Therapeutic efficacy of thiocolchicoside-nonsteroidal anti-inflammatory drug combination in pain management: A systematic review and cross-sectional real-world study

Table 1 Summary of selected study results on thiocolchicoside and nonsteroidal anti-inflammatory drug combination compared to nonsteroidal anti-inflammatory drug monotherapy

Ref.	Sample size	Indication	Intervention	Pain reduction (visual analog scale)	Disability/other outcomes	AEs
Akhter et al[25]	288	Lower back pain	D vs D + T	D: 7.31-1.35; D + T: 7.27-0.94 (from day 0 to day 7)	D + T significantly reduced hand-to-floor distance (P = 0.0005)	None reported
Iliopoulos et al[26]	134	Lower back pain	FDC vs D	FDC: > 30% pain relief in 91.9% of cases (3 hours) vs 57.4% in the D group T + D: 7.20-3.16; D: 6.52-4.45 (from baseline to 3 hours postinjection)	Superior improvement in finger-to-floor distance	Mild dizziness in 2 patients administered D
Meloncelli et al[21]	82	Lower back pain and neuropathic pain	D/T vs TRAM/DKP	TRAM/DKP: 95.5% > 30% reduction vs 71.1% in D/T (P = 0.003)	TRAM/DKP significantly reduced the douleur neuropathique 4 neuropathic pain score	TEAEs: D/T: 7.9%; TRAM/DKP: 18.2%; No serious AEs were reported, and none of the patients in the two groups discontinued therapy due to TEAEs
Patel et al[24]	300	Lower back pain	Muscle relaxant (T) + NSAIDs vs monotherapy	The combination group had a maximum disability index reduction of 54.66% ± 9.85%	Muscle relaxants are highly effective; gastrointestinal protection was given to most patients	None reported
Desai et al[27]	40	Lower back pain	T + A vs A	T + A: 77.55-9.85; A: 67.65-11.10 (P < 0.000)	Significant improvement in movement and restriction of motion in the T + A group	None reported
Sproviero et al[28]	223	Lower back pain	FDC (D + T) vs separate formulations	Similar reductions (mean: 56.92 mm vs 55.95 mm)	Muscle contracture improved equally (Schober's Index)	Test: 2.7% mild nausea; Reference: 0.9% injection site pain
Bourazani et al[29]	70	Postoperative pain (mastectomy and breast reconstruction surgery)	NSAID + T (group A) vs NSAID only (group B)	Group A: 5.14-0.71; group B: 6.20-2.80 (P < 0.0001)	Group A reported higher satisfaction and fewer side effects	None reported

A: Aceclofenac monotherapy; AEs: Adverse events; D: Diclofenac monotherapy; D + T: Diclofenac and thiocolchicoside combination therapy; FDC: Fixed-dose combination; NSAID: Nonsteroidal anti-inflammatory drug; T: Thiocolchicoside monotherapy; T + A: Thiocolchicoside plus aceclofenac; TEAEs: Treatment-emergent adverse events; TRAM/DKP: Tramadol/dexketoprofen.

Table 2 Comparative efficacy assessments of thiocolchicoside + nonsteroidal anti-inflammatory drug combination therapy with nonsteroidal anti-inflammatory drug monotherapy

Outcome	TCC + NSAIDs (mean ± SD)/%	NSAIDs monotherapy (mean ± SD)/%	Pooled effect size (SMD/OR)	95%CI	aP value	Cochran’s Q	df	I2 (%)	Interpretation
Pain intensity reduction (visual analog scale)	-6.20 ± 0.70	-5.10 ± 0.85	SMD: -1.33	-1.45 to -1.22	< 0.001	12.59	5	60.3	TCC + NSAIDs significantly reduced pain intensity compared to NSAIDs alone, with a large effect size. Found moderate heterogeneity
Functional improvement (hand-to-floor distance)	-18.20 ± 2.70	-15.10 ± 3.50	SMD: -1.08	-1.24 to -0.92	< 0.001	4.71	1	78.8	Combination therapy resulted in significantly greater functional improvement in reducing disability. Found high heterogeneity
Time to achieve > 30% pain relief (%)	86.60 ± 7.20	48.30 ± 10.00	OR = 6.71	3.48-13.10	< 0.001	3.065	2	34.7	Patients were 6.7 times more likely to achieve > 30% pain relief with combination therapy than with monotherapy
Time to achieve > 50% pain relief (%)	63.00 ± 10.50	22.80 ± 11.40	OR = 5.19	3.02-9.21	< 0.001	0.33	1	0	Combination therapy significantly increased the likelihood of achieving > 50% pain relief by a factor of approximately 5.2 times compared to monotherapy. No heterogeneity
Postsurgery pain reduction (day 3-numerical pain scale)	-4.45 ± 1.30	-3.40 ± 1.40	SMD: -0.84	-1.08 to -0.60	< 0.001	73.46	2	97.3	TCC + NSAIDs achieved better pain reduction after surgery compared to NSAID monotherapy, with a moderate to large effect. High heterogeneity
Patient satisfaction (%) (very satisfied)	69.00 ± 10.00	19.60 ± 6.50	OR = 10.14	5.48-19.50	< 0.001	9.15	1	89	Satisfaction with analgesia was substantially higher in the combination therapy group, making patients 10 times more likely to be satisfied. High heterogeneity
Adverse events (%) (mild/moderate)	157	12.1	OR = 1.30	0.68-2.48	0.378	4.01	1	75.1	No statistically significant difference in mild or moderate adverse events between the two groups, confirming the safety of the combination therapy. High heterogeneity

^aP < 0.05 was considered statistically significant.

NSAID: Nonsteroidal anti-inflammatory drug; OR: Odds ratio; SMD: Standardised mean difference; TCC: Thiocolchicoside.