First clinical trial with etomoxir in patients with chronic congestive heart failure

In the failing human myocardium, both impaired calcium homoeostasis and alterations in the levels of contractile proteins have been observed, which may be responsible for reduced contractility as well as diastolic dysfunction. In addition, levels of a key protein in calcium cycling, i.e. the sarcoplasmic reticulum Ca(2+)-ATPase, and of the alpha-myosin heavy chain have been shown to be enhanced by treatment with etomoxir, a carnitine palmitoyltransferase inhibitor, in normal and pressure-overloaded rat myocardium. We therefore studied, for the first time, the influence of long-term oral application of etomoxir on cardiac function in patients with chronic heart failure. A dose of 80 mg of etomoxir was given once daily to 10 patients suffering from heart failure (NYHA functional class II-III; mean age 55+/-4 years; one patient with ischaemic heart disease and nine patients with dilated idiopathic cardiomyopathy; all male), in addition to standard therapy. The left ventricular ejection fraction was measured echocardiographically before and after a 3-month period of treatment. Central haemodynamics at rest and exercise (supine position bicycle) were defined by means of a pulmonary artery catheter and thermodilution. All 10 patients improved clinically; no patient had to stop taking the study medication because of side effects; and no patient died during the 3-month period. Maximum cardiac output during exercise increased from 9.72+/-1.25 l/min before to 13.44+/-1.50 l/min after treatment (P<0.01); this increase was mainly due to an increased stroke volume [84+/-7 ml before and 109+/-9 ml after treatment (P<0.01)]. Resting heart rate was slightly reduced (not statistically significant). During exercise, for any given heart rate, stroke volume was significantly enhanced (P<0.05). The left ventricular ejection fraction increased significantly from 21.5+/-2.6% to 27.0+/-2.3% (P<0.01). In acute studies, etomoxir showed neither a positive inotropic effect nor vasodilatory properties. Thus, although the results of this small pilot study are not placebo-controlled, all patients seem to have benefitted from etomoxir treatment. Etomoxir, which has no acute inotropic or vasodilatory properties and is thought to increase gene expression of the sarcoplasmic reticulum Ca(2+)-ATPase and the alpha-myosin heavy chain, improved clinical status, central haemodynamics at rest and during exercise, and left ventricular ejection fraction.     

A prospective, randomized trial of BiPAP in severe acute congestive heart failure

Noninvasive positive pressure ventilation has been found to be efficacious in the setting of acute respiratory failure, specifically in chronic obstructive pulmonary disease exacerbations. Its use in congestive heart failure (CHF) is less well established. Additionally, it has been reported that there is an increase in acute myocardial infarction (AMI) rate with the use of bilevel positive pressure ventilation (BiPAP) in CHF patients. This study examined whether BiPAP decreases the intubation rate or improves cardiopulmonary parameters in severe CHF patients compared to high flow O₂ by mask (MASK), and whether there is an increase in AMI rate with the use of BiPAP. A prospective, randomized clinical trial at a county hospital teaching Emergency Department was conducted by enrolling 38 patients who were in severe CHF. Patients were randomized to receive either BiPAP or MASK in addition to adjunct therapy. Age and gender were not different between the groups. Heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, and pulse oximetry all showed no significant difference in change over time between groups, but there was a significant change over time within groups. Arterial pH, pCO₂, and pO₂ also showed no significant difference in change over time between groups, but there was a significant change over time within groups. The intubation rate for BiPAP was 23.8% (5) vs. MASK at 41.2% (7). The AMI rate was 19% (4) in the BiPAP group and 29.4% (5) in the MASK group. No true differences were detected between groups for increased oxygenation or a reduction in intubation rate. An increase in AMI rate with BiPAP was not found in this study as previously reported. This study provides support for a larger clinical trial assessing the safety and efficacy of BiPAP in acute CHF.     

