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PubMed1986

A double-blind placebo-controlled evaluation of fenflumizole in rheumatoid arthritis.

Twenty-eight patients with active classical or definite rheumatoid arthritis were randomly allocated to treatment with fenflumizole 200 mg or 100 mg or placebo daily in a 2-week double-blind placebo-controlled study. Three patients dropped out and 25 patients completed the study. Ten patients received fenflumizole 100 mg daily, 7 patients received fenflumizole 200 mg daily and 8 patients received placebo. Clinical and laboratory assessments before and during the study revealed that in patients treated with fenflumizole, grip strength, morning stiffness and walking time improved significantly. No improvement could be seen in the placebo group. No side effects attributable to fenflumizole were observed during the study.

Adult↗

PubMedDate not supplied

Prevention of oculocardiac reflex (O.C.R) during extraocular muscle surgery.

In the present study the effectiveness of intravenous atropine sulphate which blocks the peripheral muscarinic receptors at the heart and retrobulbar xylocaine hydrochloride which blocks the conduction at ciliary ganglion on the afferent limb of OCR was studied during strabismus surgery. The study was conducted on fifty three patients of either sex having squint of more than ten years duration. The patients were randomly allocated into four groups. No preanaesthetic medication with atropine or retrobulbar block with xylocaine was given in control group of patients. In the second group, only preanaesthetic medication with atropine was given; while in the third group only retrobulbar injection of xylocaine was given five minutes before operation. In the last group both atropine as preanaesthetic medication and xylocaine as retrobulbar block were given. The electrocardiographic recordings were taken before and throughout the operative procedure. It was interesting to note that in the group where atropine and xylocaine were used none of the patients exhibited activation of OCR. Results have been discussed.

Adolescent↗

PubMed1989

A comparison of nonoperative vs. preoperative radiotherapy in rectal carcinoma. A 10-year randomized trial.

From 1978 to 1980, 68 patients with rectal cancer were randomly allocated to either preoperative irradiation plus surgery or surgical treatment without any preoperative measures. The primary aim of the trial was to investigate the 5-year survival rate in both groups; a secondary aim was to analyze the local recurrence rate and finally the anatomopathologic tumoral classification after surgery. All patients were followed at least 8 years. The preoperative irradiation group (Group A) was submitted to 4000 cGy for 4 weeks and surgery was performed 1 week after irradiation. All tumors were classified anatomically and pathologically according to Broders' and Dukes' classifications. The results indicated that there is a significant difference in the five-year survival rates in both groups: group A had a corrected survival rate of 80 percent; group B (nonirradiated) had a corrected survival rate of 80 percent; group B (nonirradiated) had a corrected survival rate of 34.4 percent. The local recurrence rate was 2.9 percent in group A and 23.5 percent in group B. Regarding tumor regression, before radiotherapy 64.6 percent of the tumors were Broders' Grades 3 and 4; after radiotherapy these were reduced to 20.5 percent. As to Dukes' classification, 26.4 percent of the tumors were type C in group A and, in group B, 47 percent were considered as Dukes' C.

Adenocarcinoma↗

PubMed1979

Comparison of photochemotherapy and dithranol in the treatment of chronic plaque psoriasis.

A two-centre trial has been carried out on 224 patients with chronic plaque psoriasis randomly allocated to treatment with a standard dithranol regimen of 8-methoxypsoralen and long-wave ultraviolet light (P.U.V.A.). Lesions in 91% of the 113 in the P.U.V.A. group cleared satisfactorily compared with 82% of 111 in the dithranol group, but clearing took longer (34.4 +/- 1.8 S.E. days) with P.U.V.A. than with dithranol (20.4 +/- 0.9 S.E. days). P.U.V.A. treatment took less patient-time and nurse-time and was more convenient and acceptable to the patients. Patients in whom lesions had failed to clear with dithranol, and some who had needed methotrexate for control, responded satisfactorily to P.U.V.A. A few patients who had failed on P.U.V.A. were treated with dithranol and responded to it. There is a case for the use of P.U.V.A. for patients who would otherwise require methotrexate and those who cannot be managed successfully with dithranol. There is also no reason to withhold P.U.V.A. in patients of 60 years or above with chronic plaque psoriasis. However, despite its superiority in terms of cost and patient acceptability, P.U.V.A. cannot be recommended as the first line of treatment for patients with uncomplicated, dithranol-responsive plaque psoriasis until there is more information on relapse-rate and toxicity.

Administration, Oral↗

PubMed1988

Double-blind comparison of transdermal scopolamine, droperidol and placebo against postoperative nausea and vomiting.

