Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Primiparous?
- Jonathan S Charlton (30 January 2004)
-
Monitored nutritional repletion
- Ellen C G Grant (30 January 2004)
-
Nausea and vomiting in early pregnancy
- Mick A Leach (30 January 2004)
-
Pyridoxine, Ascorbate and, perhaps, K 1
- Dr.Herbert H. Nehrlich (30 January 2004)
-
best evidence
- Giselle Tomasso (30 January 2004)
-
Give patients a feeling of control.
- Robert D. Hoffman (1 February 2004)
-
Treating N & V in pregnancy
- David M Lewis (1 February 2004)
-
Apologies for the editorial error
- Tom Fahey, Nicola Harker, Alan Montgomery (1 February 2004)
-
Nausea & Vomiting in Pregnancy
- Michael D Croft (1 February 2004)
-
Difficulties in designing a clinical trial that will provide scientifically valid results
- Jeffrey Mann (2 February 2004)
-
Gastric outlet obstruction caused by constipation : a causative factor?
- Richard G Fiddian-Green (2 February 2004)
-
Hypnosis and Guided Imagery can be tried as alternatives
- Martin Maldonado-Durán (3 February 2004)
-
Breadth of Learning
- Ed Peile (3 February 2004)
-
Statistical commentator's response
- Michael J Campbell (4 February 2004)
-
Re: Breadth of Learning - Treatment of Nausea and Vomiting during Pregnancy
- Anthony M Barnie-Adshead (4 February 2004)
-
Might the risk of drug-induced fetal damage extend for generations?
- Richard G Fiddian-Green (4 February 2004)
-
Thiamine treatment
- william s. craig (5 February 2004)
-
Evidence for nutritional deficiencies
- Ellen C G Grant (5 February 2004)
-
Only one cure for hyperemesis
- Geraldine A Lee (8 February 2004)
-
Accupressure for N&V in Pregnancy
- Osborn A Viegas, Claire Viegas (12 February 2004)
-
Homeopathy in pregnancy
- Roger F Neville-Smith, Byland Rd, Skelton, Saltburn TS12 2NN (24 February 2004)
|
|
|||
|
Jonathan S Charlton, gp principal HA2 6HL
Send response to journal:
|
How can this lady be primiparous if she has a 5 yr old daughter? How much else of the information included in this scenario can be trusted if such a simple mistake appears unedited by yourself and BMJ staff? Phenothiazines are contraindicated during pregnancy although the older sedating anti-nauseant antihistamines aren't. Competing interests: None declared |
|||
|
|
|||
|
Ellen C G Grant, Physician and Medical Gynaecologist 20 Coombe Ridings, Kingston-upon-Thames, Surrey, KT2 7JU
Send response to journal:
|
1. What would you say to the patient about the safety of treatments (both conventional and complementary) in pregnancy? I do not give pharmaceutical drugs for hyperemesis gravidarium because all drugs are potentially dangerous to the developing foetus. I seldom find women who have been given good preconception care need to take any medications. Ideally this includes avoiding smoking, alcohol, exogenous hormones and starting a high protein low allergy diet 3-4 months before conception. I also use monitored essential nutrient repletion. I do not regard essential nutritional supplementation as either complementary or alternative but necessary to correct common important maternal physiological defects. This is necessary to minimise the risk of congenital abnormalities, learning or behaviour problems or illnesses in children. 2. What study design might provide evidence for their relative efficacy in an individual patient? The investigations and treatments must be tailored for each individual woman. Studies can be designed to look at each individual problem such as smokers versus non-smokers, iron or folate deficient or not. Usually stopping smoking and iron and folic acid tablets are advised in pregnancy, but this will not prevent sickness if the woman is zinc, magnesium or copper deficient and therefore inevitably has impaired immune responses to pregnancy and will have adverse reactions to more foods and chemicals. Avoiding cheese, chocolate and red wine does not prevent migraine if a woman has masked, but strong, reactions to wheat or cow/s milk. I use a four day rotation diet of different meats, fish, vegetables and fruit which, in my 30 years experience, in is equally effective in preventing migraine, hypertension, pregnancy sickness, and pre-eclampsia. 3. How would you rate the relevance of such evidence to another patient? A properly structured programme is effective for all women. 4. How many of your patients are using complementary therapies, and what percentage of pregnant women do you think use complementary therapies such as herbal treatments or supplements during pregnancy? All my patients are given monitored nutritional supplementation before or during pregnancy. Very few women are nutritionally replete in the most important trace minerals and as the blood levels of zinc and magnesium fall and copper levels rise during pregnancy, deficiencies of these key nutrients should be prevented. I do not practise alternative or herbal medicine, only evidence based nutritional medicine. Competing interests: None declared |
|||
|
|
|||
|
Mick A Leach, GP principle Harrogate HG1 5JP
Send response to journal:
|
Is this the first pregnancy with her current partner? Singleton pregnancy? or does she have a multiple pregnancy or a hydatidiform mole? Whilst few drugs are licenced for use in pegnancy, or their use is cautioned against in the BNF and by the manufacturers, it does not mean to say that they are recognised to be harmful. Indeed several antiemetics are used in pregnancy without harm being evident, including in addition promethazine and cyclizine. I would feel unable to offer advice about "complementary" preparations or to guarantee the quality if any. Competing interests: None declared |
|||
|
|
|||
|
Dr.Herbert H. Nehrlich, Private Practice Bribie Island, Australia 4507
Send response to journal:
|
I assume that the 5 year old daughter was adopted. No other way that the prima would fit otherwise. But, nausea and vomiting of pregnancy has been elaborately described in Dr. Jonathon Wright's book on "Healing with Nutrition" . Dr Wright published his findings in the early eighties and there really is NO excuse for not knowing about it. Very effective natural remedies exist and I wonder why any doctor would use anything else ? Pregnancy is not usually a disease but it is a lucrative thought. Competing interests: None declared |