CVVH治疗慢性肾功能不全伴充血性心力衰竭患者的疗效观察

目的探讨连续性静脉静脉血液滤过(CVVH)治疗慢性肾功能不全(CRF)伴充血性心力衰竭(CHF)患者的临床疗效及影响预后的因素。方法对上海交通大学第六医院2002年1月～2005年2月的42例CRF伴CHF的患者接受CVVH治疗,观察治疗前后心率(HR)、呼吸(RR)、血压(BP)、心功能改善情况及APACHEⅡ评分等指标变化,并检测血肌酐(Scr)、尿素氮(BUN)、血碳酸氢根浓度(HCO3-)、动脉血pH值(pH)。结果CVVH治疗能明显减少CRF伴CHF患者的水、钠潴留,改善心功能,降低APACHEⅡ评分。对死亡组和存活组进行统计学分析发现死亡组APACHEⅡ评分更高,而容量负荷(FO%)与死亡率密切相关。结论CRF伴CHF患者在血肌酐不高的情况下,如容量负荷过重即行CVVH治疗,可减少并发症,降低死亡率。     

The efficacy and safety of Tanacetum parthenium (feverfew) in migraine prophylaxis--a double-blind,multicentre, randomized placebo-controlled dose-response study

Tanacetum parthenium (feverfew), is a well-known herb for the prophylactic treatment of migraine. The primary objective was to show a dose-response of a new stable extract (MIG-99) reproducibly manufactured with supercritical CO2 from feverfew (T. parthenium). Furthermore, the study should provide data on the safety and tolerability of MIG-99. In a randomized, double-blind, multicentre, controlled trial with an adaptive design, the clinical efficacy and safety of three dosages of MIG-99 (2.08 mg; 6.25 mg; 18.75 mg t.i.d.) were compared with placebo. The patients (n = 147) suffered from migraine with and without aura according to International Headache Society (IHS) criteria and were treated with one of the study medications for 12 weeks after a 4-week baseline period. The primary efficacy parameter was the number of migraine attacks during the last 28 days of the treatment period compared with baseline. Secondary endpoints were total and average duration and intensity of migraine attacks, mean duration of the single attack, number of days with accompanying migraine symptoms, number of days with inability to work due to migraine as well as type and amount of additionally taken medications for the treatment of migraine attacks. The design of the study included a pre-planned adaptive interim analysis for patients with at least four migraine attacks within the baseline period. With respect to the primary and secondary efficacy parameter, a statistically significant difference was not found between the overall and the confirmatory intention-to-treat (ITT) sample in the exploratorily analysed four treatment groups. The frequency of migraine attacks for the predefined confirmatory subgroup of patients (n = 49) with at least four migraine attacks during the baseline period decreased in a dose-dependent manner (P = 0.001). The highest absolute change of migraine attacks was observed under treatment with 6.25 mg t.i.d. (mean +/- SD = -1.8 +/- 1.5 per 28 days) compared with placebo (-0.3 +/- 1.9; P = 0.02). Overall, 52 of 147 (35%) patients reported at least one adverse event (AE). The incidence of AEs in the active treatment groups was similar to that in the placebo group, and no dose-related effect was observed in any safety parameter. MIG-99 failed to show a significant migraine prophylactic effect in general. Accordingly, in the ITT analysis a dose-response relationship could not be observed. MIG-99 was shown to be effective only in a small predefined subgroup of patients with at least four attacks during the 28-day baseline period where the most favourable benefit-risk ratio was observed with a dosage of three capsules of 6.25 mg MIG-99 extract per day. Because of the low number of patients, these findings need to be verified in a larger sample. The incidence of AEs was similar for all treatment groups.     

A randomized, double-blind, multicentre controlled trial of ibuprofen versus acetaminophen and placebo for symptoms of acute otitis media in children

Summary— Two hundred and nineteen children (boys: 56%, girls: 44%) were included in a randomized, double-blind, multicentre (4 centres) controlled trial designed to assess the efficacy and safety of ibuprofen (IBU) in the treatment of 1 to 6 year-old children with otoscopically proven acute otitis media (AOM), either unilateral or bilateral. They randomly received 10 mg/kg IBU (n = 71), or acetaminophen (PARA) (n = 73) or placebo (PLA) (n = 75), orally, tid, for 48 hours. All received oral cefaclor (Alfatil®, Lilly, France) for seven days. They were evaluated before (D0) and at the end of treatment (D2). The main criterion of response was the aspect (landmarks and color) of the tympanic membrane assessed on a semi-quantitative scale from 0 to 6. Other criteria, assessed on semi-quantitative scales, included relief of pain (0 or 1), rectal temperature (0 to 2), and overall evaluation by parents of the improvement of quality of life on three items: appetite (0 to 2), sleep (0 to 2) and playing activity (0 to 2). The results at D2 were as follows: there was no significant difference between treatment groups as to the main criterion, but only a trend for IBU and PARA to do better than PLA but not for IBU to do better than PARA. From these data there is no argument to emphasize the utility of nonsteroidal anti-inflammatory drugs (NSAIDs) in treating the inflammatory signs of the tympanic membrane in otitis. There was a statistically significant difference between treatment groups at D2 for pain, IBU being superior to PLA (P < 0.01): 7%, 10% and 25% of the children were still suffering at D2 in the IBU, PARA and PLA treatment groups, respectively. The difference between PARA and PLA for pain was not statistically significant. There was no significant difference between treatment groups for the other criteria. All treatments were well and equally tolerated. Although no significant difference was found between the treatment groups on the aspect of the tympanic membrane, the efficacy of IBU was evidenced on the relief of pain, the symptom that most disturbs the child.     

