Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “PLACEBOS”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,315 records · Page 73Linked to original sources
PubMed2006

The efficacy of topical cyproterone acetate alcohol lotion versus placebo in the treatment of the mild to moderate acne vulgaris: a double blind study.

Acne is an inflammatory condition of the pilosebaceous unit. One of the essential factors for development of acne lesions is increased sebum excretion that is promoted by androgen. It is shown that oral cyproterone acetate significantly reduces the sebum excretion. In this study we evaluated the efficacy of cyproterone acetate alcohol lotion (CAAL) in the treatment of the mild to moderate acne vulgaris. This was a randomized double-blind clinical trial performed on 86 female patients with mild to moderate acne. They were randomly divided into 3 groups and were treated with 0.5 percent CAAL (n = 30), 1 percent CAAL (n = 13) and placebo (n = 43). They were followed every 15 days for a period of 45 days. Response to treatment was evaluated by the total acne lesions counting (TLC) and acne severity index (ASI) and was analyzed statistically by SPSS program. The efficacy of treatment on TLC was maximum for 1 percent CAAL (90 % reduction in TLC)(P value = 0.000). CAAL at 0.5 percent was able to reduce TLC as high as 80.8 percent during 6 weeks followup. The efficacy of placebo was determined to be 38.5 percent. Regarding TLC, 1 percent CAAL was 2.33 times more effective than placebo. CAAL at 0.5 percent was 2.09 times more effective than placebo in this respect. The efficacy of treatment on ASI was maximum for 1 percent CAAL (88 % reduction in ASI)(P value = 0.000). CAAL at 0.5 percent reduced ASI as much as 79.5 percent during 6 weeks of followup. The efficacy of placebo was calculated to be 9.8 percent in reduction of ASI . Regarding ASI, 1 percent CAAL was 8.97 times more effective than placebo. CAAL at 0.5 percent was 8.06 times more effective than placebo. Regarding the results of this study, we suggest the use of cyproterone acetate alcohol lotion as one of the main treatments for mild-moderate acne in female patients and as an adjuvant treatment for moderate to severe acne vulgaris.

Acne Vulgaris↗
PubMed2006

A prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intraarticular hyaluronic acid for osteoarthritis of the knee.

OBJECTIVE: To assess the efficacy of intraarticular (IA) injections of hyaluronic acid (HA) compared to placebo in patients with osteoarthritis (OA) of the knee; and to assess patient satisfaction with treatment relative to placebo, and whether there is a difference between a series of 3 versus 6 consecutive IA injections. METHODS: We conducted a randomized, double-blind, placebo controlled, 2-arm parallel design trial of 106 patients with radiologically confirmed knee OA. Two-milliliter IA injections using 20 mg/ml HA sodium salt or saline placebo were administered once weekly over 3 weeks (HA and placebo groups), followed by once weekly IA injection with 2.0 ml (20 mg/ml) HA for a further 3 consecutive weeks. The primary efficacy assessment included Western Ontario and McMaster Universities osteoarthritis index (WOMAC) score for knee pain (Week 3 score). Secondary efficacy assessments included WOMAC scores for knee pain at Weeks 6 and 12 (followup), as well as WOMAC stiffness, physical function and quality of life scores, visual analog scale (VAS) scores for pain at rest and following walking and stepping activity, range of knee joint motion, and global patient satisfaction with treatment and quality of life using the SF-36. RESULTS: After 3 weeks of study treatment, both treatment groups showed improvements in knee function, the HA group showing a greater improvement compared to placebo in WOMAC knee pain score (p < 0.01). The HA group showed greater (p < 0.05) improvement in the overall WOMAC score and VAS pain following walking and stepping activity at Week 3. Results from all other secondary efficacy assessments at Weeks 6 and 12 including patient satisfaction were similar and were not statistically significant between treatment groups, and there were no significant differences between groups for adverse events. CONCLUSION: Intraarticular HA was superior to placebo in improving knee pain and function, with no difference between 3 or 6 consecutive injections for the primary efficacy assessment.

