US3752889A - Treatment of chronic fatigue following acute disease - Google Patents
Treatment of chronic fatigue following acute disease Download PDFInfo
- Publication number
- US3752889A US3752889A US00243865A US3752889DA US3752889A US 3752889 A US3752889 A US 3752889A US 00243865 A US00243865 A US 00243865A US 3752889D A US3752889D A US 3752889DA US 3752889 A US3752889 A US 3752889A
- Authority
- US
- United States
- Prior art keywords
- treatment
- acute disease
- chronic fatigue
- mgs
- following acute
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Lifetime
Links
- 238000011282 treatment Methods 0.000 title abstract description 11
- 208000030090 Acute Disease Diseases 0.000 title abstract description 9
- 206010016256 fatigue Diseases 0.000 title abstract description 9
- VAOCPAMSLUNLGC-UHFFFAOYSA-N metronidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1CCO VAOCPAMSLUNLGC-UHFFFAOYSA-N 0.000 abstract description 8
- 229960000282 metronidazole Drugs 0.000 abstract description 8
- 241000124008 Mammalia Species 0.000 abstract description 2
- 230000001225 therapeutic effect Effects 0.000 abstract description 2
- 238000000034 method Methods 0.000 description 9
- 230000007774 longterm Effects 0.000 description 5
- 230000009467 reduction Effects 0.000 description 5
- 239000003795 chemical substances by application Substances 0.000 description 4
- 208000024891 symptom Diseases 0.000 description 4
- 238000012423 maintenance Methods 0.000 description 3
- 230000003340 mental effect Effects 0.000 description 3
- FFYTTYVSDVWNMY-UHFFFAOYSA-N 2-Methyl-5-nitroimidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1 FFYTTYVSDVWNMY-UHFFFAOYSA-N 0.000 description 2
- 241000282472 Canis lupus familiaris Species 0.000 description 2
- 230000006866 deterioration Effects 0.000 description 2
- AUZONCFQVSMFAP-UHFFFAOYSA-N disulfiram Chemical compound CCN(CC)C(=S)SSC(=S)N(CC)CC AUZONCFQVSMFAP-UHFFFAOYSA-N 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 230000035935 pregnancy Effects 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 230000004044 response Effects 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 230000008733 trauma Effects 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 208000034656 Contusions Diseases 0.000 description 1
- 206010013911 Dysgeusia Diseases 0.000 description 1
- 206010024264 Lethargy Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 208000007101 Muscle Cramp Diseases 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 1
- 208000001871 Tachycardia Diseases 0.000 description 1
- 208000036142 Viral infection Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000036626 alertness Effects 0.000 description 1
- 208000033571 alveolar capillary dysplasia with misalignment of pulmonary veins Diseases 0.000 description 1
- 229940098194 antabuse Drugs 0.000 description 1
- 230000002221 antabuse Effects 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000008175 fetal development Effects 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000012631 food intake Nutrition 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 208000034783 hypoesthesia Diseases 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 206010022437 insomnia Diseases 0.000 description 1
- 201000002364 leukopenia Diseases 0.000 description 1
- 231100001022 leukopenia Toxicity 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 230000036651 mood Effects 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 230000000926 neurological effect Effects 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 208000004594 persistent fetal circulation syndrome Diseases 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 230000037081 physical activity Effects 0.000 description 1
- 230000003169 placental effect Effects 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 230000006794 tachycardia Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 238000011269 treatment regimen Methods 0.000 description 1
- 210000001215 vagina Anatomy 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
- 230000004304 visual acuity Effects 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/415—1,2-Diazoles
Definitions
- the invention herein described relates to a method of treating long-term general functional deterioration evidenced by a chronic fatigue which occasionally follows the abatement of acute disease or other physical trauma which involved the introduction of a foreign protein into the system.
- the objects of this invention are: to provide a method for systematically treating the chronic long-term fatigue which occasionally follows the abatement of acute disease; to provide such a method which may be accomplished through the convenient oral administration of tablets; to provide such a method that is suitable for intensive therapy as well as long term maintenance and intermittent therapy, and to provide such a method which is usually well tolerated by the patient.
- metronidazole is a known alkylatin-g agent of relatively low toxicity which is thought to interfere with nucleic acid biosynthesis. It appears that metronidazole can penetrate all tissues of the body quite readily and its function, in the treatment of chronic fatigue following acute disease, is believed related to the suppression of a longterm abnormal immunologic response of the system to the introduction of foreign protein.
