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The Cochrane Database of Systematic... Apr 2016Ganoderma lucidum is a natural medicine that is widely used and recommended by Asian physicians and naturopaths for its supporting effects on immune system. Laboratory... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Ganoderma lucidum is a natural medicine that is widely used and recommended by Asian physicians and naturopaths for its supporting effects on immune system. Laboratory research and a handful of preclinical trials have suggested that G. lucidum carries promising anticancer and immunomodulatory properties. The popularity of taking G. lucidum as an alternative medicine has been increasing in cancer patients. However, there is no systematic review that has been conducted to evaluate the actual benefits of G. lucidum in cancer treatment.
OBJECTIVES
To evaluate the clinical effects of G. lucidum on long-term survival, tumour response, host immune functions and quality of life in cancer patients, as well as adverse events associated with its use.
SEARCH METHODS
We searched an extensive set of databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, NIH, AMED, CBM, CNKI, CMCC and VIP Information/Chinese Scientific Journals Database was searched for randomised controlled trials (RCTs) in October 2011. Other strategies used were scanning the references of articles retrieved, handsearching of the International Journal of Medicinal Mushrooms and contact with herbal medicine experts and manufacturers of G. lucidum. For this update we updated the searches in February 2016.
SELECTION CRITERIA
To be eligible for being included in this review, studies had to be RCTs comparing the efficacy of G. lucidum medications to active or placebo control in patients with cancer that had been diagnosed by pathology. All types and stages of cancer were eligible for inclusion. Trials were not restricted on the basis of language.
DATA COLLECTION AND ANALYSIS
Five RCTs met the inclusion criteria and were included in this review. Two independent review authors assessed the methodological quality of individual trials. Common primary outcomes were tumour response evaluated according to the World Health Organization (WHO) criteria, immune function parameters such as natural killer (NK)-cell activity and T-lymphocyte co-receptor subsets, and quality of life measured by the Karnofsky scale score. No trial had recorded long-term survival rates. Associated adverse events were reported in one study. A meta-analysis was performed to pool available data from the primary trials. Results were gauged using relative risks (RR) and standard mean differences (SMD) for dichotomous and continuous data respectively, with a 95% confidence interval (CI).
MAIN RESULTS
The methodological quality of primary studies was generally unsatisfying and the results were reported inadequately in many aspects. Additional information was not available from primary trialists. The meta-analysis results showed that patients who had been given G. lucidum alongside with chemo/radiotherapy were more likely to respond positively compared to chemo/radiotherapy alone (RR 1.50; 95% CI 0.90 to 2.51, P = 0.02). G. lucidum treatment alone did not demonstrate the same regression rate as that seen in combined therapy. The results for host immune function indicators suggested that G. lucidum simultaneously increases the percentage of CD3, CD4 and CD8 by 3.91% (95% CI 1.92% to 5.90%, P < 0.01), 3.05% (95% CI 1.00% to 5.11%, P < 0.01) and 2.02% (95% CI 0.21% to 3.84%, P = 0.03), respectively. In addition, leukocyte, NK-cell activity and CD4/CD8 ratio were marginally elevated. Four studies showed that patients in the G. lucidum group had relatively improved quality of life in comparison to controls. One study recorded minimal side effects, including nausea and insomnia. No significant haematological or hepatological toxicity was reported.
AUTHORS' CONCLUSIONS
Our review did not find sufficient evidence to justify the use of G. lucidum as a first-line treatment for cancer. It remains uncertain whether G. lucidum helps prolong long-term cancer survival. However, G. lucidum could be administered as an alternative adjunct to conventional treatment in consideration of its potential of enhancing tumour response and stimulating host immunity. G. lucidum was generally well tolerated by most participants with only a scattered number of minor adverse events. No major toxicity was observed across the studies. Although there were few reports of harmful effect of G. lucidum, the use of its extract should be judicious, especially after thorough consideration of cost-benefit and patient preference. Future studies should put emphasis on the improvement in methodological quality and further clinical research on the effect of G. lucidum on cancer long-term survival are needed. An update to this review will be performed every two years.
