Placebo controlled trial of methotrexate in systemic sclerosis.

Eighteen adult patients of systemic sclerosis were included in this prospective study from Rheumatology Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka during the period of July 1997 to December 1999 to observe the effectiveness of treatment with methotrexate (MTX) versus placebo. Among the eighteen patients 9 patients were randomly assigned to MTX and 9 to placebo therapy. Nine patients were dropped out (6 in placebo and 3 in the MTX group), because of toxicity and non-compliance. Clinical improvement following treatment was observed in 33.33% of the patient in MTX group but none in placebo group, but this difference was not statistically significant. Anorexia, nausea and occasional vomiting were common side effects in MTX group and subsided in most cases with the passage of time despite the continuation of therapy.

Vegetarian diet in the treatment of fibromyalgia.

Brain tryptophan is low in fibromyalgia. Intake of protein rich in large neutral amino acids is reported to lower brain tryptophan. This study was undertaken to assess whether any reduction of such proteins by exclusion of animal protein from the diet reduced pain and morbidity in fibromyalgia patients. It was an open, randomized controlled trial. 37 subjects with fibromyalgia were enrolled in the vegetarian diet and 41 in the amitriptyline groups. The outcome was assessed with the help of frequencies of fatigue, insomnia & non-restorative sleep, pain score on a 10-point VAS and tender point count. Fatigue, insomnia and non-restorative sleep were present in 41, 26 and 32 subjects before and in 3, 0 and 0 subjects respectively at six weeks of treatment in the amitriptyline group. The pain score and tender point count were 6.2 +/- 1.9 & 16.1 +/- 2.3 before and 2.3 +/- 1.3 & 6.4 +/- 3.0 after treatment. All these differences were significant (P < 0.001). In the vegetarian diet group, fatigue, insomnia and non-restorative sleep were present in 36, 24 and 27 subjects before and in 34, 29 and 29 subjects at six weeks of treatment. The pain score and tender point count were 5.7 +/- 1.8 and 15.7 +/- 2.4 before and 5.0 +/- 1.8 & 14.7 +/- 3.6 after treatment. All these differences were insignificant except that in the pain score. The decrease in the pain score, though significant, was much smaller than that in the amitriptyline group. So, it may be concluded that vegetarian diet is a poor option in the treatment of fibromyalgia.

Efficacy of sulphasalazine plus methotrexate in rheumatoid arthritis.

Early intervention with slow acting anti-rheumatic drugs (SAARDs) has led to improvement in substantial proportion of rheumatoid arthritis (RA) patients. The present open, controlled study was designed to assess whether a combination of SAARDs offer any added benefit. Fifty-four adult RA patients were randomly allocated to methotrexate (MTX) (n = 27) and MTX plus sulphasalazine (SSZ) (n = 27) groups. The subjects were followed-up fortnightly for four weeks then monthly for six months. The disease activity was assessed with the help of 10 clinical and four laboratory indices. The improvement was graded as: minor, mild decreases in indices, non-steroidal anti-inflammatory drugs (NSAIDs) continued, physician's global assessment (PGA) decreased by one; marked, acceptable decreases in indices, NSAIDs being taken sparingly, PGA decreased by at least 2, and complete, all indices normalised and patients discontinued NSAIDs completely. The improvement was considered clinically important when marked or complete improvement occurred. Adverse drug reactions resulted in withdrawal of 4 subjects from the MTX + SSZ group and 1 from the control groups. Four and three subjects in the combined and MTX groups respectively were lost to follow-up. Subjects in both groups showed significant decline in all indices except hemoglobin and neutrophil count. The differences between the two groups in the pre-treatment and post-treatment values were insignificant. Complete, marked, minor and no improvement occurred in 4 (21%), 12 (63%), 3 (16%) & 0 in the MTX and in 11 (48%), 7 (30%), 4 (17%) & 1 (4%) in MTX + SSZ groups respectively. The differences in the rates of complete and clinically important improvement between the two groups were insignificant (P 0.1398 and 0.7092). The incidence of side effects was insignificantly higher in the MTX + SSZ group. Most of them were mild and transient. The combination of SAARDs offered little added advantage in RA. However, the higher rate of complete improvement in the combination group justifies trials including larger samples.

Efficacy of methotrexate in rheumatoid arthritis.

Rheumatoid arthritis is a common inflammatory articular disorder in Bangladesh. Methotrexate has proved to be an effective and relatively safe disease modifying drug for this disease. A quasiexperimental trial of the efficacy of methotrexate in rheumatoid arthritis was carried out in the Rheumatology Clinic, Institute of Postgraduate Medicine & Research, Dhaka during the period between July 1992 and September 1993. Thirty eight patients fulfilling the revised ARA criteria were given methotrexate in a total weekly dose of 7.5 to 15 mg. They were followed up at weekly intervals for one month and then monthly for a total duration of six months. Twenty three subjects eventually completed the trial. The trial showed significant differences in the disease activity indices at the end of six months. The decline of activity was noted at the end of one month. As a whole the response was complete in 4(17%), marked in 14(61%), moderate in 4(17%) and nil in 1(4%). Adverse effects occurred in 27 subjects. They were mild and transient in 22. Methotrexate appeared to be an acceptable DMARD for our rheumatoid arthritis population.

Value of clinical features in the diagnosis of enteric fever.

There is no objective data on the value of individual clinical symptoms or signs in the diagnosis of enteric fever in a febrile patient. The purpose of the study was to assess the value of some clinical and simple laboratory features in the diagnosis of enteric fever. One hundred & six patients with microbiologically confirmed enteric fever and 170 patients with other established febrile illnesses were included in the evaluation. History of stepladder pattern of rise of temperature, loose motions, relative bradycardia and coated tongue proved to be powerful markers of enteric fever with high specificity (100%, 94.71%, 94.71%, 94.12% respectively), positive and negative predictive values. Headache, hepatomegaly and splenomegaly were moderately powerful. ESR and WBC count appeared to have little value in the diagnosis of enteric fever. Pattern of onset and loose motions did not discriminate between typhoid and paratyphoid fever. Most of these patients had illness persisting beyond one week by which viral infections and infectious enterocolitides were largely excluded. Elucidation of power of these markers in distinguishing enteric fever from other febrile illnesses with the help of better designed prospective studies would lessen our dependence on expensive and time consuming laboratory investigations.

Etiology and clinical profile of hepatocellular carcinoma in Bangladesh.

Sixty-four consecutive subjects with hepatocellular carcinoma were prospectively studied in the department of Hepatology, IPGMR, Dhaka. Their mean age was 50.11 years. Fifty-two were male and 12 female. Cirrhosis was present in 12 (18.75%) subjects. Thirty subjects (46.88%) had HBsAg in their sera. Seven (58.33% of females) patients gave history of use of oral contraceptives. Cirrhosis, HBV infection, male sex, middle age, and probably the use of oral contraceptives in females appeared to be important risk factors for development of HCC in Bangladesh. Majority of patients presented with upper abdominal pain, weight loss and anorexia. Hepatomegaly was invariably present. Alpha fetoprotein was significantly higher in cirrhotic HCC patients than in non-cirrhotic ones. Median survival was two months. None of the clinical or laboratory features predicted the prognosis.

Predictors of duodenal ulcer healing in sucralfate treated patients.

The objective of the study was to assess the efficacy of sucralfate in promoting duodenal ulcer healing and to assess the value of some variables in predicting outcome of such therapy. Following variables were tested for predicting the outcome: age at onset, age at presentation, duration of symptoms, sex, periodicity, smoking, nocturnal pain, relief by food, relief by antacid, gastric stasis like symptoms, associated irritable bowel syndrome, site, size and number of ulcers and degree of deformity of bulb. Sixty patients with uncomplicated DU confirmed at endoscopy were treated with sucralfate one gram before three major meals and 1 g at bedtime for two months. Endoscopy was repeated at the end of the trial. There were four drop-outs. Complete, partial and no healing occurred in 45 (80.36)%, 3 (5.36%) and 8 (14.28%) subjects. Ulcer healing rate was higher in those without gross bulbar deformity (41/46) than in those with gross deformity (4/10), (Odd's ratio 12.3, 95% ci 1.98 to 78.44). Other variables were not found to be associated with ulcer healing.

A study of prolonged pyrexia in Dhaka.

In a prospective study conducted in the Institute of Postgraduate Medicine & Research (IPGMR), Dhaka, 212 patients with prolonged pyrexia were thoroughly evaluated clinically and with the help of laboratory investigations with a view to reaching the diagnosis. Their clinical and laboratory data were recorded. Clinical features pertaining to a particular organ gave appropriate clue in 52% cases. Imaging techniques were instrumental in 24%, microbiological or serological investigations in 35%, invasive procedures were diagnostic in 42%, laparotomy had to be resorted to in five cases. Infectious diseases were the commonest causes of prolonged pyrexia accounting for about 63.21% of cases followed by neoplasms (12.74%) and connective tissue disorders (10.85%). Tuberculosis was the most common infection (24.53% of all cases) followed by enteric fever (12.74%) and visceral leishmaniasis (9.43%). Pleura was the commonest seat for tuberculosis followed by lymph nodes and abdomen. Leukemias were the commonest neoplasm and SLE the commonest connective tissue disorder presenting with prolonged fever. Several fundamental observations were made in the study. Infections are the commonest cause of prolonged fever in our community, neoplasms and connective tissue disorders are also not rare. Secondly, patients with temperature between 100 to 101 degrees F should not be denied evaluation with the apprehension of unnecessarily investigating for habitual hyperthermia, as the condition was distinctly rare in the series. Thirdly, analysis of materials from organs or systems suspected to be abnormal clinically or by simple imaging techniques had high diagnostic yield. Finally, usual causes of prolonged fever are illnesses ordinarily encountered in clinical practice, pyrexia becomes protracted either because the presentation is atypical or incomplete, or because we fail to make proper use of available clinical or paraclinical information.

