Bioidentical Progesterone Cream for Menopause-Related Vasomotor Symptoms: Is it Effective?

2012 ◽  
Vol 47 (1) ◽  
pp. 112-116 ◽  
Author(s):  
Anne Marie Whelan ◽  
Tannis M Jurgens ◽  
Melanie Trinacty
Keyword(s):  
Adverse Effects ◽  
Vaginal Bleeding ◽  
Data Extraction ◽  
Vasomotor Symptoms ◽  
Controlled Trials ◽  
Hot Flash ◽  
Data Synthesis ◽  
Randomized Controlled ◽  
Study Selection ◽  
Night Sweats

OBJECTIVE To evaluate the efficacy of bioidentical progesterone cream in the treatment of menopause-related vasomotor symptoms. DATA SOURCES A systematic search (from time of inception to September 2012) of PubMed, EMBASE, International Pharmaceutical Abstracts, International Journal of Pharmaceutical Compounding, Cochrane, and CINAHL was conducted using the terms progesterone, vasomotor symptoms, night sweats, hot flash or flush, and randomized controlled trials (RCTs). Hand-searching of citations from relevant articles was also performed. STUDY SELECTION AND DATA EXTRACTION Articles selected for inclusion described RCTs evaluating the use of bioidentical progesterone cream for the treatment of menopause-related vasomotor symptoms. Studies included were placebo controlled and participants were postmenopausal women experiencing vasomotor symptoms. DATA SYNTHESIS Searching identified 3 published RCTs. Only one study, which used a bioidentical progesterone cream specifically compounded for the trial, found that the bioidentical progesterone was more effective than placebo in relieving menopause-related vasomotor symptoms. The 2 studies using manufactured bioidentical progesterone creams found that the creams were no more effective than placebo. Vaginal bleeding and headaches were the most commonly reported adverse effects in the studies. CONCLUSIONS Available evidence from RCTs does not support the efficacy of bioidentical progesterone cream for the management of menopause-related vasomotor symptoms. Adverse effects appear to be mild and self-limiting.

Lactulose in the Management of Constipation: A Current Review

1992 ◽  
Vol 26 (10) ◽  
pp. 1277-1282 ◽  
Author(s):  
Theresa V. Kot ◽  
Ngaire A. Pettit-Young
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Clinical Studies ◽  
Data Extraction ◽  
Point Of View ◽  
Data Synthesis ◽  
Study Selection ◽  
Beneficial Response ◽  
A Current

OBJECTIVE: To review the current published clinical studies evaluating the clinical efficacy and safety of lactulose compared with other laxatives or placebo. Adverse effects associated with lactulose are also reported. DATA SOURCES: Information was retrieved by searching the MEDLINE and EMBASE databases for clinical trials, abstracts, conference proceedings, and review articles dealing with lactulose. STUDY SELECTION: Emphasis was placed on clinical trials where lactulose was compared with other laxatives or placebo in patient populations where the diagnosis of constipation was reasonably established. DATA EXTRACTION: The methodology and results from clinical studies were evaluated. Assessment of the studies was made based on diagnosis of constipation, prior management of patients, follow-up of patients, dosage, and adverse effects. DATA SYNTHESIS: Clinical trials in geriatric patients, terminally ill patients, children, and normal and constipated subjects were reviewed. In most instances, lactulose was compared with a placebo, without incorporating the current education on dietary techniques for improving defecation. CONCLUSIONS: Generally, clinical trials have demonstrated a beneficial response compared with placebo, although sometimes that response has been only marginally better, from a clinical point of view.

scholarly journals Chinese Herbal Formula Xiao Yao San for Treatment of Depression: A Systematic Review of Randomized Controlled Trials

2012 ◽  
Vol 2012 ◽  
pp. 1-13 ◽  
Author(s):  
Yuqing Zhang ◽  
Mei Han ◽  
Zhijun Liu ◽  
Jie Wang ◽  
Qingyong He ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Methodological Quality ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
International Standards ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
Study Selection ◽  
Treatment Of Depression

