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PubMed1988

Two and four mg nicotine chewing gum and group counselling in smoking cessation: an open, randomized, controlled trial with a 22 month follow-up.

The aim of this study was to examine any dose response effect of 2 and 4 mg nicotine gum (Nicorette) as well as the effect of the treatment in relation to a control group. One hundred seventy-two cigarette smokers were randomly allocated to group counselling and 2 mg- (n = 62) or 4 mg- (n = 54) nicotine chewing gum or to an "advice only" control group (n = 56). Six group meetings in a three month period were guided by physicians in groups of 10-12 members. The 4 mg gum was replaced by 2 mg after 4 weeks. The overall chemical verified success rate was significantly higher for the treatment group compared with the control group. The success rate for the gum group was 45.6% after three months versus 7.1% for the control group, 33.3% versus 3.7% after 12 months, and 27.2% versus 5.7% after 22 months, respectively (p less than 0.001). We could not demonstrate any significant dose response effect of 2 and 4 mg nicotine gum. The low dependent smokers had the best outcome. The subgroup of self-reported chronic bronchitis subjects had a significantly lower success rate than their healthy counterparts (p less than 0.002). Neither the p-nicotine level after smoking or chewing gum nor the difference between these two could predict the outcome. The gum p-nicotine after a week was only 37.1% for 2 mg and 64.3% for 4 mg of the corresponding smoking p-nicotine levels. Nicotine compensation was best for the high dependent smokers.

Adolescent↗

PubMed2003

Subdermal progestin implant (Nestorone) in the treatment of endometriosis: clinical response to various doses.

OBJECTIVE: To evaluate the efficacy of three different doses of Nestorone progestin administered by implants for relief of pain, as well as bleeding patterns and symptoms in women with endometriosis. DESIGN: An open clinical study without a control group. PATIENTS: Twenty-one women in whom endometriosis was diagnosed and treated at laparoscopy or at laparotomy. INTERVENTIONS: The patients were randomly allocated to one of three groups receiving a daily dose of either 150 micro g, 200 micro g or 400 micro g Nestorone for two to four implants inserted subcutaneously for 7 months. After removal of the implants the follow-up period was 6 months. Six patients in the 150 micro g group, seven in the 200 micro g group and five in the 400 micro g group completed the study. MEASUREMENTS: Records of bleeding and registered side-effects and endometriosis-related symptoms were kept by the patients. Ovarian status was evaluated by vaginal ultrasonography. Serum concentrations of Nestorone and of lipids were measured. RESULTS: Pelvic pain decreased significantly in response to the treatment in all groups but returned to pretreatment levels during the post-treatment period. Bleeding and spotting was the most common side-effect followed by hypoestrogenic and psychic symptoms, with no significant difference among the groups. No significant changes in the serum levels of total, HDL or LDL cholesterol were found. One patient during the treatment period and four patients during the follow ups underwent surgical procedures. CONCLUSION: All three doses of Nestorone effectively alleviated endometriosis-related pain. While the Nestorone implant provides an interesting option for the treatment of endometriosis-related pain, its role needs to be assessed in comparative trials.

Adult↗

PubMed1981

Controlled trial of biofeedback-aided behavioural methods in reducing mild hypertension.

Employees of a large industry were screened for the presence of coronary risk factors. A total of 204 employees, aged 35-64 years, with two or more such factors (serum cholesterol concentration greater than or equal to 6.3 mmol/l (243.6 mg/100 ml), blood pressure greater than or equal to 140/90 mm Hg, and current cigarette consumption greater than or equal to 10 cigarettes a day) were randomly allocated to a biofeedback group receiving training in relaxation and management of stress or a control group. Both groups received simple health education literature. After eight weeks of training, and again eight months later, the biofeedback group showed a significantly greater fall in systolic and diastolic blood pressures than the control group (p less than 0.001). Plasma renin activity and plasma aldosterone concentration were measured in a subsample at entry to the study and again at eight weeks and eight months; both showed a greater reduction in the biofeedback compared with the control group at eight weeks' follow-up. The greater reduction in blood pressure in the subjects in the biofeedback group compared with the control group (11.0 mm Hg systolic and 8.8 mm Hg diastolic), persisting eight months after the training, suggests that relaxation-based behavioural methods might be offered as a first-time treatment to patients with mild hypertension.

Adult↗

PubMed1989

Plethysmographic confirmation of the beneficial effect of calcium dobesilate in primary varicose veins.

