-
The European Journal of Contraception &... Apr 2019To evaluate the association between postpartum hormonal contraceptive use and postpartum depression.
PURPOSE
To evaluate the association between postpartum hormonal contraceptive use and postpartum depression.
MATERIALS AND METHODS
We searched the literature through March 2018 on the association between postpartum hormonal contraception use and incident postpartum depression. We used the United States Preventive Services Task Force framework to assess study quality.
RESULTS
Of 167 articles identified, four met inclusion criteria. Two studies found no differences in rates of postpartum depression between women using postpartum depot medroxyprogesterone and those not using hormonal contraception; however, a study of women receiving injectable norethisterone enanthate immediately postpartum found a 2-3-fold increased risk of depression at 6 weeks, though not at 3 months. One study compared combined hormonal contraception, progestin-only pills (POPs), etonogestrel implants and levonorgestrel intrauterine devices (LNG-IUDs) with no hormonal contraception, and found a 35-44% decreased risk of postpartum depression with POPs and LNG-IUDs, a small increased risk of postpartum antidepressant use among women using the etonogestrel implant and vaginal ring, and a decreased risk of antidepressant use with POPs.
CONCLUSIONS
Limited evidence found no consistent associations between hormonal contraceptive use and incidence of postpartum depression. Future research would be strengthened by using validated diagnostic measures, careful consideration of confounders, and ensuring adequate follow-up time.
Topics: Adult; Contraception; Contraception Behavior; Contraceptives, Oral, Hormonal; Depression, Postpartum; Female; Humans; Incidence; Postpartum Period; Pregnancy; Time Factors; Young Adult
PubMed: 30920314
DOI: 10.1080/13625187.2019.1569610 -
American Journal of Preventive Medicine Aug 2015This systematic review evaluated the evidence on the impact of family planning reminder systems-interventions intended to remind patients of behaviors to achieve... (Review)
Review
CONTEXT
This systematic review evaluated the evidence on the impact of family planning reminder systems-interventions intended to remind patients of behaviors to achieve reproductive health goals (e.g., daily text messages reminding oral contraceptive [OC] users to take a pill)-to provide information to guide national recommendations on quality family planning services.
EVIDENCE ACQUISITION
Multiple databases including PubMed were searched during 2010-2011 for peer-reviewed articles published in English from January 1985 through February 2011 describing studies evaluating reminder systems to improve family planning outcomes. Studies were excluded if they focused primarily on HIV or sexually transmitted infection prevention, focused solely on men, or were conducted outside the U.S., Europe, Australia, or New Zealand.
EVIDENCE SYNTHESIS
The initial search identified 16,129 articles, five of which met the inclusion criteria. Three studies examined the impact of OC reminder systems; two found a statistically significant positive impact on correct use. Two studies examined the impact of reminder systems among depot medroxyprogesterone acetate (DMPA) users; one found a statistically significant positive impact on correct use.
CONCLUSIONS
Although mixed support was found for the effectiveness of reminder system interventions on correct use of OCs and DMPA, the highest-quality evidence yielded null findings. The evidence base would be strengthened by the development of additional studies, especially RCTs, which objectively measure outcomes, examine additional contraceptive methods, and have sufficient sample sizes to detect behavioral outcomes at least 12 months post-intervention.
Topics: Australia; Contraception; Europe; Family Planning Services; Female; Humans; Male; New Zealand; Pregnancy; Pregnancy, Unplanned; Reminder Systems; Text Messaging; United States
PubMed: 26190847
DOI: 10.1016/j.amepre.2015.03.018 -
Journal of Musculoskeletal & Neuronal... Sep 2017To assess whether progesterone (P4) or osteoblast P4 receptor-acting progestin (P) contributed to estrogen (E) therapy-related increased areal bone mineral density (BMD)... (Meta-Analysis)
Meta-Analysis Review
Estrogen-progestin therapy causes a greater increase in spinal bone mineral density than estrogen therapy - a systematic review and meta-analysis of controlled trials with direct randomization.
OBJECTIVE
To assess whether progesterone (P4) or osteoblast P4 receptor-acting progestin (P) contributed to estrogen (E) therapy-related increased areal bone mineral density (BMD) in randomized controlled trials (RCT) with direct randomization to estrogen (ET) or estrogen-progestin (EPT) therapy.
