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Salinas-Casado, M. Esteban-Fuertes, J. Carballido-Rodríguez, J.M. Cozar-Olmo" "autores" => array:4 [ 0 => array:3 [ "nombre" => "J." "apellidos" => "Salinas-Casado" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "M." "apellidos" => "Esteban-Fuertes" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "J." "apellidos" => "Carballido-Rodríguez" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "J.M." "apellidos" => "Cozar-Olmo" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "aff0020" ] ] ] ] "afiliaciones" => array:4 [ 0 => array:3 [ "entidad" => "Servicio de Urología, Hospital Clínico San Carlos, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Servicio de Urología, Hospital Nacional de Parapléjicos de Toledo, Toledo, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Servicio de Urología, Hospital Universitario Puerta de Hierro Majadahonda, Universidad autónoma de Madrid, Madrid, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Servicio de Urología, Hospital Virgen de las Nieves, Granada, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Revisión sobre la experiencia y evidencias del <span class="elsevierStyleItalic">Pygeum africanum</span> en Urología" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Background</span><p id="par0005" class="elsevierStylePara elsevierViewall">Evidence and clinical experience-based medicine in the treatment of voiding symptoms secondary to benign prostatic hyperplasia (BPH).</p><p id="par0010" class="elsevierStylePara elsevierViewall">Physicians and methodological purists who advocate for evidence-based medicine recommend not to use a treatment when there is no solid evidence supporting it.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> While remaining methodologically correct, we can admit that this may be partially mistaken, as it would lead to an absurd paralysis in most medical and surgical specialties. “The absence of efficacy tests does not mathematically prove lack of efficacy”. That is, absence of evidence is not absence of efficacy.</p><p id="par0015" class="elsevierStylePara elsevierViewall">This is currently a motto defended by those who are against the radicalism of evidence-based medicine; many physicians in the daily clinical practice. Based on this last reasoning, one cannot, or should not, stop treating a disease just because the existing evidence in favor of such treatment does not exhaustively meet the greatest scientific requirements of evidence-based medicine. Experience-based medicine should be considered as well.</p><p id="par0020" class="elsevierStylePara elsevierViewall">In the clinical practice of Urology, a significant number of invasive treatments are ruled more by experience than by strictly conceived evidence, since the results of these have been based on expertise rather than on the rigorous methodology of evidence-based medicine for multiple reasons. Some of these are related to the clinical equipoise of randomized studies, even more in those cases with a placebo comparator group</p><p id="par0025" class="elsevierStylePara elsevierViewall">In this respect, we know that it is an objective reality that there are some medical treatments in Urology that are employed based on experience, as these are used in multiple countries, with many patients obtaining satisfactory results and minimal side effects. A representative example is the phytotherapeutic treatment, specifically, with <span class="elsevierStyleItalic">Pygeum africanum (P. africanum)</span> in patients with lower urinary tract symptoms and/or benign prostatic hyperplasia, as well as other conditions in both sexes</p><p id="par0030" class="elsevierStylePara elsevierViewall">The phytotherapeutic agents which are mostly employed in our environment are <span class="elsevierStyleItalic">P. africanum and Serenoa repens.</span> Both are extracts of complex composition derived from roots, seeds, barks or fruits of different plants. There are several extraction techniques, with variable pharmacokinetic properties among them, which makes the analysis of their effects an impossible task.</p><p id="par0035" class="elsevierStylePara elsevierViewall">The inclusion of these agents in the treatment for voiding symptoms due to BPH around 1990, and their geographical implementation is currently very variable. Since then, these constitute a classic option for this treatment and have a very high clinical experience after historically facing the placebo effect in a scenario of modification of the symptoms with the so-called at that time, and based on the methodological currents of the moment, clinical variability. The subsequent incorporation of new molecules of approved clinical efficacy in the treatment of voiding symptoms with a more demanding and updated clinical development affected the impact of pharmacological treatment on BPH and highlighted some of the weaknesses of the phytotherapy agents available until then.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,3</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">However, it is very interesting to note that, even with current knowledge, there are still many unsolved questions regarding the pathogenesis and evolution of voiding symptoms.