Effect of Immunomodulatory Supplements Based on Echinacea Angustifolia and Echinacea Purpurea on the Posttreatment Relapse Incidence of Genital Condylomatosis: A Prospective Randomized Study

Introduction.HPV infection is a highly infectious disease; about 65% of partners of individuals with genital warts will develop genital condylomatosis. Only in 20-30% it regresses spontaneously and relapse rates range deeply (9-80%). Echinacea extracts possess antiviral and immunomodulator activities. The aim of this study was to evaluate the efficacy of the therapy, using a formulation based on HPVADL18® (on dry extracts of 200 mg Echinacea Purpurea (EP) roots plus E. Angustifolia (EA)), on the posttreatment relapse incidence of genital condylomatosis.Materials and Methods.It is a prospective single-arm study. Patients with a satisfactory and positive vulvoscopy, colposcopy, or peniscopy for genital condylomatosis were divided into two random groups and subjected to destructive therapy with Co2 Laser. Group A (N=64) immediately after the laser therapy started a 4-month treatment with oral HPVADL18®; Group B (N=61) did not undergo any additional therapy. Patients were subjected to a follow-up after 1, 6, and 12 months. Differences in relapse incidence between the two groups during follow-up controls were evaluated byχ2-test; the groups were stratified by age, gender, and condylomatosis extension degree.Results and Discussion.Gender, age, and condyloma lesions’ extension degree showed no statistically significant differences between the two trial groups. The relapse incidence differs statistically between the two studied groups and progressively decreases during the 12 months after treatment in both groups. Statistically significant reduction of relapse rates has been shown in Group A in patients over 25 years old. This difference is significant for both men and women. The relapse incidence is superior in case of extended condylomatosis.Conclusions.In conclusion, the presence of a latent infection causes condylomatosis relapse; in order to reduce the relapse risk an induction of a protective immune response seems to be essential to allow rapid viral clearance from genital areas surrounding lesion and treatment zones. Echinacea promotes this process. EP and EA dry root extracts seem to be a valid adjuvant therapy in reducing relapse incidence of lesions in patients treated for genital condylomatosis.

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Anterior approach levator plication for congenital ptosis, absorpable versus non absorpable sutures

European Journal of Ophthalmology ◽

10.1177/11206721211005320 ◽

2021 ◽

pp. 112067212110053

Author(s):

Moustafa Salamah ◽

Ashraf Mahrous Eid ◽

Hani Albialy ◽

Sherif Sharaf EL Deen

Keyword(s):

Randomized Study ◽

Early Postoperative Period ◽

Polyglactin 910 ◽

Exclusion Criteria ◽

Congenital Ptosis ◽

History Of ◽

Group A ◽

Group B ◽

Over Time

Purpose: To compare the efficacy of two different suture types in levator plication for correction of congenital ptosis. Subjects and methods: Prospective comparative interventional randomized study involving 42 eyes of 42 patients aged more than 6 years with congenital ptosis and good levator action. The exclusion criteria were as follows: bilateral ptosis, history of previous surgery, fair or poor levator action, and associated other ocular diseases. Patients were randomized into group A, in which double-armed 5/0 polyester Ethibond were used, and group B, in which double-armed 5/0 Coated Vicryl® (polyglactin 910) suture material we used. Outcomes including eyelid height and stability of eyelid height over time were compared with follow-up data. The MRD was 4.05 ± 0.36 mm and 3.95 ± 0.34 after 1 week for both groups A and B, respectively. At the end of study follow up period (24 weeks), the MRD was 3.60 ± 0.42 mm in group A, and 2.52 ± 0.85 mm in group B. Conclusion: No difference in eyelid height between two groups in early postoperative period, but the postoperative eyelid height was more stable over time in the 5/0 polyester Ethibond group (group A) than in the 5/0 Coated Vicryl® (polyglactin 910) group (group B).

