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Results for “Randomized trial”

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PubMed1997

Messages from completed randomized trials in head and neck cancer.

During the last three decades numerous randomized trials have been conducted in head and neck squamous cell carcinoma. The issue of pre- vs post-operative radiotherapy in advanced cancers was settled in the late 70s in favour of the latter approach and new fractionation schemes are currently being investigated, with no definite answers as yet. There is no uniform policy regarding the problem of elective neck dissection in early stage anterior oral cavity carcinoma. Often some chemotherapeutic regimen is involved in clinical trials in an attempt to improve on the standard of surgery and radiotherapy. Neoadjuvant chemotherapy has never been proven to benefit patients with advanced squamous cell carcinoma of the head and neck despite being able to decrease the rate of distant metastases. Chemotherapy given prior to or simultaneously with definite radiotherapy seems to offer the best chances for preserving vital organs, such as the larynx. Methotrexate is still the least toxic and most potent drug in recurrent or metastatic disease. The chemoprotective effect of low-dose isotretinoin on multiple primaries in the head and neck has yet to be evaluated.

Carcinoma, Squamous Cell↗

PubMed1994

A randomized trial of single- and two-dose ivermectin versus thiabendazole for treatment of strongyloidiasis.

A randomized trial is described comparing ivermectin and thiabendazole for treatment of chronic infection with Strongyloides stercoralis. Subjects received ivermectin (200 micrograms/kg) in a single dose, ivermectin (200 micrograms/kg) on 2 consecutive days, or thiabendazole (50 mg/kg/day) twice daily for 3 consecutive days. Most subjects (94%) had intermittent symptoms, including urticaria, epigastric pain, and diarrhea. Stools were examined 7 days and 1, 3, 6, 10, and 22 months after treatment. Fifty-three subjects completed at least 3 months of follow-up. Only 1 of 34 and 2 of 19 ivermectin and thiabendazole subjects, respectively, had a stool positive for larvae after treatment. Symptoms were relieved in all 3 groups and eosinophil levels returned to normal in 90% of all subjects by 12 months. Nearly 95% of thiabendazole subjects had short-term adverse effects during therapy versus only 18% of those treated with ivermectin. One dose of ivermectin provides safety and efficacy equivalent to thiabendazole with a much lower prevalence of side effects and, consequently, better compliance.

Adolescent↗

PubMed1997

A prospective randomized trial of high versus low vacuum drainage after axillary dissection for breast cancer.

BACKGROUND AND METHODS: The influence of negative pressure on fluid production and complication rates after axillary dissection for breast cancer was studied in a prospective randomized trial. Patients were randomized for either a high or a low vacuum drainage system. Drainage volumes and complication rates were recorded. RESULTS: No statistically significant differences were found between the low vacuum group (n = 68) and the high vacuum group (n = 73) in volume (728 ml versus 780 ml) and duration (9.5 days versus 10 days) of seroma production, number of wound complications (5 versus 6), or infections (3 versus 2). There was a significant positive relationship between body mass index and seroma production, independent of the drainage system (P = 0.002). The drainage volume of the separately drained breast wound after mastectomy and lumpectomy was larger for the high vacuum system (55 ml versus 100 ml, P = 0.02). Vacuum loss was more frequent in the high vacuum drain group (11 versus 2, P = 0.01), where as leakage around the drain occurred more often in the low vacuum group (18 versus 6, P = 0.004). CONCLUSION: There are no differences in axillary fluid production or wound complication rates after axillary dissection and subsequent drainage between high and low vacuum drainage systems.

Adult↗

PubMed1990

A randomized trial comparing 12 weeks versus 36 weeks of adjuvant chemotherapy in stage II breast cancer.

A randomized trial has been performed in which women with axillary node-positive breast cancer were allocated to either a short intensive 12-week chemohormonal treatment consisting of cyclophosphamide, methotrexate, fluorouracil, vincristine, prednisone, Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and tamoxifen (CMFVP plus AT) or 36 weeks of CMFVP. The median follow-up is 37 months. Of the 222 women randomized to the 12-week treatment, 113 (50.9%) have experienced either recurrence or death as compared with 90 patients (41.9%) in the 36-week treatment group. The corresponding 3-year relapse-free survivals are 55% and 64%, respectively, P = .003. Fifty-nine (26.6%) of the patients in the 12-week group have died compared with 46 (21.4%) of the 36-week group. The corresponding 3-year survival rates are 78% and 85%, respectively, P = .04. A Cox regression analysis showed an associated increased risk ratio for recurrence or death of 1.7, P = .003, and for death of 1.8, P = .017 in the 12-week treatment group compared with the 36-week group. Thus, this 12-week regimen of adjuvant chemohormonal therapy is inadequate treatment for women with axillary node-positive breast cancer; possible explanations for this inferiority are its shorter duration and/or a negative interaction of tamoxifen on the chemotherapy.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2004

TIPS versus peritoneovenous shunt in the treatment of medically intractable ascites: a prospective randomized trial.

