Hot Flushes in Menopausal women
Menopause is defines by at least 12 months of amenorrhea in 50 year old women( with or without increase in serum level of FSH-Follicular Stimulating Hormone) , bilateral oophorectomy in women of child bearing age or negative testing for progestrone in women aged at least 45 years.
Hot flushes are sudden sensations of intense heat ,it mainly affects the upper part of body and lasts from 1 to 5 minutes. Other associated symptoms may be redness of face, heavy perspiration,anxiety,palpitations,irritability, sleeplessness and nocturnal sweating. Hot flushes are most common reason of discomfort during menopause and it reduce quality of life.
Conventional Treatment-
Hormone Replacement therapy (HRT) is advised for hot flushes and other menopausal problems but HRT has severe unfavorable effects.
Homeopathic Treatment-
Homeopathic medicines are prescribed on strict individualizations of patient. Most common medicines advised are Lachesis mutus, Sulphur,Sepia, Sanguinaria, Gloninum, Belladona and few else. Medicines are prescribed on basis of severity of symptoms, mental attitude of patient, environmental modalities,desire and aversion for different things, Temperament, Mood swings and physical constitution of patient.
More then 75% patients feel comfortable with Homeopathic prescriptions in Hot Flushes of Menopause. Noticable reduction in hot flushes and associated other menopausal symptoms improves quality of life.
Jan 31, 2008
Hair Falling
Hair Falling
Hair loss is very common disorder among males, females, all age groups and all ethnic groups. There are many patterns of Hair Falling.
A. Baldness- It is not actually hair falling.Hair becomes very fine and colorless instead of falling.Now hairs is called Vellus.
B. Alopecia aerata- It is an autoimmune disorder, body's defense system(immunity) start to destroy hair roots by forming antibodies against Hair roots. It is common among adolescents and young but may effect any age group.
C.Medications used for Gout,Heart diseases,Hypertension,Arthritis,Mental Disorders,Depression and chemotherapy used in Cancer and another cases may cause Hair Falling.
D.Male hormones(Androgens) causes hair loss,this type of hair loss is called Male Pattern Baldness. But this male pattern baldness may occur in females too,because females also have Androgen(Male Hormones).
E.Hair falling May occur in females during pregnancy and when using Birth control pills.Hair falling may continue for 6 months after stopping Birth control pills and after delivering a baby.
F.Large doses of Vitamin A may cause hair loss.
Hair Loss in diseases
A.Thyroid Disorders
B.Anemia- Low hemoglobin level in blood,generally in females.
C.Diabetes
D.Fungus infection of hair roots.
E.Major surgical procedure or some chronic illness
F.Insufficient diet specially low protein diet
G.Allergic Disorders
Few other reasons of Hair Loss
A.Frequent shampoo and conditioning of hair
B.Heat and Chemical treatment on hairs for coloring
C.Perming and Hard combing may weaken the hairs and cause hair falling
Few Facts About Hairs
A.A Person has nearly 50,00,000(5 million) hairs on all over the body. 120,000 hairs only on scalp.
B.Hairs on scalp grows continually for 5 years,after that hair stop to grow and after few weeks it fall out.Then new hair start to grow from same hair root. up to 100 hairs fall everyday normally.
C.Growth of hair depend on health status of person and blood supply to hair roots.
Common Baldness
More then 95% cases of Hair falling are of common baldness. Hairs not actually fall in Baldness but they become very thin,fine and colorless called Vellus.
Alopecia Aerata
Nearly 2% population suffer by Alopecia Areata. Usually it occurs on scalp only but sometimes may involve other part of body too. Pattern of hair loss in Alopecia Areata is different from Male pattern Baldness. Usually hair loss more on one side of scalp(Head).Hairs loss is Rapid in this condition. Alopecia Areata is an Autoimmune disorder, it means body's own immunity produces antibodies against hair roots. And those antibodies destroy the hair roots.Usually hair falls in patches.There may be more then one patch on head.
Sometimes hair falls from all of the scalp(head) and this is known as Alopecia Totalis. And sometimes this process goes further and hair falls from all over the body and now it is called Alopecia Universalis.
Treatment
Conventional Treatment
Common Baldness has no effective treatment. Lotion Minoxidil used to improve blood supply of scalp. A pill Finasteride is used to block the effect of Male Hormones(Androgens) on hair roots. But this medicine can produce Birth Defects on Pregnant Women.
Alopecia Aerata is reversed in 50% cases spontaneously in 6 months to 1 year. But the remaining cases need Treatment.Oral steroids and injections are prescribed but curability is very less. Treatment of Skin by ultraviolet rays may helpful in some cases. And somtimes Immunity suppressive drugs are used.
In conclusion Not any effective treatment is available to treat hair falling in Conventional Therapy. Very few patients get effective cure for hair falling here.
Homeopathic Treatment
Homeopathy offer very effective and permanent cure for most of cases of hair falling. In homeopathy more than 95 drugs are available for hair falling. Selection of medicine depends on Individual features of patient,modalities,behavior pattern, mental attitude,reactions,temperature modalities and coexisting disorders. Homeopathy cure effectively common baldness,Alopecia Aerata, hair falling during pregnancy and after childbirth. Treatment of Hair falling takes long time to cure. Even you will not find any sign of improvement in first few weeks,but take medicines with patience.
Polycystic Ovarian Syndrome
Polycystic Ovarian Syndrome(PCOS)
Also known as Polycystic Ovarian Disease(PCOD)
Polycystic Ovarian Syndrome - PCOS is a disorder which affect a woman's menstrual cycle, hormonal levels, fertility, insulin level, heart, blood vessels and general features. PCOS is the most common hormonal problem in women of reproductive age.It is very common cause of infertility in women( infertility means fail to conceive pregnancy). Near about 7 to 10% of women have PCOS.
PolyCystic Ovarian Syndrome ( PCOS) and Pelvic Inflammatory Disease (PID) are most common causes of Infertility in females.
Common Features in females with PCOS
1.Irregular or no menstrual cycle(Periods).
2.Increased level of Male hormones (androgen) in females.
3.May be small cysts in ovaries. Cyst is a sac full of fluids.
Causes of PCOS
No exact cause is yet known.
1. Females with PCOS have frequently a mother or sister with same disorder. But evidence for genetic link are not yet clearly available.
2.Many patients with PCOS have extra Weight .So researchers are searching for some disorder of production of Insulin hormone in body.Insulin regulates the sugar,starch and other energy needs of body.
3.Level of male hormones(Androgen) increased in blood that causes hairs growth,male pattern baldness. But not exact source of male hormones is yet known.
Symptoms of PCOS
1.Irregular Menstruation or absence of menstruation or irregular bleeding(periods).
2.Infertility - inability to get pregnant.
3.Acne( Acne are not only caused by PCOS),oily skin.
4.Excessive Hairs on face,chest,back and all over the body.
5.Weight Gain or obesity.
6.Pain in pelvic region.
7.High Blood pressure.
8.Baldness of male pattern due to excessive male hormones.
Diagnostic Tests
1.Ultrasonography-Vaginal ultrasonography for finding cysts in ovaries.
2.Hormone tests for male and female hormones.
3.Level of glucose,cholesterol in blood.
4.Insulin Level in Blood.
How Cysts form in Ovaries?
Females have two ovaries,one in each side of uterus. Each ovaries have follicles, filled with liquid and eggs. These follicles may be called cysts. Every month about 20 follicles start to mature but only one follicle success every month,and every month one ovum is excreted in uterus for pregnancy. When every month follicle mature it breaks and release egg.Remaining part of follicle start to produce progesterone.This is normal physiological process and controlled by hormones.
In cases of PCOS secretions of female hormones is insufficient. Not any egg matures. So fluid filled follicles(cysts) does not mature and breaks. Some of them remain as cysts. And they are collected in ovaries month after month. These cysts produce Male hormones(Androgen), and further increase the problem. Because no follicle matures and breaks, so production of progesterone hormone does not start which regulate the menstrual cycle. Defected production of hormone is main cause of irregular menstrual cycle in cases pf PCOS.
Treatment of PCOS
Conventional Treatment
There is no cure for PCOS.Treatment is based on symptoms and problems of every individual patient.
1. In patients who does not want pregnancy
Birth control pills can
-regulate menstrual cycles(periods)
- control extra hair growth by reducing male
hormones.
-control Acne.
But all these effects are only temporary until birth control pills are continue. These pills can not cure PCOS. Only Progesterone pills can also be used for menstrual regulation but these pills can not control Acne and Hair growth.
2.In patients who want Pregnancy
Release of Egg from follicles is necessary for Pregnancy . Hormones as FSH(follicular stimulating hormone), LH(leutinizing hormone) and GnRH(Gonadotropin Release Hormone) are used.
Clomiphene Citrate is another drug of choice in these cases.
Earlier , wedge resection of ovary(partial oophrectomy) by surgery was done.But this surgical process may cause post operative adhesion's and infertility. These days a new surgical procedure- Laser puncture of cysts- is used with more or less desirable effects.
Outcomes are not much favorable by either medicinal or surgical procedures.
Homeopathic Treatment of PCOS
Homeopathy system of medicine treat patients on basis of complete history, detail sign and symptoms, personality trait, behavioral pattern, mental make up, physical appearance, emotional indulgence and environmental modalities.
Only removal of cysts from ovaries by surgery or prescribing antagonist hormones for increased Male hormones does not solve the problem, as experience shows with conventional prescribing.
Goal of Homeopathic prescription is to stop the process which cause all these irregularities. Long term treatment is advised for cases of PCOS. After 2-3 month's treatment, most of cases start normal regular periods, ovulatory cycles, reduction in hair growth, acne and normal glucose metabolism.
Patient's suffering from infertility easily gain pregnancy, after few month's treatment.
Homeopathy advises 1 to 3 years of continue treatment for cases of PCOS for permanent cure.
PolyCystic Ovarian Syndrome ( PCOS) and Pelvic Inflammatory Disease (PID) are most common causes of Infertility in females.
Also known as Polycystic Ovarian Disease(PCOD)
Polycystic Ovarian Syndrome - PCOS is a disorder which affect a woman's menstrual cycle, hormonal levels, fertility, insulin level, heart, blood vessels and general features. PCOS is the most common hormonal problem in women of reproductive age.It is very common cause of infertility in women( infertility means fail to conceive pregnancy). Near about 7 to 10% of women have PCOS.
PolyCystic Ovarian Syndrome ( PCOS) and Pelvic Inflammatory Disease (PID) are most common causes of Infertility in females.
Common Features in females with PCOS
1.Irregular or no menstrual cycle(Periods).
2.Increased level of Male hormones (androgen) in females.
3.May be small cysts in ovaries. Cyst is a sac full of fluids.
Causes of PCOS
No exact cause is yet known.
1. Females with PCOS have frequently a mother or sister with same disorder. But evidence for genetic link are not yet clearly available.
2.Many patients with PCOS have extra Weight .So researchers are searching for some disorder of production of Insulin hormone in body.Insulin regulates the sugar,starch and other energy needs of body.
3.Level of male hormones(Androgen) increased in blood that causes hairs growth,male pattern baldness. But not exact source of male hormones is yet known.
Symptoms of PCOS
1.Irregular Menstruation or absence of menstruation or irregular bleeding(periods).
2.Infertility - inability to get pregnant.
3.Acne( Acne are not only caused by PCOS),oily skin.
4.Excessive Hairs on face,chest,back and all over the body.
5.Weight Gain or obesity.
6.Pain in pelvic region.
