The burden of non-communicable diseases among people living with HIV in Sub-Saharan Africa: a systematic review and meta-analysis.

Background: Non-communicable diseases (NCDs) are increasing among people living with HIV (PLHIV), especially in Sub-Saharan Africa (SSA). We determined the prevalence of NCDs and NCD risk factors among PLHIV in SSA to inform health policy makers. Methods: We conducted a systematic review and meta-analysis on the prevalence of NCDs and risk factors among PLHIV in SSA. We comprehensively searched PubMed/MEDLINE, Scopus, and EBSCOhost (CINAHL) electronic databases for sources published from 2010 to July 2023. We applied the random effects meta-analysis model to pool the results using STATA. The systematic review protocol was registered on PROSPERO (registration number: CRD42021258769). Findings: We included 188 studies from 21 countries in this meta-analysis. Our findings indicate pooled prevalence estimates for hypertension (20.1% [95% CI:17.5-22.7]), depression (30.4% [25.3-35.4]), diabetes (5.4% [4.4-6.4]), cervical cancer (1.5% [0.1-2.9]), chronic respiratory diseases (7.1% [4.0-10.3]), overweight/obesity (32.2% [29.7-34.7]), hypercholesterolemia (21.3% [16.6-26.0]), metabolic syndrome (23.9% [19.5-28.7]), alcohol consumption (21.3% [17.9-24.6]), and smoking (6.4% [5.2-7.7]). Interpretation: People living with HIV have a high prevalence of NCDs and their risk factors including hypertension, depression, overweight/obesity, hypercholesterolemia, metabolic syndrome and alcohol consumption. We recommend strengthening of health systems to allow for improved integration of NCDs and HIV services in public health facilities in SSA. NCD risk factors such as obesity, hypercholesterolemia, and alcohol consumption can be addressed through health promotion campaigns. There is a need for further research on the burden of NCDs among PLHIV in most of SSA. Funding: This study did not receive any funding.

Antiretroviral therapy programme outcomes at Senkatana antiretroviral therapy clinic, Lesotho: a four-year retrospective cohort study.

Introduction: sub-Saharan Africa, home to over 10% of the world´s population, is the worst Human Immunodeficiency Virus (HIV)-affected region in the world. HIV/AIDS is a major public health challenge in Lesotho, with an HIV prevalence of 25.6% in 2018. The aim of this study was to evaluate the treatment outcomes of people living with HIV (PLHIV) on antiretroviral therapy (ART) after 48 months of initiation. Methods: we conducted a register-based retrospective cohort study for all patients registered at the Senkatana ART Clinic from January to December 2014 and followed them for 48 months until 2018. The ART treatment register and treatment cards were the primary source of data. Data were captured and cleaned in Epi info version 7 and exported into Stata version 14 for analysis. Descriptive statistics were used to describe participant characteristics. Due to the lack of incident data, the factors associated with treatment outcomes were determined using Chi-square tests and logistic regression. Results: in 2014, 604 patients were enrolled on ART, of which the majority were female (59.4%) and married (54.8%). The mean age (standard deviation (SD)) at which ART was started was 36 years (10.5) years. After 48 months of initiation, the cohort consisted of 387 patients of which 365 (94.3%) were retained on treatment. In the multivariable logistic regression model, neither demographic characteristics nor clinical factors were associated with ART treatment outcome (viral load suppression, adherence, or ART retention), however, the univariable analysis showed that higher CD4 count at initiation was associated with viral load suppression. Conclusion: retention, viral load suppression, and adherence were generally good in this cohort after 48 months of initiation. CD4 at initiation was a significant predictor of viral load suppression at 48 months. The ART programme has managed to maintain high viral load suppression and improve immunity in patients who are immunocompromised. Proper data quality management is required for adequate patient monitoring to enable clinical personnel to record and use individual patient data for guiding the clinical management of such patients. Strengthening patient support and tracing will help to reduce the number of patients lost to follow-up.

Mapping Evidence on the Burden of Breast, Cervical, and Prostate Cancers in Sub-Saharan Africa: A Scoping Review.