OBJECTIVE: We undertook a prospective randomized clinical trial comparing TIPS to peritoneovenous (PV) shunts in the treatment of medically intractable ascites to establish relative efficacy and morbidity, and thereby superiority, between these shunts. METHODS: Thirty-two patients were prospectively randomized to undergo TIPS or peritoneovenous (Denver) shunts. All patients had failed medical therapy. RESULTS: After TIPS versus peritoneovenous shunts, median (mean +/- SD) duration of shunt patency was similar: 4.4 months (6 +/- 6.6 months) versus 4.0 months (5 +/- 4.6 months). Assisted shunt patency was longer after TIPS: 31.1 months (41 +/- 25.9 months) versus 13.1 months (19 +/- 17.3 months) (P < 0.01, Wilcoxon test). Ultimately, after TIPS 19% of patients had irreversible shunt occlusion versus 38% of patients after peritoneovenous shunts. Survival after TIPS was 28.7 months (41 +/- 28.7 months) versus 16.1 months (28 +/- 29.7 months) after peritoneovenous shunts. Control of ascites was achieved sooner after peritoneovenous shunts than after TIPS (73% vs. 46% after 1 month), but longer-term efficacy favored TIPS (eg, 85% vs. 40% at 3 years). CONCLUSION: TIPS and peritoneovenous shunts treat medically intractable ascites. Absence of ascites after either is uncommon. PV shunts control ascites sooner, although TIPS provides better long-term efficacy. After either shunt, numerous interventions are required to assist patency. Assisted shunt patency is better after TIPS. Treating medically refractory ascites with TIPS risks early shunt-related mortality for prospects of longer survival with ascites control. This study promotes the application of TIPS for medically intractable ascites if patients undergoing TIPS have prospects beyond short-term survival.

Aged↗

PubMed2002

Can vitamin D supplementation reduce the risk of fracture in the elderly? A randomized controlled trial.

Randomized controlled trials have shown that a combination of vitamin D and calcium can prevent fragility fractures in the elderly. Whether this effect is attributed to the combination of vitamin D and calcium or to one of these nutrients alone is not known. We studied if an intervention with 10 microg of vitamin D3 per day could prevent hip fracture and other osteoporotic fractures in a double-blinded randomized controlled trial. Residents from 51 nursing homes were allocated randomly to receive 5 ml of ordinary cod liver oil (n = 569) or 5 ml of cod liver oil where vitamin D was removed (n = 575). During the study period of 2 years, fractures and deaths were registered, and the principal analysis was performed on the intention-to-treat basis. Biochemical markers were measured at baseline and after 1 year in a subsample. Forty-seven persons in the control group and 50 persons in the vitamin D group suffered a hip fracture. The corresponding figures for all nonvertebral fractures were 76 persons (control group) and 69 persons (vitamin D group). There was no difference in the incidence of hip fracture (p = 0.66, log-rank test), or in the incidence of all nonvertebral fractures (p = 0.60, log-rank test) in the vitamin D group compared with the control group. Compared with the control group, persons in the vitamin D group increased their serum 25-hydroxyvitamin D concentration with 22 nmol/liter (p = 0.001). In conclusion, we found that an intervention with 10 microg of vitamin D3 alone produced no fracture-preventing effect in a nursing home population of frail elderly people.

Aged↗

PubMed2006

Laparoscopic varicocele ligation in children and adolescents using isosulphan blue: a prospective randomized trial.