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,4</span></a> In this sense, there are three aspects that modify their perception: a) the imperative need to share expectations with patients according to one or another therapeutic modality; b) the evidence that there is no linear relationship between prostate size, degree of the lower urinary tract obstruction and symptom severity, and c) the belief that the progression of symptomatic benign prostatic hyperplasia is not a universal phenomenon. These circumstances support the fact that we must pursue the desired individualized therapeutic decision-making.</p><p id="par0045" class="elsevierStylePara elsevierViewall">The innermost mechanism of action of phytotherapeutic agents is not yet characterized. Their decongestant, anti-inflammatory and/or hormonal effects exerted through the functional activity of phytosterols, lipoxygenase, tissue growth factors, lectins, fatty acids, β-sitosterol, etc., have almost always been observed in vitro.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Generically, its clinical efficacy has been controversial to a large extent due to the design of the available studies, poorly aligned with the methodology of evidence-based medicine (insufficient sample sizes, inappropriate definition of BPH, etc.). Moreover, these studies do not aim to evaluate long-term results or the effects on the progression of the disease.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> These circumstances have lost relevance over time as can be easily seen from the results of studies designed to demonstrate the prevention of BPH progression and the little clinical relevance they have achieved.</p><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Evidence acquisition</span><p id="par0055" class="elsevierStylePara elsevierViewall">A literature search has been performed in English and Spanish, mainly based on Pub-Med, from 1990 to 2017, using the keywords <span class="elsevierStyleItalic">Pygeum africanum</span>, BPH, Urodynamic, LUTS.</p><p id="par0060" class="elsevierStylePara elsevierViewall">There are 41 publications on the use of phytotherapy for the treatment of benign prostatic hyperplasia since 1994. Monographs and other non-indexed sources have also been considered. Those with higher number of patients or evaluating the mechanism of action of the agent, were selected.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Evidence synthesis</span><p id="par0065" class="elsevierStylePara elsevierViewall">We present the studies included in the review, structured as:</p><p id="par0070" class="elsevierStylePara elsevierViewall">Mechanism of action of <span class="elsevierStyleItalic">P. africanum</span>, in vitro as well as in vivo.</p><p id="par0075" class="elsevierStylePara elsevierViewall">Clinical efficacy of <span class="elsevierStyleItalic">P. africanum</span> in clinical trials.</p><p id="par0080" class="elsevierStylePara elsevierViewall">Efficacy in usual clinical practice.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080"><span class="elsevierStyleItalic">P. africanum</span>. Mechanism of action</span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">In vitro studies</span><p id="par0085" class="elsevierStylePara elsevierViewall">The <span class="elsevierStyleItalic">P. africanum</span> (<span class="elsevierStyleItalic">Prunus africana</span> or African plum) is a tree whose bark produces lipophilic extracts with pharmacological properties (phytosterols).</p><p id="par0090" class="elsevierStylePara elsevierViewall">It was first used in Europe in 1969, for its anti-inflammatory activity mediated by the inhibition of the chemotactic activity of leukotrienes and the inhibition of fibroblast proliferation, which resulted in histological and physiological modifications of the prostate gland.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a></p><p id="par0095" class="elsevierStylePara elsevierViewall">In vitro studies in rat prostate stromal cells (fibroblasts) have shown that <span class="elsevierStyleItalic">P. africanum</span> inhibits its basal growth and the one stimulated by EGF, IGF-I and bFGF (direct activators of protein kinase C) as well as by TPA and PDBu. This inhibition is more powerful in the case of EGF-stimulated cells, an effect that the authors did not attribute to cytotoxicity. If extrapolated to the clinical setting, these data could suggest an inhibition of prostate growth.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p><p id="par0100" class="elsevierStylePara elsevierViewall">Other experimental observations help reinforce this concept, thus, another study in human leukocytes showed that <span class="elsevierStyleItalic">P. africanum</span> produces a significant inhibition in the production of 5-lipoxygenase metabolites (5-HETE, 20-COOH LTB4, LTB4 and 20-OH LTB4).<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> Antiproliferative activity and apoptosis in stromal cells in vitro (fibroblasts) were also observed in benign prostatic hyperplasia (BPH) samples.