**2. Method and subjects**

#### **2.1. Method**

anti-inflammatory effect by inhibiting arachidonic acid metabolism [4, 7], induce apoptosis in HL-60 leukemia [8], non-small cell lung cancer cells [9] and against acute monocytic leukemia [10]. It is also reported to be chemopreventive and anti-inflammatory [11, 12]. The antioxidant, antimicrobial and cytotoxic activities of Zingiber officinale displayed specific inhibition on Escherichia coli was also studied [13]. Gingerols also promoted significant reduction in mRNA transcription of TNF-α, IL-2 and INF-γ [14]. Ginsenoside Rg5 (Rg5), an abundant natural compound in Panax ginseng, has been found to be beneficial in treating AD [15]. Pharmaco‐ logic studies in the last decades have shown that ginsenosides (ginseng saponins) are primarily responsible for the actions of ginseng [16]. In diabetes ginger supplementation in oral admin‐ istration reduced inflammation in type 2 diabetic patients [17]. Other studies have shown that ginger may benefits musculoskeletal disorder treatment [18] nausea and vomiting [19], inflammation or inflammatory states [20, 21] such as osteoarthritis [20-22], migraine [23], cancer [24], hyperlipidemia and hyperglycemia [25, 26]. In vitro studies suggest that ginger

produces its anti-inflammatory effect by inhibiting arachidonic acid metabolism4

ginger tablets to reduce postoperative pain in patients with osteoarthritis.

256 Pharmacology and Nutritional Intervention in the Treatment of Disease

**1.1. History**

**1.2. Therapeutic scope**

**1.3. Safety**

mental or musculoskeletal disorders.

chapter intends to give a brief outline of ginger health benefit and to investigate the ability of

The earliest evidence of humans' use of plants for healing dates back to the Neanderthal period [27]. In the 16th century, botanical gardens were created to grow medicinal plants for medical schools [28]. Herbal medicine practice flourished until the 17th century when more "scientific" pharmacological remedies were favoured [29]. The use of plants for healing purposes predates human history and forms the origin of much modern medicine. Many conventional drugs originate from plant sources: a century ago, most of the few effective drugs were plant based. Examples include aspirin (from willow bark), digoxin (from foxglove), quinine (from cinchona bark), and morphine (from the opium poppy). The development of drugs from plants contin‐

ues, with drug companies engaged in large scale pharmacological screening of herbs.

Although herbal preparations are widely used as self-medication for acute conditions, practitioners of herbal medicine tend to concentrate on treating chronic conditions. A typical caseload might include asthma, eczema, premenstrual syndrome, rheumatoid arthritis, migraine, menopausal symptoms, chronic fatigue, irritable bowel syndrome and lately to treat

Many plants are highly toxic. Herbal medicine probably presents a greater risk of adverse effects and interactions than any other complementary therapy. There are case reports of serious adverse events after administration of herbal products. In most cases the herbs involved were self-prescribed and bought over the counter or obtained from a source other than a registered practitioner. In the most notorious instance, several women developed

, 7 . This Fourthly patients with OA of the knee and moderate-to-severe pain were enrolled in a randomised, double –blind, placebo-controlled, two-center, parallel group, 12-week study. The primary efficacy variable was the proportion of responders experiencing a reduction in "knee pain on standing" using a visual analog scale.

The study was approved by the ethics committee of the Latvian Institute of Cardiology for clinical and physiological research, drug and pharmaceutics product clinical investigation.

Only those willing to participate and after getting their informed consent will be involved in the investigation

#### **2.2. Subjects**

Elderly patients with clinical diagnosis of osteoarthritis (OA) of the knee, defined as knee (articular and not periarticular or referred) pain for most days of the prior month and radio‐ graphic osteophytes at the tibiofemoral joint margins were involved in the study. All involved patients had a baseline pain score > 40 mm and < 90 mm on a 100-mm Visual Analogue Scale (VAS) at the time of randomization, when evaluating pain on standing during the last 24 hours. Both men and women were included.

Exclusion Characteristics


#### *2.2.1. Study design*

The study was 12 weeks, double blind, and placebo-controlled, parallel group trial performed in two social care centres for elderly people. The study was approved by the ethics committee of the Latvian Institute of Cardiology for clinical and physiological research, drug and pharmaceutics product clinical investigation. Only those willing to participate and after getting their informed consent will be involved in the investigation. Patients were randomised to receive treatment and both investigators and the patients were blind to treatment assign‐ ment.

