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PubMed2000

A multicenter trial of mizoribine compared with placebo in children with frequently relapsing nephrotic syndrome.

BACKGROUND: The use of corticosteroids or cytotoxic/immunosuppressive agents such as cyclophosphamide, chlorambucil, and cyclosporine for the treatment of frequently relapsing nephrotic syndrome (FRNS) is limited because of their adverse effects. This study was conducted to evaluate the efficacy and safety of mizoribine, a relatively new immunosuppressive drug developed in Japan, in children with FRNS. METHODS: A double-blind, placebo-controlled, multicenter trial was carried out in children, from 2 to 19 years old, with FRNS. At relapse, patients were treated with prednisolone. According to a dynamic allocation, mizoribine or a placebo was concurrently administered to each patient. Prednisolone was gradually tapered and discontinued within 12 weeks. The test drug was maintained for 48 weeks. The primary end point was the relapse rate (the total number of relapses/the total treatment days for all patients). Analyses were performed according to the intention-to-treat principle. RESULTS: The primary analysis was conducted on 99 mizoribine- and 98 placebo-treated patients. The relapse rate was lower in the mizoribine group than in the placebo group (0.0055 vs. 0.0067; ratio 0.81, 95% CI, 0.61 to 1.05, P = 0.12). The hazard ratio of the cumulative remission rate between the two groups was 0.79 (95% CI, 0. 57 to 1.08). In the subgroups consisting of patients 10 years old or younger, the relapse rate ratio between the mizoribine subgroup (54 patients) and the placebo subgroup (57 patients) was 0.66 (95% CI, 0. 44 to 0.94, P = 0.017). The hazard ratio of the cumulative remission rate between the two subgroups was 0.56 (95% CI, 0.37 to 0.85, P = 0. 007). Hyperuricemia was the most common adverse event with mizoribine (16%), but was transient. CONCLUSIONS: Compared with the placebo, mizoribine significantly decreased the relapse rate and prolonged the remission period in the subgroup consisting of patients 10 years old or younger. This drug may be useful in young children with FRNS who generally relapse more frequently than older children.

Adolescent↗
PubMed1998

Monitoring of acute migraine attacks: placebo response and safety data.

In the course of evaluating the safety and efficacy of an investigational compound for acute migraine headaches, a large number of patients received placebo at a single site, offering the opportunity to characterize subjective and clinical physiologic responses of migraine patients to placebo in a controlled environment. In a single-site, double-blind, placebo-controlled study, 67 patients reported to the clinic while suffering a moderate to severe acute migraine headache and received oral placebo. For 6 hours after treatment, a continuous electrocardiogram (ECG) was performed, and headache severity, adverse events, and vital signs were recorded. Patients returned and repeated the procedure when free from pain. A headache was considered to be improved if its severity dropped to "mild" or "none." Twenty-five patients (37%; 95% CI: 26% to 50%) experienced headache improvement within 2 hours of receiving placebo, and 32 patients (48%: 36% to 60%) improved within 4 hours. There were no clinically important ECG changes during the migraine visit, and there were no clinically relevant differences in vital signs between the migraine and pain-free visits. Thus, a substantial placebo response occurs in migraine headache. Hemodynamic and ECG parameters are unchanged between migraine and pain-free states.

Acute Disease↗
PubMed2004

[Research ethics and the use of placebo: status of the debate in Canada].

The question of the use of the placebo is one of the most controversial in the field of the ethics of research today. The use of the placebo remains the standard practice of biomedical research in spite of the fact that various revisions of the Helsinki Declaration have sought to limit its use. In Canada, the Tri-council policy statement: Ethical conduct for research involving humans adopted a very restrictive position with respect to the use of placebos, precisely defining the situations in which its use would meet the demands of ethical research. The positions taken by the various ethical decision-making bodies are, however, hardly shared by regulatory bodies such as the Food and drug administration (FDA), the Council for international organization of medical sciences (CIOMS) or the European agency for the evaluation of medicinal products (EMEA). This divergence of opinions reveals two quite different conceptions of what constitutes the ethical. In the case of decision-making bodies in the ethical field, it is clearly medicine's Hippocratic Oath which explains their reluctance to use placebos. The first responsibility of the doctor is to "do no harm" to his or her patient. This duty is inherent to the medical profession and as such is not grounded in the view of medicine as a contract for care. In the case of regulatory bodies, it is the vision of "medicine as contract" which is in view; and it is this notion that justifies the use of placebos once free and informed consent has been obtained. It is also worth noting that these regulatory bodies make frequent use of arguments based on utilitarian ends. In an unprecedented move, the World medical association published in October 2001 a clarification note about the use of placebos. An analysis of this text raises the question about its real meaning: clarification or concession?