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> After Pa administration, the alphaSMA + cells, more abundant in BPH, showed greater labeling with apoptosis evaluation by immunohistochemistry techniques. A down-regulation of the of TGFB1 (RT-PCR) expression and an inhibition of FGF2 signal were also observed. The addition of other mitogenic factors decreased sensitivity to <span class="elsevierStyleItalic">P. africanum</span> in cell cultures.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">In vivo studies</span><p id="par0105" class="elsevierStylePara elsevierViewall">In an interesting paper by Levin et al. performed in 25 rabbits after two weeks of induced partial bladder outlet obstruction, the animals were divided in 5 groups, as follows: groups 1–3 were given different oral doses of <span class="elsevierStyleItalic">P. africanum,</span> group 4 received placebo and group 5 was the control group. The study evaluated for 3 weeks the effects of this drug on detrusor contractile dysfunction (hypertrophic response) after 2 weeks of induced partial obstruction.</p><p id="par0110" class="elsevierStylePara elsevierViewall">Although no changes in detrusor mass were observed in the groups treated with <span class="elsevierStyleItalic">P. africanum</span>, the agent had a significant protective effect on the contractile response induced by the administration of bethanechol and KCl and electrostimulation.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p><p id="par0115" class="elsevierStylePara elsevierViewall">This experiment was reproduced by the same research team with 65 rabbits and similar methodology, in order to evaluate the induced changes on metabolic activity, specifically the enzyme activity of citrate synthase (marker of mitochondrial content) and calcium-ATPase (marker of sarcoplasmic reticulum activity). Once more, the model showed a protective effect of Pa on the contractile response and the metabolic activity in the partially obstructed bladder.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p><p id="par0120" class="elsevierStylePara elsevierViewall">Other experiences attributed antiandrogenic activity to <span class="elsevierStyleItalic">P. africanum</span>; in a 7-week study with rats under the administration of DHT, the simultaneous administration of <span class="elsevierStyleItalic">P. africanum</span> reduced the obstructive effects of DHT.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a></p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Clinical efficacy of <span class="elsevierStyleItalic">P. africanum</span>. Clinical trials</span><p id="par0125" class="elsevierStylePara elsevierViewall">Andro et al.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> conducted a literature review in 1995 with a total of 2262 patients of which 452 received the active ingredient (<span class="elsevierStyleItalic">P. africanum</span>). Despite announcing a clinical benefit, this review included results from uncontrolled studies, and without having been subjected to quantitative meta-analysis methodology to estimate the statistical significance of treatment efficacy, so that its validity has been questioned.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a></p><p id="par0130" class="elsevierStylePara elsevierViewall">Two studies of similar methodology<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">14,15</span></a> found clinical and urodynamic improvement in patients undergoing treatment with <span class="elsevierStyleItalic">P. africanum</span> for a minimum period of 2 months. The variables analyzed before and after treatment (without placebo arm) were compared; Breza et al.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> included 50 to 75-year-old-men with IPSS > = 12, quality of life score > = 3 and Qmáx <= 15 ml/ in three centers in the Czech Republic and Poland. Clinical and urodynamic variables were studied 2 months before and after treatment with 50 mg of <span class="elsevierStyleItalic">P. africanum</span> twice a day. 85 patients were recruited, obtaining statistically significant improvement in 40 % and 31 % in IPSS scores and quality of life, respectively. Nocturia was reduced by 32 %.</p><p id="par0135" class="elsevierStylePara elsevierViewall">Regarding urodynamic parameters, improvements were observed in maximum flow rate (2,1 mL/s) and voided volume, without finding significant difference regarding postvoid residual volume. These benefits, which were superior to those observed with placebo in other studies, were maintained for 1 month after treatment discontinuation. There was no improvement concerning prostate volume or sexual quality of life.</p><p id="par0140" class="elsevierStylePara elsevierViewall">Chatelain et al.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> analyzed 209 patients with symptomatic BPH in two randomized groups receiving <span class="elsevierStyleItalic">P. africanum</span> extract, 50 mg twice a day (arm A), and 100 mg once a day (arm B). The duration of the randomized treatment was 2 months, followed by an open phase of 10 months with 100 mg <span class="elsevierStyleItalic">P. africanum</span>, daily (174 patients). Both modalities obtained similar efficacy. There was a clear improvement in the IPSS (38 % in arm A and 35 % in arm B), quality of life (28 % in both arms), Qmax was recovered in 1,63 mL/s (16 %) ( 16 %) in arm A and 2,02 mL/s (19 %) in arm B. After 12 months of treatment, an even greater improvement in the IPSS of 46 % was observed (half of the patients with IPSS below 8, taking into account that the score before treatment was 17).