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International Urogynecology Journal Sep 2022Myofascial pain arising from pelvic floor muscles occurs in women with vaginismus, interstitial cystitis and endometriosis but is often overlooked. The aim is to examine... (Review)
Review
INTRODUCTION AND HYPOTHESIS
Myofascial pain arising from pelvic floor muscles occurs in women with vaginismus, interstitial cystitis and endometriosis but is often overlooked. The aim is to examine alternative diagnostic tests to detect pelvic floor myofascial pain compared with standardized vaginal palpation of pelvic floor muscles as the reference test.
METHODS
A systematic review was prospectively conducted (PROSPERO-CRD42020183092) according to PRISMA guidelines. Databases searched included Ovid Medline 1946-, Embase 1957-, Scopus 1960-, Cochrane Combined, Clinical trials, Google Scholar (top 200 articles), Web of Science, TRIP, BIOSIS, DARE, CINHAL, EmCare, PEDro, ProQuest and EBSCOhost up to July 2020. Articles were independently screened by two authors and assessed for bias using QUASDAS-2 tool.
RESULTS
A total of 26,778 articles were screened and 177 were selected for full text review, of which 5 were selected for final analysis. Five studies included 9694 participants of which 1628 had pelvic floor myofascial pain. Only one study reported data to calculate sensitivities and specificities of the index test, which utilized a score of > 40 on the Central Sensitization Inventory to detect women with pelvic floor myofascial pain and revealed a sensitivity of 34.8% and a specificity of 84.9% compared to the reference test.
CONCLUSIONS
This systematic review did not reveal any diagnostic test superior to the pre-defined reference test. There is a lack of consensus on the definition of pelvic floor myofascial pain and a lack of a validated diagnostic criteria which must be addressed to progress with meaningful research in this field.
Topics: Diagnostic Tests, Routine; Endometriosis; Female; Humans; Myofascial Pain Syndromes; Pain; Pelvic Floor
PubMed: 35796787
DOI: 10.1007/s00192-022-05258-7 -
International Journal of Environmental... Dec 2022In the United States, a significant amount of the population is affected by hyperlipidemia, which is associated with increased levels of serum low-density lipoprotein... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
In the United States, a significant amount of the population is affected by hyperlipidemia, which is associated with increased levels of serum low-density lipoprotein (LDL-C) and risk of cardiovascular disease. As of 2019, the guidelines set by the American College of Cardiology/American Heart Association advocate for the use of statins as the major contributor to lowering serum LDL-C. While proven to be effective, side effects, including muscle-related symptoms and new-onset diabetes mellitus, can make patients unable to tolerate statin therapy. Additionally, there is a subset of the population which does not approach a recommended LDL-C goal on statin treatment. Due to these findings, it was deemed necessary to review the literature of current statin-alternative lipid-lowering therapies.
METHODS
A systematic review of preclinical and clinical papers, and a current meta-analysis, was performed using PubMed and Google Scholar. Following the literature review, a meta-analysis was conducted using ProMeta 3.
RESULTS
Through systematic review and meta-analysis of the current literature, it is suggested that newer lipid-lowering therapies such as proprotein convertase subtilsin-kixen type 9 (PCSK9) inhibitors are a safe and effective statin alternative for the population with statin intolerance. PCSK9 inhibitors were shown to have no significant effect in causing myalgia in patients and showed no increase in adverse cardiovascular outcomes compared to a control of a current antilipemic medication regimen.
DISCUSSION
There are many statin-alternative therapies that should be investigated further as a potential replacement for patients with statin intolerance or as an addition for patients with statin resistance.
Topics: Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Proprotein Convertase 9; PCSK9 Inhibitors; Cholesterol, LDL; Cardiovascular Diseases; Anticholesteremic Agents
PubMed: 36554779
DOI: 10.3390/ijerph192416899 -
PLoS Neglected Tropical Diseases 2012The objectives of this systematic review, commissioned by WHO, were to assess the frequency and severity of clinical manifestations of human brucellosis, in view of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The objectives of this systematic review, commissioned by WHO, were to assess the frequency and severity of clinical manifestations of human brucellosis, in view of specifying a disability weight for a DALY calculation.