METHODS
Systematic literature searches in biomedical databases identified RCT with direct randomization and parallel estrogen doses that measured spinal BMD change/year. Cyclic P4/P was included in this random effects meta-analysis only if for ≥ half the number of E-days.
RESULTS
Searches yielded 155 publications; five met inclusion criteria providing eight dose-parallel ET-EPT comparisons in 1058 women. Women averaged mid-50 years, ⟨five years into menopause and took conjugated equine E daily at 0.625 mg with/without 2.5 mg medroxyprogesterone acetate (MPA). The weighted mean EPT minus ET percentage difference in spinal BMD change was +0.68%/year (95% CI 0.38, 0.97%) (P=0.00001). This result was highly heterogeneous (I²=81%) but this may reflect the small number of studies.
CONCLUSION
Estrogen with an osteoblast P4R-acting progestin (EPT) in these five published RCT provides Level 1 evidence that MPA caused significantly greater annual percent spinal BMD gains than the same dose of ET. These data have implications for management of vasomotor symptoms and potentially for osteoporosis treatment in menopausal women.
Topics: Bone Density; Estrogens; Female; Humans; Osteoporosis, Postmenopausal; Progestins; Randomized Controlled Trials as Topic
PubMed: 28860416
DOI: No ID Found -
The Cochrane Database of Systematic... Jan 2020Women who have undergone surgical treatment for epithelial ovarian cancer (EOC) may develop menopausal symptoms due to immediate loss of ovarian function following... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Women who have undergone surgical treatment for epithelial ovarian cancer (EOC) may develop menopausal symptoms due to immediate loss of ovarian function following surgery and chemotherapy. Women may experience vasomotor symptoms, sleep disturbance, difficulty concentrating, sexual dysfunction, vaginal symptoms and accelerated osteoporosis. Although hormone replacement therapy (HRT) is the most effective treatment to relieve these symptoms, its safety has been questioned for women with EOC.
OBJECTIVES
To assess the safety and efficacy of HRT for menopausal symptoms in women surgically treated for EOC.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 6), MEDLINE via Ovid (1946 to 12 June 2019) and Embase via Ovid (1980 to 2019, week 23). We also handsearched conference reports and trial registries. There was no language restriction.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) with participants of any age and menopausal status who had undergone surgery for EOC and, after diagnosis and treatment, used any regimen and duration of HRT compared with placebo or no hormone therapy. We also included trials comparing different regimens or duration of administration of HRT.
DATA COLLECTION AND ANALYSIS
Two review authors independently identified studies that met the inclusion criteria. They used Covidence to extract study characteristics, outcome data and to assess methodological quality of the included studies.
MAIN RESULTS
Our search strategy identified 2617 titles, of which 2614 titles were excluded. Three studies, involving 350 women, met our inclusion criteria. Two of the studies included pre and postmenopausal women, and the third only included premenopausal women. The overall age range of those women included in the studies was 20 to 89.6 years old, with a median follow-up ranging from 31.4 months to 19.1 years. The geographical distribution of participants included Europe, South Africa and China. All stages and histological subtypes were included in two of the studies, but stage IV disease had been excluded in the third. The three included studies used a variety of HRT regimens (conjugated oestrogen with or without medroxyprogesterone and with or without nylestriol) and HRT administrations (oral, patch and implant), In all studies, the comparisons were made versus women who had not received HRT. The studies were at low or unclear risk of selection and reporting bias, and at high risk of performance, detection and attrition bias. The certainty of the evidence was low for overall survival and progression-free survival, and very low for quality-of-life assessment, incidence of breast cancer, transient ischaemic attack (TIA), cerebrovascular accident (CVA) and myocardial infarction (MI). Meta-analysis of these studies showed that HRT may improve overall survival (hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.54 to 0.93; 350 participants, 3 studies; low-certainty evidence). Quality-of-life assessment by use of the EORTC-C30 questionnaire was performed only in one study. We are uncertain whether HRT improves or reduces quality of life as the certainty of the evidence was assessed as very low (mean difference (MD) 13.67 points higher, 95% CI 9.26 higher to 18.08 higher; 1 study; 75 participants; very low-certainty evidence). Likewise, HRT may make little or no difference to progression-free survival (HR 0.76, 95% CI 0.57 to 1.01; 275 participants, 2 studies; low-certainty evidence). We are uncertain whether HRT improves or reduces the incidence of breast cancer (risk ratio (RR) 2.00, 95% CI 0.19 to 21.59; 225 participants, 2 studies; very low-certainty evidence); TIA (RR 5.00, 95% CI 0.24 to 102.42; 150 participants, 1 study; very low-certainty evidence); CVA (RR 0.67, 95% CI 0.11 to 3.88; 150 participants, 1 study; very low-certainty evidence); and MI (RR 0.20, 95% CI 0.01 to 4.10; 150 participants, 1 study; very low-certainty evidence). The incidence of gallstones was not reported in the included studies.
