BACKGROUND: Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.
OBJECTIVES: To assess the effects of Serenoa repens in the treatment of men with LUTS consistent with BPH.
SEARCH METHODS: We performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 16 September 2022, with no restrictions on language or publication status.
SELECTION CRITERIA: We included randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion at each stage and undertook data extraction and risk of bias assessment and GRADE assessment of the certainty of the evidence. We considered review outcomes measured up to 12 months after randomization as short term, and beyond 12 months as long term. Our main outcomes included urologic symptom scores, quality of life, and adverse events.
MAIN RESULTS: For this update, we narrowed the review question to only comparisons with placebo. We included 27 studies (of which 9 were new) involving a total of 4656 participants, 19 studies comparing Serenoa repens with placebo, and 8 studies comparing Serenoa repens in combination with other phytotherapeutic agents versus placebo. Most studies included men aged > 50 (mean age range 52 to 68) with moderate urologic symptoms (International Prostate Symptom Score [IPSS] range 8 to 19). Ten studies were funded by the pharmaceutical industry; two studies were funded by government agencies; and the remaining studies did not specify funding sources. Serenoa repens versus placebo or no intervention Results for this comparison are based on predefined sensitivity analyses limited to studies at low risk of bias. Serenoa repens results in little to no difference in urologic symptoms at short-term follow-up (3 to 6 months; IPSS score range 0 to 35, higher scores indicate worse symptoms; mean difference (MD) -0.90, 95% confidence interval (CI) -1.74 to -0.07; I2 = 68%; 9 studies, 1681 participants; high-certainty evidence). Serenoa repens results in little to no difference in the quality of life at short-term follow-up (3 to 6 months; IPSS quality of life domain range 0 to 6, higher scores indicate worse quality of life; MD -0.20, 95% CI -0.40 to -0.00; I2 = 39%; 5 studies, 1001 participants; high-certainty evidence). Serenoa repens probably results in little to no difference in adverse events (1 to 17 months; risk ratio (RR) 1.01, 95% CI 0.77 to 1.31; I2 = 18%; 12 studies, 2399 participants; moderate-certainty evidence). Based on 164 cases per 1000 men in the placebo group, this corresponds to 2 more (38 fewer to 51 more) per 1000 men in the Serenoa repens group. Serenoa repens results in little to no difference in urologic symptoms at long-term follow-up (12 to 17 months, IPSS score, MD 0.07, 95% CI -0.75 to 0.88; I2 = 34%; 3 studies, 898 participants; high-certainty evidence). Serenoa repens results in little to no difference in quality of life at long-term follow-up (12 to 17 months, IPSS quality of life, MD -0.11, 95% CI -0.41 to 0.19; I2 = 65%; 3 studies, 882 participants; high-certainty evidence). There were no data on long-term adverse events for this comparison. Serenoa repens in combination with other phytotherapy versus placebo or no intervention Different phytotherapeutic agents that include Serenoa repens may result in little to no difference in urologic symptoms compared to placebo at short-term follow-up (12 to 24 weeks, IPSS score, MD -2.41, 95% CI -4.54 to -0.29; I2 = 67%; 4 studies, 460 participants; low-certainty evidence). We are very uncertain about the effects of these agents on quality of life (very low-certainty evidence). These agents may result in little to no difference in the occurrence of adverse events; however, the CIs included substantial benefits and harms (12 to 48 weeks, RR 0.91, 95% CI 0.58 to 1.41; I2 = 0%; 4 studies, 481 participants; low-certainty evidence). Based on 132 cases per 1000 men in the placebo group, this corresponds to 12 fewer (55 fewer to 54 more) per 1000 men in the combined phytotherapeutic agents with Serenoa repens group.
AUTHORS' CONCLUSIONS: Serenoa repens alone provides little to no benefits for men with lower urinary tract symptoms due to benign prostatic enlargement. There is more uncertainty about the role of Serenoa repens in combination with other phytotherapeutic agents.
BACKGROUND: Echinacea plant preparations (family Asteraceae) are widely used in Europe and North America for common colds. Most consumers and physicians are not aware that products available under the term Echinacea differ appreciably in their composition, mainly due to the use of variable plant material, extraction methods and the addition of other components.
