Comparison of three different combination therapies in the treatment of human brucellosis

The efficacy and tolerability of three different combination treatment regimens in human brucellosis were compared in 118 uncomplicated patients enrolled in a prospective study between May 1997 and December 2002. Brucellosis was diagnosed using standard clinical and microbiological findings. Patients with central nervous system involvement, spondylitis, endocarditis or children under 16 years of age were excluded from the study. Patients were randomly assigned to receive 400 mg of ofloxacin plus 600 mg of rifampicin (OR, n = 41), 200 mg of doxycycline plus 600 mg of rifampicin (DR, n = 45) or 1g intramuscularly streptomycin (administered for three weeks) plus 200 mg doxycycline (DS, n = 32) daily for 6 weeks. All patients were followed up at least 6 months after cessation of therapy.There was no statistical difference between the groups on relapse rates and clinical response to the treatment (P>0.05). Five patients in OR (12.8%), six patients in DR (14.3%) and three patients in DS groups (9.7%) suffered relapse. The side-effects were seen in eight (19.5%), 21 (46.7%) and eight (25.0%) patients of OR, DR and DS groups, respectively.The use of combination therapy of ofloxacin plus rifampicin for 6 weeks was found to be as effective as DR and DS. The side-effects of therapy in OR and DS groups was less severe than in the DR group.     

Treatment of human brucellosis with doxycycline plus rifampin or doxycycline plus streptomycin. A randomized, double-blind study.

OBJECTIVE: To compare the effectiveness of doxycycline-rifampin (DR) combination therapy with that of the classic doxycycline-streptomycin (DS) combination in patients with brucellosis. DESIGN: A randomized, double-blind study, with a mean follow-up of 15.7 months. SETTING: A 1000-bed teaching hospital in Barcelona, Spain. PATIENTS: Ninety-five patients (68 men and 27 women; mean age, 39 years) diagnosed with brucellosis on the basis of both clinical and serologic findings; 81 of these patients had blood cultures positive for Brucella melitensis. INTERVENTIONS: Forty-four patients received doxycycline, 100 mg every 12 hours, and rifampin, 15 mg/kg body weight per day in a single morning dose, for 45 days; 51 patients received the same dose of doxycycline for 45 days plus streptomycin, 1 g/d for 15 days. MAIN OUTCOME MEASURES: Therapeutic failure and relapse during the follow-up period. RESULTS: The mean time to defervescence was 4.2 days for the DR group and 3.2 days for the DS group (P greater than 0.2). The actuarial probability of therapeutic failure or relapse at 12 months of follow-up (Kaplan-Meier) was 14.4% in the DR group and 5.9% in the DS group (difference, 8.5%; 95% Cl, -4.8% to 21.6%; P greater than 0.2). All three patients with spondylitis in the DR group failed therapy compared with one of four patients in the DS group. Excluding patients with spondylitis, the actuarial failure rate was 4.9% and 4.3% in the DR and DS groups, respectively, at 12 months of follow-up (difference, 0.6%; Cl, -8.1% to 9.4%; P greater than 0.2). CONCLUSIONS: Doxycycline-rifampin combination therapy for 45 days is as effective as the classic DS combination in most patients with brucellosis; however, DR therapy might be less effective in those patients with spondylitis.     

The relationship between ritonavir plasma levels and side-effects: implications for therapeutic drug monitoring.

OBJECTIVES: To assess whether the neurological or gastrointestinal adverse effects of ritonavir correlate with parameters of ritonavir systemic exposure. METHODS: Peak (Cmax) and trough (Cmin) ritonavir plasma levels were compared in 11 patients experiencing side-effects (group A) versus 10 patients without side-effects (group B). Ritonavir was administered with the following escalation dosing scheme: 300, 400, 500 mg twice a day for 3, 4, and 5 days, respectively, then the full dose of 600 mg twice a day. Blood sampling was done in group A within 24 h of the occurrence of side-effects and in group B after at least 3 days of the full dosage regimen. RESULTS: Both Cmax and Cmax were significantly higher (Mann-Whitney U test) in patients with side-effects. Cmax was [median (interquartile range)] 26.7 (22.7-33.3) mg/l versus 16.2 (13.4-17.0) mg/l (P = 0.001) and Cmin was 12.6 (9.1-13.9) versus 7.5 (4.9-8.6) mg/l (P = 0.002). CONCLUSION: Patients with higher ritonavir concentrations are at a higher risk of experiencing neurological or gastrointestinal side-effects. Individualization of the dosage regimen, e.g. a downward titration of the ritonavir dose in patients with side-effects, guided by plasma level monitoring, may result in a substantial increase in the percentage of patients tolerating ritonavir without increasing the risk of treatment failure as a result of suboptimal systemic exposure.     