Aged↗
PubMed2005

The role of placebo and nocebo effects of perioperative administration of sedatives and opioids in interventional pain management.

BACKGROUND: The role of nonspecific treatment effects in the outcomes of patients receiving interventions for pain has been the subject of controversy and interest. While the administration of placebo and its effects have been widely studied, the role of placebo and nocebo effects of active agents administered prior to or during interventional techniques has not been explored. OBJECTIVES: The evaluation of placebo and nocebo effects of sodium chloride solution and active agents (midazolam and fentanyl) administered during interventional techniques. STUDY DESIGN: Randomized, placebo-controlled, evaluation. METHODS: A total of 360 patients were divided into three groups, with Group I receiving placebo, Group II receiving midazolam, and Group III receiving fentanyl. At 3 months, information was obtained with regards to their impressions or the experience of the study, compared to their previous experiences with the treatment and sedation. They were asked to rate their experience as better, worse, or no change compared to their previous experience. RESULTS: Between 13% to 30% of patients across all three groups of the study, rated their pain relief following injection as better than their previous experience. A smaller proportion, 3% to 8%, of patients in all three groups rated their experience following injection as worse than their previous experience. The majority of patients, 67% to 79%, regardless of group, described no significant differences as compared to their previous experiences with sedation and treatment for cervical or lumbar facet joint pain. CONCLUSION: In patients undergoing interventional procedures, sodium chloride solution, midazolam, and fentanyl produced placebo effects in 13% to 15%, 15% to 20%, and 18% to 30% of the patients respectively. Similarly, a nocebo effect was seen in 5% to 8% of the patients in the sodium chloride group, 8% of the patients in the midazolam group, and 3% to 8% of the patients in the fentanyl group. It is concluded that positive and negative effects may be seen either with placebo or active agents in 13% to 30% of the patients.

Journal Article↗
PubMed2006

A double-blind placebo-controlled randomised pilot study of nocturnal melatonin in tracheostomised patients.

BACKGROUND AND AIM: Patients in the intensive care unit often suffer from lack of sleep at night. We hypothesised that nocturnal melatonin may increase observed nocturnal sleep in tracheostomised patients. DESIGN: Double-blind, randomised, placebo-controlled pilot study. SETTING: ICU of a tertiary hospital. PARTICIPANTS: Thirty-two ICU patients with tracheostomy who were not receiving continuous sedation. METHODS: We administered either oral melatonin (3mg) or placebo at 20:00. We collected pre- and post-dosage blood samples on Days 1 and 3 to confirm drug delivery. Primary outcome measure was number of hours of observed sleep at night, assessed by the bedside nurse. Secondary outcome measures included comparison of the incidence of agitation, assessed by score on the Riker Sedation-Agitation Scale, and requirement for sedatives or haloperidol to settle agitation. RESULTS: Pre-treatment melatonin levels in the two groups were similarly low: 4.8 pg/mL (95% CI, 2.4-7.5) for melatonin versus 2.4 (95% CI, 1.6-3.2) for placebo (P=0.13). Post-treatment, melatonin levels increased significantly in the melatonin group compared with the placebo group (3543 pg/mL versus 3 pg/mL; P<0.0001). However, subsequent observed nocturnal sleep was similar in the two groups: 240 minutes (range, 75-331.3) for melatonin v 243.4 minutes (range, 0-344.1) for placebo (P=0.98). Observed diurnal sleep was also similar: 138.7 minutes (range, 50-230) with melatonin v 104 minutes (range, 0-485) for placebo (P=0.42). The incidence of agitation was non-significantly higher in the melatonin group (31% v 7%; P=0.11), while the requirement for extra sedation or use of haloperidol was slightly higher in the placebo group (57% versus 46%; P=0.56). CONCLUSION: Melatonin is well absorbed, and a standard dose increases blood levels approximately 1000-fold. However, in this pilot assessment, these high levels failed to increase observed nocturnal sleep or induce other observable benefits in tracheostomised ICU patients.