Since transdermal scopolamine (TS) seems effective against seasickness, we compared its antiemetic effect with intravenous droperidol (DHBP), our routine antidote for postoperative emesis. Ninety-six female patients (ASA I-II) scheduled for short-stay surgery were randomly allocated to three study groups after giving their informed consent. The three groups were as follows: TS adhesive, delivering 140 micrograms initially and 5 micrograms/h thereafter + placebo 0.5 ml i.v. 5 min before the end of surgery; transdermal placebo adhesive preoperatively + DHBP 0.5 ml (1.25 mg) i.v. 5 min before the end of surgery; transdermal placebo + 0.5 ml placebo i.v. as indicated above. Oxycodone i.m. and glycopyrrolate i.v. were given for premedication together with the test adhesive. Anaesthesia was induced with thiopental and maintained with nitrous oxide and oxygen, enflurane, vecuronium and fentanyl. Neostigmine and glycopyrrolate were administered for reversal. In the recovery room no differences in nausea or vomiting were observed between the groups. Sedation was significantly more marked (P less than 0.15-0.0001) after DHBP than after either TS or the given DHBP and 6% of those given the placebo (P less than 0.05). During the following 24 h nausea was reported more by the placebo patients (25) than by those on TS (20) or DHBP (15) (P less than 0.05). However, actual vomiting on the ward did not differ between the groups. Visual disturbances were more frequent after TS (P less than 0.01). We conclude that prophylactic transdermal scopolamine does not diminish postoperative emetic sequelae.

Administration, Cutaneous↗

PubMed1985

Prophylactic antimicrobials in elective colorectal and biliary surgery.

In 97 patients undergoing elective biliary (44) or colorectal (53) surgery, cases were randomly allocated to receive peri-operative prophylaxis with either cefoxitin (Mefoxin; MSD) or metronidazole, penicillin and tobramycin (MPT). Sepsis occurred in 3 of the biliary cases (6,8%) and in 16 of the colorectal cases (30,2%). In the colorectal group sepsis occurred equally in patients receiving cefoxitin (22,2%) or MPT (38,5%) (P = 0,20). Patients who developed sepsis did not have a prolonged hospital stay; strict criteria were used to define sepsis in this study and this explains the apparently high sepsis rate. A positive wound culture at the end of the operation was more common after colorectal surgery (30,2%) than after biliary surgery (4,6%) and was associated with a higher subsequent infection rate (P = 0,02).

Aged↗

PubMed1989

[Evaluation of cicletanine efficiency and tolerance in hypertensive patients treated with beta-blockaders].

Efficacy and tolerance of cicletanine, the first derivative of furopyridines have been studied in a 3 parallel groups double blind study; 120 essential mild hypertensive patients uncontrolled by beta blocking therapy were included. After a period of one month during which a treatment by placebo was added to beta blocking therapy, the patients were randomly allocated into 3 groups: group I (placebo: 40 patients), group II (cicletanine 50 mg/d: 41 patients), group III (cicletanine 100 mg/d: 39 patients). Eight patients were withdrawn in the group I (poor efficacy, n = 5 or unexpected event, n = 3), and one in the group III (unexpected event). At the beginning of the treatment period (DO), lying blood pressure (LBP) was respectively for groups I, II and III 171 +/- 14/104 +/- 6, 174 +/- 13/104 +/- 5, 172 +/- 15/105 +/- 6 mmHg. 171 +/- 14/104 +/- 6, 174 +/- 13/104 +/- 5, 172 +/- 15/105 +/- 6 mmHg. After 3 months of treatment LBP was respectively 168 +/- 21/97 +/- 10, 151 +/- 12/85 +/- 7, 147 +/- 14/82 +/- 9 mmHg. A significant treatment effect (p less than 0.001) was observed on SBP with groups II and III only, and on DBP with the 3 groups. This lowering effect was comparable in groups II and III, and greater (p less than 0.001) in these groups than in group I. At the end of this study the percentage of patients whose BP was normalized was respectively for groups I, II and III: 5 p. 100, 51 p. 100 and 74 p. 100. Clinical and biological tolerance were good.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗

PubMed1986

Effectiveness of defibrotide for prophylaxis of deep venous thrombosis in gynecological surgery: a double-blind, placebo-controlled clinical trial.