Background: Cancer remains a major public health problem, especially in Sub-Saharan Africa (SSA) where the provision of health care is poor. This scoping review mapped evidence in the literature regarding the burden of cervical, breast and prostate cancers in SSA. Methods: We conducted this scoping review using the Arksey and O'Malley framework, with five steps: identifying the research question; searching for relevant studies; selecting studies; charting the data; and collating, summarizing, and reporting the data. We performed all the steps independently and resolved disagreements through discussion. We used Endnote software to manage references and the Rayyan software to screen studies. Results: We found 138 studies that met our inclusion criteria from 2,751 studies identified through the electronic databases. The majority were retrospective studies of mostly registries and patient files (n = 77, 55.8%), followed by cross-sectional studies (n = 51, 36.9%). We included studies published from 1990 to 2021, with a sharp increase from 2010 to 2021. The quality of studies was overall satisfactory. Most studies were done in South Africa (n = 20) and Nigeria (n = 17). The majority were on cervical cancer (n = 93, 67.4%), followed by breast cancer (67, 48.6%) and the least were on prostate cancer (48, 34.8%). Concerning the burden of cancer, most reported prevalence and incidence. We also found a few studies investigating mortality, disability-adjusted life years (DALYs), and years of life lost (YLL). Conclusions: We found many retrospective record review cross-sectional studies, mainly in South Africa and Nigeria, reporting the prevalence and incidence of cervical, breast and prostate cancer in SSA. There were a few systematic and scoping reviews. There is a scarcity of cervical, breast and prostate cancer burden studies in several SSA countries. The findings in this study can inform policy on improving the public health systems and therefore reduce cancer incidence and mortality in SSA.

Mycotoxin-Linked Mutations and Cancer Risk: A Global Health Issue.

Humans continue to be constantly exposed to mycotoxins, mainly through oral exposure (dietary), inhalation, or dermal contact. Recently, it has been of increasing interest to investigate mycotoxin-linked carcinogenicity. This systematic review was conducted to synthesize evidence of the association between mycotoxin-linked mutations and the risk of cancer, to provide an overview of the data linking exposure to different mycotoxins with human cancer risk, and to provide an update on current research on the risk of cancer associated with human exposure to mycotoxins. PRISMA guidelines were used when conducting the systematic review. PubMed, MEDLINE, and CINAHL electronic databases were comprehensively searched to extract the relevant studies published from inception to May 2022. A total of sixteen relevant studies (4907 participants) were identified and included in this review. Of these, twelve studies were from Asia, while four of the studies were conducted in Africa. The overall meta-analysis result found no significant association, although some of the studies confirmed an association between mycotoxin-linked mutations and primary liver cancer risk. Mainly, the experimental studies have shown associations between mycotoxin-linked mutations and cancer risk, and there is a need for researchers to confirm these links in epidemiological studies in order to guide public health policies and interventions.

Protocol for updated systematic review and meta-analysis on the burden of non-communicable diseases among people living with HIV in sub-Saharan Africa.

INTRODUCTION: Sub-Saharan Africa (SSA) is faced with the dual epidemics of HIV/AIDS and non-communicable diseases (NCDs). Cardiovascular diseases, cancers, chronic respiratory diseases, diabetes and mental illnesses are the five major NCDs, causing death globally with low-income and middle-income countries, contributing 78% of all NCD deaths and 85% of premature deaths. There has been increased interest in the integration of HIV and NCDs care, especially in SSA that accounts for 55% of people living with HIV (PLHIV) globally. This systematic review and meta-analysis will estimate the overall prevalence or incidence of NCDs (or its risk factors) among adults living with HIV in SSA. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be used. Two authors will independently screen the title and abstracts of the articles identified from the search. Study participants will be any adult (≥18 years old) living with HIV in SSA. Exposure of interest will be HIV (with or without ART). Outcomes of interest are prevalence or incidence of any NCD/NCD risk factors. A random-effects meta-analysis will be used to estimate pooled prevalence or incidence of the five major NCDs among PLHIV, using Stata software. χ2 test and I2 statistic will be used to measure statistical heterogeneity between studies. If there is significant heterogeneity, subgroup analysis will be used to investigate potential sources. Publication bias will be assessed using funnel plots and the Stata 'metabias' command. ETHICS AND DISSEMINATION: Ethical review will not be required because it is a systematic review. Data will be kept in the institutional data repository. Study findings will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42021258769.

