Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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huge industry
- Dr.B.C. Rao (11 February 2002)
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Ingredient List Too Broad for Fair Assessment of Cough Medicines
- Jeff G Taylor (11 February 2002)
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The gap between practice and research
- Kath Checkland (11 February 2002)
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The self-medication of cough
- Merja K. K. Aaltonen, Pahlman Riitta, Pahlman Suvi, Nihtinne Juha (12 February 2002)
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Re: The gap between practice and research
- Paul C Emerson (13 February 2002)
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Placebo formulations of cough medicines.
- Hilary Davies (14 February 2002)
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Constituents of over the counter cough medicines
- Philip J Rogers (18 February 2002)
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The Cough Medicines Topic.
- Celine M Aranjo (18 February 2002)
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Review should not change existing UK guidance on cough medicines
- James Walmsley, Graham Marshall (22 February 2002)
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Re: Re: The gap between practice and research
- Kath Checkland (27 February 2002)
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Over-the-counter cough remedies
- John Widdicombe, Alyn Morice (1 March 2002)
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Re: Over-the-counter cough remedies
- Lucy A Pavesi, Egham, Surrey TW20 9NW (5 March 2002)
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NHS Direct does not advocate cough medicines
- Mike Sadler (23 April 2002)
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Established Benefit of Dextromethorphan in Cough
- R. William Soller, Ph.D. (6 June 2002)
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Non-Toxic Cough Treatment That Works
- Sharon J Williams (4 May 2003)
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Dr.B.C. Rao, General Practitioner Clinic , Apoorva Diagnostic Centre,CMH Road,Indiranagar, Bangalore, India 560008
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This should come as an eyeopener to those who generously prescribe these useless drugs. In India it is a huge industry and most prescrptions in general practice and in paediatric practice contain one of these. It twould be of interest to know the role of codeine containing cough remedies. Are they also useless? In some who have dry unproductive cough it does seem to help, though it has to be used with some degree of caution. |
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Jeff G Taylor, Associate Prof of Pharmacy Univ of Saskatchewan Canada S7N 5C9
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Dear BMJ: I am grateful to Schroeder and Fahey for their review of cough medicines. The attention is warranted given the vast prominence of these products in pharmacies across the world. I have long suspected we give agents such as cough suppressants a greater role in acute cough than they perhaps deserve. However, in fairness to OTC cough medicines in general, antihistamines alone or antihistamine-decongestant combinations should not have been included in this review of "cough" medicines. I can't definitively speak for your part of the world, but I would be surprised if any manufacturer even makes such a claim for this combination of ingredients. In Canada, one such combination (dexbrompheniramine/pseudoephedrine) claims only to provide symptomatic relief of the following: upper respiratory mucosal congestion in seasonal and perennial nasal allergies, acute rhinitis and rhinosinusitis, acute and subacute sinusitis, eustachian tube blockage, and secretory otitis media. No mention of any benefit on cough is in sight. Jeff Taylor, Ph.D.
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Kath Checkland, GP principal and NHS Executive Research Fellow Marple Cottage Surgery, 50 Church St , Marple, Stockport. SK6 5BW
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The article by Schroeder and Fahey made me laugh out loud. Of course cough medicines don't work - but as a GP I shall continue encouraging patients to use them, and I hope NHS Direct will do the same. Why? Well, parents of children with viral infections causing a cough present to doctors for a variety of reasons. Firstly, they are concerned that their child has a serious illness - usually meningitis or a chest infection. Secondly, they are generally tried after being up all night and want help - any help. Thirdly, (and this is not an exhaustive list!) they feel helpless in the face of their child's suffering and they want to be able to do something for them. So, we give them things to do, whilst they wait for the viral illness to get better on its own. We suggest calpol, we talk importantly about encouraging fluid intake and keeping the child cool, we even issue detailed instructions about how to inhale decongestants, and we advise parents of children with a cough to talk to their pharmacist about cough medicines. We then give them instructions about what to do if the condition worsens or doesn't improve over a specified (usually arbitary) time period. The object of the exercise? To make them feel that they understand what is wrong, can do something to help, and have a fallback plan if things don't get better. "Evidence based medicine" has much to offer but please don't let us confuse pharmacological efficacy with the real world of managing human emotions alongside physical illness. Kath Checkland |
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Merja K. K. Aaltonen, pharmacist, specialised in self-care and self-medication Leppävaara Community Pharmacy , 02600 Espoo, Finland, Pahlman Riitta, Pahlman Suvi, Nihtinne Juha
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Dear sirs, I found your article most interesting, because I have been working with my friends on cough and self-medication and we have very similar results with you. Our results are seen as a poster in the following adress www.fip.org, (select Community Pharmacy Practice and look for our names). With kind regards Merja Aaltonen |
