Antimalarial efficacy of a quantified extract of nauclea pobeguinii stem bark in human adult volunteers with diagnosed uncomplicated falciparum malaria. Part 2: A clinical phase IIB trial

Planta Medica

Volumn 78, Issue 9, 2012, Pages 853-860

  Mesia, Kahunu ^a   Tona, Lutete ^a   Mampunza, Ma Miezi ^a   Ntamabyaliro, Nsengi ^a   Muanda, Tsobo ^a   Muyembe, Tamfum ^a   Musuamba, Tshinanu ^b   Mets, Tony ^c   Cimanga, Kanyanga ^a,d   Totté, Jozef ^d   Pieters, Luc ^d   Vlietinck, Arnold J ^d  

^a UNIVERSITY OF KINSHASA   (Congo)

^b UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^c VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

^d UNIVERSITY OF ANTWERP   (Belgium)

Author keywords

malaria; Nauclea pobeguinii; Plasmodium falciparum; Rubiaceae; strictosamide; traditional medicine

Indexed keywords

AMODIAQUINE PLUS ARTESUNATE; ANTIMALARIAL AGENT; COARSUCAM; NAUCLEA POBEGUINII EXTRACT; PLANT EXTRACT; UNCLASSIFIED DRUG;

ADULT; AMENORRHEA; APPETITE; ARTICLE; BARK; BIOCHEMISTRY; CONTROLLED STUDY; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; EPIGASTRIC PAIN; FATIGUE; FEMALE; HEART PALPITATION; HUMAN; INSOMNIA; LIBIDO; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MALE; PARASITEMIA; PHASE 2 CLINICAL TRIAL; PLANT STEM; PLASMODIUM FALCIPARUM; PRURITUS; RASH; RHINORRHEA; SIDE EFFECT; SINGLE BLIND PROCEDURE;

ADOLESCENT; ADULT; AMODIAQUINE; ANTIMALARIALS; ARTEMISININS; DRUG COMBINATIONS; FEMALE; HUMANS; MALARIA, FALCIPARUM; MALE; MEDICINE, AFRICAN TRADITIONAL; PLANT BARK; PLANT EXTRACTS; PROSPECTIVE STUDIES; RUBIACEAE; SINGLE-BLIND METHOD; TREATMENT OUTCOME; YOUNG ADULT;

ARTESUNATE; NAUCLEA; PLASMODIUM FALCIPARUM; RUBIACEAE;

EID: 84862565962     PISSN: 00320943     EISSN: 14390221     Source Type: Journal    
DOI: 10.1055/s-0031-1298488     Document Type: Article

References (53)