泮托拉唑四联5d疗法与7d疗法随机对照研究

目的:比较泮妥拉唑四联5d疗法和7d疗法的Hpylori根除率和症状缓解率.方法:H pylori阳性的胃炎、胃溃疡或十二指肠患者70例随机接受5d(34例)或7d(36例)泮妥拉唑四联疗法:泮妥拉唑40mg、克拉霉素250mg、阿莫西林1.0g和胶体枸橼酸铋钾220 mg,均为2次/d.根除治疗后第4周复查H pylori是否根除,了解症状缓解情况.结果:5d组H pylori根除率为84.8%(PP)和82.4%(ITT),7d组H pylori根除率为88.2%(PP)和83.3%(ITT),5d组疼痛缓解率为72.0%(PP)和69.2%(ITT),7d组疼痛缓解率为83.9%(ITT)和89.7%(PP).按PP及ITT组群分析,两组方案H pylori根除率及疼痛缓解率无明显差异,两组患者均未出现严重不良反应.结论:泮妥拉唑四联5d疗法可以获得较高的H pylori根除率和疼痛缓解率,可以作为H pylori根除治疗的一线治疗方案.     

Sucralfate versus ranitidine in non-ulcer dyspepsia: results of a prospective, randomized, open, controlled trial.

In an open trial, 100 patients with non-ulcer dyspepsia were randomized to receive either ranitidine 150 mg twice daily (n = 47) or sucralfate 1 g four times a day (n = 53) for four weeks. An 'intention to treat' analysis revealed that global relief in symptoms was significantly more frequent in the sucralfate group than in the ranitidine group after two weeks (77.4% vs 59.6%; p less than 0.05) and four weeks (86.8% vs 63.8%; p less than 0.001) of treatment. It is concluded that sucralfate is superior to ranitidine in providing symptomatic relief in patients with non-ulcer dyspepsia.     

Efficacy and safety of propafenone sustained release in the prophylaxis of symptomatic paroxysmal atrial fibrillation (The European Rythmol/Rytmonorm Atrial Fibrillation Trial [ERAFT] Study)

We report a double-blind, multicenter, multinational, placebo-controlled, and well-controlled trial to prove that the sustained-release (SR) formulation of propafenone is superior to placebo in preventing symptoms of paroxysmal atrial fibrillation (AF). A total of 594 patients were enrolled in the qualifying period of the study and 293 patients were randomized at 53 centers. There were significant increases in the arrhythmia-free periods from day 5 of randomization to the first recurrence of symptomatic atrial arrhythmia in the propafenone SR 325 mg twice daily (p = 0.004) and propafenone SR 425 mg twice daily (p = 0.003) treatment groups compared with placebo. The median arrhythmia-free time was 9 days in the placebo group, 35 days in the propafenone SR 325 mg twice daily group, and 44 days in the propafenone SR 425 mg twice daily group. There was a significant reduction in average heart rate during the first recurrence of symptomatic arrhythmia after day 5 in the low-dose propafenone group compared with placebo. The median treatment failure time from day 5 (arrhythmia recurrence, adverse events, and withdrawals) was prolonged from 8 days in the placebo group to 19 days in the propafenone SR 325 mg twice daily group (p = 0.002) and to 24 days in the propafenone SR 425 mg twice daily group (p = 0.006). The percentage of patients with ≥1 serious adverse event was similar in the propafenone SR treatment groups (propafenone SR 325 mg twice daily, 10.0%; propafenone SR 425 mg twice daily, 11.2%) but lower in the placebo group (1.1%). In conclusion, the SR formulation of propafenone is superior to placebo, well-tolerated, and prevents symptoms of paroxysmal AF.     

