(2004; 358 pages)
Cortex Pruni Africanae
Cortex Pruni Africanae consists of the dried bark of the trunk of Prunus africana (Hook. f.) Kalkman (Rosaceae).
Pygeum africanum Hook. f. (1, 2).
Selected vernacular names
African plum tree, African prune, armaatet, bitter almond, Bitteramandel, chati, inkhokhokho, inyangazoma-elimnyama, kiburabura, lemalan migambo, mueri, muiru, murugutu, mutimailu, mweria, mwiritsa, nuwehout, ol-koijuk, oromoti, red stinkwood, rooistinhout, tenduet, tendwet, twendet, umdumizulu, umkakase, umkhakhazi, umlalume (1, 3-9).
1 Owing to overexploitation and other factors, Prunus africana has been listed in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (10).
Found in mountain forests of equatorial Africa including Angola, Cameroon, Ethiopia, Ghana, Kenya, Madagascar, Malawi, Mozambique, Republic of Congo, South Africa, Uganda, United Republic of Tanzania, Zambia and Zimbabwe (2, 3, 8).
An evergreen tree, usually 10-25m high, with straight, cylindrical trunk and dense, rounded crown. Leaves alternate, 8-12cm long, long-stalked, simple, elliptic, bluntly pointed at apex, with shallow crenate margins; leathery, deep green and glossy, with midrib sharply impressed or channelled on upper surface and strongly prominent on underside; smell of almonds when bruised. Leafstalks and young branchlets often reddish. Flowers small, white or cream, fragrant, in axillary racemes 3-8cm long; corolla lobes up to 2mm long. Fruits cherry-shaped, red to purplish-brown, 8-12mm in diameter; very bitter flesh and bony stone. Wood pale red, with strong cyanide smell when freshly cut, darkening to rich dark red or mahogany-brown on exposure to air; straightgrained and even textured, strong and elastic, very hard and very heavy (3, 8, 11).
Plant material of interest: dried trunk bark
Red to blackish-brown, deeply square-fissured or corrugated (1, 3, 8).
Odour: strong, characteristic almond smell (11).
To be established in accordance with national requirements.
Powdered plant material
To be established in accordance with national requirements.
General identity tests
Macroscopic examination (3, 8).
Tests for specific microorganisms and microbial contamination limits are as described in the WHO guidelines on quality control methods for medicinal plants (12).
The recommended maximum limit of aldrin and dieldrin is not more than 0.05mg/kg (13). For other pesticides, see the European pharmacopoeia (13), and the WHO guidelines on quality control methods for medicinal plants (12) and pesticide residues (14).
For maximum limits and analysis of heavy metals, consult the WHO guidelines on quality control methods for medicinal plants (12).
Where applicable, consult the WHO guidelines on quality control methods for medicinal plants (12) for the analysis of radioactive isotopes.
Other purity tests
Chemical, foreign organic matter, total ash, acid-insoluble ash, sulfated ash, water-soluble extractive, alcohol-soluble extractive and loss on drying tests to be established in accordance with national requirements.
Qualitative and quantitative analysis for the major constituents, docosanol and β-sitosterol, are performed by gas chromatography-mass spectrometry (15, 16). Quantitative analysis of docosyl (E)-ferulate is performed by highperformance liquid chromatography (17).
Major chemical constituents
The purported active constituents of a lipophilic extract of Cortex Pruni Africanae include docosanol (0.6%) and β-sitosterol (15.7%). Other major constituents include alkanols (tetracosanol [0.5%] and trans-ferulic acid esters of docosanol and tetracosanol), fatty acids (62.3%, comprising myristic, palmitic, linoleic, oleic, stearic, arachidic, behenic and lignoceric acids); sterols (sitosterone [2.0%] and daucosterol) and triterpenes (ursolic acid [2.9%], friedelin [1.4%], 2-α-hydroxyursolic acid [0.5%], epimaslinic acid [0.8%] and maslinic acid) (2, 15-21). The structures of docosanol, tetracosanol, linoleic acid, oleic acid, β-sitosterol, sitosterone, ursolic acid and friedelin are presented below.
Uses supported by clinical data
Treatment of lower urinary tract symptoms of benign prostatic hyperplasia (BPH) stages I and II, as defined by Alken (e.g. nocturia, polyuria and urinary retention), in cases where diagnosis of prostate cancer is negative (22-34).
Uses described in pharmacopoeias and traditional systems of medicine
Uses described in folk medicine, not supported by experimental or clinical data
As a purgative, for the treatment of stomach and intercostal pain (3, 35).
