Baseline status regarding compliance with neo-BFHI recommendations in South African neonatal wards: a cross-sectional survey.

BACKGROUND: In 2009, the World Health Organization and the United Nations Children's Fund issued a revised Baby-friendly Hospital Initiative (BFHI) package to encourage all healthcare facilities to promote the advice of exclusive breastfeeding. The scope of the BFHI was expanded to include neonatal units by the Nordic and Quebec Working Group. AIM: To determine the level of compliance with the recommendations outlined in the "Baby-friendly Hospital Initiative for neonatal wards" (Neo-BFHI) in the South African neonatal wards. METHOD: In this cross-sectional survey, the sample included neonatal wards (N = 33) from public and private hospital facilities. Using EasyTrial software, the Neo-BFHI self-assessment questionnaire was utilized to collect the data. The data was transferred to MS Excel (version 15.0.5127.1000) and analysed with the Statistical Package for Social Sciences version 24. RESULTS: The South African median score for Neo-BFHI compliance was 77. Neonatal wards in public hospitals scored higher (85) than those in private hospitals (73). Neonatal wards in hospitals that were accredited Baby-friendly had higher compliance scores than those without accreditation. The country had the highest compliance scores (100, 90) on Guiding Principle 1 (respect towards mothers) and step 5 (breastfeeding support), respectively. However, it scored low (71, 58) on steps 4 (enhancing kangaroo mother care) and 7 (maternal infant "togetherness"), respectively. Level 1 and 2 care facilities scored significantly higher than level 3. CONCLUSION: Although South Africa successfully implemented the Neo-BFHI recommendations, private hospitals had a smaller number of BFHI-accredited facilities and lower compliance than public hospitals. Strategies should be developed to strengthen and improve BFHI accreditation and compliance, particularly in private hospitals.

Breastfeeding and human milk in the NICU: From birth to discharge.

It is well recognized that human milk is the optimal nutritive source for all infants, including those requiring intensive care. This statement reviews evidence supporting the importance of breastfeeding and human milk for infants, and why breastfeeding practices should be prioritized in the neonatal intensive care unit (NICU). It also reviews how to optimally feed infants based on their stability and maturity, and how to support mothers to establish and maintain milk production when their infants are unable to feed at the breast.

Breastfeeding practices in neonatal wards in Spain. Neo-BFHI international survey.

INTRODUCTION: In 2017, a worldwide survey was conducted on compliance with the practices promoted by Neo-BFHI (Baby-friendly Hospital Initiative expansion to neonatal wards). OBJECTIVE: To present the results of the Spanish wards that participated in the global survey and compare them with those obtained internationally. MATERIAL AND METHODS: Cross-sectional study through a survey on compliance with the Neo-BFHI ("Three basic principles", "Ten steps adapted to neonatal wards" and "the compliance with the International Code of Marketing of Breast-milk Substitutes" and subsequent relevant World Health Assembly resolutions). Compliance was calculated as the mean in each indicator and a final mean score for each neonatal unit. For the partial and final scores for each country and at the international level, the median was used. All scores ranged between 0 and 100. RESULTS: The response rate in Spain was 90%. The range of the national mean for neonatal wards were from 37 to 99, with no differences in the final score according to the level of care. The global score for Spain (72) is below the international median (77) and this also occurs in 8 of 14 items. The neonatal wards from BFHI designated hospitals, obtained a significantly higher mean global score, and in 9 of 14 items than the non-accredited ones. CONCLUSIONS: Both international and national results indicate an improvement in breast feeding practices in neonatal units. The benefits of the BFHI accreditation of maternity reach neonatal wards. Spain has several key points below the international score.

The Baby-friendly Hospital Initiative for neonatal wards. A mini review.

The Baby-friendly Hospital Initiative for Neonatal Wards (Neo-BFHI) is an expansion of the WHO/UNICEF Ten Steps to Successful Breastfeeding to address the needs of infants and families in all levels of neonatal care. The Neo-BFHI includes Three Guiding Principles as basic tenets, Ten Steps to protect, promote and support breastfeeding closely following the original Baby-friendly Hospital Initiative, and adherence to the International Code of Marketing of Breast-milk Substitutes. In 2020, the WHO/UNICEF published recommendations for breastfeeding small, sick and preterm newborns that aligns with the Neo-BFHI. Conclusion: This mini review provides a brief description of the content in the Neo-BFHI.

Baby-Friendly Hospital Initiative for Neonatal Wards: impact on breastfeeding practices among preterm infants.

