Comparison of efficacy & safety of iron polymaltose complex & ferrous ascorbate with ferrous sulphate in pregnant women with iron-deficiency anaemia.

Background & objectives: Iron-deficiency anaemia (IDA) is a common nutritional deficiency among pregnant women in India. It has a significant impact on the health of the mother as well as that of the foetus. IDA generally responds well to treatment with oral iron supplementation. However, oral iron supplements are toxic to the gastrointestinal mucosa and intolerance is common, resulting in poor compliance and failure of treatment. The iron salts such as iron hydroxide polymaltose complex (IPC) and ferrous ascorbate (FeA) are claimed to have low gastrointestinal intolerance, therefore better patient compliance than the conventionally used ferrous sulphate (FS). These preparations also claim to increase haemoglobin level faster as well as improve the iron storage better than FS. This study was done to compare the efficacy and safety of FS with IPC and FeA. Methods: It was a randomized, parallel, open label, study among pregnant women of gestational age between 12 to 26 wk with moderate anaemia. Patients were randomly allocated to receive either FS, IPC or FeA. They were then followed up for 90 days to observe for improvement in the haemoglobin levels and other haematological parameters or any adverse drug reaction. Results: The haemoglobin levels were comparable in the three groups except at day 90 when FeA group had significantly higher haemoglobin level as compared to FS group (P<0.05). The overall adverse effect profiles were also comparable among the study groups except epigastric pain which was more commonly reported in the FS group. Interpretation & conclusions: The results of the study showed that FS, IPC and FeA have comparable efficacy and safety profile in the treatment of IDA of pregnancy.

Endoscopic, radiological, and symptom correlation of olfactory dysfunction in pre- and postsurgical patients of chronic rhinosinusitis.

The aim of the present study was to correlate olfactory dysfunction determined with psychophysical testing with nasal endoscopy, computed tomography (CT) scan, and patient's self-assessed olfactory deficit in patients of chronic rhinosinusitis (CRS) before and after sinus surgery. It was a prospective cohort study comprising of a total of 40 consecutive patients of CRS. All of them were given Connecticut Chemosensory Clinical Research Center Test for olfactory evaluation, nasal endoscopy, CT scan, and a graded questionnaire for perceived olfactory ability preoperatively on the same day after failing maximal medical management for 3 weeks. All investigations except CT scan were repeated 3 months postsinus surgery. For metrics, Visual Analog Scale (VAS) score, Lund Kennedy nasal endoscopy score, and Lund MacKay CT score were used. Spearman's correlation coefficients were determined between olfactory scores and endoscopic, CT, and VAS scores. Significant positive correlation was found between subjective VAS scores and composite odor scores both preoperatively (r = 0.89, P < 0.001) and 3 months postoperatively (r = 0.54, P < 0.001). Significant negative correlation was established between olfactory scores and CT (r = -0.71, P < 0.001). With nasal endoscopy also, the correlation results of odor scores were significant (r = -0.39, P = 0.01 in preoperative period and r = -0.47, P = 0.002 in postoperative period). Hence, it could be concluded that severity of olfactory disturbance determined by olfactory tests correlates well with nasal endoscopic findings, presence of CT opacification, and the patient's self-perceived olfactory insufficiency in CRS both before and after sinus surgery and can guide us well to determining the olfactory burden.

Evaluation of anti-inflammatory activity, effect on blood pressure & gastric tolerability of antidepressants.

