Double-blind comparison of the safety and efficacy of famotidine with ranitidine in patients with endoscopically diagnosed peptic ulcer.

In a double-blind randomised trial, 40 patients with active gastric or duodenal ulcer were treated with a single nocturnal dose of famotidine 40 mg or ranitidine 300 mg for 4 to 8 weeks. Antacid tablets were allowed as additional treatment, only if needed, for pain relief. Endoscopy was repeated after 4 weeks, and if the ulcer had not healed at 6 and/or 8 weeks. Relief of upper gastro intestinal symptoms with which the patient presented and the number of antacid tablets consumed, if any, were recorded on weekly basis. Two patients in famotidine group and 5 patients in ranitidine group did not complete the therapy and were considered dropouts. At the end of therapy, ulcers in 100% of the patients receiving famotidine & 93% of patients receiving ranitidine were healed. This difference was not statistically significant. Relief from ulcer related symptoms was rapid in both the groups. None of the patients in either group reported side effects. Overall opinion of investigator was comparable for both the treatments; however, significantly (P = 0.0334) larger proportion (100%) of patients from famotidine group rated it as an excellent therapy compared to only 73% from ranitidine group. Famotidine provides excellent healing of ulcers and early relief of upper gastrointestinal symptoms in Indian patients with peptic ulcer.

Double-blind clinical trial of nefopam in comparison with pentazocine in surgical patients.

A double-blind clinical study comparing a new non-narcotic analgesic, nefopam, with pentazocine was carried out on 50 Indian patients. Forty patients had undergone surgical procedures, and the remaining 10 had musculoskeletal or traumatic disorders. There were 25 patients in each group. It was observed that both drugs were capable of relieving post-surgical pain which was either very severe (score 4) or severe (score 3). Their efficacy was comparable. In patients who had an initial pain score of 4, a significant (p less than 0.05) fall in the sum of pain intensity scores (SPIS) occurred in two days. For an initial pain score of 3, a correspondingly significant fall in SPIS took three days. These results were statistically significant (p less than 0.01). Nefopam had a significantly better side effect profile than pentazocine. In the nefopam group, 4/25 patients had side effects, as opposed to 10/25 in the pentazocine group (p less than 0.05, Fisher's exact probability test). It was also noted that the incidence of side effects was greater in the pentazocine group (61) than the nefopam group (22), the difference being statistically highly significant (p less than 0.001, chi 2-test). A few patients (score 4) in both groups required additional morphine as relief analgesic on the first day of therapy. Thus the non-narcotic nefopam is equally effective as the narcotic pentazocine and has less side effects.

Phase IV evaluation of piroxicam in acute and chronic painful inflammatory disorders: an Indian study.

We report the first phase-IV computerized study on Piroxicam in Indian patients. Comprehensive subject record sheets were distributed to 1,000 doctors. Piroxicam at 20 mg/day was given to patients categorized as suffering from rheumatoid arthritis (RA), osteoarthritis (OA), cervical spondylitis (CS), ankylosing spondylosis (AS), soft-tissue & other pains (ST) for up to 12 weeks. Assessments of pain, tenderness, swelling, range of movements, morning stiffness as well as the grip test and walking test, were made at 24 and 72 h, and 1, 4 and 8 weeks after therapy. All side-effects were noted. Data entry and statistical analysis (95% confidence interval) for proportions expressed as percentages) were handled by computer. A total of 174 doctors (17.4%) co-operated by giving data for 844 patients, consisting of the following cases: RA (306), OA (253), AS (52), CS (113) and ST (120). Piroxicam was found to be uniformly effective in the above disorders, a favourable response to the treatment being obtained in 82%-96% of the patients. The overall response rates (with 95% confidence interval in brackets) were 93% (91-95%) in pain, 93% (91-95%) in tenderness, 90% (80-93%) in swelling, 90% (87-92%) in range of movements and 86% (83-89%) in morning stiffness. The average duration of therapy ranged from 22 to 42 days. A total of 88 (10.4%) patients reported 224 incidences of side-effects, 91% of them being gastrointestinal, but no patient had ulcer or GI bleeding. In 1.9% of the patients, therapy was stopped due to an adverse reaction.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical trial of captopril (Aceten) in Indian patients with essential hypertension.

ACE inhibitors are not available in India. Response to captopril in comparison with M-dopa was therefore seen in Indian hypertensive patients. A double blind randomized non-crossover study was carried out on 39 adult patients of either sex suffering from essential hypertension. Twenty-five patients included were resistant to earlier drug therapy. The remaining 14 were freshly detected hypertensive patients. Patients received either 150 mg/day captopril (Aceten) or 750 mg/day M-dopa in 3 equally divided doses every day for 30 days. The mean systolic and diastolic blood pressure in captopril (Aceten) group before starting drug therapy was 171 +/- 4.11 (mean +/- SE) and 111 +/- 0.22, respectively. At the end of therapy the systolic blood pressure was 132 +/- 1.86 and diastolic blood pressure was 84 +/- 1.36 mm of mercury. This fall in the blood pressure within the group was statistically highly significant (p less than 0.001). Similarly patients on M-dopa produced statistically highly significant fall in blood pressure (p less than 0.001) at the end of 4 weeks therapy. Initial systolic and diastolic blood pressure in both groups were comparable and, at the end of 2 and 4 weeks therapy, patients on captopril (Aceten) showed greater fall in both systolic (p less than 0.001) and diastolic (p less than 0.005) blood pressure than patients on M-dopa. None of the patients in the trial demonstrated clinically significant changes in the biochemical parameters. Six of nineteen patients on methyl dopa had side effects which are well known to this drug. None in the captopril showed any side effect.(ABSTRACT TRUNCATED AT 250 WORDS)

Comparative evaluation of captopril and methyldopa monotherapy for hypertension: double-blind study in Indians.

A double-blind, parallel-group study was conducted in 41 Indian men and women with hypertension to compare the antihypertensive effects of captopril and methyldopa. Twenty patients received 150 mg of captopril and 21 patients received 750 mg of methyldopa daily. The drugs were administered in three equally divided doses for four weeks. Blood pressure was measured after one, two, and four weeks of therapy. Relevant clinical and biochemical investigations were carried out before and after treatment. Sixteen patients given captopril and 11 given methyldopa responded to therapy. Among the captopril responders, initial mean systolic blood pressure (+/- SE) was 155 +/- 5.0 mmHg and diastolic blood pressure was 105 +/- 2.1 mmHg. These values were reduced to 119 +/- 9.8 and 80 +/- 6.1 mmHg, respectively, after four weeks of therapy. Similarly, among the methyldopa responders, initial mean systolic blood pressure was 180 +/- 7.4 mmHg and diastolic blood pressure was 112 +/- 3.8 mmHg. These values were reduced to 138 +/- 7.0 and 92 +/- 3.8 mmHg, respectively, after four weeks of therapy. The fall in the blood pressure in both groups was highly significant (P less than 0.001). None of the patients in either group had any clinically significant side effects. The results of this study suggest that monotherapy with captopril may be more effective than monotherapy with methyldopa in Indian hypertensives.