**Baseline data After 6 weeks after 12 weeks A B A B A B n=22 n=18 n=20 n=18 n=20 n=18**

**" A" group (n=22) "B "group (n=18)**

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259

62.95±2.2 57.11±+2.5 56.65±2.3 49.52±2.5 51.2±2.3 43.88±2.5

61.68±2.4 60.64±2.7 54.85±2.5 54±2.7 49.25±2.5 49.23±2.7

Time (weeks)

A B

Baseline

After 6 w eeks

After 12 w eeks

> 15 mm - - - - 50 44 0 – 15 mm - - - - 41 50 ≤ 0 - - - - 9 6

Age, mean ± SD years 69 ± 13,7 75 ± 8,6

Pharmacological and Clinical Effectiveness of *Zingiber officinale* and *Alpinia galanga* in Patients with Osteoarthritis

Men 23 28 Women 77 72 Body mass index ± SD kg/m2 29.31 ± 7,7 28 ± 7,0 Waste/hip ratio ± SD 0,88 ± 0,04 0,91 ± 0,04

> **Figure 1 . Pain on standing and walking after using of Ginger containg food supplements**

Figure 2. Knee pain on standing as measured by 100-mm visual analog scale at baseline and after 6 weeks and 12 weeks. Bars shows means with 2 SE (mm)

**Figure 1.** Pain on standing and walking after using of Ginger containg food supplements

More than 15mm 0 - 15 mm Negative result

6

Additionally blood sample was checked in both groups. There were no

Groups

statistically significant changes between groups.

A B

**Table 2.** Measurements for knee pain between group "A" and group "B"

Pain on standing and walking (%)

**Table 1.** Demographic characteristics

Pain on standing, mean

Pain on walking, mean

Mean +- 2 SE Pain on standing (mm)

70

60

50

40

30

± SE (mm)

Sex %

± SE (mm)

**%**

#### *2.2.2. Treatment*

During the 12-week period, patients ingested 1 capsule twice daily, morning and evening. Each capsule contained 150 mg Ginger rhizome *(lat. Zingiberis officinale rhizome)* powdered extract and 125 mg Galangae rhizome (*Alpinia officinarum rhizome)* dry extract. 22 patients were got tablets with "A" and 18 patients got tablets with "B". Examination was done at the baseline, after 6 weeks and after 12 weeks.

#### *2.2.3. Results*

#### Characteristics of the subjects

Forty patients were included in the study (for group "A"-mean age ± SD 69±13,7 and for group "B"-mean age ± SD 75 ± 8,6). There were ten males (35 %) and thirty females (75%). The patients in both groups were generally overweight, since the average was >28 kg/m2 (range 43 – 120 kg).

#### *2.2.4. Assessments*

The primary efficacy parameter was proportion of respondents experiencing at least a 15-mm reduction in pain between baseline and the final examination for knee pain on standing and walking during preceding 24 hours, as measured by a 100-mm, VAS.

The secondary measurement was mean ±SE of measurements for knee pain on standing and walking.

Pharmacological and Clinical Effectiveness of *Zingiber officinale* and *Alpinia galanga* in Patients with Osteoarthritis http://dx.doi.org/10.5772/58417 259


#### **Table 1.** Demographic characteristics

**•** Clinical signs of liver disorders;

**•** Increased oral temperature, (37,5 C) at the time of screening;

258 Pharmacology and Nutritional Intervention in the Treatment of Disease

**•** Affection of the hip to an extent that would influence the ratings done at the visits";

The study was 12 weeks, double blind, and placebo-controlled, parallel group trial performed in two social care centres for elderly people. The study was approved by the ethics committee of the Latvian Institute of Cardiology for clinical and physiological research, drug and pharmaceutics product clinical investigation. Only those willing to participate and after getting their informed consent will be involved in the investigation. Patients were randomised to receive treatment and both investigators and the patients were blind to treatment assign‐

During the 12-week period, patients ingested 1 capsule twice daily, morning and evening. Each capsule contained 150 mg Ginger rhizome *(lat. Zingiberis officinale rhizome)* powdered extract and 125 mg Galangae rhizome (*Alpinia officinarum rhizome)* dry extract. 22 patients were got tablets with "A" and 18 patients got tablets with "B". Examination was done at the baseline,

Forty patients were included in the study (for group "A"-mean age ± SD 69±13,7 and for group "B"-mean age ± SD 75 ± 8,6). There were ten males (35 %) and thirty females (75%). The patients

The primary efficacy parameter was proportion of respondents experiencing at least a 15-mm reduction in pain between baseline and the final examination for knee pain on standing and

The secondary measurement was mean ±SE of measurements for knee pain on standing and

(range 43 – 120

in both groups were generally overweight, since the average was >28 kg/m2

walking during preceding 24 hours, as measured by a 100-mm, VAS.

