-
The Journal of Sexual Medicine Jun 2019Erectile dysfunction supplements (ED-Ss) are featured on online marketplaces like Amazon.com, with dedicated pages and claims that they naturally treat ED. However,...
INTRODUCTION
Erectile dysfunction supplements (ED-Ss) are featured on online marketplaces like Amazon.com, with dedicated pages and claims that they naturally treat ED. However, their efficacy and safety are largely unknown, limiting the ability to counsel patients regarding their use.
AIM
To evaluate the highest rated and most frequently reviewed ED-Ss on Amazon.com to facilitate patient counseling regarding marketing myths, ingredient profiles, and evidence for product efficacy and safety.
METHODS
The Amazon marketplace was queried using the key term "erectile dysfunction" with default search settings and ranking items based on relevance. The top 6 ED-S products identified on September 29, 2018, were reviewed based on price, ratings, reviews, manufacturer, and ingredients. Consumer reviews were categorized using subtopics within the International Index of Erectile Function (IIEF) questionnaire to better understand ED-S efficacy and then reanalyzed following filtration of untrustworthy comments using ReviewMeta.com, a proprietary Amazon review analysis software.
OUTCOMES
Quantitative and qualitative evaluation of ED-S products sold on Amazon.com.
RESULTS
The top 6 ED-Ss had an average of 2,121 ± 1,282 reviews and a mean rating of 3.92 ± 0.42 stars. A total of 21 ingredients were identified in these ED-Ss. Ginseng, horny goat weed, L-arginine, and tongkat ali were the most popular ingredients included in the analyzed products. Our literature review identified 413 studies involving the 21 identified ingredients, of which 59 (16%) involved human subjects. Among these 69 human studies, only 12 (17%) investigated supplement ingredients individually and reported improvement in ED. Analysis of top-ranked customer reviews from the first 2 pages of reviews for each supplement revealed differences in IIEF scores before and after ReviewMeta.com filtration. After filtration, we observed a 77% decrease in reviews reporting improved erection strength, an 83% decrease in reviews reporting improved ability to maintain erection, a 90% decrease in reviews reporting increased sexual satisfaction, an 88% decrease in reviews reporting increased enjoyment with intercourse, and an 89% decrease in reviews reporting increased erection confidence.
STRENGTHS & LIMITATIONS
Study strengths include a novel approach to ascertaining consumers' perceptions and satisfaction with ED-Ss and practical summary information that clinicians can provide to patients. Limitations include selection bias, the small number of supplements analyzed, and the proprietary nature of the Amazon review analysis software.
CONCLUSIONS
Our investigation revealed that human studies evaluating the efficacy of ED-S ingredients are limited and have yielded no definitive findings of the effects on ED. Patients considering ED-S use should receive appropriate counseling, given the prevalence of disingenuous reviews and the ready availability of Food and Drug Administration-approved drug therapies. Balasubramanian A, Thirumavalavan N, Srivatsav A, et al. An Analysis of Popular Online Erectile Dysfunction Supplements. J Sex Med 2019;16:843-852.
Topics: Adult; Aged; Arginine; Coitus; Dietary Supplements; Erectile Dysfunction; Fatty Acids; Humans; Internet; Male; Middle Aged; Orgasm; Panax; Penile Erection; Plant Extracts; Treatment Outcome
PubMed: 31036522
DOI: 10.1016/j.jsxm.2019.03.269 -
Brain and Behavior Mar 2019The traditional herbal supplements Panax ginseng and Ginkgo biloba are self-medicated by members of the general public and prescribed by healthcare professionals in some...
A systematic review of research investigating the physiological and psychological effects of combining Ginkgo biloba and Panax ginseng into a single treatment in humans: Implications for research design and analysis.
BACKGROUND AND PURPOSE
The traditional herbal supplements Panax ginseng and Ginkgo biloba are self-medicated by members of the general public and prescribed by healthcare professionals in some EU countries for numerous health complaints. Clinical evidence is mixed and mechanisms of action are not fully understood. There is clinical interest into the synergistic effects of combining both herbs.
