Clinic and practice

12.2.1 Preliminary Remark

The suitability of the empirical application of chamomile flower has been confirmed by intense research work over the last years. As a matter of fact, however, experience has shown that a usual chamomile tea domestically produced with boiling hot water only contains a small portion (1-3%) of the essential oil to be found in the drug [30, 34]. The important constituents of the essential oil with an antiphlogistic effect are not water soluble and remain in the chamomile flowers. One part of the essential oil evaporates. But the tea does contain a number of water-soluble flavonoids with a spasmolytic and — according to latest tests — also an antiphlogistic effect if locally applied [14].

A systematic clinical research of chamomile preparations only started in the 1920s. In 1921 a chamomile extract under the name Kamillosan® was produced and introduced into trade. This made available a preparation containing all essential constituents of chamomile, viz., chamazulene in the form of the prestage of Matricin, (-)-a-bisabolol (INN: levomenol), bisabolol oxides, cis- and trans-spiroether, and flavonoids. Kamillosan® is produced from the chamomile varieties Degumille (DBP 24 02 802) and Manzana, being rich in azulene and bisabolol. One hundred milliliters of extract contains at least 150 mg of apigenin-7-glucoside, at least 150 mg of essential oil from chamomile flowers, at least 50 mg of levomenol, and at least 3 mg of prochamazulene/chamazulene (determined and calculated as chamazulene).

The following section reports the research results of this standardized alcoholic chamomile extract. Comparative tests with other chamomile preparations, with the exception of a few other tests, especially with alcoholic or aqueous chamomile extracts were not available before 1998. The most important components are chamazulene with an undisputed antiphlogistic effect [31] as well as (-)-a-bisabolol, a sesquiterpene alcohol with antiphlogistic, antibacterial, antimycotic, ulcus-protective, and musculotropical-spasmolytical properties. Both of them are main constituents of the essential oil. The chamomile flavones have a musculotropical, a spasmolytical, and an antiphlogistic effect if locally applied. Further important active principles are the bisabolol oxides A and B, cis- and trans-spiroether, coumarins, and mucilage.

The therapeutic value of chamomile preparations is not just based on one main active principle but on the combination of many individual ones (their effects were proved both clinically and by animal experiments and combine a total effect suitable for a wide range of indications). A chamomile extract containing all components in an optimum concentration should be given preference to a usual domestic infusion. When diluting such an extract with hot water the lipophile constituents are also partly incorporated in the tea, being most suitable both for internal as well as for external application. In addition the concentrated form of the chamomile extract makes use exceeding the usual chamomile therapy possible.

The proven antiphlogistic effect is therapeutically used by various specialized disciplines on a broad basis and in different ways. A particularly favorable judgment should be passed on the fact that the corresponding preparations can be applied both internally and externally.

12.2.2 Dermatology

Prof. Born (Dermatological Clinic in Freiburg) describes the effect as soothing and antiphlogistic. A chamomile extract is, for instance, applied for the irrigation of undermined margins of a wound, pouches, sinus tracts, and hip baths, correspondingly diluted or in concentrated form for swabbing inflammatory lesions of the mucosa [4]. It is duly emphasized that, as experience has shown, chamomile preparations are willingly accepted by the patient; medically, however, there is a well-founded understandable reserve, especially in view of allergies appearing occasionally. If an appropriate extract is applied there is no reason for such doubts. In their review article, "Evidence for the Efficacy and Safety of Topical Herbal Drugs in Dermatology: Part I: Anti-Inflammatory Agents," Hormann and Korting [29] came to a similar conclusion in 1994.

This statement clearly shows that from the medical point of view preference is always given to a standardized finished medicament compared with the usual chamomile preparations, particularly with external treatment of infected tissues.

According to Weitgasser [60], in dermatology mainly acute suppurative dermatoses of different genesis needing an additional treatment with baths or fomentions/stupes are possible as indications. A chamomile extract leads to good therapeutic success in the case of acute suppurative dermatoses such as dermatitis caused by contact — allergic exanthemata, intertrigo, ulcus cruris, and eczemas — as well as with diseases of the mucosae such as stomatitis, pemphigus vulgaris, and others. After a short treatment time relief is noticed and complaints are minimized. In this connection the cooling effect causes a particularly pleasant feeling. The antiphlogistic and slightly anaesthetizing effect of chamomile extract makes the basic therapy considerably easier. In a controlled doubleblind study the clinical effectiveness of the medicament Kamille-Spitzner® was examined [23]. The drying and epithelizing effect on suppurative dermatoses after an abrasive tattooing was taken as an objective study parameter. Statistically both the reduction of the discharging wound area and the drying tendency were marked more heavily than in the placebo group.