**•** Severe neurological diseases;

**•** History of fibromyalgia;

**•** Recurrent or active pseudo-gout;

after 6 weeks and after 12 weeks.

Characteristics of the subjects

**•** Gout;

ment.

*2.2.2. Treatment*

*2.2.3. Results*

*2.2.4. Assessments*

kg).

walking.

*2.2.1. Study design*


**Table 2.** Measurements for knee pain between group "A" and group "B" **Figure 1 . Pain on standing and walking after using of Ginger containg food** 

**supplements**

Figure 2. Knee pain on standing as measured by 100-mm visual analog scale at baseline and after 6 weeks and 12 weeks. Bars shows means with 2 SE (mm)

Time (weeks)

Baseline

After 6 w eeks

After 12 w eeks

6

Additionally blood sample was checked in both groups. There were no

Groups

statistically significant changes between groups.

A B

Mean +- 2 SE Pain on standing (mm)

70

60

50

40

30

**3. Discussion and conclusion**

ing (or at least maintaining) mobility

Ginger (Zingiber officinale Roscoe), a well-known spice plant, has been used traditionally in a wide variety of ailments including hypertension and osteoarthritis. Gingerol, the active components of ginger, derivatives are currently under investigation as potential drug therapy for disorders of platelet function, but the small amounts consumed in the diet are unlikely to influence platelet function. We report here the osteoarthritis effects of Zingiber officinale and

Pharmacological and Clinical Effectiveness of *Zingiber officinale* and *Alpinia galanga* in Patients with Osteoarthritis

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261

Osteoarthritis, the most common form of arthritis, is a debilitating progressive disease principally affecting the elderly. Osteoarthritis therapy has evolved in the past few decades from symptomatic treatment to possible disease-modifying solutions. Osteoarthritis continues to be a difficult disorder to treat, as there is no cure as such and current treatments focus mainly on relieving pain and maintaining joint function. The search nevertheless continues for management regimens that can slow, alter or reverse the degenerative processes of osteoar‐ thritis. Experimental therapies that seek to modify the course of osteoarthritis. These include such medications as colchicine, bisphosphonates and hormones. Dietary therapeutics, such as ginger extract also has been suggested. Current approaches to treating osteoarthritis-i.e. medications; nonpharmacological modalities, such as physical therapy, exercise, weight management and orthotics; and (as a last resort) surgery-focus on reducing pain and improv‐

Musculoskeletal conditions are prevalent and their impact is pervasive. They are the most common cause of severe long-term pain and physical disability. The prevalence of many of these conditions increases markedly with age, and many are affected by lifestyle factors, such as obesity and lack of physical activity. The increasing number of older people and the changes in lifestyle throughout the world mean that the burden on people and society will increase dramatically. This has been recognized by the United Nations and WHO, with their endorse‐ ment of Bone and Joint Decade 2000–2010 [30]. Osteoarthritis was estimated to be the eighth leading non-fatal burden of disease in the world in 1990, accounting for 2.8% of total years of living with disability, around the same percentage as schizophrenia and congenital anomalies [31]. It was the sixth leading cause of years of living with disability at the global level, ac‐ counting for 3% of the total global years of living with disability [32], [33], [34]. According to the American Holistic Medical Association it is believed that the spiritual element should also be taken into account when assessing a person's overall well-being [35], [36]. Ginger is an herb which has been used for centuries in Ayurdevic medicine to relieve the pain of arthritis although few studies are available to demonstrate its benefits. There appears to be good evidence from epidemiological studies and clinical trials that Zingiber officinale and Alpinia galanga tablets lower osteoarthritis tendency. The mechanism of action is believed to be due to the inhibition of prostaglandin and leukotriene synthesis. Zingiber officinale and Alpinia galanga was also tested for antibacterial activities by evaluating growth delays using human strains of the genera Staphylococcus and Micrococcus. Staphylococcus aureus was found to be sensitive to the ginger extract. When the extract was tested for the haemolytic effect, no lytic effects on procaryotic cells were found. Patients suffering from such disorders reported relief

Alpinia galanga tablets under controlled experimental conditions.

**Figure 2.** Knee pain on standing as measured by 100-mm visual analog scale at baseline and after 6 weeks and 12 weeks. Bars shows means with 2 SE (mm)

Additionally blood sample was checked in both groups. There were no statistically significant

changes between groups.


**Table 3.** Comparison of blood samples between both groups in the study.