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Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study

Journal of Obesity ◽

10.1155/2020/9792518 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7 ◽

Cited By ~ 2

Author(s):

Paolo Gentileschi ◽

Emanuela Bianciardi ◽

Leandro Siragusa ◽

Valeria Tognoni ◽

Domenico Benavoli ◽

...

Keyword(s):

Weight Loss ◽

Sleeve Gastrectomy ◽

Weight Regain ◽

Randomized Study ◽

Banded Sleeve Gastrectomy ◽

Group A ◽

The Mean ◽

Group B ◽

To Receive

Background. Weight regain after laparoscopic sleeve gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short term. We report the results of a randomized study comparing LSG and laparoscopic banded sleeve gastrectomy (LBSG) over a 4-year follow-up. Objectives. To evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the midterm. Methods. Between 01/2014 and 01/2015, we randomly assigned 50 patients to receive one of the two procedures. Patients’ management was exactly the same, apart from the band placement. We analyzed differences in weight loss, operative time, complication rate, and mortality, with a median follow-up of 4 years. Results. Twenty five patients were assigned to receive LSG (Group A) and 25 LBSG (Group B). The mean preoperative BMI (body mass index) was 47.3 ± 6.58 kg/m2 and 45.95 ± 5.85 kg/m2, respectively. There was no significant difference in the operative time. No intraoperative or postoperative complications occurred. At 12-month follow-up, the mean BMI was 29.72 ± 4.40 kg/m2 in Group A and 27.42 ± 4.47 kg/m2 in Group B (p=0.186). After a median follow-up of 4 years, the mean BMI in Group B was significantly lower than Group A (24.10 ± 4.52 kg/m2 vs 28.80 ± 4.62 kg/m2; p=0.00199). Conclusions. LBSG is a safe procedure, with no impact on postoperative complications. The banded sleeve showed a significant greater weight loss in the midterm follow-up. Considering the issue of weight regain observed after LSG, the placement of a perigastric ring during the first procedure may be a strategy to improve the results. This trial is registered with NCT04228185.

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PROSPECTIVE RANDOMIZED STUDY BETWEEN OPEN VS CLOSED LATERAL ANAL INTERNAL SPHINCTEROTOMY IN PATIENTS WITH CHRONIC FISSURE IN ANO AT SKMCH, MUZAFFARPUR, BIHAR

10.36106/ijsr/7833722 ◽

2021 ◽

pp. 65-66

Author(s):

Kumar Vikram ◽

Sanjay Kumar ◽

Manoj Kumar ◽

Debarshi Jana

Keyword(s):

Randomized Study ◽

Young Patients ◽

Fissure In Ano ◽

Common Cause ◽

Internal Sphincterotomy ◽

Acute Complications ◽

Group A ◽

Group B ◽

Cause Of Pain

Background: One of the most common cause of pain during defecation in young patients is chronic ssure in ano. Surgical treatment of choice for chronic ssure in ano is internal sphincterotomy. This procedure can be performed by open or closed method. The aim of the study was to compare the closed and open anal internal sphincterotomy in patients admitted in our hospital with chronic anal ssure. Subjects and Methods: 105 patients admitted in department of general surgery with chronic ssure in ano were divided into two groups. 50 patients (Group A) who were treated by closed method and 55 patients (Group B) who were managed by open lateralanal sphincterotomy method. A3 months follow up done in both postsurgery to observe for pain, bleeding, infection, incontinence, and recurrence. Results: Signicant difference was observed in postoperative acute complications between the two methods of internal anal sphincterotomy. Conclusion: Lateral anal sphincterotomy is the treatment of choice for chronic anal ssure, either open or closed method. However, the closed method was observed to have lesserpost operative complication compared to the open method

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Cryosurgery as a Single Agent and in Combination with Intralesional Corticosteroids Is Effective on Young, Small Keloids and Induces Characteristic Histological and Immunohistological Changes: A Prospective Randomized Trial

Dermatology ◽

10.1159/000511624 ◽

2020 ◽

pp. 1-11

Author(s):

Christos C. Zouboulis ◽

Eftychia Zouridaki

Keyword(s):

