Kanuka Randomised Controlled Trial Critical Appraisal
Acne, a common inflammatory cutaneous disease, with a recent analysis reporting an 85% prevalence in those aged between 12 and 24 years of age in the USA. A new treatment option could prove successful if alongside being efficacious avoids the many shortcomings of current treatment options e.g. antibiotics, hormone-therapy etc. These treatment options are ineffective in some sufferers, thus are untenable in improving patient care outcomes.
The papers’ objective: ‘To investigate the efficacy of Honevo, a topical 90% medical-grade kanuka honey, and 10% glycerine (honey product) as a treatment for facial acne’, is a strong foundation whereupon to run a trial.
Establishing inclusion criteria prior to participant selection optimise the overall validity; the criteria comprises of a clinical diagnosis of acne and a score of two or more on a ‘Investigator’s Global Assessment’ (IGA) scale. Conversely participant exclusion criteria was extensive, being clearly delineated, precluding sufferers with systemic illness, those currently or recently taking topical corticosteroids and antibiotics in the previous 4 weeks.
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There were 136 selected participants between the ages of 16 – 40, who were randomised to the honey product group arms using a concealed computer-generated sequence, this randomisation algorithm was used to eliminate bias, accidental or otherwise. Opaque envelopes were used to preserve participant allocation concealment, thus preventing researchers influencing outcomes through preceding knowledge of research outcomes. Furthermore, potential for bias was minimised by having a second investigator perform the IGA at each visit without knowledge of participant treatment allocation.
In my opinion the sample size seems sufficient, the size allows for equal randomisation to both treatment arms. Furthermore, recruitment of 136 participants allows for a build-in quantity to account for a 10% dropout rate, accounting for up to 13.6 (14) withdrawals.
The study has predetermined specific criteria that it will use to define success when considering the primary outcome aim, the researchers defines success as a ‘â‰¥2 point decrease in IGA score from baseline at 12â€…weeks’. There were also several secondary outcomes, summarised as follows: the average IGA score at weeks 12 and 14;an overall change in acne using a visual analogue scale (VAS); overall VAS severity at week 4 when contrasted to baseline; applications per day; weekly-reported severity using a VAS scale; and withdrawing participation should acne worsen.
RCTs have several points of interest when contrasted with other study types, commonly allowing for optimal assessment of efficacy, randomisation to abstain from confounding the results, and minimisation of bias by allocation disguise and blinding. The kanuka-based treatment has an intrinsic impediment in its appearance and smell; the innate restriction of this study prevented comprehensive blinding of members and researchers, which diminishes the studies adequacy when contrasted with comparable RCTs. This issue was tempered by blinding the researchers in charge of measuring the primary result variable. The blinding of the assessors’ producing the results considered allowed for the avoidance of assessment bias.
By providing a thorough methodology section, this research is reproducible, this was done by providing the treatment regime, number of assessments conducted, and the interval between these assessments. It is stated by the author that the setting was ‘Outpatient primary care from 3 New Zealand localities’, albeit rather vague as New Zealand covers a wide area. The issue of adherence and compliance in this study was addressed, treatment constituted ‘twice daily’ application to affected areas for ’30 and 60′ minutes. Participant adherence was important, this is supported via daily recording of applications with a check for diary completeness at each visit.
The researchers calculated 80% power at 5% significance to detect an absolute difference of 25% responders. It is therefore possible to infer that the study had an 80% chance of identifying any treatment effect, with less than a 5% risk that this was due to chance.
The primary outcome of participants showing a â‰¥2 improvement in IGA assessment at week 12 reveals that only a very small proportion of participants showed an improvement. Compared with baseline only, or the Hodges-Lehmann estimator with 95% Confidence Limit showed a 4.2 (0.5 to 39.3), with a p=0.17; in the honey product group there were 4/53 (7.6%) participants and 1/53 (1.9%) participants in the control group who met the primary outcome.
Participant withdrawal must be considered, with 15 and 14 participants who withdrew from the honey product group and control group, respectively.
The outcomes at week 12 show marginal improvement in the honey product group compared to the control group. This is shown in the proportional odds logistic regression for the IGA score at week 12, which estimated the OR (95% Cl) for improvement of 1.4 (0.7 to 2.9), p=0.33, without adjustment for baseline, and 2.0 (CI 0.9 to 4.2), p=0.075, after adjustment.
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In regards to daily self-reported use of treatment, it was found that using the The Hodges-Lehmann estimate (95% Cl), between the two study groups was âˆ’7 (âˆ’13 to âˆ’1), p=0.01, with honey product users having less applications. When considering the IGA results, there is a prominent difference in the responses amongst the participants, some participant results would indicate a worsening of symptoms.
When considering whether the secondary outcomes were efficacious there was no evidence found to support the use of the honey based product as a treatment option. Subject-rated improvement according to a VAS at both weeks 4 and 12 was better overall for the honey treatment. Bias is an issue with the VAS as it wasn’t possible to mask which participants were using the honey based treatment. There may be a type 1 error rate inflation with this variable as it was also an outcome other secondary outcome variables.
This study has given a sound premise to methodological and factual contemplations that will be worthwhile for planning comparative studies, maybe helping in defeating the inadequacies inside this study. When contrasted with current treatment options, this study doesn’t give much evidentiary support to the therapeutic utilization of kanuka honey with 10% glycerine in the treatment of acne. Advances within this field are fundamental for improving patient care, in my opinion I would recommend waiting until further research has been conducted contrasting kanuka as a treatment alternative against other treatment choices.
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