Impact of accreditation on registered ethics committees in terms of quality and governance in India: A cross-sectional study.

Background: Ethics Committee accreditation is a process to assess the performance against a set of standards. Very few studies have shown that process of accreditation results in the improvement of the overall functioning of ECs. in terms of quality and governance. Hence, the present study was planned to evaluate the impact of accreditation on registered EC in terms of quality and governance and to compare functioning of accredited versus non accredited EC in terms of quality and governance. Materials and Methods Study Design: This was a cross sectional, observational, questionnaire-based survey conducted on 28 registered Ethics Committee in India after approval from the Institutional Ethics Committee. Results: Accredited EC's (n = 12) were compared for NABH standard for accreditation before and after accreditation in terms of percentage. It was found that majority of the standards related to structure and composition, adherence to specific policies , completeness of review and after approval process were met by majority of EC's after accreditation. Only a few EC 's fulfilled some of the criteria before accreditation. There was a statistically significant difference with reference to adherence to specific policies by accredited and non-accredited EC's like updating SOP according to changing requirements (P < 0.0237), process for preparing SOP (P < 0.0237), categorization of review process mentioned in SOP (P < 0.0237) procedure to be followed for vulnerable population (P < 0.0103) , process of handling issues related to complaints by participants and other stakeholders violation (P < 0.0103) etc. Conclusion: Accreditation results in improving of EC functioning in terms of quality and governance.

Analysis of Cutaneous Adverse Drug Reactions (ADR) Reported at an ADR Monitoring Center of a Tertiary Care Teaching Institute in Central India.

Background Cutaneous adverse drug reactions (ADRs) are among the most frequent ADRs. Knowledge of the pattern of cutaneous ADRs (CADRs) and causal drugs helps prevent and reduce the incidence of CADR, which in turn reduces the incidence of hospitalization and expenses for the patient. Objectives To analyze CADR according to demographic profile, morphological pattern, causative drugs, severity, and outcome in patients suffering from CADRs. Materials and methods Retrospective data analysis was conducted in the Adverse Drug Reaction Monitoring Centre (AMC) of the tertiary care teaching institute between February 2020 and September 2023 under the Pharmacovigilance Program of India (PvPI). All ADRs reported were analyzed based on the following parameters: total number of ADRs reported, number of CADRs, information related to demographic parameters, the clinical presentation of CADRs, and suspected medication. Causality assessment was done using the World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) scale. Severity was assessed using a modified Hartwig and Seigel scale. Results A total of 125 CADRs were analyzed. Considering the gender-wise distribution, 65 females and 60 males suffered from CADR. The most common drug category responsible for CADRs was antimicrobials (63.2%), followed by topical agents (12.8%). Maculopapular rash (33.6%) was the most common presenting symptom, followed by itching (27.2%). Few patients suffered from serious CADRs such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).  Conclusion A wide clinical spectrum of CADRs ranging from maculopapular rash to fixed-drug eruption to serious SJS was observed in our study. The most common causative agents for CADRs were antimicrobials, followed by topical agents and NSAIDs. For early diagnosis and management of CADRs, it is critical to have data on the potential cutaneous adverse effects of commonly used drugs, to educate the patients regarding common early symptoms of drug reactions (e.g., erythematous rash, edema, urticaria, mucosal erosions, itching, burning of skin, etc.), and to monitor the patient, especially during the start of therapy. To ease the burden of CADRs, a therapeutic plan of anticipating, avoiding, recognizing, and responding to ADRs should be implemented.

A Novel Potential Treatment for Diabetic Foot Ulcers and Non-Healing Ulcers - Case Series.

