Rode 1999.
| Methods | Location: Slovenia Number of centres: 1 Dates and duration of recruitment period: not stated |
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| Participants | Inclusion criteria: irradiated for head and neck cancer and salivary glands included in the irradiation field Exclusion criteria: not reported Age: aged 32 to 72, median 62 years Gender (M:F): 60:9 Cancer type: oral cavity (n = 14), oropharynx (n = 33), hypopharynx (n = 8), larynx (n = 11), other (n = 3) (evenly distributed across groups) Radiotherapy: 5 Gy per day, 5 days a week. Irradiated volume reduced twice during irradiation treatment: at 40 Gy for shielding the spinal cord and at 60 Gy for treating the area of original disease, up to 70 Gy. Postoperative patients received 50 Gy ‐ 56 Gy with parallel opposed portals only. 44 patients had postoperative RT and 25 were treated by RT alone Mean irradiation dose (Gy) delivered to area of salivary glands Chemotherapy: not stated Number randomised: 69 (A: 9, B: 30, C: 30) Number evaluated: 69 (A: 9, B: 30, C: 30) |
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| Interventions |
Pilocarpine (postRT) + Biperiden (during RT) versus no intervention Group Aª: pilocarpine during RT and 6 weeks after. Pilocarpine hydrochloride (5 mg) perorally 3 times daily administered 1 hour before irradiation Group B: Biperiden during RT and pilocarpine after RT group. Biperidin chloride (2 mg tablets) 1 and a half hours before irradiation, and pilocarpine hydrochloride (5 mg 3 times daily) for 6 weeks after RT Group C: no intervention |
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| Outcomes | Xerostomia: not reported Salivary flow rates: mean quantity of non‐stimulated saliva secretion (ml/min) Adverse effects: not reported Survival data: not reported Other oral symptoms: mucositis, swallowing WHO criteria Other oral signs: not reported Quality of life: not reported Patient satisfaction: not reported Cost data: not reported Timing of assessment: end of RT, 3 months, 6 months and 12 months after end of RT |
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| Funding | Source of funding: none | |
| Trial registration | Not registered | |
| Sample size calculation presented | No | |
| Notes | ªGroup A data not used: randomisation to Group A was stopped after the first 9 patients for ethical reasons ‐ 3 months after RT total cessation of saliva secretion was observed in all except 1 patient Follow‐up: 12 months |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Information provided by author: "Sequence centrally generated" |
| Allocation concealment (selection bias) | Low risk | Author included the following in an email "randomization with permuted blocs, participants were allocated to the treatment groups randomly. Allocation sequence was generated centrally, treating physician (radiologist) enrolled patient and participants were assigned to the groups by specialist in dental medicine" Comment: centralised random allocation and was probably adequately concealed |
| Blinding (performance bias and detection bias) patients/carers | High risk | No blinding undertaken |
| Blinding (performance bias and detection bias) outcome assessment | Low risk | Salivary flow objective measure |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised patients included in analysis |
| Selective reporting (reporting bias) | High risk | Xerostomia and adverse events not reported |
| Other bias | Low risk | No other sources of bias are apparent |