Interventions for preventing postpartum constipation.

BACKGROUND: Postpartum constipation, with symptoms, such as pain or discomfort, straining, and hard stool, is a common condition affecting mothers. Haemorrhoids, pain at the episiotomy site, effects of pregnancy hormones, and haematinics used in pregnancy can increase the risk of postpartum constipation. Eating a high-fibre diet and increasing fluid intake are usually encouraged. Although laxatives are commonly used in relieving constipation, the effectiveness and safety of available interventions for preventing postpartum constipation should be ascertained. This is an update of a review first published in 2015. OBJECTIVES: To evaluate the effectiveness and safety of interventions for preventing postpartum constipation. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, and two trials registers ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 October 2019), and screened reference lists of retrieved trials. SELECTION CRITERIA: We considered all randomised controlled trials (RCTs) comparing any intervention for preventing postpartum constipation versus another intervention, placebo, or no intervention in postpartum women. Interventions could include pharmacological (e.g. laxatives) and non-pharmacological interventions (e.g. acupuncture, educational and behavioural interventions). Quasi-randomised trials and cluster-RCTs were eligible for inclusion; none were identified. Trials using a cross-over design were not eligible. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the results of the search to select potentially relevant trials, extracted data, assessed risk of bias, and the certainty of the evidence, using the GRADE approach. We did not pool results in a meta-analysis, but reported them per study. MAIN RESULTS: We included five trials (1208 postpartum mothers); three RCTs and two quasi-RCTs. Four trials compared a laxative with placebo; one compared a laxative plus a bulking agent versus the same laxative alone, in women who underwent surgical repair of third degree perineal tears. Trials were poorly reported, and four of the five trials were published over 40 years ago. We judged the risk of bias to be unclear for most domains. Overall, we found a high risk of selection and attrition bias. Laxative versus placebo We included four trials in this comparison. Two of the trials examined the effects of laxatives that are no longer used; one has been found to have carcinogenic properties (Danthron), and the other is not recommended for lactating women (Bisoxatin acetate); therefore, we did not include their results in our main findings. None of the trials included in this comparison assessed our primary outcomes: pain or straining on defecation, incidence of postpartum constipation, or quality of life; or many of our secondary outcomes. A laxative (senna) may increase the number of women having their first bowel movement within 24 hours after delivery (risk ratio (RR) 2.90, 95% confidence interval (CI) 2.24 to 3.75; 1 trial, 471 women; low-certainty evidence); may have little or no effect on the number of women having their first bowel movement on day one after delivery (RR 0.94, 95% CI 0.72 to 1.22; 1 trial, 471 women; very low-certainty evidence); may reduce the number of women having their first bowel movement on day two (RR 0.23, 95% CI 0.11 to 0.45; 1 trial, 471 women; low-certainty evidence); and day three (RR 0.05, 95% CI 0.00 to 0.89; 1 trial, 471 women; low-certainty evidence); and may have little or no effect on the number of women having their first bowel movement on day four after delivery (RR 0.22, 95% CI 0.03 to 1.87; 1 trial, 471 women; very low-certainty evidence), but some of the evidence is very uncertain. Adverse effects were poorly reported. Low-certainty evidence suggests that the laxative (senna) may increase the number of women experiencing abdominal cramps (RR 4.23, 95% CI 1.75 to 10.19; 1 trial, 471 women). Very low-certainty evidence suggests that laxatives taken by the mother may have little or no effect on loose stools in the baby (RR 0.62, 95% CI 0.16 to 2.41; 1 trial, 281 babies); or diarrhoea (RR 2.46, 95% CI 0.23 to 26.82; 1 trial, 281 babies). Laxative plus bulking agent versus laxative only Very low-certainty evidence from one trial (147 women) suggests no evidence of a difference between these two groups of women who underwent surgical repair of third degree perineal tears; only median and range data were reported. The trial also reported no evidence of a difference in the incidence of postpartum constipation (data not reported), but did not report on quality of life. Time to first bowel movement was reported as a median (range); very low-certainty evidence suggests little or no difference between the two groups. A laxative plus bulking agent may increase the number of women having any episode of faecal incontinence during the first 10 days postpartum (RR 1.81, 95% CI 1.01 to 3.23; 1 trial, 147 women; very low-certainty evidence). The trial did not report on adverse effects of the intervention on babies, or many of our secondary outcomes. AUTHORS' CONCLUSIONS: There is insufficient evidence to make general conclusions about the effectiveness and safety of laxatives for preventing postpartum constipation. The evidence in this review was assessed as low to very low-certainty evidence, with downgrading decisions based on limitations in study design, indirectness and imprecision. We did not identify any trials assessing educational or behavioural interventions. We identified four trials that examined laxatives versus placebo, and one that examined laxatives versus laxatives plus stool bulking agents. Further, rigorous trials are needed to assess the effectiveness and safety of laxatives during the postpartum period for preventing constipation. Trials should assess educational and behavioural interventions, and positions that enhance defecation. They should report on the primary outcomes from this review: pain or straining on defecation, incidence of postpartum constipation, quality of life, time to first bowel movement after delivery, and adverse effects caused by the intervention, such as: nausea or vomiting, pain, and flatus.

