Authors' reply and correction
Identifieur interne : 005F68 ( Istex/Corpus ); précédent : 005F67; suivant : 005F69Authors' reply and correction
Auteurs : Andrew Davies ; Peter WilliamsSource :
- Palliative Medicine [ 0269-2163 ] ; 1999-01.
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DOI: 10.1177/026921639901300113
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encoding="UTF-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="other" dtd-version="2.3" xml:lang="EN"><front><journal-meta><journal-id journal-id-type="hwp">sppmj</journal-id><journal-id journal-id-type="publisher-id">PMJ</journal-id><journal-title>Palliative Medicine</journal-title><issn pub-type="ppub">0269-2163</issn><publisher><publisher-name>Sage Publications</publisher-name><publisher-loc>Sage CA: Thousand Oaks, CA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.1177/026921639901300113</article-id><article-id pub-id-type="publisher-id">10.1177_026921639901300113</article-id><article-categories><subj-group subj-group-type="heading"><subject>Articles</subject></subj-group></article-categories><title-group><article-title>Authors' reply and correction</article-title></title-group>
<contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Davies</surname><given-names>Andrew</given-names></name></contrib></contrib-group>
<contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Williams</surname><given-names>Peter</given-names></name><aff>Department of Mathematical and Computing Sciences, University of Surrey, Guildford, UK</aff></contrib></contrib-group>
<pub-date pub-type="ppub"><month>01</month><year>1999</year></pub-date><volume>13</volume><issue>1</issue><fpage>82</fpage><lpage>83</lpage><custom-meta-wrap><custom-meta xlink:type="simple"><meta-name>sagemeta-type</meta-name><meta-value>Letter</meta-value></custom-meta><custom-meta xlink:type="simple"><meta-name>search-text</meta-name><meta-value> · patients who withdrew because of spontaneous improvement should have been regarded as 'treatment successes' (i.e. they should arbitrarily have been assigned a 'high' VAS score); · patients who withdrew for other reasons and were not given treatment should have been regarded as showing 'no change' (i.e. they should arbitrarily have been assigned their pre- treatment VAS score). Including all of the drop-outs would inevitably have reduced the power of the study and would have necessitated the recruitment of more patients before meaningful conclusions could have been drawn. This is an unfortunate but unavoidable con- sequence of studying patients with advanced cancer. Dr Patrick Stone, Specialist Registrar, Trinity Hospice, 30 Clapham Common North side, London, UK and Roger A'Hern, Statistician, Royal Marsden Hospital NHS Trust, London, UK. References 1 Davies AN, Daniels C, Pugh R, Sharma K. A comparison of artificial saliva and pilocarpine in the management of xerostomia in patients with advanced cancer. Palliat Med 1998; 12: 10511. 2 Peto J. Withdrawals and exclusions in randomised trials. In Buyse M, Staquet M, Sylvester R eds. Cancer clinical trials methods and practice. Oxford: Oxford Medical Publications, 1984: 375. Authors' reply and correction We would like to thank the editor for the opportu- nity to reply to the criticism of our paper.1 Stone and A'Hern suggest that we should have excluded data on the side-effects of the treatments during the second phase of the study from our analysis, because there was a significant carry-over effect with regard to the effectiveness of the treat- ments. However, we made it clear in the Methods section that the patients completed a side-effect checklist at the beginning and end of each treatment period. If a patient developed a symptom during the treatment period, then it was assumed that this symptom was a side-effect of the specific treatment (unless there was another obvious explanation). This procedure would have automatically negated any carryover effect with regard to the side-effects of the treatments. On the subject of side-effects, we would like to point out that nausea, vomiting and diarrhoea are not 'common' with pilocarpine. Indeed, the report- ed incidence of nausea is 6%, and of diarrhoea is 4%.1 Furthermore, we would reiterate the point that gastrointestinal side-effects do occur with Saliva OrthanaTM.2 Your correspondents also suggest that we should have allocated VAS scores to patients according to the reason they withdrew from the study, e.g. that we should have allocated a low VAS score to patients who withdrew from the study because of side-effects. However, this would not be an accurate reflection of the effectiveness of the treatments. Indeed, the majority of patients who withdrew from the study because of side-effects from a specific treatment reported that their xerostomia had improved with that treatment. This was particular- ly notable with SalagenTM. (One patient withdrew from the study because of excess salivation from the Salagen!) There are a number of different methods for dealing with missing data in crossover studies. How- ever, all of these methods have drawbacks. Stephen Senn states in his book on the statistical analysis of crossover studies: 'There is only one rule for reporting experiments with missing data on which we can all agree: and that is full and frank disclo- sure as to what went missing where and why'.4 We endorse these views. On the subject of analysis of data, we would like to point out that all the patients in our study received the treatment they were allocated. There- fore, the issue of 'intention to treat' is not relevant. Finally, we would like to correct an error in the Results section of our recent paper.1 The fifth para- graph should have read: The mean initial VAS score for the symptom of xerostomia in the artificial saliva group was 3.7 (cm), and for the pilocarpine group was 2.8 (cm). There was no statistical difference between these scores (unpaired t-test: P = 0.23). The mean change in VAS score for this symptom in the artificial saliva group was +12 mm and in the pilocarpine group was +46 mm. There was a sta- tistically significant difference between these 82 Correspondence results (unpaired t-test: P = 0.003), i.e. the pilo- carpine was more effective. The 95% confidence interval for this difference was +12 to +55 mm. In the original paper we erroneously reported the change in VAS score as percentages of the overall length of the VAS (100 mm) rather than as absolute values. This has no bearing on the statisti- cal analysis of the data from the study. However, we would like to apologize for any misunderstanding that may have arisen as a result of this error. Dr Andrew Davies, Clinical Research Fellow in Pal- liative Medicine, Royal Marsden Hospital, Sutton, UK and Peter Williams, Statistician, Department of Mathematical and Computing Sciences, University of Surrey, Guildford, UK. References 1 Davies AN, Daniels C, Pugh R, Sharma K. A comparison of artificial saliva and pilocarpine in the management of xerostomia in patients with advanced cancer. Palliat Med 1998; 12: 10511. 