Sixty patients with varicose veins, in the age range 25 to 52 years, entered the trial and were divided by random allocation into 2 equal groups. The first group received calcium dobesilate orally in dosage of 750 mg daily while the second remained untreated. Out of 25 patients who completed the 3-month treatment course, clinical improvement occurred in 19 (76%). Mercury strain gauge plethysmography in those 19 patients showed a statistically significant mean fall in the venous distensibility index, in maximum venous outflow and in the capillary filtration coefficient after the course of calcium dobesilate. The mean erythrocyte sedimentation rate in the 25 patients fell from 40 mm in 1 hour (Westergren) before treatment to 10 mm at the end of the course. In 42% of the patients there was a fall in serum globulin concentration and correction of the albumin/globulin ratio and in 35% there was a slight fall in serum fibrinogen concentration. Possibly calcium dobesilate's known action in lowering blood viscosity contributes to its beneficial effect in varicose veins.

Adult↗

PubMed1983

Intermittent epoprostenol (prostacyclin) infusion in patients with Raynaud's syndrome. A double-blind controlled trial.

Two groups of outpatients (7 in each group) with Raynaud's syndrome, matched for severity of illness, were randomly allocated to receive at weekly intervals for three weeks either a 5 h intravenous infusion of buffer or epoprostenol (prostacyclin, PGI2) in buffer (7.5 ng/kg/min after the first hour). PGI2 reduced the frequency and duration of ischaemic attacks (both p less than 0.01). Hand temperature measurements with a thermocouple were significantly improved at 1 week; 6 weeks after the last infusion hand temperatures had returned to baseline. There was a corresponding loss of clinical response 8-10 weeks after the last infusion.

Clinical Trials as Topic↗

PubMed1986

Trimethoprim and co-trimoxazole: a comparison of their use in respiratory tract infections.

A single blind prospective study was undertaken with 74 patients suffering from acute bronchitis, taken from general practice and one geriatric ward. Half were randomly allocated to treatment with 200 mg trimethoprim twice a day and the other half with 160 mg trimethoprim plus 800 mg sulphamethoxazole twice a day; both therapies were used for 7 days. We found little difference in the clinical or bacteriological responses to the different regimens although the higher concentration of trimethoprim in the single therapy gave a slightly more successful eradication of Haemophilus spp. Resistant bacteria appeared during and after therapy in a few cases but this was a greater problem with the sulphamethoxazole-containing preparation.

Acute Disease↗

PubMed1988

Omeprazole (40 mg) is superior to ranitidine in short-term treatment of ulcerative reflux esophagitis.

The efficacy and safety of omeprazole, 40 mg once daily for four to eight weeks of treatment, were studied in 61 patients with ulcerative reflux esophagitis. A double-blind controlled study design was used, and the patients were randomly allocated to treatment with either omeprazole 40 mg once daily or ranitidine 150 mg twice daily. Endoscopy was performed prior to inclusion into the study, after four weeks and, if unhealed, again after eight weeks. Healing of esophagitis was defined as complete disappearance of all esophageal ulcerations. Symptoms were recorded before entry, after four weeks, and again after eight weeks in unhealed patients. Fifty-one patients were included in the per-protocol analysis at day 29, and 50 patients at day 57. The healing rate after four weeks of treatment was 22 of 26 patients (85%) treated with omeprazole and 10 of 25 patients (40%) treated with ranitidine (P less than 0.001). The corresponding figures after eight weeks were 24 of 25 (96%), and 13 of 25 (52%) (P less than 0.001). These results were confirmed in the intent-to-treat analysis. Patients treated with omeprazole showed a significantly faster and more profound relief in heartburn than patients treated with ranitidine: 85% had no heartburn after four weeks of treatment with omeprazole compared to 24% in patients treated with ranitidine (P = 0.00007). The percentage of patients who were free of all reflux symptoms was significantly greater in the omeprazole-treated group as compared to the ranitidine-treated group (62% and 12% respectively; P = 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1990

[Intubation in otorhinolaryngologic surgery: propofol versus propofol-suxamethonium].