Topics: Antineoplastic Agents; Humans; Immunity, Cellular; Neoplasms; Randomized Controlled Trials as Topic; Reishi
PubMed: 27045603
DOI: 10.1002/14651858.CD007731.pub3 -
BMJ Clinical Evidence Jul 2007Seborrhoeic dermatitis affects at least 1-3% of the population. Malassezia (Pityrosporum) ovale is thought to be the causative organism, and causes inflammation... (Review)
Review
INTRODUCTION
Seborrhoeic dermatitis affects at least 1-3% of the population. Malassezia (Pityrosporum) ovale is thought to be the causative organism, and causes inflammation involving T cells and complement. Seborrhoeic dermatitis tends to relapse after treatment.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of topical treatments for seborrhoeic dermatitis of the scalp in adults? What are the effects of topical treatments for seborrhoeic dermatitis of the face and body in adults? We searched: Medline, Embase, The Cochrane Library and other important databases up to February 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 nine 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: bifonazole, emollients, ketoconazole, lithium succinate, selenium sulphide, tar shampoo, terbinafine, and topical steroids (betamethasone valerate, clobetasol propionate, clobetasone butyrate, hydrocortisone, mometasone furate).
Topics: Administration, Oral; Administration, Topical; Dermatitis, Seborrheic; Face; Humans; Ketoconazole; Lithium; Malassezia; Remission Induction; Scalp Dermatoses
PubMed: 19454093
DOI: No ID Found -
Nutrients Apr 2020For millennia, naturopaths and physicians have used (reishi mushroom) for its diverse therapeutic properties, as recorded in the oldest Chinese herbal encyclopedia.... (Meta-Analysis)
Meta-Analysis Review
For millennia, naturopaths and physicians have used (reishi mushroom) for its diverse therapeutic properties, as recorded in the oldest Chinese herbal encyclopedia. Indeed, a radioprotective effect has been reported in the isolated components of its extracts. A systematic review and meta-analyses (PRISMA) was conducted in March 2020, searching databases including PubMed, Scopus, Embase, and Google Scholar, along with Clinical Trials. The inclusion criteria were ex vivo, in vitro, and in vivo studies, with full texts in English, conducted to determine the radioprotective benefits of , or reports in which ionizing radiation was used. From a total number of 1109 records identified, 15 full text articles were eligible, none of them were clinical trials. In vivo studies reveal the efficiency of aqueous extracts of polysaccharides and triterpenes in mice exposed to -rays. In plasmid, they can reduce radiation damage as an increment of the open circular form, as well as increase the DNA extension, as shown in vitro studies. Ex vivo studies conducted in human blood cells show the radioprotective effect of β-glucan of aqueous extract of , nevertheless, its implementation as radioprotector to humans is in need of further clinical research studies.
Topics: Animals; Drugs, Chinese Herbal; Fungal Polysaccharides; Humans; In Vitro Techniques; Mice; Phytotherapy; Radiation Injuries; Radiation-Protective Agents; Reishi; Triterpenes
PubMed: 32325828
DOI: 10.3390/nu12041143 -
Integrative Cancer Therapies May 2015Polysaccharide K, also known as PSK or Krestin, is derived from the Coriolus versicolor mushroom and is widely used in Japan as an adjuvant immunotherapy for a variety... (Review)
Review
BACKGROUND
Polysaccharide K, also known as PSK or Krestin, is derived from the Coriolus versicolor mushroom and is widely used in Japan as an adjuvant immunotherapy for a variety of cancer including lung cancer. Despite reported benefits, there has been no English language synthesis of PSK for lung cancer. To address this knowledge gap, we conducted a systematic review of PSK for the treatment of lung cancer.
METHODS
We searched PubMed, EMBASE, CINAHL, the Cochrane Library, AltHealth Watch, and the Library of Science and Technology from inception to August 2014 for clinical and preclinical evidence pertaining to the safety and efficacy of PSK or other Coriolus versicolor extracts for lung cancer.
