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Science, politics, and the regulation of dietary supplements: it's time to repeal DSHEA.

Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerine and limburger cheese . . . [T]his historical experience does suggest why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of self-styled panaceas that inventive minds can devise. [Individuals have] the right to be treated by a health care practitioner with any medical treatment (including a treatment that is not approved, certified, or licensed by the Secretary of Health and Human Services) that such individual desires or the legal representative of such individual desires. The makers of our Constitution undertook to secure conditions favorable to the pursuit of happiness. They recognized the significance of man's spiritual nature, of his feelings and of his intellect. They knew that only a part of the pain, pleasure and satisfactions of life are to be found in material things. They sought to protect Americans in their beliefs, their thoughts, their emotions and their sensations. They conferred, as against the Government, the right to be left alone--the most comprehensive of rights and the right most valued by civilized men.

Complementary Therapies↗

Potential dangers from topical preparations containing methyl salicylate.

Methyl salicylate (oil of wintergreen) is widely available in many over-the-counter liniments, ointments, lotions or medicated oils for the relief of musculoskeletal aches and pains. Ingestion of methyl salicylate poses the threat of severe, rapid-onset salicylate poisoning because of its liquid, concentrated form and lipid solubility. Excessive usage of these preparations in patients receiving warfarin may result in adverse interactions and bleedings. Methyl salicylate in topical analgesic preparations may cause irritant or allergic contact dermatitis and anaphylactic reactions. Physicians should fully appreciate the potential dangers from topical preparations containing methyl salicylate.

Administration, Oral↗

Toxicity following accidental ingestion of Aconitum containing Chinese remedy.

Various species of Aconitum are commonly used in traditional Chinese medicine. These plants are known to contain highly potent cardiotoxins. A 22 year old Chinese male accidentally ingested a herbal liniment prepared from Aconitum with near fatal results. His ventricular tachyarrhythmias responded to standard treatment including the use of i.v. magnesium.

Aconitine↗

Development of emulsion type new vehicle for soft gelatin capsule. I. Selection of surfactants for development of new vehicle and its physicochemical properties.

Screening of surfactants was carried out to develop an oil in water (o/w) emulsion type new vehicle for a soft gelatin capsule (SGC), using polyethyleneglycol 400 (PEG 400) as hydrophilic phase and medium chain triglyceride (Miglyol 810), propyleneglycol dicaprylate (Sefsol 228) or soybean oil as hydrophobic phase (PEG 400: hydrophobic phase: surfactant = 87:10:3) and by means of simple homogenization. Polyoxyethylene (20) cetylether (BC-20TX), which can form homogeneous and viscous white gels using the above hydrophilic and hydrophobic phase combination, was selected as a model surfactant for developing the new vehicle. Using Miglyol 810 as hydrophobic phase, a model new vehicle formulation (PEG 400:water:Miglyol 810: BC-20TX = 77:10:10:3) was prepared, and its physicochemical properties were evaluated. The particle size distribution of the new vehicle, after diluting about 3000 times with water, ranged from about 0.5 to 50 microns. Furthermore, the new vehicle had thixotropic property at room temperature (about 25 degrees C) and temperature-dependent gel-sol transforming property with the transformation temperature of about 37 degrees C. These properties meet the requirement for encapsulation of the new vehicle in SGC and suggest that it can be expected to form the o/w emulsion state in the aqueous environment in the stomach. The rheological properties would also make it advantageous for use in other dosage forms such as suppository, cataplasm or liniment.

Capsules↗

Camphor activates and strongly desensitizes the transient receptor potential vanilloid subtype 1 channel in a vanilloid-independent mechanism.