Aged↗
PubMed1991

Iron supplementation during pregnancy. Effect on iron status markers, serum erythropoietin and human placental lactogen. A placebo controlled study in 207 Danish women.

The effect of iron supplementation, 66 mg elemental iron daily, from the 16th week of gestation to delivery, on iron status markers during uncomplicated pregnancies was assessed in a randomised, double-blind, placebo controlled study of 207 healthy women (100 iron treated, 107 placebo treated) and their newborn babies. Haemoglobin (Hb) and serum (S-) human placental lactogen (HPL) were measured in all 207 females, while transferrin saturation, S-ferritin and S-erythropoietin (EPO) were measured in 120 females at monthly intervals. Hb: from 27th week of gestation to eight weeks post partum, the placebo treated group had significantly lower Hb levels than the iron treated group (p less than 0.001). Iron status markers: in the placebo group (n = 57), 92% developed exhausted iron stores (i.e. S-ferritin less than or equal to 20 micrograms/l), 65% latent iron deficiency (i.e. S-ferritin less than or equal to 20 micrograms/l and transferrin saturation less than 15%), and 18% iron deficiency anaemia (i.e. S-ferritin less than or equal to 20 micrograms/l, transferrin saturation less than 15% and Hb less than 110 g/l). In the iron treated group (n = 63), 54% developed exhausted iron stores, 6% latent iron deficiency, and none iron deficiency anaemia. S-EPO: the placebo group had significantly higher values than the iron treated group from the 27th week of gestation to one week post partum (p less than 0.01). S-HPL: levels were identical in placebo and iron treated females. Babies of iron treated mothers had higher S-ferritin than babies of placebo treated mothers (p less than 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1991

Estazolam treatment of insomnia in generalized anxiety disorder: a placebo-controlled study.

Estazolam, a triazolobenzodiazepine with an intermediate elimination half-life, has been shown previously to be an effective and safe hypnotic in insomniacs without concomitant psychiatric illness. Our study of the efficacy of estazolam in patients with insomnia associated with generalized anxiety disorder began when 108 patients meeting criteria for generalized anxiety disorder (mean total score of Hamilton Rating Scale for Anxiety [HAM-A] = 22.0 +/- 3.1 [SD]) and insomnia were given single-blind placebo for 7 nights. Nine patients whose anxiety and/or insomnia improved were dropped as placebo responders. The remaining 99 patients were randomly allocated (1:1) to double-blind treatment with either estazolam 2.0 mg or matching placebo for 7 nights. Hypnotic efficacy, as determined by patient-completed sleep questionnaires, was statistically significant for estazolam 2.0 mg versus placebo for all sleep indices (p less than 0.01). Patients treated with estazolam 2.0 mg showed significantly greater improvement in anxiety than those receiving placebo on the mean total score of HAM-A ([placebo, -3.4; estazolam, -7.1; p less than 0.001] and without the insomnia item [placebo, -2.7; estazolam, -5.5; p less than 0.001]). Anxiety scores on the State-Trait Anxiety Inventory showed greater improvement in the estazolam group, but without statistical significance (p = 0.237). Estazolam 2.0 mg is an effective hypnotic in patients with generalized anxiety disorder and appears to have a favorable anxiolytic action.

Adult↗
PubMed1991

A double-blind, placebo-controlled, 6-day evaluation of two doses of misoprostol in gastroduodenal mucosal protection against damage from aspirin and effect on bowel habits.

