Is it worth adding loperamide to antibiotic treatment of traveler’s diarrhea? / ¿Vale la pena agregar loperamida al tratamiento antibiótico de la diarrea del viajero?

Travelers' diarrhea is a frequent condition, especially in those traveling to high-risk areas. Although antibiotic treatment reduces the duration of diarrhea, it has been suggested adding loperamide could further reduce the symptoms. To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We identified two systematic reviews including 28 studies overall, of which 15 were randomized trials relevant for the question of interest. We extracted data from the systematic reviews, reanalysed data of primary studies and generated a summary of findings table using the GRADE approach. We concluded adding loperamide to antibiotic treatment might accelerate resolution of symptoms in traveler’s diarrhea with minimal or no adverse effects.

La diarrea del viajero es una patología frecuente, en especial en quienes se dirigen a regiones de alto riesgo. Si bien el tratamiento antibiótico reduce la duración del cuadro, se ha planteado que la asociación de loperamida podría reducir aún más los síntomas. Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Identificamos dos revisiones sistemáticas que en conjunto incluyen 28 estudios primarios, de los cuales 15 corresponden a ensayos aleatorizados. Extrajimos los datos desde las revisiones identificadas y preparamos tablas de resumen de los resultados utilizando el método GRADE. Concluimos que agregar loperamida al tratamiento con antibióticos podría acelerar la resolución del cuadro, sin asociarse probablemente a efectos adversos importantes.

Adición de subsalicilato de Bismuto a la terapia triple erradicadora de la infección por Helicobacter pylori: efectividad y efectos adversos / Addition of Bismuth subsalicylate to triple eradication therapy for Helicobacter pylori infection: efficiency and adverse events

Determinar la eficacia y los efectos adversos de la adición del Subsalicilato de bismuto a la terapia triple en la erradicación de la infección del Helicobacter Pylori. Materiales y métodos: Estudio experimental controlado doble ciego. Se trabajó con 54 pacientes con diagnóstico de Helicobacter Pylori atendidos entre febrero-marzo 2012. El grupo experimental tuvo 29 pacientes a los que se les agregó subsalicilato de bismuto, a la terapia triple convencional y 24 pacientes a los que se añadió placebo. Resultados: La edad promedio fue 47 +/- 14,9 años, el 66,7% fueron mujeres. Se realizó test de aliento en ambos grupos para el control post tratamiento, obteniendo un test de aliento negativo en el 89.7% en el grupo de estudio y 80% en el grupo placebo (p=0,319). Los efectos adversos de los pacientes que recibieron tanto subsalicilato de Bismuto como aquellos que fueron tratados con Placebo fueron: diarrea en ambos grupos (10,3% primer grupo y 16% en el segundo grupo) p=0,537, Heces oscuras 37,9% en el primer grupo mientras que en el segundo grupo no hubo este tipo de consecuencia, (p=0,001). El dolor abdominal se presentó en el 20,7% del primer grupo y en el 52% del segundo grupo (p=0,016). Las náuseas se presentaron solo en el 3% del grupo placebo. (p=0,055). Conclusiones: No se encontró diferencias estadísticas con la adición de Bismuto al esquema de la terapia triple para erradicar el Helicobacter Pylori Comparado con placebo. (p=0,319).Los efectos adversos fueron menores en el grupo que recibió bismuto...

To establish the efficiency and adverse effects of the addition of bismuth subsalicylate to triple eradication therapy for Helicobacter pylori infection. Material and methods: Double blind controlled experimental trial. The study population consisted of 54 patients with Helicobacter pylori infection: 29 were allocated to the experimental group, who received the usual triple plus bismuth subsalicylate therapy, and 24 received the triple therapy plus placebo. Results: The average age was 47+/-14.9 years, 66.7% of the patients were women. Both groups underwent the breath test: it was negative in 89.7% of the patients from the experimental group and 80% of the patients from the placebo group (p=0.319). The adverse events of both groups were: diarrhea (10.3% in the experimental group vs 16% in the placebo group; p=0.537), dark feces (37.9% in the experimental group vs 0% in the placebo group; p=0.001), abdominal pain (20.7% in the experimental group vs 52% in the placebo group; p=0.016). Nausea only were present in 3% of the patients of placebo group p=0.055). Conclusions: The association of bismuth subsalicylate to the triple therapy scheme for the erradication of Helicobacter pylori was effective in 89.7% of patients, whereas 80% of efficiency was obtained in the placebo group (p=0.319). The adverse events were lesser in the experimental group...

Safety evaluation of Elixir Paregorico in healthy volunteers: a phase I study.

