Table 2 Summary of results

1. Oral systemic medications

1.1 Oral Wobe-Mugos versus no medication

Dale, 2001; Gujral, 2001 N = 219

Prevention

Primary

Development of RISR (Yes/No) (Dale, 2001 & Gujral, 2001)

Meta-analysis:

OR 0.13, 95% CI 0.05 to 0.38, p < 0.0005

(Favouring Oral Wobe-Mugos)

Treatment

Secondary

Maximum Levels of RISR (RTOG/EORTC criteria, with a possible range of 0–4) (Dale, 2001 & Gujral, 2001)

Meta-analysis:

MD -0.92, 95% CI -1.36 to -0.48, p < 0.0001

(Favouring Oral Wobe-Mugos)

1.2 Oral Pentoxifylline versus no medication

Aygenc, 2004

Prevention

Primary

N = 78

Development of RISR (Yes/No)

OR 0.18, 95% CI 0.01 to 3.95, p = 0.28

Treatment

Secondary:

Adverse Effects (Yes/No)

OR 17.24, 95% CI 0.95 to 313.28, p = 0.05

1.3 Oral Antioxidant versus placebo

Bairati, 2005

Treatment

Secondary:

MD -0.06, 95% CI -0.15 to 0.03, p = 0.17

N = 545

RISR at the end of radiation treatment (RTOG criteria, with a possible range of 0–4)

RISR at four weeks after the end of radiation treatment (RTOG criteria, with a possible range of 0–4)

MD 0.00, 95% CI -0.08 to 0.08, p = 1.00

Global quality of life at the end of radiation treatment (QoLC30, with a possible range of 0–100)

MD 0.00, 95% CI -3.95 to 3.95, p = 1.00

Global quality of life at four weeks after the end of radiation treatment (QoLC30, with a possible range of 0–100)

MD -2.00, 95% CI -5.29 to 1.29, p = 0.23

Skin-related quality of life at the end of radiation treatment (HNC-QoL, with a possible range of 0–7 with 7 representing better quality of life)

MD 0.10, 95% CI -0.16 to 0.36. p = 0.46

Skin-related quality of life at weeks after the end of radiation treatment (HNC-QoL, with a possible range of 0–7 with 7 representing better quality of life)

MD 0.00, 95% CI -0.12 to 0.12, p = 1.00

1.4 Oral sucralfate suspension versus placebo

Lievens, 1998

Treatment

Secondary:

N = 83

Maximum levels of RISR (Scoring system developed by authors, with a possible range of 0–6)

MD 0.20, 95% CI -0.34 to 0.74, p = 0.47

Adverse effect (measured as mean peak nausea, scoring system developed by authors, 0 = none, 4 = vomiting resistant to medication)

MD -0.22, 95% CI -0.61 to 0.17, p = 0.27

1.5 Oral zinc supplementation versus placebo

Lin, 2006

Treatment

Secondary:

N = 97

RISR at the completion of radiation treatment (RTOG criteria, with a possible range of 0–4)

MD -0.50, 95% CI -0.58 to -0.42, p < 0.00001

(Favouring oral zinc supplementation)

2. Skincare practices (washing practices and deodorant use)

2.1 Washing with soap versus no washing

Campbell, 1992; Roy, 2001

Prevention

Primary:

Development of RISR (Yes/No) (Roy, 2001)

OR 0.32, 95% CI 0.01 to 8.05, p = 0.49

N = 167

Treatment

Secondary:

Itch at the end of treatment (week six) and the two-week follow-up (week eight) (EORTC/RTOG criteria, with a possible score of 0–3) (Campbell, 1992)

Week 6- MD -0.43, 95% CI -0.97 to 0.11, p = 0.12,Week 8- MD-0.40, 95% CI -0.81 to 0.01, p = 0.06 (Favouring washing with soap)

Erythema at the end of treatment (week six) and the two-week follow-up (week eight) (EORTC/RTOG criteria, with a possible score of 0–3) (Campbell, 1992)

Week 6- MD-0.40 95% CI -0.77 to -0.03, p = 0.03, Week 8-MD -0.21, 95% CI -0.52 to 0.10, p = 0.18

Desquamation at the end of treatment (week six) and the two-week follow-up (week eight) (EORTC/RTOG criteria, with a possible score of 0–3) (Campbell, 1992)