|||
|
|
|||
|
Giselle Tomasso, MD Obstetrician Pereira Rossell Montevideo Uruguay 11400
Send response to journal:
|
What would you say to the patient about the safety of treatments (both conventional and complementary) in pregnancy? Anti-emetic medication appears to reduce the frequency of nausea in early pregnancy. There is some evidence of adverse effects, but there is very little information on effects on fetal outcomes from randomised controlled trials. Of newer treatments, pyridoxine (vitamin B6) appears to be more effective in reducing the severity of nausea. The results from trials of P6 acupressure are equivocal. No trials of treatments for hyperemesis gravidarum show any evidence of benefit. Evidence from observational studies suggests no evidence of teratogenicity from any of these treatments. What study design might provide evidence for their relative efficacy in an individual patient? A randomised trial in an individual. N of 1 trials can be used in medical practice to determine the optimum treatment for an individual patient. There are many ways of conducting N of 1 randomised trials, one approach is: A clinician and patient agree to test an intervention (the "experimental therapy) for its ability to improve or control the symptoms, signs, or other manifestations (the "treatment targets") of the patient's health problem. The patient then undergoes "pairs" of treatment "periods" organized so that one period of each pair applies the experimental therapy and the other period applies an alternative intervention or placebo. The order of these two periods within each pair is randomized by a coin toss or other method that ensures that patient is equally likely to receive the experimental or control intervention during any period. Whenever possible, both the clinician and the patient are blind to which intervention the patient is receiving. The clinician monitors the treatment targets, often through a patient diary, to document the effect of the intervention currently being applied. Pairs of treatment periods are replicated until the clinician and patient are convinced that the experimental therapy is effective, is harmful, or has no effect on the treatment targets. This usually requires 3 pairs How would you rate the relevance of such evidence to another patient? Poor How many of your patients are using complementary therapies, and what percentage of pregnant women do you think use complementary therapies such as herbal treatments or supplements during pregnancy? About 25% of my patients use complementary therapies. I don´t know the percentage of pregnant women do you think use complementary therapies such as herbal treatments or supplements during pregnancy? . Competing interests: None declared |
|||
|
|
|||
|
Robert D. Hoffman, Family Physician; Clinical Teacher Rehovot Israel; Tel Aviv Family Medicine Department
Send response to journal:
|
What would you say to the patient about the safety of treatments.... I would recommend consulting her gynecologist, and then coming to me ( as her "primary" consultant ) to discuss options. Patients should always feel they have options. There should always be another thing we can try. I am relctant to start any "medicine" in pregnancy. Hyperemesis is self limited, and the rate of things going wrong in pregnancy is too high to let us "guarantee" that nothing will happen if they tae a medicine. I think most alternative medicine ( including dietary changes ) give the patient a greater feeling of participation. Obviously, an open mind towards patients choices will lead to a more open discussion of what they're thinking of taking. What study design might provide evidence for their relative efficacy in an individual patient? A double blind study would be best, but it is difficult to carry out in many alternative medicine modalities. "sham" Acupucture vs real AP might work, or Vitamin supplements vs. placebo. I think episodes of actual vomiting would be much more "convenient" to count than to try to quantify Nausea. Weight loss or gain is also useful. How would you rate the relevance of such evidence to another patient? Tell her to try it. If it helps, good. If not, we have other options. How many of your patients are using complementary therapies, and what percentage of pregnant women do you think use complementary therapies such as herbal treatments or supplements during pregnancy? I would estimate that over 50% of my patients try some form of alternative medicine. If we include "folk" remedies, it would probably be closer to 75%. Over 50% of pregnant patients with hyperemsis try alternative treatment. A easy and convenient trial of an anti-emesis bracelet ( that patients can actually make themselves if they want to save the 20$ freqeuntly charged ); and teaching the acupuncture points for nausea for "self acu-pressure" is something anyone with nausea should try. Competing interests: None declared |
|||
|
|
|||
|
David M Lewis, General Practitioner Watford WD24 7PH
Send response to journal:
|
I researched this topic while an ObGyn SHO a few years ago. The hospital pharmacy team pulled load of articles and data to assist. From this analysis it was apparent that a stepwise approach to the treatment of nausea and vomiting in pregnancy could be developed. However, a few conditions ought to be excluded first: multiple pregnancy. molar pregnancy, emotional distress. It was interesting that the main cause of hyperemesis gravidarum was a high level of suppressed emotion; there is evidence that admitting these women for a few days can solve the problem without resorting to medication. To turn specifically to the questions posed in the vignette: 1. There is no evidence that guarantees the safety of any treatment for this problem. Some of the prescribed agents have been used for over 50 years in millions of women with a similar problem with no documented ill effects to their babies. While there are advocates of nutritional measures to minimise the distress of the N&V of pregnancy, if the symptoms prevent adequate oral intake a chemical state (reflected by ketonuria) can prevent spontaneous recovery. Therefore, it is my practice to offer antiemetics in a strictly stepwise fashion according to the data I reviewed years ago: 1. cyclizine; 2. prochlorperazine; 3. metoclopramide; 4. domperidone; 5. odansetron. 