WO2007008119A1 - The use of ketoprofen in treating hemorrhoids - Google Patents

The use of ketoprofen in treating hemorrhoids Download PDF

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Publication number
WO2007008119A1
WO2007008119A1 PCT/SD2005/000008 SD2005000008W WO2007008119A1 WO 2007008119 A1 WO2007008119 A1 WO 2007008119A1 SD 2005000008 W SD2005000008 W SD 2005000008W WO 2007008119 A1 WO2007008119 A1 WO 2007008119A1
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WIPO (PCT)
Prior art keywords
hemorrhoids
ketoprofen
treatment
group
months
Prior art date
Application number
PCT/SD2005/000008
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French (fr)
Inventor
El Fatih Osman Hassan
Original Assignee
El Fatih Osman Hassan
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by El Fatih Osman Hassan filed Critical El Fatih Osman Hassan
Priority to PCT/SD2005/000008 priority Critical patent/WO2007008119A1/en
Publication of WO2007008119A1 publication Critical patent/WO2007008119A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Definitions

  • Hemorrhoids is a common disease in adults of both sexes and is characterized by internal/external disorder and congestion of the ano-rectal veins leading to discomfort, pain, pruritus, mucous discharge, prolapse and bleeding.
  • Ketoprofen preparation of 2.5% dissolved in glycerol was administered b.d. to 25 patients randomly selected and denominated as group "A" or "Treatment Group". Another group of 25 patients were receiving conventional Hemorrhoids treatments and were denominated as group
  • the preparation was found to be extremely effective in complete and lasting healing of hemorrhoids when applied twice daily for a treatment duration of 7 - 14 days.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The efficacy of Ketoprofen was investigated in treating Hemorrhoids in its various forms, stages and clinical symptoms. Clinical trials were conducted in Sudan at Sadiq Abu Aagla out-patient clinic. Results from trials Data collected over a total of 6 months including after-treatment follow-up has revealed an outstanding healing effect of a 2.5% preparation of Ketoprofen dissolved in Glycerine. All treated patients fully recovered from all symptoms including pain in a period of 4 -14 days from commence of treatment. There was no relapse noted for any of the hemorrhoids clinical manifestations whatsoever within a period of 6 months after commences of treatment. It was thus concluded that Ketoprofen is a final cure for Hemorrhoids in all its stages and that it eliminates the need for surgery.