Objectives.To assess the beneficial and adverse effects of Xiaoyaosan for depression.Search Strategy. Electronic databases were searched until December 2009.Inclusion Criteria.We included randomized clinical trials testing Xiaoyaosan against placebo, antidepressants, or combined with antidepressants against antidepressants alone.Data Extraction and Analyses.Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards.Results.26 randomized trials (involving 1837 patients) were included and the methodological quality was evaluated as generally low. The pooled results showed that Xiaoyaosan combined with antidepressants was more effective in comprehensive effect, the score of HAMD and the score of SDS compared with antidepressants alone. Xiaoyaosan was superior to antidepressants for the score of HAMD. However, Xiaoyaosan was not different from placebo for the score of SDS. There was no adverse effects reported in the trials from Xiaoyaosan.Conclusions.Xiaoyaosan appears to be effective on improving symptoms in patients with depression. However, due to poor methodological quality in the majority of included trials, the potential benefit from Xiaoyaosan need to be confirmed in rigorous trials and the design and reporting of trials should follow international standards.

scholarly journals Systematic Review and Meta-Analysis of Randomized Controlled Trials of Xingnaojing Treatment for Stroke

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Weijun Peng ◽  
Jingjing Yang ◽  
Yang Wang ◽  
Weihao Wang ◽  
Jianxia Xu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Conventional Treatment ◽  
Large Scale ◽  
Data Extraction ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Study Selection ◽  
Mild Impairment

Objective. Xingnaojing injection (XNJ) is a well-known traditional Chinese patent medicine (TCPM) for stroke. The aim of this study is to assess the efficacy of XNJ for stroke including ischemic stroke, intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH).Methods. An extensive search was performed within using eight databases up to November 2013. Randomized controlled trials (RCTs) on XNJ for treatment of stroke were collected. Study selection, data extraction, quality assessment, and meta-analysis were conducted according to the Cochrane standards, and RevMan5.0 was used for meta-analysis.Results. This review included 13 RCTs and a total of 1,514 subjects. The overall methodological quality was poor. The meta-analysis showed that XNJ combined with conventional treatment was more effective for total efficacy, neurological deficit improvement, and reduction of TNF-αlevels compared with those of conventional treatment alone. Three trials reported adverse events, of these one trial reported mild impairment of kidney and liver function, whereas the other two studies failed to report specific adverse events.Conclusion. Despite the limitations of this review, we suggest that XNJ in combination with conventional medicines might be beneficial for the treatment of stroke. Currently there are various methodological problems in the studies. Therefore, high-quality, large-scale RCTs are urgently needed.

Pharmacotherapeutic Options for Overweight Adolescents

2007 ◽  
Vol 41 (9) ◽  
pp. 1445-1455 ◽  
Author(s):  
Kaelen C Dunican ◽  
Alicia R Desilets ◽  
Julie K Montalbano
Keyword(s):  
Weight Loss ◽  
Adverse Effects ◽  
Weight Reduction ◽  
English Language ◽  
Data Extraction ◽  
Short Term ◽  
Data Synthesis ◽  
Study Selection ◽  
Overweight Adolescents ◽  
Fat Soluble Vitamins

Objective: To evaluate the safety and efficacy of current pharmacotherapeutic options for weight loss in overweight adolescents. Data Sources: Literature was obtained through MEDLINE Ovid (1996–April 2007) and EMBASE Drugs and Pharmacology (1991–2nd quarter 2007) searches and a bibliographic review of published articles. Key words included adolescents, overweight, obesity, anti-obesity agents, drug therapy, orlistat, sibutramine, and metformin. Study Selection and Data Extraction: All studies published in the English language that evaluated the use of pharmacotherapy for the treatment of overweight adolescents were critically analyzed; pertinent articles were selected for this review. Data Synthesis: Orlistat has been approved for use in adolescents between the ages of 12 and 16 years. The most frequently reported adverse effects of orlistat were gastrointestinal; reduced concentrations of fat-soluble vitamins were also observed. Of the 6 clinical trials published, 5 have shown statistically significant reductions in body mass index {BMI) from baseline, ranging from 0.55 to 4.09 kg/m2; one small trial failed to demonstrate significant weight reduction compared with placebo. Sibutramine has also been evaluated for use in overweight adolescents in 6 trials. Trials demonstrated a statistically significant reduction in BMI up to 5.6 kg/m2 (from baseline). Of concern is evidence indicating that sibutramine therapy may be associated with elevated blood pressure, increased pulse rate, depression, and suicidal ideations. Lastly, metformin has recently been evaluated for weight loss in overweight adolescents; small, short-term trials demonstrate modest reductions in weight and BMI. Conclusions: Orlistat has been proven both safe and effective for weight reduction in overweight adolescents. Sibutramine has also been proven effective in reducing weight in this population; however, the potential for severe adverse effects requires further investigation. Metformin has demonstrated promising results in small trials; its role in the treatment of overweight adolescents will remain investigational until further research is conducted.

