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Therapeutic Use of Cannabis Sativa on Chemotherapy-Induced Nausea and Vomiting Among Cancer Patients: Systematic Review and Meta-Analysis

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Therapeutic Use of Cannabis Sativa on Chemotherapy-Induced Nausea and Vomiting Among Cancer Patients: Systematic Review and Meta-Analysis Review article Therapeutic use of Cannabis sativa on chemotherapy-induced nausea and vomiting among cancer patients: systematic review and meta-analysis F.C. MACHADO ROCHA, msc, phd student, Department of Psychiatry, Paulista School of Medicine, Federal University of São Paulo, São Paulo, S.C. STÉFANO, phd, psychologist, Department of Psychiatry, Paulista School of Medicine, Federal University of São Paulo, São Paulo, R. DE CÁSSIA HAIEK, msc, psychologist, Department of Psychiatry, Paulista School of Medicine, Federal University of São Paulo, São Paulo, L.M.Q. ROSA OLIVEIRA, student of medicine, Paulista School of Medicine, Federal University of São Paulo, São Paulo, & D.X. DA SILVEIRA, phd, professor, Department of Psychiatry, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil MACHADO ROCHA F.C., STÉFANO S.C., DE CÁSSIA HAIEK R., ROSA OLIVEIRA L.M.Q. & DA SILVEIRA D.X. (2008) European Journal of Cancer Care 17, 431–443 Therapeutic use of Cannabis sativa on chemotherapy-induced nausea and vomiting among cancer patients: systematic review and meta-analysis This paper aims to evaluate the anti-emetic efficacy of cannabinoids in cancer patients receiving chemotherapy using a systematic review of literature searched within electronic databases such as PUBMED, EMBASE, PSYCINFO, LILACS, and ‘The Cochrane Collaboration Controlled Trials Register’. Studies chosen were randomized clinical trials comprising all publications of each database until December 2006. From 12 749 initially identified papers, 30 fulfilled the inclusion criteria for this review, with demonstration of superiority of the anti-emetic efficacy of cannabinoids compared with conventional drugs and placebo. The adverse effects were more intense and occurred more often among patients who used cannabinoids. Five meta-analyses were carried out: (1) dronabinol versus placebo [n = 185; relative risk (RR) = 0.47; confidence interval (CI) = 0.19– 1.16]; (2) Dronabinol versus neuroleptics [n = 325; RR = 0.67; CI = 0.47–0.96; number needed to treat (NNT) = 3.4]; (3) nabilone versus neuroleptics (n = 277; RR = 0.88; CI = 0.72–1.08); (4) levonantradol versus neuroleptics (n = 194; RR = 0.94; CI = 0.75–1.18); and (5) patients’ preference for cannabis or other drugs (n = 1138; RR = 0.33; CI = 0.24–0.44; NNT = 1.8). The superiority of the anti-emetic efficacy of cannabinoids was demonstrated through meta-analysis. Keywords: cancer, cannabis, chemotherapy, meta-analysis, randomized clinical trial, systematic review. INTRODUCTION listed on the American pharmacopoeia until 1944 (Bonnie & Whitebread 1974), when it was removed due to Marijuana has been used by throughout human political pressure to ban its use in the US (Walsh et al. history for many purposes (Karniol 2000). It was 2003). Although marijuana has not returned to the American Correspondence address: Francisco Carlos Machado Rocha, Rua Joaquim de Almeida, número 81, Bairro: Mirandópolis, São Paulo, SP, CEP 04050- pharmacopoeia, in 1986 the Food and Drug Administra- 010, Brazil (e-mail: [email protected]). tion authorised the use of its active element, delta-9- Accepted 2 November 2007 tetrahydrocannabinol (THC), for medical purposes (Walsh DOI: 10.1111/j.1365-2354.2008.00917.x et al. 2003) to treat nausea and vomiting side effects in European Journal of Cancer Care, 2008, 17, 431–443 patients receiving chemotherapy. © 2008 The Authors Journal compilation © 2008 Blackwell Publishing Ltd MACHADO ROCHA et al. Cannabinoids interact with various neurotransmitters METHODS and neuromodulators, such as gamma-aminobutyric Systematic review acid (GABA), histamine, serotonin, dopamine, glutamate, norepinephrine, prostaglandins and opioid peptides (Gro- Criteria for inclusion in this review tenhermen 2002b). Type of study All randomized clinical trials about the Aside from these neurotransmitters, there seems to exist subject published in the literature were objects for this in the brain a ‘cannabinoid system’ (Karniol 2000). This study. system probably interacts with the classic neurotransmis- sion systems to produce the pharmacological actions of Type of participant People with any type of cancer receiv- Cannabis sativa (Pertwee 1990; Adams & Martin 1996; ing chemotherapeutic treatment, irrespective of gender, Mallet & Beninger 1996; Felder & Glass 1998). The exist- age and place of treatment. The chemotherapeutic schemes ence of a cannabinoid neurotransmission system in the included those of low, moderate and high emetic potential. central nervous system, the function of which is still unknown, opens a wide potential for the discovery of