RESULTS
Thirty-one reports of 28 studies were included for full review and analysis. Six studies were randomized controlled trials, 5 were nonrandomized controlled trials, and 17 were preclinical studies. Nine of the reports were Japanese language publications. Fifteen of 17 preclinical studies supported anticancer effects for PSK through immunomodulation and potentiation of immune surveillance, as well as through direct tumor inhibiting actions in vivo that resulted in reduced tumor growth and antimetastatic effects. Nonrandomized controlled trials showed improvement of various survival measures including median survival and 1-, 2-, and 5-year survival. Randomized controlled trials showed benefits on a range of endpoints, including immune parameters and hematological function, performance status and body weight, tumor-related symptoms such as fatigue and anorexia, as well as survival. Although there were conflicting results for impact on some of the tumor-related symptoms and median survival, overall most randomized controlled trials supported a positive impact for PSK on these endpoints. PSK was safely administered following and in conjunction with standard radiation and chemotherapy.
CONCLUSIONS
PSK may improve immune function, reduce tumor-associated symptoms, and extend survival in lung cancer patients. Larger, more rigorous randomized controlled trials for PSK in lung cancer patients are warranted.
Topics: Antibiotics, Antineoplastic; Basidiomycota; Complementary Therapies; Humans; Lung Neoplasms; Proteoglycans
PubMed: 25784670
DOI: 10.1177/1534735415572883 -
PloS One 2016In nature, shooting mechanisms are used for a variety of purposes, including prey capture, defense, and reproduction. This review offers insight into the working... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In nature, shooting mechanisms are used for a variety of purposes, including prey capture, defense, and reproduction. This review offers insight into the working principles of shooting mechanisms in fungi, plants, and animals in the light of the specific functional demands that these mechanisms fulfill.
METHODS
We systematically searched the literature using Scopus and Web of Knowledge to retrieve articles about solid projectiles that either are produced in the body of the organism or belong to the body and undergo a ballistic phase. The shooting mechanisms were categorized based on the energy management prior to and during shooting.
RESULTS
Shooting mechanisms were identified with projectile masses ranging from 1·10-9 mg in spores of the fungal phyla Ascomycota and Zygomycota to approximately 10,300 mg for the ballistic tongue of the toad Bufo alvarius. The energy for shooting is generated through osmosis in fungi, plants, and animals or muscle contraction in animals. Osmosis can be induced by water condensation on the system (in fungi), or water absorption in the system (reaching critical pressures up to 15.4 atmospheres; observed in fungi, plants, and animals), or water evaporation from the system (reaching up to -197 atmospheres; observed in plants and fungi). The generated energy is stored as elastic (potential) energy in cell walls in fungi and plants and in elastic structures in animals, with two exceptions: (1) in the momentum catapult of Basidiomycota the energy is stored in a stalk (hilum) by compression of the spore and droplets and (2) in Sphagnum energy is mainly stored in compressed air. Finally, the stored energy is transformed into kinetic energy of the projectile using a catapult mechanism delivering up to 4,137 J/kg in the osmotic shooting mechanism in cnidarians and 1,269 J/kg in the muscle-powered appendage strike of the mantis shrimp Odontodactylus scyllarus. The launch accelerations range from 6.6g in the frog Rana pipiens to 5,413,000g in cnidarians, the launch velocities from 0.1 m/s in the fungal phylum Basidiomycota to 237 m/s in the mulberry Morus alba, and the launch distances from a few thousands of a millimeter in Basidiomycota to 60 m in the rainforest tree Tetraberlinia moreliana. The mass-specific power outputs range from 0.28 W/kg in the water evaporation mechanism in Basidiomycota to 1.97·109 W/kg in cnidarians using water absorption as energy source.
