A Comparative Study on the Effects of “Honey and Fenugreek” with “Fenugreek” on the Breastfeeding Success: A Randomized Trial

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Abstract

Objective

Herbal galactagogues are usually recommended to be sweetened with honey. Despite the high nutritious value of honey for lactating women and extensive studies on the effects of herbal galactagogues, no investigation was made to compare galactagogue effects of using herbal galactagogues with and without honey so far. The present study aimed to compare the effect of a combination of “honey and fenugreek” with “fenugreek” on breastfeeding success (BFS).

Methods

This study is a triple-blind randomized clinical trial on 75 breastfeeding mothers referred to a Tehran-Iran health center. The participants were randomly divided into two intervention (fenugreek and honey users) and control (fenugreek users) groups. These women had infants of 1–5 months and had exclusive breastfeeding practice. Tools for data collection were (1) the personal and maternal-infant information, (2) the breastfeeding success, and (3) the complications questionnaires. Participants received 30 liquid drops, three times daily for four weeks. The BFS questionnaire was completed twice, before and 4 weeks after the intervention. The CONSORT checklist was followed.

Results

Before and after comparison showed no significant difference in the BFS score in the “fenugreek” group, while there was a significant increase in the BFS score in the “honey and fenugreek” group ( P=0.035). Between groups, comparison demonstrated a significantly higher score of BFS in the intervention group than in the control group ( P=0.023). There were no significant differences between the two groups regarding the possible complications.

Conclusion

The combination of honey with fenugreek showed a significant effect on BFS, while there was no improvement in BFS after fenugreek only uses. Trial registration: the study was approved in the Iranian registry of clinical trials with IRCT ID: IRCT20120122008801N23 on 2019-12-30 ( https://www.irct.ir/).

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Most cited references 51

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Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect.

Cesar Victora, Rajiv Bahl, Aluísio Barros … (2016)

The importance of breastfeeding in low-income and middle-income countries is well recognised, but less consensus exists about its importance in high-income countries. In low-income and middle-income countries, only 37% of children younger than 6 months of age are exclusively breastfed. With few exceptions, breastfeeding duration is shorter in high-income countries than in those that are resource-poor. Our meta-analyses indicate protection against child infections and malocclusion, increases in intelligence, and probable reductions in overweight and diabetes. We did not find associations with allergic disorders such as asthma or with blood pressure or cholesterol, and we noted an increase in tooth decay with longer periods of breastfeeding. For nursing women, breastfeeding gave protection against breast cancer and it improved birth spacing, and it might also protect against ovarian cancer and type 2 diabetes. The scaling up of breastfeeding to a near universal level could prevent 823,000 annual deaths in children younger than 5 years and 20,000 annual deaths from breast cancer. Recent epidemiological and biological findings from during the past decade expand on the known benefits of breastfeeding for women and children, whether they are rich or poor.

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A QUANTITATIVE APPROACH TO CONTENT VALIDITY

C. H. LAWSHE (1975)

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Is Open Access

Sample Size Estimation in Clinical Trial

Tushar Vijay Sakpal (2010)

Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and also to understand the effects of sample size over- estimation or under-estimation on outcome of a trial. Also an attempt is made to understand importance of minimum sample to detect a clinically important difference. This article is also an attempt to provide inputs on different parameters that impact sample size and basic rules for these parameters with the help of some simple examples.

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Author and article information

Contributors

Soheila Nazarpour:

ORCID: https://orcid.org/0000-0002-4232-6020

Journal

Journal ID (nlm-ta): Evid Based Complement Alternat Med

Journal ID (iso-abbrev): Evid Based Complement Alternat Med

Journal ID (publisher-id): ECAM

Title: Evidence-based Complementary and Alternative Medicine : eCAM

Publisher: Hindawi

ISSN (Print): 1741-427X

ISSN (Electronic): 1741-4288

Publication date Collection: 2022

Publication date (Electronic): 23 June 2022

Publication date PMC-release: 23 June 2022

Volume: 2022

Electronic Location Identifier: 6048280

Affiliations

¹Midwifery and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

²Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran

³Department of Midwifery, Chalous Branch, Islamic Azad University, Chalous, Iran

⁴Department of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran

⁵North Health Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

⁶Department of Biostatistics, School of Paramedicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Author notes

Academic Editor: Kok-Yong Chin

Author information

Masoumeh Simbar https://orcid.org/0000-0003-2843-3150

Soheila Nazarpour https://orcid.org/0000-0002-4232-6020

Faraz Mojab https://orcid.org/0000-0003-2415-2175

Farahnaz Kholosi Badr https://orcid.org/0000-0003-0590-9056

Mobina Khorrami https://orcid.org/0000-0003-4879-632X

Zahra Jafari Torkamani https://orcid.org/0000-0002-2956-6652

Hamid Alavi-Majd https://orcid.org/0000-0001-7772-2923

Article

DOI: 10.1155/2022/6048280

PMC ID: 9246572

SO-VID: 42b3b283-e4ab-4687-b5a0-ad7841727c5f

License:

This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 26 December 2021

Date revision received : 8 May 2022

Date accepted : 3 June 2022

Funding

Funded by: Shahid Beheshti University

Funded by: Shahid Beheshti University of Medical Sciences

A Comparative Study on the Effects of “Honey and Fenugreek” with “Fenugreek” on the Breastfeeding Success: A Randomized Trial

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Abstract

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The International Journal of Person Centered Medicine

Most cited references 51

Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect.

A QUANTITATIVE APPROACH TO CONTENT VALIDITY

Sample Size Estimation in Clinical Trial

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