OBJECTIVES: To evaluate, in a randomized prospective trial in children and adolescents, the feasibility of isosulphan blue-based lymphatic vessel preservation during laparoscopic varicocelectomy and its impact on the complication rate, as the operative management of varicoceles remains controversial. PATIENTS AND METHODS: In all, 50 consecutive patients were randomly assigned to two laparoscopic varicocelectomy groups. The indications for surgery included scrotal pain and a difference in testicular size, as well as severe cosmetic impairment. All the patients had a laparoscopic varicocelectomy using three ports. Patients in group A had standard laparoscopy, while those in group B had additional isosulphan blue administered. After surgery, the patients were assessed at 3, 6 and 12 months for varicocele recurrence, hydrocele formation, atrophy, pain or other complications. RESULTS: There were no intraoperative complications or conversions to open surgery. There were no adverse reactions, scrotal haematomas or atrophy. At 3 months after surgery, the incidence of hydrocele in group A was 20% whereas in group B no hydroceles were detected (P = 0.025); at 6 months the 20% still had hydroceles. One patient in each group had varicocele recurrence associated with persistent pain. In two patients in group B, blue pigmentation of the left hemiscrotum persisted at the 3-month follow-up but resolved by 6 months. CONCLUSIONS: Laparoscopic repair of varicoceles using isosulphan blue helps to identify and preserve the lymphatic drainage. It prevents secondary hydrocele formation, the most common complication, with no supplementary risk to the patient. Also, testicular oedema causing impaired spermatogenesis can be avoided.

Adolescent↗

PubMed1990

The treatment of medulloblastoma. Results of a prospective randomized trial of radiation therapy with and without CCNU, vincristine, and prednisone.

In a prospective randomized trial designed to study the effectiveness of adjuvant chemotherapy following standard surgical treatment and radiation therapy, 233 eligible patients with medulloblastoma were treated by members of the Children's Cancer Study Group and the Radiation Therapy Oncology Group. Eligible patients were randomly assigned to receive radiation therapy with or without adjuvant chemotherapy consisting of 1-(2-chloroethyl)-3-cyclohexyl-nitrosourea (CCNU), vincristine, and prednisone. The estimated 5-year event-free survival probability was 59% for patients treated with radiation therapy and chemotherapy and 50% for patients treated with radiation therapy alone, a difference which is not statistically significant. The 5-year survival probability was 65% for both groups. Although the treatment difference was not statistically significant when all patients were combined, in the small number of patients with more extensive tumors, event-free survival was better in the group receiving chemotherapy (48% vs. 0%, p = 0.006). In these latter patients the survival time is also significantly prolonged. Extent of disease (as measured by the M staging criteria described by Chang) and age at diagnosis were significantly associated with outcome; advanced disease and young age had a worse prognosis. The extent of tumor resection was not an independent prognostic factor. It is concluded that chemotherapy does not benefit patients with low-stage medulloblastoma, but may benefit those with more advanced stages of disease.

Adolescent↗

PubMed1988

Combination chemotherapy confers modest survival advantage in patients with advanced non-small cell lung cancer: report of a Canadian multicenter randomized trial.

Between February 1983 and January 1986, the National Cancer Institute of Canada conducted a prospective randomized trial comparing best supportive care (BSC) with two chemotherapy regimens: Vindesine and cisplatin (Platinol) (VP) and cyclophosphamide, doxorubicin, and cisplatin (CAP). Twenty-three centers across Canada entered 251 patients on the basis of measurable or evaluable disease, with either distant metastases or bulky limited disease considered inoperable and unsuitable for radical radiation therapy; 233 patients were eligible for evaluation. The overall response rates on the chemotherapy arms were: VP, 25.3%; CAP, 15.3%. The median survival rates were: VP, 32.6 weeks; CAP, 24.7 weeks; BSC, 17 weeks. Toxicity on the chemotherapy arms was significant. Although better therapies are required, the data in this study clearly indicate that VP and CAP combination chemotherapy confers a modest survival advantage over BSC in advanced non-small cell lung cancer.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2005

Antimicrobial therapy for children with adenotonsillar hypertrophy and obstructive sleep apnea: a prospective randomized trial comparing azithromycin vs placebo.