BACKGROUND & OBJECTIVES: Antidepressants are being used as analgesics for various pain related disorders like neuropathic and non neuropathic pain. Although their analgesic activity is well recognized but anti-inflammatory potential of antidepressants is still inconclusive. Since the antidepressants are used for longer duration, it becomes important to elucidate effect of anti-depressants on blood pressure and gastric mucosa. This study was undertaken to evaluate the anti-inflammatory potential of various antidepressant drugs as well as their effect on blood pressure and gastric tolerability on chronic administration in rats. METHODS: Rat paw oedema model was used for studying anti-inflammatory activity, single dose of test drug (venlafaxine 20 and 40 mg/kg, amitryptline 25 mg/kg, fluoxetine 20 mg/kg) was administered intraperitoneally 45 min prior to administration of 0.1 ml of 1 per cent carrageenan in sub-planter region. Oedema induced in test group was compared with normal saline treated control group. For studying effect on blood pressure and gastric tolerability, test drugs were administered for 14 days. Blood pressure was recorded on days 0, 7 and 14 using tail cuff method. On day 14, 4 h after drug administration, rats were sacrificed and stomach mucosa was examined for ulcerations. RESULTS: Pretreatment of rats with venlafaxine (40 mg/kg) resulted in a significant decrease in paw oedema as compared to control (2.4 ± 0.15 to 1.1 ± 0.16 ml, P<0.01). Similarly, in the group pretreated with fluoxetine, significant decrease in paw oedema was observed in comparison to control (P<0.05). Significant change in mean blood pressure was seen in rats pretreated with venlafaxine 40 mg/kg (126.7 ± 4.2 to 155.2 ± 9.7, P<0.05) and fluoxetine (143.5 ± 2.6 to 158.3 ± 1.2, P<0.05) on day 7. No significant difference with regard to gastric tolerability was observed among groups. INTERPRETATION & CONCLUSIONS: Our findings showed significant anti-inflammatory activity of venlafaxine (40 mg/kg) and fluoxetine but these drugs were also associated with an increase in blood pressure. No significant change in mean ulcer index was observed among groups.

Etoricoxib attenuates effect of antihypertensives in a rodent model of DOCA-salt induced hypertension.

While it is known that non-steroidal anti-inflammatory drugs including selective cyclooxygenase-2 (COX-2) inhibitors influence BP, the exact relationship and underlying mechanisms are still unclear. We investigated the effect of etoricoxib, a selective COX-2 inhibitor on the antihypertensive efficacy of atenolol; beta-blocker, ramipril; angiotensin converting enzyme inhibitor and telmisartan; angiotensin receptor blocker in deoxycorticosterone acetate (DOCA)-salt hypertensive rats, a mineralocorticoid volume expansion model. Etoricoxib attenuated the antihypertensive-induced reduction of systolic (atenolol; P < .001, ramipril; P = .011, telmisartan; P = .003) and mean arterial pressure (atenolol; P < .001, ramipril; P = .032, telmisartan; P = .023). These results demonstrate that COX-2 dependent mechanisms play a significant role in blood pressure regulation, and etoricoxib-induced COX-2 inhibition blunts the therapeutic effect of different classes of antihypertensives in this mineralocorticoid volume expansion model of hypertension.

Impact of endoscopic sinus surgery on olfaction and use of alternative components in odor threshold measurement.

BACKGROUND: One of the major causes of olfactory disturbances is chronic rhinosinusitis (CRS), and the main surgical modality to treat CRS is functional endoscopic sinus surgery (FESS). It, therefore, is essential to assess the effect of this surgery on olfaction. Also, it is necessary to find new ways of measuring olfaction so as to reduce dependability on standard tests available. OBJECTIVES: To study the prevalence of olfactory impairment in patients with CRS and to evaluate the impact of FESS on olfaction. The study also aims at investigating the use of other odorants in place of butanol-1 in the Connecticut Chemosensory Clinical Research Center test. SUBJECTS AND METHODS: Forty patients of CRS without nasal polyposis were included in the study to analyze the prevalence of olfactory dysfunction and examine the influence of FESS at 1 and 3 months after surgery. Computed tomography scores (Lund Mackay scores) were calculated preoperatively, whereas other tests, viz., visual analog scale scoring, nasal endoscopy (Lund Kennedy scoring), and composite olfactory testing with odor thresholds of butanol-1, peppermint, lemon, clove, and ethyl acetate were carried out before surgery and after surgery at 1 and 3 months. RESULTS: Of 40 patients, 70% had symptoms of hyposmia or of anosmia before surgery, which dropped to 22.5% at 1 month after surgery and to 10% at 3 months after surgery. Nasal endoscopy and visual analog scale scores improved significantly. Odor threshold and odor identification scores also improved compared with the preoperative levels. A significant positive correlation was found between the threshold scores of butanol-1 and other odorants, both before and after surgery. CONCLUSION: Significant improvement was observed in olfaction after FESS, both in patient responses and in objective testing. The olfactory results with peppermint, lemon, clove, and ethyl acetate were close to those with butanol-1, and, hence, these other odorants can be used in place of butanol-1 in measuring the odor threshold.

Plasma cortisol levels in acute asthma.