METHODS/PRINCIPAL FINDINGS
Thirty three databases were searched, with 2,385 articles published between January 1990-June 2010 identified as relating to human brucellosis. Fifty-seven studies were of sufficient quality for data extraction. Pooled proportions of cases with specific clinical manifestations were stratified by age category and sex and analysed using generalized linear mixed models. Data relating to duration of illness and risk factors were also extracted. Severe complications of brucellosis infection were not rare, with 1 case of endocarditis and 4 neurological cases per 100 patients. One in 10 men suffered from epididymo-orchitis. Debilitating conditions such as arthralgia, myalgia and back pain affected around half of the patients (65%, 47% and 45%, respectively). Given that 78% patients had fever, brucellosis poses a diagnostic challenge in malaria-endemic areas. Significant delays in appropriate diagnosis and treatment were the result of health service inadequacies and socioeconomic factors. Based on disability weights from the 2004 Global Burden of Disease Study, a disability weight of 0.150 is proposed as the first informed estimate for chronic, localised brucellosis and 0.190 for acute brucellosis.
CONCLUSIONS
This systematic review adds to the understanding of the global burden of brucellosis, one of the most common zoonoses worldwide. The severe, debilitating, and chronic impact of brucellosis is highlighted. Well designed epidemiological studies from regions lacking in data would allow a more complete understanding of the clinical manifestations of disease and exposure risks, and provide further evidence for policy-makers. As this is the first informed estimate of a disability weight for brucellosis, there is a need for further debate amongst brucellosis experts and a consensus to be reached.
Topics: Brucellosis; Endocarditis, Bacterial; Epididymitis; Female; Humans; Male; Nervous System Diseases; Orchitis
PubMed: 23236528
DOI: 10.1371/journal.pntd.0001929 -
Therapeutics and Clinical Risk... 2023The COVID-19 pandemic continues, and this condition has caused many cases in various countries around the world, resulting in more than 6 million deaths worldwide.... (Review)
Review
The Efficacy of Herbs as Complementary and Alternative Therapy in Recovery and Clinical Outcome Among People with COVID-19: A Systematic Review, Meta-Analysis, and Meta-Regression.
BACKGROUND
The COVID-19 pandemic continues, and this condition has caused many cases in various countries around the world, resulting in more than 6 million deaths worldwide. Herbal medicines can act as immunomodulators, anti-inflammatories, antioxidants, antimicrobials, and others depending on the type and content of the herbs used. Previous studies have shown that several types of herbs, such as , have proven their effectiveness as herbal plants for COVID-19.
METHODS
We conducted a comprehensive literature search through five databases, namely, PubMed, Scopus, Embase, Wiley, and ProQuest to assess the efficacy of phytopharmaceuticals until July 12, 2022. We used the Cochrane RoB 2.0 for the quality assessment of the study.
RESULTS
Phytopharmaceuticals significantly improved patients' recovery rate (OR = 3.54; < 0.00001) and reduced deaths (OR = 0.24; < 0.0001) compared to the control group. Phytopharmaceuticals also performed as a protective factor for COVID-19 clinical symptoms, such as dyspnea (OR = 0.42; < 0.05) and myalgia (OR = 0.31; = 0.02) compared to the control group. However, there is no statistically significant effect on cough (OR = 0.76; = 0.61) and fever (OR = 0.60; < 0.20). The results were not affected by patients' covariates [hypertension, diabetes mellitus, and cardiovascular diseases (meta-regression > 0.05)].
CONCLUSION
Herbal medicine has the potential as an adjuvant therapy in the management of COVID-19.
PubMed: 37484695
DOI: 10.2147/TCRM.S405507 -
Vaccines Mar 2022Background: The proportion of children and adolescents with COVID-19 had gradually increased according to data reported by WHO. However, there was no meta-analysis of... (Review)
Review
Background: The proportion of children and adolescents with COVID-19 had gradually increased according to data reported by WHO. However, there was no meta-analysis of effectiveness and safety of SARS-CoV-2 vaccines in children and adolescents. We aimed to provide investigation-based medical evidence and reference recommendations for children and adolescents in regard to SARS-CoV-2 vaccines. Methods: We systematically searched PubMed, Embase, and Web of Science from inception to 5 January 2022. RCTs and observational studies that examined the effectiveness and safety were included. Results: A total of 13 eligible studies were included for analysis. For the first dose, the effectiveness of SARS-CoV-2 vaccines against SARS-CoV-2 infection and COVID-19 was 88.5% (95% CI:15.7−98.4%, p = 0.033) and 84.3% (95% CI: 66.6−92.6%, p < 0.001) separately. For the second dose, the effectiveness against SARS-CoV-2 infection and COVID-19 was 91.6% (95% CI: 37.8−99.5%, p = 0.083) and 92.7 (95% CI: 82.2−97.0, p < 0.001) separately. Injection-site pain, fatigue, headache, anorexia, and axillary swelling were the top five adverse events after the first dose of SARS-CoV-2 vaccines. Fatigue, injection-site pain, headache, chills, and myalgia/muscle pain were the top five adverse events after the second dose of SARS-CoV-2 vaccines. Conclusions: SARS-CoV-2 vaccines had good effectiveness and safety in children and adolescents. We suggest that children and adolescents should get vaccinated as soon as possible to protect themselves and slow the spread of the pandemic.