METHODS
We systematically review the literature investigating the effects of combination treatments on physiological and psychological outcomes in humans. We identified all studies meeting inclusion criteria: (a) written in English; (b) peer-reviewed; (c) conducted in humans; (d) including either a proprietary Panax ginseng/Ginkgo biloba treatment or a study preparation containing both; (e) placebo-controlled; (f) utilizing standardized extracts. We critically discuss each trial; calculate standardized effect sizes where possible and provide recommendations for research design and analysis.
RESULTS
Eight studies were identified and all investigated a proprietary combination treatment, Gincosan . Studies are of high quality and robust; however, practice effects, choice of statistical model, and reliance upon null-hypothesis significance testing hinder generalized estimates of effect. The most consistent results are benefits to aspects of the circulatory/cardiovascular system in patient populations and "secondary memory" performance in patient and healthy populations. Two studies demonstrate synergy in healthy populations following a single dose; however, synergy in patient populations and following repeated dosing has not yet been directly tested.
CONCLUSIONS
A Panax ginseng and Ginkgo biloba combination treatment can improve aspects of physiological and cognitive function in humans; however, evidence for synergy requires further investigation and future research should directly investigate synergy following repeated dosing.
Topics: Cognition; Ginkgo biloba; Humans; Memory; Panax; Phytotherapy; Plant Extracts; Plants, Medicinal; Treatment Outcome
PubMed: 30729756
DOI: 10.1002/brb3.1217 -
The Cochrane Database of Systematic... Dec 2018Diabetic retinopathy is one of the major causes of blindness and the number of cases has risen in recent years. Herbal medicine has been used to treat diabetes and its... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Diabetic retinopathy is one of the major causes of blindness and the number of cases has risen in recent years. Herbal medicine has been used to treat diabetes and its complications including diabetic retinopathy for thousands of years around the world. However, common practice is not always evidence-based. Evidence is needed to help people with diabetic retinopathy or doctors to make judicious judgements about using herbal medicine as treatment.
OBJECTIVES
To evaluate the effectiveness and harm of single herbal medicine for diabetic retinopathy.
SEARCH METHODS
We searched CENTRAL, which contains the Cochrane Eyes and Vision Trials Register, MEDLINE, Embase, OpenGrey, the ISRCTN registry, ClinicalTrials.gov and the ICTRP. The date of the search was 12 June 2018. We also searched the following Chinese databases in June 2013: Chinese BioMedical Literature Database (CBM), Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), Wanfang China Dissertation Database (CDDB), Wanfang China Conference Paper Database (CCPD) and the Index to Chinese Periodical Literature.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs that investigated the effects of any single herb (or extracts from a single herb) as a treatment for people with diabetic retinopathy. We considered the following comparators: placebo, no treatment, non-herbal (conventional) medicine or surgical treatment.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed the risk of bias in the studies. Our prespecified outcomes were: progression of diabetic retinopathy, visual acuity, microaneurysms and haemorrhages in the retina, blood glycated haemoglobin A1c (HbA1c) (%) and adverse effects. We performed meta-analyses using risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). We assessed the certainty of the evidence using GRADE.
MAIN RESULTS
We included 10 studies involving 754 participants, of which nine were conducted in China and one in Poland. In all studies, participants in both groups received conventional treatment for diabetic retinopathy which included maintaining blood glucose and lipids using medicines and keeping a stable diabetic diet. In three studies, the comparator group also received an additional potentially active comparator in the form of a vasoprotective drug. The single herbs or extracts included Ruscus extract tablet, Sanqi Tongshu capsule, tetramethylpyrazine injection, Xueshuantong injection, Puerarin injection and Xuesaitong injection. The Sanqi Tongshu capsule, Xueshuantong injection and Xuesaitong injection were all made from the extract of Radix Notoginseng (San qi) and the main ingredient was sanchinoside. The risk of bias was high in all included studies mainly due to lack of masking (blinding). None of the studies reported the primary outcome of this review, progression of retinopathy.Combined analysis of herbal interventions suggested that people who took these herbs in combination with conventional treatment may have been more likely to gain 2 or more lines of visual acuity compared to people who did not take these herbs when compared to conventional intervention alone at the end of treatment (RR 1.26, 95% CI 1.08 to 1.48; 5 trials, 541 participants; low-certainty evidence). Subgroup analyses based on the different single herbs found no evidence for different effects of different herbs, but the power of this analysis was low. One study reported Sanqi Tongshu capsule might be associated with a greater reduction in microaneurysms and haemorrhages in the retina (very low-certainty evidence). The pooled analysis of two studies on tetramethylpyrazine or Xueshuantong injection showed such herbs may have had little effect on lowering HbA1c (MD 0.00, 95% CI -0.58 to 0.58; 215 participants; low-certainty evidence).There was very low-certainty evidence on adverse events. Two studies reported minor adverse events such as uncomfortable stomach, urticaria, dizziness and headache. There was no report of observation on adverse events in the other studies.