INTRODUCTION: Appropriate care and treatment of a wound is the need of the hour whether it is an infected or a non-infected wound. If wound healing is delayed for some reason, it leads to serious complications and further increases the hospital stay and cost of treatment. Herein, we describe a novel antimicrobial wound dressing formulation (VG111), with an objective to generate the preliminary data showing the distinct advantages in various types of wounds. METHOD: This case series involved the treatment of acute cases of wounds or chronic wounds that did not respond well to conventional wound healing treatments with VG111 in patients with different etiologies. Thirteen cases of patients that included patients with diabetes, pressure ulcers, burns, trauma, and others treated with VG111 showed rapid wound healing in all the cases, even obviating the need for a graft when complete skin regeneration occurred RESULT: This was illustrated by clearing of the wound infections, reduction/disappearance of the exudate, appearance of intense granulation, epithelialization, and anti-biofilm activity followed by complete wound closure. This VG111 precludes the need for systemic antimicrobial agents in localized infections and therefore, this single agent is an attempt to address the limitations and the drawbacks of the available products. CONCLUSION: Despite patients belonging to the old age group and having comorbidities like diabetes, still VG111 showed effective rapid wound healing, and that too without any scar formation in hardto-heal, infected, and non-infected wounds

Effect of Ramipril on Cardiac Autonomic Neuropathy in Patients With Type II Diabetes Mellitus.

Background Cardiovascular autonomic neuropathy (CAN), an important form of DAN is caused by the impairment of the autonomic nerve fibers that innervate the heart and blood vessels and leads to abnormalities in cardiovascular dynamics. The earliest finding of CAN, even at the subclinical stage, is a decrease in heart rate variability (HRV). Objective The objective is to assess the effect of ramipril 2.5mg once daily on cardiac autonomic neuropathy in type II DM patients as an add-on to a standard antidiabetic regimen for a duration of 12 months. Materials and methods A prospective, open-label, randomized, parallel-group study was conducted on type II DM with autonomic dysfunction. Patients in Group A received tablet ramipril 2.5mg daily along with the standard antidiabetic regimen which consist of Tab Metformin 500mg twice a day and Tab Vildagliptin 50mg twice a day and group B received only the standard antidiabetic regimen for 12 months. Results Among 26 patients with CAN, 18 patients completed the study. After one year in group A, Delta HR value increases from 9.77±1.71 to 21.44±8.44 and the E:I ratio (ratio of the longest R-R interval during expiration and shortest R-R interval during inspiration) improved from 1.23±0.35 to 1.29±0.23 signifying significant improvement in parasympathetic tone. Results of the postural test showed significant improvement in SBP. Analysis of HRV by time domain method showed that the standard deviation of RR (SDRR) interval and Standard deviation of differences between adjacent RR interval (SDSD) value increased significantly in group A. Analysis of HRV frequency domain indices showed that LFP:HFP ratio improved after treatment in ramipril group indicating improvement in sympatho-vagal balance. Conclusion Ramipril improves parasympathetic component more as compared to sympathetic component of DCAN in type II DM. Ramipril could be a promising option having favorable long-term outcomes in diabetic patients especially when treatment begins at subclinical stage.

Analysis of clinical trial agreement and insurance policy submitted to the ethics committee of a tertiary care teaching institute in central India.

Purpose: Very few studies conducted in India have analyzed insurance policies and clinical trial agreement (CTA) submitted to ethics committee (EC). This study was conducted to review and find out deficiencies in it. Materials and Methods: This was a retrospective observational study. All the protocols for regulatory clinical trials and academic research sponsored by the Indian Council of Medical Research or other funding agency were included. Insurance documents and CTA submitted with the study protocols were analyzed. Results: A total of seventy CTA and insurance policies were analyzed. CTA mentioned that parties involved in 60 (86%) forms, scope of the agreement in 15 (21%) forms, responsibilities of the party in 68 (97%) forms, and payment details in 58 (83%) forms. Nearly 88.5% of the insurance policies mentioned whether the policy covers the participants for injury due to all clauses and 91% of the policies mentioned the validity period of insurance. Conclusion: It was found that both the documents contained almost all the required elements. This was probably because this institutional EC insisted on and thoroughly reviewed the documents to ensure that adequate compensation of research-related injuries has been provided for and this fact is informed to the trial subject. As very few studies are available in the literature, we could not compare majority of the findings of this study with others.

Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study.

OBJECTIVE: To compare efficacy, safety, and cost-effectiveness of sertaconazole (2%) and luliconazole (1%) cream in patients with dermatophytoses. MATERIALS AND METHODS: Sixty-four patients with tinea corporis and tinea cruris infections were enrolled in this single-center, randomized, open-label, parallel study. Following inclusion and exclusion criteria, patients were randomly divided into two treatment groups and received either sertaconazole 2% cream applied topically twice daily for 4 weeks and luliconazole 1% cream once daily for 2 weeks. At follow-up, efficacy was assessed clinically using 4-point physician global assessment (PGA) scale, composite score, and mycologically by KOH mount. Safety was assessed by monitoring adverse drug events at each visit. RESULTS: The primary efficacy variables including changes in pruritus, erythema, vesicle, and desquamation (4-point PGA) were significantly (P < 0.0001) improved in both the groups, at the end of treatment. There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group (P = 0.0002) compared to the luliconazole group. Both the groups showed equal negative mycological assessment. Both the study drugs were well tolerated. Only one patient in the sertaconazole group showed allergic contact dermatitis. CONCLUSION: Sertaconazole was better than luliconazole in relieving signs and symptoms during the study and follow-up period, but cost-effectiveness wise, luliconazole was better than sertaconazole.

Effect of educational intervention on awareness of pharmacovigilance among medical undergraduates in a tertiary care teaching hospital.

AIM: (1) To assess the knowledge and attitude of undergraduates about adverse drug reaction (ADR) reporting at a tertiary care teaching hospital. (2) To assess the effect of educational intervention among medical undergraduates on knowledge and attitude about pharmacovigilance (PV). MATERIALS AND METHODS: Cross-sectional, questionnaire-based survey conducted at a tertiary care teaching hospital. Respondents were 192 undergraduate students (2nd year). The study instrument was a self-developed, prevalidated semi-structured questionnaire. Participants were given 1 h to complete the questionnaire. After this, a 2 h lecture about PV was taken. Participants were asked to fill the same questionnaire after the educational intervention. Pre- and post-test questionnaire were compared. RESULTS: There was an overall improvement in all three aspects, i.e., awareness, knowledge, and attitude. Most of the students had knowledge of the meaning of PV and reporting of ADR by doctors. However, there was a significant improvement in the knowledge regarding reporting of ADR by dentist, nurses, and pharmacist. Similarly, students were aware of the fact that ADR with allopathic medicines should be reported, but postintervention, there was improvement in percentage regarding reporting of ADR in the case of herbal and traditional medicine, blood products, and biological and medical device. There was a significant improvement in percentage regarding awareness about process of reporting ADR after exposure to lecture. CONCLUSION: There is a need of increasing awareness among the medical students to improve the reporting of ADRs. Adequate consideration needs to be given to the subject of ADRs in the clinical pharmacology and therapeutics curricula in undergraduate medical education.

Low-dose sodium valproate versus low-dose propranolol in prophylaxis of common migraine headache: A randomized, prospective, parallel, open-label study.

