Primary studies included in this broad synthesis

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Primary study

Unclassified

Tijdschrift The Journal of urology
Year 2000
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DOEL: We testten de effecten van een zag palmetto kruiden-mix bij mannen met symptomatische goedaardige prostatic hyperplasia (BPH) via een gerandomiseerde, placebo gecontroleerde trial. Materialen en methoden: We gerandomiseerde 44 mannen 45 tot 80 jaar oud met een symptomatische BPH in een proces van een zaagpalmetto kruidenmengsel versus placebo. Eindpunten opgenomen routine klinische maatregelen (symptoom score, uroflowmetrie en post-void achterblijvende urine volume), samenstelling van het bloed studies (prostaat specifiek antigeen, geslachtshormonen en multifasische analyse), prostaat Volumetrics door magnetische resonantie beeldvorming, en de prostaat biopsie voor zonale weefsel morfometrie en semi-kwantitatieve histologie studies. RESULTATEN: Saw palmetto kruidenmengsel en de placebogroep was klinische parameters verbeterd met een licht voordeel in de zaag palmetto-groep (niet statistisch significant). Geen van beide prostaat-specifiek antigeen, noch prostaat volume veranderd opzichte van de uitgangswaarde. Prostaat epithelial krimp werd opgemerkt, vooral in de overgangszone, waar procent epitheel van 17,8% bij aanvang tot 10,7% afgenomen na 6 maanden van zaagpalmetto kruidenmengsel (p <0,01). Histologisch studies bleek dat de procent van atrofische klieren steeg van 25. 2% tot 40,9% na de behandeling met zag palmetto kruiden-mix (p <0,01). Het mechanisme van actie bleek te zijn niet-hormonale, maar het werd niet geïdentificeerd door weefsel onderzoeken van apoptose, cellulaire proliferatie, angiogenese, groeifactoren of androgene receptor expressie. We merkten geen nadelige effecten van zaagpalmetto kruidenmengsel. Toen de studie werd niet meer verblind, 41 mannen gekozen om de behandeling voort te zetten in een open-label extensie. CONCLUSIES: Saw palmetto kruidenmengsel lijkt een veilige, zeer wenselijk optie voor mannen met matig symptomatische BPH. De secundaire uitkomstmaten van klinisch effect in onze studie waren slechts iets beter voor zaagpalmetto kruidenmengsel dan een placebo (niet statistisch significant). Echter, zag palmetto kruidenmengsel therapie werd in verband gebracht met epitheliale krimp, met name in de overgangszone (p <0,01), wat wijst op een mogelijk werkingsmechanisme ten grondslag liggen aan de klinische betekenis waargenomen in andere studies.

Primary study

Unclassified

Tijdschrift Archives of internal medicine
Year 2000
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BACKGROUND: Echinacea products are among the most popular phytomedicines on the North American market. Since at least half of all pregnancies are unplanned, many women inadvertently use echinacea in their first trimester. Presently, there is a paucity of information regarding the gestational safety of this herb. The primary objective of this study was to evaluate the safety of echinacea in pregnancy when used for upper respiratory tract ailments. PATIENTS AND METHODS: The study group consisted of women who were prospectively followed up after contacting the Motherisk Program regarding the gestational use of echinacea. This cohort was disease-matched to women exposed to nonteratogenic agents by maternal age, alcohol, and cigarette use. Rates of major and minor malformations between the groups were compared. RESULTS: A total of 206 women were enrolled in the study group after using echinacea products during pregnancy; 112 women used the herb in the first trimester. There were a total of 195 live births, including 3 sets of twins, 13 spontaneous abortions, and 1 therapeutic abortion. Six major malformations were reported, including 1 chromosomal abnormality, and 4 of these malformations occurred with echinacea exposure in the first trimester. In the control group, there were 206 women with 198 live births, 7 spontaneous abortions, and 1 therapeutic abortion. Seven major malformations were reported. There were no statistical differences between the study and control groups for any of the end points analyzed. CONCLUSIONS: This first prospective study suggests that gestational use of echinacea during organogenesis is not associated with an increased risk for major malformations.