Within 2 days the application of fomentions led to a considerable improvement of the inflammatory symptoms of dermatitis statica and dermatitis caused by contact. In a unilateral comparative study the fomentions with the standardized chamomile medicament turned out to be superior to those applied with salt solution. The local tolerance was very good; side effects were not observed [15, 43]. Partial baths, rinses/irrigations, and fomentions with chamomile extracts as well as the use of ointments also led to a quick disinfection of infected wounds and ulcers such as ulcera cruris [7, 13, 21, 24, 28].

After a dermabrasion of the face, especially after dermashaving, a good smooth granulation and epithelization of the skin could be observed as a positive effect with chamomile extract [22]. Decubitus ulcers, frequently found with paraplegics, are successfully treated with appropriate chamomile bath additives. A special advantage of this form of application is that it does not cause any pain. When judging the therapeutic success, the rapid reduction of the bad smell — due to the necrotizing inflammation — also plays an important role. The chamomile bath has also proved to be a success with the local treatment of deep second-degree burns. Apart from an accelerated cleansing process of a wound a significant improvement of the granulation is also observed. Deep necroses are excised; superficial ones heal without proteolytic ferments [12].

Physicians report from observational studies and case studies concerning experiences with Kamillosan® Crème under practice conditions that the effectiveness and tolerance of the preparation are very good in more than 95% of cases. As with long-term topical application of corticosteroids, the majority of the interviewed people had already noticed side effects such as atrophy, teleangi-ectasiae, etc. The product was classified as a suitable supplementary therapy and as a possibility of eliminating corticosteroids. According to the indications the elimination ranges from 20-100%, depending on the group of patients.

A controlled clinical study with 161 patients suffering from inflammatory dermatoses on their hands, lower arms, and lower legs (irritative-cumulative dermatitis caused by contact, neurodermitis, allergic eczema caused by contact, lower leg eczema, dyshidrotic and seborrhoic eczema) had already been conducted before the interview action. In a unilateral comparative study it could be shown that an interval therapy with Kamillosan® ointment and 0.25% hydrocortisone ointment is superior to the single therapy with 0.75% fluorcortinbutylester and equieffective with 5% bufexamac ointment [54].

Another use for applying chamomile extract refers to diseases of the anal regions. Here partial baths have a particularly favorable influence on pruritus ani, the perianal eczema of different genesis, and external fistulae [20]. The same good results were achieved by hip baths after anal operations, above all after operations of fistulae. Chamomile extract is also recommended for partial hand baths, especially for the after-treatment of hand injuries and hand operations [28]. For the preop-erative cleansing of the intestine, enemas are recommended, containing chamomile as an essential component and protecting against irritations of the mucosa [47]. In a comparative study an irritative dermitis caused by contact with sodium lauryl sulphate and treated with Kamillosan® Creme and 0.1% of hydrocortisone acetate, incorporated into the Kamillosan® ointment base, and the antiphlogistic effect of the three test substances was measured by means of profilometry in view of the reduction of the roughness of the skin [35].

12.2.3 Stomatology

In dental and oral medicine, as well as in orthodontics, therapy with chamomile extracts is an essential component of the medicamentous therapy for the treatment of gingivitis, stomatitis ulcerosa, and stomatitis aphtosa, i.e., for all inflammatory diseases of the gingiva and oral mucosa. Here the treatment with oral baths is most important, whereas chamomile steam inhalation is used after radical operations in the maxillary sinus, causing a very pleasant feeling [10, 36]. In a review publication about the most important herbal medicinal plant products with inflammation activities to the oral cavity and as an adjuvans for an improvement of the resistance of the oral mucosa, Schenk [50] comes to the conclusion that two of the chamomile preparations analyzed by him belong to the more suitable products that can be compared with sage tincture. At the same time, however, he also criticizes the lack of clinical tests in the region of the oral cavity.