Camphor is a naturally occurring compound that is used as a major active ingredient of balms and liniments supplied as topical analgesics. Despite its long history of common medical use, the underlying molecular mechanism of camphor action is not understood. Capsaicin and menthol, two other topically applied agents widely used for similar purposes, are known to excite and desensitize sensory nerves by acting on two members of transient receptor potential (TRP) channel superfamily: heat-sensitive TRP vanilloid subtype 1 (TRPV1) and cold-sensitive TRP channel M8, respectively. Camphor has recently been shown to activate TRPV3, and here we show that camphor also activates heterologously expressed TRPV1, requiring higher concentrations than capsaicin. Activation was enhanced by phospholipase C-coupled receptor stimulation mimicking inflamed conditions. Similar camphor-activated TRPV1-like currents were observed in isolated rat DRG neurons and were strongly potentiated after activation of protein kinase C with phorbol-12-myristate-13-acetate. Camphor activation of rat TRPV1 was mediated by distinct channel regions from capsaicin, as indicated by camphor activation in the presence of the competitive inhibitor capsazepine and in a capsaicin-insensitive point mutant. Camphor did not activate the capsaicin-insensitive chicken TRPV1. TRPV1 desensitization is believed to contribute to the analgesic actions of capsaicin. We found that, although camphor activates TRPV1 less effectively, camphor application desensitized TRPV1 more rapidly and completely than capsaicin. Conversely, TRPV3 current sensitized after repeated camphor applications, which is inconsistent with the analgesic role of camphor. We also found that camphor inhibited several other related TRP channels, including ankyrin-repeat TRP 1 (TRPA1). The camphor-induced desensitization of TRPV1 and block of TRPA1 may underlie the analgesic effects of camphor.

Animals↗

[Use of an amorphous dressing in the skin care of patients after radiotherapy].

INTRODUCTION: Skin wounds caused by acute radiogen toxicity are an important side effect caused by radiotherapy treatment, therefore the prevention and immediate care is a challenge for the nursing staff. The actual traditional treatment is based on Liniment Oleocalcareo creams with Zinc Oxide as a principal agreement, but we have discovered a new alternative that at a first instance respond more effectively to the patients needs, and are classified with the terminology "amourphous dressing". MATERIAL AND METHODS: Retrospective study of the application of the amorphous dressing on 41 patients during the period between February and June 1998 in the Radiotherapy Unit of the "Hospital Universitario Sant Joan de Reus" (Tarragona). RESULTS: The application of the amorphous dressing has allowed us to evidence a slowness and decrease in the intensity of the skin damage caused by the radiation treatment. There has been a 63.86% decrease of the nursing treatment of the skin wounds as a consequence of the radiotherapy. The use of the amourphous dressing with Zinc Oxide favours the ephithelization of the moist wounds. No adverse reaction of the dressing has been observed during the time of the study, and no infections process has been detected, in none of the case was the radiotherapy treatment interrupted due to radiodermatitis, and in none of the cases an alternative dressing was needed. In some cases the amourphous dressing in combination with a tulle and a polyamide grille the healing time of the radiodermitis wound was significantly decreased. It has also been verified that the application as well as the removal of the dressing does not involve any difficulty neither for the patients nor for the nursing staff. There also has been a better level of acceptance of the new amourphous dressing as well from both patients and staff, seeing that the therapeutic results is significantly superior than that of the previously used methods. CONCLUSIONS: Having carried out the study in our Radiotherapy Unit we can assure that the new amourphous dressing, along with a strict control of the patient's evolution, increases the comfort and the quality of life of the patients. The multidisciplinary acceptance of the new treatment in a protocolized manner implies an increase in the patient quality care as well as contributing to a more efficient allocation of resources.

Adult↗

[Dosage forms of phytogenic drugs].

Herbal drug formulation is a challenge in pharmaceutical technology due to the complex physicochemical properties of these multicomponent materials. Potential instabilities of the pharmacologically active and coactive substances as well as incompatibilities and interactions of the extracted compounds and excipients have to be considered. Microbial contamination of the applied plant material might limit the shelf life of the products. Using state of the art methods in formulation stable preparations are obtained; additionally compliance of drugs might be enhanced due to simplified application or better sensorial quality. Nowadays, besides traditional pharmacopoeial aqueous, ethanolic, or (partially) dried extracts fluid, semisolid, or solid dosage forms of these extracts are in use, for example syrups, juices, drops, liniments, gels, ointments, creams, suppositories, tablets, coated tablets (dragees) as well as soft and hard gelatine capsules.

Dosage Forms↗

[Topical pectins for the treatment of burn wounds].