Biomedical Research↗
PubMed2002

Interferon and amantadine in naive chronic hepatitis C: a double-blind, randomized, placebo-controlled trial.

Recent controlled trials on the efficacy of an amantadine/interferon combination in treatment-naive patients with chronic hepatitis C yielded contradictory results. We therefore conducted a large, double-blind, placebo-controlled, multicenter trial in naive patients with chronic hepatitis C: 246 patients were randomized to receive interferon alfa-2a (6 MIU sc thrice weekly for 20 weeks, then 3 MIU sc thrice weekly) and either amantadine sulphate (2 x 100 mg p.o. QD) or placebo. Treatment continued for a total of 52 weeks, if HCV-RNA in serum polymerase chain reaction (PCR) had fallen below detection limit (1,000 copies/mL) at treatment week 10, and stopped otherwise. All patients were followed for 24 weeks off therapy. After 10 weeks of treatment, 66/121 patients treated with amantadine (55%) and 78/125 treated with placebo (62%) had lost HCV-RNA (n.s.). After 24 weeks of follow-up, 25 patients in the amantadine (21%) and 17 (14%) in the placebo group remained HCV-RNA negative (n.s.). During therapy, virologic breakthroughs occurred less often in the amantadine than in the placebo group [14 (12%) vs. 27 (22%) patients; P =.04]. Multivariate logistic regression analysis revealed genotype, viremia level, age, and amantadine therapy [risk ratio 0.4 (95%CI 0.2-1.0), P =.05] as predictors of sustained virologic response. Adverse events and impact of therapy on quality of life were similar in amantadine and placebo treated patients. Compared with current standard treatment (interferon/ribavirin), the interferon/amantadine combination was not cost-effective. In conclusion, amantadine does not add to a clinically relevant extent to the treatment of naive patients with chronic hepatitis C.

Adult↗
PubMed2002

Placebo-controlled, double-blind, randomized study of prophylactic antibiotics in elective abdominal hysterectomy.

To assess the efficacy of a single dose of ampicillin or cefazolin in preventing fever and infection after elective abdominal hysterectomy, we conducted a multicentre, randomized, double-blind, controlled trial at Srinagarind Hospital, Faculty of Medicine, Khon Kaen University and Khon Kaen Regional Hospital. Three hundred and thirty patients scheduled for elective abdominal hysterectomy were randomly allocated into either placebo, ampicillin or cefazolin groups. Patients received sterile water (3 mL) or ampicillin (1 g) or cefazolin (1 g) intravenously according to random assignment 30 min before the operation. After the operation, all patients were assessed by blinded independent evaluators until discharged from the hospitals. Our main outcome measures were postoperative fever and infectious morbidity. We found that 321 patients (97.3% of recruited patients) were available for data analysis, 108 in placebo, 106 in ampicillin and 107 in cefazolin group. Febrile morbidity occurred in 13/108 (12.0%), 14/106 (13.2%) and 12/107 (11.2%) of patients in the placebo, ampicillin and cefazolin groups, respectively. There was no statistically significant difference in febrile morbidity between the three groups. Infectious morbidity was found in 29/108 (26.9%), 24/106 (22.6%) and 11/107 (10.3%) of patients in the placebo, ampicillin and cefazolin groups, respectively. There was a statistically significant difference between the placebo and cefazolin groups (P = 0.002). Between the placebo and ampicillin groups, the result was not significantly different (P = 0.476). There was a statistically significant difference between the cefazolin and ampicillin groups (P = 0.015). The common causes of infectious morbidity were urinary tract infection, vaginal cuff infection and surgical wound infection. We concluded that antibiotic prophylaxis by cefazolin should be recommended for elective total abdominal hysterectomy.

