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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We included published and unpublished randomized placebo or active controlled trials on the efficacy of the use of non-contraceptive oestrogen-containing preparations in the management of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 -
Endocrine-related Cancer Feb 2016Men receiving androgen deprivation therapy (ADT) for prostate cancer (PCa) are likely to develop metabolic conditions such as diabetes, cardiovascular disease, abdominal... (Review)
Review
Men receiving androgen deprivation therapy (ADT) for prostate cancer (PCa) are likely to develop metabolic conditions such as diabetes, cardiovascular disease, abdominal obesity and osteoporosis. Other treatment-related side effects adversely influence quality of life (QoL) including vasomotor distress, depression, anxiety, mood swings, poor sleep quality and compromised sexual function. The objective of this study was to systematically review the nature and effects of dietary and exercise interventions on QoL, androgen deprivation symptoms and metabolic risk factors in men with PCa undergoing ADT. An electronic search of CINAHL, CENTRAL, Medline, PsychINFO and reference lists was performed to identify peer-reviewed articles published between January 2004 and December 2014 in English. Eligible study designs included randomised controlled trials (RCTs) with pre- and post-intervention data. Data extraction and assessment of methodological quality with the Cochrane approach was conducted by two independent reviewers. Seven exercise studies were identified. Exercise significantly improved QoL, but showed no effect on metabolic risk factors (weight, waist circumference, lean or fat mass, blood pressure and lipid profile). Two dietary studies were identified, both of which tested soy supplements. Soy supplementation did not improve any outcomes. No dietary counselling studies were identified. No studies evaluated androgen-deficiency symptoms (libido, erectile function, sleep quality, mood swings, depression, anxiety and bone mineral density). Evidence from RCTs indicates that exercise enhances health- and disease-specific QoL in men with PCa undergoing ADT. Further studies are required to evaluate the effect of exercise and dietary interventions on QoL, androgen deprivation symptoms and metabolic risk factors in this cohort.
Topics: Androgen Antagonists; Antineoplastic Agents, Hormonal; Exercise; Humans; Male; Prostatic Neoplasms; Quality of Life
PubMed: 26584972
DOI: 10.1530/ERC-15-0456 -
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 -
Psychological Medicine Jul 2014Affective instability (AI) is poorly defined but considered clinically important. The aim of this study was to examine definitions and measures of AI employed in... (Review)
Review
BACKGROUND
Affective instability (AI) is poorly defined but considered clinically important. The aim of this study was to examine definitions and measures of AI employed in clinical populations.
METHOD
This study was a systematic review using the PRISMA guidelines. MEDLINE, Embase, PsycINFO, PsycArticles and Web of Science databases were searched. Also five journals were hand searched. Primary empirical studies involving randomized controlled trials (RCTs), non-RCTs, controlled before and after, and observational investigations were included. Studies were selected, data extracted and quality appraised. A narrative synthesis was completed.
RESULTS
A total of 11 443 abstracts were screened and 37 studies selected for final analysis on the basis that they provided a definition and measure of AI. Numbers of definitions for each of the terms employed in included studies were: AI (n = 7), affective lability (n = 6), affective dysregulation (n = 1), emotional dysregulation (n = 4), emotion regulation (n = 2), emotional lability (n = 1), mood instability (n = 2), mood lability (n = 1) and mood swings (n = 1); however, these concepts showed considerable overlap in features. A total of 24 distinct measures were identified that could be categorized as primarily measuring one of four facets of AI (oscillation, intensity, ability to regulate and affect change triggered by environment) or as measuring general emotional regulation.
CONCLUSIONS
A clearer definition of AI is required. We propose AI be defined as 'rapid oscillations of intense affect, with a difficulty in regulating these oscillations or their behavioural consequences'. No single measure comprehensively assesses AI and a combination of current measures is required for assessment. A new short measure of AI that is reliable and validated against external criteria is needed.
Topics: Affective Symptoms; Humans
PubMed: 24074230
DOI: 10.1017/S0033291713002407 -
Journal of Foot and Ankle Research Jan 2011The effect of footwear on the gait of children is poorly understood. This systematic review synthesises the evidence of the biomechanical effects of shoes on children...
BACKGROUND
The effect of footwear on the gait of children is poorly understood. This systematic review synthesises the evidence of the biomechanical effects of shoes on children during walking and running.
METHODS
Study inclusion criteria were: barefoot and shod conditions; healthy children aged ≤ 16 years; sample size of n > 1. Novelty footwear was excluded. Studies were located by online database-searching, hand-searching and contact with experts. Two authors selected studies and assessed study methodology using the Quality Index. Meta-analysis of continuous variables for homogeneous studies was undertaken using the inverse variance approach. Significance level was set at P < 0.05. Heterogeneity was measured by I2. Where I2 > 25%, a random-effects model analysis was used and where I2 < 25%, a fixed-effects model was used.