Clinical and microbiological features of invasive nontyphoidal Salmonella associated with HIV-infected patients, Gauteng Province, South Africa.

The aim of this study was to define factors associated with HIV-infected versus uninfected patients with invasive nontyphoidal Salmonella (iNTS) and factors associated with mortality, which are inadequately described in Africa.Laboratory-based surveillance for iNTS was undertaken. At selected sentinel sites, clinical data (age, sex, HIV status, severity of illness, and outcome) were collected.Surveillance was conducted in Gauteng, South Africa, from 2003 to 2013. Clinical and microbiological differences between HIV-infected and uninfected patients were defined and risk factors for mortality established.Of 4886 iNTS infections in Gauteng from 2003 to 2013, 3106 (63.5%) were diagnosed at sentinel sites. Among persons with iNTS infections, more HIV-infected persons were aged ≥5 years (χ = 417.6; P < 0.001) and more HIV-infected children were malnourished (χ = 5.8; P = 0.02). Although 760 (30.6%) patients died, mortality decreased between 2003 [97/263 (36.9%)] and 2013 [926/120 (21.7%)]. On univariate analysis, mortality was associated with patients aged 25 to 49 years [odds ratio (OR) = 2.2; 95% confidence interval (CI) = 1.7-2.7; P < 0.001 and ≥50 years (OR = 3.0; 95% CI = 2.2-4.1; P < 0.001) compared with children < 5 years, HIV-infected patients (OR = 2.4; 95% CI = 1.7-3.4; P < 0.001), and severe illness (OR = 5.4; 95% CI = 3.6-8.1; P < 0.001). On multivariate analysis, mortality was associated with patients aged ≥50 years [adjusted OR (AOR) = 3.6, 95% CI = 2.1-6.1, P < 0.001] and severe illness (AOR = 6.3; 95% CI = 3.8-10.5; P < 0.001).Mortality due to iNTS in Gauteng remains high primarily due to disease severity. Interventions must be aimed at predisposing conditions, including HIV, other immune-suppressive conditions, and malignancy.

Meta-Analysis of Effect Sizes Reported at Multiple Time Points Using General Linear Mixed Model.