Adult↗
PubMed2002

Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: results from a double-blind randomized placebo-controlled trial.

Basiliximab, a high-affinity chimeric monoclonal antibody, is effective in reducing acute rejection episodes in renal allograft recipients. We assessed the ability of this antibody to similarly improve the outcome in liver transplant recipients. Adult recipients of a primary cadaveric liver transplant were randomized to treatment, stratified by hepatitis C virus (HCV) seropositivity. Patients were administered 40 mg of basiliximab (n = 188) or placebo (n = 193) as two 20-mg bolus injections days 0 and 4, plus cyclosporine and steroids. Primary efficacy variables were biopsy-confirmed acute rejection and its composite end point, including death or graft loss, and were assessed at 6 and 12 months and by HCV cohort. Because of differential efficacy responses between HCV-positive and HCV-negative cohorts, an additional analysis incorporating HCV recurrence as a component of treatment failure, termed problem-free transplant, was introduced. Safety and tolerability were monitored over the 12 months of the study. All 381 patients were assessable, and no meaningful differences in background characteristics were apparent between treatment groups. Biopsy-confirmed acute rejection rates 6 months after transplantation were 35.1% in the basiliximab group versus 43.5% in the placebo group. For death, graft loss, or first biopsy-confirmed acute rejection, rates were 44.1% versus 52.8%, respectively. The reduction in rejection episodes was concentrated in the HCV-negative cohort (14.5% relative to placebo; P =.034), with a much smaller difference (2.9%) in the HCV-positive cohort. For HCV-positive patients, problem-free transplant was shown at 12 months in 26.6% of the basiliximab group versus 11.6% in the placebo group (P =.020) and for all patients at 12 months in 39.7% of the basiliximab group versus 30.1% in the placebo group (P =.035). The incidence of infection and other adverse events was similar across the two treatment groups. There were 56 deaths (25 deaths, basiliximab group; 31 deaths, placebo group) over the 12-month study. The intravenous bolus injection was well tolerated. Immunoprophylaxis with 40 mg of basiliximab, in combination with cyclosporine and steroids, reduces the incidence of acute rejection episodes with no clinically relevant safety or tolerability concerns. The influence of HCV recurrence on efficacy results can be accounted for in future trials by using the concept of problem-free transplant, incorporating recurrence as a component of treatment failure.

Adult↗
PubMed2000

Increase in systolic blood pressure and catecholamine level during hyperinsulinemia in a placebo-controlled euglycemic clamp in healthy subjects.

Hyperinsulinemia has been shown to induce vasodilation and activation of the sympathetic nervous system. Whether these effects result in changes in blood pressure (BP) is discussed controversially. We measured BP and catecholamine levels in 50 healthy subjects during a 40-min baseline phase and during a 100-min euglycemic clamp phase. In a double-blind, between-subject comparison, 30 subjects were infused with 1.5mU insulin/kg x min, 20subjects were infused with saline solution. Insulin levels increased during insulin infusion from (mean+/-SE) 23.7 0.6 pmol/l to 406.2+/-3.0 pmol/l, but remained unchanged during placebo infusion. Blood glucose levels were identical during both conditions. Systolic BP increased from 116.6+/-1.5 mmHg to 119.8+/-1.8 mmHg during insulin infusion and decreased from 116.6+/-2.3 mmHg to 114.0+/-2.4 mmHg during placebo infusion (p<0.001, for the difference between the effects of insulin vs. placebo). Heart rate was higher during insulin infusion as compared to placebo infusion (63.8+/-1.9 vs. 60.9+/-2.4 beats/min, p<0.05). Norepinephrine levels increased from 1.25+/-0.09 to 1.58+/-0.12 nmol/l during insulin infusion and remained unchanged during placebo infusion (1.24+/-0.09 vs. 1.29+/-0.11 pmol/l; p<0.001). Epinephrine levels were also higher during insulin as compared to placebo infusion (249.8+/-17.4 vs. 212.8+/-21.1 pmol/l, p<0.001). The changes did not depend on whether the subject experienced his first or second clamp. Data demonstrate reproducable increasing effects of hyperinsulinemia within the normal physiological range on catecholamine release and systolic BP in healthy humans.

