Cargando…

Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial

INTRODUCTION: The incidence of type 2 diabetes mellitus is increasing worldwide. The literature suggests that acupuncture is a possible complementary therapy for type 2 diabetes mellitus. This study aims to determine the effectiveness of acupuncture as an adjunctive therapy on homeostasis model asse...

Descripción completa

Detalles Bibliográficos
Autores principales: Cheok, Yean Chin, Mohd Shariff, Zalilah, Chan, Yoke Mun, Ng, Ooi Chuan, Lee, Ping Yein
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10511073/
https://www.ncbi.nlm.nih.gov/pubmed/37729132
http://dx.doi.org/10.1371/journal.pone.0284337
_version_ 1785108067987226624
author Cheok, Yean Chin
Mohd Shariff, Zalilah
Chan, Yoke Mun
Ng, Ooi Chuan
Lee, Ping Yein
author_facet Cheok, Yean Chin
Mohd Shariff, Zalilah
Chan, Yoke Mun
Ng, Ooi Chuan
Lee, Ping Yein
author_sort Cheok, Yean Chin
collection PubMed
description INTRODUCTION: The incidence of type 2 diabetes mellitus is increasing worldwide. The literature suggests that acupuncture is a possible complementary therapy for type 2 diabetes mellitus. This study aims to determine the effectiveness of acupuncture as an adjunctive therapy on homeostasis model assessment-insulin resistance (HOMA-IR), and health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This randomized, double-blind, placebo controlled, and parallel design trial will be carried out in a public university teaching hospitals in Malaysia. Eligible type 2 diabetes mellitus subjects will be randomly assigned to receive either acupuncture (n = 30) or a placebo (n = 30). The intervention is carried out using press needle or press placebo on abdomen area (10 sessions of treatment). Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of recruitment (-week 0), and after completion of 10 sessions (week 7) of the treatment. Additionally, secondary outcome of HRQoL will be measured at the time of recruitment (-week 0), after completion of 5 sessions (week 3/4), and 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit. DISCUSSION: The findings of this study will provide important clinical evidence for the effect of acupuncture as adjunctive therapy on HOMA-IR, adiposity and HRQoL of type 2 diabetes mellitus. TRIAL REGISTRATION NUMBER: NCT04829045.
format Online
Article
Text
id pubmed-10511073
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Public Library of Science
record_format MEDLINE/PubMed
spelling pubmed-105110732023-09-21 Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial Cheok, Yean Chin Mohd Shariff, Zalilah Chan, Yoke Mun Ng, Ooi Chuan Lee, Ping Yein PLoS One Study Protocol INTRODUCTION: The incidence of type 2 diabetes mellitus is increasing worldwide. The literature suggests that acupuncture is a possible complementary therapy for type 2 diabetes mellitus. This study aims to determine the effectiveness of acupuncture as an adjunctive therapy on homeostasis model assessment-insulin resistance (HOMA-IR), and health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This randomized, double-blind, placebo controlled, and parallel design trial will be carried out in a public university teaching hospitals in Malaysia. Eligible type 2 diabetes mellitus subjects will be randomly assigned to receive either acupuncture (n = 30) or a placebo (n = 30). The intervention is carried out using press needle or press placebo on abdomen area (10 sessions of treatment). Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of recruitment (-week 0), and after completion of 10 sessions (week 7) of the treatment. Additionally, secondary outcome of HRQoL will be measured at the time of recruitment (-week 0), after completion of 5 sessions (week 3/4), and 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit. DISCUSSION: The findings of this study will provide important clinical evidence for the effect of acupuncture as adjunctive therapy on HOMA-IR, adiposity and HRQoL of type 2 diabetes mellitus. TRIAL REGISTRATION NUMBER: NCT04829045. Public Library of Science 2023-09-20 /pmc/articles/PMC10511073/ /pubmed/37729132 http://dx.doi.org/10.1371/journal.pone.0284337 Text en © 2023 Cheok et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Study Protocol
Cheok, Yean Chin
Mohd Shariff, Zalilah
Chan, Yoke Mun
Ng, Ooi Chuan
Lee, Ping Yein
Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial
title Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial
title_full Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial
title_fullStr Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial
title_full_unstemmed Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial
title_short Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial
title_sort effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10511073/
https://www.ncbi.nlm.nih.gov/pubmed/37729132
http://dx.doi.org/10.1371/journal.pone.0284337
work_keys_str_mv AT cheokyeanchin effectivenessofacupunctureasadjunctivetherapyintype2diabeticstudyprotocolforarandomizedcontrolledtrial
AT mohdshariffzalilah effectivenessofacupunctureasadjunctivetherapyintype2diabeticstudyprotocolforarandomizedcontrolledtrial
AT chanyokemun effectivenessofacupunctureasadjunctivetherapyintype2diabeticstudyprotocolforarandomizedcontrolledtrial
AT ngooichuan effectivenessofacupunctureasadjunctivetherapyintype2diabeticstudyprotocolforarandomizedcontrolledtrial
AT leepingyein effectivenessofacupunctureasadjunctivetherapyintype2diabeticstudyprotocolforarandomizedcontrolledtrial