Dataset Information

Acupuncture for retinitis pigmentosa: study protocol for a randomised, sham-controlled trial.

ABSTRACT: Primary retinitis pigmentosa (RP) is a common hereditary retinal disease in ophthalmology that has a considerable impact on quality of life, but there are few effective therapeutic strategies. This trial aims to determine the efficacy and safety of acupuncture versus sham acupuncture (SA) for RP. This is a study protocol for a randomised, participant-blind, sham-controlled trial. 64 eligible patients with RP will randomly be divided into acupuncture group and SA group. All groups will receive 48 sessions over 3 months. Participants will complete the trial by visiting the research centre in month 6/9 for a follow-up assessment. The primary outcome is visual field mean sensitivity and visual field mean deviation at month 3/6/9 compared with baseline. Secondary outcomes include the best-corrected visual acuity, central macular thickness, subfoveal choroidal thicknes, traditional Chinese medicine syndrome score and the scale of life quality for diseases with visual impairment at month 3/6/9 compared with baseline. Adverse events and safety indexes will be recorded throughout the study. SPSS V.25.0 statistical software was used for analysis, and measurement data were expressed as mean±SD. Ethics approval was obtained from the Ethics Committee of the Chinese Clinical Trial Registry (approval no: ChiECRCT20200460). The results of this study will be published in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls. ChiCTR2000041090.

SUBMITTER: Huang H

PROVIDER: S-EPMC8593745 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundOsteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have side effects. Acupuncture is widely used for treating osteoporotic postmenopausal women because it is non-invasive and has fewer side effects, but the powerful clinical evidence for its efficacy remains insufficient. Our study intends to explore the effect of overall adjustment acupuncture (OA) in the treatment of postmenopausal osteoporosis (PMOP).Methods/designThis study is a randomized, sham-controlled, patient- and assessor-blinded trial and aims to evaluate the effect of OA in women with PMOP. We will recruit 104 women aged 45-70 years with a diagnosis of PMOP. Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group. Both groups will receive real herbal medicine treatment as a basic treatment twice a day for 3 months, the OA group receives real acupuncture treatment and the SA group receives placebo acupuncture treatment (non-penetrating, sham skin-needle therapy, sham cupping). All patients will receive acupuncture treatment twice per week for 3 months. The primary outcome is bone mineral density (BMD) and the secondary outcomes include estradiol (E2), follicle-stimulating hormone (FSH), bone gla protein (BGP), bone alkaline phosphatase (BALP), total antioxidant capacity (TAC), advanced oxidation protein products (AOPP), PPARγ, β-catenin, FoxO3a levels, visual analog pain scale score (VAS), Traditional Chinese medicine (TCM) syndrome scores and quality of daily life score (QOL). Outcome measures will be collected at baseline, middle of the treatment (1.5 months), the end of treatment (3 months). The present protocol followed the SPIRIT guidelines and fulfills the SPIRIT Checklist.ConclusionThis study will be conducted to compare the efficacy of OA versus SA. This trial should help to evaluate whether OA can effectively prevent and treat PMOP by improving the estrogen levels of postmenopausal women. The mechanism is to improve the imbalance of osteogenic differentiation and lipogenesis of bone-marrow cells under oxidative stress.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR1800017581. Registered on 5 August 2018. URL: http://www.chictr.org.cn.

Dataset Information

Acupuncture for retinitis pigmentosa: study protocol for a randomised, sham-controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets