A Multicentre, Open label, Randomized, Comparative, Parallel Group, Active-controlled, Phase III Clinical Trial to Evaluate Safety and Efficacy of Arbekacin Sulphate Injection versus Vancomycin Injection in Patients Diagnosed with MRSA Infection.

BACKGROUND: Increasing resistance to currently available antimicrobials has led to the development of new agents. Arbekacin is aminoglycoside antibiotic currently used in Japan and Korea for the treatment of infections caused by multi-resistant bacteria including MRSA. Currently there is no published data available for use of Arbekacin in Indian patient population, thus the present study was conducted to evaluate the safety and efficacy of Arbekacin in Indian population. MATERIAL AND METHODS: The study was a phase III, multi-centre, open-label, randomised comparative, active control study. Subjects with microbiologically confirmed MRSA infection were randomized in the study to receive either Arbekacin sulphate 200 mg OD or Vancomycin hydrochloride 1000 mg BD for a period of 7 to 14 days. The primary endpoint was to evaluate the overall cure rate i.e. Clinical and microbiological cure during the study. RESULTS: A total of 162 patients were randomized in 2 treatment groups (i.e. 81 patients in each group). Out of these microbiologically confirmed MRSA patients, 153 patients were admitted for SSTI while 9 patients were admitted for CAP. Overall cure rate of MRSA infection (clinical as well as microbiological cure) was comparable in both the treatment groups i.e. 97.5% (79/81) in Arbekacin group and 100 % (79/79) in Vancomycin group (p value: 0.159). Both Arbekacin and Vancomycin were well tolerated by the patients during the study period. CONCLUSION: Arbekacin can be considered as safe and effective alternative to vancomycin in the management of MRSA infections.

Effect of camel milk on glucose metabolism in adults with normal glucose tolerance and type 2 diabetes in Raica community: a crossover study.

BACKGROUND: To investigate effects of camel milk consumption on insulin sensitivity and glycemic control in normal and type-2 diabetics of Raika and Non-Raika community. METHODS: 28 raika and non-raika male were enrolled in study, categorized in 2 groups, non-diabetic and diabetic after one month stabilization. Non-diabetics were supplemented with cow milk and diabetics with camel milk; followed by one-month washout period. Afterwards regimen was interchanged for 3 months. Biochemical and anthropometric data was recorded at baseline, after stabilization, before and after washout and at end of study. RESULTS: An improving trend was observed in both the groups for camel milk effect (FBS 203.86 +/- 24.09 to 161.43 +/- 11.39 mg/dl; p<0.05, OGTT 320.86 +/- 25.34 to 213.79 +/- 15.96 mg/dl; p<0.05 in diabetics and FBS 101.79 +/- 3.06 to 96.79 +/- 2.56 mg/dl, OGTT 114.36 +/- 7.99 to 100.36 +/- 6.74 mg/dl in control). HbAlc improved due to camel milk consumption (8.39 +/- 0.64 to 7.27 +/- 0.67%) whereas deteriorated in the case of cow milk (7.36 +/- 0.66 to 8.26 +/- 0.60%) in diabetic group. The HOMA-IR reduced from 13.21 +/- 4.88 to 4.38 +/- 0.75, AUC-glucose from 37253.57 +/- 2859.08 to 30724.29 +/- 3677.33 and AUC-insulin from 5871.86 +/- 1210.73 to 3301.86 +/- 629.98 in the camel milk group. CONCLUSIONS: In type-2 diabetics camel milk reduces FBS, post-prandial glucose and HbA1c. AUC-insulin and AUC-glucose also decreased significantly along with HOMA-IR. It shows hypoglycemic effect of camel milk reducing insulin resistance. (www.actabiomedica.it).

Beneficial effect of camel milk in diabetic nephropathy.

Diabetic nephropathy is originally microvascular in nature and is widely considered an important complication of diabetes. The present study was carried out to determine the efficacy of camel milk in controlling diabetic nephropathy. Twenty-four type-1 diabetic patients were randomly recruited from the outpatient diabetic clinic in PBM Hospital, Bikaner, India. All subjects gave their written consent before participation in the study. Patients with any acute metabolic complications were not included in the study. Eligible patients entered a run-in period of 1 month in which they were oriented to achieve the best possible glycemic control through standardized diet, standardized exercise regimen and insulin administration. During this period frequent monitoring of blood sugar was performed to maintain euglycemia. At the end of the run-in period, a base line evaluation was performed, then these patients were given camel milk in addition with usual care for six months. Urine microalbumin and blood sugar was measured twice a week before breakfast and dinner. There was a significant improvement in the microalbuminuria (119.48 +/- 1.68 to 22.52 +/- 2.68; p < 0.001) after receiving camel milk for 6 months. A significant reduction in the mean dose of insulin for obtaining glycemic control was achieved (41.61 +/- 3.08 to 28.32 +/- 2.66; p < 0.01). This study was performed to observe the role of camel milk in controlling microalbuminuria levels in type-1 diabetic patients. It was observed that after adding camel milk to the usual regimen an improvement in microalbuminuria was reached (119.48 +/- 1.68 to 22.52 +/- 2.68; p < 0.001). This may be due to good glycemic control or to the direct effect of camel milk. The mechanism behind this effect is still unknown.