Description

The use of Ketoprofen in Treating Hemorrhoids
By El Fatih Osman Hassan Omran
Introduction
Hemorrhoids is a common disease in adults of both sexes and is characterized by internal/external disorder and congestion of the ano-rectal veins leading to discomfort, pain, pruritus, mucous discharge, prolapse and bleeding.
Up-to-date, no drug of steroidal or non-steroidal nature or otherwise is known to cure or even relief the pains of hemorrhoids effectively.
Objective:
The current study investigates the efficacy of Ketoprofen 2.5% in the treatment of hemorrhoids and relieving its pains.
Materials and Methods:
Studies were started on Jan. 2005 and concluded in My 2005.
Location of trials was ""Sadig Abu Aagla's public clinic. Bum, Sudan. Physician in charge:
Dr. Khalid El Tayeb Basbir
Patients of age groups 30-60 of both sexes were included in this study. Routine examinations were curried out for all positively diagnosed patients before commence of trials and results were recorded. Hemorrhoids manifestations were recorded as per attached tables (1)
Inclusion criteria; Only patients with hemorrhoids symptoms, with or without rectal bleeding were included.
Exclusion criteria: Patients with hemorrhoids symptoms but having other complications were excluded from trials.
Ketoprofen preparation of 2.5% dissolved in glycerol was administered b.d. to 25 patients randomly selected and denominated as group "A" or "Treatment Group". Another group of 25 patients were receiving conventional Hemorrhoids treatments and were denominated as group
"B" or "Control group",
Two patients of group "A" and one of group "B" have discontinued trials.
Follow-up observations and examination were made on daily basis on both groups for the first 14 days.
Examinations and collection of data were made on weekly basis then 3 months and 6 months after the start of medication to note incidence of recurrence of any of the clinical symptoms and side-effects if any.
Externally affected areas were thoroughly cleaned with dilute antiseptics (Dettol) before administration of the drug. Clean disposable syringes were used to deliver about 2 c.c. of the drug through the rectal opening to a depth of 3-4 cm to cover the affected internal areas. About another 2 c.c. were applied and thoroughly rubbed over the external affected areas. Group "B" received conventional Hemorrhoids treatments. Results and Discussion
Pre-Treatment incidence of clinical data were recorded as per attached Table (1).
Post-Treatment clinical data were recorded and analyzed as per attached Tables (2 -7).
In all 23 patients of Group "A", the need for a surgical operation was completely eliminated.
AU external and internal congested veins were ruptured painlessly discharging the congested blood and completely healed within a maximum of 14 days of treatment.
17 out of 23 patients of Group "A" achieved complete cure and healing within 7 days.
The rest (6 patients) reached to same level of cure in 14 days. Only one patient of group "B" got well after 7 days and 4 after 2 weeks and 3 months. None of the patients of group "A" had recurrence of disease symptoms during the follow-up duration of 6 months while one case of recurrence was noted in group "B".
Patients of group "A" who were suffering from itching/pain experienced immediate relief (within
2-5 minutes) following the first application. The preparation has exhibited a slight burning pain effect in some patients which lasted for about 2-5 minutes after which all pains were relieved.
Patients from group "A" who suffered from congested veins and/or bleeding experienced increase in bleeding at first due to vein rupturing followed by quick healing and complete cessation of bleeding.
In none of the 23 patients of group "A" any adverse side-effects or complications were noted.
None of the 24 patients in the control group (Group B) attained complete healing or a lasting relief of pains.
When data were analyzed statistically, results for pruritus, pain, vein congestion and bleeding were found to be statistically significant.
Those for mucous discharge and prolapse were not statistically different from the control (group
"B") which gave similar improvements in patients conditions.
Conclusion:
The following post-treatment results were obtained:
1- The preparation was found to be extremely effective in complete and lasting healing of hemorrhoids when applied twice daily for a treatment duration of 7 - 14 days.
2- It was found to be extremely effective in giving spontaneous and lasting relief of hemorrhoids pains within 2-5 minutes.
3- The preparation was found to moderately improve/cure prolapse associated with hemorrhoids, pregnancy or delivery.
4- No adverse side-effects were noted during treatment and follow-up periods.
5- It was found to be tolerably painful compared to severe pains due to hemorrhoids.
6- It was found to sooth pruritus and stop mucous discharge associated with hemorrhoids. Congested hemorrhoid veins were observed to painlessly rupture, discharge and completely heal within 7- 14 days.
Figure imgf000004_0002
Post-Treatment incidence of symptoms Table (2) Incidence of Pruritus Counts of atients showin s m toms
Figure imgf000004_0003
Anova: Two-Factor Without Replication
Figure imgf000004_0001
ANOVA
Source of Variation SS df /WS F P-value F crit
7.70864
Rows 10 1 10 8 0.047420656 9719
6.38823
Columns 43.4 4 10.85 8.68 0.029811279 3942
Error 5 4 1.25
Total 58.4 9 Table (3) incidence of pain
Figure imgf000005_0002
Aπova: Two-Factor Without Replication
Figure imgf000005_0001
ANOVA
Source of Variation SS df MS F P-value Fcrit
Rows 44.1 1 44.1 10.13793103 0.033406805 7.708649719
Columns 449.4 4 112.35 25.82758621 0.004064709 6.388233942
Error 17.4 4 4.35
Total 510.9 9
Table (3) incidence of pain
Figure imgf000006_0002
Anova: Two-Factor Without Replication
Figure imgf000006_0001
ANOVA
Source of Variation SS df MS F P-value Fcrit
Rows 44.1 1 44.1 10.13793103 0.033406805 7.708649719
Columns 449.4 4 112.35 25.82758621 0.004064709 6.388233942
Error 17.4 4 4.35
Total 510.9 9
Table (4) Incidence of Mucous Discharge
Figure imgf000007_0002
Anova: Two-Factor Without Replication
Figure imgf000007_0001
ANOVA
Source of Variation SS df MS F P-value F cήt
Rows 0.1 1 0.1 0.285714286 0.621308295 7.708649719
Columns 28.6 4 7.15 20.42857143 0.006330074 6.388233942
Error 1.4 4 0.35
Total 30.1 g
Table (5) Incidence of Prolapse
|Counts of patients showing symptoms!
TREATMENT DAY1 DAY7 DAY14 AFTER 3 MONTHS AFTER 6 MONTHS
GROUP "A" 7 6 5 5 4
GROUP "B" 6 6 6 5 5
Anova: Two-Factor Without Replication
Figure imgf000008_0001
ANOVA
Source of Variation SS df MS F P-value Fcrit
7.70864971
Rows 0.1 1 0.1 0.285714286 0.621308295 9
6.38823394
Columns 5 4 1.25 3.571428571 0.122619629 2
Error 1.4 4 0.35
Total 6.5 9
Table (6) Incidence of Bleeding
Figure imgf000009_0002
Anova: Two-Factor Without Replication
Figure imgf000009_0001
ANOVA
Source of Variation SS df MS F P-value F crit
Rows 36.1 1 36.1 15.36170213 0.017256402 7.708649719
Columns 41.4 4 10.35 4.404255319 0.090047369 6.388233942
Error 9.4 4 2.35
Total 86.9 9
Table (7) Incidence of Congestion
Counts of patients showing symptoms|
TREATMENT DAY1 DAY7 DAY14 AFTER 3 MONTHS AFTER 6 MONTHS
GROUP "A" 18 2 0 0 0
GROUP "B" 19 19 18 17 17
Anova: Two-Factor Without Replication
Figure imgf000010_0001
ANOVA
Source of Variation SS df MS F P-value Fcrit
Rows 490 1 490 18.49056604 0.01264496 7.70864971«
Columns 146 4 36.5 1.377358491 0.381952193 6.38823394.
Error 106 4 26.5
Total 742 9