Solitary thyroid nodule: a study of 100 cases.

One hundred cases of solitary thyroid nodules attending the thyroid clinic, Institute of Postgraduate Medicine & Research, Dhaka (IPGMR) and the Institute of Nuclear Medicine (INM) were included in a prospective study. Thyroid ultrasonography (USG), scintiscanning, radioactive iodine (I131) uptake (RAIU), estimation of serum total T3, T4 & TSH and Fine Needle Aspiration Cytology (FNAC) were performed in all cases. Surgical resection with histopathologic study was performed in selected cases. Extra-nodular part of the thyroid gland was normal in 68 and diffusely enlarged in 32, RAIU was normal in 62, high in 36 and very low in two subjects. Nodules were solid at USG in 67 subjects, cystic in 16 subjects and of mixed consistency in 17 subjects. Goitrous subjects had significantly lower T4 (p < 0.001) and higher T3 (p < 0.01) and TSH (p < 0.001) than non-goitrous ones. Colloid nodule was the commonest pathology occurring in 41 cases, followed by thyroid cysts (26), follicular adenoma (23), adenoma with cystic change (7), subacute thyroiditis (2) and papillary carcinoma (1). Colloid nodules were more common in goitrous subjects which could hint at iodine deficiency as the major cause of such nodules. Hyperfunctioning follicular adenomas occurred exclusively in non-goitrous subjects. Carcinoma appeared to be uncommon in patients with solitary nodules. It gives an opportunity to our physicians to be more conservative in selecting patients with solitary thyroid nodules for surgical treatment.

Sucralfate in the prevention of duodenal ulcer relapse and factors influencing the relapse rate.

Forty three subjects with DU confirmed at endoscopy and healed after eight weeks of sucralfate therapy were subjected to a randomized double-blind controlled trial for six months. Twenty one subjects received sucralfate (1 g one hour before breakfast and dinner). Twenty two subjects received placebo. Symptoms were evaluated every month. The subjects were endoscoped at the end of the trial or earlier in case symptoms recurred. Sucralfate was found to be significantly more effective than placebo (6/21 vs. 17/22, p < 0.005) in preventing DU relapse. Age at presentation, age at onset, duration of illness, sex, periodicity, smoking, gastric stasis like symptoms, associated irritable bowel syndrome, degree of deformity of the bulb and initial presence of duodenitis were the factors examined for their effect upon the relapse. In the placebo group relapsers had significantly shorter mean duration of illness indicating that DU may relapse more frequently in earlier part of its natural course. Other factors did not influence the relapse rate. In the sucralfate group, higher ages at onset and at presentation were associated with significantly higher relapse rate. Sucralfate may be less effective in preventing relapse in elderly and late onset DU patients.

Factors influencing development of bulbar deformity in duodenal ulcer disease.

Sixty subjects were carefully interrogated and repeatedly endoscoped with a view to studying the effect of sucralfate on healing and recurrence of duodenal ulcer disease. Degree of bulbar deformity was noted during each endoscopy. During the trial it appeared that deformity progressed more rapidly in late onset subjects (onset at or above 30 years of age). In eight subjects deformity became gross over a period of three years. Seven of them belonged to the late onset subgroup. Two subject had large ulcers and both belonged to the late onset subgroup, one had rapidly progressive disease. Out of six subjects with multiple ulcers four belonged to the late onset subgroup, two of the later had rapidly progressive disease.

Preliminary experience with continuous ambulatory peritoneal dialysis.

Continuous ambulatory peritoneal dialysis (CAPD) was employed in seven patients of endstage renal failure (ESRF). All the patients had symptom-free ambulant life during CAPD. Blood pressure was well controlled and the haemoglobin level improved significantly. Blood urea and serum creatinine levels were maintained near normal levels. Metabolic acidosis was corrected. Recurrent peritonitis, heavy protein loss and catheter failure were the main complications of CAPD. It appears from these observations that CAPD may be helpful in patients with ESRF.