OBJECTIVE: to assess breastfeeding support practices for preterm infants at two Baby-Friendly hospitals in southeastern Brazil, comparing the effect of implementing the guidelines for Baby-Friendly Hospital Initiative for Neonatal wards. METHODS: a quasi-experimental study, pre- and post-intervention with control. Implementation of this initiative in the intervention hospital using Knowledge Translation. Data collection on compliance with the adapted Ten Steps, Three Guiding Principles and the Code before and after the intervention was carried out via interviews with mothers of preterm babies and professionals, unit observation and documentary analysis in the intervention and control hospitals. Intra-intergroup comparison was performed. RESULTS: increases in global compliance with the Three Principles, Ten Steps, the Code, partial compliance with each Principle and in most Steps was greater in the intervention hospital. Conclusion: this initiative improved practices related to breastfeeding in the intervention hospital, demonstrating the potential to improve care and breastfeeding in neonatal wards.

[Breastfeeding practices in neonatal wards in Spain. Neo-BFHI international survey]. / Prácticas de lactancia materna en las unidades neonatales de España. Encuesta internacional Neo-IHAN.

INTRODUCTION: In 2017, a worldwide survey was conducted on compliance with the practices promoted by Neo-BFHI (Baby-friendly Hospital Initiative expansion to neonatal wards). OBJECTIVE: Present the results of the Spanish wards that participated in the global survey and compare them with those obtained internationally. MATERIAL AND METHODS: Cross-sectional study through a survey on compliance with the Neo-BFHI ("Three basic principles", "Ten steps adapted to neonatal wards" and "the compliance with the International Code of Marketing of Breast-milk Substitutes" and subsequent relevant World Health Assembly resolutions). Compliance was calculated as the mean in each indicator and a final mean score for each neonatal unit. For the partial and final scores for each country and at the international level, the median was used. All score ranged between 0 and 100. RESULTS: The response rate in Spain was 90%. The range of the national mean for neonatal wards were from 37 to 99, with no differences in the final score according to the level of care. The global score for Spain (72) is below the international median (77) and this also occurs in 8 of 14 items. The neonatal wards from BFHI designated hospitals, obtained a significantly higher mean global score, and in 9 of 14 items than the non-accredited ones. CONCLUSIONS: Both international and national results indicate an improvement in breastfeeding practices in neonatal units. The benefits of the BFHI accreditation of maternity reach neonatal wards. Spain has several key points below the international score.

Compliance With the "Baby-Friendly Hospital Initiative for Neonatal Wards" in Russian Hospitals.

BACKGROUND: The expansion of the Baby-Friendly Hospital Initiative to neonatal wards, known as the Neo-BFHI, provides recommendations to support breastfeeding, as outlined in the Three Guiding Principles, the expanded Ten Steps, and the International Code for Marketing of Breast-Milk Substitutes. In 2017, Russia participated in an international survey about compliance with the Neo-BFHI. RESEARCH AIM: To assess breastfeeding support policies and practices in Russian neonatal wards at the country and federal district level in accordance with the Neo-BFHI recommendations. METHODS: This study was a prospective cross-sectional survey. We used the Neo-BFHI Self-Assessment questionnaire to collect data from neonatal wards that had all levels of care. A total of N = 60 Russian neonatal wards in hospitals that have ever been designated Baby-Friendly or planned to do so participated in the survey. RESULTS: Compliance scores at the federal district and country level ranging from 0-100 were used to summarize results. The median country overall score was 90 (IQR = 83 - 93). Respect for mothers, continuity of care, having a breastfeeding policy, and rooming-in had the highest median scores. Family-centered care, antenatal informing, skin-to-skin contact, and human milk use had the lowest median scores. Neonatal wards in the hospitals that were ever designated as Baby-Friendly had significantly higher scores than those that were never designated. Most respondents (n = 48, 80%) expressed a desire to obtain Neo-BFHI designation in their neonatal wards. CONCLUSION: Neo-BFHI recommendations can be successfully implemented in Russian neonatal wards at hospitals designated Baby-Friendly or planning to be designated.

Shared decision-making for infant feeding and care during the coronavirus disease 2019 pandemic.