Treatment Failure ◽

Normal Skin ◽

Randomized Study ◽

Single Agent ◽

Interferon Γ ◽

Efficacy And Safety ◽

Rete Ridge ◽

Group A ◽

Group B

Background: As the pathogenesis of keloids is poorly understood, there is no sound biological basis of keloid management. Few controlled therapeutic studies have been published, and recurrences are a major reason for treatment failure. Objective: To detect efficacy and safety of cryosurgery regimens on keloids and the occurring biological changes caused by the treatment. Methods: This prospective randomized study compared efficacy and tolerability as well as histological/immunohistochemical effects of liquid nitrogen contact cryosurgery as a single regimen (group A) and combined with intralesional corticosteroids (group B) on young (<2 years old), small (≤10 cm2) keloids in 40 patients (2-sided effect, α-error 1%, power 95%). Results: Marked flattening of the lesions was achieved by both regimens. Median lesional volumes decreased from 106 to 7 mm3 in group A (p = 0.001) and from 138 to 6 mm3 in group B (p < 0.0001; ns, between groups). Good to excellent responses were registered in 83.3 and 90% of patients in groups A and B, respectively, by evaluating the lesional volume, in 80 and 95% of patients by the physician’s evaluation and in 95% of patients in either group by the patient’s assessment. Follow-up of 6–36 months revealed no further significant changes. Cryosurgery was generally well tolerated, with minor pain during treatment not requiring (27.5%) or requiring local anaesthesia (5%) – but not analgesics –, and hypopigmentation (25%). Histological examination showed increased vessel number and lumen dilatation after treatment in group B and reduction of rete ridge length in both groups with more prominent changes in group A. Tenascin C staining demarcated keloids from normal skin before therapy, while after therapy the entire treated tissue was labelled. Interferon-γ expression was significantly decreased after therapy both regarding positively stained cells and intensity in both groups. Conclusion: Cryosurgery without and with intralesional corticosteroids is effective and safe on young, small keloids not only as a destructive physical procedure, but also by inducing biochemical and immunological scar rejuvenation.

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Prospective Randomized Study between Open Vs Closed Lateral Anal Internal Sphincterotomy in Patients with Chronic Fissure in Ano

Academia Journal of Surgery ◽

10.47008/ajs/2020.3.1.36 ◽

2020 ◽

Vol 3 (1) ◽

pp. 167-171

Author(s):

Anand Shanmugaiah ◽

Saravanan Pandian

Keyword(s):

Anal Fissure ◽

Chronic Anal Fissure ◽

Randomized Study ◽

Fissure In Ano ◽

Internal Sphincterotomy ◽

Post Surgery ◽

Significant Difference ◽

Group A ◽

Group B

Background: One of the the most common cause of pain during defecationin young patientsis chronic fissure in ano. Surgical treatment of choice for chronic fissure in ano is internal sphincterotomy. This procedure can be performed by open or closed method. The aim of the study was to compare the closed and open anal internal sphincterotomy in patients admitted in our hospital with chronic anal fissure. Subjects and Methods: 105 patients admitted in department of general surgery with chronic fissure in ano were divided into two groups. 50 patients (Group A) who were treated by closed method and 55 patients (Group B) who were managed by open lateralanal sphincterotomy method. A 3 months follow up done in both post-surgery to observe for pain, bleeding, infection, incontinence, and recurrence. Results: Significant difference was observed in postoperative acute complications between the two methods of internal anal sphincterotomy. Conclusion: Lateral anal sphincterotomy is the treatment of choice for chronic anal fissure, either open or closed method. However, the closed method was observed to have lesserpost operative complication compared to the open method.

