Oral pilocarpine for radiation-induced xerostomia: Integrated efficacy and safety results from two prospective randomized clinical trials

Rieke, J.; Hafermann, Mark D.; Johnson, Jonas T.; LeVeque, Francis G.; Iwamoto, Ryan R.; Steiger, Barry W.; Muscoplat, Charles C; Gallagher, Susan C.

doi:10.1016/0360-3016(94)00361-n

Cited by 134 publications

(83 citation statements)

References 19 publications

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“…Measurement of UWS is the most reliable method for quantifying the salivary function (38), and the mean UWS (0.162 Ϯ 0.107 ml/min) of our patients was significantly lower than the normal reference value of 0.25 to 0.5 ml/min (35). We also found that hyperdipsic patients had extremely low baseline UWS (0.09 ml/min in the pilot study [ Figure 3]; 0.11 and 0.09 ml/min in each group, respectively, in the interventional trial [ Tables 4 and 6]), which was comparable with that of patients who received radiotherapy for head and neck tumors (0.113 ml/min) (39). Such low flow rates indicate massive salivary gland damage (approximate 75% of total salivary glandular tissue) (40).…”

Section: Discussionsupporting

confidence: 65%

Decreased Salivary Flow Rate as a Dipsogenic Factor in Hemodialysis Patients

Sung¹,

Kuo²,

Guo

et al. 2005

Journal of the American Society of Nephrology

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Decreased salivary flow rate causes xerostomia (symptoms of oral dryness) in patients who undergo hemodialysis (HD); however, whether it thus contributes to thirst and excess interdialytic weight gain (IDWG) remains undetermined. In the observational study, 3 mo of data of 90 stable HD patients were collected, and sensations of thirst and xerostomia were assessed by 100-mm visual analog scales (VAS). Multivariate analyses revealed that the VAS oral dryness score was an independent determinant for thirst, daily IDWG, and IDWG%. Unstimulated whole salivary flow rate (UWS) was measured in 45 participants and was negatively correlated with VAS oral dryness score (r ‫؍‬ ؊0.690, P < 0.001), daily IDWG (r ‫؍‬ ؊0.361, P ‫؍‬ 0.016), and daily IDWG% (r ‫؍‬ ؊0.302, P ‫؍‬ 0.045). In the interventional trial, the test drug was 5 mg of oral pilocarpine solution or placebo. Three types of interventions for reducing thirst (the urge to drink) and interdialytic weight gain (IDWG) are identified in the literature: dialysis protocol related (increasing frequency and varying sodium concentration) (6 -9), pharmaceutical (angiotensin-converting enzyme inhibitors [ACEI]) (10 -13), and dietetic interventions (10,14). However, no definite effectiveness could be shown (5), which might be explained by the fact that many of the underlying mechanisms for thirst and drinking behavior remain unknown.Known dipsogenic factors (factors that cause thirst and high fluid intake) in HD patients include high sodium intake, potassium depletion, increased blood urea, sugar and angiotensin II (Ang II) levels, and psychologic factors (2,3,5,10 -16). Another potential dipsogenic factor is the reduction of salivary flow rate. Recently, Brunstrom et al. (17) demonstrated that healthy volunteers consume more water and drink more frequently in the xerostomic state, which is induced by decreasing saliva in the oral cavity. Because xerostomia (symptoms of oral dryness), which is caused by the reduction of salivary flow, is prevalent among HD patients (18 -23), it is conceivable that the decreased salivary flow leads to thirst and excess IDWG. Some observational studies (24,25) have described an association between xerostomia and IDWG in HD patients; however, other known dipsogenic factors (e.g., blood urea, Ang II, sugar level) were not controlled in those studies. In addition, no interventional trial in the literature indexed by Medline has demonstrated the impact of the decreased salivary flow on IDWG. Therefore, whether the decreased salivary flow influences fluid intake in HD patients remains undetermined.We conducted a 3-mo prospective observational study followed by a trial of pilocarpine-a parasympathomimetic agent that has been shown effectively to increase salivary flow in radiation-induced xerostomia or Sjö gren syndrome (26 -29)-to determine whether the reduction of salivary flow contributes to exaggerated thirst and excess IDWG in HD patients and whether pilocarpine can alleviate it.

