Choice of plate may affect outcomes for single versus multilevel ACDF: results of a prospective randomized single-blind trial. Endodontic flare-ups: comparison of incidence between single and multiple visit procedures in patients attending a Nigerian teaching hospital. Prospective randomised trial of single and multifraction radiotherapy schedules in the treatment of painful bony metastases. 8 Gy single fraction radiotherapy for the treatment of metastatic skeletal pain: randomised comparison with a multifraction schedule over 12 months of patient follow-up. Bone Pain Trial Working Party. Single-dose v. short-term antibiotic therapy for prevention of wound infection in general surgery. A prospective, randomized double-blind trial. Postobturation pain after single- and multiple-visit endodontic therapy. A prospective study. A randomized phase II study comparing sequential versus simultaneous chemo-radiotherapy in patients with unresectable locally advanced squamous cell cancer of the head and neck. [Transdermal nitroglycerin versus corticosteroid infiltration for rotator cuff tendinitis]. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy--results of a multicentric randomized German trial in advanced head-and-neck cancer. Randomized comparisons of radiotherapy and nitrosoureas for the treatment of malignant glioma after surgery. Randomized prospective clinical study of small, large and twice-a-day fraction radiotherapy for painful bone metastases. Controlled study with BCNU vs. CCNU as adjuvant chemotherapy following surgery plus radiotherapy for glioblastoma multiforme.
Conflicting views exist according to the individual philosophy about various plate designs that can be used in anterior cervical discectomy and fusion (ACDF) to achieve clinical and radiological improvement within shortest time period. No prospective randomized study has ever been conducted to clarify the relationship between clinical outcomes, fusion rates, and the choice of plate (static vs. dynamic design).
                To compare the clinical and radiological outcomes of patients treated with one-level or multiple levels ACDF using cervical plates of dynamic (slotted-holes) versus static (fixed-holes) design.
                Single masked, prospective, randomized study.
                Over a 4-year period, 66 patients (M:F=37:29) had ACDF using either dynamic (n=33) or static (n=33) plates for intractable radiculopathy as the result of degenerative cervical spine disease. Overall, 28 patients had single-level fusion and 38 had two or three levels fused.
                Visual Analogue Pain scores (VASs), Neck Disability Index (NDI), and radiological criteria of established fusion.
                The qualifying subjects were randomized to receive ACDF using either fixed-holes (static) or the slotted-holes (dynamic) anterior cervical plates. Clinical and radiographic data were collected and analyzed. Paired-sample t test was used to correlate clinical and radiological outcomes and General Linear Model Analysis of Variance (GLM ANOVA) with repeated measures was used to detect outcome differences between the two groups for single and multiple fusions.
                At a mean follow-up of 16 months (range, 12-24), 49 patients (73.7%) had clinical success and 56 (85%) showed radiological fusion. Although clinical success was a predictor of fusion (p=.043), the reverse was not true (p=.61). In single-level fusion, no statistical difference of outcome was observed between the two groups but multilevel fusions with dynamic plate showed significantly lower VAS and NDI than those with static plates (p=.050).
                Although clinical improvement is a good predictor of successful ACDF, radiological evidence of fusion alone is not reliable as a parameter of success. The design of plate does not affect the outcomes in single-level fusions but statistics indicate that multiple-level fusions may have better clinical outcome when a dynamic plate design is used. BACKGROUND: Until recently the most accepted technique of doing root canal treatment stresses multiple visit procedure. Most schools also concentrated upon teaching the multi-visit concept. However, it has now been reported that the procedure of single visit treatment is advocated by at least 70% of schools in all geographical areas. It was therefore the aims of the present study to find the incidence of post-obturation flare-ups following single and multiple visit endodontic treatment procedures, and to establish the relationship between pre-operative and post-obturation pain in patients referred for endodontic therapy in a Nigerian teaching Hospital. METHODS: Data collected included pulp vitality status, the presence or absence of pre-operative, inter-appointment and post-obturation pain. Pain was recorded as none, slight, or moderate/severe. Flare-ups were defined as either patient's report of pain not controlled with over the counter medication or as increasing swelling. The patients were recalled at three specific post-obturation periods, 1st, 7th and 30th day. The presence or absence of pain, or the appropriate degree of pain was recorded for each recall visits and the interval between visits. The compiled data were analysed using chi-square where applicable. P level </= 0.05 was taken as significant. RESULTS: Ten endodontic flare-ups (8.1%) were recorded in the multiple visit group compared to 19 (18.3%) flare-ups for the single visit group, P = 0.02. For both single and multiple visit procedures, there were statistically significant correlations between pre-operative and post-obturation pain (P = 0.002 and P = 0.0004 respectively). Teeth with vital pulps reported the lowest frequency of post-obturation pain (48.8%), while those with nonvital pulps were found to have the highest frequency of post-obturation pain (50.3%), P = 0.9. CONCLUSION: The present study reported higher incidences of post-obturation pain and flare-ups following the single visit procedures. However, single visit endodontic therapy has been shown to be a safe and effective alternative to multiple visit treatment, especially in communities where patients default after the first appointment at which pain is relieved. A prospective randomised trial comparing a single fraction of 8 Gy with 30 Gy in 10 daily fractions for the relief of metastatic bone pain was performed. In 28 months, 288 patients were randomised. Pain was assessed using a questionnaire completed by the patient at home on a daily basis. No difference was found in the speed of onset or duration of pain relief between the two treatment regimes, and pain relief was independent of the histology of the primary tumour. To compare a single fraction of 8 Gy with a course of multifraction radiotherapy in terms of long-term benefits and short-term side effects in patients with painful skeletal metastases.