Suitable extract preparations may successfully be applied with refractory diseases of the oral mucosa and the gingiva such as ulcers and aphtae. Decubitus ulcers caused by tartar, films (on the teeth), or badly fitted prostheses disappear quickly. Besides the alcoholic extract, a chamomile ointment can also be used in the region of the oral mucosa, for example, for the massage of gingiva, which proves to be favorable for the treatment of parodontosis [18, 60].

In the Centre for Dermatology and Venerology of the University of Frankfurt/Main, 78 out-and inpatients suffering from different skin diseases and diseases of the mucosa were treated with the product base and rinses, especially irrigations produced from a chamomile extract, over a period of 27 months.

All patients with diseases of the oral mucosa noticed a relief of their symptoms as well as a pleasant cooling effect quickly. The durable and intense influence on existing bad breath (halitosis) could be objectified. On top of that the pains of those patients suffering from habitual aphtae eased remarkably, especially after eating [43]. Inflammatory diseases of the oral mucosa and the throat region (pharynx) can be treated successfully by applying Kamillosan® oral spray [10].

12.2.4 Discipline of Medicine Dealing with Ear, Nose, and Throat (Otolaryngology)

Chamomile therapy is used in otolaryngology as much as in dermatology. First tonsillectomies have to be mentioned, where badly smelling coatings are left for about 10 days. A rinse with chamomile extract leads to an antiphlogistic effect and at the same time to a deodorant effect, so that a local antibiotic treatment finally turns out to be completely superfluous. According to Hinz [27], a standardized ethanolic-aqueous chamomile flower extract is suitable for the adjuvant therapy of Angina lacunaris and for the symptomatic treatment of herpangina often occurring in (early) childhood.

Also, after operations of the paranasal sinus [27] and in cases of inflammatory and painful esophageal diseases, chamomile extract has a pain-alleviating effect, and moreover it was ascertained esophagoscopically that the process of healing is quick. After operations and with inflammatory changes of the oral mucosa or those changes caused by radio therapy, chamomile rinses alleviate the complaints. With disturbances of salivary secretion due to x-ray dermatitis of mouth and throat, chamomile extract is alternatingly added to artificial saliva. Rinses of the maxillary sinus may also be carried out only with chamomile extract without application of antibiotics [39, 40]. In an observational report of a municipal hospital, treatment with chamomile extract of at least

10,000 patients suffering from the symptoms mentioned above did not lead to any unpleasant side effects [39].

With sinusitis as well as with children's occult sinusitis, chamomile steam inhalations are recommended [42, 53]. Rinses with chamomile extract proved to be successful with postoperative treatment and as an adjuvant therapy with radiation treatment of the oral, nasopharyngeal, and pharyngeal cavity [16, 19]. Saller [48] reported a significant effectiveness (p < 0.01) of chamomile flower steam inhalations, which were produced by means of an ethanol-aqueous chamomile flower extract [48].

Patients who have to undergo radiation treatment in the nose and throat region are frequently suffering from pharyngitis sicca, as with this method of treatment the mucosa and submucosa are strongly attacked. Also in this case rinses, especially irrigations with chamomile extract, mean not only a subjective improvement that is apparent by a pleasant cooling effect in the throat and by a reduction of bad breath, but also a pharyngoscopically and laryngoscopically noticeable deconges-tion of the mucosa and reduction of inflammation. This is also applicable to pharyngitis of other etiological causes. Dryness of the mouth frequently noticed as a side effect of the radiation therapy can be significantly reduced by chamomile extract [11].

In a more recent study at an ear, nose, and throat practice, the effectiveness of Kamillosan® inhalations, especially Kamillosan® oral spray, was tested with various diseases of the oral and pharyngeal cavity (among others, uncomplicated sinusitis, pharyngitis, tonsillitis, glossitis rhinitis, state after tonsillectomy, etc.). The duration of the treatment was between 6 and 9 days. After the treatment with Kamillosan® 96% of all patients noticed a subjective improvement of their complaints [58].

