Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2001-01-17
2002-03-26
Webman, Edward J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C424S405000
Reexamination Certificate
active
06362222
ABSTRACT:
The invention relates to a new application of podophyllotoxin to topical pain relief in the treatment of pains in the genital organs, especially of vulvodynia and pains after hysterectomy.
There are several causes to pains in the female genital organs. Pains may be caused for instance by infections, tumours, circulatory disorders and various mechanical impacts. In addition to this, however, many other pains occur which cannot be explained by the factors above, all the findings being normal in examinations. Thus, for instance, a vaginal pain called vaginismus is known, which has always given a normal result in topical examination. For this reason, the pain has been considered psychogenic. A more recent denomination for a similar pain is vulvodynia, i.e. a vulvar pain for which no clinical cause can be found. The pain can be even invalidatingly strong, and it often starts suddenly as the result of an inflammation and may last for several years.
Various forms of vulvodyina are known. Vestibulitis is a finding called inflammation of the vulvar glands. In this condition, Bartholin's glands and both sides of the urethra and sometimes also the separate small glands (minor vestibular glands (gl.v.minor)) are very tender even to light palpation and still seem to be inflamed. Dysesthetic vulvodynia is otherwise identical, with the exception that the vulvar glands do not look inflamed at least macroscopically.
Since there is no overall theory for the causes of vulvodynia, there are very varied treatment, which have a very poor effect on the whole. Also, it is not obvious for physicians, not even gynecologist, to identify the condition. In fact, there have been many attempted ways of treating vulvodynia, with poor results.
The pain has assumably been caused by an inflammation in the vestibular glands, and the condition has consequently been treated as such. Various inflammatory agents have been searched with poor results. Antibiotics have not had any effect, nor have cortisone injections under the glands.
Topical pain relief has been tested by administering local anaesthetics either as injections or superficially, either in the entire vulva or under the sore glands. The results have been very unsatisfactory, and what is more, such a treatment involves the risk of allergy to anaesthetics. Systematic analgetic treatment has also been tested, however, opiates have been confirmed not to kill but rather to intensify the pain. Nor have prostaglandin suppressors relieved the pain. Among analgetics spasmolytics have proved useful in some cases, but only passingly, however.
Among antidepressants amitriptyline is probably the most frequently used and effective drug. Used for analgetic purposes it is effective in a smaller dose than used as an antidepressant. Nevertheless, this drug has bad general side effects and requires long-term treatment. No other antidepressants have been confirmed to be effective.
In the most severe cases of vulvodynia surgery is often used to remove a relatively large portion of the vulvar rear part at the line between the mucous membranes and the dermal areas. The large portion to be removed also includes Bartholin's glands. In the most severe cases, surgery helps fairly well (approx. 75%), however, it has a very invalidating effect. After surgery, vaginal humidification during intercourse is prevented. In addition, some patients still suffer from pains after the surgery, and they can hardly be offered any other treatment at all.
The description above shows that the treatment of pains in the genital organs of the type of vulvodynia is totally unsatisfactory with current techniques. The detection of the condition is perhaps additionally impaired by the absence of effective treatment and ignorance of the mechanism of the disease.
One sector of pains in the genital organs is a sore uterus, which is not considered a separate disease as such. It is treated with hysterectomy, which is often carried out because of some other diagnosis. In most cases, hysterectomy gives a distinct and permanent relief to the pain symptoms from which the patient suffers, and, in fact, the vagina is generally considered not to cause any sense of pain. Nevertheless, patients sometimes become very ill again after hysterectomy. They feel the pain in the lower abdomen, stronger on either side, and it may radiate to both flanks and to the back. It is often connected with urinary disorders, most often a need for urination, but also urinary incontinence and even cystitis.
There is no overall explanation to pains after hysterectomy. The most commonly used explanation is adhesion pains. The patient has relatively often been found to suffer from some kind of inflammatory symptoms, which develop pains after hysterectomy. The adhesions are sometimes searched by laparoscopy. Adhesions are either found or more often not found, and the treatment of found adhesions does not have any effect on the pain.
In young patients suffering from the pain endometriosis is a usual finding, which may sometimes provide an explanation to the pain. By contrast, it does not give an explanation to the pains in elderly, post-menopausal patients. The postoperative treatment of endometriosis is hormonal treatment, which does not relieve the pain, however.
Because of pains after removal of the ovaries, remaining ovarian tissue is sometimes searched in the region of the vaginal peak suspensions, and a pathologist may in fact find ovary-like tissue in the samples by careful searching. The pains may even subdue in some cases, which may be primarily due to the large section, and not to any ovarian tissue findings, which do not have any impact on successful pain relief.
Pains in the genital organs are often connected with urinary disorders, and since the urinary tracts run near the surgery region, the pains are assumably caused by these. The urinary tracts are very susceptible to pain and cause very strong pain for example in connection with cystolithiasis. However, there is no diagnostic test for stating pain in the urinary tracts nor for treating it. Patients who suffer from pain after hysterectomy under the diagnosis of ureter disorder are often transferred to some other speciality and are thus completely out of sight.
The present invention is based on the unexpected finding that podophyllotoxin topically administered has a very good effect on inexplicable pains in the genital organs. Podophyllotoxin is a previously known drug which has been used for local treatment of verrucae, especially condyloma.
The essential characteristics of the invention are defined in the accompanying claims.
The podophyllotoxic treatment of the invention can be generally applied to patients who suffer from pain in the lower abdomen and urinary disorders, for which no obvious reason can be found. The invention can be especially applied to the treatment of patients who suffer from inexplicable pains in the genital organs, i.e. vulvodynia. Usually these patients suffer from strong vulvar pain, for which no cause is found in a conventional gynecological examination. In accordance with the invention, podophyllotoxin can also be used in the treatment of patients with recurrent candidiasis.
The typical complaint of vulvodynia patients are pains during intercourse or other unspecific pains in the genital organs. Urinary disorders are common, and among these incontinence is a distinct separate symptom. Most of the incontinence disorders are mixed, i.e. prolapse is also connected with forced incontinence. Dysuria, i.e. an infection-like urinary disorder without bacteria is common. It may be impossible for the patient to remain sitting over long periods of time. Vaginal dryness is frequent as a separate symptom. Recurrent candidiasis is the sole symptom in some cases. This may be caused by a pathogenic fungus, however, a fungus-like symptom often occurs without any detectable fungus.
Unexpectedly, the patients themselves nor the physicians have not previously observed that the pain is specifically concentrated to the gland orifices. Yet it is commonly known that
Nguyen Helen
Webman Edward J.
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