Introduction
Methods
Eligibility criteria
Search strategy
Study selection
Data extraction
Assessment of methodological quality
Assessment of the evidence quality
Statistical analysis
Results
Overview of systematic reviews
Search results
Study characteristics
Author (Year) | Country | Trials (Sample size) | Intervention | Outcomes | Quality assessment tool | Main results | Adverse effects | |
---|---|---|---|---|---|---|---|---|
Treatment group | Control group | |||||||
Chen (2019) | China | 9 RCTs (316 participants) | LLLT; LLLT + conventional therapy | Conventional therapies: pneumatic compression, limb exercise, manual lymphatic drainage; Placebo laser therapy; No treatment; | Primary outcome: the difference in the limb circumference or volume Secondary outcomes: grip strength and pain scores | RoB 2.0 | LLLT demonstrated a slight improvement in reducing arm circumference and arm volume However, there was no significant difference in the reduction of the limb circumference, limb volume, grip strength or pain scores after treatment, and follow-up between the LLLT and control groups | |
Baxter (2017) | New Zealand | 7 RCTs + 4 observational studies (359 participants) | LLLT | Conventional therapies: compression bandages, pneumatic compression, manual lymphatic drainage Placebo laser therapy No treatment | Primary outcome: limb circumference, limb volume Secondary outcomes: pain intensity and range of motion | PEDro scale | LLLT in the management of BCRL is more effective for limb edema reduction than sham laser therapy and no treatment at a short-term follow-up LLLT were not more effective than other conventional treatments | |
Smoot (2015) | American | 7 RCTs + 2 observational studies (289 participants) | LLLT | Conventional therapies: intermittent compression, compression garment, manual lymphatic drainage Placebo laser therapy No treatment | Reduction in limb volume, pain reduction | PEDro scale | There was greater reduction in limb volume with treatment including LLLT versus not including LLLT There was no statistically significant difference in amount of pain reduction after LLLT as compared to other treatments | Six of the nine studies reported on adverse events or discussed harm. The total incidence of cellulitis reported in the included studies was two per group |
Monteiro (2014) | Brazil | 5 RCTs (189 participants) | LLLT | Conventional therapies: manual lymphatic drainage Placebo laser therapy | Limb circumference, limb volume, extracellular fluid, subjective symptoms: pain, heaviness, psychological and physical symptoms, quality of life | PEDro scale | All the articles included in this review resulted in reduced circumference or volume of the affected limb after LLLT However, results regarding pain were not consistent | |
E Lima (2014) | Brazil | 4 RCTs (149 participants) | LLLT | Conventional therapies: pneumatic compression Placebo laser therapy No treatment | Limb volume; tissue hardness; range of motion; grip strength; subjective symptoms: pain, heaviness, DASH questionnaire symptoms | PEDro scale | In all studies, LLLT showed favorable results in limb volume reduction as compared with the control group. Also, significant decrease in tissue hardness was observed in two studies LLLT failed to show improvement of subjective symptoms in all but one study | No adverse reactions were reported |
Omar (2012) | Egypt | 5RCTs + 3 observational studies (220 participants) | LLLT | Conventional therapies: compression therapy Placebo laser therapy No treatment | Limb circumference; limb volume; fluid distribution; tissue resistance; shoulder mobility; grip strength; subjective symptoms | PEDro scale | Five studies with moderate to strong evidences demonstrated the effectiveness of LLLT for the management of BCRL. A dose of 1–2 J/cm2 per point applied to several points covering the fibrotic area can reduce limb volume following BCRL | |