DISCUSSION AND CONCLUSIONS
The magnitude of accelerations involved in shooting is generally scale-dependent with the smaller the systems, discharging the microscale projectiles, generating the highest accelerations. The mass-specific power output is also scale dependent, with smaller mechanisms being able to release the energy for shooting faster than larger mechanisms, whereas the mass-specific work delivered by the shooting mechanism is mostly independent of the scale of the shooting mechanism. Higher mass-specific work-values are observed in osmosis-powered shooting mechanisms (≤ 4,137 J/kg) when compared to muscle-powered mechanisms (≤ 1,269 J/kg). The achieved launch parameters acceleration, velocity, and distance, as well as the associated delivered power output and work, thus depend on the working principle and scale of the shooting mechanism.
Topics: Animals; Biophysical Phenomena; Energy Metabolism; Fungi; Plant Physiological Phenomena; Predatory Behavior
PubMed: 27454125
DOI: 10.1371/journal.pone.0158277 -
The Cochrane Database of Systematic... Nov 2022Radiotherapy and chemotherapy are used to improve survival in colorectal cancer but adverse effects can be a problem. Severe adverse effects may result in dose reduction... (Review)
Review
BACKGROUND
Radiotherapy and chemotherapy are used to improve survival in colorectal cancer but adverse effects can be a problem. Severe adverse effects may result in dose reduction or cessation of treatment, which have an impact on survival. Coriolus versicolor (Trametes versicolor or 'Turkey Tail') mushroom and its extracts have been used by cancer patients to help with adverse effects.
OBJECTIVES
To assess the effects of adjunctive Coriolus versicolor (Trametes versicolor) and its extracts on adverse effects and on survival during colorectal cancer treatment (chemotherapy and radiotherapy) compared with no adjunctive treatment.
SEARCH METHODS
We searched databases including CENTRAL, MEDLINE, Embase, AMED and CINAHL, Chinese and Japanese databases, and trials registers to 12th April 2022 without restriction of language or publication status. We screened reference lists and attempted to contact researchers in the field to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) investigating the efficacy and safety of Coriolus versicolor and its extracts in adult participants with a confirmed diagnosis of colorectal cancer, in addition to conventional treatment. Interventions included any preparation of Coriolus versicolor (raw, decoction, capsule, tablet, tincture, extract, injection), any part of the fungus (cap, stem, mycelium or whole), in any dose or regimen. Outcomes included adverse events rates, survival, disease progression and recurrence, response rates and quality of life.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened and selected studies, extracted outcome data, and assessed risk of bias. We evaluated the overall certainty of evidence using the GRADE approach.
MAIN RESULTS
We included seven parallel RCTs (1569 participants). Six studies (1516 participants) were conducted in Japan and one study (53 participants) in China. Studies included both male and female participants with colorectal cancer (five studies), colon cancer (one study) or rectal cancer (one study). Participants were diagnosed with cancer ranging from stage II to stage IV. Coriolus was used in the form of an extract in all seven studies and was generally used after curative resection, although in one study it was used preoperatively. Duration of treatment with the extract varied between four weeks and three years. Chemotherapeutic regimens in six studies consisted of an oral fluoropyrimidine which was preceded by weekly intravenous 5-Fluorouracil (5-FU) in one study, by mitomycin C in two studies, and which was combined with folinic acid (Leucovorin) in two studies and with radiotherapy preoperatively in one study. XELOX (oxaliplatin intravenous infusion and capecitabine) was used in the remaining study. We found very low-certainty evidence of little to no effect of adjunctive treatment with Coriolus (in the form of an extract, polysaccharide-Krestin, PSK) on withdrawal from treatment due to adverse events (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.45 to 2.34; 703 participants; 3 studies;). We are uncertain whether adjunctive Coriolus versicolor and its extracts compared to usual care alone resulted in a difference in adverse events including neutropenia (RR 0.41, 95% CI 0.24 to 0.71; 133 participants; 3 studies; very low certainty), oral cavity disorders such as oral dryness and mucositis (RR 0.37, 95% CI 0.13 to 1.03; 1022 participants; 5 studies; very low certainty), nausea (RR 0.73, 95% CI 0.44 to 1.22; 969 participants; 4 studies; very low certainty), diarrhoea (RR 0.77, 95% CI 0.32 to 1.86; 1022 participants; 5 studies; very low certainty), and fatigue (RR 0.76; 95% CI 0.33 to 1.78; 133 participants; 3 studies; very low certainty). We found low-certainty evidence of a small effect of adjunctive Coriolus on improved survival at five years compared with no adjunctive care (RR 1.08, 95% CI 1.01 to 1.15; 1094 participants; 3 studies; number needed to benefit (NNTB) = 16 (95% Cl 9 to 70). The effect at earlier time points was unclear.
