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Frontiers in Medicine 2022Coronavirus disease-2019 (COVID-19), a worldwide disaster, has already affected lots of people. Effective care and therapy are currently being evaluated in full swing.
BACKGROUND
Coronavirus disease-2019 (COVID-19), a worldwide disaster, has already affected lots of people. Effective care and therapy are currently being evaluated in full swing.
PURPOSE
Our purpose was to investigate the effects of tocilizumab, an interleukin-6 receptor inhibitor, on treatment of adult patients with COVID-19 pneumonia.
DATA SOURCES STUDY SELECTION AND DATA EXTRACTION
We conducted a meta-analysis and searched for relevant studies on Pubmed, Embase, and the Cochrane Library without restrictions on language from inception until February 1, 2021. Fifteen studies were included for this meta-analysis. Two authors independently selected and screened these studies, assessed the quality of included studies, and extracted related information.
RESULTS
Fifteen studies were included in this meta-analysis. The main studies showed that tocilizumab was associated with lower mortality (risk ratio = 0.62, 95% confidence interval = 0.46-0.83; and hazard ratio = 0.61, 95% confidence interval = 0.51-0.72). Using tocilizumab might also affect biochemistry indicators (lowered C-reactive protein and ferritin, increased lymphocyte count).
CONCLUSION
These current bodies of evidence could indicate that early use of tocilizumab was associated with lower mortality in adult patients with COVID-19. Early use of tocilizumab could reduce the mortality rate of adult patients with COVID-19 without obvious fatal side effects, which may be a treatment option in patients with COVID-19 pneumonia.
SYSTEMATIC REVIEW REGISTRATION
The study protocol was registered on PROSPERO (ID:242811).
PubMed: 35433719
DOI: 10.3389/fmed.2022.838904 -
World Journal of Psychiatry Dec 2021Bipolar disorder (BD) is a severe psychiatric disorder characterized by mood swings. Psychosocial interventions, such as psychoeducation, play an essential role in...
BACKGROUND
Bipolar disorder (BD) is a severe psychiatric disorder characterized by mood swings. Psychosocial interventions, such as psychoeducation, play an essential role in promoting social rehabilitation and improving pharmacological treatment.
AIM
To investigate the role of psychoeducation in BD.
METHODS
A systematic review of original studies regarding psychoeducation interventions in patients with BD and their relatives was developed. A systematic literature search was performed using the Medline, Scopus, and Lilacs databases. No review articles or qualitative studies were included in the analysis. There were no date restriction criteria, and studies published up to April 2021 were included.
RESULTS
A total of forty-seven studies were selected for this review. Thirty-eight studies included patients, and nine included family members. Psychoeducation of patients and family members was associated with a lower number of new mood episodes and a reduction in number and length of stay of hospitalizations. Psychoeducational interventions with patients are associated with improved adherence to drug treatment. The strategies studied in patients and family members do not interfere with the severity of symptoms of mania or depression or with the patient's quality of life or functionality. Psychoeducational interventions with family members do not alter patients' adherence to pharmacotherapy.
CONCLUSION
Psychoeducation as an adjunct strategy to pharmacotherapy in the treatment of BD leads to a reduction in the frequency of new mood episodes, length of hospital stay and adherence to drug therapy.
PubMed: 35070785
DOI: 10.5498/wjp.v11.i12.1407 -
Iranian Journal of Nursing and... 2021After childbirth, sexual dysfunction refers to a chain of psychiatric, physiological, social changes and a couple's experiences. The purpose of our Systematic Review... (Review)
Review
BACKGROUND
After childbirth, sexual dysfunction refers to a chain of psychiatric, physiological, social changes and a couple's experiences. The purpose of our Systematic Review (Syst.Rev.) is to evaluate available high-quality evidence and construct a Bio Psycho Social (BPS) model of couple's sexual function after childbirth.
MATERIALS AND METHODS
A systematic search was done with MeSH terms in databases, including PubMed, Web of Science, Scopus, and Science direct. A total number of 9 Syst.Rev. were evaluated from 2009 to 2019 years. The quality of extracted articles was evaluated based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist of contents using two qualified reviewers. Data synthesis was performed using the thematic analysis.
RESULTS
Biopsychosocial Model of Postpartum Couple's Sexual Function (BMPCSF) is proposed as a developmental process similar to Bronfenbrenner's Bioecological Systems Model. Studies showed a significant relationship among the type of childbirth, trauma of perineum, breastfeeding, mood swings, fears, changes in the self-body image, spousal support, and Postpartum Sexual Dysfunction (PSD). Hence, the evidence about male sexuality in the postpartum period doesn't seem sufficient.