Moseley (2007) | Britain | 1RCT + 2 observational studies (71 participants) | LLLT | Placebo laser therapy No control group | Limb volume; subjective symptoms; daily living activities | PEDro scale, NOS | These three studies demonstrate that benefits including volume reduction, improved subjective symptoms and quality of life can be derived from either concentrated or scanning laser therapy |
Primary study | Systematic review with meta-analysis | Systematic review | |||||
---|---|---|---|---|---|---|---|
Chen (2019) | Smoot (2015) | Baxter (2017) | Monteiro (2014) | E Lima (2014) | Omar (2012) | Moseley (2007) | |
RCTs | |||||||
Baxter (2018) | √ | ||||||
Storz (2017) | √ | ||||||
Rinder (2013) | √ | √ | √ | √ | |||
Omar (2011) | √ | √ | √ | √ | √ | ||
Kozanoglu (2009) | √ | √ | √ | √ | √ | ||
Lau (2009) | √ | √ | √ | √ | √ | √ | |
Maiya (2008) | √ | √ | √ | ||||
Kaviani (2006) | √ | √ | √ | √ | √ | √ | |
Carati (2003) | √ | √ | √ | √ | √ | √ | √ |
Observational studies | |||||||
Mayrovitz (2011) | √ | ||||||
Dirican (2011) | √ | √ | √ | ||||
Piller (1995) | √ | √ | √ | ||||
Piller (1998) | √ | √ | √ | √ |
Methodological assessment
Study | AMSTAR 2 domains | Overall quality | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | ||
Chen (2019) | Y | Y | Y | Y | Y | Y | N | Y | Y | N | Y | Y | Y | Y | Y | Y | L |
Baxter (2017) | Y | N | N | Y | Y | Y | Y | Y | PY | Y | NMA | NMA | Y | Y | NMA | Y | L |
Smoot (2015) | Y | N | N | Y | Y | Y | N | Y | Y | N | Y | Y | Y | Y | Y | N | CL |
Monteiro (2014) | Y | N | N | Y | Y | Y | N | Y | Y | N | NMA | NMA | N | N | NMA | N | CL |
E Lima (2014) | Y | N | N | Y | Y | Y | N | Y | Y | N | NMA | NMA | Y | N | NMA | N | CL |
Omar (2012) | Y | N | Y | Y | Y | Y | N | Y | Y | N | NMA | NMA | Y | N | NMA | Y | CL |
Moseley (2007) | Y | N | N | Y | Y | Y | N | Y | Y | N | NMA | NMA | N | N | NMA | N | CL |
Evidence quality of outcomes
Outcomes | Study | Intervention | Control | Assessment times | Effect (95% CI) | Studies (participants) | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | GRADE quality of evidence |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Limb circumference | Chen (2019) | LLLT; LLLT + conventional therapy | Conventional therapies Placebo laser therapy | Post-treatment | SMD − 0.47 (− 1.34, 0.39) | 3 (117) | − 1(1c,1e) | − 1(2) | 0 | − 1(4b) | 0 | Very low quality |
Chen (2019) | LLLT; LLLT + conventional therapy | Conventional therapies Placebo laser therapy | 1-month | SMD − 0.52 (− 0.52, 0.42) | 2 (67) | − 1(1b,1c,1e) | − 1(2) | 0 | − 1(4b) | 0 | Very low quality | |
Chen (2019) | LLLT | Conventional therapies | 3-month | SMD − 0.33 (− 0.88, 0.23) | 1 (50) | − 1(1a,1c,1e) | 0 | 0 | − 1(4b) | 0 | Low quality | |
Limb volume | Chen (2019) | LLLT | Placebo laser therapy; no treatment | Post-treatment | SMD 0.04 (− 0.32, 0.41) | 3 (122) | − 1(1b,1c) | 0 | 0 | − 1(4b) | 0 | Low quality |
Smoot (2015) | LLLT | Conventional therapies Placebo laser therapy; no treatment | Post-treatment | SMD 0.62 (− 0.97, − 0.28) | 4 (138) | − 1(1b,1c,1e) | 0 | 0 | − 1(4b) | 0 | Low quality | |
Chen (2019) | LLLT | Placebo laser therapy; no treatment | 1-month | SMD − 0.53 (− 1.10, 0.04) | 2 (82) | − 1(1b,1c) | 0 | 0 | − 1(4b) | 0 | Low quality | |
Grip strength | Chen (2019) | LLLT | Conventional therapies; Placebo laser therapy; | Post-treatment | MD 1.18 (− 2.16, 4.52) | 3(140) | − 1(1b,1c,1e) | − 1(2) | 0 | − 1(4a,4b) | 0 | Very low quality |
Chen (2019) | LLLT | Placebo laser therapy; | 1-month | MD − 1.93 (− 5.15, 1.29) | 1(40) | − 1(1b,1e) | 0 | 0 | − 1(4a,4b) | 0 | Low quality | |