2. An observational study: if the symptoms resolve with the prescribed treatment, the treatment is effective. It is unethical to study this prospectively because of the implications of getting it wrong. There is sufficient absence of evidence of harm to stick with the old drugs which have been used for decades. 3. see (2) Treatment must be individualised. The data from my clinical information system could be used to review the effectiveness of the interventions and track the pregnancy outcomes. 4. A few of my pregnant patients are using vitamin supplements. None of these ladies admits to using herbal/complementary remedies. I can think of only one lady in the past year (out of some 30 women) who required high dose regular cyclizine from early gestation until the 3rd trimester. Competing interests: None declared |
|||
|
|
|||
|
Tom Fahey, Professor of Primary Care Medicine Tayside Centre for General Practice, University of Dundee, DD2 4AD, Nicola Harker, Alan Montgomery
Send response to journal:
|
We apologise to BMJ readers regarding the error with regard to the Ms Reynold's parity. In our submitted paper, we stated her parity as being Para 1+1. The BMJ editorial team changed this to her being primiparous, which is clearly not the case. Our apologies to readers for not noticing this editorial amendment when reading the proofs. To be absolutely clear Ms Reynold's parity is Para 1+1. Competing interests: None declared |
|||
|
|
|||
|
Michael D Croft, Salaried GP Gateways Surgery, Shenley, Herts WD7 9LP
Send response to journal:
|
Q1. My usual practice is to suggest to patients that no drug can be guaranteed to be safe in pregnancy, but the evidence shows that whereas some drugs carry high risks to the fetus, the use of the majority of drugs in pregnancy is not associated with evidence of harm. Patients are warned off taking medication of any sort by the manufacturers of those medications, unless it is positively indicated for a pregnancy-associated condition, and the use of such disclaimers on containers is virtually universal. This follows the experience of the Distillers Company in the 1960's with thalidomide, though it should be pointed out that this was actually marketed as a treatment for vomiting in early pregnancy. This extends to the manufacturers of complimentary therapies, and is only likely to be unobserved by manufactureres of food supplements where these deliver doses within the range of normal balanced dietery levels. Patients and their doctors are therefore advised either to avoid use of the drug in pregnancy, or to carefully address the risk-benefit issues. This suggests that we should be careful, and I put it to patients that they may choose to put up with their symptoms rather than run a small and unquantifiable risk. I also mention that 2% of pregnancies result in a significant congenital abnormality, very probably unrelated to any injudicous medication, but leaving the mother with a lifetime of wondering whether this might have been avoided, by not taking the medication. As far as complementary medication is concerned, I am inclined to regard homeopathic dilutions as overwhelmingly likely to be safe, though for the same reason to be unefficacious. Herbal remedies may be toxic, however, and accordingly best avoided. I would say that to the patient, and warn them that they should only take any complementary therapy in early pregnancy from an accredited agency such as a pharmacist, who holds a registrable qualification. Faced, myself, with a patient who has significant symptoms, I recommend Avomine, and bear in mind that patients can occasionally become very ill (one of the Bronte sisters died as a result of it). Q2. Evidence existing in the form of an adequately-powered, prospective, randomised, double blind cross-over trial of established orthodox treatments such as prochlorperazine and/or promethazine theoclate, against recommended complementary therapies, for the treatment of pregnancy induced nausea and vomiting, would be compelling. Q3. This question, I would judge, is about external validity and how much the type of patient who would consent to enter such a trial might differ from another patient who would not immediately consider complementary therapy. Put another way I would not use evidence grounded on the experience of women who asked for such therapy to inform on the suitability of such treatment for women who did not. Q4. The reported 1 yr prevalence of use of complementary medicines in the UK is 25% according to a topical article in the current BJGP (Bull WHO 2000; 78:252-257), and this can be higher in certain subgroups such as, presumably, ethnic chinese. Quite how many pregnant women take anything over the counter, with or without practitioner advice, I do not know, but would instinctively put at a much lower figure, given the perceived risk of medication in general. But this would assume that lay perceptions of the risks of complimentary medicines in pregnancy match those of orthodox medicines, and this may be questionable. I suspect that this article is steering us towards the realisation that the use of complimentary medicines in early pregnancy is more prevalent than we realise, and that the associated risks have not been accurately addressed by doctors and patients alike. Watch this space. Competing interests: None declared |
|||
|
|
|||
|
Jeffrey Mann, Retired physician Salt Lake City, UT 84103
Send response to journal:
|