- the acute disease preceding the chonic symptoms apparently may take a variety of forms, such as, trauma to a particular part of the body, pregnancy, viral or bacterial infection, etc., and the resultant fatigue often appears associated with a general deterioration which may be likened to accelerated aging.
- the agent is readily absorbable from the human intestinal tract and may be administered orally as well as by vaginal or rectal inserts when indicated.
- a typical intense treatment for an average size adult patient comprises 250 mgs. of the agent four times daily for a period of about four weeks and then a reduction to mgs. four times daily for several additional weeks and thereafter further reduction, depending upon the tolerance of the patient and the absence of symptoms.
- An ultimate effective long-term maintenance dose was found to be as low as 31 mgs. per day.
- the most common effective maintenance dose has been determined to be about 125- mgs. per day for a substantial percentage of the patients with 250 mgs. per day being indicated for other patients, depending on age, size and physical condition.
- a reasonable maximum dosage appeared to be about 1000 mgs. per day.
- a renewal of treatment appeared effective upon a return of symptoms after treatment was discontinued.
- Metronidazole has been tested on animals, particularly dogs. The agent appeared effective in improving in physical strength, agility and mental alertness in dogs otherwise lethargic, the most effective dosage being about three (3) mgs. per pound of body weight.
- Metronidazole is believed contraindicated in patients under treatment with desulfadram (Antabuse) and in uncompensated hypothyroid patients. Because metronidazole appears to cross the placental barrier and enter the fetal circulation rapidly and further since its effects on fetal development are not definitely known, it is also thought to be contraindicated during the first trimester of pregnancy.
- the method of treating humans having chronic fatigue following the abatement of acute disease which comprises the repeated administration to humans of eflective amounts of a pharmaceutical composition which contains, as an active ingredient, l-(fl-hydroxyethyD-Z- methyl-S-nitroimidazole.
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
THE ADMINISTRATION INTERNALLY TO MAMMALS OF 1-(BHYDROZYETHYL) - 2 - METHYL - 5 - NITROIMIDAZOLE (METRONIDAZOLE), IN A DOSAGE RANGE FOR ADULT HUMANS OF ABOUT 31 TO 1000 MGS. PER TWENTY-FOUR HOUR PERIOD, IS AN EFFECTIVE THERAPEUTIC TREATMENT FOR CHRONIC FATIGUE WHICH SOMETIMES FOLLOWS ACUTE DISEASE.
Description
United States Patent 3,752,889 TREATMENT OF CHRONIC FATIGUE FOLLOWING ACUTE DISEASE James B. Mercer, 13109 W. 95th St.,
Lenexa, Kans. 66215 No Drawing. Continuation-impart of abandoned apphcation Ser. No. 860,062, Sept. 22, 1969. This application Apr. 13, 1972, Ser. No. 243,865
Int. Cl. A61k 27/00 US. Cl. 424273 4 Claims ABSTRACT OF THE DISCLOSURE The administration internally to mammals of l-(B- hydroxyethyl) 2 methyl 5 nitroimidazole (metronidazole), in a dosage range for adult humans of about 31 to 1000 mgs. per twenty-four hour period, is an effective therapeutic treatment for chronic fatigue which sometimes follows acute disease.
This application is a continuation-in-part of application S'er. No. 860,062, filed Sept. 22, 1969, now abandoned.
The invention herein described relates to a method of treating long-term general functional deterioration evidenced by a chronic fatigue which occasionally follows the abatement of acute disease or other physical trauma which involved the introduction of a foreign protein into the system.
The objects of this invention are: to provide a method for systematically treating the chronic long-term fatigue which occasionally follows the abatement of acute disease; to provide such a method which may be accomplished through the convenient oral administration of tablets; to provide such a method that is suitable for intensive therapy as well as long term maintenance and intermittent therapy, and to provide such a method which is usually well tolerated by the patient.
l(fl-hydroxyethyl) 2 methyl 5 nitroimidazole (metronidazole) is a known alkylatin-g agent of relatively low toxicity which is thought to interfere with nucleic acid biosynthesis. It appears that metronidazole can penetrate all tissues of the body quite readily and its function, in the treatment of chronic fatigue following acute disease, is believed related to the suppression of a longterm abnormal immunologic response of the system to the introduction of foreign protein. The acute disease preceding the chonic symptoms apparently may take a variety of forms, such as, trauma to a particular part of the body, pregnancy, viral or bacterial infection, etc., and the resultant fatigue often appears associated with a general deterioration which may be likened to accelerated aging. The agent is readily absorbable from the human intestinal tract and may be administered orally as well as by vaginal or rectal inserts when indicated.
