Randomized controlled trial of belladonna and opiate suppository during intravesical onabotulinum toxin A injection.

BACKGROUND: Intravesical injection with onabotulinum toxin A injection can be performed in-office under local anesthesia. Rectally administered pain medication presents a potentially feasible and previously uninvestigated adjunct to office-based anesthesia protocols. OBJECTIVE: The primary aim of this study was to determine whether adding a belladonna and opiate suppository to standard lidocaine instillation resulted in reduction of bladder injection pain during onabotulinum toxin A injection procedure. STUDY DESIGN: This was a prospective, randomized, double-blind, placebo-controlled study of patients undergoing onabotulinum toxin A bladder injection at a single clinic. Patients age ≥18 years, who met clinical criteria for invasive treatment of refractory urinary symptoms, had previously documented postvoid residual volumes <150 mL, and elected for in-office intravesical onabotulinum toxin A injection were eligible to participate. Participants were randomized by computer-generated block randomization to receive a belladonna and opiate (belladonna alkaloid with morphine 16.2/7.5 mg) or placebo suppository. Suppositories were placed immediately prior to lidocaine-based anesthesia, which all participants received. All participants underwent a standardized injection procedure using the same rigid cystoscope, needle type, and injection pattern (20 injections total). A 0-10 numeric rating scale was used to assess pain intensity before anesthesia and suppository, 40 minutes after administration of anesthesia and suppository, after first 10 bladder injections, and immediately after completion of 20 injections. Pain increase during procedure was calculated using the difference between score 40 minutes after administration of anesthesia and suppository and score after first 10 bladder injections. Postvoid residual were measured immediately postprocedure and 2 weeks later. Patient satisfaction with pain control was measured using a Likert scale. Our primary outcome was change in pain level from anesthetic baseline to midprocedure (score after first 10 bladder injections to score 40 minutes after administration of anesthesia and suppository). A final sample size of 26 patients was needed to have 80% power (alpha = 0.05) to detect a 50% reduction in bladder injection pain during the procedure as defined by our primary outcome. An intent-to-treat approach was used for all analyses. RESULTS: In all, 26 participants were enrolled and randomized with 13 in each study arm. Participants in the treatment group were slightly older than in the placebo group (P = .05); there were no statistically significant differences in medical comorbidities. Median score after first 10 bladder injections to score 40 minutes after administration of anesthesia and suppository for the placebo group and treatment group was 4 (range 1-10) and 5 (range 0,9), respectively (P = .94). Median scores immediately after completion of 20 injections for the placebo group and treatment group were 3 (range 0-10) and 2 (range 0,8), respectively (P = .29). There were no significant differences in preinjection pain scores reported before anesthesia and suppository and at 40 minutes after administration of anesthesia and suppository. Postprocedure postvoid residual >200 mL was noted in 5 (38%) of the placebo group and 3 (23%) of the treatment group (P = .67). Two-week postprocedure postvoid residual >200 mL was noted in 3 (25%) of the placebo group and 2 (15%) of the treatment group (P = .64) for an overall rate of 20%. Eleven (84%) participants in each group reported being "mostly satisfied" or "very much satisfied" with pain control. CONCLUSION: Belladonna and opiate suppository use did not significantly reduce bladder injection pain, or increase risk of urinary retention immediately postprocedure or 2 weeks later. Satisfaction with pain control among onabotulinum toxin A injection patients is high.

Efficacy of treatment with belladonna in children with severe pallid breath-holding spells.

IntroductionPallid breath-holding spells are common and dramatic forms of recurrent syncope in infancy. They are very stressful despite their harmless nature and sometimes require treatment. OBJECTIVE: The objective of this study was to evaluate the efficacy of belladonna in severe breath-holding spells. METHODS: This is a multicentric, retrospective series involving 84 children with severe pallid breath-holding spells. Inclusion criteria were >1 pallid breath-holding spell with loss of consciousness, paediatric cardiology evaluation, and follow-up >6 months. In total, 45 patients received belladonna and 39 patients did not receive treatment, according to physician preference. RESULTS: Mean age was 11 months, ranging from 4 to 18 months, with 54% of males. Mean spell duration was 30 seconds (interquartile range 15, 60), and the frequency was four episodes per month (interquartile range 0.5, 6.5). Comparison of baseline characteristics between groups showed similar demographics, with the single difference in the severity of the spells, being more severe in the treated group. When comparing the treated and non-treated groups at 3 months, only two (5%) patients had a complete remission in the first group, whereas 20 (44%) had remission in the belladonna group (p<0.01). When considering the characteristics of the spells before and after the initiation of treatment with belladonna, 75% of the patients presented a positive response, with 44% of the patients presenting with complete resolution of the spells (p<0.01). No major adverse reaction was reported, with only 5% minor adverse events. CONCLUSIONS: Belladonna is highly effective to alleviate severe breath-holding spells in young children, without any major adverse effects.