Ninety-one normal, healthy volunteers participated in a single-center, double-blind, placebo-controlled, randomized, parallel group study: 1) to compare the prostaglandin E1 analog, misoprostol, given at a dose of 200 micrograms bid, with the recommended dose of 200 micrograms qid in protecting the gastroduodenal mucosa against injury due to anti-inflammatory doses of aspirin (3900 mg/day); and 2) to determine whether the reduced dose was associated with a lesser incidence of gastrointestinal (GI) side effects, particularly diarrhea. All subjects received 975 mg of aspirin qid with meals and at bedtime. They were concurrently administered either misoprostol 200 micrograms qid, misoprostol 200 micrograms bid and placebo bid, or placebo qid. All subjects were endoscopically normal at the onset of the study and were re-endoscoped on the morning of the 7th day of therapy, 2 h after the morning dose of medications. Gastric and duodenal mucosa were assessed separately on a 0-7 scale which gave a greater weight to erosions than to hemorrhages. GI symptoms, especially bowel habits, were assessed by means of diary cards. Subjects in both misoprostol groups had significantly less gastric and duodenal mucosal injury than subjects who received placebo (p less than 0.007 for each pairwise comparison). There was no statistically significant difference between the two misoprostol groups (p less than 0.093). Subjects in the misoprostol 200 micrograms qid group had significantly more loose and watery bowel movements than the subjects in the misoprostol 200 micrograms bid group (p less than 0.013), whereas there were no significant differences in bowel habits between the misoprostol 200 micrograms bid and placebo groups (p less than 0.122). More subjects in the misoprostol 200 micrograms qid group reported abdominal pain, loose stools, watery stools, flatulence, dyspepsia, and nausea than in the misoprostol 200 micrograms bid and placebo groups. In conclusion, the adverse events in the misoprostol 200 micrograms bid group were not significantly different from those in the placebo group, and were significantly better than in the misoprostol 200 micrograms qid group. The lower dose retained mucosal protective activity that was statistically indistinguishable from that of misoprostol 200 micrograms qid.

Adult↗
PubMed1991

Piroxicam 0.5% topical gel compared to placebo in the treatment of acute soft tissue injuries: a double-blind study comparing efficacy and safety.

Piroxicam 0.5% gel, administered as 5 mg q.i.d. was compared to placebo gel in a double-blind study of the treatment of selected acute soft tissue injuries (ankle or acromioclavicular sprains, supraspinatus, or achilles tendinitis). A total of 200 patients (100 per treatment) were evaluated. Six patients (6%) in the piroxicam group discontinued treatment due to inefficacy, compared to 42/100 in the placebo group (p less than 0.001). Significantly greater reduction in pain (spontaneous and on movement), degree of joint restriction, pressure threshold and tenderness of the affected site were observed with piroxicam gel compared to placebo gel. The time to improvement was significantly less with the piroxicam gel. The overall evaluation of efficacy and of benefit to injury favoured piroxicam over placebo (p less than 0.0001). Both piroxicam and placebo gels were well tolerated, with 7 piroxicam and 15 placebo patients reporting primarily skin-related adverse effects. This study indicates that piroxicam 0.5% gel, administered as 5 mg q.i.d. is an effective treatment of musculoskeletal injuries (sprains and tendinitis), is significantly more effective than placebo, and is well tolerated.

Administration, Cutaneous↗
PubMed1991

Vitamin B6 is effective therapy for nausea and vomiting of pregnancy: a randomized, double-blind placebo-controlled study.

Fifty-nine women completed a randomized, double-blind placebo-controlled study of pyridoxine hydrochloride (vitamin B6) for the treatment of nausea and vomiting of pregnancy. Thirty-one patients received vitamin B6, 25-mg tablets orally every 8 hours for 72 hours, and 28 patients received placebo in the same regimen. Patients were categorized according to the presence of vomiting: severe nausea (score greater than 7) or mild to moderate nausea (score of 7 or less). The severity of nausea (as graded on a visual analogue scale of 1-10 cm) and the number of patients with vomiting over a 72-hour period were used to evaluate response to therapy. Twelve of 31 patients in the vitamin B6 group had a pre-treatment nausea score greater than 7 (severe) (mean 8.2 +/- 0.8), as did ten of 28 patients in the placebo group (mean 8.7 +/- 0.9) (not significant). Following therapy, there was a significant difference in the mean "difference in nausea" score (ie, baseline - post-therapy nausea) between patients with severe nausea receiving vitamin B6 (mean 4.3 +/- 2.1) and placebo (mean 1.8 +/- 2.2) (P less than .01). In patients with mild to moderate nausea and in the group as a whole, no significant difference between treatment and placebo was observed. Fifteen of 31 vitamin B6-treated patients had vomiting before therapy, compared with ten of 28 in the placebo group (not significant). At the completion of 3 days of therapy, only eight of 31 patients in the vitamin B6 group had any vomiting, compared with 15 of 28 patients in the placebo group (P less than .05).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1986