2 Johnson JT, Ferretti GA, Nethery WJ et al. Oral pilocarpine for post-irradiation xerostomia in patients with head and neck cancer. N Engl J Med 1993; 329: 39095. 3 Davies AN, Singer J. A comparison of artificial saliva and pilocarpine in radiation-induced xerostomia. J Laryngol Otol 1994; 108: 66365. 4 Senn S. Crossover trials in clinical research. Chichester: John Wiley, 1993: 21921. L-dopa and cancer anorexia We would like to report the remission of anorexia after treatment with L-dopa, in a patient suffering from advanced bladder cancer. A 71-year-old man presented with macroscopic haematuria, mild anorexia, dysphagia and weak- ness. He was diagnosed as having an infiltrating bladder carcinoma (stage IIIB). He underwent a partial transurethral resection of the tumour, after which he received chemotherapy. He was then investigated with blood tests, abdominal computer- ized tomography scan, bone scintiscan, and chest X- ray. Metastases were not detected, and 7 months after diagnosis he had a second partial transurethral resection of bladder tumour. During the first 2 months after the second transurethral resection he became increasingly weak, and his performance status worsened gradu- ally to grade 4 on the ECOG performance scale. He also developed severe anorexia (food intake 200 calories/day), dysphagia (he was only able to swal- low liquids and blended food), and taste distur- bance. The patient had lost 18% of his body weight since the time of diagnosis. He also showed trem- bling and stiffness of his right hand, related to con- comitant Parkinson's disease. To palliate these symptoms and especially the dysphagia, he was treated with L-dopa in combination with carbidopa (Sinemet® , DuPont) at a dose of 375 mg/day. During the first 2 weeks of treatment, he showed a gradual reduction of tremor and hand stiffness, and his dysphagia improved such that he became able to take crushed food. Unexpectedly, his appetite also increased, and his food intake increased to 1200 calories/day. His performance sta- tus also improved slightly, to grade 3 on the ECOG scale. After the first month of treatment he showed a clear remission of both dysphagia and anorexia, and he became able to swallow solid food. His intake increased to 1800 calories/day, and his sense of taste returned. There was also a clear remission of asthenia, with an improvement of his perfor- mance status to grade 1. After 2 months of treat- ment, his body weight increased by 15%, and this was maintained during the next 4 months. After 5 months of treatment, he gradually relapsed, and all his previous symptoms returned. Because of this, the dose of L-dopa was progressively increased to 1000 mg/day for 2 weeks. On this occasion there was no improvement in his symptoms and the dose was decreased back to 750 mg/day. At the same time, pergolide (Pharken® , Lilly) was prescribed at increasing doses from 0.75 mg/day up to 1.5 mg/day over 2 weeks. This again resulted in remission of his symptoms, and this was maintained until he died of renal failure 3 months later. During the final 3 months of his life severe lymphoedema prevented accurate body weight evaluation. During the time of L-dopa treatment, the patient was not receiving any other treatment. Since anorexia is not related with Parkinson's disease, it is likely that the remission of this symptom, which is typically associated with the neoplastic process, was due to the treatment with L-dopa. This conclusion can be reinforced by previous reports Correspondence 83 </meta-value></custom-meta></custom-meta-wrap></article-meta></front><back><ref-list>
<ref>
<citation citation-type="journal" xlink:type="simple"><name name-style="western"><surname>Davies AN</surname></name>, <name name-style="western"><surname>Daniels C</surname></name>, <name name-style="western"><surname>Pugh R</surname></name>, <name name-style="western"><surname>Sharma K</surname></name>. <article-title>A comparison of artificial saliva and pilocarpine in the management of xerostomia in patients with advanced cancer</article-title>. <source>Palliat Med</source>
<year>1998</year>; <volume>12</volume>: <fpage>105</fpage>–<lpage>111</lpage>.</citation>
</ref>
<ref>
<citation citation-type="journal" xlink:type="simple"><name name-style="western"><surname>Johnson JT</surname></name>, <name name-style="western"><surname>Ferretti GA</surname></name>, <name name-style="western"><surname>Nethery WJ</surname></name> et al. <article-title>Oral pilocarpine for post-irradiation xerostomia in patients with head and neck cancer</article-title>. <source>N Engl J Med</source>
<year>1993</year>; <volume>329</volume>: <fpage>390</fpage>–<lpage>395</lpage>.</citation>
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<citation citation-type="journal" xlink:type="simple"><name name-style="western"><surname>Davies AN</surname></name>, <name name-style="western"><surname>Singer J</surname></name>. <article-title>A comparison of artificial saliva and pilocarpine in radiation-induced xerostomia</article-title>. <source>J Laryngol Otol</source>
<year>1994</year>; <volume>108</volume>: <fpage>663</fpage>–<lpage>665</lpage>.</citation>
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<citation citation-type="book" xlink:type="simple"><name name-style="western"><surname>Senn S</surname></name>. <source>Crossover trials in clinical research</source>. <publisher-loc>Chichester</publisher-loc>: <publisher-name>John Wiley</publisher-name>, <year>1993</year>: <fpage>219</fpage>–<lpage>221</lpage>.</citation>
</ref>
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