Double-blind evaluation of homeopathy on cocaine craving: a randomized controlled pilot study / 中西医结合学报

<p><b>BACKGROUND</b>Brazil is among the nations with the greatest rates of annual cocaine usage. Pharmacological treatment of cocaine addiction is still limited, opening space for nonconventional interventions. Homeopathic Q-potencies of opium and Erythroxylum coca have been tested in the integrative treatment of cocaine craving among homeless addicts, but this setting had not proven feasible, due to insufficient recruitment.</p><p><b>OBJECTIVE</b>This study investigates the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting.</p><p><b>DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS</b>A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence (F14.2). The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group).</p><p><b>MAIN OUTCOME MEASURES</b>The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were reported in both groups.</p><p><b>RESULTS</b>The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% (standard deviation (SD): 22.3%), compared to 29.8% (SD: 30.6%) in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients' appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group (P = 0.41).</p><p><b>CONCLUSIONS</b>A psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.</p><p><b>TRIAL REGISTRATION</b>RBR-2xzcwz (http://www.ensaiosclinicos.gov.br).</p>

Evaluation of the effect of coca leaf powder consumption on bone turnoverin postmenopausal women / Evaluación del efecto del consumo de hoja de coca pulverizada en marcadores de recambio óseo en mujeres posmenopáusicas

Introduction: Every year, about 25 million women all over the world experience menopause. Nearly 30% of them will suffer from osteoporosis. Conventional treatments tend to have side effects. In Peru, we have Erythroxylum coca, a vegetal alternative high in calcium, fiber and polyphenols. Objectives: To test the effects of the consumption of coca leaf powder in postmenopausal women and analyze the antioxidant capacity of coca leaf powder. Design: Quantitative, quasi-experimental, pre-test post-test study. Institution: Centro de Investigación de Bioquímica y Nutrición, Universidad Nacional Mayor de San Marcos, Lima, Perú. Participants: Volunteer postmenopausal women. Methodology: Unique and self-controlled treatment of 25 volunteers who met inclusion and exclusion criteria. Twenty one completed the treatment, which consisted of the daily ingestion of 4 g of coca leaf powder mixed with water for a period of 90 days. They kept their regular diet and lifestyle. Three blood samples per volunteer were taken before, after 45 and 90 days of treatment. Main outcomes: We measured procollagen 1 N-terminal propeptide (P1NP), N-telopeptide of type 1 collagen (NTX1), beta-crosslaps (ßCTX) and human bone alkaline phosphatase (BALP) in the volunteers. TEAC-ABTS (Trolox equivalent antioxidant capacity), FRAP (Ferric reducing antioxidant power) and polyphenols were determined in coca leaf powder. Results: A significant decrease in the bone resorption indicator NTX1 (from 12.719 to 0.9945 ng/mL; p<0.05) was found. The bone formation indicator P1NP had a positive median difference. Coca leaf powder showed antioxidant capacity (TEAC-ABTS of 2.74 μmol/mL, FRAP of 73.60 mg AAE/g); the content of polyphenols was 3 089.34 mg AG/100 g. These results show coca leaf powder could potentially benefit bone metabolism. Conclusion: The incorporation of coca leaf powder into the regular diet for a period of 90 days generated a change in the indicators of bone density in women.