[Clinical effectiveness of trimetazidine in stable effort angina. A double-blind versus placebo controlled study].

The antianginal activity of trimetazidine was evaluated in a double-blind, multicentric, drug-versus-placebo study. The 32 male patients who entered the study (mean age 59.5 years) were suffering from stable angina pectoris. The stability of angina was tested by two exercise tests performed at the beginning and at the end of a two-week preselection period with placebo. The patients received 3 tablets daily of either trimetazidine (20 mg per tablet) or placebo for one month. At the end of treatment, they underwent a third exercise test. A Mann and Whitney test, used to compare the result of pre- and post-treatment exercise tests, showed a statistically significant improvement with trimetazidine as compared with the placebo for the following parameters: total work went from 4.200 +/- 372 to 5.620 +/- 387 kpm with trimetazidine and from 4.191 +/- 399 to 4.564 +/- 431 kpm with the placebo (P = 0.012); duration of exercise from 10.2 +/- 0.5 to 12.1 +/- 0.5 min with trimetazidine and from 10.2 +/- 0.5 to 10.7 +/- 0.5 min with the placebo (P = 0.016); time to 1 mm ST segment depression from 8.3 +/- 0.6 to 9.8 +/- 0.5 min with trimetazidine and from 8.4 +/- 0.5 to 9 +/- 0.7 min with the placebo (P = 0.034). These results showed that the ischaemic threshold receded with trimetazidine, while the peripheral haemodynamic parameters were not significantly changed, either at rest or during exercise. Thus, trimetazidine does not act through a chronotropic or vasodilator mechanism but through cellular regulation mechanism.

Adult↗
PubMed1986

[The effects of trimetazidine on ergometric parameters in exercise-induced angina. Controlled multicenter double blind versus placebo study].

The antianginal effect of trimetazidine was assessed by a controlled multicentre double-blind versus placebo trial. The study included 32 males, average age 59.5 years, with stable angina of effort. The stability of angina was determined by two exercise stress tests performed at the beginning and at the end of a 15 day pre-selection period under placebo. The patients included in the trial were given 3 tablets a day of either trimetazidine (20 mg per tablet) or of placebo for one month. At the end of the treatment period the patients underwent a third exercise stress test. Comparing the results of exercise testing before and after treatment by a Mann and Whitney test, a statistically significant improvement with trimetazidine was demonstrated with respect to placebo for three parameters: total work increased from 4200 +/- 372 to 5620 +/- 387 Kpm in the trimetazidine group compared to 4191 +/- 399 to 4564 +/- 431 Kpm for placebo (p = 0.012); the duration of exercise increased from 10.2 +/- 0.5 to 12.1 +/- 0.5 minutes with trimetazidine compared to 10.2 +/- 0.5 to 10.7 +/- 0.5 with placebo (p = 0.016); the period to 1 mm ST depression increased from 8.3 +/- 0.6 to 9.8 +/- 0.5 minutes with trimetazidine compared to 8.4 +/- 0.5 to 9.0 +/- 0.7 minutes with placebo (p = 0.034). These results show that signs of ischaemia are delayed by trimetazidine. There were no significant changes in peripheral haemodynamics at rest or on effort. The antianginal action of trimetazidine seems therefore to be unrelated to a chronotropic or vasomotor effect and could be related to a mechanism of cellular regulation.