Chen (2019) | LLLT | Placebo laser therapy; | 2-month | MD 0.67 (− 2.72, 4.06) | 1(40) | − 1(1b,1e) | 0 | 0 | − 1(4a,4b) | 0 | Low quality | |
Chen (2019) | LLLT | Conventional therapies; Placebo laser therapy | 3-month | MD − 0.89 (− 3.04, 1.25) | 2(90) | − 1(1a,1c,1e) | 0 | 0 | − 1(4a,4b) | 0 | Low quality | |
Pain | Chen (2019) | LLLT; LLLT + conventional therapy | Conventional therapies Placebo laser therapy | Post-treatment | MD − 0.14 (− 0.58, 0.31) | 4(168) | -1(1b,1c,1e) | 0 | 0 | − 1(4b) | 0 | Low quality |
Smoot (2015) | LLLT | Conventional therapies | Post-treatment | SMD − 1.21 (− 4.51, 2.10) | 2(67) | − 1(1a,1c,1e) | − 1(2) | 0 | − 1(4a,4b) | 0 | Very low quality | |
Chen (2019) | LLLT; LLLT + conventional therapy | Conventional therapies; Placebo laser therapy | 1-month | MD 0.21 (− 0.27, 0.68) | 3(118) | − 1(1b) | 0 | 0 | − 1(4b) | 0 | Low quality | |
Chen (2019) | LLLT | Placebo laser therapy | 2-month | MD 0.00 (− 1.87, 1.87) | 1(40) | − 1(1b,1e) | 0 | 0 | − 1(4a,4b) | 0 | Low quality | |
Chen (2019) | LLLT | Conventional therapies Placebo laser therapy | 3-month | MD 0.01 (− 0.99, 1.02) | 3(151) | − 1(1b,1e) | − 1(2) | 0 | − 1(4b) | 0 | Very low quality |
Outcomes | Study | Overall CERQual assessment | Explanation for assessment | Contributing studies |
---|---|---|---|---|
Reduction in limb circumference (LLLT versus placebo laser at 1-month follow-up) | Baxter (2017) | Low confidence | Methodological limitations: Three studies have moderate methodological limitations; Relevance: High Coherence: High Adequacy of data: The research covers 1 developed country and 2 developing countries. The information is relatively single and limited | Omar (2011) Kaviani (2006) Carati (2003) |
Reduction in limb circumference (LLLT versus conventional therapy at short-term follow-up] | Baxter (2017) | Very low confidence | Methodological limitations: Three studies have moderate to severe methodological limitations Relevance: High Coherence: Conflicting results leads to poor consistency Adequacy of data: The research covers 1 developed country and 2 developing countries. The information is relatively single and limited | Rinder (2013) Kozanoglu (2009) Maiya (2008) |
Reduction in limb volume | E Lima (2014) | Moderate confidence | Methodological limitations: Four studies have moderate to severe methodological limitations Relevance: High Coherence: High Adequacy of data: The research covers 1 developed country and 3 developing countries. The information is relatively sufficient | Lau (2009) Kozanoglu (2009) Kaviani (2006) Carati (2003) |
Reduction in limb volume | Moseley (2007) | Low confidence | Methodological limitations: Three studies have moderate to severe methodological limitations Relevance: High Coherence: High Adequacy of data: The research covers 2 developed countries. The information is relatively single and limited | Carati (2003) Piller (1998) Piller (1995) |
Reduction in limb volume (LLLT versus placebo laser at post-treatment) | Baxter (2017) | Very low confidence | Methodological limitations: Two studies have moderate methodological limitations Relevance: High Coherence: Conflicting results leads to poor consistency Adequacy of data: The research covers 1 developed country and 1 developing country. The information is relatively single and limited | Omar (2011) Carati (2003) |
Reduction in limb volume (LLLT versus no treatment at 1-month follow-up) | Baxter (2017) | Very low confidence | Methodological limitations: One study has high methodological limitation Relevance: High Coherence: Limited data results in unclear consistency Adequacy of data: The research covers 1 developing country. The information is relatively single and limited | Lau (2009) |