PubMed: 35335053
DOI: 10.3390/vaccines10030421 -
Gland Surgery Aug 2021Recent studies on the risk of rheumatic disease among breast implant users have reported conflicting results. The primary objective of this study was to provide a... (Review)
Review
BACKGROUND
Recent studies on the risk of rheumatic disease among breast implant users have reported conflicting results. The primary objective of this study was to provide a systematic and critical review of the literature on the association between breast implants and the risk of rheumatic disease.
METHODS
A qualitative systematic review was conducted in PubMed, MEDLINE, EMBASE, EBM-Reviews and CINAHL Complete from database inception to June 23rd, 2021. Eligible papers were full-length articles in English or French reporting original data on the incident risk of rheumatic disease among individuals with and without breast implants. Data were extracted from published reports and appraised using the Newcastle-Ottawa scale. The main outcome was incident risk of systemic sclerosis (SSc), Sjögren's syndrome (SS), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), fibromyalgia and other rheumatic disorders and symptoms.
RESULTS
Out of 3,425 identified citations, 86 met inclusion criteria. Two cohort studies suggested a two-fold increase in risk of SSc, whereas three case-control studies showed no increase in risk. Three cohort studies did not find an increased risk of incident and confirmed SS among breast implant users, however symptoms of sicca, myalgia and fatigue were reported more frequently. A meta-analysis of heterogenous studies reported a less than two-fold increase in risk of RA. Studies did not support an association with SLE. Insufficient evidence was available for autoimmune myositis and other rheumatic diseases. Implant rupture detected on imaging was not clearly associated with incident rheumatic disease, although no studies specifically examined the risk associated with acute/traumatic rupture. Little data was available on the safety of saline breast implants. Explantation often led to temporary improvement.
CONCLUSIONS
Based on a small number of high-quality and methodologically robust studies, an association between breast implants and a small increase in risk of SSc and RA could not be excluded. Symptoms of sicca, myalgia and fatigue were reported more frequently among breast implant users. Overall, there remains much uncertainty in regard to the association between breast implants and the risk of incident rheumatic diseases. Individuals considering the placement of breast implants should be informed of this uncertainty.
TRIAL REGISTRATION
This study was registered in the PROSPERO database (#CRD42019133616).
PubMed: 34527567
DOI: 10.21037/gs-21-266 -
Global reports of myocarditis following COVID-19 vaccination: A systematic review and meta-analysis.Diabetes & Metabolic Syndrome Jun 2022Recent media reports of myocarditis after receiving COVID-19 vaccines, particularly the messenger RNA (mRNA) vaccines, are causing public concern. This review summarizes... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIMS
Recent media reports of myocarditis after receiving COVID-19 vaccines, particularly the messenger RNA (mRNA) vaccines, are causing public concern. This review summarizes information from published case series and case reports, emphasizing patient and disease characteristics, investigation, and clinical outcomes, to provide a comprehensive picture of the condition.
METHODS
A systematic literature search of PubMed and Google scholar was conducted from inception to April 27, 2022. Individuals who develop myocarditis after receiving the COVID-19 vaccine, regardless of the type of vaccine and dose, were included in the study.
RESULTS
Sixty-two studies, including 218 cases, participated in the current systematic review. The median age was 29.2 years; 92.2% were male and 7.8% were female. 72.4% of patients received the Pfizer-BioNTech (BNT162b2) vaccine, 23.8% of patients received the Moderna COVID-19 Vaccine (mRNA-1273), and the rest of the 3.5% received other types of COVID-19 vaccine. Furthermore, most myocarditis cases (82.1%) occurred after the second vaccine dose, after a median time interval of 3.5 days. The most frequently reported symptoms were chest pain, myalgia/body aches and fever. Troponin levels were consistently elevated in 98.6% of patients. The admission ECG was abnormal in 88.5% of cases, and the left LVEF was lower than 50% in 21.5% of cases. Most patients (92.6%) resolved symptoms and recovered, and only three patients died.