Adolescent↗
PubMed2003

[Placebo-controlled antidepressant drug trials. Considering the ethical implications].

For the approval of a new antidepressant for clinical use drug authorities still demand the proof of a significantly superior efficacy of the compound over placebo shown in controlled comparison studies. On the other side serious ethical concerns have been raised upon the use of placebos in clinical trials with depressed patients in that this would implicitly mean a withholding of an efficacious treatment from patients in the control groups of such trials. This article summarises frequently quoted arguments for and against placebo use in antidepressant clinical trials focussing on the specific issues involved in the therapeutic effect of antidepressants and placebos in depressed patients and discusses measures that might contribute to study designs that may better evaluate the true efficacy of a new drug while keeping the risk for the individual patient at the lowest possible level. A worldwide solution of the problem is clearly called for. A ban of placebos in antidepressant trials as it might be derived from the Declaration of Helsinki should be postponed until antidepressants with a more convincing superiority over placebo have been developed.

Antidepressive Agents↗
PubMed1997

A comparison of omeprazole and placebo for bleeding peptic ulcer.

BACKGROUND: The role of medical treatment for patients with bleeding peptic ulcers is uncertain. METHODS: We conducted a double-blind, placebo-controlled trial in 220 patients with duodenal, gastric, or stomal ulcers and signs of recent bleeding, as confirmed by endoscopy. In 26 patients the ulcers showed arterial spurting, in 34 there was active oozing, in 35 there were nonbleeding, visible vessels, and in 125 there were adherent clots. The patients were randomly assigned to receive omeprazole (40 mg given orally every 12 hours for five days) or placebo. The outcome measures studied were further bleeding, surgery, and death. RESULTS: Twelve of the 110 patients treated with omeprazole (10.9 percent) had continued bleeding or further bleeding, as compared with 40 of the 110 patients who received placebo (36.4 percent) (P<0.001). Eight patients in the omeprazole group and 26 in the placebo group required surgery to control their bleeding (P<0.001). Two patients in the omeprazole group and six in the placebo group died. Thirty-two patients in the omeprazole group (29.1 percent) and 78 in the placebo group (70.9 percent) received transfusions (P<0.001). A subgroup analysis showed that omeprazole was associated with significant reductions in recurrent bleeding and surgery in patients with nonbleeding, visible vessels or adherent clots, but not in those with arterial spurting or oozing. CONCLUSIONS: In patients with bleeding peptic ulcers and signs of recent bleeding, treatment with omeprazole decreases the rate of further bleeding and the need for surgery.

Adult↗
PubMed2002

Effect of 2-year placebo-controlled immunotherapy on airway symptoms and medication in patients with birch pollen allergy.

BACKGROUND: Birch pollen is a common allergen in northern, central, and eastern Europe. Earlier studies of specific immunotherapy using birch pollen extract were not placebo-controlled or were only preseasonal. Long-term, placebo-controlled studies with subcutaneously administered standardized birch pollen extract are lacking. OBJECTIVE: The aim of this study was to evaluate the effect of immunotherapy with birch pollen extract on airway symptoms and use of medication in adult birch pollen-allergic patients in a double-blind, placebo-controlled trial. METHODS: Forty-nine patients with histories of birch pollen allergy from the upper and lower airways, positive skin prick test and conjunctival provocation test results, and in vitro specific IgE to birch pollen (Betula verrucosa ) extract were included. Immunotherapy with birch pollen extract was given during 2 consecutive years in a double-blind, randomized, placebo-controlled study. Clinical symptom scores from the upper and lower airways and use of rescue medication were registered throughout the pollen season. RESULTS: Forty-six patients reached the maintenance dose and were maintained on that dose during the 2-year study. The median symptom scores during the 1997 and 1998 seasons were 1.3 and 2.6, respectively, in the specific immunotherapy group and 2.1 and 4.3, respectively, in the placebo group. The differences between the groups were significant (P =.05 in 1997 and P =.005 in 1998). The placebo group used significantly more rescue medication during both seasons than the specific immunotherapy group (P =.004 for 1997 and P =.004 for 1998). CONCLUSION: Specific immunotherapy with birch pollen extract is an effective and safe treatment for reducing clinical allergy symptoms and medication use in birch pollen-allergic patients during the pollen season.