CONCLUSIONS
The information from this study will help health policymakers develop the appropriate guidelines to inform couples and healthcare professionals about the BPS changes after childbirth and PSD. Besides, BMPCSF can be used in postpartum sexual counseling to improve sexual health and marital relationships. We propose comprehensive original study on couples' postpartum sexuality, especially men's conduct, emphasizing socio-cultural factors.
PubMed: 34900644
DOI: 10.4103/ijnmr.IJNMR_426_20 -
Journal of Tropical Pediatrics Jan 2021During the current ongoing COVID-19 pandemic, psychological problems like anxiety, depression, irritability, mood swings, inattention and sleep disturbance are fairly... (Meta-Analysis)
Meta-Analysis
Psychological and Behavioral Impact of Lockdown and Quarantine Measures for COVID-19 Pandemic on Children, Adolescents and Caregivers: A Systematic Review and Meta-Analysis.
BACKGROUND
During the current ongoing COVID-19 pandemic, psychological problems like anxiety, depression, irritability, mood swings, inattention and sleep disturbance are fairly common among quarantined children in several studies. A systematic review of these publications to provide an accurate burden of these psychiatric/behavioral problems is needed for planning mitigating measures by the health authorities.
METHODS
Different electronic databases (MEDLINE, EMBASE, Web of Science, CENTRAL, medRxiv and bioRxiv) were searched for articles describing psychological/behavioral complications in children/adolescents with/without pre-existing behavioral abnormalities and their caregivers related to the COVID-19 pandemic. Only original articles with/without comparator arms and a minimum sample size of 50 were included in the analysis. The pooled estimate of various psychological/behavioral problems was calculated using a random-effect meta-analysis.
RESULTS
Fifteen studies describing 22 996 children/adolescents fulfilled the eligibility criteria from a total of 219 records. Overall, 34.5%, 41.7%, 42.3% and 30.8% of children were found to be suffering from anxiety, depression, irritability and inattention. Although the behavior/psychological state of a total of 79.4% of children was affected negatively by the pandemic and quarantine, at least 22.5% of children had a significant fear of COVID-19, and 35.2% and 21.3% of children had boredom and sleep disturbance. Similarly, 52.3% and 27.4% of caregivers developed anxiety and depression, respectively, while being in isolation with children.
CONCLUSION
Anxiety, depression, irritability, boredom, inattention and fear of COVID-19 are predominant new-onset psychological problems in children during the COVID-19 pandemic. Children with pre-existing behavioral problems like autism and attention deficit hyperactivity disorder have a high probability of worsening of their behavioral symptoms.
Topics: Adolescent; Anxiety; COVID-19; Caregivers; Child; Cross-Sectional Studies; Depression; Humans; Mental Health; Pandemics; Problem Behavior; Quarantine
PubMed: 33367907
DOI: 10.1093/tropej/fmaa122 -
International Journal of Molecular... Oct 2020Bipolar disorder (BD) is a complex neurobiological disorder characterized by a pathologic mood swing. Digital phenotyping, defined as the 'moment-by-moment... (Meta-Analysis)
Meta-Analysis
Bipolar disorder (BD) is a complex neurobiological disorder characterized by a pathologic mood swing. Digital phenotyping, defined as the 'moment-by-moment quantification of the individual-level human phenotype in its own environment', represents a new approach aimed at measuring the human behavior and may theoretically enhance clinicians' capability in early identification, diagnosis, and management of any mental health conditions, including BD. Moreover, a digital phenotyping approach may easily introduce and allow clinicians to perform a more personalized and patient-tailored diagnostic and therapeutic approach, in line with the framework of precision psychiatry. The aim of the present paper is to investigate the role of digital phenotyping in BD. Despite scarce literature published so far, extremely heterogeneous methodological strategies, and limitations, digital phenotyping may represent a grounding research and clinical field in BD, by owning the potentialities to quickly identify, diagnose, longitudinally monitor, and evaluating clinical response and remission to psychotropic drugs. Finally, digital phenotyping might potentially constitute a possible predictive marker for mood disorders.