CONCLUSION
These findings may help public health policy to consider myocarditis in the context of the benefits of COVID-19 vaccination.
Topics: 2019-nCoV Vaccine mRNA-1273; Adult; BNT162 Vaccine; COVID-19; COVID-19 Vaccines; Female; Humans; Male; Myocarditis; Vaccination; Vaccines
PubMed: 35660931
DOI: 10.1016/j.dsx.2022.102513 -
Frontiers in Neurology 2020Some of the symptoms of COVID-19 are fever, cough, and breathing difficulty. However, the mechanism of the disease, including some of the symptoms such as the...
Some of the symptoms of COVID-19 are fever, cough, and breathing difficulty. However, the mechanism of the disease, including some of the symptoms such as the neurological and musculoskeletal symptoms, is still poorly understood. The aim of this review is to summarize the evidence on the neurological and musculoskeletal symptoms of the disease. This may help with early diagnosis, prevention of disease spread, and treatment planning. MEDLINE, EMBASE, Web of Science, and Google Scholar (first 100 hits) were searched until April 17, 2020. The key search terms used were "coronavirus" and "signs and symptoms." Only studies written in English were included. The selection was performed by two independent reviewers using EndNote and Rayyan software. Any disagreement was resolved by consensus or by a third reviewer. PRISMA guidelines were followed for abstracting data and assessing the quality of the studies. These were carried out by two and three independent reviewers, respectively. Any disagreement was resolved by consensus or by a third reviewer. The data were analyzed using qualitative synthesis and pooled using a random-effect model. Main Outcome(s) and Measure(s): The outcomes in the study include country, study design, participant details (sex, age, sample size), and neurological and musculoskeletal features. Sixty studies ( = 11, 069) were included in the review, and 51 studies were used in the meta-analysis. The median or mean age ranged from 24 to 95 years. The prevalence of neurological and musculoskeletal manifestations was 35% for smell impairment (95% CI 0-94%; 99.63%), 33% for taste impairment (95% CI 0-91%; 99.58%), 19% for myalgia (95% CI 16-23; 95%), 12% for headache (95% CI 9-15; 93.12%), 10% for back pain (95% CI 1-23%; 80.20%), 10% for dizziness (95% CI 3-19%; 86.74%), 3% for acute cerebrovascular disease (95% CI 1-5%; 0%), and 2% for impaired consciousness (95% CI 1-2%; 0%). Patients with COVID-19 present with neurological and musculoskeletal symptoms. Therefore, clinicians need to be vigilant in the diagnosis and treatment of these patients.
PubMed: 32676052
DOI: 10.3389/fneur.2020.00687 -
European Neurology 2021While the most common neurologic symptoms reported in patients affected by SARS-CoV-2 are headache, dizziness, myalgia, mental fog, and anosmia, there is a growing basis...
BACKGROUND
While the most common neurologic symptoms reported in patients affected by SARS-CoV-2 are headache, dizziness, myalgia, mental fog, and anosmia, there is a growing basis of published peer-reviewed cases reporting stroke in the setting of SARS-CoV-2 infection. The peer-reviewed literature suggests an increased risk of cerebrovascular accident (CVA) in the setting of COVID-19 infection.
METHODS
We searched 3 databases (PubMed, MEDLINE, and CINAHL) with search terms COVID-19, novel coronavirus, stroke, and cerebrovascular accident. Case series and case studies presenting patients positive for both COVID-19 and CVA published from January 1 through September 1, 2020, were included. Data collection and analysis was completed and risk of bias assessed.
RESULTS
The search identified 28 studies across 7 counties comprising 73 patients. Amongst patients hospitalized for COVID-19 infection and CVA, the average age was 60; the most common preexisting conditions were hypertension and diabetes mellitus, and those without preexisting conditions were significantly younger with an average age of 47. Amongst hospitalized patients with COVID-19 and CVA, there was a bimodal association with COVID-19 infection severity with majority of patients classified with mild or critical COVID-19 infection.