</p><p id="par0145" class="elsevierStylePara elsevierViewall">A study conducted in Spain by Virseda et al.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> included 53 patients treated daily with 90 mg of <span class="elsevierStyleItalic">P. africanum</span> + amino acids for 1 month. An improvement in IPSS score was observed, with a 14 % reduction of irritative symptoms and 18 % of obstructive symptoms. There was also an increased Qmax value of 1,9 mL/s (15 %), without changes regarding prostate volume.</p><p id="par0150" class="elsevierStylePara elsevierViewall">We must also consider the meta-analysis of the Cochrane Database of Systematic Reviews (13; 17), which included 18 randomized clinical trials (1562 men). The mean duration of treatment was 64 ± 21.1 days and ranged between 30 and 122 days. Most studies (18 studies, 1103 participants) used a standardized extract of <span class="elsevierStyleItalic">P. africanum</span>. The doses used were between 75 and 200 mg daily.</p><p id="par0155" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">P. africanum</span> demonstrated more than twicethe improvement in comparison to placebo (RR = 2.1) and reduced 19 % of nocturia. <span class="elsevierStyleItalic">P. africanum</span> also obtained better outcomes than placebo in a few urodynamic parameters: the weighted average difference of Qmax was +2,<span class="elsevierStyleItalic">5</span> mL/s (improvement of 23 %), and -13,2 mL (improvement of 24 % ) for postvoid residual volume. However, the authors emphasize that these are reviewed studies with a limited sample size, short duration, with different doses and preparations administered, and that results, in most cases, were not presented using standardized efficacy variables. They call for future randomized studies. Unfortunately, no valid studies were found comparing <span class="elsevierStyleItalic">P. africanum</span> directly with other therapeutic options, neither in monotherapy, nor as a combination.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a></p><p id="par0160" class="elsevierStylePara elsevierViewall">In relation to phytotherapeutic agents, the clinical guidelines of the European Association of Urology express that they constitute a heterogeneous therapeutic group, which may contain different concentrations of the active ingredients, based on the extraction and standardization technique. Hence, meta-analyses may not be justified, and results of any analyses have to be interpreted with caution. The Guidelines Panel does not make any specific recommendations on phytotherapy for the treatment of male LUTS.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a></p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Effectiveness in usual clinical practice</span><p id="par0165" class="elsevierStylePara elsevierViewall">As previously mentioned, (Breza et al.,<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> Chatelain et al.,<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> Vírseda et al.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> and the reviews of Wilt<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> and Ishani<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a>) improved clinical and urodynamic parameters suggest that <span class="elsevierStyleItalic">P. africanum</span> is effective in patients with symptomatic BPH. Although the benefits are modest, they seem clinically relevant. In addition, we must consider that <span class="elsevierStyleItalic">P. africanum</span> is well tolerated and costs less than other alternatives.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a></p><p id="par0170" class="elsevierStylePara elsevierViewall">The TRIUMPH multicenter study shows the prescribing habits and efficacy of drugs for the treatment of lower urinary tract symptoms in six European countries (including Spain),<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> with 2351 patients included. The most commonly prescribed drugs were alpha blockers (79.2 %), phytotherapy (15.6 %) and 5-alpha-reductase inhibitors (5.1 %). The figures for these drug groups in Spain were 85.9 %, 10.5 %, and 3.6 % respectively.</p><p id="par0175" class="elsevierStylePara elsevierViewall">The prescription frequency of <span class="elsevierStyleItalic">P. africanum</span> was 6.3 % in Europe and 5.0 % in Spain. The efficacy parameter evaluated was the IPSS score after 1 year of treatment. Although the improvement in IPSS was greater with alpha blockers,<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3,6</span></a> phytotherapy showed an improvement of 3.2 points (3.4 with <span class="elsevierStyleItalic">P. africanum</span>, p = 0.0002). We must highlight that up to 78.0 % of patients taking <span class="elsevierStyleItalic">P. africanum</span> obtained improvement in the IPSS score.