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Homeopathy in childhood asthma

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Homeopathy in childhood asthma

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                     Homeopathy in childhood asthma
                     A M Li, A Bush, N M Wilson, F Dantas, S B Brien, G Lewith, P Fisher, K Chatfield, R
                     Mathie, R Leckridge and A White

                     Thorax 2003;58;826-828
                     doi:10.1136/thorax.58.9.826


                     Updated information and services can be found at:
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      References     This article cites 6 articles, 2 of which can be accessed free at:
                     http://thorax.bmj.com/cgi/content/full/58/9/826#BIBL

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                     http://thorax.bmj.com/cgi/content/full/58/9/826#otherarticles
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                      Complementary Medicine (265 articles)
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                      Children (1806 articles)



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  Thorax 2003;58:825–828                                                                                                                                           825




  PostScript                                       ..............................................................................................


                                                                  data, and chest radiographic findings are rou-       as to the further diagnosis of the unclassified
        LETTERS TO THE EDITOR                                     tinely documented in a database. The inclu-         subgroup (fig 1). Our results also show that
                                                                  sion criteria were symptoms of COPD (chronic        stage I disease (FEV1/FVC <70% and FEV1
                                                                  cough with chronic sputum production for            >80% predicted) was very rare, constituting
                                                                  more than 2 years) and radiographic findings         only 4–5% of the patients. This indicates that
      If you have a burning desire to respond to                  of COPD (hyperinflation, diaphragmatic flat-          the distribution of the stages, especially stage
      a paper published in Thorax, why not                        tening). Patients with a history of asthma          I, is inhomogeneous.
      make use of our “rapid response” option?                    (variability of spirometric parameters, im-             Despite its retrospective design, this study
                                                                  provement in forced expiratory volume in 1          was strengthened by the fact that lung
         Log      on       to       our     website
                                                                  second (FEV1) of >20% after inhalation of β2        function data, chest radiographic findings,
      (www.thoraxjnl.com), find the paper that
                                                                  agonists, symptoms predominantly at night,          and the results of a standard clinical examina-
      interests you, and send your response via                                                                       tion were available for all patients. It therefore
                                                                  seasonal allergies, allergic rhinitis, or eczema)
      email by clicking on the “eLetters” option                  were excluded from the study, as were those         offers the chance to investigate the clinical
      in the box at the top right hand corner.                    in whom FEV1 and forced vital capacity (FVC)        impact of the GOLD classification, especially
         Providing it isn’t libellous or obscene, it              differed by more than 5% according to the           in patients with mild COPD.
      will be posted within seven days. You can                   American Thoracic Society (ATS) guidelines2             Our study therefore suggests that GOLD
      retrieve it by clicking on “read eLetters”                  and patients with an abnormal chest radio-          criteria miss an important subgroup of
      on our homepage.                                            graph or chronic cough caused by a disease          patients with clinically diagnosed COPD,
         The editors will decide as before                        other than COPD.                                    which reduces its usefulness as a clinical tool.
      whether to also publish it in a future                         FEV1 and FEV1/FVC were determined three                                                 D Köhler
      paper issue.                                                times. The predicted values for FEV1 were                    Krankenhaus Kloster Grafschaft, D-57392
                                                                  taken from the European Respiratory Society                                 Schmallenberg, Germany
                                                                  (ERS) guidelines.3 The individual values of
                                                                  FEV1 and FEV1/FVC for all patients are shown                                  J Fischer, F Raschke
                                                                  in fig 1. Almost 14% of patients clinically            Klinik Norderney, D-26548 Norderney, Germany
  Usefulness of GOLD                                              diagnosed as having COPD could not be clas-                                           B Schönhofer
  classification of COPD severity                                 sified because they had an FEV1/FVC ratio of             Abteilung für Pneumologie und Intensivmedizin,
                                                                  >70%, despite having a reduced FEV1 (<80%            Klinikum Hannover, Podbielskistrasse 380, 30659
  In 2001 the US National Heart, Lung and                         predicted). This combination is not repre-                                        Hannover, Germany
  Blood Institute (NHLBI) and the World                           sented in the GOLD classification. Less than
  Health Organization announced guidelines                        5% of all patients were classified as GOLD                Correspondence to: Dr D Köhler, Krankenhaus
  for the diagnosis, management, and treat-                       stage I.                                                  Kloster Grafschaft, D-57392 Schmallenberg,
  ment of COPD (Global Initiative for Chronic                        The finding that the GOLD classification                                Germany; D.Koehler@fkkg.de
  Obstructive Lung Disease, GOLD).1 One key                       missed an important subgroup of patients            References
  aspect of these guidelines is that COPD is                      with mild COPD challenges any proposed                1 Pauwels RA, Buist AS, Calverley PM, et al.
  classified by severity into five stages which                     advantage of this classification scheme over             Global strategy for the diagnosis,
  constitute the basis of treatment recommen-                     existing guidelines from the ATS4 and ERS.5             management, and prevention of chronic
  dations. However, to date there has been little                 Only six patients not classified as having               obstructive pulmonary disease. NHLBI/WHO
  evidence for the usefulness of these severity                   COPD by GOLD were missed using the ATS                  Global Initiative for Chronic Obstructive Lung
  stages.                                                         criteria (stage I: FEV1 >50%) and ERS criteria          Disease (GOLD) Workshop summary. Am J
                                                                                                                          Respir Crit Care Med 2001;163:1256–76.
     We retrospectively reviewed 1000 patients                    (mild: FEV1 <70% and FEV1/VC >88% for                 2 American Thoracic Society. Standardization
  with COPD diagnosed clinically in 2001; 500                     men and >89% for women). Obviously, any                 of spirometry, 1994 update. Am J Respir Crit
  patients originated from a pulmonary reha-                      arbitrary classification of a continuous vari-           Care Med 1995;152:1107–36.
  bilitation hospital. Patients’ symptoms (based                  able such as FEV1 and FEV1/FVC results in a           3 Quanjer PH, Dalhuijsen A, Van Zomeren BC.
  on a standardised interview), findings of a                      borderline group of patients. The GOLD                  Summary equations of reference values. Bull
  standardised lung examination, lung function                    classification, however, provides no guidance            Eur Physiopathol Respir 1983;19:45–51.
                                                                                                                        4 American Thoracic Society. Standards for
                                                                                                                          the diagnosis and care of patients with
                                                                                                                          chronic obstructive pulmonary disease. Am J
                100                                                                                                       Respir Crit Care Med 1995;152:S77–121.
                                          Not classified                                      0                         5 Siafakas NM, Vermeire P, Pride NB, et al.
                                                                                                                          Optimal assessment and management of
                90                                                                                                        chronic obstructive pulmonary disease
                                                                                                                          (COPD). The European Respiratory Society
                                                                                                                          Task Force. Eur Respir J 1995;8:1398–420.
                80
                                                                                                                      Sahaja yoga in asthma
                70                                                                                                    Since the publication of our paper on Sahaja
FEV1 /FVC (%)