CONTEXT: Migraine is the second most common headache disorder. However, prophylactic therapy remains underutilized. AIMS: The objective of the study was to compare the efficacy and safety of low-dose sodium valproate and low-dose propranolol sustained release (SR) in the prophylaxis of common migraine headache. SETTINGS AND DESIGN: The study was conducted in a tertiary care teaching institute. It was a randomized, prospective, parallel, open-label, clinical study. SUBJECTS AND METHODS: The study included 60 patients with common migraine headaches (≥2 attacks/month) treated for 12 weeks. The patients were randomly divided into two treatment groups treated by sodium valproate 500 mg/day and propranolol SR 40 mg/day, respectively. The primary outcome measures were the percentage of responders (i.e., >50% decrease in mean headache frequency) at the end of 12 weeks and decrease in mean headache frequency (per 4 weeks) at the end of 12 weeks. The patients were assessed at 0, 4, 8, and 12 weeks of the study. STATISTICAL ANALYSIS USED: Intention-to-treat analysis was used for all the statistical analysis. RESULTS: Fifty-five patients completed the study. At the end of the treatment, both sodium valproate and propranolol caused a significant (P < 0.0001) reduction in frequency, severity, and duration of migraine headache. Propranolol caused significantly greater reduction in the severity of headache (P = 0.0410) than sodium valproate. The percentage of responders was 60% in sodium valproate group and 70% in propranolol group. Drowsiness was the most common adverse effect noted in both the groups. CONCLUSION: Both sodium valproate and propranolol significantly reduced frequency, severity, and duration of migraine headache, but propranolol caused significantly greater reduction in the severity of headache compared to sodium valproate. Both the medications were well tolerated and did not result in discontinuation.

Efficacy and Tolerability of Olmesartan, Telmisartan, and Losartan in Patients of Stage I Hypertension: A Randomized, Open-label Study.

OBJECTIVES: To compare the efficacy and tolerability of losartan, telmisartan, and olmesartan as antihypertensive agents and evaluate and compare their effects on lipid profile and blood glucose. MATERIALS AND METHODS: This was a randomized, open-label, parallel-group, comparative study conducted in sixty patients of Stage I hypertension. The eligible patients were randomly allocated into three treatment groups: (1) Tablet olmesartan (20 mg), (2) Tablet telmisartan (40 mg), and (3) Tablet losartan (50 mg). Blood pressure (BP) was assessed at an interval of 2 weeks for 3 months. Fasting blood glucose (FBG) and lipid profile were estimated at baseline and then at 12 weeks. RESULTS: Olmesartan and telmisartan were more efficacious than losartan in reducing diastolic BP (DBP). There was a statistically significant decrease in mean blood glucose level (P < 0.02) after 12 weeks of treatment in telmisartan group when compared to baseline. Serum total cholesterol, triglycerides, and low-density lipoproteins decreased significantly after 12-week treatment with olmesartan and telmisartan. CONCLUSIONS: The most efficacious drug in reducing BP is Olmesartan whereas telmisartan and losartan show equal efficacy. Telmisartan shows the most favorable effects on FBG and lipid profile.

Efficacy and Safety of Oral Diclofenac Sustained release Versus Transdermal Diclofenac Patch in Chronic Musculoskeletal Pain: A Randomized, Open Label Trial.

INTRODUCTION: To compare the efficacy, safety, and tolerability of transdermal patches of diclofenac sodium with oral diclofenac sustained release (SR) in patients of chronic musculoskeletal MSK pain conditions. MATERIALS AND METHODS: The eligible patients were given either transdermal diclofenac patch or tablet diclofenac SR. Pain was assessed at 2 and 4 weeks using a visual analog scale. Adverse events were recorded. Patients with 18-65 years old of either gender with score of ≥4 on a 11-item numeric rating scale-numeric version of visual analog scale for pain with diagnosis of primary osteoarthritis (OA) of the knee or hand of at least 3 months duration, with independent radiological confirmation of OA or having pain associated with other MSK conditions such as soft-tissue rheumatism, cervical and lumbar back pain, and fibromyalgia, of at least 3 months duration were included in this study. RESULTS: Transdermal diclofenac diethylamine patch and tablet diclofenac sodium sustained release (SR) do not significantly differ in the reduction of numerical rating scores at the end of 4 weeks (P = 0.8393). CONCLUSION: Transdermal diclofenac was equi-efficacious as tablet diclofenac sodium SR in reducing pain due to chronic MSK pain conditions.

Comparison of Efficacy, Safety and Cost-effectiveness of Rupatadine and Olopatadine in Patients of Chronic Spontaneous Urticaria: A Randomized, Double-blind, Comparative, Parallel Group Trial.