Reduction in limb circumference or volume | Monteiro (2014) | Moderate confidence | Methodological limitations: Five studies have moderate to severe methodological limitations Relevance: High Coherence: High Adequacy of data: The research covers 2 developed countries and 3 developing country. The information is relatively sufficient | Rinder (2013) Omar (2011) Lau (2009) Kaviani (2006) Carati (2003) |
Reduction in limb circumference or volume | Omar (2012) | Moderate confidence | Methodological limitations: Five studies have moderate to severe methodological limitations Relevance: High Coherence: High Adequacy of data: The research covers 1 developed country and 4 developing countries. The information is relatively sufficient | Omar (2011) Lau (2009) Kozanoglu (2009) Kaviani (2006) Carati (2003) |
Improvement of subjective symptoms | E Lima (2014) | Low confidence | Methodological limitations: Four studies have moderate to severe methodological limitations Relevance: High Coherence: Conflicting results leads to poor consistency Adequacy of data: The research covers 1 developed country and 3 developing countries. The information is relatively sufficient | Lau (2009) Kozanoglu (2009) Kaviani (2006) Carati (2003) |
Improvement of subjective symptoms | Moseley (2007) | Low confidence | Methodological limitations: Three studies have moderate to severe methodological limitations Relevance: High Coherence: High Adequacy of data: The research covers 2 developed countries. The information is relatively single and limited | Carati (2003) Piller (1998) Piller (1995) |
Pain relief | Monteiro (2014) | Very low confidence | Methodological limitations: Three studies have moderate to severe methodological limitations Relevance: High Coherence: Conflicting results leads to poor consistency Adequacy of data: The research covers 1 developed country and 2 developing countries. The information is relatively single and limited | Lau (2009) Kaviani (2006) Carati (2003) |
Pain relief (LLLT versus placebo laser at 2-month follow-up) | Baxter (2017) | Very low confidence | Methodological limitations: One study has moderate methodological limitation Relevance: High Coherence: Limited data results in unclear consistency Adequacy of data: The research covers 1 developing country. The information is relatively single and limited | Kaviani (2006) |
Pain relief (LLLT versus conventional therapy at post-treatment) | Baxter (2017) | Very low confidence | Methodological limitations: Two studies have moderate methodological limitations; Relevance: High Coherence: Conflicting results leads to poor consistency Adequacy of data: The research covers 2 developing countries. The information is relatively single and limited | Kozanoglu (2009) Maiya (2008) |
Pain relief (LLLT versus conventional therapy at 3-month post-treatment) | Baxter (2017) | Very low confidence | Methodological limitations: One study has moderate methodological limitation; Relevance: High Coherence: Limited data results in unclear consistency Adequacy of data: The research covers 1 developing country. The information is relatively single and limited | Kozanoglu (2009) |
Improvement of quality of life; | Moseley (2007) | Very low confidence | Methodological limitations: One study has moderate methodological limitation; Relevance: High Coherence: Limited data results in unclear consistency Adequacy of data: The research covers 1 developed country. The information is relatively single and limited | Carati (2003) |
Shoulder mobility (LLLT versus placebo laser at post-treatment) | Baxter (2017) | Very low confidence | Methodological limitations: Two studies have moderate methodological limitations; Relevance: High Coherence: Conflicting results leads to poor consistency Adequacy of data: The research covers 1 developed country and 1 developing country. The information is relatively single and limited | Omar (2011) Carati (2003) |