Delirium: an under-recognized problem.

CASE STUDY: Ms. G, a 78-year-old woman with a history of heart failure and a left ventricular ejection fraction of 45%, had an exploratory laparotomy with colon resection and colostomy two days ago for an obstructive stage IIIB adenocarcinoma of the colon. She is a patient on a general surgical unit. Upon assessment at 7 am, Ms. G was easily aroused and oriented. She has a patient-controlled analgesia (PCA) pump for postoperative pain control with 1 mg of morphine available every 30 minutes; she used a total of 4 mg of morphine via IV since midnight. Ms. G requires belladonna and opium suppositories about every eight hours to treat bladder spasms associated with her urinary catheter.

Anticonvulsant hypersensitivity syndrome associated with Bellamine S, a therapy for menopausal symptoms.

Anticonvulsant hypersensitivity syndrome (AHS) is a rare, potentially fatal, idiosyncratic drug reaction characterized by fever, morbilliform rash, lymphadenopathy, hepatitis, and hematologic abnormalities. Aromatic antiepileptic agents, such as phenytoin, carbamazepine, and phenobarbital are the most frequent causes of this syndrome. We report a case of a previously healthy, postmenopausal woman who developed anticonvulsant hypersensitivity syndrome while taking Bellamine S (belladonna alkaloids; ergotamine; phenobarbital) for hot flashes. Although combinations of belladonna, ergotamine, and phenobarbital have been used for medical treatment of menopausal symptoms since the 1960s, this is the first known case report of its association with anticonvulsant hypersensitivity syndrome. Given the current debate about the risks of hormonal replacement therapy, more women are seeking alternative therapies for menopausal symptoms. Dermatologists need to be aware of this potential serious reaction to this phenobarbital-containing therapy for hot flashes.

[Mydriasis induced by splinter from belladonna bush]. / Mydriase pharmacologique par les alcaloïdes du bois d'atropa belladonna.

AIM: Pupillary dilatation with alcaloids from the Atropa belladonna plant have been used since antiquity. It is less known that the wood of the plant contains an even higher concentration of alkaloids than the ripe fruit. METHODS: Clinical case. RESULTS: A 32-year-old patient presented with a foreign body sensation after a splinter got in his eye while chopping wood of an Atropa belladonna bush in the underbrush. Ophthalmic examination showed a visual acuity of 0.9 s.c. (1.0 with pinhole) and a pupil in a fixed mydriasis without any visible rupture of the sphincter muscle. After a 3-day follow-up the pupil returned to normal size and visual acuity recovered to 1.25 s.c. CONCLUSION: The wood of the Atropa belladonna plant contains a very high concentration of alkaloids. A well-directed history may help to discover this less well-known cause of an accidental mydriasis.

Randomized double-blind placebo-controlled trial of homoeopathic 'proving' for Belladonna C30.

Homoeopathic drug pictures are developed by recording the symptomatic effects of homoeopathic remedies given to healthy volunteers (a 'proving'). In a double-blind randomized controlled trial we tested the hypothesis that individuals using an infinitesimal dilution of Belladonna (thirtieth potency, C30) would record more true symptoms, on a questionnaire that contained both true and false Belladonna proving symptoms, than those receiving placebo. 60 volunteers entered the study and 47 completed data collection. We were unable to distinguish between Belladonna C30 and placebo using our primary outcome measure. For the secondary outcome measure we analysed the number of individuals who proved to the remedy according to our predefined criteria: 4 out of 19 proved in the Belladonna C30 group and 1 out of 27 in the placebo group (difference not statistically significant). This pilot study does not demonstrate a clear proving reaction for Belladonna C30 versus placebo, but indicates how the question might be further investigated.

