Preliminary study of colistin versus colistin plus fosfomycin for treatment of carbapenem-resistant Acinetobacter baumannii infections.

Ninety-four patients infected with carbapenem-resistant Acinetobacter baumannii were randomized to receive colistin alone or colistin plus fosfomycin for 7 to 14 days. The patients who received combination therapy had a significantly more favorable microbiological response and a trend toward more favorable clinical outcomes and lower mortality than those who received colistin alone. (This study has been registered at ClinicalTrials.gov under registration no. NCT01297894.).

The efficacy of ascorbic acid in suboptimal responsive anemic hemodialysis patients receiving erythropoietin: a meta-analysis.

BACKGROUND: To determine the impact of adjuvant ascorbic acid therapy on erythropoietin-hyporesponsive, anemic patients undergoing hemodialysis. DATA SOURCES: The online databases of PubMed, Cochrane library, IPA, CINAHL, EMBASE, clinicaltrial.gov, WHO trial registry and PyschINFO were used. STUDY SELECTION: Studies comparing ascorbic acid to a control, with participants receiving erythropoietin and hemodialysis, and reported outcomes for hemoglobin or transferring saturation. DATA EXTRACTION: Two independent researchers reviewed titles and abstracts to determine relevance and extracted study design, dose, duration, baseline values, and outcomes. DATA SYNTHESIS: Five studies met all the criteria and were used for final analysis. The calculated weighted mean difference between hemoglobin in the ascorbic acid group versus the control group was 0.96 g/dL (95% CI, 0.78 to 1.14). The calculated weighted mean difference between transferrin saturation in the ascorbic acid treatment group versus the control was 8.26% (95% CI, 6.59 to 9.94). CONCLUSION: Adjuvant ascorbic acid significantly raises hemoglobin levels in patients with erythropoietin hyporesponsiveness undergoing hemodialysis. The significant rise in transferrin saturation indicates that this positive effect on erythropoietin response may be due to increased iron utilization.

Monitoring of effectiveness and safety of generic formulation of meropenem for treatment of infections at Siriraj Hospital.

OBJECTIVE: In Siriraj Hospital, generic meropenem (Monem) has been available and was substituted for original meropenem, but the effectiveness and safety of using generic meropenem in a clinical setting are the main concern. MATERIAL AND METHOD: From July 2007 to June 2009, hospitalized patients aged 18 or older who received meropenem for 48 hours were identified from the pharmacy database of Siriraj hospital. A retrospective study was conducted. Three hundred patients in each of original and generic meropenem groups were required to demonstrate non-inferiority of generic to original meropenem. RESULTS: The mean age of all patients was 63 years. Most of the patients had co-morbidities. Approximately 90% of the infections were health-care associated. Drug-resistant gram-negative bacteria including ESBL producing E. coli and K. pneumoniae, P. aeruginosa and A. baumannii account for nearly 50% of all organisms. No significant difference was found regarding characteristics, type or site of infection and pathogen between generic and original groups but for more patients in the original group having cardiovascular disease and more patients in the generic group receiving immunosuppressive agents. Eighty-two to 85% received meropenem with one of appropriate indications. No statistically significant difference occurred either in an overall favorable outcome (63% vs.70.4%, p = 0.07) or in overall mortality (38% vs. 32%, p = 0.17), as well as adverse effects between the original and the generic groups. CONCLUSION: Generic meropenem (Monem) was not inferior to original meropenem for therapy of infections in the hospitalized patients at Siriraj Hospital.

Efficacy and safety of Derris scandens Benth extracts in patients with knee osteoarthritis.

OBJECTIVES: The objectives of this study were to determine the efficacy and safety of Derris scandens Benth extracts in pain reduction and functional improvement in patients with knee osteoarthritis (OA). DESIGN: This was a prospective, randomized, controlled trial, single-blinded (assessor). SETTINGS: The study was conducted at the Rehabilitation Medicine Department, Siriraj Hospital. SUBJECTS: One hundred and seven (107) patients with primary OA knee who had pain score of ≥ 5 were recruited. INTERVENTIONS: Patients were randomized to receive naproxen 500 mg/day or Derris 800 mg/day for 4 weeks. OUTCOME MEASUREMENTS: Western Ontario McMaster Osteoarthritis Index (WOMAC) scores and 6-minute walking distance were the outcome measurements. RESULTS: Fifty-five (55) and 52 patients were randomized to Derris and naproxen groups, respectively. The mean differences of all WOMAC scores between 2 groups at week 4 adjusted by week 0 were within ± 1 point. The mean scores of the aforementioned outcomes at weeks 0, 2, and 4 were significantly improved compared to the baseline values. There was no difference of WOMAC scores between groups. The gastrointestinal irritation and dyspepsia were observed more often in the naproxen than in the Derris group. CONCLUSIONS: Derris scandens Benth extracts were efficacious and safe for the treatment of knee OA.