7.High Blood pressure.
8.Baldness of male pattern due to excessive male hormones.
Diagnostic Tests
1.Ultrasonography-Vaginal ultrasonography for finding cysts in ovaries.
2.Hormone tests for male and female hormones.
3.Level of glucose,cholesterol in blood.
4.Insulin Level in Blood.
How Cysts form in Ovaries?
Females have two ovaries,one in each side of uterus. Each ovaries have follicles, filled with liquid and eggs. These follicles may be called cysts. Every month about 20 follicles start to mature but only one follicle success every month,and every month one ovum is excreted in uterus for pregnancy. When every month follicle mature it breaks and release egg.Remaining part of follicle start to produce progesterone.This is normal physiological process and controlled by hormones.
In cases of PCOS secretions of female hormones is insufficient. Not any egg matures. So fluid filled follicles(cysts) does not mature and breaks. Some of them remain as cysts. And they are collected in ovaries month after month. These cysts produce Male hormones(Androgen), and further increase the problem. Because no follicle matures and breaks, so production of progesterone hormone does not start which regulate the menstrual cycle. Defected production of hormone is main cause of irregular menstrual cycle in cases pf PCOS.
Treatment of PCOS
Conventional Treatment
There is no cure for PCOS.Treatment is based on symptoms and problems of every individual patient.
1. In patients who does not want pregnancy
Birth control pills can
-regulate menstrual cycles(periods)
- control extra hair growth by reducing male
hormones.
-control Acne.
But all these effects are only temporary until birth control pills are continue. These pills can not cure PCOS. Only Progesterone pills can also be used for menstrual regulation but these pills can not control Acne and Hair growth.
2.In patients who want Pregnancy
Release of Egg from follicles is necessary for Pregnancy . Hormones as FSH(follicular stimulating hormone), LH(leutinizing hormone) and GnRH(Gonadotropin Release Hormone) are used.
Clomiphene Citrate is another drug of choice in these cases.
Earlier , wedge resection of ovary(partial oophrectomy) by surgery was done.But this surgical process may cause post operative adhesion's and infertility. These days a new surgical procedure- Laser puncture of cysts- is used with more or less desirable effects.
Outcomes are not much favorable by either medicinal or surgical procedures.
Homeopathic Treatment of PCOS
Homeopathy system of medicine treat patients on basis of complete history, detail sign and symptoms, personality trait, behavioral pattern, mental make up, physical appearance, emotional indulgence and environmental modalities.
Only removal of cysts from ovaries by surgery or prescribing antagonist hormones for increased Male hormones does not solve the problem, as experience shows with conventional prescribing.
Goal of Homeopathic prescription is to stop the process which cause all these irregularities. Long term treatment is advised for cases of PCOS. After 2-3 month's treatment, most of cases start normal regular periods, ovulatory cycles, reduction in hair growth, acne and normal glucose metabolism.
Patient's suffering from infertility easily gain pregnancy, after few month's treatment.
Homeopathy advises 1 to 3 years of continue treatment for cases of PCOS for permanent cure.
PolyCystic Ovarian Syndrome ( PCOS) and Pelvic Inflammatory Disease (PID) are most common causes of Infertility in females.
Psoriasis
Psoriasis
Psoriasis is a chronic,non-infectious disease. It has thick,well defined plaques of inflammatory silvery scales. 1-3% population suffer by this disease. Psoriasis is a long term disorder, exacerbation and remissions are very common. Generally people of 10-45 year of age suffer more by Psoriasis.
This disease is Non-infectious.But genetic predisposition is found ,it means if one or both parents have Psoriasis then chances of this disease in children are much more.
What happen in Psoriasis?
Our skin is made up of two layers, outer layer is epidermis and inner layer is dermis. Our outer layer of skin- Epidermis shed off in every 35 days and a new layer of epidermis grow up and takes place . But in Psoriasis this process of growing new layer of epidermis becomes fast,and whole process now complete in 3 to 5 days in place of normal 35 days.
Types of Psoriasis
1. Plaque Psoriasis:- This is most common type of psoriasis. Lesions have clear cut boundaries, size may be from a few millimeters to several centimeters in size. Psoriasis spots are red and covered with dry-silvery-scales. Usually knees,elbows and back involved in this type of Psoriasis.
2. Guttate Psoriasis:- Psoriasis spots are droplet-shaped small in size less then 1 centimeter usually and covered with scales. Often throat infection by hemolytic streptococcal bacteria is cause of this type of Psoriasis. This type of Psoriasis resolves in few months commonly but later Plaque Psoriasis can develop in these persons.Usually lesions of Guttate Psoriasis are found on trunk,upper arms,thighs,face,ears and scalp.
3. Erythrodermic Psoriasis:- Whole skin becomes red and scaly. this is an Universal pattern of Psoriasis.
4. Pustular Psoriasis:- Pustule(eruptions fill up of Pus) formed on spots of Psoriasis. Fever may or may not be present with these spots. Mostly this type of Psoriasis spots develop on palms and soles.
Causes of Psoriasis
1. Trauma- Trauma or injury to skin may produce Psoriasis. Common sites for Psoriasis is Knees,Elbows has to bear low grade injuries in day to day practices. Trauma to skin must be avoided. Concept of Kobner phenomenon is concerned with this cause of Psoriasis.
2.Infection- Streptococcal bacterial infection of throat may cause guttate Psoriasis.
3. Drugs- Several drugs causes Psoriasis.
A. Anti-Malarial drugs such as hydroxychloroquine which are used as long term therapy for arthritis and lupus.
B. Beta Blockers - Propanolol used in Hypertension(High Blood Pressure).
C. Lithium Salts.
D. Calcium channel blockers and Angiotensin Converting Enzymes(ACE) used for High Blood pressures.
E. Smoking Cessation Drug -Bupropion may cause Psoriasis.
4. Sunlight- Severe ultra violet radiation may increase Psoriasis.
5. Emotional stress,Anxiety may flare up Psoriasis.
Symptoms and Signs of Psoriasis
1. Typical spots of Psoriasis with red, thick,scaly plaques are marked.
2. Itching may or may not be present .
3. Joint pains and inflammation- About 10% patient of psoriasis may have one or more joints involved this is called Psoriatic Arthritis or Arthropathy.
4. Nail changes-Pitting, Ridges and thickening.
5. Hair falling- Psoriasis of scalp presents as falling of flakes from head like dandruff with falling of hairs.
Treatment of Psoriasis
Conventional Medicine
1. Coal Tar preparations - Crude coal tar inhibit DNA synthesis.It is effective in few patients.
2. Dithranol- It also inhibit DNA synthesis and used more commonly.
3. Calcipotriol.
4. Steroid Creams- It is effective but on withdrawal,psoriasis may relapse rapidly.
5. Systemic Treatment for extensive Psoriasis include immunosuppresive drugs such as Methotrexate etc.
6. Phototherapy- Using ultraviolet light is more effective then earlier described treatments. Earlier U VB and PUVA(UVA exposure after injesting Psoralen) were most common forms of Phototherapy. But now a days Narrow Band U VB(NB-UVB) is used with fewer side effects.
Sun light has Ultra Violet(UV) rays of three types- UVA,UVB,UBC. UBA And UVB are used for Psoriasis. Phototherapy is given constantly 3 to 5 times for 2 months at least. After one month of constant phototherapy few signs of improvement starts. And after complete treatment once a week therapy is needed for a very long time.
Homeopathic Treatment
Homeopathy has more then 100 medicines for different types of Psoriasis.Psoriasis patients need a long term therapy from 1 to 3 years. 60 to 80% cases of Psoriasis are curable by homeopathic medicines.Homeopathic medicines are prescribed on patient's Individual pattern of Psoriasis lesions,Modalities according the weather and temperature changes, Personality traits,Behavioral pattern and Mental attitude of patient. General features,family history,co-existing symptoms, temperament, likings/disliking all are important for Homeopathic Prescription.
Psoriasis is a chronic,non-infectious disease. It has thick,well defined plaques of inflammatory silvery scales. 1-3% population suffer by this disease. Psoriasis is a long term disorder, exacerbation and remissions are very common. Generally people of 10-45 year of age suffer more by Psoriasis.
This disease is Non-infectious.But genetic predisposition is found ,it means if one or both parents have Psoriasis then chances of this disease in children are much more.
© Dr. R. S. Mann 2010
 |
| Psoriasis |
What happen in Psoriasis?
Our skin is made up of two layers, outer layer is epidermis and inner layer is dermis. Our outer layer of skin- Epidermis shed off in every 35 days and a new layer of epidermis grow up and takes place . But in Psoriasis this process of growing new layer of epidermis becomes fast,and whole process now complete in 3 to 5 days in place of normal 35 days.
Types of Psoriasis
1. Plaque Psoriasis:- This is most common type of psoriasis. Lesions have clear cut boundaries, size may be from a few millimeters to several centimeters in size. Psoriasis spots are red and covered with dry-silvery-scales. Usually knees,elbows and back involved in this type of Psoriasis.
2. Guttate Psoriasis:- Psoriasis spots are droplet-shaped small in size less then 1 centimeter usually and covered with scales. Often throat infection by hemolytic streptococcal bacteria is cause of this type of Psoriasis. This type of Psoriasis resolves in few months commonly but later Plaque Psoriasis can develop in these persons.Usually lesions of Guttate Psoriasis are found on trunk,upper arms,thighs,face,ears and scalp.
3. Erythrodermic Psoriasis:- Whole skin becomes red and scaly. this is an Universal pattern of Psoriasis.
4. Pustular Psoriasis:- Pustule(eruptions fill up of Pus) formed on spots of Psoriasis. Fever may or may not be present with these spots. Mostly this type of Psoriasis spots develop on palms and soles.
Causes of Psoriasis
1. Trauma- Trauma or injury to skin may produce Psoriasis. Common sites for Psoriasis is Knees,Elbows has to bear low grade injuries in day to day practices. Trauma to skin must be avoided. Concept of Kobner phenomenon is concerned with this cause of Psoriasis.
2.Infection- Streptococcal bacterial infection of throat may cause guttate Psoriasis.
3. Drugs- Several drugs causes Psoriasis.
A. Anti-Malarial drugs such as hydroxychloroquine which are used as long term therapy for arthritis and lupus.
B. Beta Blockers - Propanolol used in Hypertension(High Blood Pressure).
C. Lithium Salts.
D. Calcium channel blockers and Angiotensin Converting Enzymes(ACE) used for High Blood pressures.
E. Smoking Cessation Drug -Bupropion may cause Psoriasis.
4. Sunlight- Severe ultra violet radiation may increase Psoriasis.
5. Emotional stress,Anxiety may flare up Psoriasis.
Symptoms and Signs of Psoriasis
1. Typical spots of Psoriasis with red, thick,scaly plaques are marked.
2. Itching may or may not be present .
3. Joint pains and inflammation- About 10% patient of psoriasis may have one or more joints involved this is called Psoriatic Arthritis or Arthropathy.
4. Nail changes-Pitting, Ridges and thickening.
5. Hair falling- Psoriasis of scalp presents as falling of flakes from head like dandruff with falling of hairs.
Treatment of Psoriasis
Conventional Medicine
1. Coal Tar preparations - Crude coal tar inhibit DNA synthesis.It is effective in few patients.
2. Dithranol- It also inhibit DNA synthesis and used more commonly.
3. Calcipotriol.
4. Steroid Creams- It is effective but on withdrawal,psoriasis may relapse rapidly.
5. Systemic Treatment for extensive Psoriasis include immunosuppresive drugs such as Methotrexate etc.
6. Phototherapy- Using ultraviolet light is more effective then earlier described treatments. Earlier U VB and PUVA(UVA exposure after injesting Psoralen) were most common forms of Phototherapy. But now a days Narrow Band U VB(NB-UVB) is used with fewer side effects.