RESULTS
Eleven studies were included. Sample size ranged from 4-898. Median Quality Index was 20/32 (range 11-27). Five studies randomised shoe order, six studies standardised footwear. Shod walking increased: velocity, step length, step time, base of support, double-support time, stance time, time to toe-off, sagittal tibia-rearfoot range of motion (ROM), sagittal tibia-foot ROM, ankle max-plantarflexion, Ankle ROM, foot lift to max-plantarflexion, 'subtalar' rotation ROM, knee sagittal ROM and tibialis anterior activity. Shod walking decreased: cadence, single-support time, ankle max-dorsiflexion, ankle at foot-lift, hallux ROM, arch length change, foot torsion, forefoot supination, forefoot width and midfoot ROM in all planes. Shod running decreased: long axis maximum tibial-acceleration, shock-wave transmission as a ratio of maximum tibial-acceleration, ankle plantarflexion at foot strike, knee angular velocity and tibial swing velocity. No variables increased during shod running.
CONCLUSIONS
Shoes affect the gait of children. With shoes, children walk faster by taking longer steps with greater ankle and knee motion and increased tibialis anterior activity. Shoes reduce foot motion and increase the support phases of the gait cycle. During running, shoes reduce swing phase leg speed, attenuate some shock and encourage a rearfoot strike pattern. The long-term effect of these changes on growth and development are currently unknown. The impact of footwear on gait should be considered when assessing the paediatric patient and evaluating the effect of shoe or in-shoe interventions.
PubMed: 21244647
DOI: 10.1186/1757-1146-4-3 -
Journal of Clinical Nursing May 2010To gain an insight into the neuropsychological care needs on a cognitive, emotional and/or behavioural level from the perspective of the person living with minor... (Review)
Review
AIMS AND OBJECTIVES
To gain an insight into the neuropsychological care needs on a cognitive, emotional and/or behavioural level from the perspective of the person living with minor traumatic brain injury.
DESIGN
A systematic literature review.
METHOD
Medline, Psychlit, CINAHL, Cochrane and Scholar databases (1995-2007) were searched.
RESULTS
The research has lead to three large-scale, American surveys on people with minor, moderate or severe traumatic brain injury. None of the surveys focused only on minor traumatic brain injury. The surveys did not made a distinction with respect to seriousness of the brain damage and the corresponding needs. In general, people with traumatic brain injury prove to have important continuing neuropsychological care needs in the chronic phase. On a cognitive level, there seems to be a particular need for aid with memory problems and problem-solving skills. The main emotional needs are help with one's 'mood', mood swings and learning how to deal with stress. For the behavioural problems, there is a particular need to help control one's temperament. The need for care, especially for cognitive and behavioural problems, seems to increase with time. The professional help offered in the long term after the traumatic event likewise seems to be inadequate.
CONCLUSION
The results of this systematic review show that we know very little about the precise needs of people with minor chronic traumatic brain injury. To change this, qualitative research is needed, allowing an in-depth analysis of the needs and experiences of patients currently living with traumatic brain injury.
RELEVANCE TO CLINICAL PRACTICE
A better knowledge and understanding of the neuropsychological needs of patients with traumatic brain injury will help health care providers to offer more effective care.
Topics: Behavior; Brain Injuries; Cognition; Emotions; Health Services Needs and Demand; Humans; Problem Solving
PubMed: 20500336
DOI: 10.1111/j.1365-2702.2009.03114.x -
Journal of Affective Disorders Oct 2010Systematic studies addressing symptoms, signs and temporal aspects of initial bipolar prodrome are reviewed to identify potential clinical targets for early intervention. (Review)
Review
BACKGROUND
Systematic studies addressing symptoms, signs and temporal aspects of initial bipolar prodrome are reviewed to identify potential clinical targets for early intervention.
METHODS
The databases PsycINFO, PubMed, EMBASE and British Nursing Index were searched for original studies.
RESULTS
Eight studies were identified. Irritability and aggressiveness, sleep disturbances, depression and mania symptoms/signs, hyperactivity, anxiety, and mood swings are clusters representing common symptoms and signs of the distal prodrome of bipolar disorder (BD). As time to full BD onset decreases, symptoms of mania and depression seem to increase gradually in strength and prevalence. The specificity of prodromal symptoms and signs appears to be low. Not every person who develops BD experiences a prolonged initial prodrome to the full illness. Current data on the mean duration of the prodrome are contradictory, ranging from 1.8 to 7.3 years. No qualitative studies were found.