Topics: Biomarkers; Bipolar Disorder; Endophenotypes; Humans; Mobile Applications; Precision Medicine; Telemedicine
PubMed: 33081393
DOI: 10.3390/ijms21207684 -
The Cochrane Database of Systematic... Sep 2020In the absence of treatment, endometrial hyperplasia (EH) can progress to endometrial cancer, particularly in the presence of histologic nuclear atypia. The development... (Meta-Analysis)
Meta-Analysis
BACKGROUND
In the absence of treatment, endometrial hyperplasia (EH) can progress to endometrial cancer, particularly in the presence of histologic nuclear atypia. The development of EH results from exposure of the endometrium to oestrogen unopposed by progesterone. Oral progestogens have been used as treatment for EH without atypia, and in some cases of EH with atypia in women who wish to preserve fertility or who cannot tolerate surgery. EH without atypia is associated with a low risk of progression to atypia and cancer; EH with atypia is where the cells are structurally abnormal, and has a higher risk of developing cancer. Oral progestogen is not always effective at reversing the hyperplasia, can be associated with side effects, and depends on patient adherence. The levonorgestrel-intrauterine system (LNG-IUS) is an alternative method of administration of progestogen and may have some advantages over non-intrauterine progestogens.
OBJECTIVES
To evaluate the effectiveness and safety of the levonorgestrel intrauterine system (LNG-IUS) in women with endometrial hyperplasia (EH) with or without atypia compared to medical treatment with non-intrauterine progestogens, placebo, surgery or no treatment.
SEARCH METHODS
We searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO, and conference proceedings of 10 relevant organisations. We handsearched references in relevant published studies. We also searched ongoing trials in ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry, and other trial registries. We performed the final search in May 2020.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and cross-over trials of women with a histological diagnosis of endometrial hyperplasia with or without atypia comparing LNG-IUS with non-intrauterine progestogens, placebo, surgery or no treatment.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed study selection, risk of bias assessment and data extraction. Our primary outcome measures were regression of EH and adverse effects associated with the LNG-IUS device (such as pelvic inflammatory disease, device expulsion, uterine perforation) when compared to treatment with non-intrauterine progestogens, placebo, surgery or no treatment. Secondary outcomes included hysterectomy, hormone-related adverse effects (such as bleeding/spotting, pelvic pain, breast tenderness, ovarian cysts, weight gain, acne), withdrawal from treatment due to adverse effects, satisfaction with treatment, and cost or resource use. We rated the overall quality of evidence using GRADE methods.
MAIN RESULTS
Thirteen RCTs (1657 women aged 22 to 75 years) met the inclusion criteria. Two studies had insufficient data for meta-analysis, thus the quantitative analysis included 11 RCTs. All trials evaluated treatment duration of six months or less. The evidence ranged from very low to moderate quality: the main limitations were risk of bias (associated with lack of blinding and poor reporting of study methods), inconsistency and imprecision. LNG-IUS versus non-intrauterine progestogens Primary outcomes Regression of endometrial hyperplasia The LNG-IUS probably improves regression of EH compared with non-intrauterine progestogens at short-term follow-up (up to six months) (OR 2.94, 95% CI 2.10 to 4.13; I² = 0%; 10 RCTs, 1108 participants; moderate-quality evidence). This suggests that if regression of EH following treatment with a non-intrauterine progestogen is assumed to be 72%, regression of EH following treatment with LNG-IUS would be between 85% and 92%. Regression of EH may be improved by LNG-IUS compared with non-intrauterine progestogens at long-term follow-up (12 months) (OR 3.80, 95% CI 1.75 to 8.23; 1 RCT, 138 participants; low-quality evidence), Adverse effects associated with LNG-IUS There was insufficient evidence to determine device-related adverse effects; only one study reported on expulsion with insufficient data for analysis. Secondary outcomes The LNG-IUS may be associated with fewer hysterectomies (OR 0.26, 95% CI 0.15 to 0.46; I² = 19%; 4 RCTs, 452 participants; low-quality evidence), fewer withdrawals from treatment due to hormone-related adverse effects (OR 0.41, 95% CI 0.12 to 1.35; I² = 0%; 4 RCTs, 360 participants; low-quality evidence) and improved patient satisfaction with treatment (OR 5.28, 95% CI 2.51 to 11.10; I² = 0%; 2 RCTs, 202 participants; very low-quality evidence) compared to non-intrauterine progestogens. The LNG-IUS may be associated with more bleeding/spotting (OR 2.13, 95% CI 1.33 to 3.43; I² = 78%; 3 RCTs, 428 participants) and less nausea (OR 0.52, 95% CI 0.28 to 0.95; I² = 0%; 3 RCTs, 428 participants) compared to non-intrauterine progestogens. Data from single trials for mood swings and fatigue had a similar direction of effect as for bleeding/spotting, nausea and weight gain. There was insufficient evidence to determine cost or resource use. LNG-IUS versus no treatment Regression of endometrial hyperplasia One study demonstrated that the LNG-IUS is associated with regression of EH without atypia (OR 78.41, 95% CI 22.86 to 268.97; I² = 0%; 1 RCT, 190 participants; moderate-quality evidence) compared with no treatment. This study did not report on any other review outcome.