Adult↗
PubMed2000

Randomized placebo-controlled trial of the activity of the morphine glucuronides.

BACKGROUND: Morphine-6-glucuronide (M6G) is an active metabolite of morphine with potent analgesic activity. Morphine-3-glucuronide (M3G), the most prevalent metabolite, has minimal affinity for opioid receptors. It has been suggested from animal model data and by examination of metabolite ratios in humans that M3G may functionally antagonize the respiratory depressant and analgesic actions of morphine and M6G. METHODS: We performed a double-blind placebo-controlled trial with 10 healthy volunteers. The trial had 6 arms: (1) placebo, (2) 10 mg/70 kg of morphine, (3) 3.3 mg/70 kg of M6G, (4) 30.6 mg/70 kg of M3G, (5) 30.6 mg/70 kg of M3G with 10 mg/70 kg of morphine, and (6) 30.6 mg/70 kg of M3G with 3.3 mg/70 kg of M6G; all were give by slow intravenous bolus. Analgesia was assessed with the use of the submaximal ischemic pain model. The effects were quantified on numerical and visual analogue scales. Respiratory parameters and response to steady state 5% carbon dioxide challenge were assessed with spirometry, mass spectroscopy, and earlobe blood gas analysis. RESULTS: Morphine and M6G produced significant pain relief compared with placebo (morphine, P < .0001; M6G, P = .033). Pain relief after M6G was less than after morphine (P = .009) and M3G was no better than placebo (P = .26). Pain relief with morphine and M6G were not significantly altered by M3G (P = .59 and P = .28, respectively). Significant and similar dysphoria and sedation occurred with both morphine (P < .002) and M6G (P < .016) but were absent with both M3G and placebo. Respiratory parameters suggested that M6G produced less respiratory depression than morphine. Both morphine and M6G caused a significant reduction in respiratory drive compared with placebo (morphine, P = .002; M6G, P = .013); this effect was not reversed by M3G (P = .35 and P = .83, respectively). CONCLUSIONS: M3G appears to be devoid of significant activity; in these circumstances and at these doses, it does not antagonize either the analgesic or respiratory depressant effects of M6G or morphine.

Adult↗
PubMed2002

Effect of atenolol on symptomatic ventricular arrhythmia without structural heart disease: a randomized placebo-controlled study.

BACKGROUND: Ventricular arrhythmia (VA) from the right ventricular outflow tract (RVOT) is a common problem. Symptomatic patients are usually treated with beta-blockers. There is little data on the systematic evaluation of the efficacy of beta-blocker. We determine the efficacy of atenolol in the treatment of symtomatic VA from RVOT compared with placebo. METHODS AND RESULTS: This was a randomized, double-blinded, placebo-controlled study. We prospectively studied 52 consecutive patients with symptomatic VA. Severity of symptoms, 24-hour ambulatory monitoring (AECG) and quality of life (QOL) were assessed at baseline and 1 month after atenolol. Exercise testing was performed at baseline. Average premature ventricular complex (PVC) count at baseline was 21,407 +/- 1740 beats per 24 hours, and 19% had ventricular tachycardia as measured by AECG. Results of this study showed that atenolol significantly decreased symptom frequency (P =.03), PVC count (P =.001) and average heart rate (P <.001) measured by AECG, whereas placebo significantly decreased symptom frequency (P =.002) but had no effect on PVC count (P =.78) or average heart rate (P =.44). Neither atenolol nor placebo had an effect on QOL. CONCLUSIONS: Atenolol improves symptoms and decreases PVC count from ambulatory monitoring. Placebo improved symptoms to the same extent as atenolol but had no effect on severity of VA. This might be the so-called placebo effect, which is a concern when treating patients or doing research on the effects of a drug.

