 33. 17 When are GnRH analogues prescribed?
Q 33. 18 What are anti-hormones?
Q 33. 19 By which routes can drugs be given and why are they chosen?
Q 33. 20 Why do I seem to be given a medication with a different name but my doctor says it is the same as before?
Q 33. 21 I am worried about the possible side-effects of a medication. What should I do?
Q 33. 22 How are new treatments developed?
Q 33. 23 What is a meta-analysis?
Q 33. 24 What is meant by the term ‘evidence based medicine’.
Q 33. 25 What is a clinical trial?
Q 33. 26 What is a placebo?
Q 33. 27 What is meant by relative risk?
Q 33. 28 What is informed consent?
Q 33. 29 What is the current opinion of the medical profession on “alternative” or “complementary” medicine?
Q 33. 30 Could I have some useful Web sites?
Women’s Health – Home Page

Q 33. 7 Why do hormone treatments sometimes cause side-effects?

There are sometimes predictable side-effects. GnRH agonists, for example, may be used to lower oestrogen as part of treatment of fibroids or endometriosis; low oestrogen levels are associated with menopausal symptoms. Progesterone is a precursor (precedes in the chemical pathway) of the glucocorticoids and mineralocorticoids (adrenal gland steroid hormones) as well as of the sex steroid hormones.

There is a great deal of chemical similarity (Figure 2.5) between the adrenal steroids, and the sex hormones – progesterone, androgens (male hormones e.g. testosterone) and the oestrogens (female hormones e.g. oestradiol). The adrenal steroids play a critical part in body protection and fluid balance. Hormones prescribed in anticipation of their action on one set of receptors, may also activate other receptors leading to side-effects. Progestogens, for example, and particularly norethisterone, may have androgenic side-effects. Fluid retention (an adrenal steroid effect), may be a side-effect of sex hormone (oestrogen and progesterone/progestogen) administration.

One Sunday morning, in the early hours, I received a telephone call from a distressed patient. She was infertile due to anovulation (Q9.3) and I had prescribed an appropriate drug to help her. She had been terrified to read in the patient information leaflet accompanying the tablets that the drug should not be taken within six weeks of trying for a pregnancy. I reassured her that the medication was licensed for the treatment of infertility.

The following day, I confirmed that she had correctly read the information leaflet and I wrote to the company concerned requesting an explanation. They kindly forwarded summaries of many medical papers, including one of my own, demonstrating that it was a safe and effective drug in the management of infertility cases. Following my second letter, they agreed that the information leaflet was misleading to patients and they would consider altering it.

It is surprising how misleading pharmaceutical data sheets supplied by the companies manufacturing medications can be (Q28.27) . The list of “warnings, precautions and side-effects” relating to most drugs is such that many patients who read them become understandably anxious. When compiling these lists, the pharmaceutical companies are indicating problems that have been reported by patients whilst taking the medication.

The fact that a patient reports a problem whilst taking a medicine does not necessarily mean that the drug was the cause of the problem; it may have been incidental. Both weight gain and weight loss have been reported by patients taking hormone replacement therapy (Q28.22). Of course some patients lose weight and others gain but this is unlikely to be related to this treatment – everyone’s weight fluctuates.

Some complications may be extremely rare but for the sake of completeness the company concerned may feel obliged to include them as potential problems. Information which the company provides for patients can occasionally be incorrect or misleading (Q28.27).

Q 33. 8 When are oestrogens prescribed?

The role of oestrogen in human biology is discussed in Q2.12. Oestrogens are employed in the management of oestrogen deficiency usually after the menopause (Q28.3) but also when oestrogen levels are low for other reasons (Q6.21). They are an essential part of combined oral contraceptive pills (Q14.3).

Q 33. 9 What are the possible side-effects and risks of oestrogen therapy?

Hormones administered for one indication may trigger another hormone receptor site (Q33.7). Oestrogens may, for example, cause fluid retention. The possible side effects of oestrogens in HRT and the combined oral contraceptive pill are discussed in the appropriate chapters (Chapter 15 & 27).

Q 33. 10 When are progestogens prescribed?            