AUTHORS' CONCLUSIONS
There is moderate-quality evidence that treatment with LNG-IUS used for three to six months is probably more effective than non-intrauterine progestogens at reversing EH in the short term (up to six months) and long term (up to two years). Adverse effects (device-related and hormone-related) were poorly and incompletely reported across studies. Very low quality to low-quality evidence suggests the LNG-IUS may reduce the risk of hysterectomy, and may be associated with more bleeding/spotting, less nausea, less withdrawal from treatment due to adverse effects, and increased satisfaction with treatment, compared to non-intrauterine progestogens. There was insufficient evidence to reach conclusions regarding device-related adverse effects, or cost or resource use.
Topics: Adult; Aged; Bias; Contraceptive Agents, Female; Endometrial Hyperplasia; Female; Humans; Hysterectomy; Intrauterine Device Expulsion; Intrauterine Devices, Medicated; Levonorgestrel; Middle Aged; Nausea; Patient Dropouts; Patient Satisfaction; Progestins; Randomized Controlled Trials as Topic; Remission Induction; Time Factors; Uterine Hemorrhage; Weight Gain; Young Adult
PubMed: 32909630
DOI: 10.1002/14651858.CD012658.pub2 -
The Cochrane Database of Systematic... Mar 2019This is an update of the original review published in the Cochrane Database of Systematic Reviews 2011, Issue 11, and updated in 2015, Issue 4.Chemotherapy has... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This is an update of the original review published in the Cochrane Database of Systematic Reviews 2011, Issue 11, and updated in 2015, Issue 4.Chemotherapy has significantly improved prognosis for women with malignant and some non-malignant conditions. This treatment, however, is associated with ovarian toxicity. The use of gonadotropin-releasing hormone (GnRH) analogues, both agonists and antagonists, may have a protective effect on the ovaries. The primary mechanism of action of GnRH analogues is to suppress the gonadotropin levels to simulate pre-pubertal hormonal milieu and subsequently prevent primordial follicles from maturation and therefore decrease the number of follicles that are more vulnerable to chemotherapy.
OBJECTIVES
To assess the efficacy and safety of GnRH analogues given before or in parallel to chemotherapy to prevent chemotherapy-related ovarian damage in premenopausal women with malignant or non-malignant conditions.
SEARCH METHODS
The search was run for the original review in July 2011, and for the first update in July 2014. For this update we searched the following databases in November 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Chinese Biomedicine Database (CBM).
SELECTION CRITERIA
Randomised controlled trials (RCTs), in all languages, which examined the effect of GnRH analogues for chemotherapy-induced ovarian failure in premenopausal women, were eligible for inclusion in the review.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed trial quality using the Cochrane 'Risk of bias' tool. We analysed binary data using risk ratios (RRs) with 95% confidence intervals (CI) and for continuous data, we used the standardized mean difference (SMD) to combine trials. We applied the random-effects model in our analyses. We used the GRADE approach to produce a 'Summary of findings' table for our main outcomes of interest.