AUTHORS' CONCLUSIONS
Hormone replacement therapy may slightly improve overall survival in women who have undergone surgical treatment for EOC, but the certainty of the evidence is low. HRT may make little or no difference to quality of life, incidence of breast cancer, TIA, CVA and MI as the certainty of the evidence has been assessed as very low. There may be little or no effect of HRT use on progression-free survival. The evidence in this review is limited by imprecision and incompleteness of reported relevant outcomes and therefore the results should be interpreted with caution. Future well-designed RCTs are required as this is an important area to women experiencing menopausal symptoms following surgical treatment for ovarian cancer, especially as doctors are often reluctant to prescribe HRT in this scenario. The evidence in this review is too limited to support or refute that HRT is very harmful in this population.
Topics: Carcinoma, Ovarian Epithelial; Female; Hormone Replacement Therapy; Humans; Menopause, Premature; Ovarian Neoplasms; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 31989588
DOI: 10.1002/14651858.CD012559.pub2 -
The Cochrane Database of Systematic... Dec 2018Endometrial carcinoma is the most common gynaecologic malignancy in the world and develops through preliminary stages of endometrial hyperplasia....
BACKGROUND
Endometrial carcinoma is the most common gynaecologic malignancy in the world and develops through preliminary stages of endometrial hyperplasia. Atypical endometrial hyperplasia suggests a significant pre-malignant state with frank progression to endometrial carcinoma, and tends to occur at a young age. Oral progestins have been used as conservative treatment in young women with atypical endometrial hyperplasia, but they are associated with poor tolerability and side effects that may limit their overall efficacy. So it has become increasingly important and necessary to find a safe and effective fertility-sparing treatment with better tolerability and fewer side effects than the options currently available. The levonorgestrel-releasing intrauterine system (LNG-IUS) has been used to provide endometrial protection in women with breast cancer who are on adjuvant tamoxifen. The antiproliferative function of levonorgestrel is thought to reduce the risk of endometrial hyperplasia.
OBJECTIVES
To determine the efficacy and safety of oral and intrauterine progestogens in treating atypical endometrial hyperplasia.
SEARCH METHODS
In July 2018 we searched CENTRAL; MEDLINE; Embase; CINAHL, PsycINFO and the China National Knowledge Infrastructure for relevant trials. Cochrane Gynaecology and Fertility (CGF) Specialised Register and Embase were searched in November 2018. We attempted to identify trials from references in published studies. We also searched for ongoing trials in five major clinical trials registries.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of oral and intrauterine progestogens (LNG-IUS) versus each other or placebo in women with a confirmed histological diagnosis of simple or complex endometrial hyperplasia with atypia.
DATA COLLECTION AND ANALYSIS
Two review authors assessed trial eligibility and risk of bias and extracted the data. The primary outcomes of the review were rate of regression and adverse effects. Secondary outcomes included rate of recurrence and proportion of women undergoing hysterectomy. We have used GRADE methodology to judge the quality of the evidence.