Adult↗
PubMed1988

Comparison of the short-acting benzodiazepines midazolam and triazolam with placebo.

The hypnotic effect of midazolam (Dormicum, 15 mg) and triazolam (0.5 mg) were compared with each other and with a placebo. Their effects on the quality of dreams and of morning awaking were also evaluated. 30 out-patients were included in a double-blind cross-over study for a period of 11 consecutive nights in which the order of the drugs was randomized according to the Latin squares method. The active substances and the placebo were each administered in 3-night blocks separated from each other by an intercalary placebo night. On waking each morning the patients answered a questionnaire concerning the previous night. Some of the responses were recorded on a visual analogue scale. Midazolam and triazolam significantly decreased the latency of onset of sleep and the number of nocturnal and premature morning awakenings. The patients' overall impression of their night was better under the active drugs than under placebo. However, there were no differences between placebo and the benzodiazepines as far as side effects or the quality of dreams and of morning awakening were concerned. The two drugs had an identical effect on sleep latency, but under midazolam the patients woke more frequently during the night and slightly earlier in the morning, suggesting that the duration of action is shorter. The intercalary placebo nights were better after 3 nights of placebo than after 3 nights of benzodiazepine. This rebound effect was more marked after triazolam than after midazolam. In conclusion the two benzodiazepines were both effective and well tolerated but midazolam is slightly shorter acting and has slightly less rebound effect than triazolam.

Adult↗
PubMed1987

Acifran: a double-blind, randomized, placebo-controlled efficacy study in type IIa hyperlipoproteinemic patients.

The antihyperlipoproteinemic agent acifran (AY-25,712) was administered double-blind to 14 Type IIa hyperlipoproteinemic patients for 12 weeks in dosages of 100 mg t.i.d. or 300 mg t.i.d. An additional seven patients received placebo. Fasting plasma lipid and lipoprotein concentrations were determined at baseline (mean of 3 values), Week 8 (mean of 6- and 8-Week values), and Week 12 (mean of 10- and 12-Week values). At Week 8, patients receiving acifran 100 mg t.i.d. showed low-density lipoprotein (LDL) cholesterol levels which were 13% lower than pretreatment baseline (p less than 0.01) and 14% lower than patients given placebo (p less than 0.05); high-density lipoprotein (HDL) cholesterol levels were 11% higher compared with either baseline or the placebo group (p less than 0.05); the LDL/HDL ratio was 20% lower than baseline (p less than 0.001) and 21% lower than the placebo group (p less than 0.05); total cholesterol was 8% lower than that of the placebo group (p less than 0.05). There was no apparent relationship between changes in plasma lipid concentrations and acifran dose or treatment duration except for triglycerides, which at Week 12 were 25% lower than baseline (p less than 0.001) and 35% lower than the placebo group (p less than 0.05) only in the acifran 300 mg t.i.d. group, in which HDL-cholesterol was concurrently 18% higher compared with placebo (p less than 0.05). In this 12-week study acifran provided safe and effective treatment for Type IIa hyperlipoproteinemia.

Adult↗
PubMed1987

Clinical efficacy of ciprofloxacin compared with placebo in bacterial diarrhea.