MAIN RESULTS
We included 12 RCTs involving 1369 women between the ages of 12 and 51.1 years. Participants were diagnosed with breast malignancy, ovarian malignancy, or Hodgkin's lymphoma, and most of them received alkylating, or platinum complexes, based chemotherapy. The included studies were funded by a university (n = 1), research centres (n = 4), and pharmaceutical companies (n = 1). Trials were at high or unclear risk of bias.Comparison 1: GnRH agonist plus chemotherapy versus chemotherapy aloneThe incidence of menstruation recovery or maintenance was 178 of 239 (74.5%) in the GnRH agonist group and 110 of 221 (50.0%) in the control group during a follow-up period no longer than 12 months (RR 1.60, 95% CI 1.14 to 2.24; 5 studies, 460 participants; I = 79%; low-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P = 0.006). However, we observed no difference during a follow-up period longer than 12 months between these two groups (P = 0.24). In the GnRH agonist group, 326 of 447 participants had menstruation recovery or maintenance (72.9%) in comparison to the control group, in which 276 of 422 participants had menstruation recovery or maintenance (65.4%) during a follow-up period longer than 12 months (RR 1.08, 95% CI 0.95 to 1.22; 8 studies, 869 participants; I = 56%; low-certainty evidence).The incidence of premature ovarian failure was 43 of 401 (10.7%) in the GnRH agonist group and 96 of 379 (25.3%) in the control group (RR 0.44, 95% CI 0.31 to 0.61; 4 studies, 780 participants; I = 0%; moderate-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P < 0.00001).The incidence of pregnancy was 32 of 356 (9.0%) in the GnRH agonist group and 22 of 347 (6.3%) in the control group (RR 1.59, 95% CI 0.93 to 2.70; 7 studies, 703 participants; I = 0%; low-certainty evidence), with no difference between groups (P = 0.09). However, we are cautious about this conclusion because there were insufficient data about whether the participants intended to become pregnant.The incidence of ovulation was 29 of 47 (61.7%) in the GnRH agonist group and 12 of 48 (25.0%) in the control group (RR 2.47, 95% CI 1.43 to 4.26; 2 studies, 95 participants; I = 0%; low-certainty evidence) with an overall effect favouring treatment with GnRH (P = 0.001).The most common adverse effects of GnRH analogues included hot flushes, vaginal dryness, urogenital symptoms, and mood swings. The pooled analysis of safety data showed no difference in adverse effects between GnRH agonist group and control group.Comparison 2: GnRH agonist-antagonist cotreatment plus chemotherapy versus chemotherapy aloneOnly one RCT discussed GnRH agonist-antagonist cotreatment. The limited evidence showed the incidence of menstruation recovery or maintenance was 20 of 25 (80%) in both cotreatment group and control group during a 12-month follow-up period (RR 1.00, 95% CI 0.76 to 1.32; 50 participants; very low-certainty evidence), with no difference between groups (P = 1.00). In the cotreatment group, 13 of 25 participants had menstruation recovery or maintenance (52.0%) in comparison to the control group, in which 14 of 25 participants had menstruation recovery or maintenance (56.0%) during a follow-up period longer than 12 months (RR 0.93, 95% CI 0.56 to 1.55; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.78). The incidence of pregnancy was 1 of 25 (4.0%) in the cotreatment group and 0 of 25 (0%) in the control group (RR 3.00, 95% CI 0.13 to 70.30; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.49).
AUTHORS' CONCLUSIONS
GnRH agonist appears to be effective in protecting the ovaries during chemotherapy, in terms of maintenance and resumption of menstruation, treatment-related premature ovarian failure and ovulation. Evidence for protection of fertility was insufficient and needs further investigation. Evidence was also insufficient to assess the effect of GnRH agonist and GnRH antagonist cotreatment on ovarian protection against chemotherapy. The included studies differed in some important aspects of design, and most of these studies had no age-determined subgroup analysis. Large and well-designed RCTs with longer follow-up duration should be conducted to clarify the effects of GnRH analogues in preventing chemotherapy-induced ovarian failure, especially on different age groups or different chemotherapy regimens. Furthermore, studies should address the effects on pregnancy rates and anti-tumour therapy.
Topics: Administration, Intranasal; Adolescent; Adult; Antineoplastic Agents; Child; Female; Gonadotropin-Releasing Hormone; Humans; Injections, Intramuscular; Injections, Subcutaneous; Menstruation; Middle Aged; Ovulation; Pregnancy; Pregnancy Rate; Premenopause; Primary Ovarian Insufficiency; Randomized Controlled Trials as Topic; Recovery of Function; Young Adult
PubMed: 30827035
DOI: 10.1002/14651858.CD008018.pub3 -
The Cochrane Database of Systematic... Mar 2017Premenstrual syndrome (PMS) is a psychological and somatic disorder of unknown aetiology, with symptoms typically including irritability, depression, mood swings,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Premenstrual syndrome (PMS) is a psychological and somatic disorder of unknown aetiology, with symptoms typically including irritability, depression, mood swings, bloating, breast tenderness and sleep disturbances. About 3% to 10% of women who experience these symptoms may also meet criteria for premenstrual dysphoric disorder (PMDD). PMS symptoms recur during the luteal phase of the menstrual cycle and reduce by the end of menstruation. PMS results from ovulation and may be due to ovarian steroid interactions relating to neurotransmitter dysfunction. Premenstrual disorders have a devastating effect on women, their families and their work.Several treatment options have been suggested for PMS, including pharmacological and surgical interventions. The treatments thought to be most effective tend to fall into one of two categories: suppressing ovulation or correcting a speculated neuroendocrine anomaly.Transdermal oestradiol by patch, gel or implant effectively stops ovulation and the cyclical hormonal changes which produce the cyclical symptoms. These preparations are normally used for hormone therapy and contain lower doses of oestrogen than found in oral contraceptive pills. A shortened seven-day course of a progestogen is required each month for endometrial protection but can reproduce premenstrual syndrome-type symptoms in these women.