AUTHORS' CONCLUSIONS
No conclusions could be drawn about the effect of any single herb or herbal extract on diabetic retinopathy from the current available evidence. It was difficult to exclude the placebo effect as a possible explanation for observed differences due to the lack of placebo control in the included studies. Further adequately designed trials are needed to establish the evidence.
Topics: China; Diabetic Retinopathy; Drugs, Chinese Herbal; Ginsenosides; Humans; Isoflavones; Microaneurysm; Phytotherapy; Plants, Medicinal; Pyrazines; Randomized Controlled Trials as Topic; Retinal Hemorrhage; Ruscus; Saponins; Vasodilator Agents; Visual Acuity
PubMed: 30566763
DOI: 10.1002/14651858.CD007939.pub2 -
Frontiers in Psychiatry 2018DSM-5 introduced the diagnostic category of substance/medication-induced bipolar and related disorder. This systematic review examines published reports linking mania...
DSM-5 introduced the diagnostic category of substance/medication-induced bipolar and related disorder. This systematic review examines published reports linking mania with the consumption of herbal medicines (HM), excluding cannabis. Putative pathophysiological mechanisms that may account for the reported HM being associated with mania are discussed. A systematic search of EMBASE, CINAHL, Health Source, PsychINFO, and PubMed. The quality of case reports meeting inclusion criteria was assessed using the modified Quality Assessment Scale by Agbabiaka. Nineteen single and seven multiple-case reports met inclusion criteria. These yielded a study sample of 35 case reports, 28 of herbal medicine associated mania, 5 of hypomania, and two mixed states, in 17 females [age in years M(SD) = 43.1(13.2)] and 18 males [40.7(18.1)]. A total of 11 herbal medicines were implicated. Case reports by herbal medicine (number of reports) comprised: St John's wort ( (14); Ginseng () (5); brindleberry () (4); ma-huang () (3); "herbal slimming pills" (2); Herbalife products (2); Hydroxycut (1); horny goat weed () (1); "herbal body tonic" (1); celery root () (1), and a "herbal mixture" (1). All case reports were associated with use rather than withdrawal of herbal medicines. Only one case report was rated for probability of association using a standardized algorithm. Laboratory assays to confirm composition of the herbal preparation were reported in only one article describing two cases and indicating admixture of a likely causal pharmaceutical in the herbal preparation. Causal attributions are problematic given the limited number of reports, antidepressant co-prescribing in 7 cases, insufficient data regarding pattern and type of herbal medicine use, and lack of a reference frequency for spontaneous mania.The quality assessment scores across the 26 papers (35 case reports) were as follows: low quality (0), lower-medium quality (9), upper-medium quality (10) and high quality (7). Putative pathophysiological mechanisms were postulated for nine of the 11 herbal medicines and centered on HPA-axis activation and increased monoamine activity. Systematic study of the association between herbal medicines and the course of bipolar disorder may contribute to defining targets for pathophysiological research.
PubMed: 30034348
DOI: 10.3389/fpsyt.2018.00280 -
Evidence-based Complementary and... 2018To determine the antiobesity effects of in animals. (Review)
Review
OBJECTIVE
To determine the antiobesity effects of in animals.