DISCUSSION
The data suggest SARS-CoV-2 is a risk factor for developing stroke, particularly in patients with hypertension and diabetes. Furthermore, the younger average age of stroke in patients with SARS-CoV-2, particularly those patients with zero identifiable preexisting conditions, creates high suspicion that SARS-CoV-2 is an independent risk factor for development of stroke; however, this cannot yet be proven without comparable control population. The data suggest the risk of developing CVA in the setting of COVID-19 infection is not dependent upon severity of illness. Continued studies must be done to understand the epidemiologic factors of COVID-19 infection and stroke and the pathophysiology of the COVID-associated hypercoagulable state.
Topics: COVID-19; Headache; Humans; Middle Aged; SARS-CoV-2; Stroke
PubMed: 34352787
DOI: 10.1159/000517403 -
Health Technology Assessment... 2001Ovarian cancer is the most common gynaecological cancer with an annual incidence of 21.6 per 100,000 in England and Wales. Due to the often asymptomatic nature of the... (Comparative Study)
Comparative Study Review
BACKGROUND
Ovarian cancer is the most common gynaecological cancer with an annual incidence of 21.6 per 100,000 in England and Wales. Due to the often asymptomatic nature of the early stages of the disease, most cases are not detected until the advanced stages. Consequently, the prognosis after diagnosis is poor and the 5-year survival rate in the UK is only about 30%. Current recommendations suggest that first-line chemotherapy for ovarian cancer should involve paclitaxel and platinum (Pt)-based therapy (cisplatin/ carboplatin), however, most patients develop resistant or refractory disease and require second-line therapy. Patients may respond to re-challenge with Pt-agents if the treatment-free interval is > 6 months, but an alternative is often required. Topotecan is one of six drugs currently licensed in the UK for second-line therapy, and recent reviews suggest that it has modest efficacy in the treatment of advanced disease and performs favourably against paclitaxel. However, these reviews are based on a limited number of reports mainly consisting of non-randomised Phase I and II studies.
OBJECTIVES OF THE REVIEW
To examine the clinical effectiveness and cost-effectiveness of oral and intravenous topotecan (Hycamtin, SmithKline Beecham, UK) for the treatment of all stages of ovarian cancer.
SEARCH STRATEGY
Sixteen electronic databases from inception to September 2000 and Internet resources were searched, in addition to the bibliographies of retrieved articles and submissions from pharmaceutical companies.
INCLUSION AND EXCLUSION CRITERIA
Two reviewers independently screened all titles/abstracts and included/excluded studies based on full copies of manuscripts. Any disagreements were resolved through discussion. Only randomised controlled trials (RCTs) and full economic evaluations comparing topotecan to non-topotecan regimens were included. All stages of therapy and disease were considered, and the outcomes included were survival, response, symptom relief, quality of life, adverse effects and costs.
METHODS
DATA EXTRACTION STRATEGY: Data were extracted into an Access database by one reviewer and checked by a second. Any disagreements were resolved through discussion.
METHODS
QUALITY ASSESSMENT STRATEGY: Two reviewers, using specified criteria, independently assessed the quality of the clinical effectiveness studies and the economic evaluations. Any disagreements were resolved through discussion.
METHODS
ANALYSIS STRATEGY: Due to the limited number of studies included in the review and the fact that they compared topotecan with different comparators, the out-come data could not be pooled statistically. Clinical effectiveness data are discussed separately under the different outcome subheadings. For time-to-event data, hazard ratios with 95% confidence intervals are presented where available, and for the remaining outcomes, relative risks are reported or calculated where sufficient data were available. Relative risk data are also presented in the form of Forest plots without pooled estimates. Economic data are presented in the form of a summary and critique of the evidence, and a grading (A-I) assigned to each study indicating the direction and magnitude of the cost-effectiveness data.
INCLUDED STUDIES
A total of 568 titles/abstracts were identified and screened for relevance. Full copies of 72 papers were assessed and seven published manuscripts reporting details of two studies of clinical effectiveness and one economic evaluation were included. Further details of the two clinical effectiveness studies and two new economic evaluations were identified from confidential company submissions. Overall, two international multicentre RCTs of effectiveness comparing topotecan with paclitaxel (trial 039) and topotecan with caelyx (trial 30-49) were included in the review. The three economic evaluations included in the review comprised one cost-minimisation analysis (CMA) comparing topotecan with caelyx, one cost-consequences analysis (CCA) comparing topotecan with paclitaxel, etoposide and altretamine and one cost-effectiveness analysis (CEA) comparing topotecan with paclitaxel.