Effects on the prostate
Intraperitoneal administration of a lipophilic trunk bark extract (10mg/kg body weight) daily for 20 days enhanced the secretory activity of the prostate and seminal vesicles in castrated rats, and antagonized the activity of testosterone on these glands. However, in rats which were castrated and adrenalectomized, the extract potentiated the effects of testosterone on both the prostate and seminal vesicles and also increased the concentration of pituitary gonadotropins (36). Intragastric administration of a lipophilic extract of the trunk bark to rats (2 mg/kg body weight) daily for 20-50 days stimulated the secretory activity of the prostate and prevented the development of prostate hyperplasia induced by intraperitoneal injection of human prostate adenoma tissue (37). Intragastric administration of a lipophilic extract of the crude drug to rats (100mg/kg body weight) daily for 3 days also increased prostate secretions (38).
Intragastric administration of a lipophilic extract of the trunk bark to ovariectomized mice (150mg/kg body weight) inhibited estrogen binding (39). Intragastric administration of a methylene chloride extract of the trunk bark to male mice inhibited the activity of 5α-reductase (ED50 0.78mg/ml). The same extract also inhibited the activity of aromatase and 5α-reductase in vitro (IC50 0.98 and 0.78mg/ml, respectively) (39). In another study, however, a lipophilic extract only marginally inhibited the activity of 5α-reductase from human prostate cells in vitro at a concentration of 63 µg/ml (40).
Intragastric administration of a lipophilic extract of Cortex Pruni Africanae (400mg/kg body weight) suppressed carrageenan-induced footpad oedema in rats. Intraperitoneal administration of the extract to rats (100mg/kg body weight) also reduced the increase in vascular permeability caused by histamine (41). A lipophilic extract of the trunk bark inhibited the production of 5-lipoxygenase metabolites, such as chemotactic leukotrienes, in human polymorphonuclear cells stimulated by the calcium ionophore A23187 (42, 43).
A lipophilic extract of the crude drug administered intragastrically to rats inhibited spasms of the bladder induced by electroshock, phenylephrine, adenosine triphosphate and carbachol (44). A reduction in carbachol-induced spasms of the bladder was observed after intragastric administration of a lipophilic extract of the crude drug to guinea-pigs (36). Intragastric administration of a lipophilic extract of the trunk bark to rabbits (100mg/kg body weight) prevented the development of contractile dysfunction induced by partial obstruction of the bladder (45). A lipophilic extract of the crude drug improved the contractility of the detrusor muscle of the bladder in old rats (46).
Inhibition of cell proliferation
A chloroform extract of the crude drug (10 µg/ml) significantly inhibited proliferation of Swiss 3T3 mouse fibroblasts induced by basic fibroblast growth factor and epidermal growth factor in vitro (P < 0.05) (47, 48). DNA synthesis in rat prostatic fibroblasts, induced by insulin-like growth factor, epidermal growth factor, 12-O-tetradecanoyl phorbol-13-acetate or basic fibroblast growth factor, was inhibited in vitro by a 95% ethanol extract of the trunk bark (IC50 12.4, 12.6, 4.5 and 7.7 µg/ml, respectively) (49).
In acute and chronic toxicity studies in mice and rats, no adverse reactions or fatalities were observed after intragastric administration of a single dose of a lipophilic extract of the trunk bark (1-6g/kg body weight in mice and 1-8g/kg body weight in rats). No adverse reactions were observed in mice and rats after chronic intragastric administration of the extract (60 and 600mg/kg body weight, respectively, daily for 11 months) (2).
Benign prostatic hyperplasia
Placebo-controlled clinical trials
Eleven double-blind, placebo-controlled studies assessed the effects of an oral lipophilic extract of Cortex Pruni Africanae in the symptomatic treatment of 717 men with mild to moderate BPH (22-28, 30, 31, 33, 34). The number of patients in each study ranged from 14 to 255, and the dosage of the trunk bark extract was 75-200 mg daily for at least 6 weeks. Eight studies measured maximum urinary flow and 10 studies measured daytime and night-time polyuria (22-26, 28, 30, 31, 33, 34). One study also included comparison with a combination of the trunk bark extract and medroxyprogesterone acetate (34). Seven trials reported a significant improvement in maximum urinary flow following treatment with the extract, as compared with placebo (22-26, 28, 31). However, in one study with only a small number of patients, no beneficial urodynamic effects were seen (27). Ten of these trials also demonstrated significant improvements in the symptoms of nocturia, daytime polyuria, dysuria, and the hesitancy and urgency of micturition, as compared with placebo (22-26, 28, 30, 31, 33, 34).
A histological study of prostate tissue biopsies from patients with BPH before and after treatment (75 mg extract daily for 1-3 months) showed that a lipophilic extract of the trunk bark enhanced prostate secretion, but did not reduce the size of the prostate (50). A lipophilic extract of the trunk bark also restored the activity of prostate acid phosphatase and the normal levels of total protein secretion from the prostate in patients with abnormally low levels of secretion (51).