Effect of Budesonide Enema on Remission and Relapse Rate in Distal Ulcerative Colitis and Proctitis

Background: Glucocorticosteroid enemas are equally effective as 5-ASA enemas in the treatment of active distal ulcerative colitis (UC). With the introduction of budesonide, the risk of systemic side effects may be reduced. We investigated whether budesonide enema, 2 mg/100 ml, administered twice daily (b.i.d.) could increase the remission rate in comparison with the once daily (o.d.) standard regimen. Furthermore, we evaluated whether 2 mg budesonide enema, given twice weekly, could have a relapse preventing effect. Methods: 149 patients with active distal UC were treated in a controlled, double-blind multicentre study with two parallel groups: placebo enema in the morning and budesonide enema in the evening (i.e. 2 mg/day) or budesonide enema b.i.d. (i.e. 4 mg/day) until remission (absence of clinical symptoms and endoscopic healing) or at most 8 weeks. Patients in remission were randomized to either budesonide enema or placebo enema twice weekly for 24 weeks or until relapse. Results: The remission rates at 4 weeks were 33% for o.d. and 41% for b.i.d. regimens (NS) and correspondingly 51% and 54% at 8 weeks (NS). The b.i.d. group had an increased frequency of impaired adrenal function, 32% versus 4.8% ( P = 0.001). The relapse rates during maintenance treatment with budesonide enema and placebo were 15% versus 24% after 8 weeks, 31% versus 27% after 16 weeks and 41% versus 51% after 24 weeks (NS). Conclusion: Budesonide enema 2 mg o.d. appears to be the optimal dosage in active distal UC. We could not show that budesonide enema twice weekly is sufficient to maintain remission.     

Comparison of etretinate (Tigason) and parenteral gold in the treatment of psoriatic arthropathy

Etretinate is a synthetic vitamin A derivate given orally for the treatment of severe skin psoriasis. This drug has been reported to be effective also in psoriatic arthropathy and in this study we compared the efficacy and side-effects of etretinate with those of parenteral gold. Sixteen out of 18 patients completed 6 months of therapy with etretinate (initial dose 0.7 mg/kg/day) whereas only 7/9 patients completed 6 months of therapy with parenteral gold. A statistically significant decrease in the joint index occurred in both groups. In the etretinate group, the musculoskeletal symptoms improved considerably in 12 (67%) patients completing the treatment, and at the end of therapy also the skin lesions had healed or improved markedly in most patients. In two patients the reasons for terminating etretinate treatment were hypertriglyceridaemia and epigastric pain. In the gold group, seven patients could not complete the treatment regimen due to the common toxic side-effects of gold. The results of this study confirm that both etretinate and parenteral gold are effective in treating psoriatic arthropathy, and show that etretinate treatment seems to cause fewer harmful side-effects than chrysotherapy with parenteral gold.     

Healing and prevention of relapse of reflux oesophagitis by cisapride.

Altogether, 138 patients were included in a study aimed at evaluating the effect of cisapride on healing and relapse of oesophagitis shown endoscopically. In the first phase of the study cisapride was given in an open fashion at 10 mg four times a day for 8 to 16 weeks, and healing was obtained in 69% of patients. Healing occurred later in patients with grades II to IV oesophagitis. The total score for reflux symptoms decreased by 67%. Eighty of the healed patients were included in the second phase. They were randomly assigned to double blind treatment with either cisapride 10 mg (n = 37) or placebo (n = 43) twice a day. Control endoscopy was performed when symptoms recurred or at the end of the six month trial. The cumulative percentage of patients in remission was higher (p = 0.06, survival analysis) in the cisapride group than in the placebo group, the relapse rates being 20% and 39%. The duration of remission tended to be longer in patients with a lower initial degree of oesophagitis. Adverse effects were no more frequent with cisapride than with placebo. In conclusion, cisapride is efficacious in healing oesophagitis, and, unlike other gastrointestinal prokinetic drugs or low dose cimetidine (400-800 mg daily) or ranitidine (150 mg daily), it may prevent relapse of oesophagitis.     

