| Outcomes | No of Participants (studies*) Follow up | Quality of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects | |
|---|---|---|---|---|---|
| Risk with Control | Risk difference with Antiviral drugs (IV acyclovir or oral valganciclovir) versus placebo (95% CI) | ||||
|
Fatigue: Multidimensional fatigue inventory (MFI-20) Scale from: 20 to 100. |
30 (1 study) 9 months |
Original analysis: ⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision |
The mean fatigue: multidimensional fatigue inventory (mfi-20) at 9 months in the control groups was −1.1 |
The mean fatigue: multidimensional fatigue inventory (mfi-20) at 9 months in the intervention group (oral valganciclovir) was 5.05 lower (11.48 lower to 1.38 higher) | |
|
PEM reanalysis: ⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | |||||
|
Fatigue: POMS fatigue Scale from: 0 to 28. |
54 (1 study) 37 days |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | The mean fatigue: poms fatigue at 37 days in the control group was not reported (between-group difference only) |
The mean fatigue: poms fatigue at 37 days in the intervention group (IV acyclovir) was 1.26 higher (1.01 lower to 3.53 higher) | |
|
Fatigue: POMS vigour Scale from: 0 to 32. |
54 (1 study) 37 days |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | The mean fatigue: poms vigour at 37 days in the control group was not reported (between-group difference only) |
The mean fatigue: poms vigour at 37 days in the intervention group (IV acyclovir) was 2.05 lower (4.65 lower to 0.55 higher) | |
|
Psychological status: POMS anxiety Scale from: 0 to 36. |
54 (1 study) 37 days |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | The mean psychological status: poms anxiety at 37 days in the control group was not reported (between-group difference only) |
The mean psychological status: poms anxiety at 37 days in the intervention group (IV acyclovir) was 2.92 higher (0.63 to 5.21 higher) | |
|
Psychological status: POMS depression Scale from: 0 to 60. |
54 (1 study) 37 days |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | The mean psychological status: poms depression at 37 days in the intervention groups was not reported (between-group difference only) |
The mean psychological status: poms depression at 37 days in the intervention group (IV acyclovir) was 3.97 higher (0.69 to 7.25 higher) | |
|
Psychological status: POMS anger Scale from: 0 to 48. |
54 (1 study) 37 days |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | The mean psychological status: poms anger at 37 days in the control group was not reported (between-group difference only) |
The mean psychological status: poms anger at 37 days in the intervention group (IV acyclovir) was 2.3 higher (0.13 lower to 4.73 higher) | |
|
Psychological status: POMS confusion Scale from: 0 to 28. |
54 (1 study) 37 days |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | The mean psychological status: poms confusion at 37 days in the control group was not reported (between-group difference only) |
The mean psychological status: poms confusion at 37 days in the intervention group (IV acyclovir) was 1.83 higher (0.57 to 3.09 higher) | |
| Adverse events: treatment-related adverse events |
30 (1 study) 9 months |
Original analysis: ⊕⊝⊝⊝ due to risk of bias, indirectness | RD 0.00 (−0.14 to 0.14) | 0 per 1000 |
0 more per 1000 (from 140 fewer to 140 more) (with oral valganciclovir) |
|
PEM reanalysis: ⊕⊝⊝⊝ due to risk of bias, indirectness | |||||
| Adverse events: reversible renal failure |
54 (1 study) 37 days |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | Peto OR 7.99 (0.8 to 80.28) | 0 per 1000 |
11 more per 1000 (from 20 fewer to 240 more) (with IV acyclovir) |
| Activity levels: rest (hours/day) |
54 (1 study) 37 days |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | The mean activity levels: rest (hours/day) at 37 days in the control group was not reported (between-group difference only) |
The mean activity levels: rest (hours/day) at 37 days in the intervention group (IV acyclovir) was 0.05 lower (0.83 lower to 0.73 higher) | |
|
Symptom scales: Wellness score Scale from: not reported. |
54 (1 study) 37 days |
⊕⊝⊝⊝ due to risk of bias, indirectness, imprecision | The mean symptom scales: wellness score at 37 days in the control group was not reported (between-group difference only) |
The mean symptom scales: wellness score at 37 days in the intervention group (IV acyclovir) was 1.08 lower (7.28 lower to 5.12 higher) | |
Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
The majority of the evidence included an indirect population (downgraded by one increment) or a very indirect population (downgraded by two increments): 1) downgraded if the ME/CFS diagnostic criteria used did not include PEM as a compulsory feature [original analysis]; percentage of participants with PEM unclear [PEM reanalysis – see Appendix G for additional details]. 2) Montoya 2013 was additionally downgraded due to population having suspected viral onset and elevated antibody tiers.
Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs
The majority of the evidence included an indirect population (downgraded by one increment) or a very indirect population (downgraded by two increments): 1) downgraded if the ME/CFS diagnostic criteria used did not include PEM as a compulsory feature; 2) additionally downgraded due to population having suspected viral onset and elevated antibody tiers (Montoya 2013) [original analysis]
The majority of the evidence included an indirect population (downgraded by one increment): requirement for suspected viral onset and elevated viral antibody tiers (Montoya 2013). [PEM reanalysis]
Studies included: Montoya 2013 (oral valganciclovir); Strauss 1988 (IV acyclovir)
From: Pharmacological interventions
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