MAIN RESULTS
We included one RCT (153 women) comparing the LNG-IUS administering 20 micrograms (μu) levonorgestrel per day versus 10 milligrams of continuous or cyclical oral medroxyprogesterone (MPA) for treating any type of endometrial hyperplasia. Only 19 women in this study were histologically confirmed with atypical complex hyperplasia before treatment. The evidence was of low or very low quality. The included study was at low risk of bias, but the quality of the evidence was very seriously limited by imprecision and indirectness. We did not find any RCTS comparing the LNG-IUS or oral progestogens versus placebo in women with atypical endometrial hyperplasia.Among the 19 women with atypical complex hyperplasia, after six months of treatment there was insufficient evidence to determine whether there was a difference in regression rates between the LNG-IUS group and the progesterone group (odds ratio (OR) 2.76, 95% confidence interval (CI) 0.26 to 29.73; 1 RCT subgroup, 19 women, very low-quality evidence). The rate of regression was 100% in the LNG-IUS group (n = 6/6) and 77% in the progesterone group (n = 10/13).Among the total study population (N = 153), over the six months' treatment the main adverse effects were nausea and vaginal bleeding. There was no evidence of a difference between the groups in rates of nausea (OR 0.58, 95% CI 0.28 to 1.18; 1 RCT, 153 women, very low-quality evidence). Vaginal bleeding was more common in the LNG-IUS group (OR 2.89, 95% CI 1.11 to 7.52; 1 RCT, 153 women, low-quality evidence). Except for nausea and vaginal bleeding, no other adverse effects were reported.
AUTHORS' CONCLUSIONS
We did not find any RCTS of women with atypical endometrial hyperplasia, and our findings derive from a subgroup of 19 women in a larger RCT. All six women who used the LNG-IUS system achieved regression of atypical hyperplasia, but there was insufficient evidence to draw any conclusions regarding the relative efficacy of LNG-IUS versus oral progesterone (MPA) in this group of women. When assessed in a population of women with any type of endometrial hyperplasia, there was no clear evidence of a difference between LNG-IUS and oral progesterone (MPA) in risk of nausea, but vaginal bleeding was more likely to occur in women using the LNG-IUS. Larger studies are necessary to assess the efficacy and safety of oral and intrauterine progestogens in treating atypical endometrial hyperplasia.
Topics: Administration, Oral; Endometrial Hyperplasia; Female; Humans; Intrauterine Devices, Medicated; Levonorgestrel; Medroxyprogesterone; Randomized Controlled Trials as Topic
PubMed: 30521671
DOI: 10.1002/14651858.CD009458.pub3 -
BMJ Sexual & Reproductive Health Jan 2020To review systematically copper intrauterine device (Cu-IUD) use and HIV acquisition in women.
OBJECTIVES
To review systematically copper intrauterine device (Cu-IUD) use and HIV acquisition in women.
METHODS
We searched Pubmed, Embase and the Cochrane Library between database inception and 26 June 2019 for longitudinal studies comparing incident HIV infection among women using an unspecified IUD or Cu-IUD compared with non-hormonal or no contraceptive users, or hormonal contraceptive users. We extracted information from included studies, assessed study quality, and summarised study findings.
RESULTS
From 2494 publications identified, seven met our inclusion criteria. One randomised controlled trial (RCT), judged "informative with few limitations", found no statistically significant differences in HIV risk between users of the Cu-IUD and either intramuscular depot medroxyprogesterone acetate (DMPA-IM) or levonorgestrel implant. One observational study, deemed "informative but with important limitations", found no statistically significant difference in HIV incidence among IUD users compared with women who had tubal ligation or who were not using any contraception. Another "informative but with important limitations" observational study found no difference in HIV incidence between Cu-IUD users and DMPA or norethisterone enanthate injectable, or implant users. An RCT considered "unlikely to inform the primary question" also found no difference in HIV risk between Cu-IUD and progestogen-only injectable users. Findings from the other three "unlikely to inform the primary question" cohort studies were consistent with the more robust studies suggesting no increased risk of HIV acquisition among Cu-IUD users.
CONCLUSION
The collective evidence, including that from a large high-quality RCT, does not indicate an increased risk of HIV acquisition among users of Cu-IUDs.
Topics: Adolescent; Adult; Contraception Behavior; Female; HIV Infections; Humans; Incidence; Intrauterine Devices, Copper
PubMed: 31919240
DOI: 10.1136/bmjsrh-2019-200512 -
Human Resources For Health Sep 2022Injectable contraceptives are the most popular method of contraception in sub-Saharan Africa (SSA), but their availability in clinical settings has been severely...