Sun light has Ultra Violet(UV) rays of three types- UVA,UVB,UBC. UBA And UVB are used for Psoriasis. Phototherapy is given constantly 3 to 5 times for 2 months at least. After one month of constant phototherapy few signs of improvement starts. And after complete treatment once a week therapy is needed for a very long time.
Homeopathic Treatment
Homeopathy has more then 100 medicines for different types of Psoriasis.Psoriasis patients need a long term therapy from 1 to 3 years. 60 to 80% cases of Psoriasis are curable by homeopathic medicines.Homeopathic medicines are prescribed on patient's Individual pattern of Psoriasis lesions,Modalities according the weather and temperature changes, Personality traits,Behavioral pattern and Mental attitude of patient. General features,family history,co-existing symptoms, temperament, likings/disliking all are important for Homeopathic Prescription.
Bronchitis
Bronchitis
Bronchitis generally refers to an acute inflammation of the air passages within your lungs. It occurs when your trachea (windpipe) and the large and small bronchi (airways) in your lungs become inflamed because of infection or other causes.
- The thin mucous lining of these airways can become irritated and swollen.
- The cells that make up this lining may leak fluids in response to the inflammation.
- Coughing is a reflex that works to clear secretions from your lungs. Often the discomfort of a severe cough leads you to seek medical treatment.
- Both adults and children can get bronchitis. Symptoms are similar for both.
- Infants usually get bronchiolitis, which involves the smaller airways and causes symptoms similar to asthma.
Bronchitis occurs most often during the cold and flu season, usually coupled with an upper respiratory infection.
- Several viruses cause bronchitis, including influenza A and B, which we commonly call "the flu."
- A number of bacteria are known to cause bronchitis, such as Mycoplasma pneumoniae, which causes so–called walking pneumonia.
- Bronchitis also can occur when you inhale irritating fumes or dusts. Chemical solvents and smoke, including tobacco smoke, have been linked to acute bronchitis.
- People at increased risk both of getting bronchitis and of having more severe symptoms include the elderly, those with weakened immune systems, smokers, and anyone with repeated exposure to lung irritants.
Bronchitis Symptoms
Acute bronchitis most commonly occurs after an upper respiratory infection such as the common cold or a sinus infection. Therefore, you may see symptoms such as fever with chills, muscle aches, nasal congestion, and sore throat.
- Cough is a common symptom of bronchitis. The cough may be dry or may produce phlegm. Significant phlegm production suggests that your lower respiratory tract and the lung itself may be infected and you may have pneumonia.
- The cough may last for more than two weeks. Continued forceful coughing may make your chest and abdominal muscles sore. Cough can be severe enough at times to injure the chest wall or even cause you to pass out.
- Wheezing may occur because of the inflammation of your airways. This may leave you short of breath.
Although most cases of bronchitis clear up on their own, some people may have complications that their doctor can ease.
- Severe coughing that interferes with rest can be reduced with prescription cough medications.
- Wheezing may respond to an inhaler (which has brochodilatordrugs) which dilates your airways.
- If fever continues beyond four to five days, see your doctor for a physical examination to rule out pneumonia.
- See a doctor if you have coughing up blood, rust–colored sputum, or an increased amount of green phlegm.
- If you experience difficulty breathing with or without wheezing ,go to a hospital's emergency department for evaluation and treatment.
Doctors diagnose bronchitis generally on the basis of your symptoms and a physical examination.
- Usually you will need no blood tests.
- If the doctor suspects you have pneumonia, you may have a chest x–ray.
- It may need to measure oxygen saturation (how well oxygen is reaching blood cells) using a sensor placed on a finger.
- Sometimes it needs to examine of phlegm cough up to look for bacteria.
Bronchitis Treatment
Self–Care at Home
- By far the majority of bronchitis cases stem from viral infections. This means that most cases of bronchitis are short–term and require nothing more than treatment of symptoms to relieve discomfort.
- Antibiotics will not cure a viral illness.
B.Doctors often prescribe antibiotics because they feel pressured by people's expectations to receive them. This expectation has been fueled by both misinformation in the media and marketing by drug companies. Don't expect to receive a prescription for an antibiotic if your infection is caused by a virus.
- Acetaminophen ,aspirin or ibuprofen will help with fever and muscle aches.
- Drinking fluids is very important because fever causes the body to lose fluid faster. Lung secretions will be thinner and thus easier to clear when you are well hydrated.
- A cool mist vaporizer or humidifier can help decrease bronchial irritation.
- An over–the–counter cough suppressant may be helpful to ease symptoms.
Medical Treatment
Treatment of bronchitis can differ depending on the suspected cause.
A. Medications to help suppress the cough or loosen and clear secretions may be helpful. If you have severe coughing spells that you cannot control, you need prescription for cough suppressants. In some cases only the stronger cough suppressants can stop a vicious cycle of coughing leading to more irritation of the bronchial tubes, which in turn causes more coughing.
B. Bronchodilator inhalers will help open airways and decrease wheezing.
C.Though antibiotics play a limited role in treating bronchitis, they become necessary in some situations if suspicion of a bacterial infection or in people with chronic lung problems.
Homeopathic Treatment
Homeopathy has very effective treatment of Bronchitis. There are more then 150 medicines for Bronchitis. In cases of children and Acute cases of Bronchitis homeopathy cure immediately. Old cases take a long time to cure. Homeopathic medicines are prescribed on basis of Individuality of a patients,his symptom complex, triggering factors, personality traits, modalities of weather and temperature changes, family history,person's mental make up and reaction pattern.
Prevention
A. Stop smoking.
B. Avoid exposure to irritants.Exposure at workplace must be prevented.
C. The dangers of passive smoke are well known. Children should be prevented from passive smoke.
D.Avoiding long exposure to air pollution from heavy traffic may help prevent bronchitis.
Acute Respiratory and Ear complaints: Comparative Study
Homeopathic and conventional treatment for acute respiratory and ear complaints: A comparative study on outcome in the primary care setting
Max Haidvogl* 1, David S Riley* 2, Marianne Heger* ^ 9,3, Sara Brien* 4 , Miek Jong5 , Michael Fischer* 6, George T Lewith* 4 , Gerard Jansen* 7 and André E Thurneysen* 8
1Ludwig Boltzmann Institute for Homeopathy, Graz, Austria
2University of New Mexico School of Medicine and Integrative Medicine Institute, Santa Fe, New Mexico, USA
3HomInt, Karlsruhe, Germany
4Complementary Medicine Research Unit; Primary Medical Care, University of Southhampton, Southhampton, UK
5VSM Geneesmiddelen, Alkmaar, The Netherlands
6ClinResearch GmbH, Cologne, Germany
7Tilburg, The Netherlands
8Institute for Complementary Medicine (KIKOM), University of Bern, Bern, Switzerland
9passed away in 2005
BMC Complementary and Alternative Medicine 2007, 7:7doi:10.1186/1472-6882-7-7
The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6882/7/7
Received: 19 September 2006
Accepted: 2 March 2007
Published: 2 March 2007
© 2007 Haidvogl et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background
The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting.
Methods
The study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (≤ 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy.
Results
Data of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) in children and 0.92 (0.63–1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both in children (p = 0.0488) and adults (p = 0.0001). Adverse drug reactions occurred more frequently in adults of the conventional group than in the homeopathic group (C: 7.6%; H: 3.1%, p = 0.0032), whereas in children the occurrence of adverse drug reactions was not significantly different (H: 2.0%; C: 2.4%, p = 0.7838).
Conclusion
In primary care, homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment.
Background
The evidence base for complementary and alternative medicine (CAM) in general is limited and there is certainly a need for more research in areas such as homeopathy [1]. Objective data collection and evaluation is needed to assist physicians in patient care and advance the quality of medical practice [2]. Clinical trials, especially randomised controlled trials (RCTs), are generally accepted as producing the highest level of evidence for medical interventions. Driven by the discovery of new pharmaceutical substances, demands from regulatory authorities for clinical data and the need of physicians for evidence based treatment strategies, the methodology of RCTs became the subject of research itself. Within this context, the strengths and weaknesses of such trials have been debated [3]. Placebo-controlled RCTs are indispensable for the development of pharmaceutical agents with unknown efficacy and safety profiles. Their limitations result from highly standardized study protocols and patient populations, which may create artificial situations that differ from daily practice. Moreover, even the fact that patients are enrolled into a placebo-controlled clinical trial will influence treatment outcome, sometimes leading to high placebo or low verum response rates [4]. Consequently, more practice-based studies have been developed such as pragmatic RCT's or non-randomised cohort studies. Especially non-interventional outcomes studies have only few inclusion and exclusion criteria. Therefore they may provide information about a broad and heterogenous patient population thus resulting in high external validity for daily medical practice. However, the fact that patients are not randomly assigned to treatments in such outcome studies may lead to baseline differences between groups and makes the interpretation of the results more susceptible to bias. This disadvantage may be overcome, at least in part, by the application of statistical methods to control for baseline differences between treatment groups.
Apart from the ongoing discussion about clinical evidence, complementary therapies are well integrated into primary care in most Western countries. Among these, homeopathy is the most frequently used form in various acute and chronic conditions [5-9]. The value of homeopathy in chronic conditions has been demonstrated in several studies. A comprehensive analysis of outcome and cost-effectiveness showed that chronically ill patients had a better overall outcome with homeopathic than with conventional care [10]. Another large-scale observational study showed a positive impact of homeopathy on the health status in a substantial proportion of patients suffering from a wide range of different chronic diseases [11]. To our knowledge, no large comparative cohort studies have been performed to investigate the outcome of homeopathic treatment for acute illnesses. Results of the first phase of this study, the International Integrative Primary Care Outcomes Study 1 (IIPCOS-1), suggest that homeopathic treatment is at least as effective as conventional treatment for acute complaints of the upper and lower respiratory tract [12]. The aim of the present study, IIPCOS-2, was to evaluate on an international basis and in a large sample size if homeopathic treatment is non-inferior to conventional treatment in patients with acute respiratory and ear complaints.
Methods
Study design
IIPCOS-2 is an international, multi-centre, comparative cohort study of non-randomised design, which was conducted between October 1998 and April 2000. Patients suffering from acute respiratory and ear complaints were recruited by physicians in 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and USA (8). The physicians belonged to 3 different groups: providing homeopathic treatment only (22), providing either homeopathic or conventional treatment (9), and providing conventional treatment only (12). The physicians, prescribing primarily homeopathic single remedies, had in addition to their conventional medical qualifications, graduated from a homeopathic training program and at least 5 years experience using homeopathy in their medical practice. The protocol was approved by the International Ethics Committee in Freiburg, Germany. The study was conducted in accordance with the declaration of Helsinki, Good Clinical Practice (GCP) guidelines and national legal requirements.
Patients
Patients older than one month, presenting themselves with at least one of five chief complaints (runny nose, sore throat, ear pain, sinus pain or cough), and onset of symptoms not more than 7 days before, were eligible to participate. Each chief complaint comprised of 5 to 9 individual symptoms, which were rated by the physicians with scores from 0 – not present to 4 – very severe. The mean score for each chief complaint was used to measure severity at baseline. Patients meeting the inclusion criteria, respectively in case of children their parents/legal guardians, were informed by the physician about the nature of the study. Prior to enrolment into the trial each patient/parent had to provide written informed consent to participate. Exclusion criteria were among others severe mental impairment, severe chronic diseases such as spinal cord injuries and alcohol or drug abuse. At centres providing both therapies (mixed centres) the treatment was chosen by the physicians and/or following the patients' preference.