Defibrotide, a new antithrombotic compound without anticoagulant activity, has been tested for prevention of deep venous thrombosis (DVT) in patients undergoing gynecological surgery (mainly hysterectomy). Eighty-nine women (mean age 48.5) were randomly allocated to defibrotide (44 patients) or placebo (45 patients). 800 mg defibrotide was given daily (200 mg intravenously 4 times a day), starting on the day before operation and then for the next 7 days. DVT were detected by the conventional 125I-fibrinogen test. The two groups were homogeneous for known risk factors (age, varicosities, obesity, neoplasia and previous thromboembolic episodes). The results showed a statistically significant reduction of DVT incidence in patients on defibrotide, as compared with those on placebo: 4/44 = 9% vs. 13/45 = 28.8% (p less than 0.05). There were no side effects, including hemorrhagic complications. The numbers of units transfused were comparable for the 2 groups. In conclusion, the trial shows that defibrotide is an effective and safe drug for the prevention of DVT in gynecological surgery.

Double-Blind Method↗

PubMed2005

[Experimental study on the prevention and treatment of radiation lung injury by blood-activating and stasis-dissipating drugs].

OBJECTIVE: To observe the pathological changes and the expression of tumor necrosis factor alpha (TNF-alpha) and transforming growth factor beta (TGF-beta) in lung tissue of rats with radiation injury for exploring the mechanism of blood-activating and stasis-dissipating drugs in radiation injury prevention and treatment. METHODS: One hundred and thirty SD female rats were randomly allocated into the simple irradiation group (n=60), the TCM herbs treatment group (n=60) and the blank control group (n=10). The right lung of all rats except those in the blank control group were irradiated by linear accelerator, 3 Gy each time, twice weekly, the maximum accumulated dose being 30 Gy. Ten rats in the two groups were randomly sacrificed at each of the 6 time points (1, 3, 5, 8, 12 and 26 weeks after repeated irradiation), their lung was harvested out, sliced and dyed with HE stain. The histological changes, levels of TNF-alpha and TGF-beta expression in the lung tissue were then observed by immunohistochemical technique. RESULTS: The most serious acute radiation pneumonia was seen in the 5th week and pulmonary fibrosis was remarkable in the 26th week in the simple irradiation group, with the expressions of TNF-alpha and TGF-beta at different time phases enhanced significantly (P < 0.01). While in the TCM herbs treatment group, the pneumonia was milder, pulmonary fibrosis in late stage was not so obvious, and the expressions of TNF-alpha and TGF-beta significantly lower than those in the simple irradiation group (P < 0.01). CONCLUSION: Blood-activating and stasis-dissipating drugs can inhibit expression of inflammation-inducing factors and fibrosis-inducing factors to lessen the inflammatory reaction of early radiation pneumonia, prolong the progression of radiation lung fibrosis, showing preventive and treating action on radiation lung injury.

Animals↗

PubMed1990

A comparative study of three oral contraceptives in Ibadan: Norinyl 1/35, Lo-Ovral and Noriday 1/50.

A study of three combined oral contraceptives, Norinyl 1/35, Lo-Ovral and Noriday 1/50, was conducted at the University of Ibadan Teaching Hospital, Ibadan, Nigeria, to determine if there were differences in continuation rates and reasons for discontinuation. This report includes analysis of 150 women, all of whom were interval patients, randomly allocated to one of the above oral contraceptives between May 1984 and February 1985. Follow-up visits were scheduled at 1, 4 and 8 months after admission. Significantly more women in the Norinyl 1/35 group (P less than 0.05) reported intermenstrual bleeding, as well as an increase in the occurrence of intermenstrual bleeding compared to women in the Lo-Ovral group. There were no other differences between the groups for side-effects. The continuation rates at 8 months were 90.8% for the Norinyl 1/35 group, 94.4% for the Lo-Ovral group and 87.1% for the Noriday 1/50 group. The corresponding rates for those lost to follow-up were 26.0, 40.8 and 17.7. The rate for total discontinuations (all discontinuations including women lost to follow-up) was 34.0% for the Norinyl 1/35 group, 44.9% for the Lo-Ovral group and 29.4% for the Noriday 1/50 group. There was a significant difference in lost to follow-up rates between the Lo-Ovral group and the Noriday 1/50 group (P less than 0.05). There were no other significant differences between the groups for life table rates (P greater than 0.05). There were no pregnancies reported during the study period.

Adult↗

PubMed2004

A comparison of methods to obtain active parental consent for an international student survey.

Many school-based research efforts require active parental consent for student participation. Maximizing rates of consent form return and agreement is an important issue, because sample representativeness may be compromised when these rates are low. This article compares two methods for obtaining active parental consent: return of consent forms in the mail versus return by students to their classrooms. The methods were tested in a pilot study of 46 schools (1,058 students), with half of the schools randomly allocated to each of the alternative methods. A hierarchical nonlinear model of consent form return and agreement rates suggests that the student-delivered method is more successful at producing higher rates of consent form return and agreement to participate in the study, after controlling for school-level characteristics. The authors discuss the findings and their implications for other researchers engaged in school-based research with adolescents.