Primary study

Unclassified

Tijdschrift Archives of internal medicine
Year 2000
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BACKGROUND: Despite a lack of medical evidence to support its therapeutic efficacy, the use of herbal medicine has increased considerably. Ginseng, one of the most widely used herbs, is hypothesized to play a role in carbohydrate metabolism and diabetes mellitus. We therefore undertook a preliminary short-term clinical study to assess whether American ginseng (Panax quinquefolius L) affects postprandial glycemia in humans. DESIGN: On 4 separate occasions, 10 nondiabetic subjects (mean [+/-SD] age, 34+/-7 years; mean [+/-SD] body mass index [BMI], 25.6 +/- 3 kg/m2) and 9 subjects with type 2 diabetes mellitus (mean [+/-SD] age, 62 +/- 7 years; mean [+/-SD] BMI, 29 +/- 5 kg/m2; mean [+/-SD] glycosylated hemoglobin A1c, 0.08+/-0.005) were randomized to receive 3-g ginseng or placebo capsules, either 40 minutes before or together with a 25-g oral glucose challenge. The placebo capsules contained com flour, in which the quantity of carbohydrate and appearance matched the ginseng capsules. A capillary blood sample was taken fasting and then at 15, 30, 45, 60, 90, and 120 (only for subjects with type 2 diabetes mellitus ) minutes after the glucose challenge. RESULTS: In nondiabetic subjects, no differences were found in postprandial glycemia between placebo and ginseng when administered together with the glucose challenge. When ginseng was taken 40 minutes before the glucose challenge, significant reductions were observed (P<.05). In subjects with type 2 diabetes mellitus, the same was true whether capsules were taken before or together with the glucose challenge (P<.05). Reductions in area under the glycemic curve were 18%+/-31% for nondiabetic subjects and 19+/-22% and 22+/-17% for subjects with type 2 diabetes mellitus administered before or together with the glucose challenge, respectively. CONCLUSIONS: American ginseng attenuated postprandial glycemia in both study groups. For nondiabetic subjects, to prevent unintended hypoglycemia it may be important that the American ginseng be taken with the meal.

Primary study

Unclassified

Tijdschrift Lancet (London, England)
Year 2000
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St John's wort reduced the area under the curve of the HIV-1 protease inhibitor indinavir by a mean of 57% (SD 19) and decreased the extrapolated 8-h indinavir trough by 81% (16) in healthy volunteers. A reduction in indinavir exposure of this magnitude could lead to the development of drug resistance and treatment failure.

Primary study

Unclassified

Tijdschrift Lancet (London, England)
Year 2000
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We report here acute rejection in two transplant patients due to a metabolic interaction of St John's wort and cyclosporin.

Primary study

Unclassified

Auteurs Philipp M , Kohnen R , Hiller KO
Tijdschrift BMJ (Clinical research ed.)
Year 1999
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DOELSTELLINGEN: Om de werkzaamheid en veiligheid van hypericum extract (STEI 300, Steiner Arzneimittel, Berlin) vergeleken met imipramine en placebo bij patiënten in de eerste lijn met een huidige episode van matige depressie te beoordelen. DESIGN: gerandomiseerde, dubbelblinde, multicenter, parallel group trial gedurende 8 weken. SNELHEID: Getrainde panel van 18 huisartsen uit vier Duitse deelstaten: Beieren, Berlijn, Rijnland Palts en Saksen. DEELNEMERS: 263 patiënten (66 mannen, 197 vrouwen) met een matige depressie volgens ICD-10 (internationale classificatie van ziekten, 10de revisie) codes F32. 1 en F33.1. INTERVENTIES: 1050 mg hypericum extract (350 mg driemaal daags), 100 mg imipramine (50 mg, 25 mg en 25 mg per dag), of een placebo drie maal daags. MAIN UITKOMSTMATEN: Verandering ten opzichte van baseline score op de 17 item versie van de Hamilton depressieschaal, de Hamilton angst schaal, de Clinical Global Impressions schaal, zelf cijfer Zung's depressieschaal, en SF-36, en bijwerkingen profiel. RESULTATEN: Hypericum extract effectiever was op het verminderen van Hamilton depressie scores dan placebo en even effectief als imipramine (onderscheidenlijk -15,4 (SD 8.1), -12,1 (7.4), en -14,2 (7.3)). Vergelijkbare resultaten werden gevonden voor Hamilton angst en Clinical Global Impressions schalen en werden het meest uitgesproken voor de Zung zelf Rating Scale for Depression. Kwaliteit van leven werd meer verbeterd in de gestandaardiseerde mentale component schaal van de SF-36 met beide actieve behandelingen dan met placebo, maar in de fysieke component schaal werd verbeterd alleen door hypericum-extract in vergelijking met placebo. De snelheid van bijwerkingen bij hypericum extract werd in het bereik van de placebogroep maar lager dan die van de imipramine (0,5, 0,6 en 1,2 gevallen per patiënt respectievelijk). Conclusies: Bij een gemiddelde dosis van 350 mg driemaal daags hypericum-extract effectiever was dan placebo en minstens zo effectief als 100 mg imipramine per dag bij de behandeling van matige depressie. De behandeling met hypericum-extract is veilig en verbetert de kwaliteit van leven.