Study protocol
During the initial patient contact the physician documented the onset of chief complaint, severity of symptoms, clinical diagnosis, concomitant medical problems and medication and primary treatment prescribed. Patients completed a questionnaire asking for demographic and health-related information. Additionally some general questions addressed the patients' willingness to pay, patient confidence in health care provider and therapy, treatment preference, willingness to be randomized (at mixed centres only) etc. The patient follow-up was carried out by telephone 7, 14 and 28 days after the initial contact. Independent external study collaborators performed the calls. According to the study protocol they were blinded for the patient's treatment. The following parameters were documented: severity of complaint-related symptoms, time until occurrence of first improvement, therapy outcome (assessed with complete recovery, major improvement, slight improvement, no change or deterioration), patient's satisfaction with the treatment (very satisfied, satisfied, neutral, dissatisfied or very dissatisfied) and general health condition. In case any adverse events had occurred, the physician was informed in order to collect more information and medically assess the case.
The response rates were defined as the proportion of patients assessing themselves as 'completely recovered' or 'major improved' after 7, 14 and 28 days of treatment. The main outcome criterion was the response rate after 14 days. Other outcome criteria were the response rates after 7 and 28 days, time to onset of first improvement (patients' assessments after how many days they had experienced a first improvement), patient satisfaction with treatment and health care provider and the occurrence of adverse events. Adverse events were coded by using the WHO-ART terminology.
A total of 72 selected homeopathic medications in potencies of 12C and higher (manufactured according to the German Homeopathic Pharmacopoeia), were given to the physicians as the basic set of study medication. Nevertheless, the physicians were free to prescribe any other remedy, any other potency or dosage form. Conventional treatment, registered in each participating country, was prescribed by the investigator and picked from a pharmacy.
Data collection and monitoring
Data were collected with a validated remote data entry system that was accessed via the Internet. The physicians entered their data online into electronic case report forms. The remote data entry system checked each entry for completeness and consistency. It recorded all data values with date and time of entry as well as all changes in the database in an audit trail. Access to the database was protected by password identification. Each user had a unique password that was provided in a sealed envelope. After entering was completed, data were transferred via Internet to the data collection centre at the former Institute for Numerical Statistics (IFNS, acquired by Omnicare Inc. in 1999) in Cologne, Germany. Monitoring was performed adherent to GCP-guidelines by an independent clinical monitor. Monitoring visits took place at least twice in order to inspect the course of the trial and to carry out source data verification. A data review tool enabled the monitor to identify missing data values, data values deviating from the normal range and among other things, data needing source verification.
Statistical methods
Data analysis was conducted by ClinResearch, Cologne, Germany, using the statistical software package SAS 9.1.3 under Windows XP Professional. The study was designed to confirm non-inferiority of the primary outcome criterion in the total patient population after homeopathic treatment in comparison to conventional treatment, using the one-sided equivalence test at the 2.5% significance level. The non-inferiority margin was defined by 5%-points. Subgroup analyses were performed on age groups (children: <>
Results
Patients
A total of 2,055 patients suffering from at least one chief complaint (acute runny nose, sore throat, ear pain, sinus pain or cough) were enrolled in the study and given either homeopathic (H: n = 1,220) or conventional treatment (C: n = 829) (Figure 1). Six patients did not receive any treatment and were excluded from further analysis. All patients from the USA and Spain (H: n = 216; C: n = 29) were excluded since telephone interviews were not performed according to the study protocol. For another 227 patients no follow-up data were available because either interviews could not be carried out or the patient withdrew from the study. Data of 1577 patients with at least one follow-up contact were evaluated (full-set analysis), 857 patients in the homeopathy group and 720 patients in the conventional treatment group. For 1116 patients (H: n = 576; C: n = 540) follow-up data on day 14 were documented, being the per-protocol set (Figure 1).
Upon enrolment in the study, patients, or the patients' legal guardians were asked for their treatment preference. In the homeopathy group, 81% of patients had a preference for homeopathy, 18% had no treatment preference. In the conventional group, 55% of the patients' preferred conventional treatment, 2% homeopathy and 43% had no treatment preference. Patients at mixed centres were additionally asked whether they would agree to be randomized if the choice of treatment was made randomly. With 68.1%, the majority of patients in the homeopathy group refused to be randomized, 30.6% had no problem with randomisation and in 1.3% no remark was given. In the conventional group willingness and unwillingness to be randomized were equally distributed (51.9% yes, 47.9% no, 0.1% no remark).
Baseline characteristics
Demographic data of children (<>
Table 1
As shown in Table 2, cough was the most frequently reported chief complaint in children, followed by sore throat and ear pain. In adults sore throat was the most frequent, followed by cough and runny nose. The overall distribution of the five chief complaints in children was comparable in both treatment groups, but differed significantly in adults (p = 0.0026, Chi-square test). The mean severity score differed significantly at baseline for 2 out of 5 chief complaints, both in children and adults (Table 2).
With regard to the diagnosis of the chief complaints, in children otitis media was most frequently diagnosed (H: 18.9%; C: 13.5%) followed by bronchitis (H: 16.7%; C: 10.7%) and laryngitis (H: 12.3%; C: 12.7%). In adults, pharyngitis (H: 23.1%; C: 14.7%), bronchitis (H: 11.5%; C: 17.1%) and tonsillitis (H: 13.9%; C: 8.9%) were most frequently diagnosed. In adults, no significant differences were observed with respect to concomitant medical problems (H: 34.2%; C: 36.6%) or concomitant medication (H: 20.7%; C: 20.1%). In the homeopathic group 21.6% of the children had concomitant medical problems versus 13.5% in conventional group (p = 0.0098; Fisher's exact test). The proportion of children receiving concomitant medication was higher in the homeopathic group (9.1%) than in the conventional group (6.7%) as well but did not reach a statistical significant level (p = 0.3098; Fisher's exact test).
Medication
A total of 62 different homeopathic remedies were prescribed primarily on an individual basis. The top 10 (Table 3) of the most frequently prescribed homeopathic remedies included typical 'acute' remedies and accounted for about 60% of the prescriptions. In the conventional group 190 different medications were prescribed. Most of them were antibiotics followed by nasal preparations and analgesics (Table 3).
Table 3. The most frequently prescribed medications
Treatment outcome
The primary outcome criterion, defined as the percentage of patients with complete recovery or major improvement after 14 days, was first calculated for the total patient population. The one-sided test of the full-set analysis showed non-inferiority of homeopathic in comparison with conventional treatment (H: 86.9%; C: 86.0%; p = 0.0003). These results were confirmed by the analysis on the per-protocol set (including all patients with data at day 14) since similar response rates were obtained in both treatment groups (H: 87.7%; C: 86.9%; p = 0.0019).
The response rates at various time points in children and adults are shown in Figure 2. The primary outcome criterion (response rate at day 14) in children was 88.5% after homeopathic and 84.5% after conventional treatment. In addition, response rates after 7 days (H: 68.8%; C: 64.3%) and 28 days (H: 93.1%; C: 92.5%) did not differ between both treatment groups either. In adults, the response rates after 7 days (H: 71.2%; C: 68.8%), 14 days (H: 85.6%; C: 86.6%, LOCF) and 28 days (H: 93.9%; C: 95.9%; LOCF) of treatment were not significantly different as well.
Since the majority of patients (> 84%) were fully recovered or major improved after 14 days of treatment, it was of relevance to look at outcome differences within the first 7 days. As shown in Figure 3, the percentage of children experiencing a first improvement at different time points within the first week of treatment was significantly higher in the homeopathy group compared to the conventional group (p = 0.0488). For adults, a similar significant difference in favour of homeopathy (p = 0.0001) was observed.
Additional analysis on the primary outcome criterion in order to correct for demographic differences at baseline was carried out (Figure 4). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) for children and 0.92 (0.63–1.34) for adults. In the subgroup of children, adjustments for age, mean severity and concomitant medical problems had little effect on the OR. The unadjusted OR for the Body-Mass-Index was 1.92 (1.03–3.60) and the only one showing a significant difference in favour of homeopathy. Adjustment for BMI differences between both treatment groups at baseline minimally reduced the OR to 1.89 (1.00–3.57). In adults, individual adjustments for all variables had little to no effect on the OR of the primary outcome criterion (Figure 4).
Another outcome measure was the occurrence of adverse drug reactions. The percentage of children experiencing a suspected adverse drug reaction was not significantly different in both groups (H: 2.0%; C: 2.4%, p = 0.7838, Fisher's exact test). In adults, the number of suspected adverse drug reactions was significantly higher after conventional than after homeopathic treatment (C: 7.6%; H: 3.1%; p = 0.0032, Fisher's exact test). Both in children and adults, the suspected adverse drug reactions occurred predominantly in the body as a whole (upon homeopathic treatment) or in the gastro-intestinal system (upon conventional treatment).
In addition, patients' satisfaction with treatment and healthcare provider was evaluated. Almost all patients in both treatment groups were either satisfied or very satisfied with the treatment after 28 days (children: 95% H; 93% C, adults: 91% H; 95% C). A very high percentage of children (H: 98%; C: 95%) and adults (H: 97%; C: 97%) were either satisfied or very satisfied with the healthcare provider.
Discussion
The overall outcome of the first phase of the IIPCOS study [12] is confirmed in the present study on a larger group of patients and a greater number of medical practices, showing that homeopathic treatment is not inferior to conventional treatment for the treatment of acute respiratory and ear complaints. In IIPCOS-1 the response rate of homeopathically treated patients was with 82.6% significantly higher than in the conventional group. In IIPCOS-2 the response to homeopathic treatment was with 86.9% even higher, confirming the good effectiveness. However, no difference was observed between both treatment groups. This is due to a much higher response rate in the conventional group in IIPCOS-2 of 86.0% compared to 68% in IIPCOS-1. One difference between both studies is that in IIPCOS-2, only patients from Europe were analysed since those recruited at practices from the USA were excluded due to protocol deviations. In IIPCOS-1, the majority of patients included had their residence in the USA. However, despite these differences, the overall conclusion from both studies can be drawn that homeopathy is not inferior to conventional therapy. Due to the study design, the findings of IIPCOS-1 and IIPCOS-2 do not provide firm data on the comparative efficacy of homeopathic and conventional treatment in acute diseases but rather underline the potential value of homeopathy in every day clinical practice. Both studies reflect the situation in every day homeopathic practice in an international setting with average patients receiving the usual treatment of a homeopathic doctor. Furthermore, patients were recruited on the basis of chief complaints and related symptoms, rather than on the clinical diagnoses. This symptomatic approach coincides with the homeopathic nature of prescription by treating each patient individually, based on specific key symptoms and patient characteristics.
In IIPCOS-2, differences for various demographic parameters and symptom-related variables were found between both groups. Thereby the profile of typical patients seeking homeopathic therapy was confirmed [13,14], i.e. they were more likely to be women, younger of age, less likely to smoke and to have a lower BMI. The severity of symptoms at baseline was significantly different between treatment groups as well. However the differences were small and their clinical relevance is doubtful. Indeed regression analysis had little effect on the primary outcome criterion, showing that treatment effects were only minimally affected by selection bias. Based on the unadjusted and adjusted odds ratios of the primary outcome criterion it appears that homeopathic treatment, in comparison to conventional treatment, is more beneficial for children than adults. This observation is in accordance with previous studies in which the improvements after homeopathic treatment were greater in children than in adults [11,13].