                                                                                                                      yoga in the management of moderate to
                                                                                                                      severe asthma1 we have received a large
                60                                                                                                    number of enquiries. One issue that has been
                                                                                                                      raised about the technique used in the study
                                                                                                                      warrants clarification and further acknowl-
                50                                                                                                    edgement.
                                                                                                                         The Sahaja yoga meditation technique used
                                                                                                                      in the study was not developed by the authors.
                40                                                                                                    The technique was taught to subjects in the
                                                                                                                      intervention group by experienced Sahaja
                30        III                IIb            IIa                           I
                                                                                                                      yoga practitioners free of charge. The tech-
                                                                                                     n = 1000         nique itself was developed by yoga expert H H
                                                                                                                      Shri Mataji Nirmala Devi and she permitted
                20                                                                                                    the investigators to conduct the study on the
                      0    10   20   30      40     50     60     70    80    90    100 110 120 130 140               following reasonable conditions: (1) that no
                                                         FEV1 (% predicted)                                           part of the technique be misrepresented, mis-
                                                                                                                      appropriated or commercialised by the inves-
  Figure 1 Plot of % predicted forced expiratory volume in 1 second (FEV1) against the ratio of                       tigators; (2) that the founder and practition-
  FEV1 to forced vital capacity (FVC) (%) of the total population (n=1000).                                           ers of the process be appropriately



