A Multicentre Hospital Study to Compare the Hypnotic Efficacy of Loprazolam and Nitrazepam

1984 ◽  
Vol 12 (4) ◽  
pp. 229-237 ◽  
Author(s):  
C Joan McAlpine ◽  
S I Ankier ◽  
Catherine S C Elliott
Keyword(s):  
Side Effects ◽  
Subjective Evaluation ◽  
Double Blind ◽  
Visual Analogue Scales ◽  
Parallel Group ◽  
Significant Difference ◽  
Hypnotic Efficacy ◽  
Hospital Study ◽  
Analogue Scales ◽  
Single Blind

A multicentre, parallel group hospital study was carried out in 190 subjects with insomnia to compare the efficacy, incidence of hangover and the side-effects of loprazolam and nitrazepam. Following 2 nights single-blind phase on placebo, loprazolam (1·0 mg), nitrazepam (5·0 mg) or placebo was administered double-blind for 7 consecutive nights. Visual analogue scales and questions were used to rate efficacy. There was no statistically significant difference between loprazolam and nitrazepam for ‘ease of getting to sleep’, ‘restfulness of sleep’ and ‘depth of sleep’. Like nitrazepam, loprazolam diminished the number of periods of wakefulness and made it ‘easier to get to sleep again’. Subjective evaluation showed that hangover was not a feature of loprazolam. It did not affect morning alertness and patients thought they had improved balance and co-ordination while on this drug. These findings are in keeping with the evidence of other workers who have shown only minimal psychomotor impairment, if any, with loprazolam (1·0 mg). There was no statistically significant difference between treatments with respect to frequency or incidence of side-effects.

A Double-Blind Study of Trazodone and Mianserin in the Treatment of Depression in General Practice

1982 ◽  
Vol 10 (3) ◽  
pp. 147-156 ◽  
Author(s):  
H H Richards ◽  
R N Midha ◽  
S Miller
Keyword(s):  
General Practice ◽  
Side Effects ◽  
Therapeutic Effect ◽  
Rating Scale ◽  
Double Blind ◽  
Global Improvement ◽  
Hamilton Depression Rating Scale ◽  
Self Rating ◽  
Visual Analogue Scales ◽  
Analogue Scales

The antidepressant and anxiolytic efficacy of trazodone (100–200 mg daily), mianserin (60–120 mg daily) and diazepam (15–30 mg daily) was evaluated in ninety-three patients suffering from mild to moderate depression, with or without anxiety, over 6 weeks in a double-blind non-crossover general practice study. Efficacy was evaluated using the Hamilton Depression Rating Scale, Patient Self-Rating Visual Analogue scales, physician global assessments and the Zung Self-Rating Anxiety Scale. All three treatments significantly reduced symptoms of depression, as measured on the Hamilton Depression Rating Scale and the physician's assessment of Global Improvement. Trazodone was significantly superior to both mianserin and diazepam. As assessed using Visual Analogue Scales, trazodone was also shown to be significantly superior to diazepam in improving the patient's ability to concentrate and in reducing daytime tiredness. Although evidence of efficacy was found, there were no differences in activity between the treatment groups using the physician's assessment of Current Severity or on assessment of Therapeutic Effect. The treatments all caused a reduction in anxiety as assessed by the Zung Self-Rating Scale. The overall incidence of side-effects was similar between groups. For those side-effects considered to be significantly interfering with the patient's function, but not outweighing the therapeutic effect, a reduction of dosage was effective. Several patients complaining of drowsiness or lethargy as an unacceptable daytime side-effect were switched successfully from twice daily to night-time dosing. Significantly more patients with side-effects (outweighing therapeutic effect or in the presence of no improvement) were withdrawn from the mianserin group than from the trazodone or diazepam groups. Overall, the therapeutic efficacy in relation to the incidence of clinically significant side-effects, favoured trazodone for the treatment of general practice patients suffering from depression, with or without anxiety.

Study of a New Analgesic Compound in the Treatment of Tension Headache*

1976 ◽  
Vol 4 (1) ◽  
pp. 74-78 ◽  
Author(s):  
J Borges ◽  
C Zavaleta
Keyword(s):  
Side Effects ◽  
Pharmacological Activity ◽  
Clinical Success ◽  
Tension Headache ◽  
Symptomatic Treatment ◽  
Blind Study ◽  
Effective Combination ◽  
Significant Difference ◽  
Starting Dose ◽  
Single Blind