AUTHORS' CONCLUSIONS
Due to the very low certainty of evidence, we were uncertain about the effect of adjunctive Coriolus (in the form of an extract PSK) on adverse events resulting from conventional chemotherapy for colorectal cancer. This includes effects on withdrawal of treatment due to adverse events and on specific adverse outcomes such as neutropenia and nausea. The uncertainty in the evidence also means that it was unclear whether any adverse events were due to the chemotherapy or to the extract itself. While there was low-certainty evidence of a small effect on overall survival at five years, the influence of reduced adverse effects on this could not be determined. In addition, chemotherapy regimens used in assessing this outcome do not reflect current preferred practice.
Topics: Adult; Female; Humans; Male; Agaricales; Colorectal Neoplasms; Drug-Related Side Effects and Adverse Reactions; Nausea; Neutropenia; Trametes; Randomized Controlled Trials as Topic
PubMed: 36445793
DOI: 10.1002/14651858.CD012053.pub2 -
International Journal of Molecular... May 2018In this study, we investigated the therapeutic potential and medical applications of () by conducting a systematic review of the existing literature and performing a... (Meta-Analysis)
Meta-Analysis Review
In this study, we investigated the therapeutic potential and medical applications of () by conducting a systematic review of the existing literature and performing a meta-analysis. The original efficacy treatment of the mushroom extract is considered primarily and searched in electronic databases. A total of 623 articles were assessed, 33 randomized controlled experiments were included after the manual screening, and some papers, review articles, or editorials that did not contain data were excluded. A comparative standard means difference (SMD) and a funnel plot between control and groups were used as parameters to demonstrate the beneficial effects of for diabetes and cancer treatment, as well as anti-inflammatory, anti-fungal and antioxidant activities. The meta-analysis was carried out using Review Manager 5.1 software. Although for therapeutic diabetes there was heterogeneity in the subgroup analysis (I² = 91.9%), the overall results showed statistically significant SMDs in major symptoms that decreased serum insulin levels (SMD = 1.92, 95% CI (1.10, 2.75), I² = 0%), wound rates (SMD = 3.55 (2.56, 4.54), I² = 40%) and contributions to an increase in nutrient intake content (SMD = 0.32 (-0.15, 0.78), I² = 0%). Simultaneously, the study confirmed the utility of treatment in terms of not only anti-cancer activity (reduction of tumor activity and survival of cancer cells I² = 42 and 34%, respectively) but also anti-inflammatory, anti-fungal and antioxidant activities (I² = 50, 44, and 10%, respectively). Our findings suggest that extracts are useful for prevention and treatment of human diseases and might be the best candidates for future medicines.
Topics: Agaricales; Biological Products; Humans; Publication Bias; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 29772715
DOI: 10.3390/ijms19051487 -
Biomedicine & Pharmacotherapy =... Mar 2022Mushroom consumption has grown extraordinarily owing to their high nutritional value, desirable taste, and aroma. Mushrooms continue generating lots of interest chiefly...
Mushroom consumption has grown extraordinarily owing to their high nutritional value, desirable taste, and aroma. Mushrooms continue generating lots of interest chiefly in their consumption as food, as a cure for different ailments, as well as important goods for commerce throughout the globe owing to their dietary, antioxidant, and therapeutic values. Higher Ascomycetes and Basidiomycetes mushrooms have different properties with anticancer and immunological potential. They as well provide vital health benefits and display a wide-ranging continuum of pharmacological effects. The antioxidant activity of different mushrooms was reviewed for different radicals including DPPH, ABTS, OH, Nitrite, metals, and lipid peroxidation. The present review presents pharmacological activities of different species of edible and medicinal mushrooms. This review provides tangible evidence that these mushrooms are an excellent source of natural constituents and antioxidants with potential application in pharmaceuticals and in treating and managing different diseases.