BACKGROUND
Injectable contraceptives are the most popular method of contraception in sub-Saharan Africa (SSA), but their availability in clinical settings has been severely limited, despite the scarcity of health care providers and limited access to health facilities. WHO and USAID have endorsed the community-based distribution of injectable contraceptives as a promising option for improving access to family planning services and expanding the method mix for women who want to limit the number of births. Studies have shown that community health workers (CHWs) can provide women with injectable contraceptives that meet acceptable quality standards. The goal of this study is to identify, evaluate and synthesize evidence supporting the use of community-based administration of injectable contraceptives in SSA.
METHODS
This review's guidance was based on a previously developed protocol. Nine international electronic databases and the websites of organizations known to support community-based reproductive health initiatives in SSA were searched systemically. Experts in this area were also contacted for the identification of unpublished literature and ongoing studies. The reference lists of eligible studies were reviewed. The Effective Public Practice Project tool was used to assess the quality and risk of bias in eligible studies. Data were extracted and analysed using a custom data extraction form and a narrative synthesis.
RESULTS
The search strategy identified a total of 1358 studies with 12 studies meeting the inclusion criteria. One unpublished study was provided by an expert making a total of 13 studies. The results showed that irrespective of the study designs, well-trained CHWs can competently administer injectable contraceptives safely and community-based delivery of injectable contraceptives is acceptable in SSA. Also, the use of community health workers in the provision of depot-medroxyprogesterone acetate expanded access to inhabitants of hard-to-reach areas and led to an overall uptake of injectable contraceptives as well as family planning. Studies that compared CHWs to clinic-based providers revealed equivalent or higher levels of performance in favour of CHWs.
CONCLUSIONS
The CHWs can competently provide injectable contraceptives within SSA communities if appropriately trained and supervised. Hence, SSA policymakers should give this initiative due consideration as a way of improving access to family planning services.
Topics: Africa South of the Sahara; Community Health Workers; Contraceptive Agents, Female; Delivery of Health Care; Family Planning Services; Female; Humans
PubMed: 36064408
DOI: 10.1186/s12960-022-00763-8 -
Frontiers in Cellular and Infection... 2021Exogenous sex steroids within hormonal contraception and menopausal hormone therapy (MHT) have been used for family planning and management of menopausal symptoms,...
BACKGROUND
Exogenous sex steroids within hormonal contraception and menopausal hormone therapy (MHT) have been used for family planning and management of menopausal symptoms, without consideration of their effects on the vaginal microbiota. This is largely because their use predates our understanding of the importance of the vaginal microbiome on human health. We conducted a systematic review (PROSPERO: CRD42018107730) to determine the influence of exogenous sex steroids, stratified by oestrogen-containing or progestin-only types of contraception, and MHT on the vaginal microbiome, as measured by molecular methods.
METHODS
Embase, PubMed and Medline were searched for relevant literature published through to December 1st 2020. Eligible studies reported on the effect of specific exogenous sex steroids on the vaginal microbiome using a molecular method. Data regarding the 'positive', 'negative' or 'neutral' effect of each type of contraceptive or MHT on the vaginal microbiome was extracted and summarised. A positive effect reflected sex steroid exposure that was associated with increased abundance of lactobacilli, a change to, or maintenance of, an optimal vaginal microbiota composition, or a decrease in bacterial diversity (specifically reflecting a low-diversity optimal microbiota state), relative to the control group. An exogenous sex steroid was designated as having a negative effect on the vaginal microbiome if it resulted in opposing effects (i.e. loss of lactobacilli, a non-optimal microbiota state). When no significant change was found, this was considered neutral/inconclusive.
RESULTS
We identified 29 manuscripts reporting on the effect of exogenous sex steroids on the vaginal microbiome; 25 investigating hormonal contraceptives, and 4 investigating MHT. Oestrogen-containing contraception, particularly reflecting the combined oestrogen and progestin-containing contraceptive pill, had a positive effect on the composition of the vaginal microbiota. Progestin-only contraception, particularly reflecting depo-medroxyprogesterone acetate, had mixed effects on the microbiota. Among post-menopausal women using MHT, exogenous oestrogen applied topically was associated with increased prevalence of lactobacilli.
CONCLUSION
Our findings suggest that oestrogen-containing compounds may promote an optimal vaginal microbiota, which could have clinical applications. The impact of progestin-only contraceptives on the vaginal microbiota is less clear; more data is needed to determine how progestin-only contraceptives contribute to adverse reproductive and sexual health outcomes.