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826                                                                                                                                                 PostScript


acknowledged as the true source and custodi-        on the homeopathic remedy, and to return               treatments on quality of life are likely to
ans of the technique and its associated             again 4 weeks later (visit 2) to assess the            involve relatively small effect sizes even when
knowledge; and (3) that it be made clear that       response after stopping the remedy. The                one treatment is clearly superior.4
the Sahaja yoga technique is, as a matter of        spirometric test results of one patient from              My paper on the safety of homeopathy5 is
policy and philosophical conviction, always         the first and second visits were missing.               misquoted; it does not in any way imply that
made available free of charge.                         No side effects were reported and all               the rate of exacerbations is a “hallmark of suc-
  The authors sincerely regret any misunder-        subjects were compliant with the homeo-                cessful treatment”. Instead, I stated that “one
standing that may have led readers or               pathic remedy. Using the Wilcoxon signed               needs to consider the way practitioners are
members of the public to believe otherwise.         ranks test, there was no significant difference         informing patients of the possibility of such
They sincerely and gratefully acknowledge           at baseline and at visits 1 and 2 in FEV1 (86%         aggravations after using homeopathic medi-
the important and crucial role played by HH         (interquartile range (IQR) 81.1–93.3) v 89%            cines, thus creating some expectations that
Shri Mataji Nirmala Devi and the Sahaja yoga        (85.0–100.0) v 85% (74.0–89.0), respectively)          will fulfil what was said in the consultation”.
practitioners of Australia in the execution of      and eNO (54 ppb (IQR 36.2–99.6) v 68 ppb                  Finally, I cannot agree with the statement
this study, and sincerely regret not having         (37.0–87.0) v 76 ppb (43.6–131.4), respec-             that the trial was designed with the input of
made more appropriate acknowledgements in           tively). This could be because of the small            experienced homeopathic practitioners for
the original article.                               sample size or because the homeopathic                 optimal conditions: individualised prescrip-
                                                    remedy genuinely did not have any anti-                tion of homeopathic medicines needs a good
                                   R Manocha        inflammatory effect.                                    medical understanding of asthma to discrimi-
Natural Therapies Unit, Royal Hospital for Women,      This study provides important baseline data         nate between disease-specific and patient-
    Locked Bag 2000, Randwick 2031, Australia;      for the calculation of the sample size needed          specific or peculiar symptoms. Treatment was
                          r.manocha@unsw.edu.au                                                            by non-medically trained homeopaths with-
                                                    to carry out a randomised, placebo controlled,
Reference                                           double blind study. A sample size of 65                out proper medical supervision, and this has
                                                    subjects per treatment arm would have 80%              implications on the selection of medicines.
  1 Manocha R, Marks GB, Kenchington P, et al.
    Sahaja yoga in the management of moderate       power to detect a difference of 10% in mean            Medical doctors prescribing homeopathic
    to severe asthma: a randomised controlled       FEV1, assuming a standard deviation of                 medicines know what the patient has in terms
    trial. Thorax 2002;57:110–5.                    difference of 28.86, using a paired t test with a      of conventional diagnosis and can distinguish
                                                    two sided significance level of 0.05.                   features typical of the disease from those spe-
                                                                                                           cific to the individual patient. This was not
Homeopathy in childhood                                                                        A M Li,     adequately considered by the authors in plan-
asthma                                                      Department of Paediatrics, Prince of Wales     ning the study.
                                                                    Hospital, Shatin, NT, Hong Kong           Taken together, these biases seriously un-
We read with interest the article by White et al                                                           dermine the validity of the claimed results.
on the use of homeopathy as an adjunct in the                        A M Li, A Bush, N M Wilson
                                                                                                           Such shortcomings should be eliminated
treatment of childhood asthma.1 We also                 Department of Paediatric Respiratory Medicine,
                                                                Royal Brompton Hospital, London, UK        from future trials of homeopathy for asthma
obtained negative findings in an open study in                                                              published by respected journals such as
which we assessed the effects of homeopathy              Correspondence to: Dr A M Li, Department of       Thorax.
on spirometry and exhaled nitric oxide (eNO)          Paediatrics, Prince of Wales Hospital, Shatin, NT,
in children with stable asthma.                                 Hong Kong; albertm68mcli@yahoo.com                                                  F Dantas
   Twelve asthmatic children (4 boys, median                                                                  Professor of Homeopathy, Federal University of
age 13.5 years, range 7–18) who satisfied the        References                                             Uberlândia, Visiting Professor, Federal University of
following inclusion criteria were recruited: (1)      1 White A, Slade P, Hunt C, et al.                            ˜