1. Willcox M, Bodeker G. Traditional herbal medicines for malaria. Br Med J: 2004; 329 1156 1159 (Pubitemid 39524776)
2. WHO Declaration of Alma-Ata. Available at http://www.who.int/hpr/NPH/ docs/declaration-almaata.pdf Accessed May 24, 2011
3. Schuster BG. A new integrated program for natural product development and the value of an ethnomedical approach. J Alternat Complement Med: 2001; 7?S 61 72
4. WHO Traditional medicine strategy 2002 - 2005. Geneva WHO/EDM/TRM 2002.1: 2002
5. Tangenyi OH. Contribution à létude des plantes médicinales utilisées contre le paludisme au Sankuru. [dissertation]. République Démocratique du Congo Université Patrice Emery Lumumba, Campus Méthodistes de Wembo-Nyama: 1996
6. Anam EM. Novel nauclequiniine from the root extract of Nauclea pobeguinii (Pob and Pellegr) Petit (Rubiaceae). Indian J Chem B Org Chem Med Chem: 1997; 36 54 56 (Pubitemid 127475445)
7. Zeches M, Richard B, Gueye-Mbahia L, Le Men-Olivier L. Constituants des écorces de racine de Nauclea pobeguinii. J Nat Prod: 1985; 48 42 46
8. Mesia K, Cimanga K, Tona L, Mampunza MM, Ntamabyaliro N, Muanda T, Muyembe T, Totté J, Pieters L, Vlietinck A. Assessment of the short-term safety and tolerability of a quantified 80 % ethanol extract from the stem bark of Nauclea pobeguinii (PR 259 CT1) in healthy volunteers: a clinical Phase I study. Planta Med: 2011; 77 111 116
9. Mesia K, Lutete Tona L, Mampunza MM, Ntamabyaliro N, Tsobo M, Muyembe T, Cimanga K, Totté J, Mets T, Pieters L, Vlietinck AJ. Assessment of the antimalarial efficacy of PR 259 CT in human adult volunteers with diagnosed uncomplicated falciparum malaria. Part 1: a clinical Phase IIA trial. Planta Med: 2012; 78 211 218
10. PNLP Echecs thérapeutiques à lartésunate-amodiaquine (ASAQ) et lartémether-luméfantrine (Coartem) chez les enfants de moins de 5 ans avec paludisme à P. falciparum en RD Congo, Février à Octobre 2005. Kinshasa Ministère de la Santé, Programme National de Lutte Contre le Paludisme: 2005
11. Willcox ML, Graz B, Falquet J, Sidibé O, Forsterd M, Diallo D. Argemone mexicana decoction for the treatment of uncomplicated falciparum malaria. Trans R Soc Trop Med Hyg: 2007; 101 1190 1198 (Pubitemid 350028620)
12. WHO Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria. Geneva WHO/HTM/RBM 2003; 50: 2003
13. WHO Traditional practitioners as primary health care workers. Geneva WHO/SHS/DHS/TRM 95.6: 1995
14. Benakis A, Paris M, Loutan L, Plessas CT, Plessas ST. Pharmacokinetics of artemisinin and artesunate after oral administration in healthy volunteers. Am Trop Med Hyg: 1997; 56 17 23 (Pubitemid 27097953)
15. Newton P, Suputtamongkol Y, Teja-Isavadharm P, Pukrittayakamee S, Navaratnam V, Bates I, White N. Antimalarial bioavailability and disposition of artesunate in acute falciparum malaria. Antimicrob Agents Chemother: 2000; 44 972 977 (Pubitemid 30165278)
16. Krishna S, White NJ. Pharmacokinetics of quinine, chloroquine and amodiaquine. Clinical implications. Clin Pharmacokinet: 1996; 30 263 299
17. Orrell C, Little F. Smith Folb P, Taylor W, Olliaro P, Barnes KI. Pharmacokinetics and tolerability of artesunate and amodiaquine alone and in combination in healthy volunteers. Eur J Clin Pharmacol: 2008; 64 683 690
18. Adjuik M, Agnamey P, Babiker A, Borrmann S, Brasseur P, Cisse M, Cobelens F, Diallo S, Faucher JF, Garner P, Gikunda S, Kremsner PG, Krishna S, Lell B, Loolpapit M, Matsiegui PB, Missinou MA, Mwanza J, Ntoumi F, Olliaro P, Osimbo P, Rezbach P, Some E, Taylor WRJ. Amodiaquine-artesunate versus amodiaquine for uncomplicated Plasmodium falciparum malaria in African children: a randomised, multicentre trial. Lancet: 2002; 359 1365 1372 (Pubitemid 34442375)
19. Adjuik M, Babiker A, Garner P, Olliaro P, Taylor WRJ, Whiteb NJ. Artesunate combination for treatment of malaria: meta-analysis. Lancet: 2004; 363 9 17 (Pubitemid 38076919)