METHODS
We conducted a systematic search for all controlled trials (up to March 2017) that assessed the antiobesity effects of in animal obesity models in the PubMed, EMBASE, Cochrane library, Web of Science, and Scopus databases. The primary outcome was final body weight measured at the longest follow-up time after administration of the intervention. The secondary outcome was the lipid profile. We assessed methodological quality using the SYRCLE risk of bias tool, and RevMan 5.3 was used to perform a meta-analysis. Finally, a subgroup analysis of parameters including intervention duration, animal models, and type of ginseng was performed.
RESULT
We identified 16 studies that met the inclusion criteria. Data from the meta-analysis indicated that the intervention group had a significantly lower body weight than the control group (SMD: -1.50, 95% CI: -1.90 to -1.11, : 78.14, < 0.0001, = 58%). Final body weight was lower in an animal obesity model induced by high-fat diet than in genetic models. Also the intervention group had a significantly higher serum HDL level and lower serum LDL, TG, and TC level than the control group.
CONCLUSION
Our meta-analysis indicated that oral administration of significantly inhibits weight gain and improves serum lipid profiles in animal obesity models. However, causes of obesity and type of ginseng may affect treatment effects.
PubMed: 29861768
DOI: 10.1155/2018/2719794 -
The Cochrane Database of Systematic... Apr 2018Postoperative ileus is a major complication for persons undergoing abdominal surgery. Daikenchuto, a Japanese traditional medicine (Kampo), is a drug that may reduce... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Postoperative ileus is a major complication for persons undergoing abdominal surgery. Daikenchuto, a Japanese traditional medicine (Kampo), is a drug that may reduce postoperative ileus.
OBJECTIVES
To assess the efficacy and safety of Daikenchuto for reducing prolonged postoperative ileus in persons undergoing elective abdominal surgery.
SEARCH METHODS
We searched the following databases on 3 July 2017: CENTRAL, MEDLINE, Embase, ICHUSHI, WHO (World Health Organization) International Clinical Trials Registry Platform (ICTRP), EU Crinical Trials registry (EU-CTR), UMIN Clinical Trials Registry (UMIN-CTR), ClinicalTrials.gov, The Japan Society for Oriental Medicine (JSOM), American Society of Clinical Oncology (ASCO), Society of American Gastrointestinal and Endscopic Surgeons (SAGES). We set no limitations on language or date of publication.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing Daikenchuto with any control condition in adults, 18 years of age or older, undergoing elective abdominal surgery.
DATA COLLECTION AND ANALYSIS
We applied standard methodological procedures expected by Cochrane. Two review authors independently reviewed the articles identified by literature searches, extracted data, and assessed risk of bias of the included studies using the Cochrane software Review Manager 5.
MAIN RESULTS
We included seven RCTs with a total of 1202 participants. Overall, we judged the risk of bias as low in four studies and high in three studies. We are uncertain whether Daikenchuto reduced time to first flatus (mean difference (MD) -11.32 hours, 95% confidence interval (CI) -17.45 to -5.19; two RCTs, 83 participants; very low-quality evidence), or time to first bowel movement (MD -9.44 hours, 95% CI -22.22 to 3.35; four RCTs, 500 participants; very low-quality evidence) following surgery. There was little or no difference in time to resumption of regular solid food following surgery (MD 3.64 hours, 95% CI -24.45 to 31.74; two RCTs, 258 participants; low-quality evidence). There were no adverse events in either arm of the five RCTs that reported on drug-related adverse events (risk difference (RD) 0.00, 95% CI -0.02 to 0.02, 568 participants, low-quality evidence). We are uncertain of the effect of Daikenchuto on patient satisfaction (MD 0.09, 95% CI -0.19 to 0.37; one RCT, 81 participants; very low-quality of evidence). There was little or no difference in the incidence of any re-interventions for postoperative ileus before leaving hospital (risk ratio (RR) 0.99, 95% CI 0.06 to 15.62; one RCT, 207 participants; moderate-quality evidence), or length of hospital stay (MD -0.49 days, 95% CI -1.21 to 0.22; three RCTs, 292 participants; low-quality evidence).