The role of progesterone in human biology is discussed in Q2.13. Progestogens are synthetic chemicals that have actions similar to progesterone. Dydrogesterone (Duphaston  – Solvay) , medroxyprogesterone acetate (Provera – Pharmacia & Upjohn) and norethisterone (Primolut  N  – Schering H.C. / Utovlan – Searle) are commonly prescribed by themselves or in combination usually with an oestrogen. Other progestogens (including norgestrel, desogestrel, levonorgestrel and ethynodiol diacetate) are used in oral contraception (Table 16.2). Progesterone is available as suppositories/pessaries (Cyclogest – Shire ), injection (Gestone  –  Ferring) and  a vaginal gel (Crinone – Serono). There is a progesterone cream for application to the skin (Progest   –   Q28.16). Progesterone and progestogens may be employed in the management of:-

 ·         infrequent periods (Q6.25).

 ·         infertility (Figure 10.3).

 ·         recurrent miscarriage (Q12.16).

 ·         contraception (Q14.5).

 ·         menorrhagia (heavy periods – Q24.17B).

 ·         premenstrual syndrome (Q25.7).

·         menopausal symptoms with hormone replacement therapy (Q28.9).

 ·        cancer (Q32.33D).

Q 33. 11 What are the possible side effects and risks of progestogen

Fluid retention may lead to a little weight gain, but no more than a pound or two and certainly not stones. You may develop a rash may occur and if this is a major problem, you should consult your doctor. Nausea, mastalgia (breast discomfort or pain), headaches and dizziness may occur in some susceptible people.

Q 33. 13 When is danazol prescribed?

Danazol (Danol – Sanofi) has several modes of action . It tends to suppress the output of pituitary gonadotrophins (Q2.11) resulting in lowering of ovarian sex hormone production. It also reduces the effect of oestrogen and progesterone. It may be used in the treatment of:
• endometriosis (Q23.21).
• heavy periods (Q24.17G).
• cyclical mastalgia (Q25.5).
• premenstrual syndrome (Q25.8).
Side-effects include nausea, rashes, headache, visual disturbance, acne and hirsutism but these are more common at high dose levels of 600 or 800mg daily. In practice, danazol tends to be used when other medications are unsuccessful. Many patients have no problems with danazol, particularly when it is used in low dosage, and it often improves symptoms.

Q 33. 14 When are androgens prescribed?

The role of androgens (male hormones) in human biology is discussed in Q2.12. There may be a place for androgen therapy in hormone replacement therapy (Q28.17) to enhance energy and libido.

Q 33. 15 What are the possible side effects of androgens?

There is a small risk of hirsutism and virilisation (Q8.1). Careful monitoring is essential.

Q 33. 17 When are GnRH analogues prescribed?

This down-regulation is employed in IVF protocols (Q10.24) to ensure that there is no natural release of LH which could result in premature and unplanned release of eggs from the ovaries. Suppression of gonadotrophins by GnRH analogues is beneficial for pre-operative preparation for fibroid removal (Q23.17) and in the management of endometriosis (Q23.21).

When administered in intermittent bolus by a pump, GnRH agonists are effective in inducing ovulation. A new generation of GnRH antagonists is being produced and they are currently under investigation. These antagonists have only inhibitory effects so that they will not cause a flare response (Q33.5).

Q 33. 18 What are anti-hormones?

An anti-hormone (hormone antagonist) blocks the action of a hormone on receptor sites. They are receiving increasing attention in a variety of treatments. The anti-oestrogens, clomiphene and tamoxifen, are used in infertility (Q10.6) and tamoxifen is also widely used for patients with breast cancer (Q32.42). The anti-androgen, cyproterone, competes with androgens and is used in the management of hirsutism (Q8.15).

Spironolactone is an aldosterone antagonist which has been used mainly to increase urine production but it also has anti-androgenic activity. Mifepristone is a synthetic anti-progesterone. It is licensed as an abortifactant (an agent used to procure cause miscarriage) up to 63 days gestation (Q19.10).

Gonadotrophin releasing hormone analogues block GnRH from the hypothalamus acting on the pituitary gland so that FSH and LH levels and consequently oestrogen levels fall (Q33.17). References: Pure anti-oestrogens (2000-3144)

Q 33. 19 By which routes can drugs be given and why are they chosen?
Oral administration

The most frequently employed route for giving medication is by mouth. The drug is usually absorbed through the lining of the small bowel after passage through the stomach. The rate of gastric (stomach) emptying varies between individuals and this may explain some differences in drug response. Absorption of hormones may be reduced by chronic bowel conditions, such as coeliac disease, or an acute gastrointestinal illness involving vomiting and diarrhoea.