OBJECTIVE: Multiple clinical trials demonstrate the value of administering antibiotics for recurrent tonsillitis. However, there is no consensus as to the role of antibiotics in the management of adenotonsillar hypertrophy and obstructive sleep apnea (OSA). It has been suggested that antibiotics may reduce adenotonsillar size, improve obstructive symptoms, and obviate the need for surgery. The goal of this pilot study was to evaluate the efficacy of a broad-spectrum antibiotic in the management of adenotonsillar hypertrophy and OSA. METHODS: Twenty-two children ages 2 through 12, with evidence of OSA, were enrolled in this double-blinded, prospective clinical trial. Children were randomly assigned into 1 of 2 groups. Group I received azithromycin for a 30-day period (12 mg/kg on days 1-5; the regimen was repeated on days 11-15 and days 21-25). Group II received a placebo administered in the same regimen for a 30-day period. Overnight polysomnography was performed before and within 2 weeks after drug administration. RESULTS: Polysomnographic indices of OSA severity appear to indicate an improvement in the antibiotic as compared to the placebo group, but a comparison of mean +/- standard error for each parameter failed to demonstrate statistical significance using the paired t test. Only 1 of 11 (9%) children had normalization of their polysomnographic parameters. CONCLUSIONS: These results suggest that a course of a broad-spectrum antibiotic may be effective in temporarily improving OSA due to adenotonsillar hypertrophy, but does not appear to obviate the need for surgery.

Adenoids↗

PubMed2004

High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: one-year results from the SCORE randomized trial.

OBJECTIVES: The Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 (SCORE) trial was a multicenter, randomized, open-label trial comparing the safety and performance of 13- and 17-mm QuaDDS stents (n = 126) (Quanam Medical Corp., Santa Clara, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated control stents (n = 140) in focal, de novo coronary lesions. BACKGROUND: The pioneering drug-delivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 microg of the paclitaxel derivative 7-hexanoyltaxol. METHODS: Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiography and intravascular ultrasound were performed post procedure and at six-month follow-up. RESULTS: In the QuaDDS group, early stent thrombosis and myocardial infarction (MI) rates were significantly higher, leading to premature cessation of enrollment. For the QuaDDS group, the stent thrombosis rate increased from 3.2% to 10.3% between 1 and 12 months, associated with increased non-Q-wave MI and death rates. The angiographic restenosis rate at six months was reduced from 32.7% (control) to 7.4% (p < 0.0001). However, the primary end point was not met with six-month target vessel revascularization (TVR) rate as well as the composite major adverse cardiac event rates (cardiac death, MI, and TVR) comparable between groups. CONCLUSIONS: Despite angiographic indications of potential anti-restenotic benefit, increased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile.

Aged↗

PubMed2001

Randomized trial of procarbazine, lomustine, and vincristine in the adjuvant treatment of high-grade astrocytoma: a Medical Research Council trial.

PURPOSE: Meta-analyses of the published literature suggest a survival benefit to adjuvant chemotherapy for high-grade astrocytoma, which individual small trials have been unable to demonstrate reliably. The Medical Research Council Brain Tumour Working Party initiated the largest randomized trial of adjuvant chemotherapy for glioma in an attempt to provide a definitive answer. PATIENTS AND METHODS: After surgery, patients aged < or = 70 years, with World Health Organization grade 3 or 4 astrocytoma, were randomized to radiotherapy alone (RT) or RT plus procarbazine, lomustine, and vincristine (PCV) chemotherapy (RT-PCV) given at 6-week intervals to a maximum of 12 courses (procarbazine 100 mg/m2 days 1 to 10, lomustine 100 mg/m2 day 1, and vincristine 1.5 mg/m2 (max 2 mg) day 1). A neuropathology panel independently reviewed all cases. To reliably detect a 10% increase in 2-year survival (from 15% to 25%), 600 patients were required. RESULTS: Between September 1988 and May 1997, 15 United Kingdom centers randomized 674 patients (RT = 339 patients; RT-PCV = 335 patients). With a median follow-up for survivors of 3 years, 617 patients have died, (RT = 310 patients; RT-PCV = 307 patients). Median survival was 9.5 months for RT and 10 months for RT-PCV (hazard ratio = 0.95; 95% confidence interval, 0.81 to 1.11; log-rank P = .50). Tests for interaction revealed no significant differences in treatment effect according to tumor grade, age, performance status, or extent of neurosurgery. CONCLUSION: This trial shows no benefit to PCV chemotherapy, and current data exclude an increase in median survival of more than 10 weeks and in a 1- or 2-year survival rate of more than 7% to 8%. This suggests that no-chemotherapy control arms remain ethical in randomized trials in high-grade astrocytoma.

Adult↗

PubMed2004

High-dose oral medroxyprogesterone acetate or tamoxifen as adjuvant hormone therapy for node-negative early-stage breast cancer: randomized trial with 7-year update.