Another possible source of bias is that the outcome criteria were assessed by the patients themselves. Since it was not possible to blind patients for their treatment, potential reporting bias from patient's expectations may have influenced the outcome. On the other hand, the patients' reports were collected by independent external study collaborators in order to minimize the influence of the patient's relationship with their physician on the treatment outcome. Although blinding of the external study coordinators was foreseen in the protocol, it cannot be ruled out that they received information from the patient revealing the nature of their medication. Therefore, blinding may not have been guaranteed in each case. Furthermore, it should be noted that at mixed centres, the choice of treatment was made by the physicians and/or following the patients' preference. The treatment decision may have been influenced by the kind or severity of the symptoms or the motivation and expectations of the patient.
Since acute respiratory and ear complaints are self-limiting conditions, it can be argued that the chosen primary outcome criterion after 14 days of treatment is not sufficiently sensitive. Patients experiencing these acute complaints may have undergone spontaneous recovery within 1 to 2 weeks. However, this outcome parameter was taken to confirm and reproduce the results of IIPCOS-1 by using a similar study design. Therefore other outcomes criteria such as the response rate after 7 days of treatment have to be considered more carefully. Moreover, the findings that the percentage of patients experiencing a first improvement within the first week was higher at all time points in the homeopathy group than in the conventional group, are at least supportive of the 14 days finding that homeopathy is not inferior to conventional medicine.
Other observational studies on the comparability of homeopathic treatment and conventional treatment of upper respiratory tract infections (URTI) have shown positive outcomes for homeopathy [15,16]. Recently, the value of homeopathic treatment for the prevention of URTIs has been demonstrated in a controlled clinical trial [17]. The consistent findings in IIPCOS-1 and IIPCOS-2 further contribute to the evidence that homeopathic treatment plays a beneficial role in the primary care of patients. Furthermore, the good tolerability of homeopathic treatment of acute respiratory and ear complaints was confirmed by the low number of patients that experienced adverse drug reactions.
The major limitation of the present study is that patients were not assigned randomly to their treatment group. The majority of patients in the homeopathic group had a strong treatment preference and consequently, they were not willing to be randomized. A similar reluctance towards randomisation has also been reported elsewhere for patients seeking anthroposophic therapy [18]. These results reveal a substantial limitation to the suitability of performing large randomized controlled trials on the efficacy of homeopathy in such a primary care setting.
Conclusion
This comparative cohort study, involving more than 1,500 patients in primary care practices of at least 6 different European countries, demonstrates that homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment. Although no firm conclusions can be drawn about the efficacy of homeopathic treatment, these results certainly contribute to the growing evidence that homeopathy is a safe and beneficial treatment strategy for acute diseases in primary care settings.
Competing interests
MJ is an employee and MHe † was an employee of the HomInt organisation. All other authors have no financial or non-financial competing interest related to the content of the manuscript.
Authors' contributions
International Integrative Primary Care Outcomes Study 2 (IIPCOS-2) collaborators: MH, DR and MHe planned and directed the study. SB, GL, GJ and AT were responsible for data collection. MJ drafted the manuscript. MF performed the statistical analysis. All authors read and approved the final version of the manuscript.
Acknowledgements
This study was carried out by the HomInt organisation, Karlsruhe, Germany. The IIPCOS-2 collaborators would like to thank Sytze de Roock for preparation of tables and figures, Rolf Hövelmann for data analysis, Wolfgang Mayer for monitoring the study and Rainer Lüdtke for his comments on the drafted manuscript. We are especially grateful to the physicians and all the patients for participating in the study.
References
1.Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, Pewsner D, Egger M: Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.
The Lancet 2005, 366:726-732. Publisher Full Text OpenURL
2.Bell IR: Evidence-based homeopathy: Empirical questions and methodological considerations for homeopathic clinical research.
AJHM 2003, 96:17-31. OpenURL
3.Walach H, Falkenberg T, Fonnebø V, Lewith G, Jonas WB: Circular Instead of Hierarchical: Methodological Principles for the Evaluation of Complex Interventions.
BMC Med Res Methodol 2006, 6:29. PubMed Abstract | BioMed Central Full Text | PubMed Central Full Text OpenURL
4.Walach H, Jonas WB, Lewith G: The role of outcomes research in evaluating complementary and alternative medicine.
Altern Ther Health Med 2002, 8:88-95. OpenURL
Return to text
5.
Baron SE, Goodwin RG, Nicolau N, Blackford S, Goulden V: Use of complementary medicine among outpatients with dermatologic conditions within Yorkshire and South Wales, United Kingdom.
J Am Acad Dermatol 2005, 52:589-594. PubMed Abstract | Publisher Full Text OpenURL
Return to text
6.
Passalacqua G, Compalati E, Schiappoli M, Senna G: Complementary and alternative medicine for the treatment and diagnosis of asthma and allergic diseases.
Monaldi Arch Chest Dis 2005, 63:47-54. PubMed Abstract | Publisher Full Text OpenURL
7.Breuer GS, Orbach H, Elkayam O: Perceived efficacy among patients of various methods of complementary alternative medicine for rheumatologic diseases.
Clin Exp Rheumatol 2005, 23:693-696. PubMed Abstract | Publisher Full Text OpenURL
8.Bensoussan M, Jovenin N, Garcia B, Vandromme L, Jolly D, Bouche O, Thiefin G, Cadiot G: Complementary and alternative medicine use by patients with inflammatory bowel disease: results from a postal survey.
Gastroenterol Clin Biol 2006, 30:14-23. PubMed Abstract | Publisher Full Text OpenURL
9.Weber U, Lüdtke R, Friese KH, Fischer I, Moeller H: A Non-Randomised Pilot Study to Compare Complementary and Conventional Treatment of Acute Sinusitis.
Forsch Komplementärmed Klass Naturheilkd 2002, 9:99-104. Publisher Full Text OpenURL
10.Witt C, Keil T, Selim D, Roll S, Vance W, Wegscheider K, Willich SN: Outcome and costs of homeopathic and conventional treatment strategies: A comparative cohort study in patients with chronic disorders.
Complement Ther Med 2005, 13:79-86. PubMed Abstract | Publisher Full Text OpenURL
11.Spence DS, Thompson EA, Barron SJ: Homeopathic treatment for chronic disease: A 6-year, university-hospital outpatient observational study.
J Altern Complement Med 2005, 11:793-798. PubMed Abstract | Publisher Full Text OpenURL
12.Riley D, Fischer M, Singh B, Haidvogl M, Heger M: Homeopathy and conventional medicine: an outcomes study comparing effectiveness in a primary care setting.
J Altern Complement Med 2001, 7:149-159. PubMed Abstract | Publisher Full Text OpenURL
13.Witt CM, Lüdtke R, Baur R, Willich SN: Homeopathic medical practice: Long-term results of a cohort study with 3981 patients.
BMC Public Health 2005, 5:115. PubMed Abstract | BioMed Central Full Text | PubMed Central Full Text OpenURL
14.Kaiser S: Comparison, using psychological constructs, between patients treated with orthodox medicine and patients treated with homeopathy.
HomInt R&D Newsletter 1998, 1:14-18. OpenURL
15.Trichard M, Chaufferin G, Nicoloyannis N: Pharmacoeconomic comparison between homeopathic and antibiotic treatment strategies in recurrent rhinopharyngitis in children.
Homeopathy 2005, 94:3-9. PubMed Abstract | Publisher Full Text OpenURL
16.Friese KH, Kruse F, Lüdtke R, Möller H: The homeopathic treatment of otitis media in children – comparisons with conventional therapy.
Int J Clin Pharmacol Ther 1997, 35:296-301. PubMed Abstract | Publisher Full Text OpenURL
17.Steinsbekk A, Fonnebo V, Lewith G, Bentzen N: Homeopathic care for the prevention of upper respiratory tract infections in children: A pragmatic, randomised, controlled trial comparing individualised homeopathic care and waiting-list controls.
Complement Ther Med 2005, 13:231-238. PubMed Abstract | Publisher Full Text OpenURL
18.Hamre HJ, Fischer M, Heger M, Riley D, Haidvogl M, Baars E, Bristol E, Evans M, Schwarz R, Kiene H: Anthroposophic vs. conventional therapy of acute respiratory and ear infections: a prospective outcomes study.
Wien Klin Wochenschr 2005, 117:256-268. PubMed Abstract | Publisher Full Text OpenURL
Max Haidvogl* 1, David S Riley* 2, Marianne Heger* ^ 9,3, Sara Brien* 4 , Miek Jong5 , Michael Fischer* 6, George T Lewith* 4 , Gerard Jansen* 7 and André E Thurneysen* 8
1Ludwig Boltzmann Institute for Homeopathy, Graz, Austria
2University of New Mexico School of Medicine and Integrative Medicine Institute, Santa Fe, New Mexico, USA
3HomInt, Karlsruhe, Germany
4Complementary Medicine Research Unit; Primary Medical Care, University of Southhampton, Southhampton, UK
5VSM Geneesmiddelen, Alkmaar, The Netherlands
6ClinResearch GmbH, Cologne, Germany
7Tilburg, The Netherlands
8Institute for Complementary Medicine (KIKOM), University of Bern, Bern, Switzerland
9passed away in 2005
BMC Complementary and Alternative Medicine 2007, 7:7doi:10.1186/1472-6882-7-7
The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6882/7/7
Received: 19 September 2006
Accepted: 2 March 2007
Published: 2 March 2007
© 2007 Haidvogl et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background
The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting.
Methods
The study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (≤ 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy.
Results
Data of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) in children and 0.92 (0.63–1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both in children (p = 0.0488) and adults (p = 0.0001). Adverse drug reactions occurred more frequently in adults of the conventional group than in the homeopathic group (C: 7.6%; H: 3.1%, p = 0.0032), whereas in children the occurrence of adverse drug reactions was not significantly different (H: 2.0%; C: 2.4%, p = 0.7838).
Conclusion
In primary care, homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment.
Background
The evidence base for complementary and alternative medicine (CAM) in general is limited and there is certainly a need for more research in areas such as homeopathy [1]. Objective data collection and evaluation is needed to assist physicians in patient care and advance the quality of medical practice [2]. Clinical trials, especially randomised controlled trials (RCTs), are generally accepted as producing the highest level of evidence for medical interventions. Driven by the discovery of new pharmaceutical substances, demands from regulatory authorities for clinical data and the need of physicians for evidence based treatment strategies, the methodology of RCTs became the subject of research itself. Within this context, the strengths and weaknesses of such trials have been debated [3]. Placebo-controlled RCTs are indispensable for the development of pharmaceutical agents with unknown efficacy and safety profiles. Their limitations result from highly standardized study protocols and patient populations, which may create artificial situations that differ from daily practice. Moreover, even the fact that patients are enrolled into a placebo-controlled clinical trial will influence treatment outcome, sometimes leading to high placebo or low verum response rates [4]. Consequently, more practice-based studies have been developed such as pragmatic RCT's or non-randomised cohort studies. Especially non-interventional outcomes studies have only few inclusion and exclusion criteria. Therefore they may provide information about a broad and heterogenous patient population thus resulting in high external validity for daily medical practice. However, the fact that patients are not randomly assigned to treatments in such outcome studies may lead to baseline differences between groups and makes the interpretation of the results more susceptible to bias. This disadvantage may be overcome, at least in part, by the application of statistical methods to control for baseline differences between treatment groups.