RESULTS
QUALITY OF CLINICAL EFFECTIVENESS DATA: Both clinical effectiveness studies (trial 30-49 and 039) were of reasonable quality, although it was unclear whether either performed valid intention-to-treat analyses. In addition, trial 30-49 failed to state whether the outcome assessors were blinded to treatment allocation. RESULTS --QUALITY OF ECONOMIC EVALUATIONS: The CCA (comparing topotecan with three comparators) was of poor quality and of little relevance to the UK NHS. The CMA and CEA were of reasonable quality overall and relevant to the UK NHS. However, both, in particular the CEA, suffered from methodological problems, and thus their findings should be interpreted with caution.
RESULTS
ASSESSMENT OF CLINICAL EFFECTIVENESS: The assessment of clinical effectiveness was based on limited data. Only two trials with a total of 709 participants were identified. In general, with a few minor exceptions, there were no statistically significant differences between topotecan and paclitaxel, or topotecan and caelyx in survival, response rate, median time to response, median duration of response and quality of life. Significant differences that were reported were mainly identified in subgroup analyses (Pt-sensitive disease and disease without ascites) of questionable validity and their relevance to a general advanced ovarian cancer patient population undergoing second-line chemotherapy is unclear. However, statistically significant differences were observed in the incidence of adverse effects. Topotecan was associated with increased incidences of haematological toxicities (including neutropenia, leukopenia, anaemia and thrombocytopenia), alopecia, nausea and vomiting. Caelyx-treated patients suffered from significantly increased incidences of Palmar-Plantar erythrodysesthesia, stomatitis, mucous membrane disorders and skin rashes. Paclitaxel was associated with significant increases in alopecia, arthralgia, myalgia, neuropathy, paraesthesiae, skeletal pain and flushing.
RESULTS
ASSESSMENT OF COST-EFFECTIVENESS: The assessment of cost-effectiveness was also based on limited data, with three evaluations identified, one of which was not relevant. The two remaining studies, comparing topotecan with paclitaxel (CEA) and topotecan with caelyx (CMA), both used effectiveness data from multicentre RCTs and based their costs on 1999/2000 UK sources. The evaluations were conducted from a UK NHS perspective and findings presented in GB pounds/Euros. Topotecan for the second-line treatment of advanced ovarian cancer was shown to be more cost-effective than paclitaxel (32,513 GB pounds versus 46,186 GB pounds per person in terms of any response (complete or partial), incremental cost-effectiveness = 3065 GB pounds) in all respects except cost per time without toxicity or symptoms, but less cost-effective than caelyx (14,023 GB pounds versus 9979 GB pounds per person regardless of whether the patient responded). However, direct comparisons of the cost findings between the two studies is difficult because they used different designs, different time horizons for the cost analyses and the findings were presented as costs per person for only patients who responded in one study (topotecan versus paclitaxel) and costs per person regardless of whether they responded in the other study (topotecan versus caelyx).
CONCLUSIONS
This review indicates that there is little evidence in the form of RCTs on which to base an assessment of the effectiveness of topotecan as second-line therapy for advanced ovarian cancer. The evidence suggests there were no statistically significant differences overall between topotecan and paclitaxel, or topotecan and caelyx in clinical outcomes. However, statistically significant differences were observed in the incidence of adverse effects. The clinical significance of the findings is not discussed. Overall, the effects of topotecan could at best be described as modest, but the alternative agents offer no real advantages except fewer side-effects and possibly improved cost-effectiveness. Both of the clinical effectiveness studies on which this evidence is based had methodological flaws, the most serious being the lack of a blinded assessor in the topotecan versus caelyx trial, which is important for unbiased assessment of response outcomes. The economic evaluations also suffered from a number of potential problems.
CONCLUSIONS
RECOMMENDATIONS FOR RESEARCH: Further good quality RCTs and CEAs are required comparing topotecan with other licensed and potentially useful (soon to be licensed) second-line treatments for ovarian cancer. At present, it is difficult to make any decisions about topotecan and other drugs for second-line therapy without good quality direct comparisons. In view of the ongoing studies identified, an update of the current review should be considered in approximately 18 months (Summer 2002) or possibly sooner if the recently commissioned National Institute for Clinical Excellence review of caelyx for ovarian cancer identifies additional data relevant to topotecan.
Topics: Antineoplastic Agents; Cost-Benefit Analysis; Female; Humans; Ovarian Neoplasms; Randomized Controlled Trials as Topic; Survival Analysis; Technology Assessment, Biomedical; Topotecan
PubMed: 11701100
DOI: 10.3310/hta5280