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Biomedical subjects

F A Akbar

Publications and source records attributed to F A Akbar.

14 recordsLinked to original sources

Double-blind comparison of two dosage regimens of misoprostol in the treatment of duodenal ulceration.

A multicenter double-blind study was conducted in 416 patients (306 male, 110 female) with active endoscopically proven duodenal ulcers who were randomly allocated to receive the prostaglandin E1 methyl ester analog (Misoprostol/Cytotec), either in a dose of 400 micrograms twice daily (206 patients) or 200 micrograms four times daily (210 patients). No significant difference in the healing rates between the two groups was observed at four or eight weeks. In patients treated twice daily, the ulcer healing rate at four weeks for the intent-to-treat cohort was 124/205 (60.5%) and for the evaluable cohort was 96/136 (69.1%). In patients treated four times daily, the healing rate was 124/207 (59.9%) for the intent-to-treat cohort and 96/148 (64.9%) for the evaluable cohort. Similarly, the healing rates achieved at eight weeks for the twice- and the four-times-daily dosages in the intent-to-treat cohort were 72.2% and 74.4%, respectively, and for the evaluable cohort were 88.0% and 86.6%, respectively. Significantly more patients receiving misoprostol twice daily were free of ulcer pain after four weeks of treatment than were those receiving misoprostol four times daily, namely, 71.4% as compared with 57.9%, respectively (P = 0.003) and for a median period of 21 as compared with 17 days (P = 0.002). Diarrhea was more common in patients receiving the drug twice daily, (15.5%) than in those treated four times daily (5%) (P = 0.001). Diarrhea, three or more stools daily, was often transient and self-limiting and only necessitated withdrawal from the trial in nine (4.4%) of those treated with misoprostol twice daily and in one patient (0.5%) of those treated four times daily.(ABSTRACT TRUNCATED AT 250 WORDS)

Alprostadil↗

The therapeutic efficacy of misoprostol in peptic ulcer disease.

Misoprostol, a synthetic methyl ester analogue of prostaglandin E1 (PGE1) is both a powerful inhibitor of gastric secretion and is able to protect the gastroduodenal mucosa from damage produced by alcohol, aspirin, naproxen and tolmetin. The results of 12 double-blind, randomized, placebo- and cimetidine-controlled trials involving 4000 patients have been reviewed here and show that misoprostol, given in a dosage of 800 micrograms daily in two or four divided doses, is able to produce rates of complete ulcer healing and pain relief in both gastric and duodenal ulcer which are significantly superior to placebo therapy and comparable to those achieved with high or conventional doses of cimetidine. One further large trial has shown that misoprostol is able to heal a significant proportion of duodenal ulcers refractory to treatment with H2 receptor antagonists. In the compromised patient, two trials have suggested that misoprostol is able to abolish the adverse effects of smoking on duodenal ulcer, although this effect was not apparent in the gastric ulcer trials or in other duodenal ulcer trials. Similarly, while in volunteers pretreatment with misoprostol is able to protect the gastric mucosa from alcohol damage, there is little clinical evidence to support improved ulcer healing in the patient who abuses alcohol. Further studies in these areas should be conducted. Misoprostol could well have an important role to play in the protection of the gastroduodenal mucosa from damage produced by non-steroidal anti-inflammatory drugs (NSAIDs) in arthritic patients compelled to take these drugs for long periods. A series of double-blind placebo-controlled trials in healthy volunteers have shown that pretreatment with, or simultaneous administration of, 800 micrograms daily of misoprostol, reduces significantly mucosal damage produced by aspirin, tolmetin and naproxen. Two controlled clinical trials in a large number of arthritic patients have shown firstly, that misoprostol 800 micrograms daily is able to reduce significantly aspirin-induced mucosal bleeding as compared with placebo and secondly, in an endoscopically, placebo-controlled trial that it reduced significantly the frequency and severity of aspirin-induced mucosal lesions, accelerated the healing of erosions and ulcers and in other patients was able to protect the undamaged mucosa from injury. Misoprostol is well tolerated--a dose related, usually self limiting, diarrhoea occurred in a small proportion of patients but only rarely enforced withdrawal. Because of its uterotropic effects misoprostol should not be given to women of child bearing age unless they are taking adequate contraceptive measures. It has no other systemic effects and no clinically significant adverse haematology or biochemical abnormalities, or drug interactions have been reported. It does not seem to induce hypergastrinaemia. Misoprostol is, therefore, a safe and effective drug in the treatment of chronic peptic ulcer and could have a beneficial action in duodenal ulcers refractory to treatment with H2-receptor antagonists. It could benefit compromised groups of ulcer patients who are smokers or alcohol users amd certainly has been shown to protect the gastroduodenal mucosa against damage induced by NSAIDs in healthy volunteers and arthritic patients.

Alprostadil↗

Misoprostol in peptic ulcer disease.