Efficacy and safety of Curcuma domestica extracts in patients with knee osteoarthritis.

OBJECTIVE: The objective of this study was to determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement in patients with knee osteoarthritis. STUDY DESIGN AND SETTING: The design and setting were a randomized controlled study at a university hospital in Bangkok, Thailand. METHODS: One-hundred and seven (107) patients with primary knee osteoarthritis (OA) with pain score of > or =5 were randomized to receive ibuprofen 800 mg per day or C. domestica extracts 2 g per day for 6 weeks. The main outcomes were improvement in pain on level walking, pain on stairs, and functions of knee assessed by time spent during 100-m walk and going up and down a flight of stairs. The adverse events were also recorded. RESULTS: Fifty-two (52) and 55 patients were randomized to C. domestica extracts and ibuprofen groups, respectively. Baseline characteristics of the patients in both groups were not different. The mean scores of the aforementioned outcomes at weeks 0, 2, 4, and 6 were significantly improved when compared with the baseline values in both groups. There was no difference in those parameters between the patients receiving ibuprofen and C. domestica extracts, except pain on stairs (p = 0.016). No significant difference of adverse events between both groups was found (33.3% versus 44.2%, p = 0.36 in C. domestica extracts and ibuprofen groups, respectively). CONCLUSIONS: C. domestica extracts seem to be similarly efficacious and safe as ibuprofen for the treatment of knee OA.

Efficacy and safety of colistin (colistimethate sodium) for therapy of infections caused by multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii in Siriraj Hospital, Bangkok, Thailand.

OBJECTIVE: To determine the efficacy and safety of colistin (colistimethate sodium) produced by a local pharmaceutical company in Thailand for the treatment of infections caused by multidrug-resistant (MDR) Pseudomonas aeruginosa and Acinetobacter baumannii. METHODS: Patients hospitalized at Siriraj Hospital between January 2005 and April 2006, who had infections caused by MDR P. aeruginosa or A. baumannii, were enrolled in the study. Colistin (colistimethate sodium) at a dosage of 5 mg/kg/day was given intravenously in two divided doses. Primary outcomes were the clinical response and 30-day mortality; secondary outcomes were microbiological response and adverse events. RESULTS: Ninety-three patients infected with MDR P. aeruginosa and A. baumannii were enrolled. Seventy-eight patients (71 with A. baumannii and seven with P. aeruginosa) received colistin, whereas 15 patients (12 with A. baumannii and three with P. aeruginosa) received other antibiotics. The mean age, gender, underlying conditions and severity of illness of the patients in both groups were not significantly different. In the colistin group, 63 patients (80.8%) had a favorable clinical response and 94.9% had a microbiological response. The overall mortality of the patients in the colistin group was 46.2% and that in the non-colistin group was 80%. Nephrotoxicity was found in 24 patients (30.8%) in the colistin group and 17 of them had predisposing factors contributing to their renal dysfunction. No neurotoxicity was observed among the 78 patients. CONCLUSION: Locally produced colistin appears to be safe and effective for the treatment of infections caused by MDR P. aeruginosa and A. baumannii in Thai adult patients.

Efficacy and safety of zidovudine and zalcitabine combined with a combination of herbs in the treatment of HIV-infected Thai patients.

A randomized double blind placebo controlled trial to determine the efficacy and safety of combined-herbs (SH) given with zidovudine (ZDV) and zalcitabine (ddC) for the treatment of HIV infection in Thai adults was conducted in 3 hospitals in northern Thailand during 2002 to 2003. The eligible subjects were HIV-infected Thai adults who had never received anti-retrovirals, had a Karnofski Performance Score (KPS) of > or = 70, and had no opportunistic infections. The subjects were randomized to receive either a combination of ZDV 200 mg three times per day, ddC 0.75 mg three times per day, and SH 2.5 g three times per day or a combination of ZDV 200 mg three times per day, ddC 0.75 mg three times per day, and placebo 2.5 g three times per day for 24 weeks. The main outcome measures were HIV-RNA, CD4 cells, and blood chemistry profiles prior to the treatment and then every 4 weeks for 24 weeks. The baseline characteristics of 60 evaluable subjects, 40 in the SH group and 20 in the placebo group, were not significantly different. HIV RNA at week 4 and thereafter was significantly decreased from the baseline value in both groups (p<0.001). However, the decline in HIV RNA in the SH group was significantly more than that in the placebo group. The CD4 cells in the SH group at week 12 and thereafter were significantly increased from the baseline value. Serious adverse events in the two groups were not observed. It is concluded that an addition of SH herbs to two nucleoside reverse transcriptase inhibitors has greater antiviral activity than antiretrovirals only. The SH herbs may be an alternative for the third anti-retroviral agent in the triple drug regimen for the treatment of HIV infected patients in countries with limited resources.