Apart from the ongoing discussion about clinical evidence, complementary therapies are well integrated into primary care in most Western countries. Among these, homeopathy is the most frequently used form in various acute and chronic conditions [5-9]. The value of homeopathy in chronic conditions has been demonstrated in several studies. A comprehensive analysis of outcome and cost-effectiveness showed that chronically ill patients had a better overall outcome with homeopathic than with conventional care [10]. Another large-scale observational study showed a positive impact of homeopathy on the health status in a substantial proportion of patients suffering from a wide range of different chronic diseases [11]. To our knowledge, no large comparative cohort studies have been performed to investigate the outcome of homeopathic treatment for acute illnesses. Results of the first phase of this study, the International Integrative Primary Care Outcomes Study 1 (IIPCOS-1), suggest that homeopathic treatment is at least as effective as conventional treatment for acute complaints of the upper and lower respiratory tract [12]. The aim of the present study, IIPCOS-2, was to evaluate on an international basis and in a large sample size if homeopathic treatment is non-inferior to conventional treatment in patients with acute respiratory and ear complaints.
Methods
Study design
IIPCOS-2 is an international, multi-centre, comparative cohort study of non-randomised design, which was conducted between October 1998 and April 2000. Patients suffering from acute respiratory and ear complaints were recruited by physicians in 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and USA (8). The physicians belonged to 3 different groups: providing homeopathic treatment only (22), providing either homeopathic or conventional treatment (9), and providing conventional treatment only (12). The physicians, prescribing primarily homeopathic single remedies, had in addition to their conventional medical qualifications, graduated from a homeopathic training program and at least 5 years experience using homeopathy in their medical practice. The protocol was approved by the International Ethics Committee in Freiburg, Germany. The study was conducted in accordance with the declaration of Helsinki, Good Clinical Practice (GCP) guidelines and national legal requirements.
Patients
Patients older than one month, presenting themselves with at least one of five chief complaints (runny nose, sore throat, ear pain, sinus pain or cough), and onset of symptoms not more than 7 days before, were eligible to participate. Each chief complaint comprised of 5 to 9 individual symptoms, which were rated by the physicians with scores from 0 – not present to 4 – very severe. The mean score for each chief complaint was used to measure severity at baseline. Patients meeting the inclusion criteria, respectively in case of children their parents/legal guardians, were informed by the physician about the nature of the study. Prior to enrolment into the trial each patient/parent had to provide written informed consent to participate. Exclusion criteria were among others severe mental impairment, severe chronic diseases such as spinal cord injuries and alcohol or drug abuse. At centres providing both therapies (mixed centres) the treatment was chosen by the physicians and/or following the patients' preference.
Study protocol
During the initial patient contact the physician documented the onset of chief complaint, severity of symptoms, clinical diagnosis, concomitant medical problems and medication and primary treatment prescribed. Patients completed a questionnaire asking for demographic and health-related information. Additionally some general questions addressed the patients' willingness to pay, patient confidence in health care provider and therapy, treatment preference, willingness to be randomized (at mixed centres only) etc. The patient follow-up was carried out by telephone 7, 14 and 28 days after the initial contact. Independent external study collaborators performed the calls. According to the study protocol they were blinded for the patient's treatment. The following parameters were documented: severity of complaint-related symptoms, time until occurrence of first improvement, therapy outcome (assessed with complete recovery, major improvement, slight improvement, no change or deterioration), patient's satisfaction with the treatment (very satisfied, satisfied, neutral, dissatisfied or very dissatisfied) and general health condition. In case any adverse events had occurred, the physician was informed in order to collect more information and medically assess the case.
The response rates were defined as the proportion of patients assessing themselves as 'completely recovered' or 'major improved' after 7, 14 and 28 days of treatment. The main outcome criterion was the response rate after 14 days. Other outcome criteria were the response rates after 7 and 28 days, time to onset of first improvement (patients' assessments after how many days they had experienced a first improvement), patient satisfaction with treatment and health care provider and the occurrence of adverse events. Adverse events were coded by using the WHO-ART terminology.
A total of 72 selected homeopathic medications in potencies of 12C and higher (manufactured according to the German Homeopathic Pharmacopoeia), were given to the physicians as the basic set of study medication. Nevertheless, the physicians were free to prescribe any other remedy, any other potency or dosage form. Conventional treatment, registered in each participating country, was prescribed by the investigator and picked from a pharmacy.
Data collection and monitoring
Data were collected with a validated remote data entry system that was accessed via the Internet. The physicians entered their data online into electronic case report forms. The remote data entry system checked each entry for completeness and consistency. It recorded all data values with date and time of entry as well as all changes in the database in an audit trail. Access to the database was protected by password identification. Each user had a unique password that was provided in a sealed envelope. After entering was completed, data were transferred via Internet to the data collection centre at the former Institute for Numerical Statistics (IFNS, acquired by Omnicare Inc. in 1999) in Cologne, Germany. Monitoring was performed adherent to GCP-guidelines by an independent clinical monitor. Monitoring visits took place at least twice in order to inspect the course of the trial and to carry out source data verification. A data review tool enabled the monitor to identify missing data values, data values deviating from the normal range and among other things, data needing source verification.
Statistical methods
Data analysis was conducted by ClinResearch, Cologne, Germany, using the statistical software package SAS 9.1.3 under Windows XP Professional. The study was designed to confirm non-inferiority of the primary outcome criterion in the total patient population after homeopathic treatment in comparison to conventional treatment, using the one-sided equivalence test at the 2.5% significance level. The non-inferiority margin was defined by 5%-points. Subgroup analyses were performed on age groups (children: <>
Results
Patients
A total of 2,055 patients suffering from at least one chief complaint (acute runny nose, sore throat, ear pain, sinus pain or cough) were enrolled in the study and given either homeopathic (H: n = 1,220) or conventional treatment (C: n = 829) (Figure 1). Six patients did not receive any treatment and were excluded from further analysis. All patients from the USA and Spain (H: n = 216; C: n = 29) were excluded since telephone interviews were not performed according to the study protocol. For another 227 patients no follow-up data were available because either interviews could not be carried out or the patient withdrew from the study. Data of 1577 patients with at least one follow-up contact were evaluated (full-set analysis), 857 patients in the homeopathy group and 720 patients in the conventional treatment group. For 1116 patients (H: n = 576; C: n = 540) follow-up data on day 14 were documented, being the per-protocol set (Figure 1).
Figure 1.
Patient flow-chart. * All patients who received at least one dose of investigational medication and having at least one follow-up contact.
Upon enrolment in the study, patients, or the patients' legal guardians were asked for their treatment preference. In the homeopathy group, 81% of patients had a preference for homeopathy, 18% had no treatment preference. In the conventional group, 55% of the patients' preferred conventional treatment, 2% homeopathy and 43% had no treatment preference. Patients at mixed centres were additionally asked whether they would agree to be randomized if the choice of treatment was made randomly. With 68.1%, the majority of patients in the homeopathy group refused to be randomized, 30.6% had no problem with randomisation and in 1.3% no remark was given. In the conventional group willingness and unwillingness to be randomized were equally distributed (51.9% yes, 47.9% no, 0.1% no remark).
Baseline characteristics
Demographic data of children (<>
Table 1
| Demographic data | |||
| Children | Homeopathy, n = 407 | Conventional n = 252 | p-value, if <> |
| | |||
| Male (%) | 51.1 | 50.0 | |
| Female (%) | 48.9 | 50.0 | |
| Age | 6.6 ± 4.3 | 7.4 ± 4.7 | = 0.0282a |
| BMI | 16.6 ± 3.0 | 17.9 ± 3.7 | = 0.0001a |
| | |||
| Adults | Homeopathy n = 445 | Conventional n = 462 | p-value, if <> |
| | |||
| Male (%) | 24.0 | 32.3 | = 0.0064b |
| Female (%) | 76.0 | 67.7 | |
| Age | 37.1 ± 12.5 | 39.6 ± 13.9 | = 0.0124a |
| BMI | 24.3 ± 4.8 | 25.0 ± 4.5 | = 0.0031a |
| Smoking (%) | 16.2 | 22.3 | |
| Full-set analysis values are either expressed as % of total or as mean ± SD, aWilcoxon rank-sum test, bFisher's exact test. | |||
As shown in Table 2, cough was the most frequently reported chief complaint in children, followed by sore throat and ear pain. In adults sore throat was the most frequent, followed by cough and runny nose. The overall distribution of the five chief complaints in children was comparable in both treatment groups, but differed significantly in adults (p = 0.0026, Chi-square test). The mean severity score differed significantly at baseline for 2 out of 5 chief complaints, both in children and adults (Table 2).
Table 2
| Distribution and severity score of chief complaints at Day 0 | |||||
| Children | Homeopathy n = 407 | Conventional n = 252 | |||
| Chief complaint | (%) | Severity score | (%) | Severity score | p-valuea if <> |
| | |||||
| Runny nose | 9.8 | 1.1 ± 0.5 | 15.5 | 1.9 ± 0.7 | = 0.0001 |
| Sore throat | 24.6 | 1.7 ± 0.6 | 23.0 | 1.6 ± 0.6 | |
| Ear pain | 23.1 | 1.4 ± 0.6 | 21.0 | 1.0 ± 0.5 | = 0.0002 |
| Sinus pain | 2.0 | 1.6 ± 0.4 | 3.6 | 1.7 ± 0.6 | |
| Cough | 40.5 | 0.9 ± 0.5 | 36.9 | 1.1 ± 0.6 | |
| | |||||
| Adults | Homeopathy n = 445 | Conventional n = 462 | |||
| Chief complaint | % | Severity score | % | Severity score | p-valuea if <> |
| | |||||
| Runny nose | 15.1 | 1.5 ± 0.8 | 14.7 | 1.9 ± 0.7 | = 0.0005 |
| Sore throat | 43.4 | 1.6 ± 0.7 | 32.3 | 1.5 ± 0.6 | |
| Ear pain | 3.4 | 1.0 ± 0.3 | 5.4 | 1.3 ± 0.5 | |
| Sinus pain | 8.3 | 1.5 ± 0.6 | 13.4 | 1.5 ± 0.6 | |
| Cough | 29.9 | 1.0 ± 0.5 | 34.2 | 1.3 ± 0.5 | = 0.0002 |
| Full-set analysis values are either expressed as % of total or as mean ± SD. aWilcoxon rank-sum test, indicating the differences between severity scores (from 0 – not present to 4 – very severe) in the homeopathy and conventional group. | |||||
With regard to the diagnosis of the chief complaints, in children otitis media was most frequently diagnosed (H: 18.9%; C: 13.5%) followed by bronchitis (H: 16.7%; C: 10.7%) and laryngitis (H: 12.3%; C: 12.7%). In adults, pharyngitis (H: 23.1%; C: 14.7%), bronchitis (H: 11.5%; C: 17.1%) and tonsillitis (H: 13.9%; C: 8.9%) were most frequently diagnosed. In adults, no significant differences were observed with respect to concomitant medical problems (H: 34.2%; C: 36.6%) or concomitant medication (H: 20.7%; C: 20.1%). In the homeopathic group 21.6% of the children had concomitant medical problems versus 13.5% in conventional group (p = 0.0098; Fisher's exact test). The proportion of children receiving concomitant medication was higher in the homeopathic group (9.1%) than in the conventional group (6.7%) as well but did not reach a statistical significant level (p = 0.3098; Fisher's exact test).