Meta-analysis of longitudinal studies combines effect sizes measured at pre-determined time points. The most common approach involves performing separate univariate meta-analyses at individual time points. This simplistic approach ignores dependence between longitudinal effect sizes, which might result in less precise parameter estimates. In this paper, we show how to conduct a meta-analysis of longitudinal effect sizes where we contrast different covariance structures for dependence between effect sizes, both within and between studies. We propose new combinations of covariance structures for the dependence between effect size and utilize a practical example involving meta-analysis of 17 trials comparing postoperative treatments for a type of cancer, where survival is measured at 6, 12, 18 and 24 months post randomization. Although the results from this particular data set show the benefit of accounting for within-study serial correlation between effect sizes, simulations are required to confirm these results.

Interventions for treating postpartum constipation.

BACKGROUND: Constipation is a functional bowel disorder that can reduce quality of life in the puerperium period. The diagnosis of postpartum constipation is both subjective and objective. It is characterised by symptoms such as pain or discomfort, straining, hard lumpy stools and a sense of incomplete bowel evacuation. Haemorrhoids, pain at the episiotomy site, effects of pregnancy hormones and hematinics used in pregnancy can increase the risk of postpartum constipation. Although a high fibre diet and increased fluid intake is encouraged to assist defecation in the puerperium, pain-relieving drugs and laxatives are common drugs of choice to alleviate constipation. However, the effectiveness and safety of laxatives on the nursing mother need to be ascertained. OBJECTIVES: To evaluate the effectiveness of interventions for treating postpartum constipation. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 March 2014), the metaRegister of Controlled Trials, the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov), the Australian New Zealand Clinical Trials Registry (ANZCTR), the World Health Organization International Clinical Trials Registry platform (ICTRP), the ProQuest database, Stellenbosch University database and Google Scholar (28 March 2014). We also searched the reference lists of potentially relevant studies identified by the search, reviewed articles for relevant trials and contacted experts to identify any additional published or unpublished trials (10 April 2014). SELECTION CRITERIA: All randomised controlled trials comparing any intervention for the treatment of postpartum constipation to another intervention, placebo or no intervention.Interventions could include laxatives, surgery, as well as educational and behavioural interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the results of the search to select potentially relevant studies using pre-designed eligibility inclusion criteria. Discrepancies were resolved through discussion. We did not identify any studies for inclusion. MAIN RESULTS: We did not identify any studies that met our inclusion criteria. We excluded nine studies. AUTHORS' CONCLUSIONS: We could not make explicit conclusions on interventions for treating postpartum constipation because we found no studies for inclusion in this review. Rigorous and well-conducted large randomised controlled trials aimed at treating postpartum women diagnosed with constipation would be beneficial. These trials should also address the criteria for administering the intervention (time and stage of a diagnosis of postpartum constipation), and the safety and effectiveness of such interventions.

Sociodemographic predictors of multiple non-communicable disease risk factors among older adults in South Africa.

BACKGROUND AND OBJECTIVE: Unhealthy lifestyle behaviours are important risk factors of morbidity and mortality. This study aimed to explore the sociodemographic predictors of multiple non-communicable disease (NCD) risk factors experienced by elderly South Africans. METHODS: We conducted a national population-based cross-sectional survey with a sample of 3,840 individuals aged 50 years or above in South Africa in 2008. The outcome variable was the co-existence of multiple NCD risk factors (tobacco use, alcohol, physical inactivity, fruit and vegetable intake, overweight or obesity, and hypertension) in each individual. The exposure variables were sociodemographic characteristics, namely, age, gender, education, wealth status, population group, marital status, and residence. Multivariate linear regression was used to assess the association between sociodemographic variables and multiple NCD risk factors. RESULTS: The mean number of NCD risk factors among all participants was three (95% confidence interval: 2.81-3.10). Multivariate linear regression analysis revealed that being female, being in the age group of 60-69 years, and being from the Coloured and Black African race were associated with a higher number of NCD risk factors. Marital status, educational level, wealth, and residence were not significantly associated with the number of NCD risk factors experienced. CONCLUSIONS: The co-existence of multiple lifestyle NCD risk factors among the elderly is a public health concern. Comprehensive health-promotion interventions addressing the co-existence of multiple NCD risk factors tailored for specific sociodemographic groups are needed.