OBJECTIVE: To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria. MATERIALS AND METHODS: A 6-week, single-centered, randomized, double blind, parallel group comparative clinical study was conducted on patients with chronic spontaneous urticaria. Following inclusion and exclusion criteria, 60 patients were recruited and were randomized to two treatment groups and received the respective drugs for 6 weeks. At follow-up, parameters assessed were mean total symptom score (MTSS) calculated by adding the mean number of wheals (MNW) and the mean pruritus score (MPS), number of wheals, size of wheal, scale for interference of wheals with sleep (SIWS). RESULTS: Both the drugs significantly reduced the MTSS, number of wheals, size of wheal, scale for interference of wheals with sleep, but olopatadine was found to be superior. In olopatadine group, there was significantly higher reduction in MTSS (p = 0.01), Number of wheals (P < 0.05), Size of wheals (p < 0.05), Scale for intensity of erythema (p < 0.05) and change in eosinopils count (p = 0.015) than that of rupatadine. Incidence of adverse effects was found to be less in olopatadine group when compared with rupatadine group. Cost effectiveness ratio was less in olopatadine group as compared to rupatadine group throughout the treatment. CONCLUSIONS: Olopatadine is a better choice in chronic spontaneous urticaria in comparison to rupatadine due to its better efficacy, safety and cost effectiveness profile.

Assessment of quality of life in epilepsy patients receiving anti-epileptic drugs in a tertiary care teaching hospital.

OBJECTIVES: Health-related quality of life (QOL) is an important outcome in epilepsy treatment. Very few studies have been carried out on the quality of life in epilepsy (QOLIE-31) in India. The present study aimed to determine the level of health-related QOLIE-31 in patients of epilepsy. MATERIALS AND METHODS: This was a cross-sectional, questionnaire-based study conducted in a tertiary care teaching hospital. Respondents were adults aged at least 18-year-old with a diagnosis of epilepsy. QOLIE-31 was used for collecting data on health-related QOL. The unpaired t-test or one-way analysis of variance was used to compare means of QOL scores between groups. RESULTS: Totally, 60 patients of epilepsy were included in the study. The mean (standard deviation) total score of QOLIE-31 was 64.61. A score of cognitive and medication effect were significantly better in carbamazepine group as compared to valproate group. CONCLUSIONS: Patients on monotherapy had a better QOL as compared to patients receiving polytherapy.

Clinical effectiveness and safety of cetirizine versus rupatadine in chronic spontaneous urticaria: a randomized, double-blind, 6-week trial.

BACKGROUND: Urticaria is a distressing condition associated with diverse clinical presentations. Chronic spontaneous urticaria (CsU) is characterized by wheals and angioedema. Its treatment requires an algorithmic approach to identify the optimum medication. OBJECTIVES: Cetirizine is commonly used in the treatment of urticaria. Rupatadine is a selective non-sedating H1 -antihistamine approved for the treatment of CsU. This trial was conducted to ascertain whether the properties of rupatadine offer advantages over cetirizine. METHODS: Seventy patients with CsU were enrolled. Parameters assessed included: (i) mean number of wheals (MNW); (ii) pruritus; (iii) mean total symptom score (MTSS); (iv) size of wheal; (v) interference of wheals with sleep; and (vi) sedation. Patients with CsU were divided randomly into two groups. Routine investigations were performed at baseline and at the end of the study. RESULTS: Evaluations of MTSS, MNW, and pruritus revealed statistically significant differences at week 3 compared with baseline in the cetirizine group. However, greater reductions in these parameters were obtained with rupatadine. In patients receiving rupatadine, reductions in the MNW, size of wheals, and intensity of erythema were also significant at six weeks (P < 0.001) and were significantly greater than those in the cetirizine group (P < 0.05). CONCLUSIONS: Improvements in MTSS, MNW, size of wheals, intensity of erythema, and differential eosinophil count imply that rupatadine is a particularly attractive therapeutic modality compared with cetirizine for the treatment of CsU.