Introducción. Anualmente, cerca de 25 millones de mujeres en el mundo ingresan a la menopausia; alrededor de 30% sufrirá osteoporosis. Los tratamientos convencionales suelen tener efectos colaterales. En el Perú, existen alternativas en los recursos vegetales, como el Erythroxylum coca, con alto contenido de calcio, fibra y polifenoles. Objetivos. Evaluar el efecto del consumo de coca pulverizada en mujeres posmenopáusicas, y analizar la capacidad antioxidante de la coca pulverizada. Diseño. Estudio cuantitativo, cuasiexperimental, preprueba-posprueba. Institución. Centro de Investigación de Bioquímica y Nutrición, Universidad Nacional Mayor de San Marcos, Lima, Perú. Participantes. Mujeres posmenopáusicas voluntarias. Metodología. Siendo un único tratamiento y autocontrolado, se seleccionaron 25 voluntarias que cumplieron los criterios de inclusión y exclusión. Terminaron 21. Se les proporcionó hoja de coca pulverizada para un consumo diario de 4 g en agua durante 90 días. Todas continuaron con su dieta normal y estilo de vida. Se tomaron tres muestras de sangre por voluntaria, al inicio, antes del consumo del pulverizado, a los 45 días y a los 90 días. Principales medidas de resultados. En las voluntarias, se midió propéptido N-terminal de procolágeno tipo 1 (P1NP), telopéptido N-terminal del colágeno tipo 1 (NTX1), beta-crosslaps (ßCTX) y fosfatasa alcalina ósea (BALP). En el micropulverizado, ABTS (capacidad antioxidante equivalente al trolox), FRAP (antioxidante potencial de reducción de hierro) y polifenoles. Resultados. Existió reducción significativa del marcador de resorción ósea NTX1 (de 12,719 a 0,9945 ng/ mL; p<0,05). El marcador de formación ósea P1NP mostró una diferencia positiva de medianas. El extracto de coca exhibió capacidad antioxidante (TEAC-ABTS de 2,74 μmol/mL, FRAP de 73,60 mg AAE/g); el contenido de polifenoles fue 3 089,34 mg AG/100 g. Estas características podrían contribuir con los beneficios potenciales en el metabolismo óseo. Conclusiones. La complementación de la dieta por 90 días con coca indujo cambios en indicadores de recambio óseo.

Análisis de cocaína en diferentes muestras por cromatografía de gases con detector de ionización de llama (CG-FID) / Analysis of cocaine in different samples by gas chromatography flame ionization detector (GC-FID) / Análise de cocaína em diferentes amostras por cromatografia gasosa com detector de ionização de chama (GC-FID)

En este estudio se realizó la validación de los métodos establecidos por la UNODC para la cuantificación y extracción de benzometilecgonina (cocaína) presente en las hojas de Erythhroxylum coca, en té de coca y en clorhidrato de cocaína. El primer método de extracción, recomendado por la UNODC, es una extracción solido-líquido (ESL), sin embargo, los resultados obtenidos indican que esta no es lo suficientemente eficiente para lograr una señal de analito distinguible de la relación señal a ruido (S/N) para las muestras de hojas de Erythhroxylum coca y té de coca. El segundo método propuesto es la extracción soxhlet, los resultados indican que esta resulta más eficiente para aislar y cuantificar el analito de interés por cromatografía de gases acoplada a un detector de ionización por llama (CG-FID). Después de someter las muestras al proceso de extracción soxhlet y cuantificación por CG-FID se encontró que la hoja de té posee 7,66×10² mg de cocaína/kg de muestra, las hojas de coca 17,15 mg de cocaína/kg de muestra y el clorhidrato de cocaína 7,15×10(5) mg de cocaína/kg de muestra. El método de análisis escogido se caracteriza por arrojar bajos límites de detección (0,169 mg/L) y por poseer parámetros estadísticos y cromatográficos ideales.

In this study validate the methods established by the UNODC for quantification and extraction benzometilecgonina (cocaine) in the leaves of Erythhroxylum coca, coca tea and cocaine hydrochloride. The first extraction method recommended by the UNODC is a solid-liquid extraction (ESL), however, the results indicate that this is not efficient enough to achieve analyte signal distinguishable from the signal to noise ratio (S/N) for samples Erythhroxylum coca leaves and coca tea. The second proposed method is soxhlet extraction, the results indicate that this is more efficient to isolate and quantify the analyte of interest by gas chromatography coupled to a flame ionization detector (GC-FID). After submitting the samples to the soxhlet extraction process and quantification by GC-FID it found that tea leaf has 7.66×10² mg of cocaine/kg sample, coca leaves 17.15 mg of cocaine/kg sample and cocaine hydrochloride concentration corresponded to 7.15×10(5) mg of cocaine/kg sample. The chosen analysis method is characterized by low detection limits shed (1.69 mg/L) and possessing ideal chromatographic and statistical parameters.