In cases of an inflammatory nasal mucous membrane, a rapid normalization with reduced or no crust formation can be achieved by applying chamomile ointment. The smell is not a disturbing one but is even felt to be pleasant, so that rinses, especially irrigations, can also be carried out. In this case a particular advantage is the fact that when swallowing no unpleasant or harmful side effects will occur [40].

Otitis externa can be treated successfully in children as well as adults by means of chamomile extract.

12.2.5 Radiation Therapy

Treatment of radiation damages in the region of the mouth, nose, and throat with chamomile extract — within the scope of an adjuvant therapy — was judged distinctly favorable by the patients [19, 40] as well as were the prophylactic effects [9] on the oral mucosa with patients irradiated or treated with chemotherapeutics ascertained by a U.S. working group. The reactions of mucosa of the rectum resulting from a highly dosed radiation therapy, frequently felt to be unendurable, can also be treated successfully with chamomile extract. For that purpose an enema is given three times a week; besides antiphlogistic properties, this also has a mild cleaning effect [3].

In gynecological radiation therapy, hip baths for the alleviation of painful skin reactions are successfully applied as well [54].

With radiation of large skin surfaces (e.g., mastocarcinoma) radiation erythemata as far as epidermolysis can be observed. Also in these cases application of chamomile extract leads to alleviation of pain during the time of treatment as well as to a quick regeneration of the skin after finishing the radiation [19].

In 1952 treatment of radiation dermatitis by means of ointment containing azulene was reported. As there was no pure chamazulene available from chamomile at that time and as the chamomile ointments did not have enough concentration of active principles, people used an ointment preparation with synthetic azulene U-isopropyl-5-methylazulene1).

1 KamiUen-Bad-Robugen, Producer: Robugen GmbH, Esslingen/N, Germany.

With the radiation of tumors of still-healthy skin, the preparation proved to be the best skin protection so that x-ray dermatitis, even with skin already damaged by radiation, could be avoided to a large extent.

This also referred particularly to the child's skin, which tolerated higher x-ray doses without showing any important formation of erythemata. Badly healing ulcerations disappeared rapidly after application of ointment containing azulene, without having to interrupt the x-ray or radium treatment [25].

At the university hospital of Helsinki the effects of Kamillosan® cream in comparison with an ointment consisting of almond oil were tested with acute reaction of radiation with patients suffering from a mastocarcinoma [38]. With additional treatment of chamomile cream a radiation erythema could not be avoided completely; however, no heavy reactions occurred with the chamomile cream — they could only be observed later, at the end of the radiation therapy.

12.2.6 pULMOLOGY

In pulmology chamomile extract is appreciated for use as an inhalation treatment due to its established antiphlogistic effect. With patients suffering from chronic bronchitis with or without obstruction, after an inhalation treatment therapeutic effects in the tracheobronchial system could be proved in a test of longer duration. The healing process of the inflamed bronchial mucosa is improved, and a bronchial restriction of the lumen possibly existing at the same time goes down.

Inflammable swellings of the mucosa of a nonallergic and abacterial nature caused primarily by noxious agents (just think of the bronchial stimulus states due to chronic inhalation of tobacco smoke) respond well to inhalation therapy by means of chamomile extract [54].

12.2.7 Pediatrics

In pediatrics the protective effect of chamomile preparations on skin and mucosa for babies and infants as well as the antiphlogistic property with diseases of these tissues is most important and well known.

Chamomile extract is outstandingly suitable for delicate skin having the tendency of being dry and forming eczemata.

According to a pediatrician's open report, very good results were achieved with using chamo-mile ointment for the treatment of napkin dermatitis. In this practice the effect of Kamillosan® ointment on the treatment of various kinds of dermatitis was tested with 76 babies (between 1 and 10 months) and little children: 49 children had napkin dermatitis, especially an inflammation of the skin in the region where napkins are used; 9 of 22 cases healed up completely within a week; another 10 improved considerably. Special emphasis is placed on easing off all complaints such as pains and itching, which affect the general condition very much. Babies' eczemas and perioral dermatitis could also be influenced positively, although within the short time of treatment according to expectations only partial success was achieved [56].