Topics: Female; Humans; Lactobacillus; Microbiota; Vagina
PubMed: 34869054
DOI: 10.3389/fcimb.2021.732423 -
Cancer Management and Research 2019This study aimed to identify potential prognostic factors for patients with complex atypical hyperplasia (CAH) or early-stage endometrial cancer (EC) who received...
Weight control is vital for patients with early-stage endometrial cancer or complex atypical hyperplasia who have received progestin therapy to spare fertility: a systematic review and meta-analysis.
This study aimed to identify potential prognostic factors for patients with complex atypical hyperplasia (CAH) or early-stage endometrial cancer (EC) who received progestin therapy to spare fertility and, thus, improve the management of this patient group. The PubMed, PMC, EMBASE, Web of Science, and Cochrane databases were searched for correlational studies published in English. Studies that evaluated the prognosis of patients with CAH or early-stage EC were pooled for a systematic review and meta-analysis. In total, 31 eligible studies, including 8 prospective and 23 retrospective studies involving 1099 patients, were included in this analysis. The most commonly used progestin agents were medroxyprogesterone acetate (MPA, 47.0%) and megestrol acetate (MA, 25.5%). The total complete response (CR) rate was 75.8% (833/1099), and the median time to CR with first-line progestin therapy was 6 months. In total, 294 (26.8%) patients who achieved CR became pregnant spontaneously (28 cases) or through assisted reproductive technology (127 cases). During the median follow-up of 39 months, 245 (22.3%) women developed recurrence. Only one patient (0.09%) died of the disease. The meta-analysis showed that compared to a BMI<25 kg/m and CAH, a body mass index (BMI) ≥25 kg/m (=0.0004, odds ratios (OR), 0.4; 95% confidence interval, 0.3-0.6) and EC (=0.0000, OR, 0.3; 95% confidence interval, 0.2-0.6) were significantly associated with a higher likelihood of a CR. Patients with a BMI≥25 kg/m (=0.0007, OR, 2.5; 95% confidence interval, 1.4-4.3), PCOS (=0.0006, OR, 3.4; 95% confidence interval, 1.5-7.9), and EC (=0.0344, OR, 2.8; 95% confidence interval, 1.4-5.3) had a significantly higher risk of recurrence. In general, patients with CAH or early-stage EC who were treated with progesterone therapy had a favorable prognosis. However, the recurrence risk was not insignificant. Weight control is crucial for improving the clinical management of this patient group.
PubMed: 31190979
DOI: 10.2147/CMAR.S194607 -
The Cochrane Database of Systematic... Apr 2019High altitude illness (HAI) is a term used to describe a group of mainly cerebral and pulmonary syndromes that can occur during travel to elevations above 2500 metres...
BACKGROUND
High altitude illness (HAI) is a term used to describe a group of mainly cerebral and pulmonary syndromes that can occur during travel to elevations above 2500 metres (˜ 8200 feet). Acute mountain sickness (AMS), high altitude cerebral oedema (HACE), and high altitude pulmonary oedema (HAPE) are reported as potential medical problems associated with high altitude ascent. In this, the third of a series of three reviews about preventive strategies for HAI, we assessed the effectiveness of miscellaneous and non-pharmacological interventions.
OBJECTIVES
To assess the clinical effectiveness and adverse events of miscellaneous and non-pharmacological interventions for preventing acute HAI in people who are at risk of developing high altitude illness in any setting.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) in January 2019. We adapted the MEDLINE strategy for searching the other databases. We used a combination of thesaurus-based and free-text search terms. We scanned the reference lists and citations of included trials and any relevant systematic reviews that we identified for further references to additional trials.
SELECTION CRITERIA
We included randomized controlled trials conducted in any setting where non-pharmacological and miscellaneous interventions were employed to prevent acute HAI, including preacclimatization measures and the administration of non-pharmacological supplements. We included trials involving participants who are at risk of developing high altitude illness (AMS or HACE, or HAPE, or both). We included participants with, and without, a history of high altitude illness. We applied no age or gender restrictions. We included trials where the relevant intervention was administered before the beginning of ascent.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures employed by Cochrane.