Interferon after surgery for women with advanced (Stage II-IV) epithelial ovarian cancer.

BACKGROUND: Epithelial ovarian cancer (EOC) is a life-threatening disease. Most often women become symptomatic only in the advanced stages of the disease, increasing the difficulty of treatment. Whilst the disease responds well to surgery and chemotherapy, the relapse rate is high. New treatments to prevent disease recurrence or progression, prolong survival, and increase the quality of life are needed. OBJECTIVES: To assess the effectiveness and safety of interferon after surgery in the treatment of advanced (stage II-IV) EOC. SEARCH METHODS: The Cochrane Gynaecological Cancer Review Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL) Issue 1, 2012, MEDLINE and EMBASE were searched to January 2012. Handsearching of conference proceedings was also undertaken. Reference lists of reviews and included trials were screened and experts in the field were contacted for additional trials. Clinical trials registers were searched for ongoing trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) involving participants with advanced EOC that compared post-operative chemotherapy alone with post-operative interferon therapy in combination with chemotherapy or post-operative chemotherapy followed by interferon or observation alone DATA COLLECTION AND ANALYSIS: Two review authors (AL and AM) independently screened the search results for relevant trials and extracted pre-specified information from each included trial. Data were managed using Review Manager 5.1. Hazard ratios (HR) were calculated for time-to-event outcomes and risk ratios (RR) for dichotomous outcomes, with corresponding 95% confidence intervals (CI). MAIN RESULTS: Five trials, including 1476 participants, were included in the review. Two trials compared interferon with observation alone and three trials compared interferon plus chemotherapy with chemotherapy alone. A meta-analysis of two trials involving 370 participants found no significant difference in both overall survival (HR 1.14, 95% CI 0.84 to 1.55) and progression free survival (HR 0.99, 95% CI 0.79 to 1.24) between the interferon and observation alone groups in post-surgical women who had undergone first-line chemotherapy for advanced EOC. One trial with 293 participants found that while no significant difference was observed in incidence of nausea or vomiting between the two treatment groups, significantly more flu-like symptoms (RR 2.25, 95% CI 1.73 to 2.91) and fatigue (RR 1.54, 95% CI 1.27 to 1.88) were reported in the interferon group. For the second comparison, a meta-analysis of two trials comprising 244 participants found that although there was no significant difference in overall survival between the interferon plus chemotherapy and the chemotherapy alone group (HR 1.14, 95% CI 0.74 to 1.76), women in the interferon plus chemotherapy group had worse progression free survival than those in the chemotherapy alone group (HR 1.43, 95% CI 1.02 to 2.00). Compared to chemotherapy alone, adding interferon to chemotherapy did not alter the incidence of adverse events in post-surgical women with advanced EOC. AUTHORS' CONCLUSIONS: Implications for practice Based on low quality evidence, the addition of interferon to first-line chemotherapy did not alter the overall survival in post-surgical women with advanced EOC compared with chemotherapy alone. There is low quality evidence to suggest that interferon in combination with chemotherapy worsened the progression free survival in post-surgical women with advanced EOC compared with chemotherapy alone. There is not enough evidence that interferon therapy alone alters overall survival or progression free survival compared to observation alone in post-surgical women who have undergone first-line chemotherapy. IMPLICATIONS FOR RESEARCH: Three of the five trials included in this review were stopped early and were, therefore, underpowered to detect any true effect of the intervention. The trials did not report the results of important outcomes in a uniform manner, preventing statistical aggregation of the results. Trial methodology was poorly reported resulting in unclear risk of bias. For clear recommendations to be made regarding the effectiveness of interferon in the treatment of advanced EOC, long-term, well conducted and adequately powered RCTs would be needed. However, the available data do not suggest that interferon has an adequately advantageous effect to warrant further investigation.

Oral evening primrose oil and borage oil for eczema.

