ObjectiveTo compare New Zealand medical grade kanuka honey with topical aciclovir for the treatment of herpes simplex labialis.DesignProspective parallel randomised controlled open-label superiority trial.Setting76 community pharmacies across New Zealand between 10 September 2015 and 13 December 2017.Participants952 adults randomised within the first 72 hours of a herpes simplex labialis episode.InterventionsRandom assignment 1:1 to either 5% aciclovir cream or medical grade kanuka honey (90%)/glycerine (10%) cream, both applied five times daily.Outcome measuresThe primary outcome was time from randomisation to return to normal skin (stage 7). Secondary outcomes included time from randomisation to stage 4 (open wound), time from stage 4 to 7, maximal pain, time to pain resolution and treatment acceptability.ResultsPrimary outcome variable: Kaplan-Meier-based estimates (95% CI) for the median time in days for return to normal skin were 8 (8 to 9) days for aciclovir and 9 (8 to 9) for honey; HR (95% CI) 1.06 (0.92 to 1.22), p=0.56. There were no statistically significant differences between treatments for all secondary outcome variables. No related serious adverse events were reported.ConclusionThere was no evidence of a difference in efficacy between topical medical grade kanuka honey and 5% aciclovir in the pharmacy-based treatment of herpes simplex labialis.Trial registration numberACTRN12615000648527;Post-results
Background and objective: Non-invasive ventilation (NIV) is part of the standard of care for hypercapnic respiratory failure secondary to COPD, but may be poorly tolerated. Preliminary evidence suggests nasal high-flow (NHF) therapy may improve hypercapnia in COPD and be well tolerated. We compared NHF and NIV in people with COPD and chronic hypercapnic respiratory failure. Methods: Single-blind randomized controlled two-way cross-over single-centre trial was conducted in New Zealand. Twenty-four participants with stable hypercapnic COPD received: NHF at 45 L/min and NIV at 15/4 cm H 2 O, each for 60 min with a 15-min washout in between. The primary outcome was transcutaneous partial pressure of carbon dioxide (PtCO 2 ) at 60 min, adjusted for baseline. Results: NIV reduced the PtCO 2 more than NHF (mean (SD) at 60 min by −5.3 (5.0) vs −2.5 (3.5) mm Hg; difference: −2.8 (−5.0 to −0.5) P = 0.021). Difference across all time points was −2.5 mm Hg (95% CI −4.5 to −0.5, P = 0.016). There was no significant difference in the proportion of participants with a reduction of PtCO 2 ≥ 4 or ≥ 8 mm Hg. Participants rated NHF significantly better for ease of application, comfort and fit. Conclusion: In stable COPD patients with chronic hypercapnia, NIV resulted in a greater reduction in PtCO 2 compared with NHF, which was of uncertain clinical significance. NHF was better tolerated than NIV and may be a therapeutic option for some people with hypercapnic respiratory failure. Clinical Trial Registration: ACTRN12616001701415 at www.anzctr.org.au
Treatment for recurrent genital herpes using edoxudine 3% cream for 5 days was evaluated in 200 patients in a randomized, multicenter, double-blind, placebo-controlled, clinic-initiated trial. Lesion tenderness was predictive of and more sensitive and longer-lasting than the symptom of pain. Among patients receiving placebo, times to crusting (P = .043), cessation of investigator-observed signs (P = .005), lesion-associated signs (P = .02), and groin signs (P = .05) were longer in women. Edoxudine reduced viral shedding in men (mean 2.7 vs. 3.4 days, P = .009) and women (2.0 days vs. 3.5 days, P = .0001). Loss of investigator-observed signs (4.4 vs. 6.2 days, P = .002), investigator-observed lesion tenderness (P = .01), lesion signs (P = .02), groin adenopathy (P = .01), and tenderness (P = .01) occurred earlier in women taking edoxudine. Edoxudine was well-tolerated and reduced several signs of herpes in women. Its clinical role in recurrent genital herpes remains to be fully determined.
IntroductionWorldwide, about 90% of people are infected with the herpes simplex virus, 30% of whom will experience recurrent herpes simplex labialis, commonly referred to as ‘cold sores’, which can last up to 10 days. The most common treatment is aciclovir cream which reduces healing time by just half a day compared with no specific treatment. This is a protocol for a randomised controlled trial (RCT) to determine the efficacy of medical grade kanuka honey-based topical treatment (Honevo) in reducing the healing time and pain of cold sores, compared with topical aciclovir treatment (Viraban).Methods and analysisThis open-label, parallel-group, active comparator superiority RCT will compare the efficacy of medical grade kanuka honey with 5% aciclovir cream in the treatment of cold sores in the setting of a pharmacy research network of 60 sites throughout New Zealand. Adults presenting with a cold sore (N=950) will be randomised by pharmacy-based investigators. The pharmacy-based investigators will dispense the investigational product to randomised participants and both study groups apply the treatment five times daily until their skin returns to normal or for 14 days, whichever occurs first. In response to a daily SMS message, participants complete an assessment of their cold sore healing, with reference to a visual guide, and transmit it to the investigators by a smartphone eDiary in real time. The primary outcome variable is time (in days) from randomisation to return to normal skin. Secondary endpoints include total healing time stratified by stage of the lesion at onset of treatment, highest pain severity and time to pain resolution.Ethics and disseminationNew Zealand Ethics Registration 15/NTB/93. Results will be published in a peer-reviewed medical journal, presented at academic meetings and reported to participants.Trial registration numberAustralia New Zealand Clinical Trials Registry: ACTRN12615000648527, pre-results.SCOTT Registration: 15/SCOTT/14Protocol version4.0 (12 June 2017)
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