Randomized controlled trial of Tinospora crispa for additional therapy in patients with type 2 diabetes mellitus.

A randomized double blind placebo controlled trial was conducted to determine the efficacy of Tinospora crispa as additional treatment in patients with type 2 diabetes mellitus who did not respond to oral hypoglycemic drugs and refused insulin injection. Twenty patients were allocated to receive Tinospora crispa powder in capsule form at a dosage of 1 gram thrice daily for 6 months. Twenty patients received a placebo. The main outcomes were changes in fasting plasma glucose, glycosylated hemoglobin and insulin levels. The baseline characteristics of the patients in both groups were not significantly different. There were no significant changes in fasting plasma glucose, glycosylated hemoglobin and insulin levels among the patients within the group and between groups. Two patients who received Tinospora crispa showed marked elevation of liver enzymes that returned to normal after discontinuing Tinospora crispa. Moreover, patients in the Tinospora crispa group had significant weight reduction and cholesterol elevation while taking Tinospora crispa. It is concluded that there is no evidence to support the use of Tinospora crispa 3 grams a day for additional therapy in patients with type 2 diabetes mellitus who did not respond to oral hypoglycemic drugs. The patients receiving Tinospora crispa may have an increased risk of hepatic dysfunction.

The efficacy of combined mefloquine-artesunate versus mefloquine-primaquine on subsequent development of Plasmodium falciparum gametocytemia.

An open randomized controlled study of mefloquine-artesunate and mefloquine-primaquine for the treatment of uncomplicated Plasmodium falciparum malaria was carried out in Kanchanaburi in the Saiyok District in western Thailand. Weekly parasite counts from thick and thin blood films were done for six weeks. The gametocyte carriage rate was calculated and compared between the two treatment groups. Gametocytes on presentation, recrudescent infection, and reinfection were the significant factors associated with subsequent development of gametocytemia. It is the increased propensity of recrudescent infections to produce gametocytes that drives drug resistance. The results of this study confirmed that the complete eradication of a sexual forms of P. falciparum by effective antimalarial treatment, but not by combination treatment with primaquine, is the most effective means to prevent subsequent gametocytemia.

Strategy to prevent falls in the Thai elderly: a controlled study integrated health research program for the Thai elderly.

Instability or falls are one of the important warning symptoms of underlying serious illness among the elderly, so many studies have concentrated on the risk factors for falls. However, a study involving a strategic method to reduce the incidence of falls is the next step and is the main objective of this study. 1,043 elderly subjects living in the urban area around Siriraj Hospital Medical School, Bangkok, were recruited, 585 of them were allocated to the study group and 458 subjects to the control group. A leaflet containing information on important risk factors of falls within their community was enclosed with a follow-up postcard in the study group only. In addition, this particular group was allowed free access to the geriatric clinic at Siriraj Hospital if there was any health problem. All of them received a postcard asking about any falls which had occurred over the previous 2 months on 6 occasions and a telephone call if the postcards were not returned to the team. The percentage of elderly who kept in contact was 92.5 per cent, 90.6 per cent, 89.3 per cent, 89.2 per cent, 86.2 per cent and 85.45 per cent for the first to final follow-up respectively. After one year of longitudinal study, the overall incidence of falls was 6.6 per cent in the study group and 10.1 per cent in the control group. The incidence of falls began to show a statistically significant difference between the two groups at the fourth and sixth episodes of follow-up (P = 0.002 and 0.004). The Kaplan-Meier survival analysis also revealed a statistically significant difference in the incidence of falls between the two groups (P =0.01). In conclusion, the incidence of falls was significantly reduced in the study group and a repeated campaign to alert the elderly to the risk of falling is a cost-effective way of fall prevention among the healthy elderly in the community.