Evaluation of Serratia peptidase in acute or chronic inflammation of otorhinolaryngology pathology: a multicentre, double-blind, randomized trial versus placebo

The efficacy and tolerability of Serratia peptidase were evaluated in a multicentre, double-blind, placebo-controlled study of 193 subjects suffering from acute or chronic ear, nose or throat disorders. Treatment lasted 7-8 days, with the drug or placebo being administered at a rate of two tablets three times a day. After 3-4 days' treatment, significant symptom regression was observed in peptidase-treated patients. There was also a significant reduction in symptoms after 7-8 days for patients in both treatment groups but the response was more marked in those patients receiving the active drug. Statistical comparison between the two groups confirmed the greater efficacy and rapid action of the peptidase against all the symptoms examined at both stages. Tolerance was found to be very good and similar for both groups. It is concluded that Serratia peptidase has anti-inflammatory, anti-oedemic and fibrinolytic activity and acts rapidly on localized inflammation.     

美托洛尔联合苯那普利治疗充血性心力衰竭伴室性心律失常的临床疗效观察

目的探讨美托洛尔联合苯那普利治疗充血性心力衰竭(CHF)伴室性心律失常的临床效果。方法选择98例CHF伴室性心律失常为研究对象,采用随机数字表法分为分为对照组(47例)和观察组(51例)。对照组予以常规内科治疗加苯那普利,观察组在上述基础上联合美托洛尔治疗。比较两组临床治疗效果,心功能指标[心率(HR)、左室舒张末期内径(LVEDD)、左室收缩末期内径(LVESDD)、左室射血分数(LVEF)、QT间期(QTc)、QT离散度(QTd)、24 h室性早搏数(24 h VPB)、24 h室性心动过速(24 h PVT)]改善情况。结果观察组总有效率、心律失常下降率明显高于对照组(98.1%vs.78.7%,49.0%vs.27.7%);HR、LVESD、LVESDD等心功能指标均明显低于对照组,LVEF明显高于对照组;QTc明显高于对照组,QTd、24 h VPB、24 h PVT明显低于对照组。结论美托洛尔联合苯那普利有利于患者心室重塑,改善心功能,降低QT离散度,减少24 h室性早搏数与24 h室性心动过速数,提高治疗效果。     

Pidotimod in the management of vulvar papillomatosis: double-blind clinical trial versus placebo

To investigate whether the immune system improvement induced by pidotimod increases the rate of spontaneous disappearance of vulvar papillomatous lesions, a multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Forty-nine patients (23 in the pidotimod group and 26 in the placebo group) with first diagnosis of vulvar papillomatosis as shown by clinical and histological findings underwent 90-day treatment with oral 800-mg pidotimod once a day or identical placebo. The main outcome measure was the difference between vulvar papillomatous infected area before and after treatment judged by the following: complete regression (complete disappearance of all papillomatous lesions); partial regression (a decrease of at least 75% of the infected area); no response (a decrease of less than 75% of the infected area or new viral lesions not present at baseline). Forty patients completed the trial according to the study protocol and were entered in the "per protocol" analysis of efficacy. Complete regression was observed in 12 of 18 patients (66.7%) receiving pidotimod compared with 7 of 22 patients (31.8%) receiving placebo. The total infected surface area at the end of treatment was 10.1 +/- 18.5 mm2 (mean +/- SD) in the pidotimod arm and 198.3 +/- 399.2 mm2 in the placebo arm (p < 0.05 between treatment). Notwithstanding the fact that better results were obtained in the pidotimod group, more data are needed to confirm our encouraging results.     