                Seven hundred and sixty-five patients with painful skeletal metastases requiring palliative radiotherapy were entered into a prospective randomised clinical trial comparing 8 Gy single fraction with a multifraction regimen (20 Gy/5 fractions or 30 Gy/10 fractions). Patients recorded pain severity and analgesic requirements on self-assessment questionnaires before treatment, at 2 weeks and at 1, 2, 3, 4, 5, 6, 8, 10 and 12 months after radiotherapy. Pain relief was the primary endpoint of treatment benefit. Short-term side-effects were compared in a subset of 133 consecutive patients who graded nausea, vomiting and antiemetic usage prior to treatment and at daily intervals from days I to 14.
                Overall survival at 12 months was 44%, with no statistically significant difference apparent between randomised groups. There were no differences in the time to first improvement in pain, time to complete pain relief or in time to first increase in pain at any time up to 12 months from randomisation, nor in the class of analgesic used. Retreatment was twice as common after 8 Gy than after multifraction radiotherapy, although retreatment for residual or recurrent pain did not reflect a difference between randomised groups in the probability of pain relief. The difference in the rate of retreatment is thought to reflect a greater readiness to prescribe radiotherapy after a single fraction, not a greater need. There were no significant differences in the incidence of nausea, vomiting, spinal cord compression or pathological fracture between the two groups.
                A single fraction of 8 Gy is as safe and effective as a multifraction regimen for the palliation of metastatic bone pain for at least 12 months. The greater convenience and lower cost make 8 Gy single fraction the treatment of choice for the majority of patients. To investigate the effectiveness of a single-dose antibiotic regimen for preventing postoperative wound infection, a prospective, randomized double-blind trial was carried out in patients undergoing "clean-contaminated", "contaminated" or "clean" (vascular) surgery. Both elective and emergency operations were included. Single-dose (preoperative) prophylaxis was compared with short-term prophylaxis (1 dose preoperatively and 2 doses postoperatively). The antibiotics were penicillin, tobramycin and metronidazole in various combinations, and comparisons between single-dose and short-term prophylaxis were made with all the regimens. The incidence of wound infection was 5/277 (1.8%) in the short-term group and 9/287 (3.1%) in the single-dose group. The difference was not statistically significant. Nor was statistically significant difference found when the type of operation and the degree of contamination were considered. Single-dose antibiotic prophylaxis thus gave a low incidence of postoperative wound infection, even in "clean-contaminated" or "contaminated" cases. This prospective study was conducted to determine whether there is any significant difference in the incidence of postobturation pain after single- and multiple-visit root canal treatment (RCT).
                The frequency of postobturation pain was recorded and evaluated over an observation period of 30 days in 291 of 300 consecutive patients receiving RCT. The patients were assigned randomly and consecutively into either single- or multiple-visit groups. The canals of all teeth were prepared and filled by a single operator using the step-back and lateral condensation techniques. The data were analysed statistically to determine the relationship, if any, between the pain experienced and pulpal vitality, tooth type, pre-operative pain, and the sex and age of the patient.
                Nine of the 300 patients were excluded from the analysis as they failed to attend for postoperative reviews. A significantly higher incidence (P < 0.01) of postobturation pain was found in the multiple-visit group (38%) than in the single-visit group (27%) within 24 h of obturation. The incidence of pain decreased thereafter, with all patients being sysmptom free at the end of the observation period. No significant correlation was found between postobturation pain and any other factor, with the exception that teeth which had nonvital pulp prior to treatment were associated with a significantly greater (P < 0.005) incidence of postobutration pain.
                Pain was significantly higher in the multiple-visit RCT group and significantly associated with the treatment of the nonvital pulp. Single-modality radiotherapy is still considered standard treatment for patients with locally advanced unresectable cancer of the head and neck. As treatment outcome is poor, attempts to integrate chemotherapy into the overall management of these patients are ongoing.