In pediatrics the antiphlogistic effect with inflammations of the mucosa is mainly used for the treatment of sinusitis. Principally the exudative and festering sinusitis is, also in pediatrics, a range of indication for chamomile steam inhalation being one of the most effective remedies. With the inhalation of chamomile steam, produced by boiling chamomile flowers moderately in a lot of water, allergic symptoms can very occasionally be caused by evaporating pollen allergens. Normally, however, inhalation of chamomile steam produced from an alcoholic extract caused no allergic reaction.

With more comprehensive defects of substance and surfaces of inflammation in the region of skin and mucosae, chamomile baths or irrigations are not only useful for the regeneration of the injured integument, but were also subjectively found to give a pleasant feeling. The chamomile bath is an essential part of the treatment of sensitive skin in the anal and genital areas of young babies, but is also meant for cleaning wound and burn surfaces as well as for skin defects and those of the mucosa (Lyell syndrome).

In pediatrics chamomile extract therapy is advisable in the following cases [52, 53]:

• For sensitive skin care of babies and immobilized children as well as seriously ill, chronically ill, and disabled children, mainly suffering from immobilized cerebral pare-ses, and wetting and defecating the bed.

• For the treatment of an inflamed skin or skin defects. The main fields of indication are, for example, dermatitis ammoniacalis, scald and burn areas and exfoliative dermatitis.

• For the treatment of inflammations of the nose and the paranasal sinus by application of a chamomile bath and inhalation.

12.2.8 Gynaecology

According to reports of various gynaecological hospitals, chamomile extract proves to be a suitable remedy for the treatment of bartholinitis, vulvitis, and mastitis and in rare cases secondarily healing episiotomies [10].

Hip baths and irrigations are principally indicated for the postoperative treatment of vaginal operation wounds [32, 33] as well as for the therapy of inflammable diseases in the genital area. Reference 44 reports about the antiphlogistic effect of Kamillosan® ointment in comparison with a nonsteroidal ointment in case of episiotomies, with colpitis senilis, and about the improvement of the healing of wounds after surgical operations carried out by laser in gynecology after taking a chamomile (hip) bath.

12.2.9 Gastroenterology

The spasmolytic and antiphlogistic effects of chamomile products are taken advantage of when treating gastrointestinal diseases of different kinds. Acute gastritis and enteritis, for example, are regarded as empirical fields of indication for chamomile. Colitis can also be treated successfully with chamomile, and irritations of the colon, for example, respond particularly well if such a state has developed from chronic constipation coming along with spasms. The effect of chamomile extract with diseases of the stomach and the duodenum was clearly proved by a number of tests. Thus, gastro-bioptic [6, 24, 41] and cytologic [8, 37, 61] tests as well as controls of the gastric juice were carried out [8, 41].

In a multcenter study of 104 outpatients with complex complaints of pressure on the stomach, sensation of repletion, eructation, heartburn, loss of appetite, nausea, and sickness without any corresponding organic findings, a 6-week therapy with Kamillosan® was carried out. Further specific medicaments were excluded. It was proved that the most frequent symptoms showed the best rate of success, always provided the symptom in question disappeared completely. As expected, there was the least influence on loss of appetite but 61% of the cases could still be influenced. Side effects and incompatibilities were found in no cases [57]. This means that with mostly nonspecific vegetatively overlapped gastric troubles, the therapy with Kamillosan® only without organic findings is most suitable.

According to Weiss [59], with different modes of gastric troubles that can be classed under the general term of "dyspepsia," the internal administration of chamomile tea or preparations from chamomile extracts is appropriate. With gastric erosions or gastric ulcers the so-called "Roll" method of treatment is recommended, in which the patient, after drinking the chamomile tea, rotates his prone position every few minutes. Apart from the spasmolytic and thereby mainly subjectively analgetic effect, the conducive effect of chamomile to the healing of wounds is much better, as experience has shown. In view of the side effects turning up quite often with the application of modern acid blockers of the cimetidine or ranitidine type (H2 antagonists) and the relatively high rate of relapse, the chamomile rotation method, which can also be combined well with traditional antacida if necessary, is currently still quite justified [51, 59].

In pediatrics chamomile extract is successfully applied due to its carminative and spasmolytic effect with diseases of the gastrointestinal tract and the effect as such is said to set in immediately after taking the preparation [53]. A comprehensive summary of all therapeutic possibilities of chamomile preparations with diseases of the gastrointestinal tract was published by Schilcher [51].

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