Primary study

Unclassified

Auteurs Mullins RJ
Tijdschrift The Medical journal of Australia
Year 1998
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A woman with atopy experienced anaphylaxis after taking, among other dietary supplements, a commercial extract of echinacea. Hypersensitivity was confirmed by skinprick and RAST testing. Regular ingestion of echinacea by up to 5% of surveyed patients with atopy, combined with detection of echinacea-binding IgE in atopic subjects (19% by skin testing; 20% with moderate to strong reactivity by RAST testing), raises the possibility of severe allergic reactions, even with first-time use, due to cross-reactivity with other structurally similar allergens. Patients with atopy should be cautioned about the risk of developing life-threatening reactions to complementary medicines, including echinacea.

Primary study

Unclassified

Auteurs Yun TK , Choi SY
Tijdschrift International journal of epidemiology
Year 1998
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BACKGROUND: A number of studies have reported that increased consumption of natural products reduced the risk of cancer. Our previous case-control studies have shown a significant reduction in the risk of cancer development among those who regularly consumed ginseng. We conducted a prospective cohort study to evaluate the preventive effect of ginseng against cancer on a population residing in a ginseng cultivation area on the basis of the result of case-control studies. METHODS: This study was conducted in Kangwha-eup from August 1987 to December 1992. We studied 4634 people over 40 years old who completed a questionnaire on ginseng intake. In an attempt to obtain detailed information about ginseng intake, we asked them to specify their age at initial intake, their frequency and duration of ginseng intake, the kind of ginseng, etc. Multiple logistic regression was used to estimate relative risks (RR) when controlling simultaneously for covariates. RESULTS: Ginseng consumers had a decreased risk (RR = 0.40, 95% confidence interval [CI] : 0.28-0.56) compared with non-consumers. On the type of ginseng, the RR was 0.31 (95% CI: 0.13-0.74) for fresh ginseng extract consumers and 0.34 (95% CI: 0.20-0.53) for consumers of multiple combinations. There was no cancer death among 24 red ginseng consumers. There was a decreased risk with a rise in the frequency of ginseng intake, showing a dose-response relationship. The RR of ginseng consumers were 0.33 (95% CI: 0.18-0.57) in gastric cancer and 0.30 (95% CI : 0.14-0.65) in lung cancer. Among ginseng preparations, fresh ginseng extract consumers were significantly associated with a decreased risk of gastric cancer (RR = 0.33, 95% CI: 0.12-0.88). CONCLUSIONS: These results strongly suggest that Panax ginseng C.A. Meyer has non-organ specific preventive effect against cancer, providing support for the previous case-control studies.

Primary study

Unclassified

Auteurs Norton SA , Ruze P
Tijdschrift Journal of the American Academy of Dermatology
Year 1994
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Kava is a psychoactive beverage used ceremonially for thousands of years by Pacific Islanders. Kava is made from the root of the pepper plant, Piper methysticum, found in Polynesia, Melanesia, and Micronesia. The beverage is a nonfermented depressant with complex neuropharmacologic properties that causes a tranquil state of intoxication. Kava also affects the skin, causing a peculiar scaly eruption. The cutaneous effects were first reported by members of Captain James Cook's Pacific expeditions, but they have never been described in dermatologic literature. Heavy kava drinkers acquire a reversible ichthyosiform eruption, kava dermopathy. The cause is unknown but may relate to interference with cholesterol metabolism. Today kava is used across the Pacific in both traditional ceremonies and informal social events. In Western nations, kava is sold as a relaxant by health food stores. This article explores the history of kava dermopathy from Cook's early reports to its presence today.

Primary study

Unclassified

Tijdschrift European urology
Year 1992
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A double-blind placebo-controlled study was performed in 35 benign prostatic hypertrophy (BPH) patients never treated before. The patients were randomized into two groups, the 1st (18 cases) receiving Serenoa repens extract (160 mg t.d.) for 3 months up to the day before the operation of transvesical adenomectomy and the 2nd (17 cases) receiving placebo. Steroid receptors were evaluated in the nuclear (n) and cytosolic (c) fraction using the saturation analysis technique (Scatchard analysis or single saturating-dose assay) for androgen (AR) and estrogen (ER) receptors and the enzyme immunoassay (EIA) for ER and progesterone receptors (PgR). Scatchard analysis of ERc and ERn revealed the presence of two classes of binding sites, one with high-affinity low-capacity binding and the other with low-affinity high-capacity binding. In the untreated BPH group, ER were higher in the n than in the c fraction: ERn were positive in 14 cases and ERc in 12 of 17 cases. In the BPH group treated with S. repens extract on the contrary, ERn were negative for both binding classes in 17 cases and ERc in 6 of 18 cases. Using EIA, ERn and ERc were detected in all 15 samples examined, but in the treated group, ERn were significantly (p less than 0.01) lower than in the untreated group, whilst ERc remained almost unchanged. Similar results were obtained measuring PgR: the n fraction of the treated group prostatic samples was significantly (p less than 0.01) lower than that of the untreated group.(ABSTRACT TRUNCATED AT 250 WORDS)