Four double-blind studies compared oral administration of a lipophilic extract of the crude drug and docosanol (one of the active constituents of the extract) with an extract of Radix Urticae Urtae, sitosterin, non-steroidal anti-inflammatory drugs and antibiotics (22, 52, 53). The total number of patients was 183, with a range of 39-53 patients per study. Patients were treated with either 100mg docosanol, 100mg trunk bark extract or varying doses of the comparative drugs. Improvements in postvoid residual volume, nocturia, daytime polyuria and the urgency of micturition were seen in all treatment groups in three studies, with the trunk bark extract appearing to be the most effective (22, 52, 53). However, no controlled studies have yet been performed to compare the effects of trunk bark extracts with newer agents (e.g. finasteride or α1-receptor antagonists, such as alfuzosin) for the treatment of BPH symptoms.
Clinical trials without controls
Fourteen clinical trials without controls demonstrated an improvement of global outcome assessments after oral treatment with a chloroform extract of the trunk bark in 461 men with stage I or II BPH (54-67). In four of these studies, a total of 180 patients received 75 mg extract daily for 21 days to 3 months (54, 56, 64, 66); in the other 10 studies, a total of 281 patients were treated with 100mg extract daily for 21 days to 3 months (55, 57-63, 65, 67). In all but three studies (59, 63, 67), the global outcome was assessed as either improved, good, very good or excellent in over 50% of the patients.
The results of 19 clinical trials without controls involving 849 men with BPH (18-59 patients per study) demonstrated an objective improvement in their symptoms following treatment with a lipophilic extract of the trunk bark (53, 68-85). Patients were treated daily with either 75 mg (116 patients), 75-100 mg (20 patients), 100 mg (523 patients), 150 mg (42 patients) or 200 mg extract (148 patients) for 20-160 days. Improvements in nocturia, daytime polyuria, postvoid residual volume and mean maximum urinary flow rate were observed in over 50% of patients in 14, eight, seven and four studies, respectively. Other symptoms such as dysuria, and hesitancy and urgency of micturition also improved (44).
A large open-label study assessed improvements in urodynamic parameters in 500 men with BPH after daily treatment with a lipophilic extract of the bark for over 5 years (doses not specified). Improvements in dysuria, daytime polyuria and nocturia were observed in over 68% of patients, and improvements in urinary flow rate and volume were reported in over 61% (32). The greatest improvements were observed in patients with moderate symptoms, who did not have a prominent median lobe of the prostate, and whose baseline postvoid residual volume was less than 100 ml (32, 44). An improvement in prostate secretion was also reported, but only in the absence of prostate infection (38).
A multicentre study without controls assessed the efficacy and safety of treatment with a trunk bark extract (50 mg) twice daily for 2 months in 85 men with symptoms of BPH (neither the extract nor the stage of BPH was described). Subjective assessment of the outcomes was made using the International Prostate Symptom Score (IPSS) and the Quality of Life score (QL), and urine flowmetry was used for objective evaluation. After treatment, the IPSS and QL improved significantly (P < 0.001) by 40% and 31%, respectively. Nocturnal frequency was also significantly reduced by 32% (P < 0.001) (55).
Cortex Pruni Africanae is contraindicated in cases of known allergy to plants of the Rosaceae family. It is also contraindicated during pregnancy and lactation and in children under the age of 12 years because of its effects on androgen and estrogen metabolism (39, 86).
Cortex Pruni Africanae relieves the symptoms associated with BPH, but does not have an effect on the size of the prostate. If symptoms worsen or do not improve, or if blood appears in the urine or acute urinary retention occurs, contact a physician.
Carcinogenesis, mutagenesis, impairment of fertility
A lipophilic extract of Cortex Pruni Africanae had no effect on fertility in male rats and rabbits at doses up to 80mg/kg body weight daily (44). No mutagenic or clastogenic activity has been observed in vitro or in vivo (44).
Pregnancy: teratogenic effects
See Contraindications. There is no therapeutic rationale for the use of Cortex Pruni Africanae during pregnancy.
Pregnancy: non-teratogenic effects
See Contraindications. There is no therapeutic rationale for the use of Cortex Pruni Africanae during pregnancy.
See Contraindications. There is no therapeutic rationale for the use of Cortex Pruni Africanae during lactation.
See Contraindications. There is no therapeutic rationale for the use of Cortex Pruni Africanae in children.
No information available on general precautions or precautions concerning drug interactions; or drug and laboratory test interactions.
Data from clinical studies show that a lipophilic extract of Cortex Pruni Africanae is well tolerated in humans. A few cases of minor transient gastrointestinal side-effects, such as diarrhoea, gastric pain and nausea, were reported in two clinical trials (22, 23), and single cases of constipation, dizziness and visual disturbance were also reported (23).
Lipophilic extract of the crude drug (1, 2). Store in a cool, dry place.
(Unless otherwise indicated)
Daily dosage: 75-200mg lipidosterolic extract of the crude drug, in divided doses. To minimize gastrointestinal disturbances, take with food or milk.
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