Adrenergic beta-Antagonists↗
PubMed2001

A phase III, randomized, double-blind, placebo-controlled study of peldesine (BCX-34) cream as topical therapy for cutaneous T-cell lymphoma.

BACKGROUND: The purine nucleoside phosphorylase inhibitor peldesine is a new agent being evaluated as a T-cell inhibitor. OBJECTIVE: We attempted to determine the efficacy of peldesine (BCX-34) in a 1% dermal cream formulation as a treatment for cutaneous T-cell lymphoma (CTCL). METHODS: Ninety patients with patch and plaque phase CTCL, histologically confirmed by a referee dermatopathologist, were enrolled in a randomized, double-blind, placebo-controlled study. BCX-34 dermal cream 1% or the vehicle cream (as a placebo control) was applied twice daily to the entire skin surface for up to 24 weeks. Efficacy of the topical therapy was assessed in terms of complete or partial (> or = 50%) clearing of patches and plaques. RESULTS: Of the 89 patients able to be examined, 43 received BCX-34 and 46 received the placebo vehicle cream. One patient withdrew early and was not analyzed. The two groups were well balanced for potential prognostic factors. A total of 28% (12/43) of the patients treated with BCX-34 showed a response, but 24% (11/46) of patients who received vehicle also responded (P =.677). CONCLUSION: Although BCX-34 dermal cream 1% was not significantly better than the control as therapy for patch and plaque-phase CTCL, this appears to be the first published placebo-controlled trial evaluating treatment for CTCL. Whether the vehicle cream has more than a placebo therapeutic effect is unclear. The relatively high (24%) placebo response rate should be kept in mind in assessing other treatments for early-stage CTCL.

Administration, Cutaneous↗
PubMed2003

Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study.

OBJECTIVE: The purpose of this study was to evaluate the effect of prophylactic vaginal progesterone in decreasing preterm birth rate in a high-risk population. STUDY DESIGN: A randomized, double-blind, placebo-controlled study included 142 high-risk singleton pregnancies. Progesterone (100 mg) or placebo was administered daily by vaginal suppository and all patients underwent uterine contraction monitoring with an external tocodynamometer once a week for 60 minutes, between 24 and 34 weeks of gestation. Progesterone (n = 72) and placebo (n = 70) groups were compared for epidemiologic characteristics, uterine contraction frequency, and incidence of preterm birth. Data were compared by chi(2) analysis and Fisher exact test. RESULTS: The preterm birth rate was 21.1% (30/142). Differences in uterine activity were found between the progesterone and placebo groups (23.6% vs 54.3%, respectively; P <.05) and in preterm birth between progesterone and placebo (13.8% vs 28.5%, respectively; P <.05). More women were delivered before 34 weeks in the placebo group (18.5%) than in the progesterone group (2.7%) (P <.05). CONCLUSION: Prophylactic vaginal progesterone reduced the frequency of uterine contractions and the rate of preterm delivery in women at high risk for prematurity.

Adult↗
PubMed2000

Variables of stimulation and placebo in acupuncture reflexotherapy.

Placebo can be defined as "the idea of recovery." It represents the natural impulse toward recovery that is catalyzed by treatment or even simply by the idea of treatment. Therefore, placebo is not an "active" treatment; it is used in scientific research to discriminate between the actual effect of a drug or therapeutic technique and the result of chance or the will to recover. Even though it is only an idea, placebo can cause improvement and recovery in approximately 30% of the subjects treated with any therapeutic program and for very different pathologies. Acute pathologies are more sensitive to placebo than chronic ones; functional disorders respond better than organic alterations, and so on. The main controversial issues in the methodology of acupuncture research are: placebo, double-blinding, and the intensity of stimulation of needles. The most used placebo method is sham acupuncture, which is the insertion of the needles outside acupuncture points. It is argued that this methodologically incorrect choice leads to studying the importance of the acupuncture point, rather than that of acupuncture as a transdermic stimulation technique.