Range of movement in the affected limb [LLLT versus placebo laser at short-term follow-up (< 6 months)] | Baxter (2017) | Low confidence | Methodological limitations: Two studies have moderate methodological limitations; Relevance: High; Coherence: High Adequacy of data: The research covers 1 developed country and 1 developing country. The information is relatively single and limited | Kaviani (2006) Carati (2003) |
Decrease in tissue hardness | E Lima (2014) | Low confidence | Methodological limitations: Two studies have moderate methodological limitations; Relevance: High; Coherence: High Adequacy of data: The research covers 1 developed country and 1 developing country. The information is relatively single and limited | Lau (2009) Carati (2003) |
Author (year) | Inclusion criteria | No. of patients | Intervention group | Control group | Co-intervention | Assessment times | Outcomes reported |
---|---|---|---|---|---|---|---|
Kilmartin (2020) | 1) Woman aged ≥ 21 year; 2) Diagnosis of BCRL (girth ≥ 2 cm circumferential difference and/or volume ≥ 200 mL compared with the uninvolved upper extremity at any 4 cm segment) 3) Stage II or III lymphedema (as defined by the International Society of Lymphology) | L:11 C:10 | CDT + active LLLT (2 times/w × 8–16 sessions with 1.5 J/cm2, 1 min/10 sites in the axilla and a portion of the chest wall on the affected side) | CDT + inactive laser | NR | Pre-treatment; post-treatment (8 sessions); post-treatment (16 sessions); 3-week follow-up; 6-week follow-up; 12-week follow-up | Lymphedema symptoms, symptom distress, limb volume |
Baxter (2018) | 1) Woman aged over 18 year; 2) Diagnosis of BCRL (defined as a circumference increase over 7.5% at any measurement level in the operated arm compared with the control) | L:9 C:8 | Conventional therapy + LLLT (2 times/w × 6 w with 6 J/cm2, wavelength with 980/810 nm; output power with 500 mW beam spot size 5 cm2; irradiance with 100 mW/cm2, 1 min/10 sites from axilla to wrist) | Conventional therapy (continuous wearing of a pressure garment, massage therapy, and remedial exercises, e.g., aerobic exercise, strength training, and stretching exercises) | NR | Pre-treatment; post-treatment 6-week follow-up | Limb circumference differences; participant’s perceived symptoms (pain and heaviness); psychological impacts (self-consciousness, anxiety, perception of arm swelling, and emotion changes); activity disability |
Storz (2017) | ≧ 3 months history of PML (either modified radical mastectomy or breast-conserving surgery with axillary dissection or sentinel lymph node biopsy) | L:20 C:20 | Active laser (2 times/w × 4 w with 4.89 J/cm2, wavelength with 980 nm; total power output with 640 mW; 10 min/session, over the whole axillary) | Placebo laser | Daily limb exercises; skin care | Pre-treatment post-treatment 4-week follow-up; 8-week follow-up; 12-week follow-up | Lymphedema-related pain; quality of life; grip strength; limb volume difference |
Ridner (2013) | 1) Age≧ 21 year 2) Stage I or II lymphedema as determined by a physician and defined by the International Society of Lymphology (1995) | L: 15 M:16 L + M:15 | LLLT alone (20 ~ 30 s/point in each grid, 20 min/session) MLD + LLLT (each session 20 min of LLLT + 20 min of MLD); | MLD alone (40 min/session) | Compression bandaging after treatment | Pre-treatment; post-treatment | Limb volume (circumferential measurement); extracellular fluid (bioelectrical impedance); psychological and physical symptoms; quality of life |