Neste estudo validaram-se os métodos estabelecidos pelo UNODC para a quantificação e extração de benzometilecgonina (cocaína) nas folhas de Erythhroxylum coca; em chá de coca e cloridrato de cocaína. O primeiro método de extração recomendado por UNODC é uma extração sólido-líquido (ESL), no entanto, os resultados indicam que esta não é suficientemente eficaz para atingir um sinal de analito distinguível da relação sinal-ruído (S/N) para amostras de folhas Erythhroxylum coca e chá de coca. O segundo método proposto é uma extração soxhlet, os resultados indicam que este é mais eficiente para isolar e quantificar o analito de interesse por cromatografia gasosa acoplada a um detector de ionização de chama (GC-FID). Depois de enviar as amostras para o processo de extração soxhlet e quantificação por GC-FID descobriu-se que as folhas de chá têm 7,66×10² mg de cocaína/kg de amostra, as folhas de coca 17,15 mg de cocaína/kg de amostra e o cloridrato de cocaína 7,15×10(5) mg de cocaína/kg de amostra. O método de análise escolhido é caracterizado por ter baixos limites de detecção (1,69 mg/L) e possuir parâmetros estatísticos e cromatográficos ideais.

Evaluación de la respuesta glucemica post-ingesta de la hoja de coca (Erythroxylum coca) en personas sin antecedente patológico metabólico / Evaluation of the glycemic response post-intake coca leaf (Erythroxylum coca) in people without metabolic pathologic background

Considerando la veracidad de los beneficios de la hoja de Coca (Erythroxylum coca), este estudio tiene por objetivo evaluar la respuesta glucémica post ingesta de hoja de coca en personas sin previa patología metabólica. La metodología empleada es experimental, tipo ensayo clínico de campo. De una población de 345 personas de la Escuela Militar de Sargentos del Ejército de la ciudad de Cochabamba - Bolivia, se seleccionaron a 90 personas, de sexo masculino entre 18 a 25 años, sin antecedentes personales patológicos, con índices antropométricos normales y glucemia en ayunas de 60 a 100 mg/dl . La muestra se dividió en un grupo control, un grupo post-ingesta de mate de 5 gr. de hoja de coca y otro grupo post-masticación de 5 gr. de hoja de coca, durante una prueba de tolerancia oral a la glucosa, evaluada por la toma glucemia capilar en ayunas y dos horas postprandial. Se analizaron: el promedio, desviación estándar y prueba t student. Los resultados más relevantes fueron: Glucemia postprandial del grupo control 100,4 (± 11,9) mg/dl y (p=2,129), en el grupo de mate de coca 81,8 (±7,5) mg/dl y (p=0,003), y en el grupo de masticación de hoja de coca 82,07 (± 8,8) mg/dl y (p=0,082). Se concluye que la hoja de coca (Erythroxylum coca) reduce la glucemia postprandial en este grupo, siendo estadísticamente significativa en las dos formas de consumo mate y masticación en comparación que el grupo control.

Considering the veracity of the benefits of coca leaf (Erythroxylum coca), this study aims to evaluate the glycemicresponse post ingestion of coca leaf in people without metabolic pathologic background. It was used an experimental field trial type study. In a population of 345 people from the Military Academy Army of Sergeants in Cochabamba - Bolivia, 90 male people of 18 to 25 years old were selected with no medical history, normal anthropometric measures normal glucose on of 60 to 100 mg/dl.The sample was divided in a control group post-intake mate of 5 gr. coca and a post-chewing group 5 gr. coca leaf during an oral glucose tolerance test assessed by fasting capillary blood glucose two hours postprandial. It has been analyzed the mean, standard deviation and test student t. Most important result was: In the control group a postprandial glycemic of 100.4 (± 1 1.9) mg / dl (p = 2.129), the coca tea group was 81.8 (± 7.5) mg / dl (p = 0.003), group the chewing coca leaf was 82.07 (± 8.8) mg / dl (p = 0.082). It was been concluded that Coca (Erythroxylon coca) reduces postprandial glycemic in people without metabolic pathologic background, and it's statistically significant in the two ways of cultural consumption in the compering groups.