20. Mokuolu OA, Okoro EO, Ayetoro SO, Adewara AA. Effect of artemisinin based treatment policy on consumption pattern of antimalarials. Am J Trop Med Hyg: 2007; 76 7 11 (Pubitemid 351627794)
21. WHO World malaria report 2008. Geneva WHO/HTM/GMP 2008.1: 2008
22. Guthmann JP, Cohuet S, Rigutto C, Fortes F, Saraiva N, Kiguli J, Kyomuhendo J, Francis M, Noël F, Mulemba M, Balkan S. High efficacy of two artemisinin-based combinations (artesunate + amodiaquine and artemether + lumefantrine) in Caala, Central Angola. Am J Trop Med Hyg: 2006; 75 143 145 (Pubitemid 351627583)
23. Meremikwu M, Alaribe A, Ejemot R, Oyo-Ita A, Ekenjoku J, Nwachukwu C, Ordu D, Ezedinachi E. Artemether-lumefantrine versus artesunate plus amodiaquine for treating uncomplicated childhood malaria in Nigeria: randomized controlled trial. Malaria J: 2006; 5 43
24. Swarthout TD, Van De Boek IV, Kayembe G, Montgomery J, Pota H, Roper C. Artesunate + amodiaquine and Artesunate + sulphadoxine-pyrimethamine for treatment of uncomplicated malaria in Democratic Republic of Congo: a clinical trial with determination of sulphadoxine and pyrimethamine-resistant haplotypes. Trop Med Int Health: 2006; 11 1503 1511 (Pubitemid 44450555)
25. Brasseur P, Agnamey P, Gaye O, Vaillant M, Taylor WRJ, Olliaro PL. Efficacy and safety of artesunate plus amodiaquine in routine use for the treatment of uncomplicated malaria in Casamance, southern Sénégal. Malaria J: 2007; 6 150
26. Faye B, Ndiaye JL, Ndiaye D, Dieng Y, Faye O, Gaye O. Efficacy and tolerability of four antimalarial combinations in the treatment of uncomplicated Plasmodium falciparum malaria in Senegal. Malaria J: 2007; 6 80
27. Sowunmi A, Balogun T, Gbotosho GO, Happi CT, Adedeji AA, Fehintola FA. Activities of amodiaquine, artesunate, and artesunate-amodiaquine against asexual- and sexual-stage parasites in falciparum malaria in children. Antimicrob Agents Chemother: 2007; 51 1694 1699 (Pubitemid 46744147)
28. Adjei GO, Kurtzhals JA, Rodrigues P, Alifrangis M, Hoegberg LC, Kitcher ED, Badoe EV, Lamptey R, Goka BQ. Amodiaquine-artesunate vs. artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. Malaria J: 2008; 7 127
29. Falade CO, Ogundele AO, Yusuf BO, Ademowo OG, Ladipo SM. High efficacy of two artemisinin-based combinations (artemether-lumefantrine and artesunate plus amodiaquine) for acute uncomplicated malaria in Ibadan, Nigeria. Trop Med Int Health: 2008; 13 635 643 (Pubitemid 351561605)
30. Kobbe R, Klein P, Adjei S, Amemasor S, Thompson WN, Heidemann H, Nielsen MV, Vohwinkel J, Hogan B, Kreuels B, Bührlen M, Loag W, Ansong D, May J. A randomized trial on effectiveness of artemether-lumefantrine versus artesunate plus amodiaquine for unsupervised treatment of uncomplicated Plasmodium falciparum malaria in Ghanaian children. Malaria J: 2008; 7 261
31. Owusu-Agyei S, Asante KP, Owusu R, Adjuik M, Amenga-Etego S, Dosoo DK, Gyapong J, Greenwood B, Chandramohan D. An open label, randomised trial of artesunate + amodiaquine, artesunate + chlorproguanil-dapsone and artemetherlumefantrine for the treatment of uncomplicated malaria. PLoS One: 2008; 3 e2530
32. Mutabingwa TK, Anthony D, Heller A, Hallett R, Ahmed J, Drakeley C, Greenwood BM, Whitty CJ. Amodiaquine alone, amodiaquine + sulfadoxine- pyrimethamine, amodiaquine + artesunate, and artemether-lumefantrine for outpatient treatment of malaria in Tanzanian children: a four-arm randomised effectiveness trial. Lancet: 2005; 365 1474 1480 (Pubitemid 40591692)
33. Oyakhirome S, Pötschke M, Schwarz NG, Dörnemann J, Laengin M, Salazar CO, Lell B, Kun JF, Kremsner PG, Grobusch MP. Artesunate-amodiaquine combination therapy for falciparum malaria in young Gabonese children. Malaria J: 2007; 6 29
34. Sowunmi A, Balogun ST, Gbotosho GO, Happi CT. Effects of amodiaquine, artesunate, and artesunate-amodiaquine on Plasmodium falciparum malaria-associated anaemia in children. Acta Trop: 2009; 109 55 60
35. Olliaro P, Taylor WRJ. Phase scaling of artesunate-amodiaquine combination therapy for acute, uncomplicated falciparum malaria in the Oussouye District, Southern Sénégal. Geneva WHO/CDS/TDR unpublished data: 2002