The effect of a new analgesic compound ( propoxyphene, acetaminophen, caffeine, hydroxyzine) was investigated in a single-blind study comparing it with plain acetaminophen administered to forty patients with tension headache. For the study, patients were assigned to one of two groups of twenty each. Starting dose for each group was one to two tablets followed by one tablet every four to six hours. The results show that 90% clinical success was obtained with the analgesic compound, while a 45% success was obtained with plain acetaminophen. This is a statistically significant difference. Side-effects observed with analgesic compound were primarily drowsiness and dizziness of mild intensity; acetaminophen caused gastro-intestinal alterations ( nausea, vomiting) and dizziness of greater severity. Therapy was withdrawn in 20% of patients taking acetaminophen because of side-effects. The dosage of analgesic compound required to control each episode of tension headache way smaller than that of acetaminophen. These results can be explained by a possible potentiation of pharmacological activity of the compound's components. It can be concluded that the analgesic compound is a new and effective combination for the symptomatic treatment of tension headache.

scholarly journals Topical Diltiazem Versus Topical Glyceryl Trinitrate In The Management Of Chronic Anal Fissure

JMS SKIMS ◽  
2014 ◽  
Vol 17 (2) ◽  
pp. 55-58
Author(s):  
Shams Ul Bari ◽  
Ajaz Ahmad Malik ◽  
Khurshid Alam Wani ◽  
Ajaz A Rather
Keyword(s):  
Side Effects ◽  
Anal Fissure ◽  
Chronic Anal Fissure ◽  
P Value ◽  
Double Blind ◽  
Surgical Methods ◽  
Significant Difference ◽  
Topical Glyceryl Trinitrate ◽  
One Year

Background: Chemical sphincterotomy is a novel way for treating patients of chronic anal fissure which avoids the risk of fecal incontinence associated with traditional surgical methods. Aims and objectives: The aim of this study was to compare the results of topical Diltiazem with topical Glyceril trinitrate in the management of chronic anal fissure. Methods: 71 patients in the age group of 15 - 61 years with chronic anal fissure were included in this prospective, randomized, double-blind trial over a period of two years with further follow up for one year. The patients were randomly allocated to either Diltiazem gel 2% (37 patients) or Glyceril trinitrate ointment 0.2% (34 patients) and were asked to use the treatment twice daily for 8 weeks. Each patient was reviewed every two weeks. Symptoms, healing, side effects and recurrence were compared using SPSS version 10 employing X2 test. A p-value below 0.05 was considered statistically significant. Results: Patients who received topical diltiazem (DTZ) showed statistically significant difference than those who were prescribed topical glyceril trinitrate in terms of symptoms, wound healing, side effects ( headaches) and recurrence (p=0.03 and 0.003 respectively). Healing occurred in 34 of 37 (92%) patients treated with Diltiazem after 6 weeks and 27 of 34 (80%) patients treated with Glyceril trinitrate after 8 weeks, which shows a significant difference in favour of Diltiazem (P < 0.001). The rest of the patients did not heal and underwent sphincterotomy (SILS). Headache occurred in all of the patients treated with Glyceril trinitrate but none of the patients treated with Diltiazem. Conclusion: Diltiazem gel was found to be better than Glyceril trinitrate ointment due to significantly higher healing rate and fewer side-effects. JMS 2014;17(2):55-58

scholarly journals Perbandingan Efektivitas Anestesi Spinal dengan Bupivacain 12,5 Mg dan Bupivacain 5 Mg yang ditambah Fentanyl 50 Mcg pada Seksio Sesarea

2021 ◽  
Vol 4 (1) ◽  
pp. 11-7
Author(s):  
Fritzky Indradata ◽  
Heri Dwi Purnomo ◽  
Muh. Husni Thamrin ◽  
Sugeng Budi Santoso ◽  
Ardana Tri Arianto ◽  
...  
Keyword(s):  
Side Effects ◽  
Cesarean Section ◽  
Spinal Anesthesia ◽  
Randomized Control Trial ◽  
Hyperbaric Bupivacaine ◽  
Chi Square ◽  
Double Blind ◽  
Duration Of Action ◽  
Significant Difference ◽  
Randomized Control