                                                                                                                   Sao Paulo, Rua Pedro de Toledo 920, Sao   ˜
                                                        Individualised homeopathy as an adjunct in                               Paulo-SP, 04039–020, Brazil;
stable asthma with no clinical indication for
                                                        the treatment of childhood asthma: a                                            fdantas@climed.epm.br
change in treatment, on any dose of inhaled
corticosteroid and any other asthma medica-             randomised placebo controlled trial. Thorax        References
tions; (2) raised eNO level at the start of the         2003;58:317–21.
                                                                                                             1 White A, Slade P, Hunt C, et al.
study despite clinical stability; (3) identifiable                                                              Individualised homeopathy as an adjunct in
sensitivity to house dust mite (HDM, n=3) or        Homeopathy deserves to be scientifically ap-                the treatment of childhood asthma: a
cat and HDM (n=9) by history and skin prick         praised by good quality studies and the results            randomised placebo controlled trial. Thorax
test (SPT); (4) no hospital admission or emer-      published without bias which could distort                 2003;58:317–21.
                                                                                                             2 National Asthma Education Program.
gency department attendance for asthma in           future meta-analyses. The study on childhood               Guidelines for the diagnosis and management
the previous 3 months; (5) no history of con-       asthma by White et al1 published recently in               of asthma. Publication No 91-3042.
sumption of oral corticosteroid in the previous     Thorax has critical flaws which seriously                   Bethesda, MD: National Heart, Lung and
3 months; (6) no homeopathic treatment              undermine its conclusion. The main weak-                   Blood Institute, National Institutes of Health,
within the previous 6 months, allergen desen-       nesses of the study, which were mentioned by               1991.
sitisation within the previous year, or HDM         the authors but not given due attention, were            3 Enright PL, Lebowitz MD, Cockroft DW.
avoidance measures or removal of household          the limitations of the primary outcome meas-               Physiologic measures: pulmonary function
pet to which the subject had a positive SPT in      ure and the mildness of the children’s asthma.             tests. Am J Respir Crit Care Med 1994;149:
                                                                                                               S9–18.
the previous 3 months.                              However, there is also concealed selection and           4 Richards JM, Hemstreet MP. Measures of life
   At baseline all recruited patients under-        measurement bias which could have been pre-                quality, role performance and functional status
went SPT if this had not been done within the       vented when planning the trial.                            in asthma research. Am J Respir Crit Care
previous 2 years, eNO measurement (NIOX,              Available guidelines for the diagnosis of                Med 1994;149: S31–9.
Aerocrine, Sweden), and spirometric testing         asthma were not properly used for inclusion              5 Dantas F, Rampes H. Do homeopathic
(Vitalograph, Buckingham, UK) measuring             of patients, leaving room for doubt as to                  medicines provoke adverse effects? A
forced expiratory volume in 1 second (FEV1).        whether or not the included patients had                   systematic review. Br Homeopath J 2000;89
The mean of three best efforts was recorded         asthma. Classification of asthma severity                   (Suppl 1):35–8.
and the result was expressed as percentage          could be established at entry by using
predicted. The homeopathic remedy was               published international paediatric asthma              The efficacy and clinical effectiveness of
prescribed according to the child’s SPT result.     consensus or guidelines.2 Better physiological         homeopathy engenders considerable debate;
This was a preparation of HDM or cat dander         measures could have been used—peak expira-             it is therefore essential that clinical trials are
(or both, if appropriate) in the form of two        tory flow results are less reliable than forced         accurately interpreted and reported. The
lactose globules. The preparation was made up       expiratory volume in 1 second, which is the            recent publication by White et al1 has high-
according to the principles laid out in the         most reproducible pulmonary function                   lighted this issue.
British Homeopathic Pharmacopoeia. The              parameter.3 All patients were using β adrener-            The study—which assessed classical home-
patients were told to take the globules daily       gic inhalers and more than two thirds had              opathy as an adjunctive treatment for child-
for the next 4 weeks while continuing with          been prescribed inhaled steroids at baseline           hood asthma—concluded that, based on the
the same conventional asthma treatment. A           and were well controlled; at least 50% of              primary outcome (the active quality of living
diary was given to each child to encourage          patients in the homeopathic group had had              subscale of the Childhood Asthma Question-
compliance and to document any break-               no asthma event in the previous 12 months,             naire), classical homeopathy was not superior
through symptoms or side effects from the           suggesting a design bias against homeopathy            to placebo. We disagree with this conclusion.
remedy during the study period. The subjects        (ceiling effect). Sample size was calculated           The scale used to assess the primary outcome
were told to return for eNO measurement and         without a pilot study and did not allow for the        was inappropriate; it does not distinguish
spirometric assessment after 4 weeks (visit 1)      fact that comparisons of the impact of asthma          between asthmatics and non-asthmatics2 and



