Patient discomfort and other side effects after bilateral sagittal split osteotomy or distraction osteogenesis of the mandible: a randomized clinical trial

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

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A randomized clinical trial comparing the short-term side effects of sublingual and buccal routes of misoprostol administration for medical abortions up to 63 days’ gestation

Contraception ◽

10.1016/j.contraception.2012.09.022 ◽

2013 ◽

Vol 87 (4) ◽

pp. 480-485 ◽

Cited By ~ 14

Author(s):

Joyce Chai ◽

Ching Yin Grace Wong ◽

Pak Chung Ho

Keyword(s):

Clinical Trial ◽

Side Effects ◽

Randomized Clinical Trial ◽

Short Term

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A NEW METHOD OF EPISTAXIS MANAGEMENT USING NASAL GEL: A SINGLE CENTER, RANDOMIZED CLINICAL TRIAL

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2018.v11i3.22462 ◽

2018 ◽

Vol 11 (3) ◽

pp. 104 ◽

Cited By ~ 2

Author(s):

Mehdi Torabi ◽

Ava Roughani Esfahani ◽

Shiva Moeinaddini ◽

Mohammad Reza Baneshi

Keyword(s):

Clinical Trial ◽

Side Effects ◽

Randomized Clinical Trial ◽

Patients Satisfaction ◽

Stop Time ◽

Common Causes ◽

Procedural Time ◽

Nasal Bleeding ◽

The Common ◽

Discharge Length

Objective: Epistaxis is one of the common causes of patients’ referral to the emergency departments. In the majority of cases, epistaxis is managed by traditional methods. We investigated the efficacy of nasal gel (NG) in comparison to anterior nasal packing (ANP) to stop mild-to-moderate anterior nasal bleeding.Methods: In this prospective, randomized clinical trial, patients were divided into two groups of ANP (n=60) and NG (n=40). We determined and compared the efficacy of treatment (bleeding stop time and recurrence), patients’ satisfaction at discharge (length of stay in the hospital, pain during the procedure, and procedural time), and safety (less side effects) in both groups.Results: The procedural time ≤2 min was observed in 90% and 58.33 % of NG group and ANP group, respectively (p<0.001). Pain score during procedure ≤4 and patients’ satisfaction ≥7 were, respectively, seen in 87.5% and 65% of NG group, but it was 43.33% and 41.7% in ANP group, respectively (p<0.001, p=0.02). The side effects in ANP group were 35%; however, no side effects were observed in NG group.Conclusion: In the management of mild-to-moderate anterior nasal bleeding although NG efficacy is equivalent to ANP, using NG may be more convenient and satisfactory for patients. In addition, the use of this gel may result in more safety and fewer side effects.

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Randomized clinical trial of tamoxifen alone or combined with fluoxymesterone in postmenopausal women with metastatic breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.1988.6.5.825 ◽

1988 ◽

Vol 6 (5) ◽

pp. 825-831 ◽

Cited By ~ 23

Author(s):

J N Ingle ◽

D I Twito ◽

D J Schaid ◽

S A Cullinan ◽

J E Krook ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Metastatic Breast Cancer ◽

Side Effects ◽

Postmenopausal Women ◽

Randomized Clinical Trial ◽

Statistical Significance ◽

Metastatic Breast ◽

Rank Test ◽

Breast Cancer Patients

A randomized clinical trial was performed to determine if combination hormonal therapy with tamoxifen (TAM) and fluoxymesterone (FLU) was more efficacious than TAM alone for the treatment of postmenopausal women with metastatic breast cancer. Patients failing TAM could subsequently receive FLU. The dose of both drugs was 10 mg orally twice daily. Objective responses were seen in 50 of 119 TAM patients (42%) and 63 of 119 TAM plus FLU patients (53%) (one-sided P = .05). Time to disease progression distributions were better for TAM plus FLU (median, 350 days v 199 days), but the log rank test only approached statistical significance (one-sided P = .07). Duration of response and survival distributions were similar between the two treatment arms. Toxicities, in terms of androgenic side effects, were greater on the TAM plus FLU regimen. Fifty-two patients are evaluable for response with FLU following TAM and 21 (40%) have achieved a response. We conclude that the advantages in terms of response rate and time to progression observed with TAM plus FLU probably represent a biological effect, but are not of sufficient magnitude to justify the routine clinical use of this combination given the lack of survival advantage and side effects encountered.

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