Latar Belakang: Anestesi spinal mempunyai efek samping berupa hipotensi dan mual muntah. Tujuan: penelitian ini adalah membandingkan efek anestesi spinal bupivacain dosis normal 12,5 mg dan bupivacain dosis rendah 5 mg dengan fentanyl 50 mg pada seksio sesarea terhadap perubahan hemodinamik, ketinggian blok, onset, durasi dan efek samping. Subjek dan Metode: Penelitian double blind randomized control trial pada 36 pasien yang memenuhi kriteria. Pasien dibagi menjadi dua kelompok, yang masing-masing terdiri 18 pasien, kelompok 1 dilakukan anestesi spinal dengan bupivacain hiperbarik 5 mg ditambah adjuvan fentanyl 50 mcg, sedangkan kelompok 2 diberikan bupivacain hiperbarik 12,5 mg. Penilaian meliputi saat mula kerja blokade sensorik, mula kerja blokade motorik, durasi, tekanan darah, laju nadi, dan saturasi oksigen, lama kerja dan efek samping. Data hasil penelitian diuji secara statistik dengan uji chi-square. Hasil: Terdapat perbedaan signifikan pada onset dan durasi blokade sensorik dan motorik, bupivacain 12,5 mg lebih baik dibandingkan bupivacain 5 mg + fentanyl 50 mcg (p<0.05). Tidak ada perbedaan signifikan pada perubahan tanda vital dan efek samping (p>0.05). Simpulan: Bupivacain 12,5 mg menghasilkan onset lebih cepat dan durasi lebih lama dibandingkan bupivacain 5 mg + fentanil 50 mcg pada anestesi spinal untuk seksio sesarea   Comparison of The Effectiveness Spinal Anesthesia with Bupivacaine 12,5 Mg and Bupivacaine 5 Mg added Fentanyl 50 Mcg in Caesarean Section Abstract Background: Spinal anesthesia has side effects such as hypotension and nausea and vomiting. Objective: The aim of this study was to compare the effects of spinal anesthesia with normal doses of 12,5 mg of bupivacaine and 5 mg of low-dose bupivacaine with fentanyl 50 mg in the cesarean section on hemodynamic changes, block height, onset, duration, and side effects. Subjects and Methods: Double-blind randomized control trial in 36 patients who met the criteria. Patients were divided into two groups, each consisting of 18 patients, group 1 underwent spinal anesthesia with 5 mg of hyperbaric bupivacaine plus 50 mcg of fentanyl adjuvant, while group 2 was given 12,5 mg of hyperbaric bupivacaine. Assessments include the initiation of sensory block action, onset of motor block action, duration, blood pressure, pulse rate, and oxygen saturation, duration of action, and side effects. The research data were statistically tested with the chi-square test. Results: There were significant differences in the onset and duration of sensory and motor blockade, bupivacaine 12,5 mg was better than bupivacaine 5 mg + fentanyl 50 mcg (p <0.05). There was no significant difference in changes in vital signs and side effects (p> 0.05). Conclusion: Bupivacaine 12,5 mg resulted in a faster onset and longer duration than bupivacaine 5 mg + fentanyl 50 mcg in spinal anesthesia for cesarean section.

scholarly journals Effects of the Toll-like receptor 7 (TLR7) agonist, AZD8848, on allergen-induced responses in patients with mild asthma: a double-blind, randomised, parallel-group study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Brian R. Leaker ◽  
Dave Singh ◽  
Sam Lindgren ◽  
Gun Almqvist ◽  
Leif Eriksson ◽  
...  
Keyword(s):  
Immune System ◽  
Allergic Asthma ◽  
Allergen Challenge ◽  
Forced Expiratory Volume ◽  
Post Treatment ◽  
Double Blind ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Significant Difference ◽  
Th2 Responses

Abstract Background Although allergic asthma is a complex area with many interacting factors involved, the ‘hygiene hypothesis’ proposes that a lack of exposure to infection during childhood may polarise the immune system towards allergen-reactive Th2-type responses in genetically susceptible individuals. Toll-like receptors (TLRs) play a key role within the innate immune system and TLR7 agonists have previously been shown to up-regulate Th1 responses and down-regulate Th2 responses to allergens in murine models of allergic or chronic asthma. This study aimed to examine the efficacy and safety of the novel TRL7 agonist AZD8848, which has been developed as an antedrug. Methods In this double-blind, randomised, parallel-group study, AZD8848 60 μg or placebo was administered intranasally once-weekly for 8 weeks in patients with mild-to-moderate allergic asthma (NCT00999466). Efficacy assessments were performed at 1 and 4 weeks after the last dose. The primary outcome was the late asthmatic response (LAR) fall in forced expiratory volume in 1 s (FEV1) after allergen challenge at 1-week post-treatment. Results AZD8848 significantly reduced average LAR fall in FEV1 by 27% vs. placebo at 1 week after treatment (p = 0.035). This effect was sustained at 4 weeks post-treatment; however, it did not reach clinical significance. AZD8848 reduced post-allergen challenge methacholine-induced airway hyper-responsiveness (AHR) vs. placebo at 1 week post-dosing (treatment ratio: 2.20, p = 0.024), with no effect at 4 weeks. There was no significant difference between the two groups in plasma cytokine, sputum Th2 cytokine or eosinophil responses post-allergen challenge at 1 week after treatment. The incidence of adverse events was similar in the two groups. AZD8848 was generally well tolerated. Conclusions and clinical relevance In patients with allergic asthma, TLR7 agonists could potentially reduce allergen responsiveness by stimulating Type 1 interferon responses to down-regulate the dominant Th2 responses. Trial registration clinicaltrials.gov identifier NCT00999466.

