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A pseudo-randomised clinical trial of in situ gels of fluconazole for the treatment of oropharngeal candidiasis

Harish M Nairy*, Narayana R Charyulu, Veena A Shetty and Prabhu Prabhakara

Trials 2011, 12:99  doi:10.1186/1745-6215-12-99

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Comparing apples and oranges

Joselita Salita   (2011-07-21 12:45)  Freelance Medical Writer/JTS email

I appreciate the goals of Nairy et al.'s paper. However, their primary objective was incomplete which made them design an experiment which compared apples and oranges. The three groups could only be partially compared: group 1 vs 2 and 1 vs 3, which in the end, could not support their conclusions.

In order to assess the efficacy of in-situ gels in treating OPC, one compares in-situ gels with a placebo or a comparator (in this case, flucanozole tablets) or both among one patient type. Having two types of patients, with one type incompletely represented was a major flaw. The choice of comparing responses among HIV/AIDS patients as a patient type was also not a good idea due to confounding effects. The resulting „good clinical response“ of HIV patients after 21 days in which 85% in Group I receiving in situ gels were considered OPC cured compared to 66% HIV patients in Group III treated with tablets could be insignificant not only due to small sample size (n=15) but also to confounding effects. So did relapse of 80 and 90% respectively. Group II was comprised of non-HIV patients and was treated with in situ gels. Better outcomes for this group (clinical response=100% and relapse=0) may have resulted because the subjects were HIV-free (therefore responded better) and similar results could have been obtained if this group received placebo in-situ gel or flucanozole tablets. For this particular data set no statistical tests were performed but comparison was not valid anyway.

All other data with or without statistical support showed the same trends, that is, Group II having the most positive outcome and Group III the least. I think they have no relevance under the same reasoning. The only valid conclusion in this paper is that in situ gels are more efficacious in patients without HIV/AIDS than those with HIV/AIDS. Whether in situ gels are better than tablets among healthy or HIV patients is unanswered.

Competing interests

I do not have any competing interest.

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To the Editor

Dirk Kuhlmann   (2011-06-23 12:09)  Geistlich Pharma AG email

The study showing an in situ gel formulation is an interesting approach for treatment of OPC. The clinical study data presented by Nairy et al. is poorly organized and confusing.

The reliability of the results is questionable due to incomplete outcome data and selection bias from randomization based on clinical evaluation. The three study groups are only partially comparable. As group II is missing a control group, the data is not supportive of the aim of the study.

Severity of signs and symptoms are mild to absent according to table 3. An effect of treatment on moderate to severe cases is not presented. Patient demographics of group 3 are diverse with a possible confounding bias associated with a large variance in CD4 count.

The primary endpoints are not specified to be at EOT or after follow-up. Data and results presented throughout the paper are not consistent thereby decreases their validity. Gender counts for group II vary in the study design and table 2. Changes in symptoms vary throughout the paper. In the abstract, 97% of group I were cured. In the discussion, 95% of this group were cured but only 80% showed a good clinical response in the in vivo evaluation up to 21 days. At EOT, group III showed 85% improvement in the abstract and 93% and 66.6% as cured in the discussion section and in vivo evaluation respectively. The results in figure 2 are not supportive of other data. Percentage points do not correlate to natural numbers of patients.

In group I and II, 40% of the patients experienced gastrointestinal symptoms. Unfortunately no mention of adverse events is made for the control group.

According to the authors, there is no significant difference in clinical response at EOT and at end of follow-up and no improvement in group I and III at the end of the study.
In my opinion, the data is not supportive for concluding a better clinical efficacy in HIV/AIDS patients. Successful clinical outcome was only reported during the treatment duration. Insufficient information is given to discern whether the in situ gel is a viable alternative to conventional formulations.

It would be advantageous if the authors could repeat the study in a larger, randomized patient group with a suitable control group and study setup and with treatment endpoints comparable to other OPC studies.

Yours sincerely
D. Kuhlmann

Competing interests

I declare that I have no competing interest.

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