The results of the burned wounds treatment with 1-2% solution of apple or beet pectins were analysed. The control results were examined at the same patients with symmetrical wounds treated by chlorhexidine, levomecol, furacillin liniment. Clinical evaluation demonstrated good tolerability of the treatment regime, absence of side effects and complications, inhibition of inflammation, acceleration of epithelisation of the burns II-IIIA class, allowed to diminish the preliminary period before autodermoplastic operation (burns of IIIB class), diminished microbial dissemination and dissemination with Pseudomonas aeruginosa. The best results were demonstrated when the pectins application was performed since the first day after the burned injury.

Administration, Topical↗

[Use of miramistin for the treatment of patients with odontogenic phlegmons in the maxillofacial area].

In experimental and clinical conditions the use of miramystin (0.1% solution and liniment) was validated for complex treatment of patients with odontogenic maxillofacial phlegmons (110 patients with mild, moderate and severe inflammation). Significant efficacy of a wide spectrum antiseptic (miramystin) and laser fluorescent diagnostic method for achievement of objective assessment of the treatment of patients with phlegmons in maxillofacial area is shown. The disease duration (time from its onset till discharge from the hospital) varied from 8.2 to 24.1 days depending upon the degree of severity of the inflammatory process versus 13.7 to 30.4 days in controls, respectively. The developed treatment-and-diagnostic methodology is recommended for wide clinical practice.

Administration, Topical↗

[A new clinical trial in intravesical chemotherapy with instillation of peplomycin preparation as an emulsion in hydroxypropylcellulosum--preliminary study of patients with bladder tumor].

A new peplomycin (PEP) preparation was employed as an emulsion form in hydroxypropylcellulosum (HPC), which is familiar to have a liniment effect with a strong affinity to mucosa of the organ, in the management of 6 patients with bladder tumors. This emuled PEP in HPC (HPC-PEP) was instillated and thereafter, maintained for at least 2 hours at the frequency of once a week. All 6 patients had histopathologically confirmed T1 or T2 transitional cell carcinoma on biopsied specimen. The histological grading of the tumors were divided to 2 in G1, 3 in G2, and 1 in G3 of transitional cell carcinoma. The instillated agent was prepared from the mixture of 15 ml of 6% HPC and 90 mg PEP in 15 ml saline prior to use. A response to this treatment was evaluated primarily by cystoscopic findings and urine cytology 7 days after the instillation. In the present study, the beneficial effects of this treatment were briefly segregated into 4 categories as follows: excellent, good, fair and no responses were referred respectively to as complete eradication of visible tumor with negative urine cytology, a complete disappearance of the primary tumor with a persistent positive cytology, regression of the tumor size and no change of the primary tumor with sustained positive cytology. According to this estimation, 6 patients were categorized to 1 in excellent, 2 in good, 2 in fair and 1 in no responses to this new therapeutic preparation. Furthermore, urinary and serum levels of PEP were determined daily for 7 days after the instillation.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intravesical↗

[A case of bullous-ulcerative lichen ruber planus].

Bullous ulcerative lichen ruber planus (BULRP) in a 58-year-old woman is described. Besides the common symptoms (papular rash, vesicles and ulcers on the soles, detachment of the nail plates, atrophic foci on the hairy part of the head), the patient has developed erosions on the buccal and vaginal mucosa, articular involvement, complete loss of hair in the armpits and on the pubis. Local dibunol liniment has been effective in therapy of the mucosal erosions.

Chronic Disease↗

Differential diagnosis of unusual skin diseases in infants.

There are a number of relatively unique clinical skin diseases that may develop on the buttocks of infants. These include iatrogenic skin diseases caused by external medicine; skin tumors caused by methylrosaniline chloride (Pyoktanin); atrophy of the skin due to steroidal liniments; nevus and tumor diseases, such as nevoxanthoendothelioma and Letterer-Siwe disease. Finally, there is chronic granulomatous disease. These unusual cases are reviewed and their differential diagnoses discussed.

Diagnosis, Differential↗

[Results of using dibunol in bladder tumors].

Intravesical instillations of 10% dibunol liniment were used for the treatment of 132 patients with bladder tumors. An objective improvement was noted in 62.4%, including considerable lessening of the tumor size in 20% and its disappearance in 8.8% of patients. An efficacy of the treatment was considerably greater in bladder cancer in stages T1--T2 than in stages T3 and T4. The frequency of bladder cancer recurrence is found to be lowered following surgery associated with application of dibunol, also the manifest antiinflammatory activity of the drug is emphasized. No side effects relative to the toxic action of dibunol were observed. The use of dibunol seems to be rational in patients with bladder tumors of early stages, especially if associated with surgical therapy, and in tumor recurrences, and also with the symptomatic purposes in inoperable patients.