Topics: Agaricales; Antioxidants; Functional Food; Humans
PubMed: 35026489
DOI: 10.1016/j.biopha.2022.112621 -
Molecules (Basel, Switzerland) Aug 2023Fruits and vegetables are used not only for nutritional purposes but also as therapeutics to treat various diseases and ailments. These food items are prominent sources... (Review)
Review
Fruits and vegetables are used not only for nutritional purposes but also as therapeutics to treat various diseases and ailments. These food items are prominent sources of phytochemicals that exhibit chemopreventive and therapeutic effects against several diseases. Hirsutine (HSN) is a naturally occurring indole alkaloid found in various Uncaria species and has a multitude of therapeutic benefits. It is found in foodstuffs such as fish, seafood, meat, poultry, dairy, and some grain products among other things. In addition, it is present in fruits and vegetables including corn, cauliflower, mushrooms, potatoes, bamboo shoots, bananas, cantaloupe, and citrus fruits. The primary emphasis of this study is to summarize the pharmacological activities and the underlying mechanisms of HSN against different diseases, as well as the biopharmaceutical features. For this, data were collected (up to date as of 1 July 2023) from various reliable and authentic literature by searching different academic search engines, including PubMed, Springer Link, Scopus, Wiley Online, Web of Science, ScienceDirect, and Google Scholar. Findings indicated that HSN exerts several effects in various preclinical and pharmacological experimental systems. It exhibits anti-inflammatory, antiviral, anti-diabetic, and antioxidant activities with beneficial effects in neurological and cardiovascular diseases. Our findings also indicate that HSN exerts promising anticancer potentials via several molecular mechanisms, including apoptotic cell death, induction of oxidative stress, cytotoxic effect, anti-proliferative effect, genotoxic effect, and inhibition of cancer cell migration and invasion against various cancers such as lung, breast, and antitumor effects in human T-cell leukemia. Taken all together, findings from this study show that HSN can be a promising therapeutic agent to treat various diseases including cancer.
Topics: Animals; Humans; Biological Products; Alkaloids; Vegetables; Agaricales
PubMed: 37630393
DOI: 10.3390/molecules28166141 -
The Cochrane Database of Systematic... Mar 2021This is a updated version of our Cochrane Review published in Issue 6, 2012. Sexually-transmitted infections (STIs) continue to rise worldwide, imposing an enormous... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This is a updated version of our Cochrane Review published in Issue 6, 2012. Sexually-transmitted infections (STIs) continue to rise worldwide, imposing an enormous morbidity and mortality burden. Effective prevention strategies, including microbicides, are needed to achieve the goals of the World Heath Organization (WHO) global strategy for the prevention and control of these infections.
OBJECTIVES
To determine the effectiveness and safety of topical microbicides for preventing acquisition of STIs, including HIV.
SEARCH METHODS
We undertook a comprehensive search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, CLIB, Web of Science, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and reference lists of relevant articles up to August 2020. In addition, we contacted relevant organisations and experts.