                A randomized study was undertaken to compare a sequential with a simultaneous chemoradiotherapy program. Between February 1986 and February 1991, 93 eligible patients with locally advanced unresectable cancer of the head and neck were stratified by WHO PS, T and N class and primary site and then randomized to receive either three courses of neoadjuvant chemotherapy with cisplatin (100 mg/m2 i.v. d 1) and 5-fluorouracil 1000 mg/m2/days 1-5 by continuous i.v. infusion every 3 weeks prior to definitive conventional radiotherapy of 65-70 Gy (sequential treatment), or cisplatin 100 mg/m2 on days 1, 22, 43 given simultaneously for the duration of the same conventional radiotherapy (simultaneous treatment).
                At the end of the entire treatment 18 complete responses (47%) in the sequential-treatment arm and 18 (41%) in the simultaneous treatment arm were obtained. No statistically significant differences in the 5-yr progression-free survival, in the median time to loco-regional and distant progression and in the 5-yr overall survival were observed. Leukopenia was more frequent in the simultaneous than in the sequential arm (p = 0.03), whereas alopecia (p = 0.008) and phlebitis (p < 0.0001) were more frequent in the sequential-treatment arm. A better compliance was associated with the concomitant treatment, with 87% of the patients completing the entire radiotherapy program versus 63% of those in the sequential arm (p = 0.01).
                In the present study, the two treatment arms showed similar activity (complete response, progression-free and overall survival rates). Compliance to treatment was better in the concomitant arm. These data suggest that concomitant chemo-radiation therapy might be considered an option in unresectable locally advanced cancer of the head and neck. Phase III studies are needed in order to establish the superiority of this combination of cisplatin and radiotherapy versus radiotherapy alone. To compare transdermal nitroglycerin (NTG) and corticosteroid infiltration in patients with rotator cuff tendinitis (RCT).
                Experimental, randomized controlled study.
                Semirural basic health area in the Garraf region of Barcelona province, Spain, with a population of public health service users of 12000.
                Patients diagnosed as having RCT of less than 6 weeks' evolution who had not responded to treatment with oral nonsteroid antiinflammatory drugs. The patients were distributed randomly into two groups: a) group A, local infiltration via a posterior approach with a depot corticosteroid and local anesthesia, and b) group B, treated for 3 days with a 5-mg NTC patch.
                Age, sex, pain (measured with an analog visual scale) and adverse events. In patients who showed a partial response, treatment was repeated up to 3 times at 15-day intervals. Pain was tested after 7-10 days of treatment. Complete improvement was considered a reduction in pain of more than 5 points on the analog visual scale; partial improvement was considered a reduction of 3-5 points, and treatment failure was recorded when there was no improvement in pain or when there was a decrease of less than 3 points.
                A total of 48 patients were included; 33 (69%) were women and 15 (31%) were men. Mean age was 61 years. In group A, complete improvement was seen in 19 patients and partial improvement in 3; treatment failed in 2 patients. In group B complete improvement was seen in 5 patients, partial improvement in 5, and failure of treatment in 14. The difference between groups was statistically significant. Adverse events were mild pain at the injection site in 4 patients from group A, and headache in 15 patients from group B, 8 of whom abandoned treatment for this reason.
                Treatment with NTG is not a clear alternative to infiltration of corticosteroids in patients with RCT, because of its lack of effectiveness and because of the greater number of patients who had adverse events that lead them to abandon treatment. To demonstrate the efficacy of radiochemotherapy (RCT) as the first choice of treatment for advanced unresectable head-and-neck cancer. To prove an expected benefit of simultaneously given chemotherapy, a two-arm randomized study with hyperfractionated accelerated radiochemotherapy (HF-ACC-RCT) vs. hyperfractionated accelerated radiotherapy (HF-ACC-RT) was initiated. The primary endpoint was 1-year survival with local control (SLC).
                Patients with Stage III and IV (UICC) unresectable oro- and hypopharyngeal carcinomas were randomized for HF-ACC-RCT with 2 cycles of 5-FU (600 mg/m(2)/day)/carboplatinum (70 mg/m(2)) on days 1--5 and 29--33 (arm A) or HF-ACC-RT alone (arm B). In both arms, there was a second randomization for testing the effect of prophylactically given G-CSF (263 microg, days 15--19) on mucosal toxicity. Total RT dose in both arms was 69.9 Gy in 38 days, with a concomitant boost regimen (weeks 1--3: 1.8 Gy/day, weeks 4 and 5: b.i.d. RT with 1.8 Gy/1.5 Gy). Between July 1995 and May 1999, 263 patients were randomized (median age 56 years; 96% Stage IV tumors, 4% Stage III tumors).