OBJECTIVES
To determine the effectiveness and safety of non-contraceptive oestrogen-containing preparations in the management of PMS.
SEARCH METHODS
On 14 March 2016, we searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register; Cochrane Central Register of Studies (CRSO); MEDLINE; Embase; PsycINFO; CINAHL; ClinicalTrials.gov; metaRegister of Controlled trials (mRCT); and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Search Portal. In addition, we checked the reference lists of articles retrieved.
SELECTION CRITERIA
We included published and unpublished randomized placebo or active controlled trials on the efficacy of the use of non-contraceptive oestrogen-containing preparations in the management of premenstrual syndrome in women of reproductive age with PMS diagnosed by at least two prospective cycles without current psychiatric disorder.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies, assessed risk of bias, extracted data on premenstrual symptoms and adverse effects and entered data into Review Manager 5 software. Where possible, intention-to-treat or modified intention-to-treat analysis was used. Studies were pooled using a fixed-effect model, analysing cross-over trials as parallel trials. Standardised mean differences (SMDs) with 95% confidence intervals (CIs) were calculated for premenstrual symptom scores. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated for dichotomous outcomes. The overall quality of the evidence was assessed using the GRADE working group methods.
MAIN RESULTS
The search resulted in 524 potentially relevant articles. Five eligible randomized controlled trials (RCTs) were identified (305 women). Trials using oral tablets, transdermal patches and implants were identified. No trial used gels.One small cross-over trial (11 women, effective sample size 22 women considering cross-over trials) compared oral luteal-phase oestrogen versus placebo. Data were very low quality and unsuitable for analysis, but study authors reported that the intervention was ineffective and might aggravate the symptoms of PMS. They also reported that there were no adverse events.Three studies compared continuous oestrogen with progestogen versus placebo (with or without progestogen). These trials were of reasonable quality, although with a high risk of attrition bias and an unclear risk of bias due to potential carry-over effects in two cross-over trials. Continuous oestrogen had a small to moderate positive effect on global symptom scores (SMD -0.34, 95% CI -0.59 to -0.10, P = 0.005, 3 RCTs, 158 women, effective sample size 267 women, I² = 63%, very low quality evidence). The evidence was too imprecise to determine if the groups differed in withdrawal rates due to adverse effects (RR 0.64, 95% CI 0.26 to 1.58, P = 0.33, 3 RCTs, 196 women, effective sample size 284 women, I² = 0%, very low quality evidence). Similarly, the evidence was very imprecise in measures of specific adverse events, with large uncertainties around the true value of the relative risk. None of the studies reported on long-term risks such as endometrial cancer or breast cancer.One study compared patch dosage (100 vs 200 µg oestrogen, with progestogen in both arms) and had a high risk of performance bias, detection bias and attrition bias. The study did not find evidence that dosage affects global symptoms but there was much uncertainty around the effect estimate (SMD -1.55, 95% CI -8.88 to 5.78, P = 0.68, 1 RCT, 98 women, very low quality evidence). The evidence on rates of withdrawal for adverse events was too imprecise to draw any conclusions (RR 0.70, 95% CI 0.34 to 1.46, P = 0.34, 1 RCT, 107 women, low-quality evidence). However, it appeared that the 100 µg dose might be associated with a lower overall risk of adverse events attributed to oestrogen (RR 0.51, 95% Cl 0.26 to 0.99, P = 0.05, 1 RCT, 107 women, very low quality evidence) with a large uncertainty around the effect estimate.The overall quality of the evidence for all comparisons was very low, mainly due to risk of bias (specifically attrition), imprecision, and statistical and clinical heterogeneity.
AUTHORS' CONCLUSIONS
We found very low quality evidence to support the effectiveness of continuous oestrogen (transdermal patches or subcutaneous implants) plus progestogen, with a small to moderate effect size. We found very low quality evidence from a study based on 11 women to suggest that luteal-phase oral unopposed oestrogen is probably ineffective and possibly detrimental for controlling the symptoms of PMS. A comparison between 200 µg and 100 µg doses of continuous oestrogen was inconclusive with regard to effectiveness, but suggested that the lower dose was less likely to cause side effects. Uncertainty remains regarding safety, as the identified studies were too small to provide definite answers. Moreover, no included trial addressed adverse effects that might occur beyond the typical trial duration of 2-8 months. This suggests the choice of oestrogen dose and mode of administration could be based on an individual woman's preference and modified according to the effectiveness and tolerability of the chosen regimen.