OBJECTIVES: To assess whether there is evidence that Echinacea preparations are effective and safe compared to placebo in the prevention and treatment of the common cold.
SEARCH METHODS: We searched CENTRAL 2013, Issue 5, MEDLINE (1946 to May week 5, 2013), EMBASE (1991 to June 2013), CINAHL (1981 to June 2013), AMED (1985 to February 2012), LILACS (1981 to June 2013), Web of Science (1955 to June 2013), CAMBASE (no time limits), the Centre for Complementary Medicine Research (1988 to September 2007), WHO ICTRP and clinicaltrials.gov (last searched 5 June 2013), screened references and asked experts in the field about published and unpublished studies.
SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing mono-preparations of Echinacea with placebo.
DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed eligibility and trial quality and extracted data. The primary efficacy outcome was the number of individuals with at least one cold in prevention trials and the duration of colds in treatment trials. For all included trials the primary safety and acceptability outcome was the number of participants dropping out due to adverse events. We assessed trial quality using the Cochrane 'Risk of bias' tool.
MAIN RESULTS: Twenty-four double-blind trials with 4631 participants including a total of 33 comparisons of Echinacea preparations and placebo met the inclusion criteria. A variety of different Echinacea preparations based on different species and parts of plant were used. Evidence from seven trials was available for preparations based on the aerial parts of Echinacea purpurea.
Ten trials were considered to have a low risk of bias, six to have an unclear risk of bias and eight to have a high risk of bias. Ten trials with 13 comparisons investigated prevention and 15 trials with 20 comparisons investigated treatment of colds (one trial addressed both prevention and treatment).
Due to the strong clinical heterogeneity of the studies we refrained from pooling for the main analysis. None of the 12 prevention comparisons reporting the number of patients with at least one cold episode found a statistically significant difference. However a post hoc pooling of their results, suggests a relative risk reduction of 10% to 20%. Of the seven treatment trials reporting data on the duration of colds, only one showed a significant effect of Echinacea over placebo. The number of patients dropping out or reporting adverse effects did not differ significantly between treatment and control groups in prevention and treatment trials. However, in prevention trials there was a trend towards a larger number of patients dropping out due to adverse events in the treatment groups.
AUTHORS' CONCLUSIONS: Echinacea products have not here been shown to provide benefits for treating colds, although, it is possible there is a weak benefit from some Echinacea products: the results of individual prophylaxis trials consistently show positive (if non-significant) trends, although potential effects are of questionable clinical relevance.
ACHTERGROND: In sommige landen extracten van de plant Hypericum perforatum L. (in de volksmond Sint-Janskruid) worden op grote schaal gebruikt voor de behandeling van patiënten met depressieve symptomen.
DOELSTELLINGEN: te onderzoeken of extracten van hypericum effectiever zijn dan placebo en even werkzaam als standaard antidepressiva bij de behandeling van ernstige depressie, en of ze minder bijwerkingen dan de standaard antidepressiva hebben.
Zoekmethoden: Proeven werden gezocht in geautomatiseerde gegevensbestanden, door het controleren van bibliografieën van relevante artikelen, en door contact op fabrikanten en onderzoekers.
SELECTIECRITERIA: Trials werden opgenomen indien zij: (1) werden gerandomiseerd en dubbelblind, (2) opgenomen patiënten met een ernstige depressie, (3) ten opzichte van extracten van sint-janskruid met placebo of standaard antidepressiva; (4) inbegrepen klinische uitkomsten het beoordelen van depressieve symptomen.
Gegevensverzameling en-analyse: ten minste twee onafhankelijke beoordelaars gewonnen informatie uit onderzoeksrapporten. De belangrijkste uitkomstmaat voor de beoordeling van de werkzaamheid was de responder rate ratio (het relatieve risico van het hebben van een respons op de behandeling). De belangrijkste uitkomstmaat voor nadelige effecten was het aantal patiënten uitval als gevolg van bijwerkingen.