MAIN RESULTS
We included 20 studies (1406 participants, 21 references) in this review. Thirty studies (14 ongoing, and 16 pending classification (awaiting)) will be considered in future versions of this suite of three reviews as appropriate. We report the results for the primary outcome of this review (risk of AMS) by each group of assessed interventions.Group 1. Preacclimatization and other measures based on pressureUse of simulated altitude or remote ischaemic preconditioning (RIPC) might not improve the risk of AMS on subsequent exposure to altitude, but this effect is uncertain (simulated altitude: risk ratio (RR) 1.18, 95% confidence interval (CI) 0.82 to 1.71; I² = 0%; 3 trials, 140 participants; low-quality evidence. RIPC: RR 3.0, 95% CI 0.69 to 13.12; 1 trial, 40 participants; low-quality evidence). We found evidence of improvement of this risk using positive end-expiratory pressure (PEEP), but this information was derived from a cross-over trial with a limited number of participants (OR 3.67, 95% CI 1.38 to 9.76; 1 trial, 8 participants; low-quality evidence). We found scarcity of evidence about the risk of adverse events for these interventions.Group 2. Supplements and vitaminsSupplementation of antioxidants, medroxyprogesterone, iron or Rhodiola crenulata might not improve the risk of AMS on exposure to high altitude, but this effect is uncertain (antioxidants: RR 0.58, 95% CI 0.32 to 1.03; 1 trial, 18 participants; low-quality evidence. Medroxyprogesterone: RR 0.71, 95% CI 0.48 to 1.05; I² = 0%; 2 trials, 32 participants; low-quality evidence. Iron: RR 0.65, 95% CI 0.38 to 1.11; I² = 0%; 2 trials, 65 participants; low-quality evidence. R crenulata: RR 1.00, 95% CI 0.78 to 1.29; 1 trial, 125 participants; low-quality evidence). We found evidence of improvement of this risk with the administration of erythropoietin, but this information was extracted from a trial with issues related to risk of bias and imprecision (RR 0.41, 95% CI 0.20 to 0.84; 1 trial, 39 participants; very low-quality evidence). Regarding administration of ginkgo biloba, we did not perform a pooled estimation of RR for AMS due to considerable heterogeneity between the included studies (I² = 65%). RR estimates from the individual studies were conflicting (from 0.05 to 1.03; low-quality evidence). We found scarcity of evidence about the risk of adverse events for these interventions.Group 3. Other comparisonsWe found heterogeneous evidence regarding the risk of AMS when ginkgo biloba was compared with acetazolamide (I² = 63%). RR estimates from the individual studies were conflicting (estimations from 0.11 (95% CI 0.01 to 1.86) to 2.97 (95% CI 1.70 to 5.21); low-quality evidence). We found evidence of improvement when ginkgo biloba was administered along with acetazolamide, but this information was derived from a single trial with issues associated to risk of bias (compared to ginkgo biloba alone: RR 0.43, 95% CI 0.26 to 0.71; 1 trial, 311 participants; low-quality evidence). Administration of medroxyprogesterone plus acetazolamide did not improve the risk of AMS when compared to administration of medroxyprogesterone or acetazolamide alone (RR 1.33, 95% CI 0.50 to 3.55; 1 trial, 12 participants; low-quality evidence). We found scarcity of evidence about the risk of adverse events for these interventions.
AUTHORS' CONCLUSIONS
This Cochrane Review is the final in a series of three providing relevant information to clinicians, and other interested parties, on how to prevent high altitude illness. The assessment of non-pharmacological and miscellaneous interventions suggests that there is heterogeneous and even contradictory evidence related to the effectiveness of these prophylactic strategies. Safety of these interventions remains as an unclear issue due to lack of assessment. Overall, the evidence is limited due to its quality (low to very low), the relative paucity of that evidence and the number of studies pending classification for the three reviews belonging to this series (30 studies either awaiting classification or ongoing). Additional studies, especially those comparing with pharmacological alternatives (such as acetazolamide) are required, in order to establish or refute the strategies evaluated in this review.
Topics: Acetazolamide; Altitude Sickness; Brain Edema; Ginkgo biloba; Humans; Hypertension, Pulmonary; Medroxyprogesterone; Plant Extracts; Randomized Controlled Trials as Topic
PubMed: 31012483
DOI: 10.1002/14651858.CD013315