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Paul C Emerson, Consultant in Public Health Medicine DHSS, Douglas, Isle of Man
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Editor, It is with some concern that I note a degree of cynicism in the response entitled"the gap between practice and research" as it appears to originate from a member of the NHS Executive and a senior GP. Not only is the original article referring to adults thus excluding the reference to children in the response but is it good medical practice to administer ant -tussives to children ? I believe not if one believes that the cough is present to expel what needs expelling - in the same way as you incise an abscess. If medical colleagues and nurses explain carefully the reason for the cough as is suggested then why the need to administer a cough mixture. I hope the loud laugh is not symptomatic of all NHS Executive professionals when some sound advice is relayed to them which appears to be evidence-based and has the support of the WHO from 10 years ago. sincerely.... |
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Hilary Davies, Pharmacist Worsley Pharmacy, 435 High Road. Chilwell , Beeston, Nottingham. NG9 5EA
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My own opinion is that most cough medicines act by the soothing effect of the syrupy formulation on the irritation causing the cough. Sucking a sweet produces a similar effect. It therefore follows the the 'placebo' formulations used in this study, which would have been similar in consistency to the 'active' formulations, would have had some effect in soothing cough. As a result, it is difficult to conclude that there is 'no good evidence for their effectiveness'. I will continue to recommend cough linctuses when asked, with, as usual, the appropriate advice to go with them, including the statement that they help the symptoms a little but do not cure. |
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Philip J Rogers, Boots Teache-Practitioner / Visiting Senior Lecturer in Pharmacy Practice Department of Pharmacy & Pharmacology, University of Bath, Bath BA2 7AY
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Dear Sir I am grateful to the authors for collating this systematic review, but would wish to challenge the review on two points. First, in Table 2, Sudafed Expectorant and Robitussin Chesty Cough with Congestion are listed as examples of antihistamine-decongestant combinations. This is not the case. They should have been classified as decongestant-combinations. My second point concerns antitussives. The vast majority of antitussives marketed in the UK contain pholcodine as their active ingredient. None of the five antitussive trials highlighted in the review referred to pholcodine, but rather to codeine, dextromethorphan or mogusteine. Further studies should be conducted to assess the efficacy of pholcodine in a self-medication setting. Readers and media reviewers need to be cautious in their interpretation of the presented review. Yours sincerely Philip Rogers |
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Celine M Aranjo, general practice retired. Australia, 2208
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Dear BMJ, I believe that cough is part of a disease or disorder, & that it deserves as much in diagnostic skill as any other in General Practice. How can OTC medication for cough stop the cough for example due to certain medication use e.g.ACE-inhibitors, or for that matter cough due to carcinoma/tuberculosis/bronchiectasis, etc? It is the fundamentals learned in Med.School that need to be implemented to correctly treat Cough--Acute or Chronic. C.Aranjo.MBBS. |
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James Walmsley, Senior Medical Advisor Boots The Chemists, Graham Marshall
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Editor, Schroeder and Fahey are right to urge caution interpreting the results of their systematic review on cough medicines and their recommendation to change existing guidance on cough medicines in the UK is not justified.(1) The review considered a heterogeneous group of products that included many different active ingredients from several different drug classes. It is surely impossible to draw from this any meaningful conclusions about over the counter cough medicines as a whole. Many of the products and active ingredients in the reviewed trials are either not available at all in the UK (moguistene, bromhexine), are only available on prescription (salbutamol, terfenadine), or are not actually indicated for the relief of cough (loratadine, terfenadine). Only 15 trials were included in the review, and only one reported a power calculation. As the authors concede, it seems highly likely that many of the remainder did not include sufficient patients to detect a difference from placebo, should one exist. The predictable upshot of this is that the review demonstrated no evidence of effect, not evidence of no effect, as many will have inferred. Would the authors have made the same recommendations if they had found no trials suitable for inclusion in the review? (And would the BMJ have published it?) All the review really demonstrates is the lack of good quality research on over the counter cough medicines. This should surprise no-one, as most of the active ingredients contained in these medicines are old enough to have lost patent protection, and there are more pressing items on the research agenda. Patients derive enough benefit from over the counter cough medicines to purchase them in the first place, and keep coming back for more. This in itself is evidence – although not of the double-blind, randomised, placebo-controlled variety. If current advice on cough medicines is changed to appease the evidence-based medicine purists, patients with uncomplicated upper respiratory tract infection are likely to consult their doctor. Not only is this an unnecessary use of a scarce resource, it is also likely to increase the number of inappropriate prescriptions for antibiotics. 1 Schroeder K, Fahey T. Systematic review of randomised controlled trials of over the counter cough medicines for acute cough in adults. BMJ 2002; 324: 1-6 |