Dr. Lewis recommends an observational study as the method of studying a new anti-emetic drug in early pregnancy, and he specifically states-: “observational study: if the symptoms resolve with the prescribed treatment, the treatment is effective. It is unethical to study this prospectively because of the implications of getting it wrong. There is sufficient absence of evidence of harm to stick with the old drugs which have been used for decades.” I think that he is wrong on multiple accounts. An observational study has near-zero likelihood of providing the world with scientifically valid results because of the potential presence of many confounding variables. If the symptoms resolve with the prescribed treatment, Dr. Lewis concludes that the treatment is effective. He therefore postulates a direct causal connection between the treatment (cause) and the resolution of symptoms (effect). However, that causal connection can only be regarded as being full-proof and scientifically valid if there are no other confounding variables that could explain the resolution of symptoms eg. variations in the natural course of the disease such that a significant number of patients tend to get better spontaneously, deliberate or inadvertent changes in the patient’s nutritional status, and/or patients concurrently taking vitamins or other complementary medications that could be having a significant therapeutic effect. If we could easily get scientifically valid results from observational studies, then we would never need to perform randomised double-blind placebo controlled trials (RCTs). However, I believe that RCTs are usually necessary if one wants to significantly increase one’s chances of getting scientifically valid results. Dr. Lewis also believes that it is unethical to study a new investigational drug prospectively because of the implications of getting it wrong. That belief is only valid if the potential harm from prospectively testing a new investigational drug (which has been safely tested in animals, and in phase 1 and 2 trials of human subjects) in a well-designed RCT could cause more harm than accepting the status quo situation of not having any solid scientific evidence that any anti-emetic agent is consistently effective in the treatment of hyperemesis gravidarum. Although I believe that a RCT is much more likely to produce scientifically valid results than an observational study, I actually suspect that it is very unlikely that one can design a randomised clinical trial that can accurately answer the question as to whether a particular therapy can successfully treat the nausea and vomiting of early pregancy. For the scientific evidence to be valid, one would have to design a clinical trial where one could be certain that the clinical effect (clinical resolution of the nausea and vomiting of early pregnancy) is due to the treatment and not due to confounding variables. The type of trial that is most frequently used to provide scientific evidence of the highest quality is the randomised, double-blind, placebo controlled trial. However, even if it were actually possible to ensure double-blinding in this clinical situation, a RCT can only provide evidence of high quality if the therapeutic agent has a large effect in a homogeneous group of patients. Those requirements are unlikely to be met in patients with nausea and vomiting of early pregnancy. I know of no therapeutic agent that is likely to have a large therapeutic effect in patients with severe hyperemesis gravidarum. More importantly, there are too many confounding variables that can invalidate the trial’s results. For a RCT to be internally valid when using a therapeutic agent of limited efficacy (limited magnitude of effect), the sample size would have to be very large. I suspect that it would be very difficult to enroll a sufficiently large number of patients in a RCT of an experimental drug for the treatment of nausea and vomiting of early pregnancy, to provide statistically valid results. The second requirement is that the patient population has to be homogeneous in terms of baseline prognosis if untreated. Patients with nausea and vomiting of early pregnancy vary considerably in terms of the severity of their condition, and their likelihood of having remissions and relapses. It would therefore be very difficult to ensure that the treated and placebo groups are balanced at baseline in terms of those prognostic variables, and to be certain that the treated and placeo patients will have the same likelihood of spontaneous improvement due to the natural course of the disease. If the treated and placebo patients are not perfectly balanced at baseline, then one could not be certain whether the difference in response between treated and placebo patients is due to the active drug, or due to an imbalance in baseline prognostic variables. If by chance, the placebo arm had a slightly larger number of patients with intractable hyperemesis gravidarum, which is totally unresponsive to anti-emetic treatment, than the treatment arm of the RCT, then the trial’s final “average” result could be invalidated. For a RCT’s results to be valid, the enrolled patients would also have to take their prescribed drugs faithfully (low drop-out rate) and not take any other therapeutic agent that can confound the results. I suspect that the drop-out rate will be high in this type of trial and that many patients will stop taking their prescribed medication. I also suspect that there may be a high cross-over rate as placebo patients start to take the active drug, in a non-prescribed fashion. It is also very likely that many patients will take other agents that could be potentially therapeutic (eg. complementary or alternative medications) in an arbitrary, and an uncontrolled manner. That phenomenon could invalidate the trial’s results. Taking other non-prescription drugs, or herbal medicines (surreptitiously or overtly) can also invalidate the RCT’s results even if they do not have an intrinsic therapeutic effect -- if they co-interact with the active drug, and either enhance or deflate its therapeutic effect. Obviously, it would be difficult, and perhaps unethical to enroll pregnant patients in a placebo controlled randomised trial because 50% of the patients would not be receiving an active anti-emetic agent. Therefore, one would have to consider an active control trial using a frequently used anti-emetic drug as the comparator agent when testing the new investigational anti-emetic drug. So, for instance, if one decided to test odansetron against standard anti-emetic therapy, one would be faced with a problem – which anti-emetic drug should be chosen as the standard therapy for comparison purposes? There is no anti-emetic drug which has been proven to be consistently effective in hyperemesis gravidarum, and many people would argue that if