Lindelof 1989.
Methods | This was a randomised, double‐blind, internally‐controlled study. There was cross‐over to active treatment for the placebo‐treated group after 10 weeks. It was unclear if intention‐to‐treat analysis was conducted. |
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Participants |
Inclusion criteria of the trial
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Interventions |
The grenz ray machine factors were 10 kV, 10 mA, half‐value layer 0.02 mm Al, half‐value depth in tissue 0.5 mm, focus skin distance 10 cm. Active treatment was given to the former placebo‐treated hands after 10 weeks. The participants were then followed for 6 months. |
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Outcomes |
Outcomes of the trial
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Notes | The participant had been untreated for at least 6 months before the start of the study. 5 participants showed slight pigmentation of the grenz ray treated nail fold. No other local or systematic adverse reactions were noted. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: '...double blind trial, participants were randomly allocated." Comment: This was probably done. |
Allocation concealment (selection bias) | Unclear risk | Comment: No information about randomisation of the hands was available. |
Blinding (performance bias and detection bias) Clinician/ Investigator | Low risk | Quote: "...double blind trial, neither the participant nor the evaluating doctor knew which side had received active grenz ray therapy." |
Blinding (performance bias and detection bias) Participants | Low risk | Quote: "...double blind study, neither the participant nor the evaluating doctor knew which side had received active grenz ray therapy." Comment: Placebo was administered by allowing the apparatus to hum without irradiation. |
Blinding (performance bias and detection bias) Outcome assessor | Low risk | Quote: "...double blind study, neither the participant nor the evaluating doctor knew which side had received active grenz ray therapy." Comment: The blinded doctor was the outcome assessor. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 participants failed to participate throughout the study, because of illness in their families |
Selective reporting (reporting bias) | High risk | The nail signs were not separately discussed in the results. |
Other bias | Unclear risk | There was no information about the baseline characteristics. |