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Kath Checkland, GP and Research Fellow Stockport SK6 6BW
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I am sorry that I am thought to be cynical, and embarassed that I am identified as being high up in the NHS executive! In fact I am a research fellow funded by the NHS executive, and I hope that, after 10 years as a GP, I am realistic rather than cynical. I plead quilty to misreading the article in question as relating to children as well as adults, and I rarely write a prescription for any anti-tussive. However I hope my point remains valid. I simply believe that there is more to decisions about whether or not to advise self-medication (or to decisions about what to prescribe) than the available evidence of clinical efficacy, useful though that is. Parents consult us partly in order to have their fears allayed, and validating their caring by offering a suggestion for self-medication has a useful part to play in this process.The clinical effectiveness of that self-medication is only a small part of the picture when viewed from a practice perspective. Kath Checkland |
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John Widdicombe, Emeritus Professor University of London, Alyn Morice
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We agree with the response by Walmsley and Marshall (1) to the article by Schroeder and Fahey (2). Absence of evidence is not evidence of absence. The article's conclusion that there was no convincing evidence that over-the-counter (OTC) treatments were helpful in acute cough was correct; but the extrapolation, highlighted in This Week in the BMJ item, that therefore these remedies should not be recommended for first line treatment for cough associated with upper respiratory tract infection (RTI), is false. Walmsley and Marshall argue convincingly that, given the paucity of good random controlled trials, other evidence which is mainly positive should be taken into consideration. Unless there is good evidence that they do not work these OTC remedies should not be discarded. The Schroeder and Fahey article was presumably written before publication of the paper by Parvesi et al. (3) which showed that the standard OTC dose (30 mg) of dextromethorphan caused a significant improvement in four-out-of-five objective measures of cough (12-17 %, compared with placebo), based on a meta-analysis of 710 patients. Because of the high variability of responses, due to many frequently-discussed reasons, a large population has to be studied. We have recently co-authored an editorial (4) on the subject which, while regretting the paucity of good studies on RTI cough, takes a more balanced approach to OTC remedies than does the BMJ. Most of us do not seek clinical intervention for acute cough. Yet it is by far the most frequent cause of consultation in primary care in, for example, the USA (5). Annually over £100 million is spent in the UK on OTC cough medicines. What this enormous health care burden requires is funding for good quality research and not sensational extrapolation from inadequate data. 1. Walmsley J, Marshall G. Review should not change existing UK guidance on cough medicines. Response to (2). 2. Schroeder K, Fahey T. Systematic review of randomized controlled trials of over the counter cough medicines for acute cough in adults. BMJ 2002; 324; 329-332. 3. Parvesi L, Subburaj S, Porter-Shaw K. Application and validation of a computerized cough acquisition system for objective monitoring of acute cough. Chest 2001; 120: 1121-1128. 4. Morice AH, Widdicombe J, Dicpinigaitis P, Groenke L. Understanding cough. Eur Respir J 2002; 19: 6-7. 5. Schappert KT. National Ambulatory Medical Care Survey: 1991 Summary. Advance Data 93 A.D.: Number 230. |
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Lucy A Pavesi, Senior Medical Advisor Procter & Gamble Technical Centres Ltd. Rusham Park Technical Centre, Whitehall Lane,, Egham, Surrey TW20 9NW
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Please note, correct spelling of surname for author of published article referenced as (3) in Widdicombe and Morice's letter: "Pavesi" (not Parvesi). |
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Mike Sadler, Medical Adviser, NHS Direct Online Berrywood Business Village, Tollbar Way, Hedge End, Hampshire SO30 2UN
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Editor Schroeder and Fahey note the lack of good evidence of the effectiveness of over the counter cough medicines.1 They comment that the NHS Direct Healthcare Guide2 recommends simple cough medicines for dry cough, and suggest that this advice should be restricted until more evidence becomes available. Readers not familiar with the healthcare guide should be aware that it does not uncritically advocate these medicines, as implied in the article. The first edition of the Healthcare Guide was published in 2000. The self-care advice in the ‘colds and flu’ algorithm includes the statement that ‘a simple cough medicine may help a ticklish dry cough’ The self-care advice in the ‘coughing adults’ algorithm includes the statement that ‘cough medicines may be of some value. Ask your pharmacist for advice’. Neither of these can be reasonably described as ringing endorsements, and cough medicines are excluded from the proposed home ‘medicine chest’. As Medical Adviser to NHS Direct Online, and Chair of the NHS Direct Online Editorial Board, I was closely involved in the content review for the second edition.3 We considered carefully the balance between the lack of evidence of effectiveness, and the occasional anecdotal assurance of effectiveness familiar to all primary care practitioners. The self-care advice in ‘colds and flu’ algorithm now includes the following statement: ‘Some people may find that a simple cough medicine helps to soothe a ticklish dry cough’. The NHS Direct self-help guide, as it is now entitled, has proved extremely popular, both in its printed form, and on the NHS Direct Online website (www.nhsdirect.nhs.uk). The self-care advice sections attempt to steer a reasonable course between practical advice to help patients deal with self-limiting illness, and the often scanty research base for over the counter remedies. I think that on cough medicines, the balance is probably right. Dr Mike Sadler