Administration, Topical↗

The local skin blood flow in areas at risk for pressure sores treated with massage.

In order to evaluate methods to prevent pressure sores the effect of massage on the local skin blood flow was studied in normal skin and in skin with discolouration (red or reddish blue). In this study massage is defined as small circular movements with the fingertips using liniment. The cutaneous blood flow was measured with a laser Doppler flowmeter. To study the long term effect of massage on normal skin ten patients were measured over a twenty day period with five days before and after a ten day period with massage. Twenty-nine patients with cerebral haemorrhage were measured for two days each to examine the effect immediately after the massage on normal skin. Fifteen patients with discolouration were measured for one day each both on normal skin and injured skin. The difference in blood flow before and after the ten day period of massage was inconsistent and insignificant. The effect of massage which appeared one to two minutes after the stimulus was implemented varies between individuals and within individuals; significantly more women than men increased their skin blood flow bilaterally after massage. In the centre of the injured skin the basal blood flow was higher than in normal skin and it decreased after the massage was implemented. The results stress the importance of continued research to provide an opportunity for individualization in the selection of methods to prevent and treat pressure sores.

Aged↗

Esophageal-atrial perforation due to recurrent esophagitis 18 years after esophageal bypass surgery.

A 62-year-old man presented with a grand mal seizure, progressive abdominal distention, and refractory hypotension 18 years after colonic bypass of a benign stricture of the low middle third of the esophagus. He died 3 hours after admission to the hospital. The patient had a history of liniment ingestion in childhood plus a long history of dysphagia and substernal pain. Autopsy disclosed a large ulcer of the anterior wall of the distal esophagus, which had eroded through the posterior wall of the left atrium. Histologic examination revealed chronic esophagitis with fibrous obliteration of the esophageal wall, pericardium, and left atrial myocardium near the site of perforation. Foreign material was present within small arteries of multiple viscera, and in several of these fragments transverse striations were demonstrated. Esophageal-atrial perforation is a rare but fatal complication of chronic esophageal ulceration. The clinical and pathological features of this and previously reported cases of nontraumatic esophageal-atrial perforation are reviewed.

Esophageal Fistula↗

[Reaction of peripheral blood leukocytes to wound processes during phytohemagglutinin therapy in rabbits with different hypersensitivity of delayed type].

Altogether 165 rabbits were distributed into strongly and poorly reacting groups in terms of delayed type hypersensitivity (DTH) to phytohemagglutinin (PHA). It was established that leukocyte response to wound process correlated with the intensity of DTH. The strongly reacting animals manifested of DTH. The strongly reacting animals manifested an adequate response (leukocytosis, neutrophilosis, nomocytosis, lymphocytosis, a decrease in myeloperoxidase and enhancement of phagocytic activity of neutrophils), while the poorly responding animals an in adequate one (passivity of the leukocytic parameters with the exception of monocytosis). Application of the liniment containing PHA (3.3 micrograms per g base, Difco, USA) does not change the response in the strongly reacting animals and essentially corrects all the leukocytic parameters in the poorly reacting animals with the exception of phagocytic activity of neutrophils. From the leukocytic response pattern a conclusion is made about multiple defect of the leukocytic system under poor DTH to PHA and about the leading role of monocytes in correcting the defect by PHA.

Animals↗

[Effect of the synthetic antioxidants ionol and dibunol on hemorrhagic ulcerative lesions of the stomach in rats].

Comparative studies made on 79 male rats indicate that the synthetic antioxidants ionol and dibunol liniment administered intragastrically in a dose of 50 mg/kg for 7 days do not exert any protective effect on gastric mucosa lesions caused by ligation of the pylorus by Shay's method. At the same time the antioxidants had an inhibitory effect on activation of lipid peroxidation in gastric tissues of rats operated on according to Shay. The absence of the protective action of the antioxidants on ulcer formation together with an inhibitory effect on activation of lipid peroxidation in gastric tissues provide no evidence in favor of the leading role of lipid peroxidation during gastric lesion in animals with ligated pylorus.

Animals↗