Misoprostol, a synthetic prostaglandin E1 (PGE1) methyl ester analog has potent antisecretory and cytoprotective effects on the gastric and duodenal mucosa which should make it an effective drug in the treatment of gastric and duodenal ulcer. In two multicenter, randomised, double-blind, controlled studies involving over 900 patients with endoscopically proven benign gastric ulcer and in six similar studies involving over 2000 patients with active duodenal ulcers, differing doses of misoprostol have been compared with either placebo therapy or with conventional doses of cimetidine. In these studies misoprostol 800 mcg daily given as two or four divided doses has been shown to produce rates of complete ulcer healing and pain relief which were significantly superior to placebo therapy and comparable to those achieved with cimetidine. Drug related adverse effects were infrequent. A dose related diarrhea occurred in a small proportion of patients which seldom necessitated suspension of therapy. Because of the known uterotropic effect of prostaglandins the drug should not be used in pregnant women or women of child bearing age unless they are using adequate contraceptive measures. No clinically significant adverse, hematological or biochemical effects have been reported. Two studies suggested that misoprostol reduced the adverse effect of smoking on the healing of duodenal ulcer. In addition, misoprostol has been shown to protect the gastro-duodenal mucosa from the damaging effects of alcohol and non-steroidal anti-inflammatory drugs. This action may prove of value in the treatment of ulcer patients who are inveterate smokers, alcohol users or who are compelled to consume non-steroidal anti-inflammatory drugs for pain relief from rheumatic and allied diseases.

Alprostadil↗

A double-blind, placebo-controlled evaluation of spironolactone in the premenstrual syndrome.

The effect of spironolactone in the alleviation of the symptoms of the premenstrual syndrome was compared with placebo in a double-blind, parallel group controlled study. One tablet daily of 100 mg spironolactone or placebo was given to 63 women from Day 12 of the menstrual cycle until the first day of the next menstrual bleed. This regimen was repeated for two consecutive cycles. Spironolactone was statistically significantly superior in providing relief from bloatedness (p less than 0.001). No statistically significant changes were observed in blood biochemistry of plasma hormone levels of oestradiol, progesterone or prolactin, though an increase in serum aldosterone levels was seen in the spironolactone-treated group. No differences were detected in weight, blood pressure or the incidence and severity of complaints following treatment.

Adult↗

A controlled trial of tiaprofenic acid versus ibuprofen in rheumatoid arthritis.

Tiaprofenic acid, 200 mg three times a day, was compared with ibuprofen, 400 mg three times a day, in 41 patients suffering from rheumatoid arthritis and already receiving nonsteroidal anti-inflammatory drugs in a double-blind controlled study. The degree of disability expressed as functional class was significantly improved on tiaprofenic acid. There were no other significant differences from initial values on either treatment in any other clinical measure of therapeutic efficacy. Side-effects were few and minor and there were no significant differences between the drugs in this respect.

Adult↗

A comparative study of floctafenine (Idarac) and ibuprofen in the treatment of osteoarthrosis.

A two-by-two-week crossover trial was conducted in patients with osteoarthrosis, using a double-dummy technique of drug administration. The drugs used were floctafenine (Idarac) and ibuprofen both given in a dose of 200 mg four times daily. Both drugs provided comparable relief of pain. Side-effects were few and generally mild. The results indicate that in the treatment of osteoarthrosis, floctafenine is comparable to ibuprofen (in the dose used in the study) in terms of efficacy and toxicity.

Aged↗

Floctafenine (Idarac) in the management of rheumatoid arthritis.

A double-blind controlled cross-over trial comparing floctafenine 1.6 g daily with soluble aspirin 4.0 g daily and matching placebo, in 48 patients suffering from rheumatoid arthritis, is reported. Floctafenine and aspirin gave statistically significant reduction in morning stiffness, grip strength and better subjective assessment than the placebo. There was no difference in the relief of pain between the three treatments under the conditions of this trial where paracetamol was allowed as an additional escape analgesic. During the period of aspirin therapy there was a higher indicence of concurrent complaints, faecal occult blood loss and a reduction in haemoglobin. An open long-term study in 12 rheumatoid patients receiving floctafenine 1.6 g daily for 3--6 months showed satisfactory management of their clinical condition. There were no significant or serious side-effects or change in biochemical or haematological parameters, and patients completed their course of therapy.

Analgesics↗

An analgesic comparison of floctafenine (Idarac) and dihydrocodeine in post-operative pain.

A double-blind crossover study comparing floctafenine 200 mg, a new analgesic drug, and dihydrocodeine 60 mg, was performed on 72 patients suffering from post-operative pain. Degree of pain relief by floctafenine was similar to that of dihydrocodeine but the relief afforded by the former was of longer duration. Side-effects associated with dihydrocodeine were statistically higher than those associated with floctafenine. Floctafenine was demonstrated to be an effective analgesic with an insignificant incidence of untoward side-effects.

Adult↗

A comparison of a new analgesic, floctafenine, with dextropropoxyphene and aspirin in post-operative pain..

Seventy-seven patients took part in a double-blind crossover trial to compare the effects of floctafenine, dextropropxyhene and aspirin in the relief of post-operative pain. Pain levels were recorded at hourly intervals and pain relief scores calculated. For Dose 1, the difference between the mean pain relief score for patients receiving floctafenin (12.8) and that for patients receiving dextropropoxyphen (6.2) was significant, (p smaller than 0.05) but the difference between the mean score for aspirin (9.2) and that for dextropropoxyphene was not significant. For Dose 2, there were no significant differences between the mean pain relief scores for floctafenine (12.5), for aspirin (10.9) and for dextropropoxyphene (13.2).

Adult↗