Despite decades of research establishing the importance of breastfeeding, skin-to-skin contact and mother-infant closeness, the response to the coronavirus disease 2019 (COVID-19) pandemic has underscored the hidden assumption that these practices can be dispensed with no consequences to mother or child. This article aims to support shared decision-making process for infant feeding and care with parents and health care providers during the unprecedented times of the pandemic. It proposes a structure and rationale to guide the process that includes (1) discussing with parents evidence-based information and the different options to feed and care for an infant and young child in the context of the pandemic as well as their potential benefits, risks and scientific uncertainties; (2) helping parents to recognize the sensitive nature of the decisions and to clarify the value they place on the different options to feed and care for their infant or young child; and (3) providing guidance and support needed to make and implement their decisions. A shared decision-making process will help parents navigate complex feeding and care decisions for their child as we face the different stages of the COVID-19 pandemic.

Baby-Friendly Hospital Initiative for Neonatal Wards: impact on breastfeeding practices among preterm infants / Iniciativa Hospital Amigo del Niño para Unidades Neonatales: impacto en las prácticas de lactancia materna en prematuros / Iniciativa Hospital Amigo da Criança para Unidades Neonatais: impacto nas práticas do aleitamento em prematuros

ABSTRACT Objective: to assess breastfeeding support practices for preterm infants at two Baby-Friendly hospitals in southeastern Brazil, comparing the effect of implementing the guidelines for Baby-Friendly Hospital Initiative for Neonatal wards. Methods: a quasi-experimental study, pre- and post-intervention with control. Implementation of this initiative in the intervention hospital using Knowledge Translation. Data collection on compliance with the adapted Ten Steps, Three Guiding Principles and the Code before and after the intervention was carried out via interviews with mothers of preterm babies and professionals, unit observation and documentary analysis in the intervention and control hospitals. Intra-intergroup comparison was performed. Results: increases in global compliance with the Three Principles, Ten Steps, the Code, partial compliance with each Principle and in most Steps was greater in the intervention hospital. Conclusion: this initiative improved practices related to breastfeeding in the intervention hospital, demonstrating the potential to improve care and breastfeeding in neonatal wards.

RESUMEN Objetivo: evaluar las prácticas de atención de la lactancia materna en prematuros en dos hospitales Amigo del Niño en el sureste de Brasil, comparando el efecto de la implementación de los lineamientos de la Iniciativa de Hospitales Amigos del Niño para Unidades Neonatales. Métodos: estudio cuasi-experimental, pre y post intervención con grupo control. Implementación de esta iniciativa en el hospital de intervención mediante la traducción del conocimiento. Recolección de adherencia a los Diez Pasos Adaptados, Tres Principios Rectores y Código antes y después de la intervención realizada mediante entrevistas a madres de prematuros y profesionales, observación de las unidades y análisis documentario en los hospitales de intervención y control. Se realizó una comparación intra e intergrupal. Resultados: el aumento en la adherencia global a los Tres Principios, Diez Pasos y el Código asi como la adherencia parcial a cada Principio y en la mayoría de los Pasos fue mayor en el hospital de intervención que en el control. Conclusión: esta iniciativa mejoró las prácticas relacionadas con la lactancia materna en el hospital de intervención, demostrando el potencial para mejorar la atención y la lactancia materna en las Unidades Neonatales.

RESUMO Objetivo: avaliar as práticas assistenciais do aleitamento materno em prematuros de dois hospitais Amigo da Criança do sudeste brasileiro, comparando o efeito da implementação das diretrizes da Iniciativa Hospital Amigo da Criança para Unidades Neonatais. Métodos: estudo quase-experimental, pré e pós-intervenção com controle. Implementação dessa Iniciativa no hospital intervenção com uso da Knowledge Translation. Coleta da adesão aos Dez Passos adaptados, Três Princípios Norteadores e Código antes e após a intervenção realizadas por entrevistas com mães de prematuros e profissionais, observação das unidades e análise documental nos hospitais intervenção e controle. Realizou-se comparação intra-intergrupos. Resultados: o aumento da adesão global aos Três Princípios e Dez Passos, Código, adesão parcial em cada Princípio e na maioria dos Passos foi maior no hospital intervenção que no controle. Conclusão: essa Iniciativa aprimorou as práticas relacionadas ao aleitamento materno no hospital intervenção, demonstrando potencial em aprimorar a assistência e a amamentação nas Unidades Neonatais.

