A Comparison of Naproxen Sodium, Acetaminophen and Placebo in the Treatment of Muscle Contraction Headache

Abstract

SYNOPSIS The purpose of the present study was to compare the efficacy and safety of naproxen sodium (550 mg), acetaminophen (650 mg) and placebo in the treatment of muscle‐contraction, or tension headache. Six investigators participated in this randomized, double‐blind, 3‐way parallel study, in which 149 patients were entered. Each patient treated one episode of moderate‐to‐severe headache with the test medication. The intensity of the headache pain was recorded on 10 cm visual analogue scales (VASs) by patients for up to 12 hours after treatment with the study medication. In addition, the degree of pain relief (PR) was recorded in a similar manner. Mean pain intensities (Pls), percentage changes in mean pain intensities, pain intensity differences (PIDs) and the sum of these differences (SPIDs) were calculated. From the data collected in 124 patients eligible for efficacy analysis, naproxen sodium was shown to provide a significantly greater percentage change in mean PI compared to acetaminophen (p<0.01) or placebo (p<0.001). Mean PID and SPID scores also showed naproxen sodium to be significantly more effective in relieving pain compared to acetaminophen (p<0.02) or placebo (p<0.001). Mean pain relief scores and calculated total pain relief (TOTPAR) scores correlated well with the reduction in pain intensity. During the trial 13 patients reported side effects including nausea, dizziness and drowsiness. None of the side effects were considered clinically significant. The results from this study demonstrated naproxen sodium to be a well tolerated analgesic, which provided statistically significantly superior analgesia compared to acetaminophen or placebo in the treatment of muscle‐contraction or tension headaches.

Information content of advertising: Empirical evidence from the OTC analgesic industry

“…This is a natural condition given that the leakage itself is increasing in s g (for example, if leakage were proportional to generic market size times an increasing and concave function of information cues). This is consistent with the rationale that brands that emphasize product quality also provide free advertising for generic counterparts of their products 8 , and therefore this would decrease the incentive to include information in the ads. On the other hand, consumers of brands might not be inclined to consume generics, and, in that case, brands might include information in their ads, independently of the size of the generic counterpart.…”

Multi-center Randomized Control Trial of Etizolam Plus NSAID Combination for Tension-type Headache

“…The analgesic agents [acetaminophen (3)(4)(5)(6)(7), aspirin (3,6), ibuprofen (5,(7)(8)(9)(10)(11)(12)(13), ketoprofen (6,12,13), and naproxen (4,12)] are all effective as analgesics in TTH.…”

“…The most widely used evidence-based drugs for the management of TTH are the non-steroidal anti-inflammatory drugs (NSAIDs) in acute treatment and antidepressants for preventive treatment (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14). Benzodiazepines are commonly used for the treatment of TTH (15)(16)(17)(18), however, there are few randomized controlled trials (RCTs) recommending the use of these drugs (19).…”

Current and potential future drug therapies for tension-type headache

“…The administration of 400 mg of ibuprofen was shown to be more effective than placebo 30 minutes after administration [23]. There are several comparative randomized, placebo-controlled trials regarding the efficacy of NSAIDs in episodic tension-type headache [5,8,10,12,13,15,16,20,21,[24][25][26][27].…”

“…In an early double-blind, placebo-controlled, crossover trial, aspirin at doses of 1000 mg, 500 mg, and 250 mg was shown to be more effective than placebo in the treatment of nonmigraineous headache [4]. Moreover, a significant dose-response relationship was established for aspirin; 1000 mg of aspirin was superior to 500 mg and 500 mg was superior to 250 mg. Several comparative, randomized, placebo-controlled trials have shown that aspirin [5][6][7][8][9][10][11] and acetaminophen [11][12][13][14][15][16][17][18][19][20][21] are effective in the acute therapy of tension-type headache. One of the first placebocontrolled trials demonstrated that 648 mg of solid aspirin and 648 mg of effervescent aspirin were more effective than placebo [6]; there was no difference between solid and effervescent aspirin.…”