This study was carried out to assess the conditions of intubation in head and neck surgery when using propofol alone or associated with suxamethonium. Sixty patients were randomly allocated in two groups of 30. Group I was given 3 mg.kg-1 propofol and Group II 3 mg.kg-1 propofol immediately followed by 1.5 mg.kg-1 suxamethonium. All patients were premedicated orally with midazolam 0.1 mg.kg-1, 0.5 to 1 mg atropine and 7 to 10 micrograms.kg-1 alfentanil, while a colloidal solute (Plasmion) up to 250-500 ml was infused. One minute after injection of propofol, lidocaine 5% was pulverized on the glottis and intubation performed. The mean time required for intubation was similar in both groups: 128 +/- 10 sec in group I vs 132 +/- 9.7 sec in group II. Thirty-five % of patients had to be considered as difficult to intube but the mean times in these cases were not statistically different: 169 +/- 14 sec in group I vs 175 +/- 13 sec in group II. Opening of the glottis was found to be better in group II than in group I (p less than 0.01) and bucking was more frequent in group I (p less than 0.01). Successful intubation was obtained after one attempt at a similar rate in the two groups. The haemodynamic variations consisted in a significant decrease of systolic blood pressure compared to the initial value but these variations were similar in the two groups at each time (2.3 and 5 min) from induction.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1979

Antibiotic prophylaxis in total hip replacement.

A controlled prospective trial to compare the efficacy of the antibiotics cephaloridine and flucloxacillin in preventing infection after total hip replacement was conducted at three hospitals. The antibiotic regimens began before surgery, cephaloridine being continued for 12 hours and flucloxacillin for 14 days afterwards. Over an 18-month period 297 patients undergoing a total of 310 hip replacements were entered into the trial and randomly allocated to one of the regimens. The follow-up period ranged from one to two and a half years. All operations were performed in conventional operating theatres; at two of the hospitals these were also used by various other surgical disciplines. Four patients developed deep infection, two having received the cephaloridine and two the flucloxacillin regimen. The overall rate of deep infection was therefore 1.3%. Thus three doses of cephaloridine proved to be as effective as a two-week regimen of flucloxacillin. Giving a prophylactic systemic antibiotic reduced the incidence of infection to a level comparable with that obtained in ultra-clean-air operating enclosures.

Aged↗

PubMed1990

Statistical models for evaluating the penetrating ability of endodontic instruments.

An in vitro study was conducted to evaluate the penetrating ability of hand instruments (No. 10 K-file and "Pathfinder") and an automated device with a No. 08 (Canal Finder System) file in 270 extracted curved and narrow molar roots. The roots were randomly allocated to six groups, each one corresponding to a different permutation of the three instruments. The experiment was performed in three sequential stages, and Stages II and III were undertaken only in roots where no apical penetration was achieved in the previous stage(s). Statistical models were designed to fit the resulting clinical data. The No. 08 Canal Finder System and No. 10 K-file proved to be similar in their penetrating ability in Stage I (with estimated probabilities of 71.1% and 68.8%, respectively). The No. 08 Canal Finder was found to be the most efficient in Stage II and especially in Stage III, with a probability of penetration of 20.7%, compared with 9.8% for the "Pathfinder" and 7.4% for the No. 10 K-file.

Dental Pulp Cavity↗

PubMed1987

Hormonal response to captopril pre-treatment during sodium nitroprusside-induced hypotension in man.

To assess the hormonal response to captopril pre-treatment during sodium nitroprusside (SNP) -induced hypotension, 12 patients were studied during a spinal surgical procedure. Haemodynamic data, plasma-renin activity, aldosterone, adrenaline and noradrenaline levels were measured. Patients were randomly allocated to two groups: Group I, control patients; Group II, 3 mg kg-1 captopril pre-treated patients. SNP requirement for the same level (mean arterial pressure (MAP) = 55 mmHg) and duration of hypotension (88.5 +/- 28.7 vs. 95.2 +/- 22.5 min) was significantly lower in Group II than in Group I (16.5 +/- 14.2 mg vs. 39.3 +/- 16.7 mg; P less than 0.05) and a lower SNP infusion rate was required to induce and to maintain hypotension. In Group II patients, MAP remained significantly lower than the control and Group I values for 30 min after SNP withdrawal. Cardiac index (CI) remained stable in both groups. Heart rate was not modified in Group II during hypotension. Plasma-renin activity rose more dramatically in Group II patients than in Group I both during hypotension (13.9 +/- 7.5 vs. 2.8 +/- 0.9 ng ml-1 h-1; P less than 0.05) and after hypotension (23.4 +/- 15.4 vs. 2.2 +/- 0.8 ng ml-1 h-1; P less than 0.05). Plasma catecholamine levels increased in both groups during hypotension and remained raised in captopril patients after SNP withdrawal. It can be concluded that recovery from hypotension may be delayed when using captopril and that sympathoadrenal activity induced by hypotension is not substantially altered by captopril pre-treatment, suggesting that sympathetic blockade might not be the mechanism by which captopril reduces SNP requirement during controlled hypotension for surgical procedure in man.