Baby-Friendly Hospital Initiative for Neonatal Wards: impact on breastfeeding practices among preterm infants / Iniciativa Hospital Amigo del Niño para Unidades Neonatales: impacto en las prácticas de lactancia materna en prematuros / Iniciativa Hospital Amigo da Criança para Unidades Neonatais: impacto nas práticas do aleitamento em prematuros

ABSTRACT Objective: to assess breastfeeding support practices for preterm infants at two Baby-Friendly hospitals in southeastern Brazil, comparing the effect of implementing the guidelines for Baby-Friendly Hospital Initiative for Neonatal wards. Methods: a quasi-experimental study, pre- and post-intervention with control. Implementation of this initiative in the intervention hospital using Knowledge Translation. Data collection on compliance with the adapted Ten Steps, Three Guiding Principles and the Code before and after the intervention was carried out via interviews with mothers of preterm babies and professionals, unit observation and documentary analysis in the intervention and control hospitals. Intra-intergroup comparison was performed. Results: increases in global compliance with the Three Principles, Ten Steps, the Code, partial compliance with each Principle and in most Steps was greater in the intervention hospital. Conclusion: this initiative improved practices related to breastfeeding in the intervention hospital, demonstrating the potential to improve care and breastfeeding in neonatal wards.

RESUMEN Objetivo: evaluar las prácticas de atención de la lactancia materna en prematuros en dos hospitales Amigo del Niño en el sureste de Brasil, comparando el efecto de la implementación de los lineamientos de la Iniciativa de Hospitales Amigos del Niño para Unidades Neonatales. Métodos: estudio cuasi-experimental, pre y post intervención con grupo control. Implementación de esta iniciativa en el hospital de intervención mediante la traducción del conocimiento. Recolección de adherencia a los Diez Pasos Adaptados, Tres Principios Rectores y Código antes y después de la intervención realizada mediante entrevistas a madres de prematuros y profesionales, observación de las unidades y análisis documentario en los hospitales de intervención y control. Se realizó una comparación intra e intergrupal. Resultados: el aumento en la adherencia global a los Tres Principios, Diez Pasos y el Código asi como la adherencia parcial a cada Principio y en la mayoría de los Pasos fue mayor en el hospital de intervención que en el control. Conclusión: esta iniciativa mejoró las prácticas relacionadas con la lactancia materna en el hospital de intervención, demostrando el potencial para mejorar la atención y la lactancia materna en las Unidades Neonatales.

RESUMO Objetivo: avaliar as práticas assistenciais do aleitamento materno em prematuros de dois hospitais Amigo da Criança do sudeste brasileiro, comparando o efeito da implementação das diretrizes da Iniciativa Hospital Amigo da Criança para Unidades Neonatais. Métodos: estudo quase-experimental, pré e pós-intervenção com controle. Implementação dessa Iniciativa no hospital intervenção com uso da Knowledge Translation. Coleta da adesão aos Dez Passos adaptados, Três Princípios Norteadores e Código antes e após a intervenção realizadas por entrevistas com mães de prematuros e profissionais, observação das unidades e análise documental nos hospitais intervenção e controle. Realizou-se comparação intra-intergrupos. Resultados: o aumento da adesão global aos Três Princípios e Dez Passos, Código, adesão parcial em cada Princípio e na maioria dos Passos foi maior no hospital intervenção que no controle. Conclusão: essa Iniciativa aprimorou as práticas relacionadas ao aleitamento materno no hospital intervenção, demonstrando potencial em aprimorar a assistência e a amamentação nas Unidades Neonatais.

Compliance with the "Baby-friendly Hospital Initiative for Neonatal Wards" in 36 countries.

In 2012, the Baby-friendly Hospital Initiative for Neonatal Wards (Neo-BFHI) began providing recommendations to improve breastfeeding support for preterm and ill infants. This cross-sectional survey aimed to measure compliance on a global level with the Neo-BFHI's expanded Ten Steps to successful breastfeeding and three Guiding Principles in neonatal wards. In 2017, the Neo-BFHI Self-Assessment questionnaire was used in 15 languages to collect data from neonatal wards of all levels of care. Answers were summarized into compliance scores ranging from 0 to 100 at the ward, country, and international levels. A total of 917 neonatal wards from 36 low-, middle-, and high-income countries from all continents participated. The median international overall score was 77, and median country overall scores ranged from 52 to 91. Guiding Principle 1 (respect for mothers), Step 5 (breastfeeding initiation and support), and Step 6 (human milk use) had the highest scores, 100, 88, and 88, respectively. Step 3 (antenatal information) and Step 7 (rooming-in) had the lowest scores, 63 and 67, respectively. High-income countries had significantly higher scores for Guiding Principles 2 (family-centered care), Step 4 (skin-to-skin contact), and Step 5. Neonatal wards in hospitals ever-designated Baby-friendly had significantly higher scores than those never designated. Sixty percent of managers stated they would like to obtain Neo-BFHI designation. Currently, Neo-BFHI recommendations are partly implemented in many countries. The high number of participating wards indicates international readiness to expand Baby-friendly standards to neonatal settings. Hospitals and governments should increase their efforts to better support breastfeeding in neonatal wards.