BACKGROUND: Eczema is a chronic inflammatory skin condition, which usually develops in early childhood. Many children outgrow this disorder as they reach secondary school age, and although It may improve with age, there is no cure. Constant itch makes life uncomfortable for those with this condition, no matter what age they are, so it may have a significant effect on a person's quality of life. Its prevalence seems to be increasing as populations move from rural locations to cities. Some people, who do not see an adequate improvement or fear side-effects of conventional medical products, try complementary alternatives to conventional treatment. This is a review of evening primrose oil (EPO) and borage oil (BO) taken orally (by mouth); these have been thought to be beneficial because of their gamma-linolenic acid content. OBJECTIVES: To assess the effects of oral evening primrose oil or borage oil for treating the symptoms of atopic eczema. SEARCH METHODS: We searched the following databases up to August 2012: Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 1946), EMBASE (from 1974), AMED (from 1985), and LILACS (from 1982). We also searched online trials registers and checked the bibliographies of included studies for further references to relevant trials. We corresponded with trial investigators and pharmaceutical companies to try to identify unpublished and ongoing trials. We performed a separate search for adverse effects of evening primrose oil and borage oil in November 2011. SELECTION CRITERIA: All randomised controlled, parallel, or cross-over trials investigating oral intake of evening primrose oil or borage oil for eczema. DATA COLLECTION AND ANALYSIS: Two review authors independently applied eligibility criteria, assessed risk of bias, and extracted data. We pooled dichotomous outcomes using risk ratios (RR), and continuous outcomes using the mean difference (MD). Where possible, we pooled study results using random-effects meta-analysis and tested statistical heterogeneity using both the Chi(²) test and the I(²) statistic test. We presented results using forest plots with 95% confidence intervals (CI). MAIN RESULTS: A total of 27 studies (1596 participants) met the inclusion criteria: 19 studies assessed evening primrose oil, and 8 studies assessed borage oil. For EPO, a meta-analysis of results from 7 studies showed that EPO failed to significantly increase improvement in global eczema symptoms as reported by participants on a visual analogue scale of 0 to 100 (MD -2.22, 95% CI -10.48 to 6.04, 176 participants, 7 trials) and a visual analogue scale of 0 to 100 for medical doctors (MD -3.26, 95% CI -6.96 to 0.45, 289 participants, 8 trials) compared to the placebo group.Treatment with BO also failed to significantly improve global eczema symptoms compared to placebo treatment as reported by both participants and medical doctors, although we could not conduct a meta-analysis as studies reported results in different ways. With regard to the risk of bias, the majority of studies were of low risk of bias; we judged 67% of the included studies as having low risk of bias for random sequence generation; 44%, for allocation concealment; 59%, for blinding; and 37%, for other biases. IMPLICATIONS FOR PRACTICE: Oral borage oil and evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials. Oral BO and EPO are not effective treatments for eczema.In these studies, along with the placebos, EPO and BO have the same, fairly common, mild, transient adverse effects, which are mainly gastrointestinal.The short-term studies included here do not examine possible adverse effects of long-term use of EPO or BO. A case report warned that if EPO is taken for a prolonged period of time (more than one year), there is a potential risk of inflammation, thrombosis, and immunosuppression; another study found that EPO may increase bleeding for people on Coumadin® (warfarin) medication. IMPLICATIONS FOR RESEARCH: Noting that the confidence intervals between active and placebo treatment are narrow, to exclude the possibility of any clinically useful difference, we concluded that further studies on EPO or BO for eczema would be hard to justify.This review does not provide information about long-term use of these products.

Pycnogenol® (extract of French maritime pine bark) for the treatment of chronic disorders.