Topics: Administration, Oral; Drug Implants; Drug Therapy, Combination; Estrogens; Female; Humans; Luteal Phase; Premenstrual Dysphoric Disorder; Premenstrual Syndrome; Progestins; Randomized Controlled Trials as Topic; Transdermal Patch
PubMed: 28257559
DOI: 10.1002/14651858.CD010503.pub2 -
International Journal of Surgery... Jan 2015Previous studies have shown that parathyroidectomy for primary hyperparathyroidism (PHPT) improve the function and quality of life of patients. The aim of this... (Meta-Analysis)
Meta-Analysis Review
The extent of improvement of health-related quality of life as assessed by the SF36 and Paseika scales after parathyroidectomy in patients with primary hyperparathyroidism--a systematic review and meta-analysis.
BACKGROUND
Previous studies have shown that parathyroidectomy for primary hyperparathyroidism (PHPT) improve the function and quality of life of patients. The aim of this systematic review and meta-analysis is to determine the health-related quality of life outcomes among those having surgical management for PHPT.
METHODS
Several databases were searched (MEDLINE, EMBASE, PubMed, Current Contents) for studies in which health-related quality of life was measured by reliable and validated instruments (SF-36 and Paseika Questionnaire) before and after parathyroidectomy for patients with primary hyperparathyroidism (PHPT). For the SF-36, score differences greater than 5 points indicate clinically relevant changes.
RESULTS
There were six studies with quality of life data. The SF-36 data was derived from 238 patients, with a mean age of 59 years and 71% were females. The range of follow up after surgery was 6 months to one year. The pre- and post-parathyroidectomy SF-36 quality of life scale scores were vitality (44 vs. 60, p<0.001), physical functioning (51 vs. 69, p<0.001), bodily pain (50 vs. 65, p<0.001), general health (54 vs. 64, p<0.001), role physical (34 vs. 52, p<0.001), role emotional (43 vs. 59, p<0.001), role social (60 vs. 74, p<0.001), and mental health (55 vs. 71, p<0.001). The Paseika data was derived from 203 patients, with a mean age of 54 years and 67% were females. The pre- and post-parathyroidectomy Paseika scores were feeling tired (51 vs. 19, p<0.001), feeling thirsty (29 vs. 12, p<0.001), mood swings (33 vs. 12, p<0.001), joint pains (32 vs. 14, p<0.001), irritability (31 vs. 10, p<0.001), feeling blue (31 vs. 14, p<0.001), feeling weak (37 vs. 15, p<0.001), itchy (17 vs. 7, p<0.001), forgetful (27 vs. 16, p<0.001), headache (18 vs. 5, p<0.001), abdominal pain (19 vs. 8, p<0.001), bone pain (38 vs. 17, p<0.001), ability to move off chair (27 vs. 11, p<0.001).
CONCLUSION
Parathyroidectomy significantly improves the short to medium-term health-related quality of life of patients suffering from primary hyperparathyroidism.
Topics: Female; Humans; Hyperparathyroidism, Primary; Middle Aged; Parathyroidectomy; Prospective Studies; Psychometrics; Quality of Life; Surveys and Questionnaires
PubMed: 25542340
DOI: 10.1016/j.ijsu.2014.12.004 -
The Cochrane Database of Systematic... Aug 2014Corticosteroids are effective for induction, but not maintenance of remission in Crohn's disease. Significant concerns exist regarding the risk for adverse events,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Corticosteroids are effective for induction, but not maintenance of remission in Crohn's disease. Significant concerns exist regarding the risk for adverse events, particularly when corticosteroids are used for long treatment courses. Budesonide is a glucocorticoid with limited systemic bioavailability due to extensive first-pass hepatic metabolism and is effective for induction of remission in Crohn's disease.
OBJECTIVES
To evaluate the efficacy and safety of oral budesonide for maintenance of remission in Crohn's disease.
SEARCH METHODS
The following databases were searched from inception to 12 June 2014: PubMed, MEDLINE, EMBASE, CENTRAL, the Cochrane IBD/FBD Group Specialised Trial Register, and ClinicalTrials.gov. Reference lists of articles, as well as conference proceedings were manually searched.
SELECTION CRITERIA
Randomized controlled trials comparing budesonide to a control treatment, or comparing two doses of budesonide, were included. The study population included patients of any age with quiescent Crohn's disease.