Comparison between cimetidine and Caved-S in the treatment of gastric ulceration, and subsequent maintenance therapy.

One hundred patients with benign gastric ulceration were treated in a single-blind, endoscopically controlled trial to assess the relative efficacy of cimetidine (1 g daily) and Caved-S (six tablets daily). Ulcer healing was assessed after six weeks' treatment, and, if incomplete, after a further six weeks. There was no significant difference between the two drug regimens (approximately 63% at six weeks and 91% at 12 weeks). If an ulcer remains unhealed after 10 weeks' treatment the patient should undergo surgery. There was no difference in the relief of day pain between the two drug regimens but cimetidine was more effective over the first two weeks of treatment relieving night pain, than was Caved-S (p less than 0 . 02). After ulcer healing, drug dosage was reduced (cimetidine to 400 mg at night and Caved-S to two tablets twice daily). So far, 56 patients, 28 in each group, have completed the first year's maintenance treatment, and there have been four ulcer recurrences in each group (14%).     

Esomeprazole regimens for reflux symptoms in Chinese patients with chronic gastritis

AIM: To compare symptom control with esomeprazole regimens for non-erosive reflux disease and chronic gastritis in patients with a negative endoscopy.METHODS: This randomized, open-label study was designed in line with clinical practice in China. Patients with typical reflux symptoms for ≥ 3 mo and a negative endoscopy who had a Gastroesophageal Reflux Disease Questionnaire score ≥ 8 were randomized to initial treatment with esomeprazole 20 mg once daily either for 8 wk or for 2 wk. Patients with symptom relief could enter another 24 wk of maintenance/on-demand treatment, where further courses of esomeprazole 20 mg once daily were given if symptoms recurred. The primary endpoint was the symptom control rate at week24 of the maintenance/on-demand treatment period.Secondary endpoints were symptom relief rate, success rate(defined as patients who had symptom relief after initial treatment and after 24 wk of maintenance treatment), time-to-first-relapse and satisfaction rate.RESULTS: Based on the data collected in the modified intention-to-treat population(MITT; patients in the ITT population with symptom relief after initial esomeprazole treatment, n = 262), the symptom control rate showed a small but statistically significant difference in favor of the 8-wk regimen(94.9% vs 87.3%, P = 0.0473).Among the secondary endpoints, based on the data collected in the ITT population(n = 305), the 8-wk group presented marginally better results in symptom relief after initial esomeprazole treatment(88.3% vs83.4%, P = 0.2513) and success rate over the whole study(83.8% vs 72.8%, P = 0.0258). The 8-wk regimen was found to provide a 46% reduction in risk of relapse vs the 2-wk regimen(HR = 0.543; 95%CI:0.388-0.761). In addition, fewer unscheduled visits and higher patient satisfaction supported the therapeutic benefits of the 8-wk regimen over the 2-wk regimen.Safety was comparable between the two groups, with both regimens being well tolerated.CONCLUSION: Chinese patients diagnosed with chronic gastritis achieved marginally better control of reflux symptoms with an 8-wk vs a 2-wk esomeprazole regimen, with a similar safety profile.     

Effect of budesonide enema on remission and relapse rate in distal ulcerative colitis and proctitis

BACKGROUND: Glucocorticosteroid enemas are equally effective as 5-ASA enemas in the treatment of active distal ulcerative colitis (UC). With the introduction of budesonide, the risk of systemic side effects may be reduced. We investigated whether budesonide enema, 2 mg/100 ml, administered twice daily (b.i.d.) could increase the remission rate in comparison with the once daily (o.d.) standard regimen. Furthermore, we evaluated whether 2 mg budesonide enema, given twice weekly, could have a relapse preventing effect. METHODS: 149 patients with active distal UC were treated in a controlled, double-blind multicentre study with two parallel groups: placebo enema in the morning and budesonide enema in the evening (i.e. 2 mg/day) or budesonide enema b.i.d. (i.e. 4 mg/day) until remission (absence of clinical symptoms and endoscopic healing) or at most 8 weeks. Patients in remission were randomized to either budesonide enema or placebo enema twice weekly for 24 weeks or until relapse. RESULTS: The remission rates at 4 weeks were 33% for o.d. and 41% for b.i.d. regimens (NS) and correspondingly 51% and 54% at 8 weeks (NS). The b.i.d. group had an increased frequency of impaired adrenal function, 32% versus 4.8% (P = 0.001). The relapse rates during maintenance treatment with budesonide enema and placebo were 15% versus 24% after 8 weeks, 31% versus 27% after 16 weeks and 41% versus 51% after 24 weeks (NS). CONCLUSION: Budesonide enema 2 mg o.d. appears to be the optimal dosage in active distal UC. We could not show that budesonide enema twice weekly is sufficient to maintain remission.     