BACKGROUND: Oxidative stress has been implicated in the development of a number of conditions including cancer, arthritic disorders and cardiovascular disease. Pycnogenol(®), a herbal dietary supplement derived from French maritime pine bark extract, is standardised to contain 70% procyanidin which is a powerful antioxidant. Pycnogenol(®) is marketed as a supplement for preventing or treating a wide range of chronic conditions. OBJECTIVES: To assess the efficacy and safety of Pycnogenol(®) for the treatment of chronic disorders. SEARCH METHODS: We searched CENTRAL (until 18 September 2010), MEDLINE (until 18 September 2010) and EMBASE (until 13 October 2010) as well as three trial registries. We also contacted the manufacturer of Pycnogenol(®) and hand-searched bibliographies of included studies. SELECTION CRITERIA: Randomised controlled trials evaluating the effectiveness of Pycnogenol(®) in adults or children with any chronic disorder were included. We assessed clinical outcomes directly related to the disorder (stratified as participant- and investigator-reported) and all-cause mortality as primary outcomes. We also assessed adverse events and biomarkers of oxidative stress. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial eligibility, extracted all data and assessed risk of bias. A third author additionally extracted information on outcomes and results. With three exceptions, results for outcomes across studies could not be pooled. MAIN RESULTS: This review includes 15 trials with a total of 791 participants that have evaluated Pycnogenol(®) for the treatment of seven different chronic disorders. These included asthma (two studies; N = 86), attention deficit hyperactivity disorder (one study; N = 61), chronic venous insufficiency (two studies; N = 60), diabetes mellitus (four studies; N = 201), erectile dysfunction (one study; N = 21), hypertension (two studies; N = 69) and osteoarthritis (three studies; N = 293). Two of the studies were conducted exclusively in children; the others involved adults.Due to small sample size, limited numbers of trials per condition, variation in outcomes evaluated and outcome measures used, as well as the risk of bias in the included studies, no definitive conclusions regarding the efficacy or safety of Pycnogenol(®) are possible. AUTHORS' CONCLUSIONS: Current evidence is insufficient to support Pycnogenol(®) use for the treatment of any chronic disorder. Well-designed, adequately powered trials are needed to establish the value of this treatment.

Pycnogenol(®) for the treatment of chronic disorders.

BACKGROUND: Oxidative stress has been implicated in the development of a number of conditions including cancer, arthritic disorders and cardiovascular disease. Pycnogenol(®), a herbal dietary supplement derived from French maritime pine bark extract, is standardised to contain 70% procyanidin which is a powerful antioxidant. Pycnogenol(®) is marketed as a supplement for preventing or treating a wide range of chronic conditions. OBJECTIVES: To assess the efficacy and safety of Pycnogenol(®) for the treatment of chronic disorders. SEARCH METHODS: We searched CENTRAL (until 18 September 2010), MEDLINE (until 18 September 2010) and EMBASE (until 13 October 2010) as well as three trial registries. We also contacted the manufacturer of Pycnogenol(®) and hand-searched bibliographies of included studies. SELECTION CRITERIA: Randomised controlled trials evaluating the effectiveness of Pycnogenol(®) in adults or children with any chronic disorder were included. We assessed clinical outcomes directly related to the disorder (stratified as participant- and investigator-reported) and all-cause mortality as primary outcomes. We also assessed adverse events and biomarkers of oxidative stress. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial eligibility, extracted all data and assessed risk of bias. A third author additionally extracted information on outcomes and results. With three exceptions, results for outcomes across studies could not be pooled. MAIN RESULTS: This review includes 15 trials with a total of 791 participants that have evaluated Pycnogenol(®) for the treatment of seven different chronic disorders. These included asthma (two studies; N = 86), attention deficit hyperactivity disorder (one study; N = 61), chronic venous insufficiency (two studies; N = 60), diabetes mellitus (four studies; N = 201), erectile dysfunction (one study; N = 21), hypertension (two studies; N = 69) and osteoarthritis (three studies; N = 293). Two of the studies were conducted exclusively in children; the others involved adults.Due to small sample size, limited numbers of trials per condition, variation in outcomes evaluated and outcome measures used, as well as the risk of bias in the included studies, no definitive conclusions regarding the efficacy or safety of Pycnogenol(®) are possible. AUTHORS' CONCLUSIONS: Current evidence is insufficient to support Pycnogenol(®) use for the treatment of any chronic disorder. Well-designed, adequately powered trials are needed to establish the value of this treatment.