Rifaximin: A New Treatment for Travelers' Diarrhea

2005 ◽  
Vol 39 (2) ◽  
pp. 284-289 ◽  
Author(s):  
Amy L Pakyz
Keyword(s):  
Adverse Effects ◽  
Drug Interactions ◽  
English Language ◽  
Data Extraction ◽  
Cross Resistance ◽  
Double Blind ◽  
Data Synthesis ◽  
Medline Search ◽  
Study Selection ◽  
New Treatment

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, adverse effects, drug interactions and precautions, and dosing recommendations of rifaximin, a new nonabsorbed antimicrobial agent for travelers' diarrhea. DATA SOURCES: A MEDLINE search (1966–July 2004) was conducted to extract human and animal research data in the English language on rifaximin. STUDY SELECTION AND DATA EXTRACTION: Randomized, double-blind, placebo-controlled trials were reviewed and included to evaluate the efficacy of rifaximin in the treatment of travelers' diarrhea. DATA SYNTHESIS: Rifaximin is approved for the treatment of travelers' diarrhea in patients ≥12 years of age with diarrhea caused by noninvasive strains of Escherichia coli. Rifaximin was superior to placebo and trimethoprim/sulfamethoxazole and equivalent to ciprofloxacin in the primary clinical endpoint of the time to the last unformed stool passed. CONCLUSIONS: Rifaximin is a viable alternative to ciprofloxacin for the treatment of travelers' diarrhea. As rifaximin is not systemically absorbed, it offers the advantage of leading to the development of less resistance compared with systemically absorbed antibiotics, in addition to fewer systemic adverse effects and drug interactions. However, the potential for cross-resistance between rifaximin and rifampin, as well as with other classes of antibiotics, is of concern and needs to be elucidated.

Hormone Therapy for the Management of Menopausal Symptoms

2010 ◽  
Vol 23 (6) ◽  
pp. 540-547 ◽  
Author(s):  
C. Brock Woodis
Keyword(s):  
Hormone Therapy ◽  
Dosage Form ◽  
Hot Flashes ◽  
Menopausal Symptoms ◽  
Vasomotor Symptoms ◽  
Controlled Trials ◽  
Patient Evaluation ◽  
Health Initiative ◽  
Randomized Controlled ◽  
Night Sweats

Nearly 50 million women each year are projected to reach menopause by 2030. Many of these women will experience vasomotor symptoms such as night sweats and hot flashes as they enter the menopausal transition. Up until the release of the findings of the Women’s Health Initiative (WHI) studies, women were frequently prescribed hormone therapy (HT) to alleviate bothersome and sometimes debilitating menopausal symptoms as well as to prevent osteoporosis and coronary heart disease (CHD). Although the WHI studies were the first large, randomized, controlled trials that contradicted what was historically believed about the benefits of HT in postmenopausal women, important limitations including baseline demographics of WHI participants and investigation of only one HT strength/dosage form exist. HT may be a reasonable pharmacotherapy option for the management of menopausal symptoms following complete patient evaluation by experienced clinicians. Updated recommendations addressing management of menopausal symptoms, a new HT product containing the spironolactone-analogue drospirenone (DRSP), and discontinuation methods of HT are also discussed in this review.