Adolescent↗

PubMed1988

[Prolongation of spinal anesthesia with hyperbaric bupivacaine by adrenaline and clonidine in the elderly].

So as to determine the effects of vasoconstriction on the duration of hyperbaric bupivacaine spinal anaesthesia, a prospective controlled study was carried out on 80 ASA class II or III patients, aged 75 years or more, who were scheduled for spinal anaesthesia for lower limb surgery. They were randomly allocated to four groups, and were each given 3 ml (15 mg) of 0.5% bupivacaine in plain solution with 0.5 ml of 30% dextrose solution, together with 1 ml normal saline in group I, 0.15 mg clonidine in group II, 0.2 mg adrenaline in group III, and 0.4 mg adrenaline in group IV. All patients therefore received 4.5 ml of 0.33% bupivacaine solution in 3.3% dextrose solution. The injection was made in the lateral position, and the patients turned supine immediately afterwards. The segmental level of sensory loss was tested using forceps. The time course required for maximal spread of the sensory blockade did not differ in the four groups. No difference was observed between median highest levels of sensory analgesia. Adding 0.15 mg clonidine or 0.4 mg adrenaline significantly prolonged mean times for two- and four-segment regression and mean times for regression to L2 level. The addition of 0.2 mg adrenaline only prolonged the mean regression time to L2 level. Regression times tended to increase more with 0.4 mg than with 0.2 mg adrenaline. Significant prolongation of motor block was also associated with the addition of vasoconstrictors. It is concluded that addition of 0.15 mg clonidine or 0.4 mg adrenaline may be useful to increase duration of hyperbaric bupivacaine spinal anaesthesia in elderly patients.

Aged↗

PubMed1985

Trial of relaxation in reducing coronary risk: four year follow up.

On screening 192 men and women aged 35-64 were identified as having two or more of the following risk factors: blood pressure greater than or equal to 140/90 mm Hg, plasma cholesterol concentration greater than or equal to 6.3 mmol/l (243.6 mg/100 ml), and current smoking habit greater than or equal to 10 cigarettes a day. They were randomly allocated to a group for modification of behaviour or to serve as controls. Both groups were given health education leaflets containing advice to stop smoking, to reduce animal fats in the diet, and on the importance of reducing blood pressure. In addition, the treatment group had group sessions of one hour a week for eight weeks in which they were taught breathing exercises, relaxation, and meditation and about managing stress. It had previously been found that after eight weeks and eight months there was a significantly greater reduction in both systolic and diastolic blood pressures in the group taught to relax compared with the control group. After four years of follow up these differences in blood pressure were maintained. Plasma cholesterol concentration and the number of cigarettes smoked were lower in the treatment group at eight weeks and eight months but not at the four year follow up. At four years more subjects in the control group reported having had angina and treatment for hypertension and its complications. Incidence of ischaemic heart disease, fatal myocardial infarction, or electrocardiographic evidence of ischaemia was significantly greater in the control group. If the results of this study could be obtained in a larger study the financial and health care implications would be enormous.

Adult↗

PubMed1983

Reality orientation therapy--a controlled trial.

Sixty long-stay patients who were demented or withdrawn or both were randomly allocated to reality orientation or diversional occupational therapy and were assessed blind on two scales. Owing to a high drop-out rate only 19 organic and 19 functional patients satisfied reasonable criteria for inclusion in the analyses. Those treated by reality orientation therapy fared better than the controls but not significantly so. Initial test scores were no guide to outcome. The results suggested that both organic and functional patients benefited cognitively, but hardly at all behaviourally, from both types of treatment.

Adult↗

PubMed1988

Ethanolamine oleate versus absolute alcohol as a variceal sclerosant: a prospective, randomized, controlled trial.

Forty-seven patients with esophageal variceal bleeding were randomly allocated to undergo sclerotherapy on a 3 weekly schedule with either 5% ethanolamine oleate (23 patients) or absolute alcohol (24 patients), in an attempt to compare the efficacy and safety of the two sclerosants. Sclerotherapy with absolute alcohol eradicated esophageal varices significantly earlier compared with ethanolamine oleate (12.9 +/- 5.2 vs 22.3 +/- 8.2 wk, respectively, p less than 0.001). The mean number of injection courses and the mean amount of sclerosant required for variceal obliteration was also significantly (p less than 0.001) less in the alcohol-injected group. Although the total number of rebleeding episodes were significantly (p less than 0.05) less in the alcohol-injected group, the frequency of rebleeding was not significantly different between the two groups (20.8% vs 30.4%, respectively, p greater than 0.05). Two (8.1%) patients died due to rebleeding in the ethanolamine-injected group, whereas in the alcohol group, none died. There was no significant difference in the frequency of complications with the two sclerosants. Besides the relative ease of rapid injection due to its aqueous nature, alcohol is readily available and relatively economical (total cost of sclerosant per patient; alcohol US $0.50, ethanolamine US $60). In conclusion, absolute alcohol appears to be a useful alternative to 5% ethanolamine oleate as a variceal sclerosant.