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PostScript                                                                                                                                                827


is more suitable as a cross sectional measure         scale validation study cited in the paper by         Methods such as that developed by Jadad et
than as a longitudinal outcome, and the abil-         White et al.2 Furthermore, the CAQ QoL scale         al4 would assess this as a high quality study,
ity to identify any therapeutic improvement           does not discriminate between non-asthmatic          and the primary outcome appears to be nega-
was severely reduced due to ceiling/flooring           and mildly asthmatic children.                       tive. As we have shown, this interpretation is
effects in both the primary and some second-             Similar floor and ceiling effects are seen in      fundamentally flawed. We believe a correction
ary outcome data. For example, baseline               many of the secondary outcome measures—              should be published which should focus on
scores identified that the study population            for example, in the homeopathy group at              (1) the inappropriate scope of the original
had good quality of life, and that two of the         entry the peak expiratory flow rate was               conclusions, and (2) clarification of the
three age groups studied had mild asthma.             100.4% of expected and the median number             secondary outcomes and the conclusions
Any therapeutic improvement would there-              of asthma episodes in the preceding year was         drawn from them.
fore be hard to identify, let alone quantify.         zero. These are all “hard” floor/ceiling effects;
   Other design issues were apparent—for              no improvement at all could have been                                                          P Fisher
example, no data were reported on homeo-              expected. There is also a strong suggestion of        Director of Research, Royal London Homoeopathic
pathic exacerbations (an indicator of the             floor/ceiling effects in other outcomes such as                         Hospital, London W1W 5BP, UK;
healing response), and the security of blind-         days lost from school, but we cannot be                                             peter.fisher@uclh.org
ing was not assessed. Yet, despite these              certain from the published data. Other sec-
limitations, some encouraging therapeutic             ondary outcomes show relative floor/ceiling                                                 K Chatfield
effects were apparent. For example, a clini-          effects—for instance, the mean final value in                Director of Research, Society of Homeopaths
cally relevant improvement in asthma severity         the CAQA parental severity score was 5.5 on a         Faculty of Health, University of Central Lancashire,
                                                      scale of 5–19. Since this was an intention to                                        Preston PR1 2HE, UK
(unadjusted scores) was seen in two of the
three groups, and a favourable pattern in the         treat analysis, 20% of the values were simply
                                                      pretreatment values carried forward.                                                          R Mathie
days off school/days attended was seen in the
                                                         Other CAQ subscales analysed as secondary                             Research Development Adviser,
homeopathic treated children (although no                                                                         Faculty of Homeopathy, Hahnemann House,
data were presented).                                 outcomes consistently favour homeopathy.
                                                                                                                     29 Park Street West, Luton LU1 3BE, UK
   We suggest that a balanced and accurate            For the severity subscales the improvement
conclusion to these data would be that no             was statistically highly significant (p=0.01)
definitive conclusions could be drawn but that         with 95% confidence intervals not including           References
further investigation is needed. We therefore         zero. This again was an intention to treat             1 White A, Slade P, Hunt C, et al.
hope that the authors’ inaccurate conclusions         analysis, and while there are good reasons for           Individualised homeopathy as an adjunct in
                                                      performing such analyses, effect size esti-              the treatment of childhood asthma: a
neither dampen future research nor bias                                                                        randomised placebo controlled trial. Thorax
future systematic reviews.3                           mates should be based on data for subjects
                                                      who have actually taken the treatment and                2003;58:317–21.
                                                                                                             2 French DJ, Christie MJ, Sowden AJ. The
                            S B Brien, G Lewith       had its impact evaluated; in this case, 20% did
                                                                                                               reproducibility of the childhood asthma
    Complementary Medicine Research Unit, Royal       not. In addition, there was a floor effect (see           questionnaires: measures of quality of life for
   South Hants Hospital, Southampton SO14 0YG,        above) in one of the severity scales. A similar          children with asthma aged 4–16 years. Qual
              Hampshire, UK; s.brien@soton.ac.uk      pattern is seen for other subscales of the CAQ,          Life Res 1994;3:215–24.
                                                      but no statistical analysis is presented.              3 Linde K, Clausius N, Ramirez G, et al. Are
References                                               The question most frequently posed about              the clinical effects of homeopathy placebo
  1 White A, Slade P, Hunt C, et al.                  homeopathy is “is it all placebo effect?” Most           effects? A meta-analysis of placebo-controlled
    Individualised homeopathy as an adjunct in        meta-analyses have concluded that it is not. If          trials. Lancet 1997;350:834–43.
    the treatment of childhood asthma: a                                                                     4 Jadad AR, Moore RA, Carrol D, et al.