Desogestrel, Norgestimate, and Gestodene: The Newer Progestins

1995 ◽  
Vol 29 (7-8) ◽  
pp. 736-742 ◽  
Author(s):  
Barbara Kaplan
Keyword(s):  
Adverse Effects ◽  
Data Extraction ◽  
English Literature ◽  
Continuous Administration ◽  
Data Synthesis ◽  
Study Selection ◽  
The Us ◽  
Primary Literature ◽  
Pressure Changes ◽  
First Time

Objective: To review and compare the newer progestins desogestrel, norgestimate, and gestodene with regard to chemistry, pharmacokinetics, efficacy, and tolerability. Data Sources: Primary literature on desogestrel, norgestimate, and gestodene was identified from a comprehensive MEDLINE English-literature search from 1984 through 1994, with additional studies selected by review of the references. Indexing terms included progestins, desogestrel, gestodene, norgestimate, levonorgestrel, and norgestrel. Study Selection: Only human clinical and pharmacokinetic trials performed in Europe, Canada, and the US were included. Data Extraction: All available data from human studies were reviewed; both comparative and noncomparative studies were included because of the paucity of direct comparative information available. Data Synthesis: The newer progestins were designed to minimize the adverse effects (e.g., acne, hirsuitism, nausea, carbohydrate and lipid metabolism changes) observed with older oral contraceptives (OCs) while maintaining efficacy and good menstrual cycle control. Desogestrel, norgestimate, and gestodene have minimal amounts of androgenicity and antiestrogenic potential. All of these agents are pharmacokinetically similar to older agents: they are highly bioavailable when administered orally, hepatically metabolized, and obtain steady-state concentrations after 8-10 days of continuous administration. The newer agents have similar Pearl Indexes and slightly better cycle control. Furthermore, the new progestins appear to cause fewer adverse effects, such as acne and hirsuitism, and similar rates of weight gain, blood pressure changes, and lipid and carbohydrate metabolism changes. Conclusions: Desogestrel, norgestimate, and gestodene appear to offer clinical advantages because of their decreased androgenicity. Women whose cycles are currently well controlled with other OCs should not be switched to a newer progestin. However, any of the combination OC products that contain these progestins may be prescribed for women intolerant of older agents or to first-time users of OCs. The newer progestins appear to be efficacious and offer similar cycle control, improved safety and tolerability profiles, and comparable price with the older agents.

Felbamate

1993 ◽  
Vol 27 (9) ◽  
pp. 1073-1081 ◽  
Author(s):  
Nina M. Graves
Keyword(s):  
Adverse Effects ◽  
Data Extraction ◽  
Pharmacokinetic Studies ◽  
Newly Diagnosed ◽  
Pertinent Literature ◽  
Complex Partial Seizures ◽  
Data Synthesis ◽  
Study Selection ◽  
Antiepileptic Medication ◽  
Subsequent Literature

OBJECTIVE: To provide an up-to-date review of the current literature on felbamate (FBM) and its use as an antiepileptic medication (AEM). DATA SOURCES: All published literature (manuscripts and abstracts) on FBM was reviewed. The initial bibliography (up to September 1992) was provided by the manufacturer (Carter-Wallace Laboratories); subsequent literature was obtained from American Epilepsy Society presentations in December 1992 and manuscripts published up to January 1993. STUDY SELECTION/DATA EXTRACTION: All pertinent literature was reviewed. Information from the publications was abstracted and organized by the author. DATA SYNTHESIS: FBM is effective in complex partial seizures either as monotherapy or as an adjunct in patients receiving other AEMs. In addition, it has shown efficacy in some seizures associated with the Lennox-Gastaut syndrome. Adverse effects appear to be mild. When FBM is given as monotherapy, the primary adverse effects are insomnia and weight loss. Patients receiving multiple AEMs may have increased adverse effects. CONCLUSIONS: FBM appears to be an effective new AEM. Additional studies as to its role in newly diagnosed and pregnant patients are needed. Pharmacokinetic studies in children, patients with renal failure, and patients on nonepilepsy drugs also are needed.

