Effect on weight gain of routinely giving albendazole to preschool children during child health days in Uganda: cluster randomised controlled trial

BMJ 2006; 333 doi: http://dx.doi.org/10.1136/bmj.38877.393530.7C (Published 13 July 2006)
Cite this as: BMJ 2006;333:122

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Rapid Response re: Increased Weight Gain in Preschool Children due to Mass Albendazole Treatment Given During “Child Health Days” in Uganda: A Cluster Randomized Controlled Trial. Harold Alderman, International Food Policy Research Institute

Shortly after my paper on deworming in Uganda was published in the BMJ, I had an exchange of correspondence with Dr. Garner regarding the standard errors reported in one table. After that exchange I shared the following letter with the BMJ and with him in April 2007.

“Dear Editor,

Prof. Paul Garner has kindly pointed out that, in an article published in the BMJ, my coauthors and I inadvertently failed to adjust standard errors in one of the tables for cluster based sampling. While table 2 of that paper reports means for growth in grams of 2413 [CI=2373 - 2454] and 2259 [CI=2216 - 2301] for the treatment and control groups respectively, once the design effect is taken into consideration the confidence intervals should, in fact, be [CI=2295 - 2533] and [CI=2121 - 2396].

The conclusions of the study, however, are unaffected as they are based on the multivariate regressions reported in table 3 for which the standard errors had been corrected for cluster based sampling. For example, the confidence interval for the finding that the children who attended child health days every six months where deworming medicine was provide had a significantly greater weight gain than similar children who attended child health days at which albendazole was not provided is unaffected; the CI for the difference in weight gain remains [59g - 262 g].”

Recently the BMJ has invited me to submit a letter addressing the earlier comments as well as more recent variations of that theme. I believe that it is sufficient to indicate that the results presented in the multivariate analysis remain the basis for the conclusion of the study. Given the heterogeneity of ages in the study population and the fact that the velocity of weight gain is dependent on age, table 2 was presented for background only while the primary analysis was presented in table 3. The results in this table control for these covariates as well as the duration of time between visits or the total time a child participated in the child health days organized for his or her community. These results provide more precise estimates of treatment effects.

Competing interests: None declared

Harold A Alderman, economist

Inthernational Food Policy Research Institute, 2033 K St NW Washington DC 20006 USA

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Dear Dr Alderman,

I am writing in relation to the paper you published in the BMJ in 2006 on the effect of albendazole on the weight of pre-school children in Uganda. I remember that, at the time it was published, concerns were raised that the confidence intervals of the main outcome, weight gain, were wrongly calculated.

I had thought that this had led to a correction on bmj.com. But it has been brought to my attention that there is no correction. I have now learnt that the correction you submitted presented the data in a different way as a letter. It did not adequately address the need for a formal correction in the abstract, and, although a series of emails ensued, the matter was never resolved. We, the BMJ, should have pursued this but did not. I am now doing so.  

I see from the rapid response from David Taylor-Robinson and Paul Garner that you provided the Cochrane review group with adjusted data and that a correction has been published against the Cochrane review.

Please could you now do two things. First, provide us with a correction that we can place against the BMJ article. This will need to fully address the fact that recalculation taking into account the cluster design of your trial changes the main result and the overall message. We will need to get the text of this correction statistically peer reviewed. Secondly, could you post a rapid response in reply to the one from Taylor-Robinson and Garner addressing all their points.

While awaiting these two things from you, I am posting this email as a rapid response to your paper on bmj.com. I look forward to hearing from you as soon as possible and certainly before 12 December.

Best wishes,

Fiona Godlee

Competing interests: I am the editor of the BMJ and am responsible for all it contains

Fiona Godlee, Editor

BMJ, London WC1H 9JR

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To the editor

In a trial featured on the cover of the BMJ Alderman et al report on weight gain in 27,995 children who were cluster randomized in 48 parishes to either albendazole for treatment of soil-transmitted helminths or nothing (1).

We have recently published a Cochrane review of the effects on growth and school performance of deworming for soil-transmitted helminths in children and included this study (2). The paper reported a weight gain of 2.413 kg in the 25 treatment parishes and 2.259 kg in the control parishes at an unspecified follow-up point. The 154 g difference was reported as statistically significant in the paper. We contacted the authors as the paper did not make it clear if the design effects had been taken into account in this result. The authors wrote that the result was unadjusted, and kindly provided us with adjusted data: these results showed no significant difference detected for the primary outcome of weight gain between intervention and control groups (difference 154 g; 95% CI -19.7 to 330 g).

We think it is important that the correction outlined above - which is now published (2) - is linked to the published version of this trial.

1. Alderman H, Konde-Lule J, Sebuliba I, Bundy D, Hall A. Effect on weight gain of routinely giving albendazole to preschool children during child health days in Uganda: cluster randomised controlled trial. BMJ 2006;333(7559):122.

2. Taylor-Robinson DC, Jones AP, Garner P. Deworming drugs for treating soil-transmitted intestinal worms in children: effects on growth and school performance. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD000371. DOI: 10.1002/14651858.CD000371.pub3.

Competing interests: None declared

Competing interests: None declared

David C Taylor-Robinson, Clinical Lecturer in Public Health

Paul Garner, LSTM

Division of Public Health, University of Liverpool, L69 3GB

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It was interesting to read the study by Alderman et al on deworming the malnourished children and demonstrating its effects on weight gain (1). It is quite amusing to note that when developing world is combating malnutrition by treating worm infestation, developed countries are looking at the worms with more respect and planning to use them as treatment in many conditions. Weinstock et al suggest that helminths induce regulatory T cell activity and these effects may have protected individuals from many of the emerging immune-mediated illnesses like IBD, multiple sclerosis, type I diabetes, and asthma (2). Trichuris suis ova therapy was found to be useful in the treatment of both ulcerative colitis and crohn’s disease (3,4). This contrasting approach towards worms in different parts of world points to the gap of knowledge about nature's influence on immunity and the need for extensive research on the impact of helminthic infection and immune regulation.

Competing interests to declare: none

References.

1.Harold Alderman, Joseph Konde-Lule, Isaac Sebuliba, Donald Bundy, and Andrew Hall. Effect on weight gain of routinely giving albendazole to preschool children during child health days in Uganda: cluster randomised controlled trial BMJ 2006 333: 122

2. Weinstock JV, Summers RW, Elliott DE. Role of helminths in regulating mucosal inflammation. Springer Semin Immunopathol. 2005 Jun;27(2):249-71.

3. Summers RW, Elliott DE, Urban JF Jr, Thompson RA, Weinstock JV. Trichuris suis therapy for active ulcerative colitis: a randomized controlled trial. Gastroenterology. 2005 Apr;128(4):825-32.

4. Summers RW, Elliott DE, Urban JF Jr, Thompson R, Weinstock JV Trichuris suis therapy in Crohn's disease. Gut. 2005 Jan;54(1):77, 96

Competing interests: None declared

Competing interests: None declared

Rafeeq Muhammed, Specialist Registrar Paediatrics

University Hospital of North Durham, Durham DH1 5TW

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