Medication
A total of 62 different homeopathic remedies were prescribed primarily on an individual basis. The top 10 (Table 3) of the most frequently prescribed homeopathic remedies included typical 'acute' remedies and accounted for about 60% of the prescriptions. In the conventional group 190 different medications were prescribed. Most of them were antibiotics followed by nasal preparations and analgesics (Table 3).
Table 3. The most frequently prescribed medications
Table 3
| The most frequently prescribed medications | |||
| Children | Adults | ||
| Homeopathic treatment n = 407 | % | Homeopathic treatment n = 445 | % |
| | |||
| 1. Belladonna | 13.3 | 1. Hepar sulphuris | 9.7 |
| 2. Pulsatilla | 10.6 | 2. Belladonna | 8.3 |
| 3. Hepar sulphuris | 6.6 | 3. Bryonia alba | 7.2 |
| 4. Mercurius solubilis | 6.4 | 4. Lycopodium clavatum | 7.2 |
| 5. Phosphorus | 4.9 | 5. Kalium bichromicum | 5.8 |
| 6. Bryonia alba | 3.7 | 6. Mercurius solubilis | 4.9 |
| 7. Calcarea carbonica | 3.7 | 7. Allium cepa | 4.5 |
| 8. Lycopodium clavatum | 3.7 | 8. Phosphorus | 3.4 |
| 9. Sulphur | 3.7 | 9. Causticum | 3.1 |
| 10. Phytolacca decandra | 3.4 | 10. Gelsemium sempervirens | 2.7 |
| | |||
| Conventional treatment n = 252 | % | Conventional treatment n = 462 | % |
| | |||
| 1. Antibacterials | 28.2 | 1. Antibacterials | 39.4 |
| 2. Nasal preparations | 22.6 | 2. Nasal preparations | 15.2 |
| 3. Analgesics | 12.7 | 3. Analgesics | 9.5 |
| 4. Stomatological preparations | 8.7 | 4. Cough/cold preparations | 8.7 |
| 5. Anti-asthmatics | 5.6 | 5. Stomatological preparations | 5.2 |
Treatment outcome
The primary outcome criterion, defined as the percentage of patients with complete recovery or major improvement after 14 days, was first calculated for the total patient population. The one-sided test of the full-set analysis showed non-inferiority of homeopathic in comparison with conventional treatment (H: 86.9%; C: 86.0%; p = 0.0003). These results were confirmed by the analysis on the per-protocol set (including all patients with data at day 14) since similar response rates were obtained in both treatment groups (H: 87.7%; C: 86.9%; p = 0.0019).
The response rates at various time points in children and adults are shown in Figure 2. The primary outcome criterion (response rate at day 14) in children was 88.5% after homeopathic and 84.5% after conventional treatment. In addition, response rates after 7 days (H: 68.8%; C: 64.3%) and 28 days (H: 93.1%; C: 92.5%) did not differ between both treatment groups either. In adults, the response rates after 7 days (H: 71.2%; C: 68.8%), 14 days (H: 85.6%; C: 86.6%, LOCF) and 28 days (H: 93.9%; C: 95.9%; LOCF) of treatment were not significantly different as well.
Figure 2.
Response rates after 7, 14 and 28 days of treatment. Response rates (% of patients with complete recovery or major improvement) at 7, 14 and 28 days after treatment in children and adults. Full-set analysis with last observation carried forward (LOCF) at day 14 and 28. Children n = 659 (homeopathy, 407; conventional, 252) and adults n = 907 (homeopathy, 445; conventional, 462).
Since the majority of patients (> 84%) were fully recovered or major improved after 14 days of treatment, it was of relevance to look at outcome differences within the first 7 days. As shown in Figure 3, the percentage of children experiencing a first improvement at different time points within the first week of treatment was significantly higher in the homeopathy group compared to the conventional group (p = 0.0488). For adults, a similar significant difference in favour of homeopathy (p = 0.0001) was observed.
Figure 3.
Onset of improvement within the first week. Onset of improvement within the first week of treatment (cumulative percentages of patients that experienced their first improvement). Children n = 659 (homeopathy, 407; conventional, 252) and adults n = 907 (homeopathy, 445; conventional, 462). Full-set analysis values with * p = 0.0448 for children and * p = 0.0001 for adults, using the Chi-square test on data points of the whole curve.
Additional analysis on the primary outcome criterion in order to correct for demographic differences at baseline was carried out (Figure 4). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) for children and 0.92 (0.63–1.34) for adults. In the subgroup of children, adjustments for age, mean severity and concomitant medical problems had little effect on the OR. The unadjusted OR for the Body-Mass-Index was 1.92 (1.03–3.60) and the only one showing a significant difference in favour of homeopathy. Adjustment for BMI differences between both treatment groups at baseline minimally reduced the OR to 1.89 (1.00–3.57). In adults, individual adjustments for all variables had little to no effect on the OR of the primary outcome criterion (Figure 4).
Figure 4.
Main outcome measure – corrections for baseline. Main outcome measure: response to treatment (complete recovery or major improvement) of full-set analysis data at day 14, unadjusted odds ratio's and adjusted odds ratio's for baseline differences with 95% confidence intervals. Between brackets: the number of responders in the homeopathy group and conventional group, respectively. Odds ratio above 1 indicates a better outcome upon homeopathic treatment.
Another outcome measure was the occurrence of adverse drug reactions. The percentage of children experiencing a suspected adverse drug reaction was not significantly different in both groups (H: 2.0%; C: 2.4%, p = 0.7838, Fisher's exact test). In adults, the number of suspected adverse drug reactions was significantly higher after conventional than after homeopathic treatment (C: 7.6%; H: 3.1%; p = 0.0032, Fisher's exact test). Both in children and adults, the suspected adverse drug reactions occurred predominantly in the body as a whole (upon homeopathic treatment) or in the gastro-intestinal system (upon conventional treatment).
In addition, patients' satisfaction with treatment and healthcare provider was evaluated. Almost all patients in both treatment groups were either satisfied or very satisfied with the treatment after 28 days (children: 95% H; 93% C, adults: 91% H; 95% C). A very high percentage of children (H: 98%; C: 95%) and adults (H: 97%; C: 97%) were either satisfied or very satisfied with the healthcare provider.
Discussion
The overall outcome of the first phase of the IIPCOS study [12] is confirmed in the present study on a larger group of patients and a greater number of medical practices, showing that homeopathic treatment is not inferior to conventional treatment for the treatment of acute respiratory and ear complaints. In IIPCOS-1 the response rate of homeopathically treated patients was with 82.6% significantly higher than in the conventional group. In IIPCOS-2 the response to homeopathic treatment was with 86.9% even higher, confirming the good effectiveness. However, no difference was observed between both treatment groups. This is due to a much higher response rate in the conventional group in IIPCOS-2 of 86.0% compared to 68% in IIPCOS-1. One difference between both studies is that in IIPCOS-2, only patients from Europe were analysed since those recruited at practices from the USA were excluded due to protocol deviations. In IIPCOS-1, the majority of patients included had their residence in the USA. However, despite these differences, the overall conclusion from both studies can be drawn that homeopathy is not inferior to conventional therapy. Due to the study design, the findings of IIPCOS-1 and IIPCOS-2 do not provide firm data on the comparative efficacy of homeopathic and conventional treatment in acute diseases but rather underline the potential value of homeopathy in every day clinical practice. Both studies reflect the situation in every day homeopathic practice in an international setting with average patients receiving the usual treatment of a homeopathic doctor. Furthermore, patients were recruited on the basis of chief complaints and related symptoms, rather than on the clinical diagnoses. This symptomatic approach coincides with the homeopathic nature of prescription by treating each patient individually, based on specific key symptoms and patient characteristics.
In IIPCOS-2, differences for various demographic parameters and symptom-related variables were found between both groups. Thereby the profile of typical patients seeking homeopathic therapy was confirmed [13,14], i.e. they were more likely to be women, younger of age, less likely to smoke and to have a lower BMI. The severity of symptoms at baseline was significantly different between treatment groups as well. However the differences were small and their clinical relevance is doubtful. Indeed regression analysis had little effect on the primary outcome criterion, showing that treatment effects were only minimally affected by selection bias. Based on the unadjusted and adjusted odds ratios of the primary outcome criterion it appears that homeopathic treatment, in comparison to conventional treatment, is more beneficial for children than adults. This observation is in accordance with previous studies in which the improvements after homeopathic treatment were greater in children than in adults [11,13].
Another possible source of bias is that the outcome criteria were assessed by the patients themselves. Since it was not possible to blind patients for their treatment, potential reporting bias from patient's expectations may have influenced the outcome. On the other hand, the patients' reports were collected by independent external study collaborators in order to minimize the influence of the patient's relationship with their physician on the treatment outcome. Although blinding of the external study coordinators was foreseen in the protocol, it cannot be ruled out that they received information from the patient revealing the nature of their medication. Therefore, blinding may not have been guaranteed in each case. Furthermore, it should be noted that at mixed centres, the choice of treatment was made by the physicians and/or following the patients' preference. The treatment decision may have been influenced by the kind or severity of the symptoms or the motivation and expectations of the patient.
Since acute respiratory and ear complaints are self-limiting conditions, it can be argued that the chosen primary outcome criterion after 14 days of treatment is not sufficiently sensitive. Patients experiencing these acute complaints may have undergone spontaneous recovery within 1 to 2 weeks. However, this outcome parameter was taken to confirm and reproduce the results of IIPCOS-1 by using a similar study design. Therefore other outcomes criteria such as the response rate after 7 days of treatment have to be considered more carefully. Moreover, the findings that the percentage of patients experiencing a first improvement within the first week was higher at all time points in the homeopathy group than in the conventional group, are at least supportive of the 14 days finding that homeopathy is not inferior to conventional medicine.
Other observational studies on the comparability of homeopathic treatment and conventional treatment of upper respiratory tract infections (URTI) have shown positive outcomes for homeopathy [15,16]. Recently, the value of homeopathic treatment for the prevention of URTIs has been demonstrated in a controlled clinical trial [17]. The consistent findings in IIPCOS-1 and IIPCOS-2 further contribute to the evidence that homeopathic treatment plays a beneficial role in the primary care of patients. Furthermore, the good tolerability of homeopathic treatment of acute respiratory and ear complaints was confirmed by the low number of patients that experienced adverse drug reactions.
The major limitation of the present study is that patients were not assigned randomly to their treatment group. The majority of patients in the homeopathic group had a strong treatment preference and consequently, they were not willing to be randomized. A similar reluctance towards randomisation has also been reported elsewhere for patients seeking anthroposophic therapy [18]. These results reveal a substantial limitation to the suitability of performing large randomized controlled trials on the efficacy of homeopathy in such a primary care setting.
Conclusion
This comparative cohort study, involving more than 1,500 patients in primary care practices of at least 6 different European countries, demonstrates that homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment. Although no firm conclusions can be drawn about the efficacy of homeopathic treatment, these results certainly contribute to the growing evidence that homeopathy is a safe and beneficial treatment strategy for acute diseases in primary care settings.
Competing interests
MJ is an employee and MHe † was an employee of the HomInt organisation. All other authors have no financial or non-financial competing interest related to the content of the manuscript.
Authors' contributions
International Integrative Primary Care Outcomes Study 2 (IIPCOS-2) collaborators: MH, DR and MHe planned and directed the study. SB, GL, GJ and AT were responsible for data collection. MJ drafted the manuscript. MF performed the statistical analysis. All authors read and approved the final version of the manuscript.
