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  • BMJ  (3)
  • 1
    Online Resource
    Online Resource
    Moxibustion as adjuvant therapy for preventing bone loss in postmenopausal women: protocol for a randomised controlled trial
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 12 ( 2022-12), p. e062677-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 12 ( 2022-12), p. e062677-
    Abstract: Postmenopausal osteoporosis, caused by ageing and oestrogen deficiency, seriously threatens women’s physical and mental health. Postmenopausal osteopenia is the transition from healthy bone to osteoporosis, and it may be the key period for preventing bone loss. Moxibustion, a physical therapy of Traditional Chinese Medicine, has potential benefits for osteoporosis treatment and prevention, but it has not been adequately studied. This study aims to explore the clinical effects and safety of moxibustion in delaying bone loss in postmenopausal women. Methods and analysis In this parallel-design, randomised, patient-blind and assessor-blind, controlled clinical study, 150 women with osteopenia at low fracture risk will be randomly assigned to a moxibustion treatment (MT) group or a placebo-moxibustion control (PMC) group in a 1:1 ratio. In addition to the fundamental measures (vitamin D3 and calcium) as recommended by the guidelines, participants of the two groups will receive MT or PMC treatment for 42 sessions over 12 months. The primary outcome will be the bone mineral density (BMD) of the lumbar spine at the end of the 12-month treatment, and secondary outcomes will be the BMD of the femoral neck and total hip, T-scores, bone turnover markers, serum calcium levels, serum magnesium levels, serum phosphorus levels, serum parathyroid hormone levels and 25-hydroxyvitamin D levels, intensity of bone pain, quality of life, incidence of osteoporosis and fractures, usage of emergency drugs or surgery, participant self-evaluation of therapeutic effects and the rate of adverse events. All statistical analyses will be performed based on the intention-to-treat and per-protocol principle. Ethics and dissemination Ethics approval has been obtained from the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (permission number: 2021-1243). The results are expected to be published in peer-reviewed journals. Trial registration number ChiCTR2100053953.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2022-062677
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2599832-8
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  • 2
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    Efficacy of acupuncture treatment for chronic spontaneous urticaria: study protocol for a randomised controlled trial
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 2 ( 2022-02), p. e045027-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 2 ( 2022-02), p. e045027-
    Abstract: Chronic spontaneous urticaria (CSU) is a troublesome dermatological problem that can have a significant impact on quality of life. Previous studies have indicated that acupuncture may be beneficial for patients with CSU. However, well-designed studies determine the effects of acupuncture on CSU are rare. The aim of this study is to investigate the efficacy and safety of acupuncture treatment for patients with CSU. Methods and analysis This study is designed as a multicentre, parallel, three-arm, randomised, sham-controlled trial. A total of 330 patients diagnosed as CSU will be randomly allocated into three groups: the verum acupuncture group, the sham acupuncture group and the waiting-list control group in a 1:1:1 ratio. Patients in the verum and sham acupuncture groups will receive 16 treatment sessions over 4 weeks, while patients in the waiting-list control group will not receive any acupuncture treatment. The primary outcome is the changes of weekly urticaria activity scores at the end of treatment. Secondary outcomes include itching severity measurement, Dermatology Life Quality Index, Hamilton Depression Scale, Hamilton Anxiety Scale, Pittsburgh Sleep Quality Index and serum total IgE level. Adverse events will be recorded during the study observation period. All patients who are randomised in this study will be included in the intention-to-treat analysis. Ethics and dissemination Ethical approval of this study has been granted by the Sichuan Regional Ethics Review of Committee on Traditional Chinese Medicine (TCM) (ID: 2019 kl-006), the Medical Ethic Committee of the First Hospital of Wuhan (ID: (2019) number 7)) and the Medical Ethics Committee of the First Hospital of Hunan University of TCM (ID: HN-LLKY-2019-017-01/03) in three clinical centres in China, respectively. The results will be disseminated through peer-reviewed journals. Trial registration number ChiCTR1900022994.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-045027
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2599832-8
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  • 3
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    Acupuncture for patients with chronic pruritus: protocol of a systematic review and meta-analysis
    BMJ ; 2020
    In:  BMJ Open Vol. 10, No. 8 ( 2020-08), p. e034784-
    Details
    In: BMJ Open, BMJ, Vol. 10, No. 8 ( 2020-08), p. e034784-
    Abstract: Chronic pruritus (CP) frequently occurs in many skin and systemic diseases, and adversely affects quality of life. This systematic review aims to evaluate treatment effects of acupuncture on CP. Methods and analysis An electronic and manual search will be conducted for all acupuncture treatments for CP, from the inception date of predefined database up to 28 February 2020. Databases include PubMed, Embase, Springer, Web of Science, the Cochrane Library, the World Health Organization International Clinical Trial Registration Platform, the Chinese Medicine Database, the China National Knowledge Infrastructure, the Chinese Biomedical Literature Database, the China Science Journal Database and the Wanfang Database. Other sources, including existing systematic reviews, conference proceedings and reference lists of identified publications will also be searched. Additionally, any clinical randomised controlled trials related to acupuncture treatment for CP, regardless of the publication status and language limitations, will be included. Study selection, data extraction and research quality assessments will be conducted independently by two researchers. The primary outcome measures include the Visual Analogue Scale, Urdu 5D-Itch Scale or other validated scales implemented after at least 2 weeks of treatment. Secondary outcomes include the effective rate, Quality of Life Scale (eg, the EQ-5D third level, the Dermatology Life Quality Index, etc.), Pittsburgh Sleep Quality Index, recurrence rate during the follow-up period and adverse events. If possible, meta-analyses will be performed using RevMan V.5.3 statistical software; otherwise, a descriptive analysis or subgroup analysis will be conducted. The results will be presented as the risk ratio of the binary data and the mean difference (MD) or standardised MD of the continuous data. Ethics and dissemination This systematic review protocol does not require formal ethical approval because the data are not personalised. It will be published in peer-reviewed journals and presented at international academic conferences. PROSPERO registration number CRD42019136727.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2019-034784
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2599832-8
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    Online Resource
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