the RCT demonstrated that the new investigational drug was superior to the chosen control drug, that it would not necessarily prove that it was better than their favorite standard anti-emetic agent. It is also important to realise that a superiority trial would require an even larger sample size than a placebo controlled trial. I will not even address the formidable problem of proving that any new investigational drug is truly safe, because it is extremely difficult to prove that a drug is safe during a RCT of limited size and limited duration. Safety problems may only become apparent when the drug is used in clinical practice and a much larger number of patients are exposed to the drug over an extended period of time. I think that many people would be less convinced that their favorite therapeutic agent (eg. acupuncture, pyridoxine, ascorbic acid, trace mineral) is efficacious if they really understood the scientific basis of “causation”, and if they understoood that the results of clinical trials (or observational studies) are merely statistical “associations” between two events, which are not necessarily causally-related. I think that all BMJ readers should read James Penston’s short book “Fiction and Fantasy in Medical Research: The Large-scaled Randomised Trial” if they really want to understand why most clinical trials produce scientifically invalid results. Jeff Mann, MD. Competing interests: None declared |
|||
|
|
|||
|
Richard G Fiddian-Green, None None
Send response to journal:
|
We have reported a case in which chronic constipation with a phytobezoar, that developed in the right colon due to psyllium seed husks, caused a complete gastric outlet obstruction by extrinsic compression (1). This raises the possiblity that a similar mechanism might on occasion be operative in patients who develop nausea and vomiting during pregnancy. The presence of an empty rectum on rectal examination does not exclude the possibility of impaction in the right colon. A gastric splash and palpation should reveal the presence of gross outlet obstruction in a fasting patient and impaction in the right and transverse colon respectively. Constipation can develop during pregnancy (2), but the definition of constipation in these circumstancs is compromised by the fear of giving markers and taking radiographs to monitor their passage through the colon. The constipation might be caused by a fear of aborting a fetus by excessive straining during defaecation. The inhibitory effects which the hormonal changes in pregnancy can have upon smooth muscle function might be a compounding aetiological factor. In late pregnancy compression by the gravid uterus upon the colon or rectum might be a additional factor. Excluding the possiblity of significant gastric outlet obstruction would seem desirable before administering any medications as all are suspect in pregnancy, especially in the first trimester, and some have the potential to cause or compound the severity of any constipation present. In one study 31% of patients given granisetron to prevent nausea and vomiting developed constipation and 6% of those given prochlorperazine(3). An objective measure of gastric emptying would seem most appropriate test to perform after a rectal and abdominal examination. A test using ultrasonography that has been devised for children might be safely applied and validated for use in pregnancy (4). Ultrasonography should also improve the diagnotic accuracy of the physical examination for gross outlet obstruction and constipation. The presence of cholelithiasis could also be excluded. If emptying is delayed and constipation is thought to be the cause gentle enemata might be the safest therapeutic option to consider. 1. Agha FP, Nostrant TT, Fiddian-Green RG. "Giant colonic bezoar:" a medication bezoar due to psyllium seed husks. Am J Gastroenterol. 1984 Apr;79(4):319-21. 2. Wald A. Constipation, diarrhea, and symptomatic hemorrhoids during pregnancy. Gastroenterol Clin North Am. 2003 Mar;32(1):309-22, vii. 3. Burris H, Hesketh P, Cohn J, Moriconi W, Ryan T, Friedman C, Fitts D. Efficacy and Safety of Oral Granisetron versus Oral Prochlorperazine in Preventing Nausea and Emesis in Patients Receiving Moderately Emetogenic Chemotherapy Cancer J Sci Am. 1996 Mar;2(2):85. 4. Gomes H, Hornoy P, Liehn JC. Ultrasonography and gastric emptying in children: validation of a sonographic method and determination of physiological and pathological patterns. Pediatr Radiol. 2003 Aug;33(8):522-9. Competing interests: None declared |
|||
|
|
|||
|
Martin Maldonado-Durán, adjunct professor, Kansas State University Family SErvice and Guidance Center. Topeka, Kansas USa 66604
Send response to journal:
|
I would suggest that first it must be ensured that the patient does not have a major medical condition as a source of the vomiting, as it has been suggested, some form of obstruction or a metabolic problem. As it is used to treat nausea/vomiting in patients who are exposed to chemotherapy, hypnosis ( and later on self-hypnosis) as well as guided imagery can be used with success to treat the nausea and vomiting. These are obviously purely psychological interventions that may have an influence on the mechanisms triggering the nausea. They can be used also in cases of hyperemesis gravidarum. The patient is trained, by a mental health professional with training on the procedure, to imagine (perceive in the mind) pleasant odors, objects with a sensory effect that is refreshing or pleasurable to the patient (each patient selects their own preferences) and can be helped to evoke these sensations at the most difficult times, e.g. in the morning. After a few sessions when the patient is able to feel these experiences, a tape can be made and taken home with which the patient can practice the procedure; alterantively she may just be sensitive enough to do it wihtout the aid of a tape. I know of several patients with whom this approach has been quite helpful and at least ameliorated the symptoms. Competing interests: none |
|||
|
|
|||
|
Ed Peile, Professor of Medical Education Warwick Medical School, University of Warwick CV4 7AL
Send response to journal:
|