Efficacy of short-term corticosteroid therapy in outpatient treatment of acute bronchial asthma

A group of adults with 76 episodes of acute asthma needing emergency therapy, but not requiring hospitalization, were discharged from an emergency department following standardized therapy with bronchodilators. Upon discharge, the patients were treated with a controlled regimen of oral theophylline, and were randomly assigned in double-blind manner to either a placebo treatment (42 patient episodes) or a corticosteroid treatment group (34 patient episodes). The latter were given an intravenous bolus of methylprednisolone followed by an eight-day tapering course of oral methylprednisolone, starting at 32 mg twice a day. Follow-up was carried out seven or 10 days after treatment in the emergency department. Relapse could not be predicted on the basis of peak expiratory flow rates measured during care in the emergency department. Those patients who received corticosteroids had a decrease in the need for repeated emergency care (5.9 percent versus 21 percent for placebo) and fewer respiratory symptoms (15.6 percent versus 36.4 percent for placebo). It is concluded that a short course of high-dose corticosteroids in outpatients reduces the relapse rate and symptoms following an acute asthmatic attack.     

根除幽门螺杆菌对功能性消化不良疗效的研究

背景:功能性消化不良(FD)的患病率始终居高不下,目前就幽门螺杆菌(H.pylori)阳性的FD患者是否需根除H.pylori尚存在争议。目的:探讨根除H.pylori对H.pylori阳性FD患者的疗效。方法:200例H.pylori阳性FD患者随机分为治疗组(100例.予以枸橼酸铋雷尼替丁400mg+阿莫西林1000mg+克拉霉素250mg,2次/d,疗程1周)和对照组(100例,予以铝碳酸镁1000mg,3次/d,疗程1周)。随访结束后评估H.pylori根除率和FD症状改善情况。结果:治疗组的H.pylori根除率分别为87.5%(PP分析)和84.0%(ITT分析),对照组H.pylori根除率为0%。H.pylori根除亚组FD症状改善的总有效率显著高于H.pylori未根除亚组和对照组(90.5%对41.7%和45.9%,P0.01)。结论:部分H.pylori阳性FD患者根除H.pylori后,其症状可长期缓解,因此对部分H.pylori阳性FD患者根除H.pylori是一种值得推广的有效治疗手段。     

Effect of cisapride on relapse of esophagitis

The effect of a prokinetic agent, cisapride, on the relapse of reflux esophagitis was investigated in a randomized, double-blind trial conducted in 443 patients whose esophagitis had previously been healed with an acid antisecretory drug. Patients received cisapride, 20 mg at night, cisapride 10 mg twice daily, or placebo for 12 months or until endoscopic relapse was confirmed endoscopically. In 88% of all patients (respectively 133, 132, and 124), endoscopic data were available at discontinuation of treatment. In comparison with placebo, the two cisapride regimens prolonged both the time to endoscopically confirmed relapse (Kaplan-Meier analysis;P=0.001) and the time to symptomatic relapse (P=0.012). The life-table endoscopic relapse rates at 12 months were 51% for placebo, 32% for cisapride 20 mg at night (P=0.005), and 34% for cisapride 10 mg twice daily (P=0.02). Patients with more severe esophagitis before healing relapsed more rapidly during maintenance therapy, regardless of the treatment regimen. Adverse events were infrequent in all three groups. These findings indicate that maintenance treatment with the prokinetic drug cisapride prevents the relapse of esophagitis after it has been healed by acid antisecretory therapy.This work was supported by the Janssen Research Foundation and the Swiss National Foundation. Grant SNF 32-26369.89.     