                This analysis is based on 240 patients: 113 patients with RCT and 127 patients with RT, qualified for protocol and starting treatment. There were 178 oropharyngeal and 62 hypopharyngeal carcinomas. Treatment was tolerable in both arms, with a higher mucosal toxicity after RCT. Restaging showed comparable nonsignificant different CR + PR rates of 92.4% after RCT and 87.9% after RT (p = 0.29). After a median observed time of 22.3 months, l- and 2-year local-regional control (LRC) rates were 69% and 51% after RCT and 58% and 45% after RT (p = 0.14). There was a significantly better 1-year SLC after RCT (58%) compared with RT (44%, p = 0.05). Patients with oropharyngeal carcinomas showed significantly better SLC after RCT (60%) vs. RT (40%, p = 0.01); the smaller group of hypopharyngeal carcinomas had no statistical benefit of RCT (p = 0.84). For both tumor locations, prophylactically given G-CSF was a poor prognostic factor (Cox regression), and resulted in reduced LRC (log-rank test: +/- G-CSF, p = 0.0072).
                With accelerated radiotherapy, the efficiency of simultaneously given chemotherapy may be not as high as expected when compared to standard fractionated RT. Oropharyngeal carcinomas showed better LRC after HF-ACC-RCT vs. HF-ACC-RT; hypopharyngeal carcinomas did not. Prophylactic G-CSF resulted in an unexpected reduced local control and should be given in radiotherapy regimen only with strong hematologic indication. Within three weeks of definitive surgical intervention, 467 patients with histologically proved malignant glioma were randomized to receive one of four treatment regimens: semustine (MeCCNU), radiotherapy, carmustine (BCNU) plus radiotherapy, or semustine plus radiotherapy. We analyzed the data for the total randomized population and for the 358 patients in whom the initial protocol specifications were met (the valid study group). Observed toxicity included acceptable skin reactions secondary to radiotherapy and reversible leukopenia and thrombocytopenia due to chemotherapy. Radiotherapy used alone or in combination with a nitrosourea significantly improved survival in comparison with semustine alone. The group receiving carmustine plus radiotherapy had the best survival, but the difference in survival between the groups receiving carmustine plus radiotherapy and semustine plus radiotherapy was not statistically significant. The combination of carmustine plus radiotherapy produced a modest benefit in long-term (18-month) survival as compared with radiotherapy alone, although the difference between survival curves was not significiant at the 0.05 level. This study suggests that it is best to use radiotherapy in the post-surgical treatment of malignant glioma and to continue the search for an effective chemotherapeutic regimen to use in addition to radiotherapy. A prospective randomized clinical trial comparing small, large and twice-a-day fraction for the relief of painful bone metastases was performed from 1981 to 1986 at Tokyo Women's Medical College Hospital. Eighty patients with painful bone metastases (92 sites) were divided into three radiation methods which were conventional fraction scheme of 5 times/week at 2 Gy/day for a total of 30 Gy/15 fractions (Group I, TDF: 49), 2 times/week at 4.5 Gy/day for a total of 22.5 Gy/5 fractions (Group II, TDF: 50) and 3 times/week at 2 Gy/day twice a day at a minimum interval of 6 h for a total of 20 Gy/10 fractions (Group III). Pain was assessed using a score and response rate was 76% in Group I, 75% in Group II and 78% in Group III which were not statistically significant mutually. Group II and III regimes were found to have an earlier shorter onset of pain relief than Group I, but the dose of onset of pain relief was almost the same. Our data suggested that individualization of radiotherapy schedules based on to assess the patient's condition and the expected quality of life and to consider radiation site and size of field, was more important than the fractionation regime in the treatment of painful bone metastases. From September, 1972 to December, 1976, 102 consecutive patients operated on for glioblastoma multiforme were randomized, after total or subtotal tumor resection, to receive irradiation alone, irradiation plus BCNU or irradiation plus CCNU. BCNU and CCNU adjuvant chemotherapy was repeated every 6--8 weeks as long as the patients remained in complete remission. Patients were comparable for median age, type of surgery, and histological grade III and IV. Radiotherapy was administered at the tumor dose of about 5000 rads in all three groups. The percent of optimal dose administered was 96% for BCNU and 93% for CCNU. In the group treated with radiotherapy alone (32 cases) the median survival was 10.5 months, while in the groups treated with BCNU (34 cases) and CCNU (36 cases) the median survival was 12 and 16 months, respectively. Both relapse-free (P = 0.05) and total survival (P = 0.03) were significantly improved only in patients who were treated with radiotherapy plus CCNU compared to patients receiving radiotherapy alone after surgery. Present results show that in resectable glioblastoma multiforme, a slightly improved survival rate can be achieved by the prolonged use of adjuvant CCNU following maximal surgical resection and radiotherapy. The cure rate was not improved.
No difference exists in the effectiveness of RoCT, in terms of radiological success, between single- and multiple-visit RoCT. Most short- and long-term complications are also similar in terms of frequency, although patients undergoing a single visit may experience a slightly higher frequency of swelling and are significatively more likely to take painkillers.