1. Schroeder K, Fahey T. Systematic review of randomised controlled trials of over the counter cough medicines for acute cough in adults. BMJ 2002;324:329-31 2. Banks I. The NHS Direct Healthcare Guide (first edition). London: Stationery Office, 2000 3. Banks I. The NHS Direct self-help guide (second edition). London: Stationery Office, 2001 |
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R. William Soller, Ph.D., Senior Vice President and Director of Science & Technology Consumer Healthcare Products Association, 1150 Connecticut Ave. NW, Washington, DC 20036
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According to the Food and Drug Administration (FDA) OTC cough suppressants are generally recognized as safe and effective when used according to the label directions. The review of selected trials by Schroeder and Fahey (BMJ USA 2: 207-210, 2002) otherwise, but it is weakened by its study selection, neglect of the limitations of cough assessment methodology, and omission of important clinical data. Acute cough associated with flu or the common cold is difficult to measure. Among the methodological issues are: high variability within and among patients, the difficulty in recruiting patients in the acute phase of the cold, limited validated objective measures of cough, and the voluntary control aspect of cough. These issues may lead to findings of relatively small clinical benefits of treatment over placebo. As a result, larger study populations and validated methods to assess cough suppression are needed to have an appropriately powered and sensitive study to identify statistically significant effects. Schroeder and Fahey do not adequately methodological issues, reviewing selected publications and acknowledging the inability to do a meta- analysis. However, a recently published meta-analysis by Pavesi et al. (CHEST 120: 1121-1128, 2001)assessed six trials in 710 adult patients using an identical validated computerized cough acquisition and analysis system that is portable and usable in the natural environment. Pavesi et al. conclude: "[the meta-analysis] demonstrated significantly greater overall reductions in cough bouts, cough components and cough effort, and an increase in cough latency, for patients treated with dextromethorphan, 30 mg, vs those treated with placebo." While the treatment effect was small, on the order of 12% to 17% but in line with other studies, the researchers point out the inherent difficulties in measuring cough which will dampen the measurable effect reported in the clinic or in-home setting. In conclusion, before clinical recommendations to avoid the use of dextromethorphan are made based on a selected review of clinical studies with variable methodologies, consideration should be given to the rigorous research efforts of Pavesi and colleagues. These latter efforts have shown that a validated sensitive method for assessing cough in an appropriately powered study establishes the clinical effect of 30 mg dextromethorphan in suppresses cough associated with uncomplicated URTI. R. William Soller, Ph.D.
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Sharon J Williams, Retired Registered Nurse n/a
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I agree with the studies showing the lack of efficacy of over the counter cough medicines. Their continued presence on Pharmacy shelves is a testament to the advertising power of their makers and the gullibility of the public. Here's a simple checklist for those who need to know some basics about coughs: 1. Establish the cause of the cough. Coughing can signal airway obstruction.Check the airway - some coughs are useful. 2. Is it productive or non-productive? 3. Productive coughs should not be suppressed; your lungs and/or breathing passages are clogged and must be cleared. They may,however require a mucolytic agent to be thin the mucous so you can cough it up. See your Doctor before treating yourself.Potassium Iodide is an old remedy that still works. Breathing steam with menthol (crystals or Mentholatum) works well and helps relieve sinus congestion at the same time. 4. Non-productive coughs are usually due to irritants. The cough itself may be causing additional irritation. If the irritant is an allergen, treat the allergy. If it is secondary to a medication, review the medication e.g.asthma inhalers are a frequent cause of throat irritation. A different drug or homeopathic remedy may deal with the problem more effectively. Nova's Cough Complex or Unda's Lobelia Plex are both good for relieving coughs and the cost per dose is 1/8 of the OTC cough syrups (which I agree are virtually useless). Both of these are safe and non-addictive, but should be prescribed by a homeopath. 5. A frequently ignored cause of cough is stress. Again, address the cause. People who are under constant stress may need counselling, yoga or other stress management techniques. 6. Exposure to cold, exercise, heat or low or high humidity can cause coughing. 7. Air pollution indoors and out is increasing the incidence of allergies by overloading our immune systems. Do your part to minimize the causes and your own exposure. Washable furnace filters and portable HEPA filters are very useful in reducing the immune system load. Contrary to the manufacturers instructions, the expensive HEPA part can be cleaned and reused. Use a non-toxic household cleaner such as Simple Green, rinse well, allow to dry and reinstall. 8. Overuse of OTC cough medicines can lead to dependence, rebound cough on withdrawal and damage to your cashflow. I hope the above will be useful. Sharon Williams Competing interests: None declared |
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