AUTHORS' CONCLUSIONS
Evidence from current literature was unclear whether Daikenchuto reduced postoperative ileus in patients undergoing elective abdominal surgery, due to the small number of participants in the meta-analyses. Very low-quality evidence means we are uncertain whether Daikenchuto improved postoperative flatus or bowel movement. Further well-designed and adequately powered studies are needed to assess the efficacy of Daikenchuto.
Topics: Abdomen; Defecation; Elective Surgical Procedures; Flatulence; Humans; Ileus; Panax; Patient Satisfaction; Plant Extracts; Postoperative Complications; Randomized Controlled Trials as Topic; Time Factors; Zanthoxylum; Zingiberaceae
PubMed: 29619778
DOI: 10.1002/14651858.CD012271.pub2 -
Oxidative Medicine and Cellular... 2017Ginseng is an important herbal drug that has been used worldwide for many years. Ginsenoside Rb1 (G-Rb1), the major pharmacological extract from ginseng, possesses a... (Review)
Review
Ginseng is an important herbal drug that has been used worldwide for many years. Ginsenoside Rb1 (G-Rb1), the major pharmacological extract from ginseng, possesses a variety of biological activities in the cardiovascular systems. Here, we conducted a preclinical systematic review to investigate the efficacy of G-Rb1 for animal models of myocardial ischemia/reperfusion injury and its possible mechanisms. Ten studies involving 211 animals were identified by searching 6 databases from inception to May 2017. The methodological quality was assessed by using the CAMARADES 10-item checklist. All the data were analyzed using RevMan 5.3 software. As a result, the score of study quality ranged from 3 to 7 points. Meta-analyses showed that G-Rb1 can significantly decrease the myocardial infarct size and cardiac enzymes (including lactate dehydrogenase, creatine kinase, and creatine kinase-MB) when compared with control group ( < 0.01). Significant decrease in cardiac troponin T and improvement in the degree of ST-segment depression were reported in one study ( < 0.05). Additionally, the possible mechanisms of G-Rb1 for myocardial infarction are antioxidant, anti-inflammatory, antiapoptosis, promoting angiogenesis and improving the circulation. Thus, G-Rb1 is a potential cardioprotective candidate for further clinical trials of myocardial infarction.
Topics: Animals; Disease Models, Animal; Female; Ginsenosides; Male; Myocardial Reperfusion Injury; Panax; Rats
PubMed: 29430282
DOI: 10.1155/2017/6313625 -
Planta Medica Feb 2018Ginsenoside Rh1 is one of major bioactive compounds extracted from red ginseng, which has been increasingly used for enhancing cognition and physical health worldwide.... (Review)
Review
Ginsenoside Rh1 is one of major bioactive compounds extracted from red ginseng, which has been increasingly used for enhancing cognition and physical health worldwide. The objective of this study was to review the pharmacological effects of ginsenoside Rh1 in a systematic manner. We performed searches on eight electronic databases including MEDLINE (Pubmed), Scopus, Google Scholar, POPLINE, Global Health Library, Virtual Health Library, the System for Information on Grey Literature in Europe, and the New York Academy of Medicine Grey Literature Report to select the original research publications reporting the biological and pharmacological effects of ginsenoside Rh1 from and studies regardless of publication language and study design. Upon applying the inclusion and exclusion criteria, we included a total of 57 studies for our systemic review. Ginsenoside Rh1 exhibited the potent characteristics of anti-inflammatory, antioxidant, immunomodulatory effects, and positive effects on the nervous system. The cytotoxic effects of ginsenoside Rh1 were dependent on different types of cell lines. Other pharmacological effects including estrogenic, enzymatic, anti-microorganism activities, and cardiovascular effects have been mentioned, but the results were considerably diverged. A higher quality of evidence on clinical trial studies is highly recommended to confirm the consistent efficacy of ginsenoside Rh1.
Topics: Animals; Antineoplastic Agents, Phytogenic; Antioxidants; Estrogens; Ginsenosides; Humans; Immunologic Factors; Nervous System; Panax; Phytotherapy; Plants, Medicinal
PubMed: 29329463
DOI: 10.1055/s-0043-124087 -
Medicine Sep 2016The aim of this systematic review was to update, complete, and critically evaluate the evidence from placebo-controlled randomized clinical trials (RCTs) of ginseng for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The aim of this systematic review was to update, complete, and critically evaluate the evidence from placebo-controlled randomized clinical trials (RCTs) of ginseng for managing menopausal women's health.
