Sardella 2008.
| Methods | Single centre, placebo‐controlled parallel RCT | |
| Participants | 43 BMS patients Mean age 64.9 SD 4.7 years Sex: 35 F:4 M (reported per protocol) (F 90%:M 10%) Inclusion/exclusion and diagnostic criteria appropriate |
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| Interventions |
Intervention category: dietary supplements Group 1: (n = 21) hypericum perforatum extract 300 mg capsules (hypericin 0.31%, hyperforin 3.0%) 3 times a day for 12 weeks Group 2: (n = 22) placebo capsules "identically appearing" 3 times a day for 12 weeks |
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| Outcomes | 10 cm VAS consisting of a horizontal line marked from 0 (no pain) to 10 (the worst pain ever experienced) measured at first visit (t0) and at 3 follow‐up visits (after 4 (t28), 8 (t56), and 12 (t84) weeks) Number of oral mucosa sites with reported burning symptoms measured at first visit (t0) and at 3 follow‐up visits (after 4 (t28), 8 (t56), and 12 (t84) weeks) Non‐standardised assessment of quality of life ‐ self‐reported descriptions in response to "simple questions (i.e. did you feel irritable/depressed/worry? or did oral burning sensations interfere with your daily activities? or have you had difficult in concentrating on things as reading or watching a TV movie?)" |
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| Source of funding | "This study has been supported by a grant of the University of Milan (FIRST, Fondo Interno per la Ricerca Scientifica e Tecnologica, no 12‐1‐5201001‐540). We also thank Body Spring (Ancona, Italy) that kindly supplied both hypericum extract and placebo" | |
| Notes | SES: not reported Conflict of interests: not reported Data analysis: per protocol | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quotation: "random allocation sequence was generated using online software available at http://graphpad.com/quickcalcs/randomise1.cfm" Comment: appropriate |
| Allocation concealment (selection bias) | Low risk | Quotation: "To guarantee allocation concealment, the researchers deciding on patient eligibility did not know the sequence, and a researcher who was not involved in patient enrolment assigned the patients to one of the two arms" Comment: concealed allocation |
| Blinding (performance bias and detection bias) Blinding of participants | Low risk | Quotations: "double‐blind, placebo‐controlled study"; "Patients were randomized to receive indistinguishable 300‐mg capsules of H. perforatum extract (hypericin 0.31%, hyperforin 3.0%; Test Group) or placebo (Control Group)" Comment: probably achieved |
| Blinding (performance bias and detection bias) Blinding of outcome assessors | Low risk | Quotation: "double‐blind, placebo‐controlled study" Comment: patient‐reported outcomes only |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all dropouts and missing data accounted for Proportions similar across groups Reasons similar across groups |
| Selective reporting (reporting bias) | Low risk | Comment: all primary outcomes were presented in the prespecified format |
| Other bias | Low risk | Comment: no other obvious risk of bias |