Week 6- MD -0.47, 95% CI -0.83 to -0.11, p = 0.01, Week 8- MD -0.82, 95% CI -1.16 to -0.48, p < 0.00001 (Favouring washing with soap)

2.2 Washing with water versus no washing

Campbell, 1992

Treatment

Secondary:

N = 58

Itch at the end of treatment (week six) and the two-week follow-up (week eight) (EORTC/RTOG criteria, with a possible score of 0–3)

Week 6- MD -0.27, 95% CI -0.83 to 0.29, p = 0.35, Week 8- MD -0.46, 95% CI -0.83 to -0.09, p = 0.01 (Favouring washing with water)

Erythema at the end of treatment (week six) and the two-week follow-up (week eight) (EORTC/RTOG criteria, with a possible score of 0–3)

Week 6- MD -0.34, 95% CI -0.69 to 0.01, p = 0.06, Week 8- MD -0.44, 95% CI -0.72 to -0.16, p = 0.002 (Favouring washing with water)

Desquamation at the end of treatment (week six) and the two-week follow-up (week eight) (EORTC/RTOG criteria, with a possible score of 0–3)

Week 6- MD -0.59, 95% CI -0.94 to -0.24, p = 0.001, Week 8- MD -0.62, 95% CI -0.96 to -0.28, p = 0.0004 (Favouring washing with water)

2.3 Washing with water versus washing with soap

Campbell, 1992

Treatment

Secondary:

N = 64

Itch at the end of treatment (week six) and the two-week follow-up (week eight) (EORTC/RTOG criteria, with a possible score of 0–3)

Week 6- MD 0.16, 95% CI -0.35 to 0.67, p = 0.54, Week 8- MD -0.06, 95% CI -0.39 to 0.27, p = 0.72

Erythema at the end of treatment (week six) and the two-week follow-up (week eight) (EORTC/RTOG criteria, with a possible score of 0–3)

Week 6- MD 0.06, 95% CI -0.26 to 0.38, p = 0.71, Week 8- MD -0.44, 95% CI -0.72 to -0.16, p = 0.001 (Favouring washing with water)

Desquamation at the end of treatment (week six) and the two-week follow-up (week eight) (EORTC/RTOG criteria, with a possible score of 0–3)

Week 6- MD -0.12, 95% CI -0.51 to 0.27, p = 0.54, Week 8- MD 0.20, 95% CI -0.16 to 0.56, p = 0.27

2.4 Deodorant versus no deodorant

Bennett, 2009; Gee, 2000; Theberge, 2009; Watson, 2012

Prevention

Primary:

Development of RISR (Yes/No) (Bennett, 2009 & Gee, 2000)

Meta-analysis:

OR 0.80, 95% CI 0.47 to 1.37, p = 0.42

Development of RISR in patients with axilla treated (Yes/No) (Bennett, 2009)

OR 0.06, 95% CI 0.01 to 0.60, p = 0.02

N = 509

Treatment

Secondary:

RISR at the end of radiation treatment and at the two-week follow-up (CTCAE criteria version 3, with a possible range of 0–3) (Watson, 2012)

End of treatment- MD 0.01, 95% CI -0.17 to 0.19, p = 0.91, Two-week follow-up- MD 0.01, 95% CI -0.21 to 0.23, p = 0.93

Maximum RISR rated by researcher (RTOG criteria, with a possible range of 0–3) (Bennett, 2009)

MD = -0.74, 95% CI -1.22 to -0.26, p = 0.003

(Favouring deodorant)

Moderate-to-severe pain at the end of radiation treatment and at the two-week follow-up (Yes/No) (Theberge, 2009)

End of treatment- OR 0.77, 95% CI 0.29 to 2.09, p = 0.61, Two-week follow-up- OR 2.16, 9% CI 0.65 to 7.14, p = 0.21

Pruritus at the end of radiation treatment and at the two-week follow-up (Yes/No) (Theberge, 2009)

End of treatment- OR 2.62, 95% CI 1.01 to 6.78, p = 0.05, Two-week follow-up- OR 1.47, 95% CI 0.57 to 3.77, p = 0.42

Sweating at the end of radiation treatment and at the two-week follow-up (Yes/No) (Theberge, 2009)

End of treatment- OR 0.34, 95% CI 0.12 to 0.93, p = 0.04, Two-week follow up- OR 0.70, 95% CI 0.25 to 1.99, p = 0.51