Prevention of cisplatin-induced emesis: a double-blind multicenter randomized crossover study comparing ondansetron and ondansetron plus dexamethasone.

1991 ◽  
Vol 9 (4) ◽  
pp. 675-678 ◽  
Author(s):  
F Roila ◽  
M Tonato ◽  
F Cognetti ◽  
E Cortesi ◽  
G Favalli ◽  
...  
Keyword(s):  
Side Effects ◽  
Crossover Study ◽  
Receptor Antagonist ◽  
Treatment Preference ◽  
Complete Protection ◽  
Double Blind ◽  
Significant Difference ◽  
Antiemetic Activity ◽  
To Receive ◽  
Randomized Crossover Study

Ondansetron (OND) is a new 5-HT3 receptor antagonist that give complete protection from emesis/nausea in approximately 50% of cisplatin (CDDP)-treated patients. To evaluate if dexamethasone (DEX) added to OND increases antiemetic efficacy, we carried out a double-blind randomized crossover study to compare the antiemetic activity of OND with OND plus DEX. One hundred two chemotherapy-naive patients (44 women and 58 men) scheduled to receive CDDP chemotherapy at doses greater than or equal to 50 mg/m2 entered the study. Eighty-nine patients completed both cycles with the following results: complete protection from emesis/nausea was obtained in 57/59 patients (64.0%/66.3%) with OND and in 81/79 (91.0%/88.8%) with OND plus DEX (P = .0005/P = .0021). At the end of the study, 53% of the patients expressed a treatment preference, and of these, 74% chose OND plus DEX compared with 26% who preferred OND alone, a statistically significant difference (P less than .003). Side effects were very mild and not significantly different between the two treatments. We conclude that OND plus DEX is more efficacious than OND in protecting patients from CDDP-induced emesis and nausea.

scholarly journals Patient-Controlled Epidural Analgesia in Labour — is a Continuous Infusion of Benefit?

1992 ◽  
Vol 20 (1) ◽  
pp. 15-20 ◽  
Author(s):  
M. J. Paech
Keyword(s):  
Side Effects ◽  
Epidural Analgesia ◽  
Patient Controlled Analgesia ◽  
Self Administration ◽  
High Quality ◽  
Active Labour ◽  
Background Infusion ◽  
Significant Difference ◽  
Continuous Background ◽  
Single Blind

A randomised, single-blind study was conducted among 52 gravida in active labour, to investigate two variants of patient-controlled epidural analgesia — bolus only versus bolus plus infusion. Patient-controlled analgesia variables, using an epidural solution of 0.125% bupivacaine plus fentanyl 3 mcg per ml, were a 4 ml incremental bolus with 15 minute lockout, plus or minus a 4 ml per hour infusion. Up to three additional staff-administered supplements of 0.5% bupivacaine 4 ml (20 mg) were allowed. There was no significant difference between groups with respect to pain relief, supplementary boluses required, satisfaction, side-effects or details of patient-controlled epidural analgesia, with the exception of greater fentanyl usage in the bolus plus infusion group (P < 0.003). Both groups had high quality analgesia, low rates of bupivacaine usage and were highly satisfied. However, under the conditions of the study, the addition of a continuous background infusion to self-administration conferred no benefit.

Double-Blind Comparison of Maternal Analgesia and Neonatal Neurobehaviour following Intravenous Butorphanol and Meperidine

1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain
Keyword(s):  
Side Effects ◽  
Severe Pain ◽  
Randomized Study ◽  
Analgesic Efficacy ◽  
Foetal Heart Rate ◽  
Efficacy And Safety ◽  
Cervical Dilation ◽  
Double Blind ◽  
Significant Difference ◽  
Blind Comparison

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).

Dibenzepin and Amitriptyline in the Treatment of Depression

1971 ◽  
Vol 118 (546) ◽  
pp. 523-524 ◽  
Author(s):  
M. Y. Ekdawi
Keyword(s):  
Side Effects ◽  
Antidepressant Drug ◽  
Comparative Trial ◽  
Tricyclic Antidepressant ◽  
Pharmacological Properties ◽  
Double Blind ◽  
Depressed Patients ◽  
Treatment Of Depression ◽  
Significant Difference

Dibenzepin hydrochloride is a new tricyclic antidepressant drug with pharmacological properties midway between those of imipramine and amitriptyline. In a double-blind comparative trial, J. M. Fielding (Med. J. Australia, 1969, 1, 614) found no significant difference in the speed of the effect of the two drugs in depressed patients. He reported that side-effects rated subjectively by patients were maximal before starting on the drugs and tended to decrease with time. The following trial was accordingly staged.

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