苯那普利联合美托洛尔治疗心力衰竭的疗效观察

目的观察苯那普利联合美托洛尔治疗充血性心力衰竭(CHF)的临床疗效。方法200例CHF均经临床表现、超声心动图及心脏二位片确诊,按就诊顺序随机分为A、B两组,A组100例给予苯那普利5~10 mg/d,美托洛尔6.25~100 mg/d,B组100例服同等剂量安慰剂,两组基础治疗类同。定期来院随访,坚持服药0.5~2.0年,平均服药时间为327 d,随访满半年后复查心脏B超,判定疗效的终点事件为临床心功能状况。结果苯那普利联合美托洛尔使CHF患者心率减慢,心功能改善,超声心动图复查显示左室舒张末期内径及左房内径缩小,左室射血分数增高,半年随访心功能改善者明显多于对照组。结论CHF患者长期服用苯那普利加美托洛尔可使其心功能改善,提高生活质量。     

The effects of statin therapy on inflammatory cytokines in patients with bacterial infections: a randomized double-blind placebo controlled clinical trial

Objective  To determine if statin therapy reduces the incidence of severe sepsis and the levels of inflammatory cytokines in patients with acute bacterial infection. Design  Double-blind placebo controlled randomized clinical trial. Setting  Department of medicine and medical intensive care unit in a tertiary university medical center. Patients and participants  A total of 83 patients with suspected or documented bacterial infection were enrolled. We randomly assigned 42 patients to receive 40 mg of simvastatin orally, followed by 20 mg of simvastatin, and 41 to receive matching placebo. Measurements and results  The study was prematurely terminated due to slow recruitment rate. Here we report the analysis of the secondary outcome: change in cytokines levels at 72 h. Both groups were evenly matched in terms of co-morbidity and severity of illness on admission. Four of the 83 patients enrolled developed severe sepsis, two in each group. No difference was observed in other clinical variables and there were no mortalities. Cytokine levels were randomly assessed in 40 patients (20 in each group). Both TNF-α and IL-6 levels were significantly reduced in the simvastatin group (p = 0.02 and p = 0.02, respectively), while no such difference was observed in the placebo group (p = 0.35 and 0.39, respectively). Conclusions  Statin therapy may be associated with a reduction in the levels of inflammatory cytokines in patients with acute bacterial infections. Large controlled trials will determine if this reduction will translate into a clinical benefit. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users.     

A randomized,double-blind,placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy

The objective of these studies was to assess the efficacy and safety of pregabalin in the treatment of human immunodeficiency virus (HIV)–associated neuropathic pain. Patients with HIV-associated distal sensory polyneuropathy (DSP) were randomized to treatment with flexible-dose pregabalin (150–600 mg/day) or placebo for 17 weeks in a single-blind, placebo lead-in, randomized, double-blind, parallel-group, placebo-controlled multinational trial. The primary efficacy outcome was the change in mean pain score on an 11-point numeric rating scale (NRS) from baseline to study endpoint. Participants who completed this trial were invited to participate in a 6-month open-label extension study with pregabalin. Of the 377 patients enrolled in the randomized controlled trial (pregabalin, n = 183; placebo, n = 194), 68.4% completed treatment. In the open-label extension, 217 patients were treated and 59.4% completed treatment. Both studies were terminated by the sponsor after a preplanned interim analysis indicated trial futility. At endpoint, the change from baseline in least-squares mean NRS pain scores in the intent-to-treat population was −2.04 for pregabalin versus −2.11 for placebo (P = .709). There were no significant differences between the pregabalin and placebo groups in the secondary efficacy measures. Incidence of adverse events was lower than seen in previous pregabalin studies. Overall, this trial did not show pregabalin to be more efficacious than placebo in treating HIV-associated DSP. Studies such as these, which fail to support their primary hypotheses, may be important in informing the methodology of future trials, especially when novel approaches to limit variability in the control group are included.     

