ABSTRACT
OBJECTIVES: To assess the influence of vitamins B1, B6 and B12 on the analgesia success achieved by diclofenac in subjects with acute lumbago. RESEARCH DESIGN AND METHODS: A randomised, double blind controlled clinical study in parallel groups, in which subjects received twice-daily oral administration of either the combination therapy, Group DB (50 mg diclofenac plus 50 mg thiamine, 50 mg pyridoxine and 1 mg cyanocobalamin) or diclofenac monotherapy, Group D (50mg diclofenac). The study period lasted a maximum of 7 days. If sufficient pain reduction was achieved (defined as Visual Analogue Scale <20 mm and patient's satisfaction), subjects could withdraw from the treatment after 3 or 5 days. All subjects gave written informed consent to participate in the study. MAIN OUTCOME MEASURES: The primary confirmatory study objective was to determine the number of patients with sufficient pain reduction after 3 days of treatment. RESULTS: Three hundred and seventy-two subjects were allocated at random to either treatment group: Group DB - 187 subjects and Group D - 185 subjects. After 3 days of treatment, a statistically significant higher proportion of subjects in Group DB (n = 87; 46.5%) than in Group D (n = 55; 29%) terminated the study due to treatment success (chi(2): 12.06; p = 0.0005). Furthermore, the combination therapy yielded superior results in pain reduction, improvement of mobility and functionality. Drug safety monitoring profile throughout the trial was within the expected safety profile of diclofenac. CONCLUSIONS: The combination of diclofenac with B vitamins was superior to diclofenac monotherapy in lumbago relief after 3 days of treatment. As a study drawback, daily VAS measurements were only recorded until subject withdrawal from treatment, whether after 3, 5, or 7 days. There were no differences in safety profile between the two study groups.
Subject(s)
Diclofenac/administration & dosage , Low Back Pain/drug therapy , Vitamin B Complex/administration & dosage , Adolescent , Adult , Aged , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Diclofenac/adverse effects , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Drug Therapy, Combination/adverse effects , Female , Humans , Male , Middle Aged , Treatment Outcome , Vitamin B Complex/adverse effects , Young AdultABSTRACT
An unidentified organism was found in the stools of 55 immunocompetent patients who presented to the CIWEC Clinic in Kathmandu, Nepal between June and November 1989. The microscopic features of the organism share characteristics of both coccidia and cyanobacteria species. From June 26, 1989 to November 17, 1989, 55 persons were identified as having the organism in at least one stool sample. The illness was characterized by prolonged watery diarrhea, anorexia, fatigue, and weight loss. The mean +/- SD duration of illness was 43 +/- 24 days (range 4-107). Thirty-four patients received a total of 78 courses of antimicrobial treatment (2.3 courses/patient). The mean +/- SD duration of illness in 34 treated patients was 46 +/- 24 days. In 14 untreated patients, the mean +/- SD duration of illness was 35 +/- 23 days. The organism is 8.0-9.0 microns in diameter, floats in Sheather's solution, and stains red with the modified acid-fast stain. Since the agent was closely associated with a prolonged, self-limited diarrheal illness, it could easily have been misdiagnosed as Cryptosporidium. The organism should be looked for in the stools of patients with persistent diarrhea and a history of foreign travel.
Subject(s)
Cyanobacteria/isolation & purification , Diarrhea/epidemiology , Disease Outbreaks , Adolescent , Adult , Aged , Bacterial Infections/epidemiology , Bacterial Infections/microbiology , Child , Child, Preschool , Cyanobacteria/classification , Diarrhea/microbiology , Feces/microbiology , Female , Humans , Infant , Male , Middle Aged , Nepal/epidemiologyABSTRACT
A spherical organism 9-10 microns in diameter, seen in three outbreaks of diarrhea in Southeast Asia and the United States during the past 2 years, bore characteristics of a cyanobacterium when observed in formalin-preserved stool specimens and by electron microscopy. Organisms in freshly passed stool specimens showed an internal morula of lipid-containing globules. In fresh water, the morula divided into two sausage-shaped structures resembling the sporocysts of an isosporid coccidian. After 7 months, the organisms had not developed the crescentic sporozoites seen in the Coccidia but had begun to multiply slowly in culture. It was impossible to stain the internal structures of the organisms because the outer cyst wall ruptured during desiccation, releasing the contents of the cysts. The organisms were readily identified by their intense blue autofluorescence under UV light, but they were also recognizable by bright-field microscopy and by a modified acid-fast stain. Almost all infected persons suffered intermittent diarrhea for 2-3 weeks and many emphasized a feeling of intense fatigue during the course of their illness.