This may result in unwanted pregnancy in women taking oral contraceptives, or irregular bleeding in women taking either the oral contraceptive pill or HRT. The circulation is such that blood from the small bowel travels directly to the liver. The liver may break down most of the drug on this ‘first pass’.

Other routes are chosen for a variety of reasons including problems getting the drug safely through the acid milieu of the stomach and yet in a suitable state for absorption by the small bowel and also if the liver will let very little through during the first pass after absorption from the bowel.

Vaginal or rectal routesRectal or vaginal progesterone suppositories/pessaries have been frequently prescribed for patients with premenstrual syndrome (PMS – Q25.7), for infertility including IVF (Q10.24) and to try to reduce miscarriages for those with recurring problems (Q12.16). More recently a vaginal progesterone gel (Crinone®– Serono) has been marketed for infertility, PMS and in the management of the menopause. The vagina has been shown to be a useful route of administration of oestrogen in hormone replacement therapy (Menoring® – estradiol acetate – Galen Ltd).

Some drugs that are usually taken by mouth, such as bromocriptine and cabergoline (Q6.21) may cause nausea or vomiting even when taken after meals, as they have a direct action on the stomach. The vagina may prove to be a useful alternative route.

Intramuscular and subcutaneous routesMost drugs are water-soluble and they are readily absorbed by the small intestine, or they are lipid (fat) soluble. Lipid soluble drugs are absorbed when injected into a muscle (intramuscular) or into the fat under the skin (subcutaneous). A depot preparation of medroxyprogesterone acetate provides reliable contraception for three months (Q14.19). Diabetics have undertaken self-injection of insulin for many years. Patients are increasingly being taught to self-inject hormones for infertility treatment.

Implants of oestradiol and testosterone are inserted under the skin for some women requiring hormone replacement therapy (Q28.5). Similarly, one GnRH agonist implant, goserelin (Zoladex® -Zeneca) is introduced monthly for some patients with endometriosis (Q23.21) or with fibroids before surgery (Q23.17).

Transdermal routeThere are a variety of patches favoured by some patients for their hormone replacement. Some contain oestradiol only (Table 28.2) while others have oestradiol combined with progestogen either cyclically or continuously.

Nasal routeGonadotrophin-releasing hormone agonists, including nafarelin and buserelin, can be administered by nasal spray for treatment of endometriosis, pre-operative preparation for myomectomy (fibroid removal – Q23.17), preparation of the endometrium before endometrial ablation (Q24.28) and in some infertility regimens (Q10.24). A new HRT preparation (Aerodiol® – estradiol hemihydrate – Servier) is administered by nasal spray (Q28.5).

Intrauterine routeThe levonorgestrel intrauterine system (Mirena®) is an intrauterine contraceptive device (IUCD) that releases the equivalent of two progestogen only pills each week. It is licensed for contraception (Q14.26) but it may also have a place in the management of dysfunctional uterine bleeding (heavy periods with no specific cause – Q14.36).

It provides not only contraception in pre-menopausal women but endometrial protection when oestrogen is administered either to control premenstrual (Q14.37) or menopausal symptoms (Q28.15). A variety of other applications are under consideration including the management of endometriosis.

Q 33. 20 Why do I seem to be given a medication with a different name but my doctor says it is the same as before?

Most medicines have generic names (according to their chemical structure) and a second “brand” name used by the pharmaceutical company manufacturing them. Usually, when a company develops a new medication they apply for a patent. After a number of years the patent expires and other companies may produce it. Norethisterone, for example, is the generic name of a progestogen. It is released by one company as “Primolut N” and by another as “Utovlan”. Norethisterone is included in eleven oral contraceptive pills and twelve combined HRT preparations. The generic name and the brand name of a drug may vary from country to country.

Q 33. 21 I am worried about the possible side-effects of a medication. What should I do?

Every medicine that has proven benefits will have occasional side-effects. Prescribing is always a matter of weighing up the potential benefits and risks (Figure 33.1). Before prescribing a medication, your doctor will probably let you know if there are any major side-effects and what you should do if they occur.