Looking at the early responses to this paper I am struck by the range of anecdotal, experience-based, and evidence-based contributions. This is real life - no different from raising an interesting question over coffee with colleagues,except perhaps that BMJ enables us to reach a wider range of colleagues than taht in the normal medical workplace. I am struck by one comment, "There is really NO (sic) excuse for not knowing about..."( a book published in the early eighties. I beg to differ. In modern medical practice we don't need excuses for being unfamiliar with even quite seminal texts on aspects of medicine and science. Effective learning, I suggest, depends on the skills to derive and update scientific proinciples, to refine approaches to problems and critical thinking, and on nurturing a spirit of enquiry which leads us to tap into the views and experience of others, and into the database of scientific literature on an as-required basis. That is how we learn from cases. Competing interests: I act in an editorial advisory role for the BMJ and receive honoraria for work in respect of Interactive Case Learning |
|||
|
|
|||
|
Michael J Campbell, Professor of Medical Statistics Institute of Primary Care, University of Sheffield, Northern general Hospital, Sheffield S5 7AU
Send response to journal:
|
Comments Dr Tomasso gives an admirable description of an N of 1 trial for the evaluation of treatments for nausea and vomiting in pregnancy. These trials are good for trying to decide what treatment actually benefits an individual patient and are a more scientific method of decision making than the usual GP method of asking the patient to return if the first treatment doesn’t work and trying a second one(1). However it is worth mentioning a few problems associated with them. Firstly, they are usually used in chronic illness, such as arthritis, to evaluate the best long term treatment for a patient. Nausea in pregnancy is obviously a limited illness. Few treatment periods will be available, and so for example even with 3 pairs of treatment periods there would not be much power to detect a big effect unless it was dramatic. They are also vulnerable to carry- over effects, if the effect of treatment extens to the next treatment period. Dr Mann is an enthusiast of RCTs over observational studies. I think he is rather pessimistic about the ability of RCTs to cope with patient heterogeneity. In a large randomised trial one would expect on average patients would be balanced. If there is a major confounder, such as severity, then this can be allowed for by stratified randomisation. Lack of balance after the trial can be adjusted for by an analysis of covariance (although one must beware fitting large numbers of covariates just to see what effect they have). We also need to consider whether this is a pragmatic or an explanatory trial. Clearly lack of compliance and a low dropout out are necessary for the validity of an explanatory trial, However in a pragmatic trial which asks what is the effect of _prescribing_ this medication rather than what is the effect of a patient _taking_ the medication, these factors reflect what happens in real life. The main problem is they tend to reduce the effect size, and so require a larger sized trial for a given power. 1.Guyatt GH, Sackett DL, Adachi JD et al. A clinician’s guide for conducting randomised trials in individual patients. Can Med J 1988; 139: 497-503. Competing interests: None declared |
|||
|
|
|||
|
Anthony M Barnie-Adshead, Retired GP Retired GP
Send response to journal:
|
Conventional treatment for this lady should start with the reassurance that, because this is the first pregnancy in which she has encountered nausea and vomiting of pregnancy (NVP), it does not mean that there is anything wrong with her baby, or that the baby will be suffering in any way. Indeed,we can say to her that there is good evidence that you are less likely to miscarry if you have NVP with the pregnancy. NVP, though unpleasant, is a symptom that is associated with the prospect of a successful outcome to the pregnancy. In fact, at least a third of women have varying symptoms of NVP in their pregnancies. NVP is a very common condition, about 70% of women suffer from some degree of this condition and it affects women of all psychological types, ethnic backgrounds and types of employment. There is nothing you are doing or have done which has brought on these symptoms, apart from being pregnant. Only about 10% of NVP becomes worse after week 10 of a pregnancy and for 90% of women, NVP will improve by weeks 12-14 of pregnancy, although a few women will have symptoms for longer than 20 weeks of pregnancy. Conventional treatment will include advice about lifestyle, which of course, is perfectly safe. Your lifestyle is obviously affected, as you say, you have some difficulty in managing your five year old daughter. Women who have suffered from NVP recommend first that you avoid unpleasant odours which make your NVP worse, particularly cooking odours. Ask your partner, family member or friends if they will do more of the cooking for you. (Is your partner supportive and understanding of your problems with NVP? As yet, not everyone is! If not, encourage him to read the leaflet I shall give you). As you are vomiting 4 times per day, I am sure you will be having nausea before and after mid-day. 85% of women have at least 2 episodes of nausea each day. The condition should never be called morning sickness, but pregnancy sickness or NVP. Between episodes of nausea there will be nausea free periods which occur at about the same time each day, when symptoms are at there worse. Keep this daily diary sheet which I give you now and you will be able to anticipate the nausea free times of the day when you can eat comfortably. Apart from the foods you have been advised to avoid during pregnancy, such as pate, soft cheeses, liver, under cooked eggs which may contain infection and peanuts, eat as soon as your nausea improves and eat what you fancy. Do you have cravings for certain foods, despite the NVP? 60% of women with NVP have at least one craving! Drink plenty of alcohol free fluid, not more than 3 cups of coffee or tea per day and avoid soft drinks with a high caffeine content. Water alone