Maintenance treatment with budesonide 6 mg versus 9 mg once daily in patients with Crohn's disease in remission

BACKGROUND: In previous trials, budesonide 6 mg/day was able to prolong the time to relapse in patients with quiescent Crohn's disease and budesonide 9 mg/day was effective in active disease with limited side effects. The aim of this study was to compare the effectiveness of budesonide 9 mg vs 6 mg once daily on the maintenance of remission and occurrence of adverse events. METHODS: Double-blind, randomised trial in patients with Crohn's disease in remission. Patients were randomised to receive 6 mg/day or 9 mg/day of budesonide (Budenofalk) without concomitant treatment for Crohn's disease. Endpoints were the time to relapse and relapse rates after one year. RESULTS: Seventy-six patients were randomised to 6 mg/day and 81 patients to 9 mg/day. Survival analysis showed no differences in the time to relapse. One-year relapse rates were not significantly different (6 mg group 24%; 9 mg group 19%). Any adverse event was reported in 61 and 68% of patients in the 6 mg and 9 mg groups, respectively; none of the 12 serious adverse events were drug related. CONCLUSION: The one-year relapse rates were low and not significantly different between the group of patients treated with budesonide 6 mg vs 9 mg/day. Also, time to relapse and the number of adverse events were similar in both treatment groups.     

Ciprofloxacin once daily versus twice daily for the treatment of pulmonary tuberculosis

Summary Ciprofloxacin was used as an antituberculous drug in adult patients who could not tolerate standard regimens or had to be treated with alternative combinations for resistance problems. During October 1986 to December 1991, 241 patients received ciprofloxacin in two daily 500 mg doses administered under supervision at 8.30 a.m. and 5 p.m., respectively. This group of patients was submitted to retrospective analysis for tolerability and clinical as well as microbiological efficacy. In January 1992, a once daily regimen with 1,000 mg of ciprofloxacin was introduced in order to simplify drug administration together with the other combination partners and to take advantage of higher drug levels at the site of infection. These patients were followed prospectively for safety and efficacy. Until July 1993, 227 patients with smear-positive pulmonary tuberculosis were included in this open study. Comparative analysis was carried out for a selected group of patients who had remained smear and culture positive for more than 27 days after start of treatment. Fifty-four patients who had received ciprofloxacin twice daily and 35 patients on the once daily regimen were evaluable. Both regimens were equally well tolerated. The once daily regimen was associated with a trend towards earlier conversion to smear negativity and a significantly shorter time to culture negativity. Smears became negative on average within 84 days with the once daily and in 94 days with the twice daily schedule (p=0.19). Culture negativity occurred at 60 and 76 days in the respective groups (p=0.0013; log Rank test). Of the patients who received ciprofloxacin twice daily, 33% were still smear and culture positive 90 days after start of treatment compared to only 15% of the patients treated with the once daily schedule. We conclude that ciprofloxacin, given as a single daily dose of 1,000 mg is as safe as two 500 mg doses, more convenient to apply and probably more efficacious.     

Amoxicillin plus omeprazole versus triple therapy for eradication of Helicobacter pylori in duodenal ulcer disease: a prospective, randomized, and controlled study.

Treatment with amoxicillin and omeprazole resulted in encouraging Helicobacter pylori eradication rates in pilot studies that included medium term follow up. These results were evaluated in a prospective, randomised and controlled study. Forty patients with active duodenal ulcer disease and H pylori colonisation of the gastric mucosa were randomly assigned to receive either omeprazole (20 mg twice daily) and amoxicillin suspension (500 mg four times daily) for two weeks (group I) or bismuth subsalicylate (600 mg three times daily), metronidazole (400 mg three times daily), tetracycline (500 mg three times daily), and ranitidine (300 mg in the evening) for two weeks (group II). Study medication was followed in both groups by a four week treatment course with 300 mg ranitidine up to the final examination. One patient from each group was lost to follow up. H pylori was eradicated in 78.9% of group I and 84.2% of group II (p = 1.00). All ulcers in patients on omeprazole plus amoxicillin healed but in the triple treatment group four patients had residual peptic lesions after six weeks (ulcer healing rate: 78.9%, p = 0.11). Complete pain relief occurred after a median duration of 1 day in group I and of 6 days in group II (p = 0.03). There were no major complications in either group but minor side effects were more frequently recorded in patients on triple therapy (63.2% v 15.8%, p < 0.01). In conclusion, two weeks of treatment with omeprazole plus amoxicillin is as good as triple therapy plus ranitidine in eradicating H pylori but seems better with regard to safety, pain relief, and ulcer healing. Thus, amoxicillin plus omeprazole should be recommended as the treatment of choice in eradicating H pylori in patients with duodenal ulcer disease.     