Basic biostatistics for post-graduate students.

Statistical methods are important to draw valid conclusions from the obtained data. This article provides background information related to fundamental methods and techniques in biostatistics for the use of postgraduate students. Main focus is given to types of data, measurement of central variations and basic tests, which are useful for analysis of different types of observations. Few parameters like normal distribution, calculation of sample size, level of significance, null hypothesis, indices of variability, and different test are explained in detail by giving suitable examples. Using these guidelines, we are confident enough that postgraduate students will be able to classify distribution of data along with application of proper test. Information is also given regarding various free software programs and websites useful for calculations of statistics. Thus, postgraduate students will be benefitted in both ways whether they opt for academics or for industry.

Supplementation of vitamin C reduces blood glucose and improves glycosylated hemoglobin in type 2 diabetes mellitus: a randomized, double-blind study.

No study has ever examined the effect of vitamin C with metformin on fasting (FBS) and postmeal blood glucose (PMBG) as well as glycosylated hemoglobin (HbA1c) in the treatment of type 2 diabetes mellitus (DM). The goal was to examine the effect of oral vitamin C with metformin on FBS, PMBG, HbA1c, and plasma ascorbic acid level (PAA) with type 2 DM. Seventy patients with type 2 DM participated in a prospective, double-blind, placebo-controlled, 12-week study. The patients with type 2 DM were divided randomly into placebo and vitamin C group of 35 each. Both groups received the treatment for twelve weeks. Decreased PAA levels were found in patients with type 2 diabetes mellitus. This level was reversed significantly after treatment with vitamin C along with metformin compared to placebo with metformin. FBS, PMBG, and HbA1c levels showed significant improvement after 12 weeks of treatment with vitamin C. In conclusion, oral supplementation of vitamin C with metformin reverses ascorbic acid levels, reduces FBS, PMBG, and improves HbA1c. Hence, both the drugs in combination may be used in the treatment of type 2 DM to maintain good glycemic control.

Comparison of safety, efficacy, and cost effectiveness of benzyl benzoate, permethrin, and ivermectin in patients of scabies.

OBJECTIVE: To compare three treatment modalities in scabies for safety, efficacy, and economy in a local population of Nagpur. MATERIALS AND METHODS: This was a prospective, randomized, comparative clinical trial conducted in 103 participants, randomly allocated to three groups. First group received benzyl benzoate (BB) 25% lotion, second group received permethrin 5% cream, whereas third group received tablet ivermectin 200 mug/kg as a single dose. The participants were recalled after one week for follow-up evaluation. If there were no signs of cure, the same intervention was repeated. The participants were followed up for two weeks for cure rate, adverse drug reaction (ADR) monitoring, and postintervention observation. The follow-up was stopped after two weeks. STATISTICS: Fischer's exact test using Graph pad Instat v 3.05. RESULTS: Ivermectin showed 100% cure rate after two weeks of treatment. Permethrin decreased pruritus by 76% at the end of one week and had significantly better cure rate than ivermectin. At the end of two weeks treatment, this finding was reversed, that is, cure rate in ivermectin group was 100%. For cost-effectiveness analysis, treatment regimens were formulated hypothetically for comparison from Markov population tree for decision analysis. It was found that BB and ivermectin each consecutively for two weeks were most cost effective regimens giving complete cure in four weeks, while ivermectin was the fastest regimen giving the same results in two weeks. CONCLUSION: Benzyl benzoate as first line intervention and ivermectin in the remaining gave best cost-effective results in the study patients of scabies.

Antioxidant enzymes and lipid peroxidation in different stages of breast cancer.