BELANGRIJKSTE RESULTATEN: Een totaal van 29 studies (5489 patiënten) met 18 vergelijkingen met placebo en 17 vergelijkingen met synthetische standaard antidepressiva voldeden aan de inclusiecriteria. Resultaten van placebogecontroleerde studies bleek gemarkeerd heterogeniteit. In negen grotere studies de gecombineerde response rate ratio (RR) voor hypericum extract in vergelijking met placebo was 1,28 (95% betrouwbaarheidsinterval (CI), 1,10 tot 1,49) en van negen kleinere studies was 1,87 (95% CI, 1,22 tot 2,87). Resultaten van studies vergelijken hypericum extracten en standaard antidepressiva waren statistisch homogeen. Vergeleken met tri-of tetracyclische antidepressiva en selectieve serotonine heropname remmers (SSRI's), respectievelijk RR's respectievelijk 1,02 (95% BI, 0,90 tot 1,15, 5 studies) en 1,00 (95% BI, 0,90 tot 1,11; 12 trials). Zowel in placebo-gecontroleerde studies en in vergelijking met standaard antidepressiva, zijn proeven uit Duitstalige landen rapporteerden bevindingen gunstiger zijn voor hypericum. Patiënten die hypericum extracten van de proeven ten gevolge van bijwerkingen daalde minder vaak zijn dan die oudere antidepressiva (odds ratio (OR) 0,24; 95% BI, 0,13 tot 0,46) of SSRI's (OR 0,53, 95% CI, 0.34 tot 0.83).
AUTEURS 'CONCLUSIES: De beschikbare gegevens blijkt dat de hypericum-extracten getest in de meegeleverde trials a) zijn superieur aan placebo bij patiënten met een ernstige depressie, b) zijn even effectief als standaard antidepressiva, c) en hebben minder bijwerkingen dan de standaard antidepressiva. De vereniging van het land van herkomst en precisie met effecten maten bemoeilijkt de interpretatie.
DOEL: De optimale behandeling van de claudicatio intermittens is nog niet geïdentificeerd. Ginkgo biloba-extract is gemeld dat het positieve effecten hebben. We voerden een meta-analyse van de werkzaamheid van Ginkgo biloba-extract voor claudicatio intermittens op basis van de resultaten van gerandomiseerde, placebo-gecontroleerde, dubbelblinde studies.
Methode: Literatuuronderzoek van MEDLINE, EMBASE, BIOSIS, Amed, CISCOM,-en de Cochrane Library werd uitgevoerd om studies over het onderwerp te identificeren. De fabrikanten van commerciële Ginkgo biloba-producten en auteur van een oorspronkelijk publicaties en onderzoeken zijn benaderd om aanvullende informatie te verstrekken. Geen enkele taal beperkingen werden opgelegd.
RESULTATEN: acht gerandomiseerde, placebo-gecontroleerde, dubbelblinde studies werden opgenomen. Meta-analyse vonden een significant verschil in de toename van de pijnvrije loopafstand in het voordeel van Ginkgo biloba (gewogen gemiddelde verschil: 34 meter, 95% betrouwbaarheidsinterval [BI]: 26 tot 43 meter). In onderzoek met vergelijkbare methodologische kenmerken (ergometer snelheid: 3 km / h, neiging: 12%) was dit verschil 33 meter in het voordeel van Ginkgo biloba (95% BI: 22 tot 43 meter). Bijwerkingen waren zeldzaam, milde en voorbijgaande aard.
Conclusies: Deze resultaten suggereren dat Ginkgo biloba-extract is beter dan placebo in de symptomatische behandeling van claudicatio intermittens. Echter, de omvang van het totale effect van de behandeling is bescheiden en van onzekere klinische betekenis.
BACKGROUND: Depressive disorders are persistent, recurring illnesses that cause great suffering for patients and their families.
PURPOSE: To evaluate the benefits and adverse effects of newer pharmacotherapies and herbal treatments for depressive disorders in adults and adolescents.
DATA SOURCES: English-language and non-English-language literature from 1980 to January 1998 was identified from a specialized registry of controlled trials, meta-analyses, and experts.
STUDY SELECTION: Randomized trials evaluating newer antidepressants (such as serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and St. John's wort) that reported clinical outcomes were selected.
DATA EXTRACTION: Two persons independently abstracted data that were then synthesized descriptively; some data were pooled by using a random-effects model.