</p><p id="par0180" class="elsevierStylePara elsevierViewall">Currently, the patient's profile is what mainly affects the treatment option. Phytotherapy has been used in younger patients with milder symptoms and smaller prostates.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a></p><p id="par0185" class="elsevierStylePara elsevierViewall">Most studies showing the efficacy of <span class="elsevierStyleItalic">P. africanum</span> have used a daily dose of 100 mg,<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> which is why a similar daily dose is recommended in clinical practice.</p><p id="par0190" class="elsevierStylePara elsevierViewall">In the previously mentioned meta-analysis of the Cochrane Database of Systematic Reviews,<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> the adverse effects of <span class="elsevierStyleItalic">P. africanum</span> were minimal and comparable with those of placebo. The abandonment rates were 13 % and 11 % for <span class="elsevierStyleItalic">P. africanum</span> and placebo, respectively. In our environment, as well as in a multicenter study (n = 340) <span class="elsevierStyleItalic">P. africanum</span> showed an excellent safety profile,<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> with no adverse effects such as ejaculatory dysfunction, erectile dysfunction, decreased libido or hypotension. Moreover, we observed an improvement in IPSS score similar to other alternatives evaluated.</p><p id="par0195" class="elsevierStylePara elsevierViewall">As evidenced by several clinical trials, the indication of treatment with <span class="elsevierStyleItalic">P. africanum</span> has lower efficacy<span class="elsevierStyleSup">19</span> in comparison to other therapeutic alternatives. However, the improvement in symptomatology was similar to that of other treatments in studies based on the usual clinical practice. Its correct indication depends on an adequate patient profile, who would ideally present mild/moderate symptoms. These patients will receive the advantages of its safety profile, compared to other alternatives, being unlikely to suffer adverse effects typical of other therapeutic alternatives, such as hypotension, ejaculatory dysfunction or decreased libido.<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13,20</span></a> For all this, it is essential to consider the criteria of the clinical decision and to adapt the objectives of the treatment to patients' expectations.</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Conclusions</span><p id="par0200" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">P. africanum</span> seems to be a dual-action agent. On the one hand, it supposedly affects the prostate, and on the other, it has shown an association with bladder contractility, (histamine-dependent anti-inflammatory). This could explain the results on the symptoms (obstructive and filling). P. africanum is a treatment with low abandonment rate, very useful in certain groups of patients due to its safety profile. The extensive experience in the use of <span class="elsevierStyleItalic">P. africanum</span> with good safety and efficacy outcomes is a useful option for urologists.</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Conflict of interests</span><p id="par0205" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:9 [ 0 => array:3 [ "identificador" => "xres1290202" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Context" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Evidence acquisition" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Evidence synthesis" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1192000" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1290203" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Contexto" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Adquisición de la evidencia" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Síntesis de la evidencia" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1192001" "titulo" => "Palabras clave" ] 4 => array:3 [ "identificador" => "sec0005" "titulo" => "Background" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0010" "titulo" => "Evidence acquisition" ] 1 => array:2 [ "identificador" => "sec0015" "titulo" => "Evidence synthesis" ] 2 => array:3 [ "identificador" => "sec0020" "titulo" => "P. africanum. Mechanism of action" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0025" "titulo" => "In vitro studies" ] 1 => array:2 [ "identificador" => "sec0030" "titulo" => "In vivo studies" ] ] ] 3 => array:2 [ "identificador" => "sec0035" "titulo" => "Clinical efficacy of P. africanum. Clinical trials" ] ] ] 5 => array:2 [ "identificador" => "sec0040" "titulo" => "Effectiveness in usual clinical practice" ] 6 => array:2 [ "identificador" => "sec0045" "titulo" => "Conclusions" ] 7 => array:2 [ "identificador" => "sec0050" "titulo" => "Conflict of interests" ] 8 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2019-06-03" "fechaAceptado" => "2019-08-27" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1192000" "palabras" => array:4 [ 0 => "Pygeum africanum" 1 => "BPH" 2 => "Urodynamics" 3 => "LUTS." ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1192001" "palabras" => array:4 [ 0 => "Pygeum africanum" 1 => "HBP" 2 => "Urodinámica" 3 => "STUI." ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Context</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleItalic">Pygeum africanum</span> is still being employed in urology practice for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostate hyperplasia (BPH).</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Evidence acquisition</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A non-exhaustive review has been carried out about <span class="elsevierStyleItalic">Pygeum africanum</span>, its mechanisms of action "in vitro" as well as "in vivo", clinical trials and routine clinical practice.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Evidence synthesis</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The conclusions of the review and the reflections of the authors on the use of <span class="elsevierStyleItalic">Pygeum africanum</span> are described.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Although with an evidence level IV (based on expert opinion) the use of <span class="elsevierStyleItalic">Pygeum africanum</span> seems to be an option in the urological therapeutic arsenal.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Context" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Evidence acquisition" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Evidence synthesis" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Contexto</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">El <span class="elsevierStyleItalic">Pygeum africanum</span> sigue siendo utilizado por parte de los urólogos para el tratamiento de los síntomas urinarios del Tracto Urinario Inferior secundarios a Hiperplasia Benigna de Próstata.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Adquisición de la evidencia</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se ha realizado una revisión no exhaustiva sobre el <span class="elsevierStyleItalic">Pygeum africanum</span>, sus mecanismos de acción, tanto “in vitro “como “in vivo”, de los ensayos clínicos y en la práctica clínica habitual</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Síntesis de la evidencia</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se muestran las conclusiones de la revisión y las reflexiones de los autores sobre la utilización del <span class="elsevierStyleItalic">Pygeum africanum.</span></p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Aunque con un nivel de evidencia 4 (basado en la opinión de expertos, la utilización del <span class="elsevierStyleItalic">Pygeum africanum</span> parece ser una opción en el arsenal terapéutico del urólogo.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Contexto" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Adquisición de la evidencia" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Síntesis de la evidencia" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Salinas-Casado J., Esteban-Fuertes M., Carballido-Rodríguez J., Cozar-Olmo J.M. Revisión sobre la experiencia y evidencias del <span class="elsevierStyleItalic">Pygeum africanum</span> en Urología. Actas Urol Esp. 2019. <span class="elsevierStyleInterRef" id="intr0005" href="https://doi.org/10.1016/j.acuro.2019.08.002">https://doi.org/10.1016/j.acuro.2019.08.002</span></p>" ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:1 [ 0 => array:4 [ "apendice" => "<p id="par0215" class="elsevierStylePara elsevierViewall">“La Medicina Basada en la Experiencia puede ser igual de buena que aquella basada en la Evidencia.”</p> <p id="par0220" class="elsevierStylePara elsevierViewall">“Existe un fenómeno dual del <span class="elsevierStyleItalic">Pygeum africanum</span> con acción prostática, por una parte, y de modulación de la contractilidad vesical, por otra (antiinflamatorio histamina dependiente) que explica los resultados sobre ambos síntomas: obstructivos y de llenado.”</p> <p id="par0225" class="elsevierStylePara elsevierViewall">“El perfil de seguridad del <span class="elsevierStyleItalic">Pygeum africanum</span> lo convierte en un tratamiento con baja tasa de abandono, muy útil en ciertos grupos de pacientes.”</p> <p id="par0230" class="elsevierStylePara elsevierViewall">“Décadas de utilización del <span class="elsevierStyleItalic">Pygeum africanum</span> con seguridad y eficacia lo convierten en un fármaco útil en el vademécum del urólogo.”</p>" "etiqueta" => "Appendix A" "titulo" => "Annex shows the AEU recommendations on <span class="elsevierStyleItalic">P. africanum</span> based on the expert panel (level of evidence type 4)" "identificador" => "sec0060" ] ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:20 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "[1]" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Hiperplasia prostática benigna y medicina basada en la evidencia: su aproximación a la práctica clínica" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "J. 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