Clinical observations upon the administration of metronidazole in treatment of the noted symptoms have demonstrated marked patient improvement in energy and strength, resistance of the skin to bruises, breathing during physical activity, mental activity, reduction of muscle cramps and numbness of limbs, and in the ability to rest and sleep effectively. Persons receiving the drug sometimes showed response by a distinct warming of the entire body, especially the extremities which had theretofore been cold for long periods, even months or years. A notable increase in strength and endurance to perform tasks requiring physical labor, many of which would not Patented Aug. 14, 1973 ice have been attempted prior to the treatment, was also shown as well as a feeling of well being with less anxiety and greater mental and visual acuity.
A typical intense treatment for an average size adult patient comprises 250 mgs. of the agent four times daily for a period of about four weeks and then a reduction to mgs. four times daily for several additional weeks and thereafter further reduction, depending upon the tolerance of the patient and the absence of symptoms.
An ultimate effective long-term maintenance dose was found to be as low as 31 mgs. per day. The most common effective maintenance dose has been determined to be about 125- mgs. per day for a substantial percentage of the patients with 250 mgs. per day being indicated for other patients, depending on age, size and physical condition. A reasonable maximum dosage appeared to be about 1000 mgs. per day. A renewal of treatment appeared effective upon a return of symptoms after treatment was discontinued.
Regarding side elfects, some persons were found to experience nausea but it generally disappeared after a few weeks. In rare instances there was a slight soreness of the mouth or a white tongue and in such cases a dosage reduction is indicated. Some dizziness and dryness of the mouth and vagina were occasionally noted and a few persons complained of a bad taste. Also, moderate leukopenia -was occasionly observed, which noramlly returned to normal after dosage reduction or completion of a treatment regimen.
Metronidazole has been tested on animals, particularly dogs. The agent appeared effective in improving in physical strength, agility and mental alertness in dogs otherwise lethargic, the most effective dosage being about three (3) mgs. per pound of body weight.
Metronidazole is believed contraindicated in patients under treatment with desulfadram (Antabuse) and in uncompensated hypothyroid patients. Because metronidazole appears to cross the placental barrier and enter the fetal circulation rapidly and further since its effects on fetal development are not definitely known, it is also thought to be contraindicated during the first trimester of pregnancy.
The initial neurological signs of metroidazole overdose in humans appeared to be increased pulse rate, difficulty in reading small print, difiiculty in handling small objects and insomnia. Progressively, it is understood that tachycardia may occur, and a slightly unstable person, especially, may suffer marked swings in mood. Physical exercise apparently becomes increasingly fatiguing, and weight loss occurs despite substantial food intake. When the medication is withdrawn, the adverse reaction apparently clears totally in one week.
It is to be understood that, while certain practices of this invention have been described herein, it is not to be limited to the specific form and dosages described except insofar as such limitations are included in the claims.
What is claimed and desired to secure by Letters Patent is:
1. The method of treating humans having chronic fatigue following the abatement of acute disease which comprises the repeated administration to humans of eflective amounts of a pharmaceutical composition which contains, as an active ingredient, l-(fl-hydroxyethyD-Z- methyl-S-nitroimidazole.
2. The method as set forth in claim 1 wherein the dosage range of the composition in adult humans is about 31 mgs. to 1000 mgs. per twenty-four hour period.
3 4 3. The method as set forth in claim 1 wherein said References Cited amounts are reduced following the initial administration. n LOS Angeles N 5 29458-163 (1963), pp.
4. The method as set forth in claim 1 wherein said composition is administered at a dosage of about 125 mgs. per twenty-four hour period. 5 STANLEY J. FRIEDMAN, Primary Examiner
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US24386572A | 1972-04-13 | 1972-04-13 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| US3752889A true US3752889A (en) | 1973-08-14 |
Family
ID=22920443
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US00243865A Expired - Lifetime US3752889A (en) | 1972-04-13 | 1972-04-13 | Treatment of chronic fatigue following acute disease |
Country Status (1)
| Country | Link |
|---|---|
| US (1) | US3752889A (en) |
-
1972
- 1972-04-13 US US00243865A patent/US3752889A/en not_active Expired - Lifetime
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