LIMITATIONS
Because of the scarcity of data, studies that did not explicitly investigate bipolar prodrome were included when thematically relevant. The selected studies are methodologically diverse and the validity of some findings is questionable. Findings must be interpreted cautiously.
CONCLUSIONS
The initial prodrome of BD is characterized by dysregulation of mood and energy. Because of the apparently low specificity of prodromal symptoms and signs of BD, it is currently neither possible nor advisable to predict the development of BD based solely on early phenomenology. More well-designed in-depth studies, including qualitative ones, are needed to characterize the initial bipolar prodrome.
Topics: Adolescent; Age of Onset; Aggression; Bipolar Disorder; Child; Disease Progression; Female; Humans; Irritable Mood; Male; Mood Disorders; Prognosis; Time Factors; Young Adult
PubMed: 19883943
DOI: 10.1016/j.jad.2009.10.003 -
BMJ Clinical Evidence Aug 2007Bipolar disorder, with mood swings between depression and mania, may affect up to 1.5% of adults, and increases the risk of suicide and disability. Most people improve... (Review)
Review
INTRODUCTION
Bipolar disorder, with mood swings between depression and mania, may affect up to 1.5% of adults, and increases the risk of suicide and disability. Most people improve over time, but two thirds may have residual dysfunction, and at least 40% may have recurrent episodes.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments in people with mania associated with bipolar disorder? What are the effects of treatments in bipolar depression? What are the effects of interventions to prevent relapse of mania or bipolar depression? We searched: Medline, Embase, The Cochrane Library and other important databases up to July 2006 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 60 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antidepressants, carbamazepine, chlorpromazine, clonazepam, cognitive therapy, education, family-focused psychoeducation, gabapentin, haloperidol, lamotrigine, lithium, olanzapine, psychological treatments, quetiapine, risperidone, topiramate, valproate, and ziprasidone.
Topics: Acute Disease; Antidepressive Agents; Antipsychotic Agents; Bipolar Disorder; Double-Blind Method; Humans; Risperidone; Treatment Outcome
PubMed: 19454110
DOI: No ID Found -
The Cochrane Database of Systematic... 2000The effectiveness of clomiphene citrate has been clearly demonstrated in the treatment of sub-fertility associated with oligo-ovulation. The multiple pregnancy rate... (Review)
Review
BACKGROUND
The effectiveness of clomiphene citrate has been clearly demonstrated in the treatment of sub-fertility associated with oligo-ovulation. The multiple pregnancy rate associated with clomiphene, however, is elevated at approximately 10%. Additional side effects associated with clomiphene use also include hot flashes, mood swings, headaches and visual disturbances. A variety of publications have raised the question of increased ovarian cancer risks associated with clomiphene use. Understanding the effectiveness of clomiphene in this patient group is therefore, extremely important.
OBJECTIVES
To determine the effectiveness of clomiphene citrate given to women with unexplained subfertility, in a dose range of 50-250 mg for up to 10 days. The primary outcome was clinical pregnancy.
SEARCH STRATEGY
RCTs were identified using the search strategies developed for the menstrual disorders and subfertility group. See review group for more information.
SELECTION CRITERIA
Randomized controlled trials were included if they were relevant to the clinical question posed and reported data in treated and untreated groups. Cohort studies were excluded.
DATA COLLECTION AND ANALYSIS
Eleven potentially relevant trials were identified, of which six were included in this review. All trials were assessed for quality in terms of method of randomization, completeness of follow up, presence or absence of cross-over and co-intervention.
MAIN RESULTS
Clomiphene appeared to be superior to no treatment or placebo. The common odds ratios for clinical pregnancy per patient and per treatment cycle were 2.37 (1.22-4.62) and 2.5 (1.35-4.62) respectively. Although there was some clinical heterogeneity between studies, the results were statistically homogeneous (p>0.1). These data suggest statistically and clinically significant improvement in pregnancy rate following clomiphene citrate in women with unexplained infertility.
REVIEWER'S CONCLUSIONS
Although the absolute treatment effect is small, given the low cost and ease of administration, clomiphene citrate appears to be a sensible first choice treatment for women with unexplained infertility. However, in making this treatment choice, concerns of long-term use and ovarian cancer risk, multiple pregnancy risk and minor symptoms should be discussed. Given the extensive use of clomiphene in ovulatory women and recent concerns associated with long term use, a definitive trial with adequate power is warranted to establish effectiveness in women with unexplained subfertility.
Topics: Clomiphene; Female; Fertility Agents, Female; Humans; Infertility, Female; Randomized Controlled Trials as Topic
PubMed: 10908459
DOI: 10.1002/14651858.CD000057