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  • Protocol for a randomised controlled trial of 90% kanuka honey versus 5% aciclovir for the treatment of herpes simplex labialis in the community setting

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Complementary medicine
Protocol
Protocol for a randomised controlled trial of 90% kanuka honey versus 5% aciclovir for the treatment of herpes simplex labialis in the community setting
  1. Alex Semprini1,2,
  2. Joseph Singer1,
  3. Nicholas Shortt1,
  4. Irene Braithwaite1,
  5. Richard Beasley1,2
  6. The Pharmacy Research Network
  1. 1 Medical Research Institute of New Zealand, Wellington, New Zealand
  2. 2 Victoria University Wellington, Wellington, New Zealand
  1. Correspondence to Dr Alex Semprini; alex.semprini{at}mrinz.ac.nz

Abstract

Introduction Worldwide, 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 analysis This 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 dissemination New 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 number Australia New Zealand Clinical Trials Registry: ACTRN12615000648527, pre-results.

SCOTT Registration: 15/SCOTT/14

Protocol version 4.0 (12 June 2017)

  • herpes simplex
  • cold sore
  • aciclovir
  • kanuka honey
  • pharmacy research

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-017766

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    Footnotes

    • Contributors AS, IB and RB: designed the study. AS, JS and NS: manage the study participants and data. AS and RB: drafted the manuscript. All authors: reviewed and edited the manuscript drafts.

    • Funding HoneyLab, Tauranga, New Zealand.

    • Competing interests None declared.

    • Ethics approval NZ Ethics Registration 15/NTB/93.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators Pharmacy Research Network: John Castle Chemist: Shahlaa Al Salih and Noor Al Rawe; Countdown Pharmacy Newtown: Eddie See and Raksha Goundar; Life Pharmacy Tauranga: Garth Mitchinson; Countdown Pharmacy Petone: Nimmi Gnanasekaran; Countdown Pharmacy Cambridge: Vish Gangapuri; University of Waikato Pharmacy: Kerry Dean; Cook St Pharmacy: Anthony Roberts and Anne Lim; Alexander Pharmacy: Angela Liu, Lorraine Brunton and Kate Adam; Countdown Pharmacy Eastgate: Michelle Hwang; Countdown Pharmacy Church Corner: Henriette Meyer, Outi Kolju, Tyler Pornchaisuksiri and Mate Hegedus- Gaspar; The Pharmacy@Phillipstown: Ruby Willing and Shirin Namjou; The Pharmacy @ St Georges: Ray Sefton; Pharmacy@Ferrymead: Grant Bell and Nehad Kamel; University of Canterbury Pharmacy: Lesley Robertson; The Dispensary 914: Angela Blackwood; Life Pharmacy Coastlands: Debora Nguy; Life Pharmacy Kilbirnie: Androulla Kotrostos; Victoria University Pharmacy: Melanie Wong, Sascha Ion, Alice Manch and William Gin; Unichem Johnsonville: Matthew Grey, Dipika Parmar and Maureen Raju; Crofton Downs Pharmacy: Karen Rich and Catherine Hosler; Unichem Karori Mall: Brian Johnston; Unichem Owles Naenae: Patrick Lim and Janet Downing; Unichem Guys: Chau Ly and Alice Liu; Unichem Leabank: Kerry Oxenham, Yolanda Savage and Navjot Kaw; Unichem Greenlane: Chris Wrapson and Danielle Stewart; Unichem Milford: Julie Earwaker; Westgate Pharmacy: Rav Singh; Unichem Apollo: Elisabeth Lubbe; Unichem Riccarton Clinic: Jim Sherborne, Chuck Varghese, Hayley Garvin, Nicholas Tee, Kelly Burgess and Shuyi Zhang; Unichem Levin: Malli Kotali and Ingrid Nickson; Bay Plaza Pharmacy Hastings: Peter Neal and Natasha Roughton; Life Pharmacy Howick: Leane Steele; Life Pharmacy Manukau: Kritika Singh; Wairau Pharmacy Blenheim: Joanna Topliss, Kayleigh Mackel, Claire Livingstone, Joy Birch, Marion Gray, Sally Rudie and Robyn Morrison; Life Pharmacy Chartwell: Glenn Summerville, Neville Puckley, Lorina Lu, Jenni Puckley and Shilpa Narain; Unichem Rotoruna: Jenny Wu, Shazeel Rauf, Angeline Day-Mesuré and Jordan Hinton; Ranolf Pharmacy Rotorua: Charlotte Schimanski and Carina Soeteman; Unichem Cherrywood: Rachelle Smith and Sam Appleford; Life Pharmacy Bayfair: Linda Southby; Mypharmacy Papamoa: Reece Olsen, Delphine Destrez, Michelle Speirs and Jordan Jeffray; Harley's Pharmacy Tahunanui: Violet Harley; McGlashen Pharmacy Nelson: Andrew McGlashen; Unichem Excelsa: Cassie Butler, Sonia Schwamm, Jacqui Brus and Alaina van Zyl; Life Pharmacy Matamata: Jess Ensor and Aidan Kortegast; South City Pharmacy Invercargill: Steve Jo, Eric Li, Jenna Ludlow and Zheng Li; Unichem Cashel Street: Brendon McIntosh and Annabel Turley; Countdown Ponsonby: Eddie See; Waitara Pharmacy: Margaret Helms, Ashley Cronin, Kelly Shearer, Leanne Herbert, Kadyn Lowe, Corry Bezems, Deb Laurence, Chantelle Kissick, Wendy Purkes, Sheryl Montgomerie, Fiona McLachlan, Amanda Barkley and Cathy Hight; Unichem Kaikohe: Alexander Graham, Jilly Alexander and Lara Blaikie; Davids Pharmacy Whangarei: David Postlewaight; Unichem Kerikeri: Vicki Douglas and Ingrid Reed; Life Pharmacy the Palms:Karen Chen, Malinda Ouk, Jan Green, Jackie Jamieson, Linda Herman, Debra Clutterback, Sultana Zannat, Sharon Sullivan and Lucy Armstrong; Orrs Unichem Ruakaka: Warren Greene; Orrs Unichem Tui: Donnie Yoh; Orrs Unichem Dargavaille: Marcus Liddle; Orrs Unichem Maungaturoto: Simerjeet Saini; Life Pharmacy Eastridge: Saif Al-Sheibani and Lisa Josephs; Andersons Pharmacy Dunedin: Bob Kim; Life Pharmacy Te Puke: Renee Belling, Deborah Ellison, Abbie Copinga and Julie Summers.