A liquid alcoholic extract of Papaver somniferum named Elixir Paregorico is extensively used for diarrheal diseases in Brazil. Its increased popularity has brought concerns and fears over the safety of this herbal product. Given the lack of investigative clinical studies, in this regard, this study investigated whether Elixir Paregorico administration causes any noticeable toxic effects in healthy volunteers. In all, 28 middle-aged healthy male (n = 14) and female (n = 14) were enrolled. After screening and a washout period, eligible subjects received four oral doses per day of Elixir Paregorico (3 mL diluted in 30 mL of water) over a 10-day period. Altogether, all 28 participants completed the study. The results of hematological and biochemical tests performed pre and post-treatment were within the normal range. In both male and female volunteers, there were no statistical differences (P > 0.05) in the results of clinical and laboratory tests performed at screening, on 5th and 10th day visits, and at final assessment. Although mild adverse events were related, which subsided spontaneously, no serious untoward reactions were reported following Elixir Paregorico administration. To our knowledge, this is the first demonstration that Elixir Paregorico administered four times a day for 10 days is safe and does not cause any noticeable toxic effect in healthy volunteers.

Antidiarrhoeal effects of Ocimum gratissimum leaf extract in experimental animals.

The aqueous extract of the leaves of Ocimum gratissimum was screened for antidiarrhoeal effects. The extract inhibited castor oil-induced diarrhoea in rats as judged by a decrease in the number of wet faeces in the extract-treated rats. In addition, the extract inhibited the propulsive movement of intestinal contents. On the isolated ileum of guinea-pig, the extract showed no direct action; however, it reduced the responses of the guinea-pig ileum to acetylcholine, nicotine and histamine. Phytochemical tests revealed the main constituents as tannins, steroids, triterpenoid and carbohydrates. These findings suggested that the aqueous extract of the leaves of O. gratissimum might elicit an antidiarrhoeal effect by inhibiting intestinal motility, partly via muscarinic receptor inhibition.

Role of a novel antidiarrheal agent, BW942C, alone or in combination with trimethoprim-sulfamethoxazole in the treatment of traveler's diarrhea.

The efficacy of BW942C, a novel enkephalinlike pentapeptide antidiarrheal agent, was compared with the efficacy of trimethoprim-sulfamethoxazole (TMP-SMX) and the combination of the two agents in a placebo-controlled trial of the 72-h treatment of acute diarrhea. Subjects with diarrhea but without bloody stools or fever greater than 102 degrees F (38.9 degrees C) were enrolled. Administered to 134 U.S. adults with diarrhea that developed shortly after their arrival in Guadalajara, Mexico, BW942C was more efficacious than TMP-SMX in relieving diarrhea and cramps in the first 12 h of therapy, especially among subjects with diarrhea caused by enterotoxigenic E. coli. In the BW942C treatment group, 25% of subjects eventually took additional therapy because their diarrhea did not respond to BW942C alone. Neurological side effects such as dizziness and light-headedness occurred more frequently among BW942C-treated subjects. Therapy for 3 days with TMP-SMX provided lasting relief comparable with previously reported 5-day therapy. Use of the combination of both agents provided the benefits of prompt relief afforded by BW942C and lasting relief afforded by TMP-SMX. BW942C might prove to be an agent suitable for the treatment of acute diarrhea, with TMP-SMX reserved for treatment of those who do not respond adequately. The empiric use of the combination of BW942C and TMP-SMX appears appropriate for the treatment of severe nondysenteric disease.

[Evaluation of the safety and effectiveness of WHR-1142A in the treatment of non-specific acute diarrhea]. / Valoración de la seguridad y eficacia del WHR-1142A en el tratamiento de la diarrea aguda inespecífica.

A randomized double-blind placebo controlled trial of the safety and efficacy of lidamidine hydrochloride (WHR-1142A) in thirty patients with acute nonspecific diarrhea was conducted. During their 29-hour hospital treatment period, the average number of bowel movements for each ten patient treatment group was: placebo, 5.1: lidamidine hydrochloride (10 mg), 2.4; lidamidine hydrochloride (18 mg), 2.5. The average weight of the feces of the patients in each treatment group was: placebo, 576 grams; lidamidine hydrochloride (10 mg), 364 grams; lidamidine hydrochloride (18 mg), 435 grams. Time intervals between each of the first two doses were greater for those patients in the active treatment groups (lidamidine hydrochloride) when compared to the placebo group. Overall evaluation of therapy was rated by physician and patient at end of study: placebo, 10 of 10, not effective; lidamidine hydrochloride (10 mg), 10 of 10 (100%) effective; lidamidine hydrochloride (18 mg), 10 of 10 (100%) effective. Vital signs and laboratory values remained within normal ranges throughout the duration of study, and no clinically significant adverse effects were reported.