Shortening diclofenac therapy by B vitamins. Results of a randomized double-blind study, diclofenac 50 mg versus diclofenac 50 mg plus B vitamins, in painful spinal diseases with degenerative changes

The use of nonsteroidal anti-inflammatory drugs (NSAID) such as diclofenac for treatment of degenerative rheumatic disorders of the lumbar spine is of great significance in orthopedic practice. Clinical studies have shown that concomitant treatment with vitamins B1, B6, B12 and diclofenac provides more efficient pain relief than treatment using diclofenac alone. This study was undertaken in order to determine whether the duration of treatment with diclofenac for lower back pain can be shortened by adding B-vitamins to the therapeutic regimen. From September through December of 1986, 256 patients participated in a multicenter, controlled, randomized double-blind trial which compared the clinical efficacy of diclofenac (50 mg) with a combined therapy of diclofenac (50 mg) and vitamins B1, B6, and B12 (thiamine nitrate, pyridoxine hydrochloride, and cyanocobalamine, resp.; in dosages of 50 mg, 50 mg, and 0.25 mg, resp.). Patients were treated with 3 X 1 capsule daily for a maximum of two weeks, having the option to terminate participation in the trial after 1 week in the event of total pain relief. The data of 238 patients were able to be included in the evaluation. 29 patients opted to discontinue therapy due to remission on symptoms. Nineteen (65.6%) of these patients belonged to the combined therapy group, the other 10 (34.4%) having taken diclofenac alone; this difference is statistically significant (p less than 0.05). An important aspect in the evaluation of therapy was the patient response regarding the improvement of painful symptoms which, in addition to their subjective feedback, was reflected in the test results of the "Hoppe Pain Questionnaire (HPQ)." All parameters used as a measure of pain relief indicated superior results with the B-vitamin supplemented therapy when compared with results obtained with diclofenac alone. Moreover, after 3 days of therapy the "sensory" pain factor "sharpness" improved significantly. Undesirable side-effects were documented with 39 patients, 14 of them having discontinued therapy for this reason. No statistically significant difference could be determined within this group with regard to therapy. The study results document the positive influence of B-vitamins on painful symptoms and indicate that less NSAID is needed for pain relief when combined with B-vitamins.     

Two and four weeks' treatment for duodenal ulcer. Symptom relief and clinical remission comparing omeprazole and ranitidine. Scandinavian Clinics for United Research

In a Swedish-Norwegian multicentre study patients with endoscopically verified duodenal ulcers (greater than 5 mm) were randomized to 2 or 4 weeks of treatment with either 20 mg omeprazole once daily or 300 mg ranitidine once daily. The aim was to evaluate 2 and 4 weeks' treatment with regard to symptomatic improvement during treatment, relapse after treatment, and safety of the two drugs. Endoscopy was not performed to check healing at the end of treatment. Instead the patients were instructed to contact the investigator in the event of recurrence of symptoms for renewed endoscopy. Follow-up was ended 10 weeks after stopping active treatment. Altogether 450 patients were evaluated at 17 centres. The symptomatic improvement during treatment was good in all groups, with significantly better reductions of daytime pain and heartburn in omeprazole-treated patients. Symptomatic relapse was commonest in the 2-week ranitidine group (57%), significantly more than in the 2-week omeprazole group (31%) (p less than 0.003). In the 4-week groups relapse rates were 34% (ranitidine) and 39% (omeprazole) (NS). It is suggested that in the short-term treatment of acute duodenal ulcer 20 mg omeprazole once daily is most rationally used in a 2- to 4-week regimen, whereas 300 mg ranitidine once daily should not be used for less than 4 weeks.