3. Steroidal topical ointment/cream

3.1 Topical 0.1% mometasone furoate cream versus placebo

Miller, 2011

Prevention

Primary:

N = 166

Development of RISR (Yes/ No)

OR 0.60, 95% CI 0.28 to 1.31, p = 0.20

Treatment

Secondary:

RISR at the two-week follow-up after the completion of radiation treatment (CTCAE criteria version 3.0, with a possible range of 0–3)

MD -0.39, 95% CI -0.80 to 0.02, p = 0.06

Maximum RISR level (CTCAE criteria version 3.0, with a possible range of 0–3)

MD -0.10, 95% CI -0.35 to 0.15, p = 0.43

3.2 Topical betamethasone cream versus placebo

Omidvari, 2007

Prevention

Primary:

N = 36

Development of RISR (Yes/No)

There was an equal proportion of people developing a RISR (summary statistics not estimated)

Treatment

Secondary:

RISR at the end of treatment (week five) and the two-week follow-up (week seven) (RTOG criteria, with a possible range of 0–4)

End of treatment- MD -0.10, 95% CI -0.28 to 0.08, p = 0.28, two-week follow-up- MD -0.55, 95% CI -0.71 to -0.39, p < 0.00001 (Favouring topical betamethasone cream)

Maximum level of RISR (RTOG criteria, with a possible range of 0–4)

MD -1.62, 95% CI -2.03 to -1.21, p < 0.00001 (Favouring topical betamethasone cream)

3.3 Topical betamethasone versus no topical treatment

Omidvari, 2007

Prevention

Primary:

N = 36

Development of RISR (Yes/ No)

There was an equal proportion of people developing a RISR (summary statistics not estimated)

Treatment

Secondary:

RISR at the end of treatment (week five) and two weeks after treatment (week seven) (RTOG criteria, with a possible range of 0–4)

End of treatment- MD -0.40, 95% CI -0.62 to -0.15, p = 0.002, two-week follow-up- MD -0.30, 95% CI -0.53 to -0.07, p = 0.01

(Favouring topical betamethasone cream)

Maximum level of RISR (RTOG criteria, with a possible range of 0–4)

MD -0.27, 95% CI -0.75 to 0.21, p = 0.27

3.4 Topical corticosteroid versus another topical corticosteroid

Glees, 1979

Prevention

Primary:

N = 53

Development of RISR (Yes/ No)

OR 3.35, 95% CI 0.13 to 86.03, p = 0.46

3.5 Topical corticosteroid plus antibiotics versus corticosteroid alone

Halnan, 1962

Prevention

Primary:

N = 20

Development of RISR (Yes/ No)

There was an equal proportion of people developing a RISR (summary statistics not estimated)

3.6 Topical corticosteroid plus antibiotics versus no treatment

Halnan, 1962

Prevention

Primary:

N = 20

Development of RISR (Yes/ No)

OR 0.07, 95% CI 0.01 to 0.84, p = 0.04

(Favouring topical corticosteroid plus antibiotics)

3.7 Topical corticosteroid versus dexpanthenol

Schmuth, 2002

Treatment

Secondary:

N = 21

Levels of RISR at the end of radiation treatment (week six) (The clinical symptom score with a possible range of 0–3)

MD -0.10, 95% CI -0.57 to 0.37, p = 0.68

Levels of RISR at the two-week follow-up after the end of radiation treatment (week eight) (The clinical symptom score with a possible range of 0–3)

MD -1.40, 95% CI -1.97 to -0.83, p < 0.00001

(Favouring topical corticosteroid)

4. Dressings

4.1 Hydrogel dressing versus Gentian violet dressing

Gollins, 2008

Treatment

Secondary:

N = 20

Time to heal (days)

HR 7.95, 95% CI 2.20-28.68, p = 0.002

(Favouring hydrogel dressing)

Adverse events (measured as stinging, yes or no)

OR 3.89, 95% CI 0.62 to 24.52, p = 0.15

4.2 Gentian violet dressing versus non-adherent dressing

Mak, 2005

Treatment

Secondary:

N = 39

Time to heal (days)

HR 0.73, 95% CI 0.52-1.03, p = 0.07

Pain at week two after the application of dressing (Scoring system developed by authors, with a possible range of 0–5)