Type of intervention Pharmacological interventions therapeutic drugs with action on it (Karniol 2000). based on substances derived from C. sativa and/or smoked Nausea and vomiting, which can be ‘acute’, ‘retarded’ cannabis, irrespective of the time of intervention and of or ‘anticipatory’ reactions (Fiori & Gralla 1984), are the the association with other types of therapy for nausea and chemotherapy side effects considered by patients as the vomiting in cancer patients receiving chemotherapy. most stressful (Barowski 1984). Up to three-fourths of all cancer patients experience chemotherapy-related emesis Search strategy for study identification (Schwartzberg 2007). Chemotherapy-induced nausea and Searches were made on the electronic databases vomiting also have the potential to cause depression, MEDLINE (PUBMED), EMBASE, PSYCINFO, LILACS and anxiety and a feeling of helplessness (Wilcox et al. 1982; ‘The Cochrane Collaboration Controlled Trials Register’. Dodds 1985). The bibliographic search strategy comprised the initial Today, there are three synthetic cannabinoid drugs that period of the databases until December 2006. The first have been evaluated in clinical trials for the treatment of authors of the selected studies were contacted, and the nausea and vomiting in patients receiving chemotherapy: bibliographies and references of these papers were also delta-9-THC, nabilone and levonantradol (Walsh et al. examined. There was no language restriction, but only 2003). complete papers published in peer-reviewed journals were Up until now, two medications, Marinol (dronabinol, considered. Data related to other clinical settings (e.g. delta-9-THC) and Cesamet (nabilone), have been approved radiotherapy) were not considered. to be prescribed for nausea and vomiting associated with The search expression was based on the following chemotherapy in cancer patients. Marinol has also been Medical Subject Heading terms and categories: ‘therapeu- approved for use in cases of anorexia and cachexia in AIDS tics’, ‘drug therapy’, ‘chemical and pharmacologic patients (Grotenhermen 2002a). phenomena’, ‘neoplasms’, ‘antineoplastic and immuno- This study describes a systematic research for evalua- suppressive agents’, ‘marijuana abuse’, ‘Cannabis’, ‘ran- tion of cannabis as a therapeutic agent for treating domized controlled trials’, ‘double-blind method’, ‘single- chemotherapy-induced nausea and vomiting in cancer blind method’, ‘clinical trials’, ‘placebos’, ‘research patients. design’, ‘comparative study’, ‘evaluation studies’, ‘follow-up studies’, ‘prospective studies’ and ‘random allo- cation’. Adjustments were made to the terms used accord- OBJECTIVE ing to the electronic database consulted. This review aims to evaluate, through a systematic litera- Study description ture review, interventions using C. sativa in the treat- ment of nausea and vomiting in patients with any type of The characteristics of the included studies are shown in cancer receiving chemotherapy, tested in randomized Table 1. clinical trials and compared with any type of control Methodological quality of the included studies group. The methodological quality evaluation of the clinical studies is considered of vital importance for conducting 432 © 2008 The Authors Journal compilation © 2008 Blackwell Publishing Ltd Journal compilation © 2008© Blackwell 2008 Publishing The Ltd Authors Table 1 Characteristics of the included studies Interventions and Chemotherapic Methodologic Study Methods Participants therapeutic schedules Outcomes agents quality Ahmedzai et al. Randomized, cross-over and Patients with lung cancer Nabilone 2 mg ¥ 2 (27) vs Nausea, vomiting, anorexia, adverse Cyclophosphamide, adriamycin, B (1983) double-blind (small cell bronchial prochlorperazine 10 mg ¥ 3 (30) effects and preference etoposide, methotrexate, vincristin carcinoma) Chan et al. (1987) Randomized, cross-over and Children with various Nabilone 1–4 mg (30) vs prochlorperazine Vomiting, adverse effects and Doxorubicin, cyclophosphamide B double-blind paediatric malignancies 5–20 mg (30) preference fluorouracil, methotrexate, vincristin, etoposide; cisplatin was not used Chang et al. (1979) Randomized, double-blind and Patients with osteogenic Dronabinol 10 mg/m2 ¥ 4 (15) vs placebo Nausea, vomiting, food intake, adverse High dose of methotrexate B paired (dronabinol-placebo or sarcoma (15) effects and THC plasma avaliation placebo-dronabinol) Chang et al. (1981) Randomized, double-blind and Patients with sarcoma Dronabinol 10 mg/m2 ¥ 4 (8) vs placebo Nausea, vomiting, adverse effects and Combination of doxorubucin and B paired (dronabinol-placebo or (8) THC plasma avaliation cyclophosphamide placebo-dronabinol) Colls et al. (1980) Randomized, double-blind, Patients with solid Dronabinol 12 mg/m2 ¥ 2 (35) vs Nausea, vomiting and adverse effects Cyclophosphamide, mustine, and B cross-over and multicentric tumours metoclopramide 4,
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