Oxidative stress resulting from an imbalance between pro-oxidants and anti-oxidants seems to play an important role in human breast carcinogenesis. There are conflicting reports regarding the tissue levels of malondialdehyde (MDA), ascorbic acid and superoxide dismutase (SOD) in breast cancer patients whereas few blood values have been reported. The present study was carried out to observe the changes in serum MDA, serum SOD and plasma ascorbic acid with the stage-wise progression of the disease. Serum MDA and serum SOD levels were found to be increased gradually from Stage I to Stage IV as compared to control group (p < 0.001). The maximum rise was in Stage IV patients. In contrast, mean plasma ascorbic acid levels were low in all stages compared to control group (p < 0.001). The decrease was more pronounced in Stage III and Stage IV. The study would be of immense help for establishing blood based biochemical marker in breast cancer patients.

Antiulcer activity of levcromakalim and nicorandil in albino rats: a comparative study.

The objective of the present study was to investigate and compare the antiulcer effect of potassium channel openers, nicorandil and levcromakalim in the models of ulcer induced by pylorus ligation, aspirin and water immersion plus restraint stress in albino rats. Levcromakalim (250 microg/kg) and nicorandil (10 mg/kg) were administered intraduodenally immediately after pylorus ligation. Ulcer index was determined and gastric juice was subjected to analysis of total acid output (TAO) and pH. In aspirin-induced gastric ulcer model, the drugs were administered orally 30 min prior to noxious challenge, and in water immersion restraint stress model, the drugs were administered orally and ulcer index was determined. A significant reduction in ulcer index was observed after treatment with both potassium channel openers in all the gastric ulcer models. In pylorus-ligated rats, a significant decrease in TAO was noted. The conclusion is that potassium channel openers possess antiulcer activity. Antiulcer activity of levcromakalim is better than nicorandil but comparable to that of cimetidine. The antiulcer action of potassium channel openers is mediated partially by a decrease in gastric acid secretion, increase in gastric mucosal resistance and improvement in gastric mucosal blood flow.

Serum and plasma concentration of oxidant and antioxidants in patients of Helicobacter pylori gastritis and its correlation with gastric cancer.

Serum superoxide dismutase, plasma ascorbic acid and lipid peroxidation in H. pylori gastritis and gastric cancer patients were compared with values for age matched healthy subjects. Serum superoxide dismutase and serum malondialdehyde were analyzed spectrophotometrically whereas plasma ascorbic acid was determined by colorimetric method. Significant increase in serum superoxide dismutase and serum malondialdehyde and significant decrease in plasma ascorbic acid were observed in H. pylori gastritis and gastric cancer patients compared to control subjects. The concentration of serum superoxide dismutase and serum malondialdehyde was significantly higher and plasma ascorbic acid was significantly lower in gastric cancer as compared to H. pylori gastritis patients. Our results demonstrate that a correlation existed between the concentration of serum superoxide dismutase, plasma ascorbic acid and lipid peroxidation in H. pylori gastritis and gastric cancer patients.

Oxidative damage and major depression: the potential antioxidant action of selective serotonin re-uptake inhibitors.

There is evidence of derangement of oxidant and antioxidant defense systems in depression. The present study examined the effects of fluoxetine and citalopram, standard selective serotonin re-uptake inhibitors, on lipid peroxidation, superoxide dismutase (SOD) activity and ascorbic acid concentrations. For this, a prospective open-labeled, randomized design was utilized. Patients with major depression (n = 62) were compared with age- and sex-matched healthy volunteers (n = 40). There was a significant increase in serum SOD, serum MDA and decrease in plasma ascorbic acid levels in patients of major depression as compared to control subjects. The trend reversed significantly after treatment with fluoxetine and citalopram. Results indicate a greater reduction in oxidative stress with citalopram than fluoxetine. The Hamilton Rating Scale for Depression (HRSD) score also improved with fluoxetine and citalopram treatment. These findings indicate that major depression is associated with increased levels of serum SOD, serum MDA and decreased levels of plasma ascorbic acid. Treatment with fluoxetine and citalopram reversed these biochemical parameters. This study can be used as a predictor of drug response by fluoxetine and citalopram in major depression.