Acupuncture Therapy↗
PubMed1988

Multicenter comparison of dilevalol to placebo in patients with mild hypertension.

The antihypertensive effects of oral dilevalol, a beta-blocking agent with vasodialating properties were compared with placebo in 128 mildly hypertensive patients (supine diastolic blood pressure 95 to 105 mm Hg) in a multicenter, double-blind, parallel group study. Following a 4-week placebo phase, 63 patients were randomly assigned to receive dilevalol and 65 to receive placebo. A titration phase followed during which the dose of dilevalol was increased every other week from 100 mg to 800 mg to achieve a supine diastolic blood pressure (SDBP) less than 90 mm Hg and decreased by 10 mm Hg or more from baseline. A matching number of placebo capsules for each dose level of dilevalol was dispensed for blinding purposes. Patients who had at least a 5 mm Hg reduction in SDBP entered a 1-month maintenance phase. Blood pressure and heart rate were measured weekly 20 to 24 hours after a dose. This study demonstrated that the minimally effective dose of dilevalol was 100 mg, which was shown to result in a significantly (P less than or equal to 0.05) greater reduction in systolic BP. A once-daily dose of 200 mg was superior to placebo in both systolic and diastolic BP effects (P less than 0.001 and less than 0.001, respectively), and this superiority was seen again at both the end of titration and the end of the study. The BP reduction was accompanied by a small (5 bpm) decrease in heart rate. The side effect profile of dilevalol was not different from placebo. Dilevalol appears to have no adverse effect on plasma lipids.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1986

Temazepam and trimeprazine compared with placebo as premedication in children. An investigation extended into the first 2 weeks at home.

Temazepam, trimeprazine and placebo were compared as premedication in 85 children undergoing routine otolaryngological operations. Premedication with trimeprazine caused significantly more sedation than temazepam or placebo in patients on arrival in the anaesthetic room (P less than 0.02). Recovery time was significantly longer after trimeprazine than temazepam or placebo (P less than 0.012). Significantly more children (P less than 0.05) failed to recall a picture shown immediately before induction after trimeprazine and temazepam than with placebo. Fewer patients vomited after operation with trimeprazine than with temazepam or placebo (P less than 0.01). The majority of children exhibited some behavioural problem during the first 2 weeks at home, although this rarely lasted for more than a few days. More children exhibited apathetic/withdrawn behaviour after receiving placebo (P less than 0.05), although the significance of this should be interpreted with caution.

Anesthesia Recovery Period↗
PubMed2002

The effect of contraceptive pills on the measured blood loss in medical termination of pregnancy by mifepristone and misoprostol: a randomized placebo controlled trial.

BACKGROUND: A prospective randomized placebo controlled trial was performed to assess the immediate use of oral contraceptive (OC) on the amount of blood loss in the post-abortion period in women undergoing medical abortion by mifepristone and misoprostol. METHODS: One hundred women were randomized by computer to receive either OC pills or placebo, immediately after medical abortion. RESULTS: There was no difference in the complete abortion rate between the two groups. The complete abortion rate was 98 and 92% in the OC and placebo groups respectively. The side-effects and duration of bleeding were also similar. The median days of vaginal bleeding were 17 (range: 3-41) and 15 (range: 5-48) in the OC and placebo groups respectively. There was a statistically significant decrease in the mean haemoglobin level on day 15 in the OC group (from 12.0 to 11.5 g/dl) whereas the mean haemoglobin level in the placebo group remained stable. The median measured blood loss was 69.9 ml in the OC group and 72.8 ml in the placebo group and there was no statistically significant difference between the two groups. CONCLUSION: We conclude that it is safe to offer women combined OC pills immediately after medical abortion as an option of contraception, as it does not affect the duration or amount of vaginal bleeding or the complete abortion rate.

Abortifacient Agents↗