                                                      the outcome measures which could not have
    randomised placebo controlled trial. Thorax                                                                Assessing the quality of reports of randomized
    2003;58:317–21.                                   improved are excluded, the results of this trial
                                                      accord with those of the largest meta-analysis           clinical trials: is blinding necessary? Control
  2 French DJ, Christie MJ, Snowden AJ. The                                                                    Clin Trials 1996;17:1–12.
    reproducibility of the childhood asthma           of homeopathy; they “are not compatible with
    questionnaires: measures of quality of life for   the hypothesis that the clinical effects of
    children with asthma aged 4–16 years. Qual        homeopathy are completely due to placebo”.3          The study by White et al1 of quality of life in
    Life Res 1994;3:215–24.                           The treatment effect size was relatively small,      children with asthma treated with homeo-
  3 White P, Lewith G, Berman B, et al. Reviews       but classical homeopathy is a complex and            pathy is fatally flawed. The Childhood Asthma
    of acupuncture for chronic neck pain: pitfalls    non-standardised intervention. The practi-           Quality of Life instrument used was validated
    in conduting systematic reviews.
    Rheumatology 2002;41:1224–31.
                                                      tioners involved had no particular experience        in a study by French et al.2 The children
                                                      of asthma. There is thus considerable scope          entered into the study by White et al had
                                                      for refinement.                                       scores consistent with those of normal chil-
The paper by White et al1 in the April issue of          Regrettably, the conclusions do not ad-           dren who don’t have asthma. For a statisti-
Thorax purports to show that adjunctive               equately reflect the shortcomings of the trial.       cally significant improvement to occur in this
homeopathic treatment has no effect on the            The authors state that “there was no evidence        score, the treated group would have to develop
quality of life of asthmatic children. The            of a clinically relevant change in quality of life   scores of around 100%—that is, better than
primary outcome measure was the active                score”, but omit to mention that none was            normal non-asthmatic children. This is clearly
Quality of Life (QoL) scale of the Childhood          expected since the QoL scores were normal at         highly unlikely. In addition, a similar “ceiling
Asthma Questionnaire (CAQ). This measure              entry. There is no reference to the many floor/       effect” applies to the peak expiratory flow
was inappropriate, and no such conclusion is          ceiling effects.                                     readings which at entry were 100.4% and
justified. As table 1 shows, the children                 Our greatest concern is that the bias in the      96.9% of expected for the verum and placebo
enrolled had QoL scores virtually identical to        interpretation of the results will carry             groups, respectively.
those of non-asthmatic children in a large            through to future meta-analyses and reviews.            This is a very poor quality trial which does
                                                                                                           absolutely nothing to further our understand-
                                                                                                           ing of the potential value of homeopathic
                                                                                                           treatment in children with asthma. In fact,
   Table 1 Comparison of Childhood Asthma Questionnaire (CAQ) active
                                                                                                           the press release from the journal has been
   quality of life scores in in paper by White et al1 and CAQ validation study by                          picked up by the media and used to support
   French et al2                                                                                           the headline “Homeopathy of no use in
                                                                                                           asthma”.
                                                      CAQ validation study (French et al2), n=535
                                                      (median)                                                Publishing this quality of research at best
                              White et al1, n=93                                                           does not improve our necessary evidence base
                              (mean at entry)         Asthmatic            Non-asthmatic                   and, at worst, contributes to the denial of
                                                                                                           services which may indeed be of value to
    CAQA: range 10–40         35.2                    34                   34                              patients. A close analysis of the study shows
    (4–7 years)                                                                                            that the treatment group had a trend to better
    CAQB: range 7–35          28.1                    28                   29
                                                                                                           outcomes than the placebo group. If this were
    (8–11 years)
                                                                                                           a pilot study, it would be indicating that there
    CAQC: range 8–36          29.4                    No data              No data
    (12–16 years)                                                                                          is indeed a potential benefit to asthmatic
                                                                                                           children from homeopathy which should be
    Higher values indicate better quality of life.                                                         investigated with a proper trial of good meth-
                                                                                                           odological quality.