When a new medication is being evaluated, the company is likely to record all the symptoms that the evaluating patients describe. These may appear on patient information leaflets without any statistical evidence that the ‘side-effect’ is related to the medication or how frequently the problem is likely to be encountered. If you think that you are developing a worrying side-effect, you should seek the advice of your doctor.

Q 33. 22 How are new treatments developed?

Doctors are always seeking better treatments for their patients and behind the scenes there is a vast amount of research being conducted. Biology is subject to variation. No two people are identical – not even “identical twins”. The way in which we respond to treatment will vary. One woman, for instance, may be happy with one oral contraceptive pill but not another.

Statistical analysis forms the basis for many conclusions in the medical sciences. It is a very exacting science and most medical schools as well as other institutions have professional medical statisticians. Most research starts by asking a question. A method of collecting relevant data (information) is planned and the results collected. Data analysis is undertaken with the purpose of answering the original question, sometimes called a hypothesis.

Frequently, in research we use a placebo such as a tablet with no medicine in it to compare with a new drug (Q33.26). Let us consider the case of a comparison of two drugs used to reduce heavy periods. Fifty women receive drug “A” and another fifty drug “B”. If forty women in each group report improvement no analysis would be required to say that the two drugs are equally effective.

If all fifty report improvement with drug “A” and none with drug “B” then again it would seem fairly obvious that drug “A” is better than “B”. Clearly sometimes a symptom may resolve by itself and one must be aware that the new drug is not necessarily beneficial.

If drug “A” produces improvement in forty out of fifty patients and drug “B” is associated with improvement in twenty out of fifty a statistician could calculate the likelihood of this happening by chance. This is usually expressed as a “p” (probability) value. Usually we accept that if the chance of the difference in results is less than one-in-twenty (p<0.05; 5 out of 100) the findings are significant.

There will often be a number of studies addressing the same question and they will each have their own unique set of data. The larger the amount of data collected in the study the more “powerful” the results. Frequently different studies come to conflicting conclusions.

Q 33. 23 What is a meta-analysis?

Meta-analyses seek to combine the results of the various studies addressing the same question. The results of small studies may suggest that a treatment looks promising but the numbers involved may be relatively small and therefore inconclusive.

If the results from all relevant research are combined the numbers may become more meaningful. Great caution is required as the studies are unlikely to have collected data in identical ways. Nevertheless, as the meta-analysis will include more data, the overall conclusions may be more powerful than those from individual studies.

Q 33. 24 What is meant by the term ‘evidence based medicine’

Medicine is becoming more evidence based. Our ability to collate vast amounts of information has been enhanced by computers. In an ideal world no investigation or treatment would be offered to a patient until all possible research had been completed. Sadly such a state of utopia is not possible. I sometimes say to my juniors that no operation should be performed by a surgeon who has performed that procedure less than one hundred times. Of course, when surgeons are training there must be a senior with them to guide them.

Every time there is a new development, we subsequently learn of possible risks. It was only shortly after the second world war that antibiotic treatment for tuberculosis (TB) became feasible. Until that time TB was one of the more common causes of premature death. The mother of one of my friends was one of those first treated with streptomycin. The TB was cured but sadly the streptomycin resulted in her becoming deaf. Whilst an advance in medicine had saved her life, she never really forgave her doctors for the deafness which was particularly tragic as her daughter became a talented singer.

A recent radio advertisement for vacations in the West Indies starts by saying “Tomorrow the weather will be hot. Next week rain ——- is unlikely.” To those of us living in Northwest Europe the weather is so unpredictable that it is a common starting point of conversation. Medicine is far more like the weather in Northwest Europe than in the West Indies: weather forecasting is not an exact science even for predicting the next 24 hours.

A colleague of mine recently returned with his family from vacation in the West Indies. Shortly after the plane started back across the Atlantic, it was unexpectedly attacked by a severe storm and everyone on the plane, including the staff were pleasantly surprised that they made it back. Doctors can advise from the best currently available information but we are not prophets who can accurately predict future developments.

Every aspect of medicine is under evaluation, re-evaluation and debate. Some patients may find this confusing. There is, however, variation of opinion in every profession whether it be in the domain of politics, science, education, art or religion. There is always need to evaluate the information and make an informed choice. Whenever there is good evidence, medicine should be based on it. Medicine, however, must strive to find a balance between utilisation of the latest advances and the current tried-and-tested investigations and treatment.