Expansion of the baby-friendly hospital initiative ten steps to successful breastfeeding into neonatal intensive care: expert group recommendations.

In the World Health Organization/United Nations Children's Fund document Baby-Friendly Hospital Initiative: Revised, Updated and Expanded for Integrated Care, neonatal care is mentioned as 1 area that would benefit from expansion of the original Ten Steps to Successful Breastfeeding. The different situations faced by preterm and sick infants and their mothers, compared to healthy infants and their mothers, necessitate a specific breastfeeding policy for neonatal intensive care and require that health care professionals have knowledge and skills in lactation and breastfeeding support, including provision of antenatal information, that are specific to neonatal care. Facilitation of early, continuous, and prolonged skin-to-skin contact (kangaroo mother care), early initiation of breastfeeding, and mothers' access to breastfeeding support during the infants' whole hospital stay are important. Mother's own milk or donor milk (when available) is the optimal nutrition. Efforts should be made to minimize parent-infant separation and facilitate parents' unrestricted presence with their infants. The initiation and continuation of breastfeeding should be guided only by infant competence and stability, using a semi-demand feeding regimen during the transition to exclusive breastfeeding. Pacifiers are appropriate during tube-feeding, for pain relief, and for calming infants. Nipple shields can be used for facilitating establishment of breastfeeding, but only after qualified support and attempts at the breast. Alternatives to bottles should be used until breastfeeding is well established. The discharge program should include adequate preparation of parents, information about access to lactation and breastfeeding support, both professional and peer support, and a plan for continued follow-up.

Compliance with Baby-Friendly policies and practices in hospitals and community health centers in Quebec.

BACKGROUND: Since 2001, Quebec's ministry of health and social services has prioritized implementation of the Baby-Friendly Initiative (BFI), which includes the original hospital initiative and its expansion to community services. OBJECTIVE: The objective was to document across the province compliance with the BFI's Ten Steps to Successful Breastfeeding in hospitals, Seven Point Plan in community health centers (CHCs), and International Code of Marketing of Breast-Milk Substitutes (Code). METHODS: Using managers/staff, mothers, and observers, the author measured the extent of implementation of indicators formulated for each step/point and the Code, based on the revised WHO/UNICEF recommendations. RESULTS: Mean compliance scores in Quebec were 3.13 for 140 CHCs (range, 0 to 7) and 4.54 for 60 hospitals/birthing centers (range, 0 to 10). The mean compliance score for the Code was 0.69 for both CHCs and hospitals/birthing centers. The evaluation documented marked variations in implementation level for each of the steps/points and the Code. Also, managers/staff, mothers, and observers differed in their report of BFI compliance for most steps/points and the Code. Facilities that had applied for or obtained BFI designation demonstrated higher compliance with the BFI than those that had not. CONCLUSIONS: Results disseminated to participating organizations allowed comparisons on a regional/provincial perspective and in relation to BFI-designated facilities. Furthermore, this first portrait of BFI compliance in Quebec provided provincial, regional, and local health authorities with valuable information that can be used to bring about policy and organizational changes to achieve the international standards required for Baby-Friendly certification.

Expansion of the ten steps to successful breastfeeding into neonatal intensive care: expert group recommendations for three guiding principles.

The World Health Organization/United Nations Children's Fund Baby-Friendly Hospital Initiative: Revised, Updated, and Expanded for Integrated Care (2009) identifies the need for expanding the guidelines originally developed for maternity units to include neonatal intensive care. For this purpose, an expert group from the Nordic countries and Quebec, Canada, prepared a draft proposal, which was discussed at an international workshop in Uppsala, Sweden, in September 2011. The expert group suggests the addition of 3 "Guiding Principles" to the Ten Steps to support this vulnerable population of mothers and infants: 1. The staff attitude to the mother must focus on the individual mother and her situation. 2. The facility must provide family-centered care, supported by the environment. 3. The health care system must ensure continuity of care, that is, continuity of pre-, peri-, and postnatal care and post-discharge care. The goal of the expert group is to create a final document, the Baby Friendly Hospital Initiative for Neonatal Units, including standards and criteria for each of the 3 Guiding Principles, Ten Steps, and the Code; to develop tools for self-appraisal and monitoring compliance with the guidelines; and for external assessment to decide whether neonatal intensive/intermediate care units meet the conditions required to be designated as Baby-Friendly. The documents will be finalized after consultation with the World Health Organization/United Nations Children's Fund, and the goal is to offer these documents to international health care, professional, and other nongovernmental organizations involved in lactation and breastfeeding support for mothers of infants who require special neonatal care.