Omar (2011) | 1) Stage II or III lymphedema 2) Diagnosis of BCRL (an increase in arm circumference at any level by 2 cm and less than 8 cm compared with the contralateral side) | L:25 C:25 | Active LLLT (3 times/w × 12 w with 1.5 J/cm2, wavelength with 904 nm; power with 5 mW; seven points over the axillary and arm areas) | Placebo sham | Limb exercise Skin care instructions Wear pressure garment | Pre-treatment; post-treatment; 4-week follow-up | Limb circumference difference; shoulder mobility; grip strength |
Lau (2009) | 1) Women aged ≧ 18 year had undergone unilateral standard or modified radical mastectomy with subsequent radiotherapy or chemotherapy 2) Diagnosis of BCRL (more than 200 mL difference between arms) | L:11 C:10 | LLLT: 3 times/w × 4 w with 2 J/cm2, wavelength with 905 nm, output with 24 mW, frequency varying from 1 to 10,000 Hz; wavelength with 808 nm, output with 500 mW, frequency varying from 1 to 1500 Hz; 20 min/session) | No treatment | Lymphedema education session | Pre-treatment; post-treatment; 4-week follow-up | Limb volume; tissue resistance subjective symptoms [Disabilities of Arm, Shoulder, and Hand (DASH) questionnaire] |
Kozanoglu (2009) | 1) ≧3 months history of arm lymphedema 2) Diagnosis of lymphedema (a difference of more than 2 cm at at least three of the seven points, including the axilla, 10 cm proximal and distal to the antecubital fossa, elbow, 5 cm proximal to the wrist, wrist and midpalm) | L:25 C:25 | LLLT (3 times/w × 4 w with 1.5 J/cm2; 20 min/session; wavelength with 904 nm; treatment area over three points on the antecubital fossa and at seven points on the axilla) | Pneumatic compression therapy (2 h with pressure of 60 mmHg) | Daily limb exercises (active range of motion, elevation and pumping exercises); hygiene; skin care | Pre-treatment; post-treatment; 3-month follow-up; 6-month follow-up; 12-month follow-up | Difference between sum of the circumferences of affected and unaffected limbs; pain; range of motion of the upper extremity joints; grip strength |
Maiya (2008) | Women with unilateral BCRL (> 2-cm interlimb difference at 2 sites) | L:10 C:10 | LLLT (34 min/session, daily for 10 days, wavelength with 632.8 nm and 850 nm; 2.4 J/cm2) | Compression bandage | Upper extremity exercise program | Pre-treatment; post-treatment | Limb circumference Pain |
Kaviani (2006) | 1) ≧ 3 months history of unilateral arm lymphedema in women after modified radical mastectomy and received radiation therapy 2) Arm lymphedema was defined as 2 cm or more difference in circumference between the two arms at midhumeral line | L:6 C:5 | LLLT: 2 blocks (3 times/w × 3 w with 1.5 J/cm2, wavelength with 890 nm; output Power with 10 W; over the five points applied to the axillary region) separated by 8 w rest period | Placebo laser | NR | Pre-treatment; during the treatment (weeks 3, 9, 12, 18, and 22) | limb circumference difference; pain; range of motion; heaviness; desire to continue the treatment |
Carati (2003) | 1) women aged ≧ 18 years 2) diagnosis of clinically manifest PML (> 200 mL difference between arms or ≥ 2 cm difference in arm circumference at ≥ 3 positions) | L:33 C:28 | 2 blocks of active LLLT (3 times/w × 3 w with 1.5 J/cm2, wavelength with 904 nm; power with 5 mW from a treatment head measuring 0.2 cm2 in size; 1 min/17 treatment points) separated by 8 w rest period | 1 block of sham therapy followed by 8 w rest period then 1 block of active LLLT (3 times/w × 3 w with 1.5 J/cm/2) | NR | Pre-treatment; post-treatment: 1-month follow-up; 2-month follow-up; 3-month follow-up | Limb volume; bioimpedance; tissue resistance; shoulder range of movement; self-report (perceptual symptoms of their affected limb, the ability to perform specific activities of daily living, overall feelings regarding quality of life) |