Prevention of airway obstructions during sleep in infants with breath-holding spells by means of oral belladonna: a prospective double-blind crossover evaluation.

We investigated whether the brief airway obstructions seen during sleep in infants with breath-holding spells were controlled by the autonomic nervous system. We studied 20 infants, with a history of breath-holding spells and a median age of 12 wk (range 4-46 wk). During sleep they had a median of 6 airway obstructions per 10-hr recording (range 3-16 events), with a median duration of 8 sec (range 4-12 sec). No explanation was found for the airway obstructions. In every infant, a double-blind crossover challenge was conducted. It included oral administration of tincture of belladonna, equivalent to 0.01 mg/kg weight of atropine, and placebo syrup containing no belladonna. The belladonna, or the placebo, was administered at bedtime for 7 days, followed by a 7-day washout period. Another 7-day series of syrup administration was then undertaken. A nighttime polygraphic recording was made after each 7-day series. It was the belladonna, and not the placebo, that induced the disappearance of the obstructions in 10 infants; these were called "drug responsive". In 5 children no effect was observed after either the placebo or belladonna; these infants were defined as "drug unresponsive". In 4 subjects the obstructions disappeared after both belladonna and the placebo; the children were considered to have an "inconclusive response". One infant was excluded from the study because he developed an airway infection. It is concluded that in some breath-holding infants, obstructed breathing episodes during sleep disappear after the administration of an atropinic drug. The observation could indicate a role of the autonomic nervous system in the control of the upper airways during sleep in infants.

Psychosis following use of proprietary antidiarrhoeal medicines.

Anticholinergic psychosis was observed to follow ingestion of proprietary antidiarrhoeal preparations by a 63-year-old woman. Possible abuse or accidental overuse of such medicines in the acutely psychotic patient should always be considered.

[Prolonged mydriasis caused by Lamaline]. / Mydriase prolongée à la Lamaline.

Atropine derivatives. The presence of atropine derivatives in numerous combined medicines is often ignored or reflected. A case report of prolonged bilateral non reactive mydriasis with "cycloplegia", linked with the utilisation of a therapeutic dose of Lameline suppositories raises the question of individual susceptibility, with particular ocular sensitivity. This urge one not to ignore the presence of these products and to respect the contraindications, even with minute doses.

Valor actual de vagolitos de uso frecuente a dosis consideradas "habituales" / Current value of commonly used anticholinergic drugs in doses considered as habitual

Se plantea que los medicamentos anticolinérgicos clásicamente han encontrado un lugar importante en el tratamiento médico del síndrome ulceroso gastroduodenal, dado que la hiperfunción vagal causante de hipersecreción gástrica se ha considerado fundamental en la etiología de la úlcera péptica, bien por la acción misma del nervio, como por su participación en otras fases del mecanismo secretorio gástrico. Sin embargo, estos medicamentos, a las dosis consideradas "habituales" no sólo no cumplen el objetivo de la "vagotomía medicamentosa", sino que pueden desencadenar respuestas paradójicas perjudiciales para el paciente. Se deduce que del estudio de este trabajo de 24 pacientes a los que se les determinó clorhidria basal de 1 hora antes y después de la ingestión de medicamentos anticolinérgicos- se habren nuevos caminos de trabajo que permitirán profundizar más en estos problemas (AU)

Physiologic/clinical comparisons of a sustained-release decongestant combination, its components and placebo in patients with allergic rhinitis.

Fifteen subjects with chronic allergic rhinitis had measurements of nasal airways flow/resistance (Rn) made before, and for 12 hours after, single doses of a sustained release decongestant combination, some of its components given alone or together, and placebo, in a randomized double-blind trial. The magnitude of improvement in Rn was statistically greater for the the four active preparations than for placebo over the first 8 hours; the effects of phenylpropanolamine/chlorpheniramine were still present after 10 hours, while at the end of 12 hours only the full triple-drug capsule had significant activity. Patient-estimates of symptomatic improvement generally mirrored these physiologic changes although statistical differences among the active capsules were not delineated. The data confirm the ability of electronic posterior rhinometry to discriminate between the effects of active medications and placebo at the 95 per cent confidence level or better and suggest that observed decreases in elevated Rn mean reflected helpful clinical activity as well as increased nasal patency.