Claims

C L A I M
Ketoprofen is generally used for killing pains specially rheumatic pains connected with arthritis .
It is not known to have an effect on Hemorrhoids.
It's indication for treating hemorrhoids is considered here to be a first report to this effect.
The claim is "The USE of ketoprofen for treating Hemorrhoids" in all its forms, stages and its related symptoms.
Hence protection required is for the Indication of Ketoprofen for Treating Hemorrhoids.
PCT/SD2005/000008 2005-07-12 2005-07-12 The use of ketoprofen in treating hemorrhoids WO2007008119A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/SD2005/000008 WO2007008119A1 (en) 2005-07-12 2005-07-12 The use of ketoprofen in treating hemorrhoids

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SD2005/000008 WO2007008119A1 (en) 2005-07-12 2005-07-12 The use of ketoprofen in treating hemorrhoids

Publications (1)

Publication Number Publication Date
WO2007008119A1 true WO2007008119A1 (en) 2007-01-18

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Country Status (1)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5602183A (en) * 1991-03-01 1997-02-11 Warner-Lambert Company Dermatological wound healing compositions and methods for preparing and using same
US5894019A (en) * 1995-03-17 1999-04-13 Gebro Broschek Gesellschaft M.B.H. Topically applied pharmaceutical composition, method of preparing it and its use
WO2000030630A1 (en) * 1998-11-23 2000-06-02 Linden Biotechnology, Inc. Combination products of a guanylate cyclase inhibitor and a local anesthetic for pain relief

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5602183A (en) * 1991-03-01 1997-02-11 Warner-Lambert Company Dermatological wound healing compositions and methods for preparing and using same
US5894019A (en) * 1995-03-17 1999-04-13 Gebro Broschek Gesellschaft M.B.H. Topically applied pharmaceutical composition, method of preparing it and its use
WO2000030630A1 (en) * 1998-11-23 2000-06-02 Linden Biotechnology, Inc. Combination products of a guanylate cyclase inhibitor and a local anesthetic for pain relief

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