A randomized adjuvant trial compared tamoxifen 20 mg daily for 5 years with high-dose oral medroxyprogesterone acetate (MPA) 1 g orally for 9 months. One hundred ninety-four patients with histologically proven primary node-negative breast carcinoma were enrolled between December 1990 and October 1996, with 98 patients randomized into the tamoxifen arm and 96 into the MPA arm. At a median follow-up of 86 months, 25 relapses and 13 deaths were recorded. The relapse-free survival rate at 7 years in the tamoxifen arm was 93%, versus 81% in the MPA arm (P = 0.02). The difference was observed in patients with stage T2 disease (100% in the tamoxifen group vs. 64% in the MPA group; P = 0.01), in younger and/or premenopausal patients (in patients < 50 years of age, 100% in the tamoxifen arm vs. 81% in the MPA arm [P = 0.02], and in patients > or = 50 years of age, 90% in the tamoxifen arm vs. 82% in the MPA arm [P = 0.16]). Also, the overall survival rate at 7 years was lower in women < 50 years of age (P = 0.04).

Age Factors↗

PubMed1999

Methodological arguments for the necessity of randomized trials in high-dose chemotherapy for breast cancer.

In the past ten years high-dose chemotherapy with autologous haematopoietic stem-cell support (HD-CT) has increasingly been used for breast cancer. But the vast majority of trials are small phase I/II studies showing until now not enough evidence that HD-CT is superior to conventional-dose chemotherapy (CD-CT). In contrast to this, the public perception of this treatment is different. Patients as well as physicians often uncritically believe in reports contrasting the positive results obtained in case series treated by HD-CT with those of historical control groups. This leads to the problem that many patients and also clinicians are not willing to participate in randomized trials on this topic. A critical assessment of current knowledge on the effectiveness of HD-CT in breast cancer is given. The problems related to the use of historical controls, in general, and especially in the setting of HD-CT are demonstrated. Using data of patients treated with CD-CT within trials of the German Breast Cancer Study Group (GBSG) it will be shown that results similarly favorable to those reported from patients treated with a high-dose regimen may be produced using quite simple selection mechanisms. Comparisons of patients treated with HD-CT with historical control groups of patients treated with CD-CT may be misleading. A valid treatment comparison is only possible by means of large randomized trials. Clinicians should participate in the ongoing trials and enter all eligible patients.

Age Factors↗

PubMed1990

A randomized trial of terlipressin plus nitroglycerin vs. balloon tamponade in the control of acute variceal hemorrhage.

A randomized trial was undertaken to determine the efficacy of nitroglycerin in addition to terlipressin infusion to improve the control of acute variceal hemorrhage compared with balloon tamponade. Forty-seven bleeding episodes in 34 cirrhotic patients were included, with terlipressin plus sublingual nitroglycerin in 23 episodes (group I) and balloon tamponade in 24 episodes (group II). At the end of the 12-hr period, hemorrhage had been equally controlled in both groups (18 of 23; 78% in group I and 19 of 24; 79% in group II). When attempted, balloon tamponade appeared more efficient in the failures of group I (4 of 4) than did terlipressin plus nitroglycerin in the failures of group II (0 of 3), although this difference was not significant. Major complications were rare (one in each group) and never required cessation of therapy. Thus terlipressin and nitroglycerin were as effective as balloon tamponade in controlling variceal hemorrhage and were associated with few minor complications.

Adult↗

PubMed2002

Improving family physicians' use of evidence-based smoking cessation strategies: a cluster randomization trial.

BACKGROUND: Family physicians (FPs) in Australia underutilize effective strategies to help patients stop smoking. We conducted a cluster randomization trial to evaluate a multifaceted, practice-based intervention involving audit, feedback, and academic detailing to improve FP smoking cessation advice. METHODS: Sixty FPs in 39 practices participated. FPs' provision of smoking cessation advice was measured by patient recall, medical record audit, and FP self-report. Logistic regression analysis using generalized estimating equations was performed to assess improvements in practice, after adjustment for clustering by practice. RESULTS: Improvements between baseline and posttest in patient recall of FP advice about nicotine replacement patches and gum were significantly greater in the intervention than in the control group (P = 0.0056 and P = 0.0002, respectively). While there were substantial increases in patient recall of assessment of smoking status and FP use of "quit dates," behavioral advice, and written materials in the intervention group, these changes were not significantly greater than those in the control group. Notation of patients' smoking status and smoking cessation advice in medical records remained suboptimal in both groups. CONCLUSIONS: This multifaceted intervention was successful only in promoting FPs' use of nicotine replacement therapy. While the use of other effective cessation strategies appeared to increase, a larger trial is needed for further evaluation.