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Section: Discussionsupporting

confidence: 65%

Decreased Salivary Flow Rate as a Dipsogenic Factor in Hemodialysis Patients

Sung¹,

Kuo²,

Guo

et al. 2005

Journal of the American Society of Nephrology

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“…Essa xerostomia pode ser irreversí-vel, com tendência de recuperação de até 50% da quantia inicial de saliva, caso o volume da parótida irradiado e a dose final de irradiação fique em valores os mais baixos possíveis (8)(9)(10)(11)(12) . Várias técnicas são descritas na literatura para prevenção da xerostomia e da mucosite oral, como o uso de amifostina, pilocarpina, Biotene ® , bochechos com bicarbonato de sódio, uso de antibióticos e anestésicos tópicos, entre outros, todas com suas limitações (13)(14)(15)(16)(17)(18)(19) . Lasers de baixa potência (LBP) são lasers que possuem baixa energia, sem potencial fototérmico, sendo utilizados para biomodulação.…”

Section: Introductionunclassified

Prevenção da xerostomia e da mucosite oral induzidas por radioterapia com uso do laser de baixa potência

Lopes¹,

Mas

Zângaro

2006

Radiol Bras

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OBJETIVO: Verificar se o uso do laser de InGaAlP com comprimento de onda de 685 nm pode reduzir a incidência de xerostomia, gravidade da mucosite oral e da dor associada à mucosite em pacientes portadores de câncer de cabeça e pescoço submetidos a radioterapia. MATERIAIS E MÉTODOS: Sessenta pacientes portadores de carcinoma de cabeça e pescoço foram submetidos a radioterapia com dose diária de 1,8 a 2,0 Gy e dose final de 45 a 72 Gy. O volume salivar foi medido nos dias um, 15, ao final do tratamento e após 15 e 30 dias, e a mucosite oral em avaliações semanais. Vinte e nove pacientes se submeteram a radioterapia sem laser e 31 foram submetidos a radioterapia e laser com dose diária de 2 joules/cm² em pontos pré-determinados da mucosa oral e glândulas parótida e submandibular. RESULTADOS: No grupo submetido a radioterapia e laser, a incidência de mucosite (F < 0,001) e dor (F < 0,016) foram significativamente menores e o volume salivar se manteve maior (F < 0,001) durante e após o tratamento. CON-CLUSÃO: Os pacientes submetidos à associação de radioterapia e laser tiveram menor incidência de xerostomia, mucosite oral e dor quando comparados ao grupo de radioterapia sem laser, com resultados com significância estatística. Unitermos: Laser de baixa potência; Xerostomia; Mucosite; Radioterapia; Quimioterapia.Low level laser therapy in the prevention of radiotherapy-induced xerostomia and oral mucositis. OBJECTIVE: To verify if the use of InGaAIP laser with 685 nm wave length can reduce the xerostomy incidence, the oral mucositis severity and the pain related to mucositis in patients with head and neck cancer submitted to radiotherapy. MATERIALS AND METHODS: Sixty patients presenting head and neck carcinoma were submitted to radiotherapy with daily doses of 1.8 to 2.0 Gy and a final dose of 45 to 72 Gy. The salivary volume was evaluated in the first and fifteenth days, at the end of the treatment and after 15 and 30 days. The oral mucositis was evaluated on a weekly basis. Twenty-nine patients were submitted to radiotherapy without laser and 31 were submitted to radiotherapy and laser with daily doses of 2 joules/ cm² in predetermined areas of the oral mucosa and the parotid and submandibular glands. RESULTS: In the group submitted to radiotherapy and laser the incidence of mucositis (F < 0.001) and pain (F < 0.016) was significantly lower and the salivary volume (F < 0.001) was kept higher during and after the treatment. CONCLUSION: The group of patients submitted to radiotherapy and laser had lower incidence of xerostomy, oral mucositis and pain when compared to the group treated with radioteraphy without laser, producing statistically significant results. Keywords: Low level laser; Xerostomy; Mucositis; Radiotherapy; Chemotherapy.Resumo Abstract * Trabalho realizado no Instituto de Radioterapia do Vale do Paraíba, São José dos Campos, SP.