MD -0.29, 95% CI = -0.66 to 0.08, p = 0.13

4.3 Silver nylon dressing versus standard care

Niazi, 2012

RISR severity at the end of radiation treatment (CTCAE criteria version 4, with a possible range of 0–4)

MD = -0.86, 95% CI -1.59 to -0.13, p = 0.02

N = 40

(Favouring silver nylon dressing)

4.4 MVP dressings versus Lanolin dressing

Shell, 1986

Shell 1986 compared moisture vapour permeable (MVP dressing) compared with lanolin dressings. We were unable to extract data from the study. Insufficient information was provided in relation to the time to healing outcome as well as the RISR scores (no SD provided). The trial authors reported “the trend to faster healing in the MVP group was not statistically significant”.

N = 16

4.5 Mepilex lite dressing versus aqueous cream

Paterson, 2012

Paterson 2012 compared Mepilex lite dressing with aqueous cream alone. We were unable to extract data from the study. However, the trial authors reported that ”Mepilex Lite dressings did not significantly reduce the incidence of moist desquamation, but did reduce the overall severity of skin reactions by 41% (p < 0.001), and the average moist desquamation score by 49% (p = 0.043).“ The trial authors were contacted for further information. However, no replies were received at the time of publishing this review.

N = 74

5. Non-steroidal ointment/cream

5.1 Hyaluronic acid versus placebo cream

Kirova, 2011; Leonardi, 2008; Liguori, 1997; Primavera, 2006

Prevention

Primary:

Development of RISR (Yes/No) (Leonardi, 2008)

OR 0.39, 95% CI 0.01 to 10.10, p = 0.57

Treatment

Secondary:

Severe pain (>2) at week one, week two and week three of radiation treatment (as defined as >2 on a visual analogue scale, Yes/No) (Kirova 2011)

Week One- OR 1.25, 95% CI 0.67 to 2.32, p = 0.49, Week Two- OR 1.79, 95% CI 0.97 to 3.27, p = 0.06, Week Three- OR 1.30, 95% CI 0.66 to 2.59, p = 0.45

N = 384

Quality of life at week four of radiation treatment (EORTC CLC Q30) (Kirova 2011)

MD -0.10, 95% CI -6.75 to 6.55, p = 0.98

RISR severity at the end of radiation treatment (Scoring system developed by authors, with a possible range of 0–6) (Liguori 1997)

MD -0.73, 95% CI -1.04 to -0.42, p < 0.00001

(Favouring hyaluronic acid)

RISR severity at four weeks after radiation treatment completion (Scoring system developed by authors, with a possible range of 0–6) (Liguori 1997)

MD -0.35, 95% CI -0.68 to -0.02, p = 0.04

(Favouring hyaluronic acid)

Maximum RISR over the duration of radiation treatment (CTCAE, with a possible range of 0–4) (Leonardi, 2008)

MD-0.95, 95% CI -1.23 to -0.67, p < 0.00001

(Favouring hyaluronic acid)

Pain, itching and burning at four weeks of radiation treatment (0–10 cm visual analogue scale, with a possible range of 0–10) (Leonardi, 2008)

Pain- MD -0.50, 95% CI -1.72 to 0.72, p = 0.42, Itching- MD -0.18, 95% CI -1.39 to 1.03, p = 0.77, Burning- MD -0.91, 95% CI -2.01 to 0.19, p = 0.10

Adverse effects (yes/no) (Leonardi, 2008)

OR 0.17, 95% CI 0.02 to 1.65, p = 0.13

5.2 Aloe vera versus aqueous cream

Heggie, 2002

Heggie 2002 reported that “aqueous cream was significantly better than aloe vera in reducing dry desquamation and pain related to treatment”. However, this study did not contain data or summary statistics concerning the outcomes as defined by this review.

N = 225

5.3 Aloe vera gel and soap versus soap alone

Olsen, 2001

Olsen 2001reported that “when the cumulative of radiation dose was high (>2700 cGy), the median time was give weeks prior to any skin changes in the aloe/soap arm versus three weeks in the soap only arm. When cumulative dose increases over time, there seems to be a protective effect of adding aloe to the soap regimen.” However, this study did not contain data or summary statistics concerning the outcomes as defined by this review.