Measuring compliance with the Baby-Friendly Hospital Initiative.

OBJECTIVE: The WHO/UNICEF Baby-Friendly Hospital Initiative (BFHI) is an effective strategy to increase breast-feeding exclusivity and duration but many countries have been slow to implement it. The present paper describes the development of a computer-based instrument that measures policies and practices outlined in the BFHI. DESIGN: The tool uses clinical staff/managers' and pregnant women/mothers' opinions as well as maternity unit observations to assess compliance with the BFHI's Ten Steps to Successful Breastfeeding (Ten Steps) and the International Code of Marketing of Breastmilk Substitutes (Code) by measuring the extent of implementation of two to fourteen indicators for each step and the Code. Composite scores are used to summarize results. SETTING: Examples of results from a 2007 assessment performed in nine hospitals in the province of Québec are presented to illustrate the type of information returned to individual hospitals and health authorities. SUBJECTS: Participants included nine to fifteen staff/managers per hospital randomly selected among those present during the interviewer-observer's 12 h hospital visit and nine to forty-five breast-feeding mothers per hospital telephoned at home after being randomly selected from birth certificates. RESULTS: The Ten Steps Global Compliance Score for the nine hospitals varied between 2.87 and 6.51 (range 0-10, mean 5.06) whereas the Code Global Compliance Score varied between 0.58 and 1 (range 0-1, mean 0.83). Instrument development, examples of assessment results and potential applications are discussed. CONCLUSIONS: A methodology to measure BFHI compliance may help support the implementation of this effective intervention and contribute to improved maternal and child health.

Understanding breastfeeding behavior: rates and shifts in patterns in Québec.

The study objective was to measure breastfeeding rates and patterns in the Montérégie region of Québec. A survey of 632 mothers of 6-month-old infants was performed, of which 80% initiated breastfeeding, and 68% exclusively breastfed at birth. Breastfeeding rates progressively decreased with time: 63%, 56%, 51%, 44%, 39%, and 32% of mothers breastfed at 1, 2, 3, 4, 5, and 6 months, respectively. Among mothers breastfeeding at a given period, 62%, 57%, 48%, 35%, and 10% of women exclusively breastfed since birth for 1, 2, 3, 4, and 5 months, respectively. Exclusive breastfeeding for 6 months among the 200 women still breastfeeding was practically nonexistent. Introduction of nonhuman milk or solids was primarily responsible for the shift in patterns from exclusive to complementary feeding without passing through predominant breastfeeding. These findings confirm the need to prioritize effective hospital-based and community-based interventions to increase breastfeeding duration and exclusivity in the region.

St John's wort or sertraline? Randomized controlled trial in primary care.

OBJECTIVE: To compare the change in severity of depressive symptoms and occurrence of side effects in primary care patients treated with St John's wort (SJW) and sertraline. DESIGN: Double-blind, randomized 12-week trial. SETTING: Community-based offices of 12 family physicians practising in greater Montreal, Que. PARTICIPANTS: Eighty-seven men and women with major depression and an initial score of > or = 16 on the Hamilton Rating Scale for Depression (Ham-D). INTERVENTIONS: Patients were randomized to treatment with either sertraline (50 to 100 mg/d) or SJW (900 to 1800 mg/d) in a double-blind fashion. Assessment of depression was done at entry and at 2, 4, 8, and 12 weeks using the Ham-D, the Beck Depression Inventory (BDI), and a questionnaire asking about compliance and side effects. MAIN OUTCOME MEASURES: Changes from baseline in Ham-D and BDI scores and self-reported side effects. RESULTS: There were no important differences in changes in mean Ham-D and BDI scores (using intention-to-treat analysis), with and without adjustment for baseline demographic characteristics, between the two groups at 12 weeks. Significantly more side effects were reported in the sertraline group than in the SJW group at 2 and 4 weeks' follow up. CONCLUSION: The more benign side effects of SJW make it a good first choice for this patient population.