METHODS
We searched the literature using 13 databases (MEDLINE, AMED, EMBASE, the Cochrane Library, 6 Korean Medical, and 3 Chinese Databases) from their inception to July 2016 and included all double-blind RCTs that compared any type of ginseng with a placebo control in postmenopausal women. The methodological quality of all studies was assessed using a Cochrane risk of bias tool.
RESULTS
Ten RCTs met our inclusion criteria. Most RCTs had unclear risk of bias. One RCT did not show a significant difference in hot flash frequency between Korean red ginseng (KRG) and placebo. The second RCT reported positive effects of KRG on menopausal symptoms. The third RCT found beneficial effects of ginseng (Ginsena) on depression, well-being, and general health. Four RCTs failed to show significant differences in various hormones between KRG and placebo controls except dehydroepiandrosterone. Two other RCTs failed to show effects of KRG on endometrial thickness in menopausal women. The other RCT also failed to show the effects of American ginseng on oxidative stress markers and other antioxidant enzymes.
CONCLUSION
Our systematic review provided positive evidence of ginseng for sexual function and KRG for sexual arousal and total hot flashes score in menopausal women. However, the results of KRG or ginseng failed to show specific effects on hot flash frequency, hormones, biomarkers, or endometrial thickness. The level of evidence for these findings was low because of unclear risk of bias.
Topics: Complementary Therapies; Double-Blind Method; Female; Humans; Menopause; Panax; Phytotherapy; Plant Extracts; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome; Women's Health
PubMed: 27661038
DOI: 10.1097/MD.0000000000004914 -
Medicine Feb 2016Few randomized clinical trials have evaluated the efficacy of ginseng in patients with type 2 diabetes mellitus (T2DM). The current meta-analysis evaluated the... (Meta-Analysis)
Meta-Analysis Review
Few randomized clinical trials have evaluated the efficacy of ginseng in patients with type 2 diabetes mellitus (T2DM). The current meta-analysis evaluated the ginseng-induced improvement in glucose control and insulin sensitivity in patients with type-2 diabetes or impaired glucose tolerance.Randomized clinical trials comparing ginseng supplementation versus control, in patients with T2DM or impaired glucose tolerance, were hand-searched from Medline, Cochrane, and Google Scholar databases by 2 independent reviewers using the terms "type 2 diabetes/diabetes/diabetic, impaired glucose tolerance, and ginseng/ginsenoside(s)." The primary outcome analyzed was the change in HbA1c, whereas the secondary outcomes included fasting glucose, postprandial glucose, fasting insulin, postprandial insulin, insulin resistance Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), triglycerides, total cholesterol, low density lipoprotein (LDL), and high density lipoprotein (HDL).Of the 141 studies identified, 8 studies were chosen for the current meta-analysis. The average number of patients, age, and sex distribution among the groups were comparable. Results reveal no significant difference in HbA1c levels between the ginseng supplementation and the control groups (pooled standardized difference in means = -0.148, 95% CI: -0.637 to 0.228, P = 0.355). Ginseng supplementation improved fasting glucose, postprandial insulin, and HOMA-IR levels, though no difference in postprandial glucose or fasting insulin was observed among the groups. Similarly, triglycerides, total cholesterol, and LDL levels showed significant difference between the treatment groups, while no difference in HDL was seen. In addition, ginseng-related therapy was ineffective in decreasing the fasting glucose levels in patients treated with oral hypoglycemic agents or insulin.The present results establish the benefit of ginseng supplementation in improving glucose control and insulin sensitivity in patients with T2DM or impaired glucose intolerance.
Topics: Diabetes Mellitus, Type 2; Drugs, Chinese Herbal; Humans; Hypoglycemic Agents; Models, Statistical; Panax; Phytotherapy; Plant Extracts; Treatment Outcome
PubMed: 26871778
DOI: 10.1097/MD.0000000000002584