OBJECTIVE: The study was undertaken with the aim to determine correlation between the initial plasma cortisol level and severity of asthma attack and the response to standard treatment for acute exacerbation of bronchial asthma in pediatric age group. METHODS: The study was performed in 33 asthmatic patients between 5-12 years of age, presenting to pediatric emergency with acute exacerbation of bronchial asthma. None of the patients included in the present study was on steroids. Venous blood sample for determination of plasma cortisol level was taken and patients were nebulized with salbutamol every 20 minutes, up to 1 hour. The patients who failed to respond even after three nebulizations were labeled as nonresponders and repeat venous blood sample for plasma cortisol estimation was taken before giving injection hydrocortisone. In responders sample was taken 1 hour after last nebulization. RESULTS: The mean plasma cortisol value at the time of admission in responders (12.42 +/- 1.9 microg/dl) was not found to be significantly different from that in nonresponders (13.1 +/- 2.74 microg/dl). Children with severe attack of asthma had significantly higher plasma cortisol levels both at the time of admission (p=0.03) and at the end of study (p=0.001), as compared to patients with moderate attack. The mean percentage change in plasma cortisol levels in nonresponders was an increase of 80.65 +/- 60.64%, whereas, in responders it decreased by 16.49 +/- 21.7% and this difference was statistically significant (p<0.05). CONCLUSION: The hypothalamo pituitary adrenal axis functions normally in asthmatic patients, producing a rise in cortisol levels corresponding to degree of stress; and from initial cortisol level alone, it cannot be predicted, whether a patient will respond to beta-2 agonist (salbutamol) nebulization alone or will require exogenous corticosteroids.

Evaluation of the analgesic and anti-inflammatory activity of fixed dose combination: non-steroidal anti-inflammatory drugs in experimental animals.

BACKGROUND: In India, a number of fixed dose drug combinations of non-steroidal anti-inflammatory drugs (NSAID's) are available, often as over-the-counter products. These combinations are being prescribed too. Evidence for efficacy of NSIAD fixed dose combination is lacking. OBJECTIVES: The current study was undertaken to assess the analgesic and anti-inflammatory efficacy of these combinations over their individual components. MATERIALS AND METHODS: The study used three NSAIDs viz; paracetamol, ibuprofen and diclofenac sodium, alone or in combination with paracetamol. Animals were divided into six groups with six animals in each group. Analgesic activity was tested by writhing test and paw edema model was used to assess the anti-inflammatory activity. The test drugs were administered orally 30 min prior to injecting 0.6% solution of glacial acetic acid intraperitoneally for writhing test. For paw edema test, after 30 min of drugs administration, animals were injected with 0.1 ml of 1% carrageenan in subplanter region for inducing inflammation. Paw volume was again measured at baseline and after 3 h of subplanter injection of 1% carrageenan. RESULTS: The analgesic and the anti-inflammatory activity of paracetamol and ibuprofen combination were significantly greater than the individual agents when used alone. However, no significant difference in the analgesic or anti-inflammatory activity was found between diclofenac sodium and its combination with paracetamol. It was observed that diclofenac sodium was the most efficacious of the analgesics tested. Combining paracetamol with diclofenac did not show superior analgesic activity compared to diclofenac alone (P = 0.18). CONCLUSION: Combining paracetamol with ibuprofen enhances analgesic/anti-inflammatory activity over their individual component but potentiation of analgesic activity of diclofenac was not seen when paracetamol was added to it.

Efficacy of sodium valproate and haloperidol in the management of acute mania: a randomized open-label comparative study.

This study was carried out to compare the efficacy of intravenous sodium valproate with intramuscular haloperidol in patients with acute mania. A total of 30 patients meeting DSM-IV criteria for acute manic episodes were enrolled. They were randomly assigned to 2 groups of 15 patients each. Both groups were treated twice daily with haloperidol (10 mg, intramuscular) and sodium valproate (500 mg, intravenous). The patients were assessed on days 1, 5, 9, and 13. Improvement in symptoms was assessed by reduction in the Young Mania Rating Scale (YMRS). Outcome criterions for analysis were latency of response and remission; additional drugs were required for sedation. At the end of the 2-week study period, overall response rate in both the groups was similar (P > .1). In comparison to haloperidol group, patients treated with sodium valproate showed faster response, and on day 5, significant reduction in YMRS score was observed in the group treated with sodium valproate (P < .05). Total amount of lorazepam was less in patients treated with sodium valproate. Extrapyramidal symptom episodes were observed in 60% of patients treated with haloperidol. Sodium valproate in the treatment of acute mania is as efficacious as haloperidol but provides a faster response. It is safer compared to haloperidol.