Comparative evaluation of efficacy and tolerability of apremilast and methotrexate in patients of moderate-to-severe palmoplantar psoriasis: A randomized, parallel, open-label clinical trial.

BACKGROUND: Variable results about efficacy as well as safety of apremilast compared to methotrexate are reported in different trials. Hence, it is necessary to collect more evidence to prove the role of Apremilast in palmoplantar psoriasis. METHODOLOGY: The study was a randomized, prospective, parallel-group, open-label study conducted in patients with moderate-to-severe palmoplantar psoriasis. They were randomized into two groups, methotrexate (n = 19) or apremilast (22) for 16 weeks. Primary efficacy parameter was reduction in modified palmoplantar psoriasis area and severity index (mPPPASI) score from week 0 to week 16. Other parameters were proportion of patients attaining Static Physician Global Assessment score of 0 (clear) or 1 (almost clear), proportion of patients attaining mPPPASI75 (75% reduction in mPPPASI score) at the end of 16 weeks, and proportion of patients showing at least 5-point decline in dermatology life quality index from baseline. RESULTS: Decline in m-PPPASI score from 0 week to 16 weeks within the group was significant statistically though decline in score of m-PPPASI between these two groups was not statistically significant at 16 weeks. Similar results were obtained with the secondary efficacy parameters. In methotrexate group, there were 24 adverse events recorded including abnormal liver function tests in three patients. In apremilast group, 19 adverse events were recorded, in which two patients suffered from upper respiratory tract infection. CONCLUSION: Apremilast is as effective as methotrexate for the management of moderate-to-severe palmoplantar psoriasis with better tolerability. Hence, it can be considered alternative to established drugs in patients having palmoplantar psoriasis not responding to or tolerating other drugs. REGISTRATION: The study was registered with Clinical Trial Registry of India (CTRI/2020/05/025198).

To study the learning curve of capsulorhexis in manual small incision cataract surgery among postgraduate residents in central India.

PURPOSE: To evaluate the learning curve of continuous curvilinear capsulorhexis (CCC) and to assess the number of surgeries required to master it among residents in a postgraduate teaching institute. METHODS: The present prospective observational study was based on the completion time and complication rates related to CCC performed using various techniques by 10 students in the 2nd (JR2) and 3rd-year (JR3) of residency. CCC was performed either by a cystotome or capsulorhexis forceps or by a combined method in 253 eyes, of which 160 eyes (63.2%) were operated by JR3 and 93 (36.8%) by JR2. The complication rates were studied with respect to the number of capsular extensions, posterior capsular rent (PCR), zonular dehiscence, need for senior surgical assistance, and nucleus drop. RESULTS: The average time required for the completion of CCC was 412 ± 90.5 s. The average number of times residents required to fill the anterior chamber with viscoelastic was 6.9 ± 1.4. The average size of CCC was 7 ± 0.66 mm. Extended CCC was the most common complication. JR2 required assistance from a senior surgeon in 47 eyes (50.5%), whereas JR3 required assistance in 39 eyes (24.4%) (P = 0.0001). The rate of PCR was not significantly different in JR2 (7.5%) and JR3 (8.8%). CONCLUSION: CCC is a difficult step to master in the trainee. Focusing and practicing on this step will help to reduce the complications and maximize proficiency. Approximately 6-eight surgeries are required to master CCC.

Assessment of adherence to medication during chronic illnesses in pregnancy.

PURPOSE/AIM: To evaluate adherence to medication in chronic illnesses during pregnancy and to identify factors responsible for non-adherence. METHODS: This was a prospective, cross-sectional, questionnaire based study initiated after approval of the institutional ethics committee. Pregnant women suffering from any chronic illness (except HIV) were questioned to evaluate adherence to medication in chronic illnesses during pregnancy and to detect factors responsible for non-adherence using a semi-structured, open-ended questionnaire. Adherence to medication was also assessed using 4-item Morisky's medication adherence scale. RESULTS: Rate of high adherence was significantly more (58.77%) with medications for chronic illness compared to medications for normal pregnancy (15.78%). Majority of women were more concerned about the chronic illness and believed that keeping the chronic illness under control is more important for normal growth of the baby. Unawareness about usefulness of each medicine and forgetfulness were the most common reasons for non-adherence to medications. Not taking prescribed dose was the most common type of non-adherence. Level of adherence positively correlated with level of education while it was inversely related to number of tablets per day. CONCLUSION: Higher adherence to medications for chronic illnesses during pregnancy is an encouraging finding but at the same time poor adherence to medications for normal pregnancy is a matter of concern. Most of the issues responsible for non-adherence to medication as reported in this study can be resolved to a significant extent by planning and implementing interventions aimed at improving adherence to treatment during pregnancy in which health professionals play a major role.

N-acetylcysteine as an add-on to Directly Observed Therapy Short-I therapy in fresh pulmonary tuberculosis patients: A randomized, placebo-controlled, double-blinded study.