Acknowledgements
This study was carried out by the HomInt organisation, Karlsruhe, Germany. The IIPCOS-2 collaborators would like to thank Sytze de Roock for preparation of tables and figures, Rolf Hövelmann for data analysis, Wolfgang Mayer for monitoring the study and Rainer Lüdtke for his comments on the drafted manuscript. We are especially grateful to the physicians and all the patients for participating in the study.
References
1.Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, Pewsner D, Egger M: Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.
The Lancet 2005, 366:726-732. Publisher Full Text OpenURL
2.Bell IR: Evidence-based homeopathy: Empirical questions and methodological considerations for homeopathic clinical research.
AJHM 2003, 96:17-31. OpenURL
3.Walach H, Falkenberg T, Fonnebø V, Lewith G, Jonas WB: Circular Instead of Hierarchical: Methodological Principles for the Evaluation of Complex Interventions.
BMC Med Res Methodol 2006, 6:29. PubMed Abstract | BioMed Central Full Text | PubMed Central Full Text OpenURL
4.Walach H, Jonas WB, Lewith G: The role of outcomes research in evaluating complementary and alternative medicine.
Altern Ther Health Med 2002, 8:88-95. OpenURL
Return to text
5.
Baron SE, Goodwin RG, Nicolau N, Blackford S, Goulden V: Use of complementary medicine among outpatients with dermatologic conditions within Yorkshire and South Wales, United Kingdom.
J Am Acad Dermatol 2005, 52:589-594. PubMed Abstract | Publisher Full Text OpenURL
Return to text
6.
Passalacqua G, Compalati E, Schiappoli M, Senna G: Complementary and alternative medicine for the treatment and diagnosis of asthma and allergic diseases.
Monaldi Arch Chest Dis 2005, 63:47-54. PubMed Abstract | Publisher Full Text OpenURL
7.Breuer GS, Orbach H, Elkayam O: Perceived efficacy among patients of various methods of complementary alternative medicine for rheumatologic diseases.
Clin Exp Rheumatol 2005, 23:693-696. PubMed Abstract | Publisher Full Text OpenURL
8.Bensoussan M, Jovenin N, Garcia B, Vandromme L, Jolly D, Bouche O, Thiefin G, Cadiot G: Complementary and alternative medicine use by patients with inflammatory bowel disease: results from a postal survey.
Gastroenterol Clin Biol 2006, 30:14-23. PubMed Abstract | Publisher Full Text OpenURL
9.Weber U, Lüdtke R, Friese KH, Fischer I, Moeller H: A Non-Randomised Pilot Study to Compare Complementary and Conventional Treatment of Acute Sinusitis.
Forsch Komplementärmed Klass Naturheilkd 2002, 9:99-104. Publisher Full Text OpenURL
10.Witt C, Keil T, Selim D, Roll S, Vance W, Wegscheider K, Willich SN: Outcome and costs of homeopathic and conventional treatment strategies: A comparative cohort study in patients with chronic disorders.
Complement Ther Med 2005, 13:79-86. PubMed Abstract | Publisher Full Text OpenURL
11.Spence DS, Thompson EA, Barron SJ: Homeopathic treatment for chronic disease: A 6-year, university-hospital outpatient observational study.
J Altern Complement Med 2005, 11:793-798. PubMed Abstract | Publisher Full Text OpenURL
12.Riley D, Fischer M, Singh B, Haidvogl M, Heger M: Homeopathy and conventional medicine: an outcomes study comparing effectiveness in a primary care setting.
J Altern Complement Med 2001, 7:149-159. PubMed Abstract | Publisher Full Text OpenURL
13.Witt CM, Lüdtke R, Baur R, Willich SN: Homeopathic medical practice: Long-term results of a cohort study with 3981 patients.
BMC Public Health 2005, 5:115. PubMed Abstract | BioMed Central Full Text | PubMed Central Full Text OpenURL
14.Kaiser S: Comparison, using psychological constructs, between patients treated with orthodox medicine and patients treated with homeopathy.
HomInt R&D Newsletter 1998, 1:14-18. OpenURL
15.Trichard M, Chaufferin G, Nicoloyannis N: Pharmacoeconomic comparison between homeopathic and antibiotic treatment strategies in recurrent rhinopharyngitis in children.
Homeopathy 2005, 94:3-9. PubMed Abstract | Publisher Full Text OpenURL
16.Friese KH, Kruse F, Lüdtke R, Möller H: The homeopathic treatment of otitis media in children – comparisons with conventional therapy.
Int J Clin Pharmacol Ther 1997, 35:296-301. PubMed Abstract | Publisher Full Text OpenURL
17.Steinsbekk A, Fonnebo V, Lewith G, Bentzen N: Homeopathic care for the prevention of upper respiratory tract infections in children: A pragmatic, randomised, controlled trial comparing individualised homeopathic care and waiting-list controls.
Complement Ther Med 2005, 13:231-238. PubMed Abstract | Publisher Full Text OpenURL
18.Hamre HJ, Fischer M, Heger M, Riley D, Haidvogl M, Baars E, Bristol E, Evans M, Schwarz R, Kiene H: Anthroposophic vs. conventional therapy of acute respiratory and ear infections: a prospective outcomes study.
Wien Klin Wochenschr 2005, 117:256-268. PubMed Abstract | Publisher Full Text OpenURL
Jan 29, 2008
Backache during Pregnancy
Backache during Pregnancy
Backache is very common in pregnancy, affecting one in every two women, especially in the later months. There are two main causes.
First, as baby grows, the increasing weight of abdomen tends to pull lower spine forwards, so that it is curved. This puts a strain on lower back muscles. As lower spine is pulled forward, so shoulders tend to be
pulled back to compensate, and this puts a strain on the muscles in upper back.
pulled back to compensate, and this puts a strain on the muscles in upper back.Secondly, pregnancy hormones have the effect of softening and stretching ligaments, especially those around pelvis (to allow pelvis to open up when your baby passes through it). This can make the joints in and around your pelvis ache.
Towards the end of pregnancy, you may get backache if your baby has moved into your pelvis so that its back is lying against your back.
Do's
- Be careful about posture. Try not to let abdomen tip too far forward. You can correct this by tilting your pelvis forward instead (as if you were pressing your lower back into a wall). Open out your shoulders so that they are not pressed together and lift your rib cage.
- Be careful when lifting - squat down to pick up anything heavy; never bend forward from the waist. Better still, get someone else to do it
- Wear flattish comfortable shoes, not high heels
- Put a cushion behind your lower back when you are sitting
- Put something hot (like a hot water bottle) or cold (like a bag of frozen peas) against your lower back
- Get someone to give you a back massage
- Sleep on a firm mattress
- Talk to your midwife about using a special maternity girdle if the problem is severe. She can supply one and show you how to use it
- If your backache is due to the position your baby is in, try kneeling down on all fours. This moves the weight of the baby off your back and can give fast relief
Don't s
- Don'tsleep on a soft bed
- Don't sleep on your back. try to sleep on your side.
- Don't bend over from the waist to pick things,better is to sit down, keep your back straight and pick up things
- Don't lift heavy objects
- Avoid excessive weight gain
How can Homeopathy help in Backache during pregnancy?
There are some of the commonly used homeopathic medicines for Backache during pregnancy-
- Aesculus hip- if severe, continuous, dull ache in lower back and hips, Back feels tired and weak when walking, Backache worse when walking or stooping.
- Arnica montana - Backache due to strain on back muscle of injury, sore,lame, bruised feeling as if beaten, bed seems too hard, can not walk straight.
- Rhus toxicodendron - Pain and stiffness in the lower back, Pain better when moving, lying on something hard and on hot fomentation, pain worse while sitting.
Always take medicine after consulting a physician.
Gall Bladder Stones (Cholelithiasis)
Formation of gallstones in the biliary tract is common disorder and is associated with diseased gallbladder. It is unusual for the gall bladder to be diseased in the absence of gallstones.
Types of gallstones
Cholesterol stones- these stones have more than 70% of their dry weight as cholesterol and are commonest type (80%) in industrialized countries. Effective medical therapy is available presently for the cholesterol stones.
Pigment stones- these stones have less than 20% of their dry weight as cholesterol. They are uncommon and seen more frequently in developing countries.
Mixed stones
Pathogenesis
Cholesterol stones formation is the result of secretion of abnormal bile (lithogenic bile) by the liver. Cholesterol in the bile is kept in soluble form by bile salts in two physical forms. Either an excess of cholesterol or a relative decrease in the bile salt could lead the super saturation of the bile with cholesterol, which may get precipitated, in the form of gall stone. The lithogenic bile may have any of three reasons either defective bile acid synthesis or loss of bile salts (steatorrhoea) or excessive cholesterol secretion and impaired gallbladder functions.
Pigment stones are almost always the result of bacterial and parasitic infection in the biliary tree. These are of two types: black pigmentation stones found in gallbladder and earthy brown pigment stones found in common bile duct. The pigment stones are result of excess of unconjugated bilirubin in the bile, which get precipitated as insoluble bilirubin polymer (calcium bilirubinate). Haemolysis is the important cause of these pigment stones.
Risk factors for Gallstones
1.Cholesterol Stones
A.Increase cholesterol secretion
a. Elderly Persons
b. Obesity
c. Female
d. Pregnancy
B.Impaired Gall bladder emptying
a. Fasting
b. Total parenteral nutrition
c. Bile stasis in gallbladder
d. Spinal injury
e. Pregnancy
C.Bile salt secretion
a. Pregnancy
2.Pigment stones
a.Haemolysis
b.Hepatic cirrhosis
c.Age related
d.Ileac resection / disease
e.Stasis of infected bile
Clinical Features
Mostly the gallstones are asymptomatic and remain so for a long period. The occurrence is denoted by 4F (Fatty, Female, Forty and Fair) which mean that Gall stones are common in fatty, fair complexioned females above the age of 40 years. Only about 10% patients has symptoms either as biliary colic or acute inflammation of gall bladder. If the gall stone impacted in cystic duct the patient experience acute pain that remains for about 1-2 hours.
Prolonged pain more than 6 hours suggests either inflammation of gall bladder or pancreatitis (inflammation of Pancreas), as a complication of gall stone.
The stone in common bile duct due to migration of a gall stone produces biliary colic and obstructive jaundice due to cholestasis. Painless progressive obstructive jaundice, fever with rigor and itching over skin.
Diagnosis
Plain X-Ray of abdomen
Ultrasonography
CT Scan and MRI
Oral Cholecystography
Complications
Empyema of gall bladder
Pancreatitis
Cancer of gall bladder
Fistula formation with gallstone
Treatment
Asymptomatic gallstones are not usually treated. The best curative treatment for symptomatic gall stone is surgery. And in non surgical treatment gall stones can be dissolved and removed by ERCP.
Homeopathic Treatment
Acute pain, swelling ,vomiting, sign and symptoms related to gall stones can easily be treated by Homeopathic medicines. Gall stone colic cases may become asymptomatic again by homeopathic treatment. But in recurrent cases, after symptoms subside, surgery is recommended.
More then 70 medicines are available in homeopathy for gall stone cases. Few common medicines are following:-
Belladona, Berberis Vulg, China, Cardus Mar, Calcarea Carb, Chelidonium, Chionanthus, Dioscorea, Lachesis, Nux Vomica, Podophyllum, Lithium Carb, Cholesterinum etc.
Subscribe to:
Posts (Atom)