Q 33. 25 What is a clinical trial?

A clinical trial is a research study designed to answer specific questions about a new treatment. There are very strict rules governing clinical research. Before a new treatment can be tested, the proposed study must be scrutinised by an ethics committee which has the power to advise hospital management on whether the research is appropriate. Ethics committees include clinical experts as well as lay-members. An approved set of rules, called a protocol, is set out indicating the people that can be approached for the study and the schedule of investigations, treatment and outcome measures to be evaluated.

Q 33. 26 What is a placebo?

A placebo is designed to look like a treatment but it contains no active ingredient. Some patients in a trial may receive the active drug and others the placebo. Patients receiving the placebo are said to be in the ‘control’ group. A trial with a control group is called a controlled trial. Ideally, neither the patient nor the doctor directly involved knows which each patient is receiving.

As an example, our maternity unit at Whipps Cross Hospital has joined a multicentre study to evaluate the potential benefit of an antibiotic drug to see whether this will reduce the risks of premature delivery in a group of women believed to be at high risk. This trial will be ‘double-blind’ as neither the patients nor those directly involved in their care will know whether an individual participant is taking the antibiotic or the placebo.

The allocation of the tablets follows a strict protocol with the hospital pharmacist supervising the allocation of pre-prepared packets of the tablets. The protocols required have been prepared with the advice of statisticians to ensure that the results can be analysed to determine whether any perceived benefits of medication are real and not due to chance.

Q 33. 27 What is meant by relative risk?

Relative risk compares the risk of a problem with a particular treatment. If we take the example of HRT, 7.5% of women aged fifty will develop breast cancer by the age of seventy-five whereas 9% of these women will develop breast cancer by the age of seventy five if they take HRT for fifteen years. The relative risk is 9 to 7.5 or 1.2.

Q 33. 28 What is informed consent?

Any treatment provided for you can only be given with your consent. Informed consent is a specific term indicating that the proposed treatment is relatively new or is the subject of a research study. It would be appropriate for informed consent to be requested when the medication being offered is outside the current licence. For example, the author is currently prescribing metformin for PCOS (Q7.14) only with informed consent.

There is a wealth of information about metformin and international authorities have documented the potential value of this treatment. Metformin, however, is not yet licensed for the treatment of PCOS. Similarly, the author has initiated a research study to investigate the potential value of antibiotics for couples with infertility and/or recurrent miscarriage.

The research has the approval of the hospital and the local research ethics committee. As there is no proof that these couples have an infection, the relevant antibiotics can only be prescribed with informed consent.

Whenever a doctor is providing you with a treatment that is still under relatively early evaluation, your informed consent is required. Your doctor should ensure that you are given a full explanation in the clinic and usually some written information sheets.

This information should indicate:

• the objectives of the treatment / study.
• what will be required from you.
• any possible risks.
• potential benefits.
• other treatments that are available.
• confirmation that you have the right not to enter the trial and that you may leave it should you wish to do so

Q 33. 29 What is the current opinion of the medical profession on “alternative” or “complementary” medicine?

Conventional mainstream medicine has always prided itself on being supported by science. In recent years it has focused on treatment that is evidence-based (Q23.24). “Alternative” and “complementary” medicines have always existed but we doctors have tended to shun them as being quackery.

Those who genuinely believe in treatments such as acupuncture and homeopathy have equally derided doctors for ignoring treatments that they believe are effective. There has been a tendency for medicine to take a mature look at the alternatives: two series of articles on these subjects that appeared in the British Medical Journal in 1999 and in 2001 (Figure33-02) bear testimony to this change in position.

It is now recognised that there is a need for objective, scientific evaluation of all treatment modalities. For the moment at least conventional medicine is unconvinced at most of the claims made by the “alternatives” but it correctly takes a similar cautious attitude to new ideas emanating from within the medical profession.


Complementary medicine today:

Patient decision for physician or magician? – A comparative study of patients deciding in favour of alternative therapies (1996-3231) Conventional or complementary medicine: What makes the patient choose? (1994-3230)

Q 33. 30 Could I have some useful Web sites?

Evaluation of the quality of Web sites is discussed in Q4.27. You may find that several general women’s health sites may help you (Q4.28). The following are more specialised Web sites on topics found in this chapter:- Clinical trials:

• Medicines:
• Alternative and complementary medicine.

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