PURPOSE: Pulmonary tuberculosis is associated with increased oxidative stress, enhanced lipid peroxidation, and decreased glutathione (GSH) levels. N-acetylcysteine (NAC) effectively increases GSH levels, improves lipid peroxidation, and decreases reactive oxygen species levels as reported by earlier studies. Hence, we planned to clinically evaluate the effect of NAC as add-on to Directly Observed Therapy Short-I (DOTS-I) regimen on treatment outcome in PTB with the objectives to study the effect of NAC as an add-on to intensive phase of DOTS-I (2 months) on sputum conversion, radiological improvement, GSH peroxidase (GPx) level, and weight and immunological response compared to placebo add-on at the end of 2 and 6 months. MATERIALS AND METHODS: This was a design-prospective, randomized, parallel group, add-on design, placebo-controlled, double-blinded, 24-week study. Parameters studied were sputum acid-fast bacillus examination, radiological improvements, GPx level, weight, and Mantoux response. NAC/placebo was added to DOTS Category I in intensive phase. RESULTS: Totally 48 patients completed the study. In NAC group, 23 patients achieved sputum negativity in 3 weeks while 14 patients in PLACEBO group. There was a significant clearing of infiltration and reduction in cavity size in NAC group compared to placebo at 2 months. At 2 and 6 months, NAC significantly raised GPx level and body weight. In 2 months, the patients with Mix ≤5 became Mx positive (100%) in NAC group while none in placebo group. CONCLUSION: NAC addition to DOTS-I significantly brings about faster sputum negativity, improves radiological response, weight, raises serum GPx level, and rectifies the deregulated immune response. Thus, NAC may be a useful adjuvant to DOTS in PTB.

Hyperprolactinaemia and its comparision with hypothyroidism in primary infertile women.

AIM AND OBJECTIVE: To study the serum prolactin levels and the serum TSH in primary infertile females. MATERIAL AND METHOD: In this study, we investigated thirty women who were diagnosed cases of primary infertility, who attended the Biochemistry Department, Sir JJ Group of Hospitals, Mumbai, India, for hormonal evaluations. Thirty fertile women with similar ages were enrolled as the controls. The status of the thyroid dysfunction and the levels of serum prolactin were reviewed in infertile women and in the controls. The serum Prolactin and the thyroid stimulating hormone levels were measured by using Siemens kits in IMMULITE 1000 chemiluminescence immunoassays. RESULTS: In our study, the serum prolactin levels in the infertile group were found to be high as compared to those in the control group and they were highly significant (p<0.0001). The serum TSH levels in the infertile group were found to be high, as compared to those of control group and they were highly significant (p<0.0001). CONCLUSION: There is a higher incidence of hyperprolactinaemia in infertile patients. There is also a greater propensity for thyroid disorders in infertile women than in the fertile ones. The incidence of hypothyroidism in the hyperprolactinaemic subjects in the study population was found to be highly significant than the normal controls.

Study of the effect of nortriptyline and fluvoxamine on psychomotor functions in healthy volunteers.

BACKGROUND: Today, many antidepressants are available, but they often cause adverse effects, particularly psychomotor and cognitive. It leads to patient maladjustment and may impair psychomotor performance. Fluvoxamine is a newer antidepressant and hence the present study was planned to investigate its effect on psychomotor functions and compare with nortriptyline and record their adverse reactions. MATERIALS AND METHODS: A total of 26 healthy volunteers were included in this double-blind, placebocontrolled, crossover study. Single oral doses of fluvoxamine 50 mg, nortriptyline 50 mg and placebo were administered following a Latin square design. The objective parameters-six digit cancellation test, digit symbol substitution test, critical flicker fusion test, arithmetic ability test, hand steadiness test and subjective parameters such as visual analogue scale 1, 2, 3 were tested at 0, 2 and 4 h. The side-effects were also investigated. RESULTS: Nortriptyline impaired all subjective and objective psychomotor functions while fluvoxamine did not show any significant effect on objective tests. However, on subjective parameters, there was a significant effect. The side-effects observed were dryness of mouthwith the nortriptyline and nausea and headache with fluvoxamine. CONCLUSION: Fluvoxamine is a better antidepressant drug in comparison with nortriptyline as it causes a less impairment of psychomotor functions.

Oxidative damage and schizophrenia: the potential benefit by atypical antipsychotics.

There is evidence to suggest the derangement of the oxidant and antioxidant defense system in schizophrenia. The present study examined the effect of atypical antipsychotics on lipid peroxidation, superoxide dismutase (SOD) and ascorbic acid. For this purpose, a prospective, open-label, 8-week study design was utilized. Serum SOD, serum malondialdehyde (MDA) and plasma ascorbic acid were estimated. Schizophrenic patients (n = 48) were compared with age- and sex-matched healthy volunteers (n = 40). There was a significant increase in serum SOD, serum MDA and a decrease in plasma ascorbic acid in schizophrenic patients as compared to control subjects. The trend altered significantly after the treatment with atypical antipsychotics. The results of the Brief Psychiatric Rating Scale for schizophrenia also improved with the treatment. The findings indicate an involvement of free radicals in schizophrenia and its modification by treatment with atypical antipsychotics. This study can also be used as a predictor of drug response by atypical antipsychotics in schizophrenia.

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.