Adult↗

PubMed1982

[Effect of levamisole in postoperative adjuvant immunochemotherapy of stomach cancer--randomized controlled study of MMC-tegafur combination therapy with or without levamisole. 1].

The effects of levamisole used in combination with Mitomycin C and Tegafur in patients with resectable stomach cancer were investigated in 10 cooperative institutes. The patients were randomly allocated to the treatment with either control or levamisole by envelope method. Levamisole group was treated with Mitomycin C (day 0, 20 mg, day 1, 10 mg, one shot i.v.), Tegafur (600 mg/day, p.o.) and levamisole (150 mg/day, p.o.). Levamisole was administered 3 consecutive days prior to surgery, and 3 consecutive days every fortnight after surgery. The control group was administered Mitomycin C and Tegafur. The both drugs were administered by the same method as above. Two hundred and twenty-two patients were entered in this trial. However, with the exclusion of 67 patients, the eligible patients were 155, consisting of 77 in the control group and 78 in the levamisole group. In stage III patients, the disease-free interval and survival time were significantly prolonged in the levamisole group compared to the control group (generalized Wilcoxon test p less than 0.05). The side effects were observed a little more frequently in the levamisole group. However, there was no significant difference. From this result, it can be considered that levamisole is effective in delaying recurrence and in prolonging survival time of the patients when used in combination with adjuvant chemotherapy after resection of stomach cancer.

Adjuvants, Immunologic↗

PubMed1986

Withdrawal of inhaled corticosteroid under cover of nedocromil sodium.

Patients satisfactorily controlled on both an inhaled corticosteroid and a regularly inhaled bronchodilator were randomly allocated to 12 weeks of treatment with either nedocromil sodium (4 mg q.i.d.) or matching placebo. After 3 weeks of treatment, inhaled steroids were abruptly withdrawn. Severity of asthma deteriorated in both groups but more rapidly in the placebo group (p less than 0.05). Lung function tests showed little between-group difference. Nedocromil sodium had greater efficacy than placebo in the control of asthma in patients requiring an inhaled corticosteroid but abrupt corticosteroid withdrawal is not recommended. However, there are some clinical suggestions of the benefits of the combined use of nedocromil sodium and an inhaled corticosteroid.

Adolescent↗

PubMed1986

Cisplatin and vindesine combination chemotherapy for non-small cell lung cancer: a randomized trial comparing two dosages of cisplatin.

Forty-five patients with advanced non-small cell lung cancer were randomly allocated to receive vindesine (3 mg/m2 every week) plus either high-dose cisplatin (120 mg/m2 every 4 weeks) or low-dose cisplatin (80 mg/m2 every 3 weeks). All patients were previously untreated. The response rate for the high-dose regimen of cisplatin was 39% (9/23) and that for the low-dose regimen of cisplatin was 33% (7/21); the difference was not statistically significant. Only one patient treated with high-dose cisplatin achieved complete response, lasting 6.5 months. The median duration of response was 5.6 months (range, 2.7-7.7) in the high-dose cisplatin group and 6.8 months (range, 1.9-8.9) in the low-dose cisplatin group. The median survival times for the 23 patients treated with the high-dose regimen of cisplatin and for the 21 patients treated with the low-dose regimen of cisplatin were 9.0 and 10.8 months, respectively. Significantly more azotemia occurred in the high-dose cisplatin group than in the low-dose cisplatin group (P less than 0.05). Combination chemotherapy with cisplatin and vindesine showed significant antitumor activity in patients with non-small cell lung cancer. However, the high-dose regimen of cisplatin did not result in a significantly better response rate or survival advantage, and was associated with greater toxicity.

Adult↗

PubMed1986

Effects of combined therapy with amiloride and hydrochlorothiazide on plasma and total body potassium, blood pressure, and the renin-angiotensin-aldosterone system in hypertensive patients.