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Continuous versus intermittent chemotherapy in metastatic colorectal cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.3582 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 3582-3582 ◽

Cited By ~ 6

Author(s):

C. G. Alexopoulos ◽

A. A. Kotsori

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Stable Disease ◽

Randomized Study ◽

Intermittent Chemotherapy ◽

Group A ◽

Group B ◽

Line Chemotherapy

3582 Background: The current policy concerning the duration of chemotherapy in metastatic colorectal cancer (MCC) varies considerably (Clin Oncol 1997;9:248) while no benefit of continuous versus intermittent 5-FU was found in a published randomized study (Lancet 2003;361:457). Serious cumulative toxicity is not usually a problem with long-term 5-FU/FA, but this is not the case with contemporary triple regimens (FOLFIRI, FOLFOX). We, therefore, performed a randomized study of continuous versus intermittent FOLFIRI as first line chemotherapy in MCC. Methods: Patients with MCC and ECOG 0–2 were given 6 biweekly courses of FOLFIRI (Irinotecan 180mg/m2 + De Gramont). Patients with response or stable disease were randomized to continue with another 6 FOLFIRI (group A) or discontinue until relapse when 6 FOLFIRI were readministered (group B). Time to progression (TTP) was calculated from study entrance until 1st progression for group A, and 2nd progression for group B, and overall survival (OS) from study entrance until death. Results: Fifty eight (M=38, F=20) patients entered into the study. Two (3.4%) withdrew before evaluation, 1 (1.7%) died of stroke, 1 (1.7%) was lost to FU and 15 (26%) progressed before or at the completion of 6 FOLFIRI. Thirty nine (67%) patients (M=25, F=14), median age 69 (38–79) responded (21=54%) or had stable disease (18=46%) and were randomized: 19 (49%) to group A and 20 (51%) to group B. Median TTP was 8 months 95% CI: 5.3–10.7) for group A and 9 (95% CI: 7.8–10) for group B (p=NS). 10/19 (52%) in group A received 2nd line chemotherapy vs 7/20 (35%) in group B (p=NS). With a median follow-up of 13 months, 21 patients are alive (12 in group A and 9 in group B). Median OS was 21 months (95% CI: 15 - 26.7) in group A vs 15 (95% CI: 12.6 - 17.3) in group B (p=NS), and 18 months (95% CI: 15.5 - 21) for all 39 patients. Conclusions: In MCC, when response or stability has been achieved after 6 courses ofFOLFIRI there seemstobe little more benefit from continuing chemotherapy than from retreating patients at relapse No significant financial relationships to disclose.

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Treatment of Severe Aplastic Anaemia (SAA) with Antilymphocyte Globulin (ALG), Cyclosporine (CyA) and Granulocyte Colony Stimulating Factor (G-CSF) 5 μG vs 10 μG/Kg : A Gitmo Prospective Randomized Study.

Blood ◽

10.1182/blood.v104.11.3700.3700 ◽

2004 ◽

Vol 104 (11) ◽

pp. 3700-3700

Author(s):

Anna Locasciulli ◽

Barbara Bruno ◽

Alessandro Rambaldi ◽

Paola Saracco ◽

Carlo Dufour ◽

...

Keyword(s):

