Efficacy and safety of acupuncture for postpartum hypogalactia: Protocol for a systematic review and meta-analysis

ABSTRACT

Breast milk is recognised as the best natural food for neonates; however, many women experience postpartum hypogalactia (PH). The available treatments for PH are limited in clinical settings, and acupuncture is a valid alternative treatment for PH, as proven by randomised trials. However, systematic reviews demonstrating the safety and efficacy of acupuncture for PH are still lacking; therefore, this systematic review aims to evaluate the efficacy and safety of acupuncture for PH.

Methods and analysis Eight English (PubMed, Cochrane Library, MEDLINE, EMBASE, EBSCO, Scopus, Ovid, Web of Science) and four Chinese databases (China National Knowledge Infrastructure, Wan-Fang, Chinese Biomedical Literature, Chinese Scientific Journal) will be systematically searched from their establishment to 1 September 2022. Randomised controlled trials (RCTs) of the efficacy of acupuncture for PH will be reviewed. The study selection, data extraction, and research quality evaluation will be conducted independently by two reviewers. The primary outcome is the change in serum prolactin (PRL) level from baseline to the end of treatment. Secondary results include milk secretion volume, total effectiveness rate, degree of mammary fullness, rate of exclusive breastfeeding, infant weight gain, and adverse events. A meta-analysis will be performed using RevMan V.5.4 statistical software. Otherwise, a descriptive analysis will be conducted. The risk of bias will be assessed using the revised Cochrane risk-of-bias tool.

Ethics and dissemination This systematic review protocol does not require ethical approval because it does not include private information/data of the participants. This article will be published in peer-reviewed journals.

PROSPERO registration number CRD42022351849

Strengths and limitations of this study

This study will be the first systematic review to evaluate the efficacy and safety of acupuncture for PH by including available clinical trials that have been published in the past.

The quality of the included trials will be assessed using the Revised Cochrane Risk of Bias Tool for Randomised Trials (ROB2).

This study will provide more reliable evidence for clinical management because most RCTs on acupuncture for PH have small sample sizes.

This study will include only English and Chinese trials, which may lead to missing studies in other languages.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study was funded by the Yunnan Province Ten Thousand Plan Industrial Technology Leading Talents Funding Project (NO.YNWR-CYJS-2019-036), Yunnan Medical Leading Talents Training Program (NO.L-201619), and State Administration of Traditional Chinese Medicine.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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