In a double-blind, randomized trial, 85 adult patients with acute diarrhea (more than three watery stools per day) received either 500 mg of ciprofloxacin twice daily or placebo for five days. Seventy-six patients were evaluated, 38 patients in the ciprofloxacin group (16 with Salmonella species, 19 with Campylobacter jejuni, and three with Shigella species) and 38 patients in the placebo group (21 with Salmonella species, 11 with C. jejuni, and six with Shigella species). The duration of fever in patients treated with ciprofloxacin was 1.3 days versus 3.1 days in the placebo group (p less than 0.05). The mean duration of diarrhea in the ciprofloxacin group was 1.5 days versus 2.9 days in the placebo group (p less than 0.001). The corresponding numbers in patients with salmonellosis were 1.9 versus 3.4 days (p less than 0.01). In the ciprofloxacin group, all stool culture results became negative within 48 hours of treatment. Relapse occurred in four patients with salmonellosis within three weeks after the end of treatment. In the placebo group, only four of 38 patients had negative stool culture results during treatment and results were negative in only 13 at one week after the treatment period (p less than 0.001). Modest transient elevation of serum transaminase levels was detected in three patients in the ciprofloxacin group and in two patients in the placebo group. Epigastric pain occurred in one patient, and leukopenia occurred in one patient in the ciprofloxacin group. Gastrointestinal discomfort was recorded in two patients and rash was found in one patient in the placebo group.

Adult↗
PubMed1985

Effects of L-carnitine on exercise tolerance in chronic stable angina: a multicenter, double-blind, randomized, placebo controlled crossover study.

L-carnitine was studied in forty-four men with stable chronic angina in a multicenter, double-blind, randomized, placebo controlled crossover trial. A cycloergometer exercise test was performed after a 10-day wash-out with placebo and at the end of each 4-week treatment period with either L-carnitine (1 g twice daily) or placebo. The mean (+/- SD) exercise work load showed an increase after L-carnitine compared to placebo (102.73 +/- 22.23 and 97.05 +/- 22.77 watts respectively, p = 0.001), as did the watts to onset of angina (95.7 +/- 24.07 and 87.44 +/- 24.67, p = 0.000). On the contrary, the ST segment depression was reduced by L-carnitine compared to placebo both at the maximum work load (1.40 +/- 0.90 and 1.69 +/- 0.82 mm, p = 0.05) and at the maximum work load common to L-carnitine and placebo (1.24 +/- 0.90 and 1.66 +/- 0.79 mm, p = 0.005). 22.7% of the patients became free of angina with L-carnitine and 9.1% with placebo. Resting and exercise blood pressure, heart-rate and double product were unaffected by L-carnitine. 1 patient decided to discontinue the trial because of gastric pyrosis while taking the active drug. The results of this study show that treatment with L-carnitine increases exercise tolerance and reduces ECG indices of ischemia in stable effort-induced angina.

Angina Pectoris↗
PubMed1994

Aprotinin for coronary bypass operations: efficacy, safety, and influence on early saphenous vein graft patency. A multicenter, randomized, double-blind, placebo-controlled study.

The purpose of this study was to evaluate the efficacy and safety of aprotinin in a U.S. population of patients undergoing coronary artery bypass grafting. Early vein graft patency rates were assessed by ultrafast computed tomography. A total of 216 patients at five centers were randomized to receive either high-dose aprotinin or placebo during the operation; 151 patients underwent primary operation, and 65 underwent repeat procedures. Total blood product exposures in the primary group were 2.2 per patient receiving aprotinin as compared with 5.7 per patient receiving placebo (p = 0.010). The repeat group had 0.3 exposures per patient receiving aprotinin as compared with 10.7 per patient receiving placebo (p = < 0.001). Consistent reductions in the percent of patients requiring donor red blood cells and in the number of units of platelets, fresh frozen plasma, and cryoprecipitate required were associated with the use of aprotinin in both primary and repeat groups. Mortality was 5.6% in the aprotinin group and 3.7% in the placebo group (p = 0.517). In the primary group, clinical diagnoses of myocardial infarction were made in 8.9% of patients receiving aprotinin as compared with 5.6% of the patients receiving placebo (p = 0.435). In the repeat group, infarctions occurred in 10.3% of patients receiving aprotinin and 8.3% of patients receiving placebo (p = 1.000). Secondary analysis of electrocardiograms and available enzyme data showed no significant difference in infarction rates between the treatment groups. There was no difference in clinically significant renal dysfunction. The early vein graft patency rates were 92.0% in the aprotinin group and 95.1% in the placebo group (p = 0.248). In this study, aprotinin was effective in reducing bleeding and blood product transfusion rates, and its use was not associated with an increase in complications. An adverse effect on early vein graft patency rates was not demonstrated, but the number of grafts assessed was insufficient for absolute conclusions in this regard.