Peripheral Blood ◽

Randomized Study ◽

Prospective Trial ◽

Actuarial Survival ◽

Group A ◽

Group B ◽

Cox Analysis ◽

Design And Methods ◽

To Receive

Abstract Background and objective. In a previous study we showed encouraging outcome in severe aplastic anemia (SAA) patients treated with anti-lymphocyte globulin (ALG), cyclosporin (CyA) and G-CSF 5mg/Kg/day (Blood2000; 95: 1931–4.). However failure to respond, delayed responses, partial responses, relapses and early deaths remain signifcant problems. The aim of the present study was to test whether an increased dose of G-CSF (10 mg/Kg/day) would reduce these complications. Design and methods. This is a multicenter prospective trial in 77 SAA patients treated with horse ALG (15 mg/kg/day day1–5) and CyA (5 mg/kg/day day 1–180). Patients were randomized to receive G-CSF 5 mg/Kg/day (n=38, group A) or 10 mg/Kg/day (n=39, group B) from day +1 to day +30. All patients then received G-CSF 5 mg/Kg/day from day +31 to day +90. Primary end point was response at day +120. Secondary end points were early deaths , blood counts at day +120, and survival. Results. At day +120 responses were classified as absent, partial, complete in 12, 22, 4 patients in group A and in 23, 7, 9 patients in group B (p=0.001). At last follow up these figures were respectively 9,12,17 vs 19,2,18 (p=0.004). Thirteen patients (5 in group A and 8 in group B) died before day 120 (p=0.3). Median peripheral blood counts an day 120 were comparable in the two groups: Hb 10.5 vs 9.5 gr% (p=0.6), Neutrophils 2.4 vs 1.9x10^9/l (p=0.4) and platelets 42 vs 36 x10^9/l (p=0.3). The actuarial survival at 4 years is 72% in group A vs 67% in group B (p=0.3). An additional finding of this study is a strong age effect, with an actuarial 4 year survival of 81% in patients aged 0–20 , 80% in patients aged 21–40 and 34% in patients over 40 (p=0.0002). This correlated with the inability of older patients to increase their white blood cell (WBC) counts above 5x10^9/L, during G-CSF treatment. In a multivariate COX analysis patient age and highest WBC counts during G-CSF, were both significant predictors of survival. Interpretation and conclusions. Increasing the dose of G-CSF does not appear to reduce early deaths, does not improve peripheral blood counts nor survival, and may reduce the response rate in patients with SAA receiving ALG and CyA. Older age and failure to improve WBC are negative predictors of survival.

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Parsplana vitrectomy alone versus parsplana vitrectomy combined with phacoemulsification for the treatment of rhegmatogenous retinal detachment: a randomized study

BMC Ophthalmology ◽

10.1186/s12886-021-01954-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Paolo Mora ◽

Stefania Favilla ◽

Giacomo Calzetti ◽

Giulia Berselli ◽

Lucia Benatti ◽

...

Keyword(s):

Retinal Detachment ◽

Rhegmatogenous Retinal Detachment ◽

Randomized Study ◽

Retinal Breaks ◽

Retinal Tears ◽

Retinal Reattachment ◽

Group A ◽

The Difference ◽

Group B

Abstract Background To compare parsplana vitrectomy (PPV) with and without phacoemulsification to treat rhegmatogenous retinal detachment (RRD). Methods Subjects aged 48–65 years with RRD in a phakic eye due to superior retinal tears with an overall extension of retinal breaks < 90° underwent to PPV alone (group A); or PPV plus phacoemulsification (phacovitrectomy, PCV, group B). Post-operative follow-up visits occurred at 1 week, 1 month (m1), 3 months (m3), and 6 months (m6) after surgery. The main outcome was the rate of retinal reattachment. Secondary outcomes included best-corrected visual acuity (BCVA), intraocular pressure (IOP), central macular thickness (CMT), and cataract progression (in the lens-sparing [PPV-alone] group). Results In this initial phase of the study a total of 59 patients (mean age: 55 years, 59 eyes) were enrolled: 29 eyes in group A and 30 eyes in group B. Both groups had similar gas tamponade. During the follow-up there were three cases of RRD recurrence in group A and one in group B. The relative risk of recurrence in group A was 3.22 times higher but the difference was not significant (p = 0.3). The two groups were also similar in terms of BCVA and IOP variation. At m3, CMT was significantly higher in group B (p = 0.014). In group A, cataract progression was significant at m6 (p = 0.003). Conclusions In a cohort of RRD patients selected according to their preoperative clinical characteristics, PPV was comparable to PCV in terms of the rate of retinal reattachment after 6 months. Trial registration ISRCTN15940019. Date registered: 15/01/2021 (retrospectively registered).