Maximizing Pharmacodynamics with High-Dose Levofloxacin

2005 ◽  
Vol 40 (9) ◽  
pp. 777-788 ◽  
Author(s):  
Kurt A. Wargo ◽  
Nichole A. Wargo ◽  
Edward H. Eiland
Keyword(s):  
Adverse Effects ◽  
Data Extraction ◽  
Community Acquired Pneumonia ◽  
High Dose ◽  
Data Synthesis ◽  
Search Terms ◽  
Short Course ◽  
Study Selection ◽  
Dosage Formulation

Objective To review published literature of levofloxacin 750 mg for the treatment of community-acquired pneumonia (CAP), nosocomial-acquired pneumonia (NAP), and skin and skin-structure infections (SSSI) focusing on microbiology, pharmacokinetic, and pharmacodynamic parameters. Data Sources MEDLINE was searched for clinical trials and review articles (1966 to September 2004). Also included were data from the manufacturer. Search terms utilized were levofloxacin, pneumonia, skin infections, adverse effects, pharmacokinetics, pharmacodynamics, and resistance. Study Selection and Data Extraction All articles and product labeling regarding levofloxacin for the treatment of CAP, NAP, and SSSI were included for review. Data Synthesis Compared with the other currently marketed fluoroquinolones, levofloxacin demonstrates similar in vitro activity to a number of commonly identified microorganisms. Levofloxacin 750 mg has shown equivalency to various non-fluoroquinolone regimens for the treatment of NAP and SSSI. Furthermore, a short, 5-day course of levofloxacin 750 mg was similar in efficacy to a longer, 10-day course of levofloxacin 500 mg for the treatment of CAP. Adverse events associated with levofloxacin therapy are dose independent; therefore, the adverse effects seen with high-dose levofloxacin are comparable to lower doses. Conclusions The levofloxacin 750 mg dosage formulation is a logical option when evaluating the antimicrobial armamentarium commonly utilized for the empiric treatment of CAP, NAP, and SSSI. Pharmacodynamic parameters are optimized and resistance is minimized when high-dose, short-course therapy is implemented.

scholarly journals There Is Inadequate Evidence to Determine the Effectiveness of Nonpharmacological and Nonsurgical Interventions for Hand Osteoarthritis: An Overview of High-Quality Systematic Reviews

2009 ◽  
Vol 89 (12) ◽  
pp. 1363-1370 ◽  
Author(s):  
Rikke H. Moe ◽  
Ingvild Kjeken ◽  
Till Uhlig ◽  
Kåre Birger Hagen
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Health Care Professionals ◽  
Data Extraction ◽  
Controlled Trials ◽  
Hand Osteoarthritis ◽  
High Quality ◽  
Randomized Controlled ◽  
Study Selection ◽  
Topical Capsaicin

Background Patients with hand osteoarthritis are commonly treated by health care professionals (allied to medicine). Practice should be informed by updated evidence from systematic reviews of randomized controlled trials. Purpose The purpose of this overview is to summarize the evidence from systematic reviews of the effectiveness of nonpharmacological and nonsurgical interventions for patients with hand osteoarthritis. Data Sources and Study Selection Systematic reviews published between January 2000 and October 2008 were identified by a comprehensive literature search. Data Extraction and Synthesis Two reviewers independently selected reviews for inclusion, assessed their methodological quality, and extracted and synthesized data according to predefined criteria. Four systematic reviews finally were included. Based on single randomized controlled trials, there is some evidence of the effect of pain relief from topical capsaicin compared with placebo and for favorable functional outcomes for exercise and education compared with osteoarthritis information alone. Limitations In overviews, results are dependent on available systematic reviews. They are important tools to guide choice of interventions and locate areas where more research is needed, but they might not be useful for deciding specifically how interventions should be carried out. Conclusions There currently is insufficient high-quality evidence regarding nonpharmacological and nonsurgical interventions for hand osteoarthritis. Considering the limited research evidence and the prevalence and impact of the disease, there is an urgent need for more trials of nonpharmacological and nonsurgical interventions for hand osteoarthritis.

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