is excellent, though you may prefer fruit drinks or lemonade. If nausea is very persistent, eat and drink small quantities of each alternately, still using your limited nausea free times effectively. Rest, with your feet up, is described by women who have had NVP, as the second most important factor to relieve their symptoms. Ask help from your partner, family or friends for the daily jobs you cannot manage, particularly after your child comes home from school. Explain you need their help, as rest is essential to reduce your symptoms. Do you go to work? If so, is your boss sympathetic and understanding of the symptoms you are suffering? It may be necessary to tell him or her that approximately 30% of pregnant women in paid employment need time off work due to NVP. He may then agree to let you have more rest during the day when you need it. The safest prescribed medicine to take is tabs Diclectin (which contain Doxylamine 10mg, an antihistamine, and pyridixine 10mg vitamin B6). The same compounds were found in the tablets called Bendectin until 1983. It has been taken by 33 million women with NVP and is approved by the Society of Obstetricians and Gynaecologist of Canada for the treatment of NVP. It will improve your NVP, although not necessarily relieve it completely. Its only side-effect may be drowsiness due to the antihistamine, so the recommended dose is 1 tablet early in the morning, 1 at about 2 pm and 2 at night when you go to bed. The sooner you start taking these tablets, the more likely it is that they will relieve your NVP. I recommend we start these as soon as possible, if you agree. As an alternative therapy, you can use acupressure in the form of seabands, a band to be put 3 finger widths above your wrists, with a small button to press on the P6 point - an acupunctue significant point. The bands may decrease NVP in about 50% of sufferers, there are no theoretical concerns about the safety of this type of acupressure at present. Have you tried any treatments for NVP that you have purchased from a health food shop or chemist? You may have felt you must try something! The most commonly used herbal treatment is ginger, but there are concerns about the safety of 1000mg of ginger per day. It would be very interesting to survey a large group of women who have suffered from NVP, asking if they used any therapy not recommended by a doctor and if they have found anything helpful to reduce NVP. Would you be prepared to be part of such an investigation? Please don't worry about the pregnancy, all is well. However, NVP can be most unpleasant for you. Try these simple lifestyle adjustments we have suggested in this leaflet, which has been produced by the trustees of the recently formed Pregnancy Sickness Support Charity. At present the good news is that there is every chance your NVP will improve in the near future. Please come to see me in 2 weeks time when I hope you will have started the Diclectin tablets. Competing interests: I am a trustee of the pregnancy sickness support charity, which has received an unrestricted education grant from Duchesnay Inc, Canada. |
|||
|
|
|||
|
Richard G Fiddian-Green, None None
Send response to journal:
|
We have been educated to believe that it was relatively safe for the fetus for mothers to take medications after the first trimester when organogenesis is complete. If DNA mismatch repair and the ability to dispose of toxins is acquired in utero with the development of cellular differentiation and specialised functions this may indeed be appropriate but only relatively so. The evidence-base upon which current practice is based has been drived from studies of clearly defined congenital anatomic abnormalities, such as those encounted following rubella infections and taking thalidomide. These might well be the tip of a very large iceberg which includes cognitive impairment, mood and behavioural disorders, learning disabilities, mutant DNA, and the increased risk of chronic diseases such as those encountered in survivors of the Leningrad siege (1). In other words the evidence-base upon which current recommendations are being made might be very specific but very poorly sensitive. The risk of drug-induced damage to the gamete, fetus, infant, child and adult might be better thought of as a continuum that extends for generations. In which case no drug should ever be prescribed for an extended period to any woman or indeed man unless there is no prospect of them ever being a new parent or there is unequivocal evidence of life- saving benefit in the short term. The same might well apply to those chemicals and techniques being used in vitro fertilisation. The future of humanity may depend upon us taking decisive global action on this issue and related issues in the very near future, the risk to future generations including all environmental exposures to pollutants in air, water and food. Viewed in this context the proliferation of GM products is indeed alarming. The corollary is that the evidence-base for pharmacological interventions can never be complete in people who might conceive a new child in the future. 1. Pär Sparén, Denny Vågerö, Dmitri B Shestov, Svetlana Plavinskaja, Nina Parfenova, Valeri Hoptiar, Dominique Paturot, and Maria Rosaria Galanti Long term mortality after severe starvation during the siege of Leningrad: prospective cohort study BMJ 2004; 328: 11-0 Competing interests: None declared |
|||
|
|
|||
|
william s. craig, retired obstetrician Sudbury regional hospital Ontario p3e 5j6
Send response to journal:
|
It is important to remember to give thiamine to patients with NVP. Dr. Nelson-Piercy has pointed to 3 maternal deaths in U.K. in the 90s from Wernicke's encephalopathy. I have also found it useful to keep the husband out of the way and this was recommended by Ian Donald. Competing interests: None declared |
|||
|
|
|||
|
Ellen C G Grant, Physician and Medical Gynaecologist 20 Coombe Ridings, Kingston-upon-Thames, Surrey, KT2 7JU, UK
Send response to journal:
|