Adult↗

PubMed1986

Clinical pharmacology of tritoqualine: a comparative study against dexchlorpheniramine in allergic rhinitis.

The effect of tritoqualine on seasonal allergic rhinitis caused by grass pollen was compared to that of dexchlorpheniramine maleate (DCPM) in 21 patients randomly allocated into two parallel groups. There were rapid improvements of all symptoms considered after treatment with either tritoqualine or DCPM. A significant reduction of plasma histamine concentrations was observed during the treatment with tritoqualine whereas no modification occurred with DCPM. Finally, it was shown that tritoqualine did not modify reaction times to visual and auditive stimuli whereas DCPM induced a significant slowing-down of the reaction time to visual stimuli. From this pilot study tritoqualine appears to have the same efficacy for the treatment of seasonal allergic rhinitis as classic anti-H1 antihistamines, but without central nervous system side-effects.

Adolescent↗

PubMed1988

A prospective randomized study comparing the effects of large and small volumes of the sclerosant 5% ethanolamine oleate injected into esophageal varices.

The safety efficacy and complications of injections of large and small volumes of 5% ethanolamine oleate (EO) were examined prospectively in the sclerotherapy of esophageal varices in 39 consecutive cirrhotic patients. Twenty patients were randomly allocated to the large-volume group (LVG) injected with up to 30 ml per session, and 19 to the small-volume group (SVG) injected with up to 15 ml per session. The two groups were comparable with regard to age, etiology and severity of liver disease. Post-injection bleeding occurred in 15.8% (3/19) after 1-3 sessions in the SVG and in 0% in the LVG. The LVG showed a significantly higher rate of decrease in variceal size (95.0% vs 53.2%, p less than 0.05) and disappearance of red color signs (RCS) on the variceal surface (95.0% vs 52.6%, p less than 0.01) one week after the initial session. The treatment period and number of sessions of endoscopic injection sclerotherapy (EIS) for eradication of varices were significantly (p less than 0.01) smaller in LVG than in SVG (LVG: 2.7 +/- 0.6 sessions over 4.2 +/- 0.7 weeks vs SVG: 5.4 +/- 0.9 sessions over 6.0 +/- 1.6 weeks). There were no life-threatening complications, and the incidence of minor complications did not differ between the two groups. The persistence of RCS and the occurrence of post-injection bleeding may imply that esophageal varices are not always completely obliterated despite 1-3 sessions in the SVG. We conclude that the large volume of EO is superior to the small volume for repeated EIS to eradicate esophageal varices.

Adult↗

PubMed1983

The Göteborg metoprolol trial. Effects on mortality and morbidity in acute myocardial infarction.

In the Göteborg Metoprolol Trial, 1395 patients with suspected acute myocardial infarction were, on admission, randomly allocated to double-blind treatment, 697 to placebo and 698 to metoprolol (15 mg i.v. + 200 mg/day) for 90 days. During this period, there were 62 deaths in the placebo group (8.9%) and 40 in the metoprolol group (5.7%), a mortality reduction of 36% (p less than 0.03). This effect persisted regardless of age, previous infarction or previous chronic beta blockade. All deaths were classified as cardiovascular. After 3 months, all patients were recommended open treatment with metoprolol, and the difference in mortality between the two groups was maintained after 1 year. Early institution of metoprolol (within 12 hours) influenced infarct development during the first 3 days (infarct diagnosis and indirect measures of infarct size). Metoprolol also reduced the incidence on fatal and nonfatal infarction during the next 4-90 days by 35%. Furthermore, fewer episodes of ventricular fibrillation were recorded in the metoprolol than in the placebo group (six vs 17 patients). The tolerance was judged to be very good. The same percentage of patients (19%) was withdrawn from the blind treatment in the two groups. Fewer patients in the metoprolol group used lidocaine, furosemide and analgesics. We conclude that metoprolol therapy instituted on admission in patients with suspected acute myocardial infarction reduced 3-month mortality and exerted beneficial clinical effects.

Adult↗