Analgesic and anti-inflammatory activities of Trigonella foenum-graecum (seed) extract.

Analgesic and anti-inflammatory effects were examined in a partially purified fraction (MTH) of the Trigonella foenum-graecum seed extract. The analgesic effects of graded doses of fraction (MTH in 10-40 mg/kg p.o.) were evaluated in mice against acetic acid induced writhing (chemically induced pain) and hot-plate method (thermally induced pain). The analgesia produced by MTH was compared with the standard analgesics pentazocine (PTZ, 5 mg/kg p.o.) and diclofenac sodium (DIS, 5 mg/kg p.o.). Acute anti-inflammatory activity of fraction (MTH) was also evaluated in carrageenan-induced rat paw edema model at the doses 10 and 20 mg/kg i.p. and compared with diclofenac sodium (5 mg/kg i.p.). In comparison to control group MTH showed highly significant, dose dependent analgesic activity against thermally as well as chemically induced pain (p < 0.001). MTH at the dose of 40 mg/kg has shown significant analgesic activity (p < 0.001) as compared to diclofenac sodium and pentazocine at the doses employed. In comparison to control, MTH at the employed doses produced marked acute anti-inflammatory activity in rats (p <0.001). The results suggest that the water soluble fraction (MTH) of herbal origin has significant analgesic and anti-inflammatory potential as reflected by the parameters investigated. Further investigations are, however, necessary to explore mechanism(s) of action involved in these pharmacological activities.

Exercise-induced anaphylaxis and antileukotriene montelukast.

We report a rare case of exercise-induced anaphylaxis (EIA), occurring exclusively with exercise, without any other associated trigger, detected in the prodromal phase, and prevented from additional anaphylaxis episodes by treatment with cetirizine and 10 mg daily of antileukotriene montelukast to date. EIA is a syndrome in which patients experience a spectrum of the symptoms of anaphylaxis ranging from mild cutaneous signs to severe systemic manifestations such as hypotension, syncope, and even death after increased physical activity. Many people have triggers, such as, a variety of foods, various medications, alcohol, cold weather, humidity, and seasonal and hormonal changes along with exercise that cause the symptoms. Typically, either exercise or the specific trigger alone will rarely cause symptoms. It is differentiated from cholinergic urticaria by the absence of response to passive body warming and emotional stress.

Beneficial effect of chromium supplementation on glucose, HbA1C and lipid variables in individuals with newly onset type-2 diabetes.

PROJECT: Chromium is an essential nutrient involved in normal carbohydrate and lipid metabolism. It influences glucose metabolism by potentiating the action as taking part in insulin signal amplification mechanism. A placebo-controlled single blind, prospective study was carried out to investigate the effect of chromium supplementation on blood glucose, HbA(1)C and lipid profile in newly onset patients with type-2 diabetes. PROCEDURE: Total 40 newly onset type-2 diabetics were selected and after 1 month stabilization further randomly divided into two groups viz. study group and placebo group. The study group received 9 g brewer's yeast (42 µg Cr) daily and the other placebo group received yeast devoid of chromium for 3 months. Subjects were instructed not to change their normal eating and living habits. Fasting blood glucose, HbA(1)C and lipid profile were analyzed at beginning and completion of the study. RESULTS: Results revealed that fasting blood glucose level significantly reduced in the subjects consuming yeast supplemented with chromium (197.65±6.68 to 103.68±6.64 mg/dL; p<0.001). HbA(1)C values improved significantly from 9.51±0.26% to 6.86±0.28%; p<0.001 indicating better glycaemic control. In experimental group total cholesterol, TG and LDL levels were also significantly reduced from 199.66±3.11 to 189.26±3.01 mg/dL; p<0.02, 144.94±8.31 to 126.01±8.26; p<0.05 and 119.19±1.71 to 99.58±1.10; p<0.001 respectively. CONCLUSIONS: These data demonstrate beneficial effect of chromium supplementation on glycaemic control and lipid variables in subjects with newly onset type-2 diabetes.