I have been asked by a GP to attach references for the benefits of monitored nutritional repletion and low allergy high protein diet in pregnancy sickness. Like me, she suffered from sickness and migraine in pregnancy and has not found medications helpful or desirable. In the 1970s I found that migraine headaches reduced ten fold when patients stopped ergot medications, or contraceptive and menopausal progestogens and oestrogens, or smoking.1 Patients who still had headaches carried out Dr John Mansfield’s exclusion diet of lamb, pears and spring water for a five day withdrawal period. Symptoms and pulse changes were monitored when individual foods were reintroduced. The commonest foods causing reactions, after this unmasking procedure, were wheat, oranges, eggs, tea, coffee, chocolate, cow’s milk, beef, corn, cane sugar and yeast. All patients improved and 85% of patients complying had no more headaches and those with hypertension became normotensive. 2 Similar results have been listed for a range of other conditions such as eczema, hyperactivity, irritable bowel syndrome, and arthritis.3 The importance of preconception care and the results of nutritional analysis and repletion, with zinc and magnesium being the commonest deficiencies, were given at conferences held by the British Society for Allergy, Environmental and Nutritional Medicine (BSAENM) and also by Foresight; the Society for the Promotion of Preconceptional Care.4-7 The BSEANM has useful textbooks and runs training courses for doctors. The most accurate tests for zinc and magnesium deficiencies are assessments of concentrations in white blood or red blood cells respectively, which are available at Biolab Medical Unit in London. A functional blood superoxide dismutase test is useful for diagnosing copper deficiency. Foresight has recommended nutritional repletion and avoidance of toxins before conception for couples since 1978. Assessing minerals in hair samples does not always reliably diagnose zinc and magnesium deficiencies. Excellent results appear to be achievable with nutritional supplementation in preventing unexplained infertility, recurrent miscarriages, and illness in pregnancy, and congenital abnormalities. A normally functioning immune system needs to have an adequate essential nutrient status.8 1. Grant ECG. Food allergies and migraine. Lancet 1978;2:581. 2. Grant ECG .Food allergy and migraine. Lancet 1979;2:966- 968. 3. Anthony H, Birtwhistle S, Eaton K, Maberly J. Environmental Medicine in Clinical Practice. BSAENM Publications 1997. 4. Barnes B, Grant ECG et al. Nutrition and preconception care. Lancet 1985;2:1297. 5. Grant ECG. The declining health of the pill generations. J Nutr Med 1994;4:283-86. 6. Ward N. Preconceptional care and pregnancy outcome. J Nutr Med 1995;5:205-6. 7. Grant ECG. The pill, hormone replacement therapy, vascular and mood over-reactivity, and mineral imbalance. J Nutr Environ Med 1998;8:105-116. 8. Sherman AR. Immune dysfunction in iron, copper, and zinc deficiencies. In: Bodgen JD, Klevay LM, eds. Clinical Nutrition of the Essential Trace Elements and Minerals: The Guide for Health Professionals. Totawa, NJ: Humana Press Inc., 2000: 309-331. Competing interests: None declared |
|||
|
|
|||
|
Geraldine A Lee, Lecturer La Trobe University, School of Nursing & Midwifery, Melbourne 3086
Send response to journal:
|
Hyperemesis can be a distressing condition and requires an open- minded patient, doctor and midwife. From my own personal experience pressure bands, ginger and prochlorperazine all failed. As a last resort (with a BP of 80/50 and ketonuria), a hospital midwife qualified in acupuncture, suggested I have some treatment. At 20 weeks gestation no decrease insymptoms, three half hour sessions were carried out. The nausea and vomiting disappeared after the second session with no recurrence. From a patient perspective, there were no guidelines on how much nausea and vomiting is acceptable during pregnancy nor at what stage weight loss becomes significant. A better informed patient with a series of treatment options available may help unearth the best treatment for individuals. Competing interests: None declared |
|||
|
|
|||
|
Osborn A Viegas, Professor of Obstetrics & Gynaecology, University Malaysia Sabah Universiti Malaysia Sabah, BEG BERKUNCI NO. 2073, 88999 KOTA KINABALU, SABAH, MALAYSIA, Claire Viegas
Send response to journal:
|
The first priority, in my view, is to exclude any serious underlying disease. We personally have seen gastric carcinoma, astrocytoma and thyroid dysfunction masquerade as hyperemis gravidarum. Besides this concern, the spectre of Thalidomide must cast a shadow over all practising obstetricians. Therefore, pharmacological therapy ought to be kept as a last resort. Furthermore, this should be restricted to those patiens requiring rehydration and must be administered parenterally. The habit of prescribing oral treatment to a patient who is vomiting repeatedly can only be wasteful. In our practice in SE Asia, we have witnessed some success with stimulation of accupuncture point 6 in the wrist using a metal bangle (accupressure). However, the ability to test the value of such a procedure in a randomised controlled trial remains problematic. Competing interests: None declared |
|||
|
|
|||
|
Roger F Neville-Smith, General Practitioner Skelton Health Centre, Byland Rd, Skelton, Saltburn TS12 2NN
Send response to journal:
|
Patients often have symptoms in pregnancy where conventional treatment is either inadequate or contraindicated. Homeopathy is safe and, I believe, effective, particularly if a prescription is based on details which are individual to the patient. I do not routinely ask about my patients about the use of complementary or alternative treatments and I think I should do this more. Evidence for effectiveness is important and as a practicing homeopath I know that my colleagues and I could make significant progress if all homeopathic prescriptions and the outcomes of this treatment were recorded. The Faculty of Homeopathy is committed to high quality research. "Soft" data recording is helpful in targetting research projects where useful results are likely to be achieved. Other Complementary and Alternative Medical practitioners should embrace this committement. The resulting evidence base could be hugely helpful for conventional GPs, so that advice can be safe and effective. Competing interests: None declared |
|||