Aprotinin↗
PubMed1994

One-year clinical and echocardiographic follow-up of patients with congestive cardiomyopathy treated with captopril compared to placebo.

The beneficial hemodynamic and clinical effects of angiotensin-converting enzyme (ACE) inhibition in patients with severe congestive heart failure has recently been documented in large-scale studies. This mode of therapy when added to digitalis and diuretics improves survival. To evaluate the clinical effect and the changes in cardiac dimensions of captopril compared to placebo we followed 50 patients with severe congestive heart failure over 1 year using echo-Doppler cardiography. After randomization, 25 patients were started on captopril and 25 patients on placebo. At baseline and at 6 and 12 months, each patient underwent exercise tolerance test, radionuclide angiography to estimate left and right ventricular ejection fraction, M mode and two-dimensional echocardiography and Doppler cardiography to calculate cardiac dimensions and stroke volumes. During follow-up two patients in the captopril group and four in the placebo group died. Due to clinical deterioration nine patients in the placebo group had to be started on open-label captopril. Treatment with captopril was associated with a more significant improvement in functional class and exercise duration compared to placebo. Forward stroke volume estimated from Doppler echocardiography increased significantly by captopril from 47 +/- 3 to 55 +/- 3 ml and decreased in the placebo-treated patients from 49 +/- 5 to 44 +/- 4 ml. This improvement was associated with a trend towards reduced heart rate by captopril. Left ventricular end diastolic volume tended to increase in the placebo group and did not change in the captopril group. Calculated mitral regurgitant volume at 6 and 12 months tended to be lower in the captopril-treated patients. Thus captopril therapy proved efficacious in patients with severe congestive heart failure and resulted in increased forward stroke volume; it may have a beneficial effect on cardiac dimensions and on mitral regurgitation.

Analysis of Variance↗
PubMed1994

Antihypertensive efficacy of a slow release nifedipine tablet formulation given once daily in patients with mild to moderate hypertension. A placebo-controlled, double-blind parallel-group trial.

In a double-blind, randomized parallel-group, multi-center study the antihypertensive efficacy of a slow release tablet containing 60 mg nifedipine (Aprical long, CAS 21829-25-4) has been investigated. After two-weeks wash-out of previous antihypertensive medication and a two-weeks placebo run-in period, 88 patients of both gender with a diastolic blood pressure between 95 and 115 mmHg received either nifedipine or placebo for 8 weeks. Blood pressure was measured at the end of the dose interval at rest by a semi-automatic, auscultatory device. Control measurements were recorded using a standard cuff sphygmomanometer. Primary efficacy criterion was the drop in diastolic blood pressure (DBP, measured semi-automatically) after 8 weeks therapy. 88 patients were randomized to nifedipine or placebo. 86 patients completed the protocol (42 nifedipine, 44 placebo). However, only in 73 patients BP measurements were recorded appropriately with the semi-automatic device (36 nifedipine, 37 placebo). In the nifedipine group, blood pressure fell from 152 (+/- 18)/102 (+/- 6) mmHg to 139 (+/- 16)/91 (+/- 10) mmHg. Blood pressure under placebo was determined to 149 (+/- 20)/102 (+/- 8) mmHg before treatment and 146 (+/- 18)/100 (+/- 10) mmHg at the end of the study. Heart rate was not affected under both treatments. The 90% confidence interval of the difference between the mean fall in DBP ranged from 5.0 to 12.5 mmHg, the point estimator was 8.8 mmHg. At the end of the study, 21 of 36 patients under nifedipine and 10 of 37 patients under placebo had a DBP below 90 mmHg and/or a decrease in DBP > 10 mmHg.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