N = 73

5.4 Aloe vera gel versus placebo

Williams, 1996

Williams 1996 reported that “skin dermatitis scores were virtually identical on both treatment arms, and that, aloe vera gel does not protect against radiation treatment-induced dermatitis”. However, this study did not contain data or summary statistics concerning the outcomes as defined by this review.

N = 194

5.5 Aloe vera gel versus an Anionic Phospholipid-Based (APP) cream

Merchant, 2007

Merchant 2007 (n = 194) reported that statistically significant differences were found favouring the APP cream over the aloe vera gel in a number of outcomes including skin comfort, RISR skin severity. However, this study did not contain data or summary statistics concerning the outcomes as defined by this review.

N = 194

5.6 Trolamine versus usual care as per institutional preference

Elliott, 2006; Fisher, 2000

Prevention

Primary:

Development of RISR (yes/no) (Elliot 2006)

OR 0.40, 95% CI 0.08 to 2.11, p = 0.28

N = 462

Treatment

Secondary:

Maximum levels of RISR (NCI CTC criteria and RTOG criteria, with a possible range of 0–4) (Eilott, 2006 & Fisher,2000)

Meta-analysis:

MD 0.00, 95% CI -0.13 to 0.13, p = 0.97

5.7 Trolamine versus Placebo

Gosselin, 2010

Patient satisfaction (Scoring system developed by authors, with a possible range of 0–5, 5-best satisfaction)

MD 1.12, 95% CI 0.56 to 1.68, p < 0.00001 (Favouring trolamine)

N = 102

Ease of use (Scoring system developed by authors, with a possible range of 0–5, 5-highest level of ease)

MD 0.44, 95% CI 0.01 to 0.87, p = 0.04

(Favouring trolamine)

5.8 Trolamine versus Calendula

Pommier, 2004

Treatment

Secondary:

OR 7.68, 95% CI 3.07 to 19.17, p < 0.0001

N = 254

Ease of use (measured as difficult to use- yes or no)

(Favouring trolamine)

Allergic reaction (yes/no)

OR 0.11, 95% CI 0.01 to 2.05, p = 0.14

5.9 Trolamine versus ETA Gel (99% Avene Thermal Spring Water)

Ribet, 2008

Treatment

Secondary:

N = 54

RISR severity at the end of radiation treatment (NCI CTC criteria, with a possible range of 0–4)

MD -0.14, 95% CI -0.58 to 0.30, p = 0.53

5.10 Trolamine versus topical Qingdiyou medication

Zhang, 2011

Zhang 2011 compared trolamine and topical qingdiyou medication. We could not extract data from this study. The trial authors reported that patients who received qingdiyou medication had significantly less severe RISR (p < 0.05). The trial authors did not provide a time point as to when the assessments were undertaken. We attempted contacted authors for further information. However, no further information was available.

N = 72

5.11 Sorbolene versus wheatgrass extract cream

Wheat, 2006; Wheat, 2007

Wheat 2006 (n = 30) and Wheat 2007 (n = 20) compared Sorbolene and wheatgrass extract cream. We could not extract data from these two studies. The trial authors did not provide SE, SD or 95% CI for the mean scores reported. The trial authors were contacted for further information. However, no replies were received at the time of publishing this review. Both studies reported that there were no statistically significant differences between the two arms with respect to the peak RISR severity or time to peak RISR rating. The trial authors reported a statistically significant improvement in quality of life of patients in the wheatgrass group at week five and week six of radiation treatment.

N = 50

5.12 Sucralfate mixed with Sobolene (10% w/w (50 g of sucralfate crushed in 500 g of sorbolene) versus Sorbolene cream

Delaney, 1997

The trial authors of Delaney 1997 reported that mean time to healing for the sucralfate and control groups, respectively were 14.8 days (coefficient of variation (c.v. = 70%) and 14.2 days (c.v. = 75%). The ratio of mean times to healing was 1.043 and was not statistically different from 1. (p = 0.86, 95% CI 0.65, 1.67). Estimates of the SD could not be calculated as it was unsure whether the c.v. data presented by the authors was based on the log transformed time-to-heal data or the untransformed data. The trial authors reported that “there was no statistically significant difference was found between the two arms in either from randomisation to healing or improvement in pain score”. We could not extract data from this study. The trial authors were contacted for further information. However, no replies were received at the time of publishing this review.