Adolescent↗

PubMed2004

The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial.

BACKGROUND: A previous paper reported the 6-month comparison of weight loss and metabolic changes in obese adults randomly assigned to either a low-carbohydrate diet or a conventional weight loss diet. OBJECTIVE: To review the 1-year outcomes between these diets. DESIGN: Randomized trial. SETTING: Philadelphia Veterans Affairs Medical Center. PARTICIPANTS: 132 obese adults with a body mass index of 35 kg/m2 or greater; 83% had diabetes or the metabolic syndrome. INTERVENTION: Participants received counseling to either restrict carbohydrate intake to <30 g per day (low-carbohydrate diet) or to restrict caloric intake by 500 calories per day with <30% of calories from fat (conventional diet). MEASUREMENTS: Changes in weight, lipid levels, glycemic control, and insulin sensitivity. RESULTS: By 1 year, mean (+/-SD) weight change for persons on the low-carbohydrate diet was -5.1 +/- 8.7 kg compared with -3.1 +/- 8.4 kg for persons on the conventional diet. Differences between groups were not significant (-1.9 kg [95% CI, -4.9 to 1.0 kg]; P = 0.20). For persons on the low-carbohydrate diet, triglyceride levels decreased more (P = 0.044) and high-density lipoprotein cholesterol levels decreased less (P = 0.025). As seen in the small group of persons with diabetes (n = 54) and after adjustment for covariates, hemoglobin A1c levels improved more for persons on the low-carbohydrate diet. These more favorable metabolic responses to a low-carbohydrate diet remained significant after adjustment for weight loss differences. Changes in other lipids or insulin sensitivity did not differ between groups. LIMITATIONS: These findings are limited by a high dropout rate (34%) and by suboptimal dietary adherence of the enrolled persons. CONCLUSION: Participants on a low-carbohydrate diet had more favorable overall outcomes at 1 year than did those on a conventional diet. Weight loss was similar between groups, but effects on atherogenic dyslipidemia and glycemic control were still more favorable with a low-carbohydrate diet after adjustment for differences in weight loss.

Adolescent↗

PubMed1999

A randomized trial of the effect of moistening misoprostol before vaginal administration when used with methotrexate for abortion.

A prospective multicenter, randomized trial was performed to evaluate if moistened misoprostol results in a more rapid abortion and a higher rate of complete abortion compared with dry misoprostol when administered intravaginally for medical abortion after methotrexate. A total of 240 pregnant women < or = 49 days gestation seeking elective abortion received 50 mg/m2 methotrexate intramuscularly followed 5-6 days later by 800 micrograms misoprostol vaginally. The misoprostol dose was repeated in 1-2 days if the abortion did not occur. Group 1 moistened the misoprostol before administration and group 2 used dry tablets. There was no statistically significant difference in the cumulative rate of abortion after the first misoprostol dose (73.0% vs 71.3%, p = 0.87), second misoprostol dose (84.1% vs 81.1%, p = 0.65), or by 35 days after methotrexate administration (95.2% vs 91.8%, p = 0.40) between groups 1 and 2, respectively. The proportion of subjects with embryonic cardiac activity 2 weeks after methotrexate injection was greater in group 2 (5.7%, 95% confidence interval [CI] 1.0%, 9.9%) than in group 1 (2.4%, 95% CI 0%, 5.0%), although not statistically significant (p = 0.21). The immediate success rate in Pittsburgh was greater, albeit not statistically, for the women that moistened the misoprostol (87% vs 76%, p = 0.19); these rates were also not statistically different in Havana (82% vs 86%, p = 0.62). The rate of side effects after methotrexate was not different between groups but women in group 1 had significantly more diarrhea (36% vs 21%, p = 0.02) and fever/warmth/chills (44% vs 30%, p = 0.04). Moistening misoprostol before vaginal administration in a medical abortion regimen with methotrexate does not statistically improve efficacy. This trial demonstrates the importance of prospective, randomized studies to prove the relative efficacy of any medical abortion treatment regimen.

Abortifacient Agents, Nonsteroidal↗