DATA COLLECTION AND ANALYSIS
Two independent investigators reviewed studies for eligibility, extracted data and assessed study quality using the Cochrane risk of bias tool. The primary outcome was maintenance of remission at various reported follow-up times during the study. Secondary outcomes included: time to relapse, mean change in CDAI, clinical, histological, improvement in quality of life, adverse events and study withdrawal. We calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI) for dichotomous outcomes and the mean difference (MD) and 95% CI for continuous outcomes. Data were analysed on an intention-to-treat basis. The Chi(2) and I(2) statistics were used to assess heterogeneity. Random-effects models were used to allow for expected clinical and statistical heterogeneity. The overall quality of the evidence supporting the primary outcome was assessed using the GRADE criteria.
MAIN RESULTS
Twelve studies (n = 1273 patients) were included in the review: eight studies compared budesonide to placebo, one compared budesonide to 5-aminosalicylates, one compared budesonide to traditional systemic corticosteroids, one compared budesonide to azathioprine, and one compared two doses of budesonide. Nine studies used a controlled ileal release form of budesonide, while three used a pH-modified release formulation. Nine studies were judged to be at low risk of bias. Three studies were judged to be at high risk of bias due to blinding and one of these studies also had inadequate allocation concealment. Budesonide 6 mg daily was no more effective than placebo for maintenance of remission at 3 months, 6 months or 12 months. At three months 64% of budesonide 6 mg patients remained in remission compared to 52% of placebo patients (RR 1.25, 95% CI 1.00 to 1.58; 6 studies, 540 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low due to moderate heterogeneity (I(2) = 56%) and sparse data (315 events). At six months 61% of budesonide 6 mg patients remained in remission compared to 52% of placebo patients (RR 1.15, 95% CI 0.95 to 1.39; 5 studies, 420 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was moderate due to sparse data (238 events). At 12 months 55% of budesonide 6 mg patients remained in remission compared to 48% of placebo patients (RR 1.13; 95% CI 0.94 to 1.35; 5 studies, 420 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was moderate due to sparse data (215 events). Similarly, there was no significant benefit for budesonide 3 mg compared to placebo at 6 and 12 months. There was no statistically significant difference in continued remission at 12 months between budesonide and weaning doses of prednisolone (RR 0.79; 95% CI 0.55 to 1.13; 1 study, 90 patients). A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was low due to sparse data (51 events) and high risk of bias (no blinding). Budesonide 6 mg was better than mesalamine 3 g/day at 12 months (RR 2.51, 95% CI 1.03 to 6.12; 1 study, 57 patients). A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was very low due to very sparse data (18 events) and high risk of bias (no blinding). There was no statistically significant difference in continued remission at 12 months between budesonide and azathioprine (RR 0.81; 95% CI 0.61 to 1.08; 1 study 77 patients). A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was very low due to sparse data (55 events) and high risk of bias (single-blind and no allocation concealment). The use of budesonide 6 mg resulted in slight improvements in CDAI scores when assessed at 6 months (MD -24.30, 95% CI -46.31 to -2.29) and 12 months (MD -23.49, 95% CI -46.65 to -0.32) and mean time to relapse of disease (MD 59.93 days, 95% CI 19.02 to 100.84). Mean time to relapse was significantly shorter for patients receiving budesonide than for those receiving azathioprine (MD -58.00, 95% CI -96.68 to -19.32). Adverse events were not more common in patients treated with budesonide compared to placebo (6 mg: RR 1.51, 95% CI 0.90 to 2.52; 3 mg: RR 1.19, 95% CI 0.63 to 2.24). These events were relatively minor and did not result in increased rates of study withdrawal. Commonly reported treatment-related adverse effects included acne, moon facies, hirsutism, mood swings, insomnia, weight gain, striae, and hair loss. Abnormal adrenocorticoid stimulation tests were seen more frequently in patients receiving both 6 mg (RR 2.88, 95% CI 1.72 to 4.82) and 3 mg daily (RR 2.73, 95% CI 1.34 to 5.57) compared to placebo.
AUTHORS' CONCLUSIONS
These data suggest budesonide is not effective for maintenance of remission in CD, particularly when used beyond three months following induction of remission. Budesonide does have minor benefits in terms of lower CDAI scores and longer time to relapse of disease. However, these benefits are offset by higher treatment-related adverse event rates and more frequent adrenocorticoid suppression in patients receiving budesonide.
Topics: Administration, Oral; Anti-Inflammatory Agents; Budesonide; Crohn Disease; Humans; Induction Chemotherapy; Maintenance Chemotherapy; Randomized Controlled Trials as Topic; Risk; Secondary Prevention
PubMed: 25141071
DOI: 10.1002/14651858.CD002913.pub3