N = 39

5.13 Sucralfate cream versus placebo cream

Maiche, 1994

Maiche 1994 compared sucralfate cream and placebo cream. The trial authors reported that “grade 1 and grade 2 reactions appeared significantly later on the areas treated with sucralfate cream. Grade 2 reactions were observed highly significantly more often at four weeks (p = 0.01) and at five weeks (p < 0.05) in favour of sucralfate. No allergic reactions were observed in either group. No other data were available after attempts to contact trial authors for more information.

N = 44

5.14 Sucralfate cream versus aqueous cream

Wells, 2004

Wells 2004 compared Sorbolene and aqueous cream. We could not extract data from this study. The trial authors did not provide SE, SD or 95% CI for the mean scores reported. However, the authors reported that no statistically significant differences were found in the severity of skin reactions suffered by patients in either of the treatment arms.

N = 357

5.15 Non-steroidal restitutio restructuring cream formula A and non-steroidal restitutio restructuring cream formula B

Garibaldi, 2009

Prevention

Primary:

N = 64

Development of RISR (yes/no)

OR 0.64 95% CI 0.22 to 1.88, p = 0.41

5.16 WO1932 oil in water emulsion versus usual care/untreated

Jenson, 2011

Treatment

Secondary:

N = 66

RISR severity at the end of radiation treatment (Oncology Nursing Society Skin Reaction Scoring System, with a possible range of 0–3)

MD -0.21, 95% CI -0.43 to 0.01, p = 0.07

5.17 Aquaphor ointment versus placebo

Gosselin, 2010

Treatment

Secondary:

N = 106

Patient satisfaction (Scoring system developed by authors, with a possible range of 0–5, 5-best satisfaction)

MD 0.59, 95% CI 0.04 to 1.15, p = 0.04

(Favouring aquaphor ointment)

Ease of use (Scoring system developed by authors, with a possible range of 0–5, 5-best level of ease)

MD -0.10, 95% CI -0.61 to 0.41, p = 0.70

5.18 RadiaCare gel versus placebo

Gosselin, 2010

Treatment

Secondary:

N = 106

Patient satisfaction (Scoring system developed by authors, with a possible range of 0–5, 5-best satisfaction)

MD 0.91, 95% CI 0.36 to 1.46, p = 0.001

(Favouring radiacare gel)

Ease of use (Scoring system developed by authors, with a possible range of 0–5, 5-best level of ease)

MD 0.16, 95% CI -0.30 to 0.62, p = 0.49

5.19 Topical Lian Bai liquid versus no Lian Bai liquid

Ma, 2007

Prevention

Development of RISR (yes or no)

OR 0.04, 95% CI 0.01 to 0.12, p < 0.00001

N = 126

(Favouring topical lian bai liquid)

5.20 Formulation A topical cream (capprais spinosa, opuntia coccinellifera and olive leaf extract) versus no treatment

Rizza, 2010

Treatment

Secondary:

N = 44

Maximum RISR over eight weeks (modified RTOG criteria, with a possible range of 0–4)

MD -1.17, 95% CI -1.59 to -0.75, p < 0.00001

(Favouring formulation A topical cream)

5.21 Formulation B topical cream (non-steroidal water based emulsion) versus no Treatment

Rizza, 2010

Treatment

Secondary:

N = 42

Maximum RISR over eight weeks (modified RTOG criteria, with a possible range of 0–4)

MD -0.79, 95% CI -1.21 to -0.37, p < 0.00001

(Favouring formulation B topical cream)

5.22 Formulation A topical cream (capprais spinosa, opuntia coccinellifera and olive leaf extract) versus formulation B topical cream (non-steroidal water based emulsion)

Rizza, 2010

Treatment

Secondary:

N = 50

Maximum RISR over eight weeks (modified RTOG criteria, with a possible range of 0–4)

MD -0.38, 95% CI -0.69 to -0.07, p = 0.02

(Favouring formulation A topical cream)

6. Other interventions

6.1 LED versus no LED treatment

Fife, 2010

Prevention

Primary:

N = 33

Development of RISR

OR 3.83, 95% CI 0.14 to 101.07, p = 0.42

Treatment

Secondary:

Levels of RISR at week five (CTCAE criteria version 4, with a possible range of 0–4)

MD 0.00 95% CI -0.43 to 0.43, p = 1.00