After a run-in period of 8 weeks on a regimen of hydrochlorothiazide (HCT, median dosage 75 mg/day), patients with essential hypertension were randomly allocated to continued hydrochlorothiazide therapy (Group I) or additional treatment with amiloride (Group II, median dosage 15 mg/day, or 5 mg per 25 mg hydrochlorothiazide) for the following 12 weeks. Thereafter all the patients were changed to treatment with a fixed combination tablet containing 5 mg amiloride and 50 mg hydrochlorothiazide (Moduretic), keeping the thiazide dosage unchanged for an additional 12 weeks. In Group I patients there was no change in plasma potassium, total body potassium content or the renin-angiotensin-aldosterone system during the 12 weeks on HCT. When the treatment was changed to Moduretic, significant increases were found of 10% in plasma potassium and 3% in total body potassium content. No important stimulation of the renin-angiotensin-aldosterone system was found. In Group II patients addition of an average of 15 mg amiloride to the hydrochlorothiazide treatment led to significant increases in plasma potassium and total body potassium content of approximately 15% and 4%, respectively. There was also a significant increase in the plasma concentrations of renin, angiotensin II and aldosterone. Reducing the average dose of amiloride to 7.5 mg/day by use of Moduretic did not lead to decrease in plasma potassium or total body potassium content. Plasma concentrations of renin, angiotensin II, and aldosterone were decreased, but the individual changes varied markedly and no significant overall change was found.

Adult↗

PubMed1985

A double-blind group comparative study using the new anti-depressant Org 3770, placebo and diazepam in patients with expected insomnia and anxiety before elective gynaecological surgery.

Two hundred and fifty female patients about to undergo elective gynaecological surgery, were randomly allocated to a single oral dose of either 5, 15, 30 mg Org 3770, placebo, or 10 mg diazepam the evening before operation. Assessment of sleep quality next morning using self-rated questionnaires showed that both Org 3770 and diazepam were significantly better than placebo in enhancing sleep. In addition, a dose-response effect was seen with Org 3770, 15 mg seeming optimal. Assessment of presurgery anxiety, again using self-rated questionnaires, showed that 15 mg Org 3770, and 10 mg diazepam were significantly more effective than placebo at reducing anxiety. None of the medications produced any troublesome side effects nor did they have an effect on blood pressure.

Adult↗

PubMed1988

Cefotaxime plus metronidazole appears more effective than piperacillin in the prevention of postappendicectomy wound sepsis. Preliminary results of a comparative trial.

Metronidazole suppositories have previously been shown to be superior to povidone iodine intraoperative wound spray in reducing postappendicectomy wound sepsis. In subsequent studies metronidazole suppositories and cefotaxime injections reduced the sepsis rate to 9.3%, while the same combination produced a wound sepsis rate of 7.6% compared with 17.2% for cefotaxime alone. In an ongoing study, metronidazole and cefotaxime are now being compared with piperacillin in a single-blind trial. Adult patients undergoing emergency appendicectomy in Nottingham have been included in this study, which has ethical committee approval. When the decision to perform emergency appendicectomy was made, the patient was randomly allocated a numbered pack. This contained either 3 x 1g injections of cefotaxime and 6 x 1g metronidazole suppositories or 3 x 2g injections of piperacillin and 6 placebos. 40 minutes before operation the patient received the first suppository and the remainder every 8 hours. The patient received the first injection of antibiotic by intravenous or intramuscular injection and the remaining doses 8 and 16 hours later. A wound was regarded as infected if pus discharged either spontaneously or on incision. 175 patients have been studied to date. The treatment groups were well matched for age and sex. Seven of the 77 patients in the cefotaxime/metronidazole group (9.1%) compared with 12 of the 76 in the piperacillin group (15.8%) have developed wound infections. This study confirms that the combination of cefotaxime and metronidazole seems to be more effective than piperacillin alone in the reduction of postappendicectomy wound sepsis. Currently cefotaxime plus metronidazole is the therapy of choice.

Administration, Rectal↗

PubMed1985

Abdominal wound closure comparing the proximate stapler with sutures.

Proximate staple closure of transverse and vertical abdominal wounds is compared with suture closure in a prospective, blind, randomized trial. Fifty-seven wounds were randomly allocated to 3/0 Prolene or Proximate staple closure. Each wound was photographed after removal of staples or sutures and again in the sixth postoperative week. The photographic slides were independently assessed by eight observers, who graded the cosmetic result of each wound on a scale from 1 to 10. The cosmetic score in transverse wounds closed with sub-cuticular sutures was better than with staples. Cosmetic scores in vertical wounds were almost equal for staples and sutures. Staple closure was faster than suture closure. Proximate staple closure is considered a suitable and faster method for vertical abdominal wounds.

Abdomen↗