A randomized,double-blind,placebo-controlled trial evaluating the efficacy and safety of ABT-594 in patients with diabetic peripheral neuropathic pain

ABT-594 is a neuronal nicotinic acetylcholine receptor (NNR) agonist that exhibits potent analgesic activity in preclinical models of acute, chronic, and neuropathic pain. The purpose of this phase 2, randomized, multicenter, double-blind, placebo-controlled study was to evaluate the safety and analgesic efficacy of ABT-594 in patients with diabetic peripheral neuropathic pain (DPNP). A total of 266 DPNP patients were randomized 1:1:1:1 to receive placebo, ABT-594 150 μg BID, ABT-594 225 μg BID, or ABT-594 300 μg BID. Patients were titrated to a fixed-dose of ABT-594 over 7 days and remained at this dose for another 6 weeks. Compared to placebo, all three ABT-594 treatment groups showed significantly greater decreases on the average diary-based 0–10 Pain Rating Scale (PRS) score from baseline to final evaluation, the primary efficacy measure (placebo, −1.1; 150 μg BID, −1.9; 225 μg BID, −1.9; 300 μg BID, −2.0). The proportion of patients achieving at least a 50% improvement in the average diary-based PRS was greater in all three ABT-594 treatment groups. However, adverse event (AE) dropout rates were significantly higher in all three ABT-594 treatment groups (28% for 150 μg BID, 46% for 225 μg BID, and 66% for 300 μg BID) than for the placebo group (9%). Consistent with the expected side-effect profile of NNR agonists, the most frequently reported AEs were nausea, dizziness, vomiting, abnormal dreams, and asthenia. This study establishes proof of concept for NNR agonists as a new class of compounds for treating neuropathic pain.     

0.1%西吡氯铵含漱液治疗牙龈炎和抑制菌斑疗效及安全性的多中心随机双盲临床试验

目的 对0．1％西吡氯铵含漱液治疗牙龈炎和抑制菌斑的疗效及安全性进行评价。方法多中心随机、双盲、阳性药物对照、左右半口对照设计。首诊(D0)时对左侧上下牙齿洁治，结束时右侧洁治。两组均每日漱口5次，方法相同。从治疗前后临床及微生物学改变评价疗效，第4(D4)、8(D8)日复查。D0-D4停止刷牙，D4-D8恢复刷牙。结果 符合纳入标准144例，4例失访，试验组69例、对照组71例可进行分析。基线分析表明两组性别年龄分布、临床及微生物学指标均具有可比性。D4复查治牙侧两组菌斑累积量在同一水平并均显低于未治牙侧。两侧牙龈指数(GI)、出血指数(SBI)及口臭VAS记分均显低于基线值。D8复查两组菌斑指数(PI)、GI、SBI、口臭VAS比D4复查值进一步显减少，菌斑及唾液中可疑致病菌半数以上被清除，菌量显减少，但组间比较均无显差异，均未见菌群失调。试验组17例(24．6％)发生不良反应，均轻微一过性。体外抑菌实验证实试验药可杀灭或抑制多种与口咽、颌面部感染、牙龈炎、牙周炎、龋齿等有关的可疑致病菌。结论 西吡氯铵含漱液确能减少或抑制牙菌斑的形成、治疗牙龈炎、减少口臭，与国家已批准上市的西吡氯铵含漱液疗效相同。     

抗心衰标准三联疗法联合应用美托洛尔治疗老年人慢性充血性心力衰竭

目的　探讨 β 肾上腺素能受体阻滞剂美托洛尔治疗老年人慢性充血性心力衰竭 (congestiveheartfailure ,CHF)的有效性和安全性。方法　采用多中心、随机、单盲、安慰剂对照、平行组试验。入选老年CHF患者 2 36例 ,随机分为美托洛尔组 (A组 )和对照组 (B组 ) ,均予标准抗心衰治疗 (依那普利、速尿、地高辛 ) ;A组联用美托洛尔 6 .2 5～15 0mg/d ,B组联用与美托洛尔外观相同的淀粉安慰剂。观察治疗前和治疗后 1个月、6个月、12个月时的临床指标变化 ,评价其临床有效性和安全性。结果　与B组比较 ,A组心率、血压下降迅速且持久 (P <0 .0 5 ) ;无创心排量指标和临床心功能分级于 6个月时亦显著改善 (P <0 .0 5 ) ,12个月时改善更显著 ;总心脏事件的发生率于 12个月时也显著减少 (P <0 .0 5 )。结论　长期应用美托洛尔可明显改善老年人CHF患者的心脏功能 ,提高患者的生活质量和生存率 ,安全可靠     

A multicentre trial to evaluate the efficacy and tolerability of alpha-glycerylphosphorylcholine versus cytosine diphosphocholine in patients with vascular dementia