36. Maiteki-Sebuguzi C, Jagannathan P, Yau VM, Clark TD, Njama-Meya D, Nzarubara B, Talisuna AO, Kamya MR, Rosenthal PJ, Dorsey G, Staedke SG. Safety and tolerability of combination antimalarial therapies for uncomplicated falciparum malaria in Ugandan children. Malaria J: 2008; 7 106
37. Marsh K, Forster D, Waruiru C, Mwangi I, Winstanley M, Marsh V, Newton C, Winstaley P, Warn P, Peshu N, Pavol G, Snow R. Indicators of life threatening malaria in African children: clinical spectrum and simplified prognostic criteria. N Engl J Med: 1995; 332 1399 1404
38. Van Hensbroek M, Onyiorah E, Jaffar S, Scheider G, Palmer A, Frenkel J, Ewere G, Forck S, Nusmeijes A, Benett S, Grenwod B. A trial of artemether or quinine in children with cerebral malaria. N Engl J Med: 1996; 335 69 75 (Pubitemid 26240107)
39. Orrell C, Taylor WR, Olliaro P. Acute asymptomatic hepatitis in a healthy normal volunteer exposed to 2 oral doses of amodiaquine and artesunate. Trans R Soc Trop Med Hyg: 2001; 95 517 518 (Pubitemid 34947408)
40. Guévart E, Aguémon A. Deux hépatites fulminantes survenues au cours dun traitement curatif par lassociation artésunate- amodiaquine. Méd Mal Infect: 2009; 39 57 60
41. Willcox ML. A clinical trial of "AMo", a Ugandan herbal remedy for malaria. J Pub Health Med: 1999; 21 318 324 (Pubitemid 29446072)
42. Silverthorn DU. Human physiology: an integrated approach. New Jersey Prentice Hall: 1998; 478
43. Taylor WRJ, White NJ. Antimalarial drug toxicity. A review. Drug Saf: 2004; 27 25 61
44. Maude RJ, Plewes C, Faiz MA, Hanson J, Charunwattana P, Lee SJ, Tärning J, Yunus EB, Hoque MG, Hasan MU, Hossain A, Lindegardh N, Day NPJ, White NJ, Dondorp AM. Does artesunate prolong the electrocardiograph QT interval in patients with severe malaria? Am J Trop Med Hyg: 2009; 80 126 132
45. White NJ. Cardiotoxicity of antimalarial drugs. Lancet: 2007; 7 549 558 (Pubitemid 47077715)
46. Ngouesse B, Basco LK, Ringwald P, Keundjian A, Blackett KN. Cardiac effects of amodiaquine and sulfadoxine-pyrimethamine in malaria-infected African patients. Am J Trop Med Hyg: 2001; 65 711 716 (Pubitemid 34051331)
47. Hien TT, Day NPJ, Phu NH, Mai NTH, Chau TH, Loc PP, Singh DX, Chuong VL, Vinh H, Waller D, Chir B, Peto TEA, Phil D, Wite JN. A controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria. N Engl J Med: 1996; 335 76 83 (Pubitemid 26240108)
48. Karbwang J, Laothavorn P, Sukontason K, Thiha T, Rimchala W, Na-Bangchang K, Bunnag D. Effect of artemether on electrocardiogram in severe falciparum malaria. Southeast Asian J Trop Med Pub Health: 1997; 28 472 475 (Pubitemid 127523374)
49. Benoit-Vical F, Valentin A, Dab B, Dakuyoc Z, Descamps L, Mallié M. NDribala (Cochlospermum planchonii) versus chloroquine for treatment of uncomplicated Plasmodium falciparum malaria. J Ethnopharmacol: 2003; 89 111 114 (Pubitemid 37163808)
50. Diallo D, Maïga B, Diakité C, Willcox M. Malarial-5: development of an antimalarial phytomedicine in Mali. In: Willcox M, Bodeker G, Rasoanaivo P. editors Traditional medicinal plants and malaria. Boca Raton CRC Press: 2004; 117 130
51. Mueller MS, Runyambo N, Wagner I, Borrmann S, Dietz K, Heide L. Randomised controlled trial of a traditional preparation of Artemisia annua L. (annual wormwood) in the treatment of malaria. Trans R Soc Trop Med Hyg: 2004; 98 318 321 (Pubitemid 38950411)
52. Winn D. Phyto-Laria: a promising herbal antimalarial from Ghana. The Africa Herbal Antimalaria Meeting, ICRAF House, Nairobi, Kenya, 20-22/3/2006. Available at http://www.worldagroforestry.org/treesandmarkets/antimalariameeting Accessed May 24, 2011
53. Willcox M, Benoit-Vical F, Fowler D, Bourdy G, Burford G, Giani S, Graziose R, Houghton P, Randrianarivelojosia M, Rasoanaivo P. Do ethnobotanical and laboratory data predict clinical safety and efficacy of anti-malarial plants? Malaria J: 2011; 10 S7