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“…Também é usada no tratamento de certos tipos de glaucoma. A pilocarpina é também um poderoso estimulante da salivação e da transpiração (Merck 1989); em 1994 foi aprovada pela Food and Drug Administration (FDA) norte-americana para o tratamento de xerostomia de pós-irradiação (boca seca) em pacientes com câncer de cabeça e de pescoço (Valdez et al 1993;Joensuu et al 1993;Rieke et al 1995;Wynn 1996).…”

Section: Introductionunclassified

Extrativismo, cultivo e privatização do jaborandi (Pilocarpus microphyllus Stapf ex Holm.; Rutaceae) no Maranhão, Brasil

Pinheiro

2002

Acta Bot. Bras.

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RESUMO -(Extrativismo, cultivo e privatização do jaborandi (Pilocarpus microphyllus Stapf ex Holm.; Rutaceae) no Maranhão, Brasil). Um dos processos associados com a expansão de fronteiras em países em desenvolvimento consiste na privatização de recursos naturais, anteriormente de uso comum por populações tradicionais. Em geral, a privatização não só conduz à degradação dos recursos como também ao empobrecimento de comunidades locais dependentes desses recursos. Um exemplo desta transformação está no Estado do Maranhão, especialmente em uma região conhecida como "Pré-Amazônia", onde o jaborandi (Pilocarpus microphyllus Stapf ex Holm.; Rutaceae), um recurso natural que beneficiava milhares de pessoas da zona rural, foi gradativamente privatizado. A expansão do mercado de pilocarpina (um alcalóide de extenso uso em oftalmologia) nos últimos 30 anos, provocou crescimento descontrolado no extrativismo de folhas de jaborandi, conduzindo ao esgotamento e à ameaça de extinção das populações naturais deste recurso vegetal. Paralelamente, esta pressão sobre as populações naturais acelerou o processo de domesticação desta espécie e a sua privatização pela indústria farmacêutica. Este estudo teve como objetivo principal avaliar a exploração e cultivo do jaborandi no Maranhão, buscando o esclarecimento sobre os benefícios e malefícios econômicos, sociais e ambientais decorrentes da sua exploração. Os resultados obtidos mostram que, historicamente, não houve nenhum benefício significativo compartilhado entre a indústria farmacêu-tica e as populações envolvidas no extrativismo do jaborandi no Maranhão. Palavras-chave -Pilocarpus microphyllus, Extrativismo, Cultivo, Privatização, MaranhãoABSTRACT -Extractivism, cultivation and privatization of jaborandi (Pilocarpus microphyllus Stapf ex Holm.; Rutaceae) in Maranhão, Brazil). A process associated with frontier expansion in developing countries is the privatization of natural resources formerly held in common by traditional populations. An example of this transformation comes from Maranhão State, in a region of mid-northern Brazil known as "Pre-Amazônia" (PreAmazon), where jaborandi (Pilocarpus microphyllus Stapf ex Holm.; Rutaceae), a plant resource that used to benefit thousands of rural poor, is being increasingly privatized. This process began with the expansion of the pilocarpine market in the world, provoking uncontrolled growth in extraction of native plants and resource depletion. This paper reports the latest developments regarding the exploitation of P. microphyllus in Maranhão, describing the current system of production, from leaf collection to industrialization. It also discusses social, economic and environmental benefits/damages to the people who exploited jaborandi and to the natural populations of this plant species. The results showed that, historically, there were no significant benefits shared between the pharmaceutical industry and people in the past.

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Oral pilocarpine for radiation-induced xerostomia: Integrated efficacy and safety results from two prospective randomized clinical trials

Cited by 134 publications

References 19 publications

Decreased Salivary Flow Rate as a Dipsogenic Factor in Hemodialysis Patients

Decreased Salivary Flow Rate as a Dipsogenic Factor in Hemodialysis Patients

Prevenção da xerostomia e da mucosite oral induzidas por radioterapia com uso do laser de baixa potência

Extrativismo, cultivo e privatização do jaborandi (Pilocarpus microphyllus Stapf ex Holm.; Rutaceae) no Maranhão, Brasil

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