An open clinical trial was carried out to compare the efficacy and the tolerability of 1 g/day alpha-glycerylphosphorylcholine (alpha-GPC) with 1 g/day cytosine diphosphocholine (CDP) both given intramuscularly for 90 days in 120 patients with mild to moderate vascular dementia. The clinical evaluation, carried out at the start as well as halfway through (45 days) and at the end of treatment (90 days), was expressed by psychometric tests (modified Parkside behaviour rating scale, Sandoz clinical assessment geriatric scale, word fluency test, Hamilton's rating scale of depression, narration subtest of Wechsler memory scale). Both treatments produced a definite symptomatic improvement and showed a very good tolerability. The results suggest that in most tests alpha-GPC possessed a statistical higher efficacy and an overall more satisfactory activity assessed by both patients and investigators compared with CDP.     

静脉点滴呋噻米治疗难治性充血性心力衰竭23例

目的评价呋噻米静脉点滴（简称静点）治疗难治性充血性心力衰竭的疗效。方法常规治疗加静脉注射呋噻米效果差的充血性心力衰竭23例,加用大剂量呋噻米静脉点滴5d,观察静点呋噻米的利尿效应,实验治疗前后监测血压、电解质、心率及体重。治疗过程中适当补充钠钾和维持血压。结果静点呋噻米每日尿量较实验治疗前明显增加（P〈0.01）;第2、3、4、5天静点呋噻米量明显少于静点前一天静注剂量及第一天静点剂量（P〈0.05,0.01）;实验治疗后心率、体重及血压显著降低（P〈0.05,0.01）,实验治疗前后血清钾和血清钠无明显改变（P〉0.05）。实验治疗后所有患者临床症状和体征明显改善。结论大剂量静点呋噻米用于难治性充血性心力衰竭患者安全有效。     

Effectiveness of the clinical pathway in the management of congestive heart failure

BACKGROUND: The prevalence of congestive heart failure (CHF) in the United States is approximately 4 million, with associated annual health care expenditures exceeding dollar 8 billion. Clinical pathways for CHF have been developed, but they have not been rigorously evaluated regarding efficacy and improvement in the quality of care. We sought to evaluate the effect of a CHF clinical pathway on hospital charges, length of stay, and use of angiotensin-converting enzyme (ACE) inhibitors in patients with CHF in a retrospective cohort study. METHODS: We studied 371 patients (age range, 44-92 yr) with discharge diagnoses of CHF in a 376-bed community hospital between July 1996 and December 1997. We conducted chart reviews to determine length of stay, hospital charges, and use of ACE inhibitors. RESULTS: Of the 371 patients, 174 were assigned to the clinical pathway and 197 were not. Baseline characteristics of the two groups were similar. The benchmark of less than 4 days' in-hospital stay was achieved in 65% of patients on the pathway and 42% who were not on the pathway (odds ratio, 2.6; 95% confidence interval, 1.67-4.05; P < 0.001). The median hospital charges were lower in the group on the clinical pathway (dollar 3,000 versus dollar 5,500, P < 0.001). In addition, 81% of the patients on the clinical pathway were administered ACE inhibitors, compared with 48% of equally eligible patients from the nonpathway group (odds ratio, 4.68; 95% confidence interval, 2.85-7.72; P < 0.001). CONCLUSION: The clinical pathway for CHF was associated with increased use of ACE inhibitors as well as reduced length of stay and hospital charges.     

Acrivastine in two doses compared with placebo in a multicentre, parallel group study for the treatment of seasonal allergic rhinitis

In a placebo controlled, randomised, multicentre study the efficacy and safety of multiple doses of acrivastine, a derivative of the antihistamine tripolidine (Actidil) were evaluated in patients exhibiting symptoms of seasonal allergic rhinitis. Over the 10 day treatment period, 103 patients received, twice daily, either 4 mg and 8 mg of acrivastine or a placebo. Three patients withdrew from the study due to poor symptom control and two due to adverse experiences. The reporting of adverse experiences was evenly distributed between the treatment and placebo periods. Acrivastine did not affect the haematological, biochemical or urinalysis screens. Both 4 mg and 8 mg acrivastine alleviated the symptoms of seasonal allergic rhinitis with significant improvements in the symptom scores for sneezing, running nose and the calculated overall score. In addition, 8 mg acrivastine reduced the symptom scores for watery eyes and itchy throat. Acrivastine was both well tolerated and effective in the treatment of seasonal allergic rhinitis.