SELECTION CRITERIA
We included randomised controlled trials of vaginal microbicides compared to placebo (except for nonoxynol-9 because it is covered in related Cochrane Reviews). Eligible participants were sexually-active non-pregnant, WSM and MSM, who had no laboratory confirmed STIs.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened and selected studies, extracted data, and assessed risks of bias in duplicate, resolving differences by consensus. We conducted a fixed-effect meta-analysis, stratified by type of microbicide, and assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included eight trials from the earlier version of the review and four new trials, i.e. a total of 12 trials with 32,464 participants (all WSM). We did not find any eligible study that enrolled MSM or reported fungal STI as an outcome. We have no study awaiting assessment. All 12 trials were conducted in sub-Saharan Africa, with one having a study site in the USA, and another having a site in India. Vaginal microbicides tested were BufferGel and PRO 2000 (1 trial, 3101 women), Carraguard (1 trial, 6202 women), cellulose sulphate (2 trials, 3069 women), dapivirine (2 trials, 4588 women), PRO 2000 (1 trial, 9385 women), C31G (SAVVY) (2 trials, 4295 women), and tenofovir (3 trials, 4958 women). All microbicides were compared to placebo and all trials had low risk of bias. Dapivirine probably reduces the risk of acquiring HIV infection: risk ratio (RR) 0.71, (95% confidence interval (CI) 0.57 to 0.89, I = 0%, 2 trials, 4588 women; moderate-certainty evidence). The other microbicides may result in little to no difference in the risk of acquiring HIV (low-certainty evidence); including tenofovir (RR 0.83, 95% CI 0.68 to 1.02, cellulose sulphate (RR 1.20, 95% CI 0.74 to 1.95, BufferGel (RR 1.05, 95% CI 0.73 to 1.52), Carraguard (RR 0.89, 95% CI 0.71 to 1.11), PRO 2000 (RR 0.93, 95% CI 0.77 to 1.14), and SAVVY (RR 1.38, 95% CI 0.79 to 2.41). Existing evidence suggests that cellulose sulphate (RR 0.99, 95% CI 0.37 to 2.62, 1 trial, 1425 women), and PRO 2000 (RR 0.95, 95% CI 0.73 to 1.23) may result in little to no difference in the risk of getting herpes simplex virus type 2 infection (low-certainty evidence). Two studies reported data on tenofovir's effect on this virus. One suggested that tenofovir may reduce the risk (RR 0.55, 95% CI 0.36 to 0.82; 224 participants) while the other did not find evidence of an effect (RR 0.94, 95% CI 0.85 to 1.03; 1003 participants). We have not reported the pooled result because of substantial heterogeneity of effect between the two studies (l = 85%). The evidence also suggests that dapivirine (RR 1.70, 95% CI 0.63 to 4.59), tenofovir (RR 1.27, 95% CI 0.58 to 2.78), cellulose sulphate (RR 0.69, 95% CI 0.26 to 1.81), and (Carraguard (RR 1.07, 95% CI 0.75 to 1.52) may have little or no effect on the risk of acquiring syphilis (low-certainty evidence). In addition, dapivirine (RR 0.97, 95% CI 0.89 to 1.07), tenofovir (RR 0.90, 95% CI 0.71 to 1.13), cellulose sulphate (RR 0.70, 95% CI 0.49 to 0.99), BufferGel (RR 0.97, 95% CI 0.65 to 1.45), Carraguard (RR 0.96, 95% CI 0.83 to 1.12), and PRO 2000 (RR 1.01, 95% CI 0.84 to 1.22) may result in little to no difference in the risk of acquiring chlamydia infection (low-certainty evidence). The evidence also suggests that current topical microbicides may not have an effect on the risk of acquiring gonorrhoea, condyloma acuminatum, trichomoniasis, or human papillomavirus infection (low-certainty evidence). Microbicide use in the 12 trials, compared to placebo, did not lead to any difference in adverse event rates. No study reported on acceptability of the intervention. AUTHORS' CONCLUSIONS: Current evidence shows that vaginal dapivirine microbicide probably reduces HIV acquisition in women who have sex with men. Other types of vaginal microbicides have not shown evidence of an effect on acquisition of STIs, including HIV. Further research should continue on the development and testing of new microbicides.
Topics: Acrylic Resins; Adenine; Administration, Intravaginal; Agaricales; Anti-HIV Agents; Anti-Infective Agents, Local; Bias; Cellulose; Female; HIV Infections; Humans; Naphthalenesulfonates; Placebos; Polymers; Pyrimidines; Seaweed; Sexually Transmitted Diseases; Tenofovir
PubMed: 33719075
DOI: 10.1002/14651858.CD007961.pub3