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Comparison between stapler hemorrhoidectomy and open hemorrhoidectomy in the management of grade III and IV hemorrhoids: a prospective randomized study

International Surgery Journal ◽

10.18203/2349-2902.isj20181990 ◽

2018 ◽

Vol 5 (6) ◽

pp. 2069

Author(s):

Shailendra Pal Singh ◽

Somendra Pal Singh ◽

Vipin Gupta ◽

Kutubuddin Quadri ◽

Mohit Gupta

Keyword(s):

Pain Score ◽

Randomized Study ◽

Lithotomy Position ◽

Open Hemorrhoidectomy ◽

Early Results ◽

Group A ◽

The Difference ◽

Group B ◽

Grade Iii

Background: Haemorrhoids are one of the most common anorectal disorders. Haemorrhoids or piles are dilated veins of the anal canal and are more common in obesity, constipation and pregnancy. Classically they occur in the 3, 7 and 11 o'clock position with the patient in lithotomy position. Symptoms of haemorrhoids are per rectal bleeding and prolapse. Bleeding is bright red in colour and which is painless. The aim of the study was to compare the early results in 60 patients randomly allocated to undergo either stapled or open hemorrhoidectomy.Methods: Out of 60 patients, 30 (50.0%) patients underwent hemorrhoidectomy by Open Milligan-Morgan’s method were classified as Group A while rest 30 (50.0%) patients underwent hemorroidectomy by Stapler method after anal stretching, these patients were classified as Group B.Results: Pain score of majority of patients of Group A was ≥7 (76.7%), only 6.7% had pain score <3 and rest 16.7% had pain score 3 to 6. On comparing the difference of pain in passage of first stool among patients of Group A and Group B statistically was found to be highly significant. Pain in follow up at 3, 7 and 15th day was also significantly higher in group A in comparison to group B.Conclusions: Of the 60 patients in the current study, 32 are still in the follow up with the maximum follow up period of 11 months. There was no case of recurrence of haemorrhoids in this study. The factor of cost was not evaluated in the study since the hospital stay as well as stapling instrument was totally free in U.P, UMS, Saifai.

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Parsplana Vitrectomy Alone Versus Parsplana Vitrectomy Combined With Phacoemulsification for The Treatment of Rhegmatogenous Retinal Detachment: A Randomized Study

10.21203/rs.3.rs-294145/v1 ◽

2021 ◽

Author(s):

Paolo Mora ◽

Stefania Favilla ◽

Giacomo Calzetti ◽

Giulia Berselli ◽

Lucia Benatti ◽

...

Keyword(s):

Retinal Detachment ◽

Rhegmatogenous Retinal Detachment ◽

Randomized Study ◽

Retinal Breaks ◽

Retinal Tears ◽

Retinal Reattachment ◽

Group A ◽

The Difference ◽

Group B

Abstract BACKGROUND: To compare parsplana vitrectomy (PPV) with and without phacoemulsification to treat rhegmatogenous retinal detachment (RRD).DESIGN: parallel, randomized trial.METHODS: subjects aged 48 - 65 years with RRD in a phakic eye due to superior retinal tears with an overall extension of retinal breaks < 90° underwent to PPV alone (group A); or PPV plus phacoemulsification (phacovitrectomy, PCV, group B). Post-operative follow-up visits occurred at 1 week, 1 month (m1), 3 months (m3), and 6 months (m6) after surgery. The main outcome was the rate of retinal reattachment. Secondary outcomes included best-corrected visual acuity (BCVA), intraocular pressure (IOP), central macular thickness (CMT), and cataract progression (in the lens-sparing [PPV-alone] group).RESULTS: in this initial phase of the study a total of 59 patients (mean age: 55 years, 59 eyes) were enrolled: 29 eyes in group A and 30 eyes in group B. Both groups had similar gas tamponade. During the follow-up there were three cases of RRD recurrence in group A and one in group B. The relative risk of recurrence in group A was 3.22 times higher but the difference was not significant (p = 0.3). The two groups were also similar in terms of BCVA and IOP variation. At m3, CMT was significantly higher in group B (p = 0.014). In group A, cataract progression was significant at m6 (p = 0.003).CONCLUSIONS: In a cohort of RRD patients selected according to their preoperative clinical characteristics, PPV was comparable to PCV in terms of the rate of retinal reattachment after 6 months.TRIAL REGISTRATION: ISRCTN15940019Date registered: 15/01/2021 (retrospectively registered)

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