DATA SYNTHESIS: Of 315 eligible trials, most evaluated antidepressants in adults with major depression, were conducted among outpatients, and examined acute-phase treatment. Newer antidepressants were more effective than placebo for major depression (relative benefit, 1.6 [95% CI, 1.5 to 1.7]) and dysthymia (relative benefit, 1.7 [CI, 1.3 to 2.3]). They were effective among older adults and primary care patients. Efficacy did not differ among newer agents or between newer and older agents. Hypericum (St. John's wort) was more effective than placebo for mild to moderate depression (risk ratio, 1.9 [CI, 1.2 to 2.8]), but publication bias may have inflated the estimate of benefit. Newer and older antidepressants did not differ for overall discontinuation rates, but side effect profiles varied significantly. Data were insufficient for determining the efficacy of newer antidepressants for subsyndromal depression, depression with coexisting medical or psychiatric illness, or depression in adolescents.
CONCLUSIONS: Newer antidepressants are clearly effective in treating depressive disorders in diverse settings. Because of similar efficacy, both newer and older antidepressants should be considered when making treatment decisions. Better information is urgently needed on the efficacy of newer antidepressants in patients with nonmajor depression and in special populations, including adolescents.
Synthetische anxiolytische middelen zijn effectief voor de behandeling van angst, maar ze zijn belast met schadelijke effecten. Beperkingen op de middelen en tijd vaak maken therapieën, zoals psychologische interventies onuitvoerbaar. Zo zou een effectieve orale medicatie met weinig negatieve effecten zijn een welkome aanvulling op de therapeutische repertoire. Deze systematische review en meta-analyse was gericht op de beoordeling van de bewijzen voor of ten opzichte van de werkzaamheid van kava extract als een symptomatische behandeling van angst. Systematisch literatuuronderzoek werd uitgevoerd in de geautomatiseerde gegevensbestanden MEDLINE, EMBASE, BIOSIS, Amed, CISCOM,-en de Cochrane Library (alle van hun respectievelijke begin tot juni 1998). De gebruikte zoektermen waren kava, Kawa, kavain, Piper methysticum en Rauschpfeffer (Duitse term voor Piper methysticum). Experts op het onderwerp werden gecontacteerd om nadere informatie te verstrekken. Er waren geen beperkingen ten aanzien van de taal van de publicatie. Dubbelblinde, gerandomiseerde, placebo-gecontroleerde studies van orale kava-extract voor de behandeling van angst werden opgenomen. Alle publicaties zijn verblind voor de beoordeling door een persoon die niet betrokken is bij de studie. De gegevens werden geëxtraheerd in een gestandaardiseerde, vooraf gedefinieerde manier onafhankelijk van elkaar door de twee recensenten. De methodologische kwaliteit van alle studies werd beoordeeld. Superioriteit van de kava-extract ten opzichte van placebo werd voorgesteld door alle zeven beoordeeld proeven. De meta-analyse van de drie onderzoeken blijkt een significant verschil in de vermindering van de totale score op de Hamilton Rating Scale for Anxiety in het voordeel van kava extract (gewogen gemiddelde verschil, 9,69, 95% betrouwbaarheidsinterval, 3.54-15.83). Deze gegevens suggereren dat kava extract superieur is aan een placebo symptomatische behandeling van angst. Daarom is kava-extract is een kruiden-behandeling voor angst, dat is het overwegen waard.
U wilt adresseren de vraag of sint-janskruid is handig voor het de behandeling van depressie hebben we geprobeerd om alle Engels-taal artikelen op te halen met gegevens over de werkzaamheid, veiligheid, en beschikbaarheid van wort St John's. Gerandomiseerde, gecontroleerde, dubbelblinde studies werden geselecteerd en beoordeeld op methodologische kwaliteit met behulp van een gestandaardiseerde checklist, en gegevens over farmacologie, kosten, regelgeving, veiligheid en werden geëxtraheerd. Acht studies werden geïdentificeerd, gevonden te zijn van in het algemeen goede methodologische kwaliteit, en vastbesloten om een bescheiden bedrag van gegevens te verstrekken om te suggereren dat St John's wort effectiever is dan placebo in de behandeling van lichte tot matige depressie. De absolute verhoogde respons met het gebruik van sint-janskruid varieerde van 23% tot 55% hoger dan met placebo, maar varieerde van 6% tot 18% lager in vergelijking met tricyclische antidepressiva. Meer gegevens zijn nodig om zowel het gebruik ervan in een ernstige depressie en de werkzaamheid in vergelijking met andere antidepressiva te beoordelen. De tarieven van bijwerkingen effecten waren laag. Als een voedingssupplement, sint-janskruid is op dit moment nauwelijks regels voor, maar de Food and Drug Administration herziet plannen om zijn regelgevend toezicht vast te zetten.
Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.
OBJECTIVES:
To assess the effects of Serenoa repens in the treatment of men with LUTS consistent with BPH.
SEARCH METHODS:
We performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 16 September 2022, with no restrictions on language or publication status.
SELECTION CRITERIA:
We included randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment.
DATA COLLECTION AND ANALYSIS:
Two review authors independently assessed studies for inclusion at each stage and undertook data extraction and risk of bias assessment and GRADE assessment of the certainty of the evidence. We considered review outcomes measured up to 12 months after randomization as short term, and beyond 12 months as long term. Our main outcomes included urologic symptom scores, quality of life, and adverse events.
MAIN RESULTS:
For this update, we narrowed the review question to only comparisons with placebo. We included 27 studies (of which 9 were new) involving a total of 4656 participants, 19 studies comparing Serenoa repens with placebo, and 8 studies comparing Serenoa repens in combination with other phytotherapeutic agents versus placebo. Most studies included men aged > 50 (mean age range 52 to 68) with moderate urologic symptoms (International Prostate Symptom Score [IPSS] range 8 to 19). Ten studies were funded by the pharmaceutical industry; two studies were funded by government agencies; and the remaining studies did not specify funding sources. Serenoa repens versus placebo or no intervention Results for this comparison are based on predefined sensitivity analyses limited to studies at low risk of bias. Serenoa repens results in little to no difference in urologic symptoms at short-term follow-up (3 to 6 months; IPSS score range 0 to 35, higher scores indicate worse symptoms; mean difference (MD) -0.90, 95% confidence interval (CI) -1.74 to -0.07; I2 = 68%; 9 studies, 1681 participants; high-certainty evidence). Serenoa repens results in little to no difference in the quality of life at short-term follow-up (3 to 6 months; IPSS quality of life domain range 0 to 6, higher scores indicate worse quality of life; MD -0.20, 95% CI -0.40 to -0.00; I2 = 39%; 5 studies, 1001 participants; high-certainty evidence). Serenoa repens probably results in little to no difference in adverse events (1 to 17 months; risk ratio (RR) 1.01, 95% CI 0.77 to 1.31; I2 = 18%; 12 studies, 2399 participants; moderate-certainty evidence). Based on 164 cases per 1000 men in the placebo group, this corresponds to 2 more (38 fewer to 51 more) per 1000 men in the Serenoa repens group. Serenoa repens results in little to no difference in urologic symptoms at long-term follow-up (12 to 17 months, IPSS score, MD 0.07, 95% CI -0.75 to 0.88; I2 = 34%; 3 studies, 898 participants; high-certainty evidence). Serenoa repens results in little to no difference in quality of life at long-term follow-up (12 to 17 months, IPSS quality of life, MD -0.11, 95% CI -0.41 to 0.19; I2 = 65%; 3 studies, 882 participants; high-certainty evidence). There were no data on long-term adverse events for this comparison. Serenoa repens in combination with other phytotherapy versus placebo or no intervention Different phytotherapeutic agents that include Serenoa repens may result in little to no difference in urologic symptoms compared to placebo at short-term follow-up (12 to 24 weeks, IPSS score, MD -2.41, 95% CI -4.54 to -0.29; I2 = 67%; 4 studies, 460 participants; low-certainty evidence). We are very uncertain about the effects of these agents on quality of life (very low-certainty evidence). These agents may result in little to no difference in the occurrence of adverse events; however, the CIs included substantial benefits and harms (12 to 48 weeks, RR 0.91, 95% CI 0.58 to 1.41; I2 = 0%; 4 studies, 481 participants; low-certainty evidence). Based on 132 cases per 1000 men in the placebo group, this corresponds to 12 fewer (55 fewer to 54 more) per 1000 men in the combined phytotherapeutic agents with Serenoa repens group.
AUTHORS' CONCLUSIONS:
Serenoa repens alone provides little to no benefits for men with lower urinary tract symptoms due to benign prostatic enlargement. There is more uncertainty about the role of Serenoa repens in combination with other phytotherapeutic agents.