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828                                                                                                                                               PostScript


                                     R Leckridge      scale measures symptoms only, and active               understand the current literature. Professor
        Glasgow Homeopathic Hospital, Glasgow         quality of life is much more appropriate for           Coggon moves rapidly through types of data
         G12 0XQ, UK; bob.leckridge@virgin.net        the holistic approach of homeopathy.                   (continuous, ordinal or univariate and multi-
                                                         The claim by Fisher et al and Dantas that the       variate) to methods of summarising data on
References                                            homeopaths were inadequate to the task is              which a fair amount of time is spent. Tabular
  1 White A, Slade P, Hunt C, et al.                  speculative and one we reject. Dantas would            and graphical (dot, line, bar and pie chart)
    Individualised homeopathy as an adjunct in                                                               presentations are discussed with numerous
    the treatment of childhood asthma: a
                                                      prefer us to have used more rigorous criteria
                                                      for inclusion and assessment, but the study            illustrations from everyday clinical practice.
    randomised placebo controlled trial. Thorax
                                                      was especially designed to reflect “real life”          The interpretation of graphical data and its
    2003;58:317–21.
  2 French DJ, Christie MJ, Sowden AJ. The            pragmatically by rigorously applying the               limitations—a very important part of under-
    reproducibility of the childhood asthma           criteria used by the GPs, the children, and            standing current medical research—are thor-
    questionnaires: measures of quality of life for   their families. We cited his paper as the only         oughly discussed. The concept of probability is
    children with asthma aged 4–16 years. Qual        systematic and objective report on homeo-              introduced and combining probabilities is
    Life Res 1994;3:215–24.                           pathic aggravations that we were aware of,             explained. Sensitivity and specificity are de-
                                                      and if we gave the impression that he stated           fined here but could more appropriately be
Author’s reply                                                                                               placed later as they are, in fact, properties of
                                                      that aggravations are a hallmark of success,
These authors are to be thanked for their con-        then we regret it.                                     statistical tests. Hypothesis testing, confi-
tribution to the debate about the interpret-                                                                 dence intervals, and the basis of sample size
ation of the results of our trial, and it is                                                   A White       calculations (though not how to calculate the
conceded that ceiling effects may exist which              Complementary Medicine, Peninsula Medical         size of a sample) are also discussed. The
limit the interpretation of our results. If the        School, Universities of Exeter and Plymouth, Exeter   author explains the two most common meth-
children were already effectively medicated, it                  EX2 4NT, UK; adrian.white@pms.ac.uk         ods of statistical modelling—linear regression
may not have been possible to show any ben-                                                                  and survival analysis—and concludes with a
efit from homeopathic treatment in quality of                                                                 section on meta-analyses and the importance
life. It would require a much larger study to                    BOOK REVIEW                                 of involving statisticians very early in the
show any differential change in conventional                                                                 planning stage of a study.
                                                                                                                This is an excellent introduction to practis-
medication or global indicators, which were           Statistics in Clinical Practice                        ing statistics in medicine and will be ex-
absent from the results. Because of ethical
                                                                                                             tremely useful for medical students and clini-
issues, it may be difficult to conduct a defini-        David Coggon. 2nd edition. London: BMJ                 cians alike. Medical researchers will, however,
tive trial in children with severe asthma.            Books, 2002. £14.95, 120 pp. ISBN                      need to follow this text with a more advanced
   Leckridge, Fisher et al, and Brien and             0727916092                                             one.
Lewith suggest that we should have concen-
trated instead on the small changes in the            This is a very clearly written introduction to                                         T Seemungal
severity subscales, the estimate of which is          statistics, suitable for medical students and          Barts and The London Medical School, London, UK;
not clinically relevant. However, the severity        doctors who need a quick update in order to                                        tseemungal@aol.com




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